As filed with the Securities and Exchange Commission on December 14, 2023
Registration No. 333-275534
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-1
Amendment No. 1
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF 1933
TELOMIR PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Florida |
2834 |
87-2606031 | ||
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification No.) |
855
N Wolfe Street, Suite 601
Baltimore, Maryland 21205
(737) 289-0835
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Dr. Christopher Chapman, Jr.
Chief
Executive Officer
Telomir Pharmaceuticals, Inc.
900 West Platt Street, Suite 200
Tampa, Florida 33606
(737) 289-0835
(Name, address, including zip code, and telephone number including area code, of agent for service)
Copies of all communications, including communications sent to agent for service, should be sent to:
Curt P. Creely Neda Sharifi Foley & Lardner LLP 100 North Tampa Street, Suite 2700 Tampa, Florida 33602 (813) 229-2300 |
Joseph M. Lucosky, Esq. Lucosky
Brookman LLP |
Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”), check the following box. ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ | Accelerated filer ☐ |
Non-accelerated filer ☒ | Smaller reporting company ☒ |
Emerging growth company ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
EXPLANATORY NOTE
This Registration Statement contains two prospectuses as set forth below.
● | Public Offering Prospectus: A prospectus to be used for the initial public offering by the Company of 1,000,000 shares of its common stock through the underwriters named on the cover page, which we refer to as the “Public Offering Prospectus”. | |
● | Resale Prospectus: A prospectus to be used for the potential resale by selling stockholders of up to 6,203,696 shares of common stock of the Company, which we refer to as the “Resale Prospectus”. |
The Resale Prospectus is substantively identical to the Public Offering Prospectus, except for the following principal points:
● | they contain different outside and inside front covers; |
● | they contain different Offering sections in the Prospectus Summary section; |
● | they contain different Use of Proceeds sections; |
● | the Capitalization and Dilution sections are deleted from the Resale Prospectus; |
● | a Selling Stockholders section is included in the Resale Prospectus; |
● | the Underwriting section from the Public Offering Prospectus is deleted from the Resale Prospectus and a Plan of Distribution is inserted in its place; and |
● | the Legal Matters section in the Resale Prospectus deletes the reference to counsel for the underwriters. |
We have included in this Registration Statement, after the financial statements, a set of alternate pages after the back cover page of the Public Offering Prospectus, which we refer to as the “Alternate Pages”, to reflect the foregoing differences in the Resale Prospectus as compared to the Public Offering Prospectus. The Public Offering Prospectus will exclude the Alternate Pages and will be used for the public offering by the registrant. The Resale Prospectus will be substantively identical to the Public Offering Prospectus except for the addition or substitution of the Alternate Pages and will be used for the resale offering by the selling stockholders.
The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell, and it is not soliciting an offer to buy, these securities in any state where the offer or sale is not permitted.
Subject to completion, dated December 14, 2023
PROSPECTUS
1,000,000 Shares
Common Stock
This is the initial public offering of 1,000,000 shares of common stock, no par value, of Telomir Pharmaceuticals, Inc.
Prior to this offering, there has been no public market for shares of our common stock. The assumed initial public offering price is $7.00 per share. We have applied to have shares of our common stock listed on the Nasdaq Capital Market (“Nasdaq”) under the symbol “TELO”. If shares of our common stock are not approved for listing on Nasdaq, we will not consummate this offering. No assurance can be given that our application will be approved.
Unless otherwise noted, the share and per share information in this prospectus reflects a 1-for-2.05 reverse stock split of our common stock that became effective as of December 11, 2023.
We are an “emerging growth company” as defined in the federal securities laws, and, as such, are subject to reduced public company reporting requirements. See “Prospectus Summary — Implications of Being an Emerging Growth Company”.
Investing in shares of our common stock involves risks. See “Risk Factors” beginning on page 11 to read about factors you should consider before buying shares of our common stock.
Neither the Securities and Exchange Commission nor any state securities commission or other regulatory body has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
Per Share | Total | |||||||
Initial public offering price | $ | 7.00 | $ | 7,000,000 | ||||
Underwriting discounts and commissions(1) | $ | 0.49 | $ | 490,000 | ||||
Proceeds, before expenses, to us | $ | 6.51 | $ | 6,510,000 |
(1) | See “Underwriting” for a description of the compensation payable to the underwriters. |
The underwriters have the option for a period of 45 days from the date of this prospectus to purchase up to 150,000 additional shares of our common stock from us at the initial public offering price, less underwriting discounts and commissions. If the underwriters exercise the option in full, the total underwriting discounts and commissions payable by us will be $563,500, and the total proceeds, before expenses, to us will be $7,486,500.
The underwriters expect to deliver the shares to investors on or about , 2023.
Kingswood Investments
division of Kingswood Capital Partners, LLC
The date of this prospectus is , 2023
TABLE OF CONTENTS
Please read this prospectus carefully. It describes our business, financial condition, results of operations and prospects, among other things. We are responsible for the information contained in this prospectus and in any free-writing prospectus we have authorized. Neither we nor the underwriters have authorized anyone to provide you with different information, and neither we nor the underwriters take responsibility for any other information others may give you. Neither we nor the underwriters are making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. The information contained in this prospectus is accurate only as of the date on the front of this prospectus, regardless of the time of delivery of this prospectus or any sale of securities. You should not assume that the information contained in this prospectus is accurate as of any date other than its date.
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We are responsible for the disclosure in this prospectus. However, this prospectus includes industry data that we obtained from internal surveys, market research, publicly available information, and industry publications. We did not fund and are not otherwise affiliated with any of the sources cited in this prospectus. The market research, publicly available information, and industry publications that we use generally state that the information contained therein has been obtained from sources believed to be reliable. The information therein represents the most recently available data from the relevant sources and publications, and we believe remains reliable. However, this data involves a number of assumptions and limitations regarding our industry which are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors.” Forward-looking information obtained from these sources is also subject to the same qualifications and additional uncertainties regarding the other forward-looking statements in this prospectus.
We own or have rights to various trademarks, service marks and trade names that we use in connection with the operation of our business. This prospectus may also contain trademarks, service marks and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks and trade names or products in this prospectus is not intended to, and does not imply a relationship with, or endorsement or sponsorship by us. Solely for convenience, the trademarks, service marks and trade names referred to in this prospectus may appear without the ®, trademark (™) or servicemark (SM) symbols, but the omission of such references is not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable owner of these trademarks, service marks and trade names.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar expressions. In particular, statements about the markets in which we operate, including growth of our various markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance contained in this prospectus under the headings “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business” are forward-looking statements.
We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed in this prospectus under the headings “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” may cause our actual results, performance, or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share price. Important factors that could cause actual results or events to differ materially from those expressed in forward-looking statements include, but are not limited to, the following:
● | our use of the net proceeds from this offering; | |
● | our ability to obtain and maintain regulatory approval of our product candidates; | |
● | our ability to successfully commercialize and market our product candidates, if approved by the FDA; | |
● | our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately; | |
● | the potential market size, opportunity, and growth potential for our product candidates, if approved by the FDA; |
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● | our ability to obtain additional funding for our operations and development activities; | |
● | the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing; | |
● | the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; | |
● | the timing of anticipated regulatory filings; | |
● | the timing of availability of data from our clinical trials; | |
● | our future expenses, capital requirements, need for additional financing, and the period over which we believe that the net proceeds from this offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements; | |
● | our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; | |
● | our ability to advance product candidates into, and successfully complete, clinical trials; | |
● | our ability to recruit and enroll suitable patients in our clinical trials; | |
● | the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives; | |
● | the pricing and reimbursement of our product candidates, if approved by the FDA; | |
● | the rate and degree of market acceptance of our product candidates, if approved by the FDA; | |
● | the implementation of our business model and strategic plans for our business, product candidates, and technology; | |
● | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; | |
● | developments relating to our competitors and our industry; | |
● | the development of major public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the future impact of it and COVID-19 on our clinical trials, business operations and funding requirements; and | |
● | other risks and factors listed under “Risk Factors” and elsewhere in this prospectus. |
Given the risks and uncertainties set forth in this prospectus, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements contained in this prospectus are not guarantees of future performance and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this prospectus. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate, are consistent with the forward-looking statements contained in this prospectus, they may not be predictive of results or developments in future periods.
Any forward-looking statement that we make in this prospectus speaks only as of the date of such statement. Except as required by federal securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this prospectus.
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GLOSSARY OF CERTAIN SCIENTIFIC TERMS
The following medical and scientific terms used in this prospectus have the following meanings:
“Antineoplastic drugs” are medications used to treat cancer, also known as chemotherapies.
“API” stands for Active Pharmaceutical Ingredient, which is the main ingredient in a medicine that causes the desired effect of the medicine.
“AMES test” is a biological assay to assess the mutagenic potential of chemical compounds. It utilizes bacteria to test whether a given chemical can cause mutations in the DNA of the test organism.
“C282Y” is a gene mutation associated with hereditary hemochromatosis.
“CDMO” stands for Contract Development and Manufacturing Organization, a specialized type of supplier of development and production services to the pharmaceutical industry.
“cGMP” is the current Good Manufacturing Practices under the US Food and Drug Administration’s standards. cGMP contains the minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a drug product. The regulations make sure that a product is manufactured under conditions and tested to ensure that it meets standards of identity, strength, quality, and purity.
“CMC” stands for chemistry, manufacturing, and controls and covers the various procedures used to assess the physical and chemical characteristics of drug products, and to ensure their quality and consistency during manufacturing.
“CYP” stands for cytochrome P450 enzymes, which are a complex and important component of drug metabolism. It is the root of many drug interactions due to inhibition, induction, and competition for common enzymatic pathways by different drugs.
“Cytokines” are a broad category of small proteins that are important in cell signaling. The release of pro-inflammatory cytokines leads to activation of immune cells and production of and release of additional cytokines.
“DNA” is the molecule that carries genetic information for the development and functioning of an organism.
“FDA” is the U.S. Food and Drug Administration.
“GMP” is good manufacturing practice – a standard that is observed in regulated pharmaceutical-manufacturing facilities.
“H63D” is a gene mutation associated with hereditary hemochromatosis.
“HFE gene” is a gene that provides instructions for producing a protein that is located on the surface of cells, primarily liver and intestinal cells.
“Hereditary Hemochromatosis” a genetic disorder that can cause severe liver disease and other health problems.
“IL-17” or Interleukin-17 is a pro-inflammatory cytokine that modulates protective innate immunity to pathogens or contributes to the pathogenesis of inflammatory conditions.
“In situ” means in the original or normal place.
“Iron Overload” is a condition in which your body stores too much iron.
“Maximum tolerated dose” is the highest dose of a drug or treatment that does not cause unacceptable side effects. The maximum tolerated dose is determined in clinical trials by testing increasing doses on different subjects until the highest dose with acceptable side effects is found.
“Metabolite” is a substance made or used when the body breaks down food, drugs or chemicals, or its own tissue.
“mTOR” stands for mammalian target of rapamycin which regulates cell proliferation, autophagy, and apoptosis by participating in multiple signaling pathways in the body.
“Pluripotent stem cells” are stem cells that are able to self-renew by dividing and developing into primary groups of cells that make up the human body.
“qPCR” stands for quantitative polymerase chain reaction (qPCR). qPCR is the accumulation of amplification product is measured as the reaction progresses, in real time, with product quantification after each cycle.
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The following summary highlights selected information about our company and this offering that is included elsewhere in this prospectus in greater detail. It does not contain all of the information that you should consider before investing in our common stock. Before investing in our common stock, you should read this entire prospectus carefully, including the information presented under the heading “Risk Factors” and in our financial statements and notes thereto.
Unless otherwise noted, the share and per share information in this prospectus reflects a 1-for-2.05 reverse stock split of our common stock that became effective as of December 11, 2023.
In this prospectus, unless we indicate otherwise or the context requires, “Telomir,” “the company,” “our company,” “we,” “our,” “ours” and “us” refer to Telomir Pharmaceuticals, Inc.
Business Summary
Overview
We are a pre-clinical-stage pharmaceutical company focused on the development and commercialization of TELOMIR-1, a novel small molecule being developed to function as an oral in situ therapeutic treatment for human stem cells. Based on our pre-clinical studies and if approved by the FDA and comparable foreign regulators, we believe that TELOMIR-1 may potentially serve as a metal enzyme inhibitor of essential metals such as zinc and copper. These essential metals play an important role in the production and function of many enzymatic reactions and the modulation of key cellular pathways. In particular, zinc is essential to the function of pro-inflammatory cytokines such as Interleukin-17, or IL-17, that play a role in a host of age-related inflammatory conditions such as hemochromatosis and osteoarthritis as well as in post-chemotherapy health problems. IL-17 is a type of pro-inflammatory cytokine, and while the pro-inflammatory properties of IL-17 are key to its host-protective capacity, unrestrained IL-17 signaling is associated with immunopathology, inflammatory disease and cancer progression. Our initial focus will be on treatments to inhibit the production of pro-inflammatory cytokines, such as IL-17, by oral administration of TELOMIR-1 as a therapeutic treatment for stem cells in situ. To the best of our knowledge, there is no approved oral IL-17 inhibitor. Our goal is to advance the clinical development of TELOMIR-1 in the United States for the treatment of age-related inflammatory conditions such as hemochromatosis and osteoarthritis, as well as in post-chemotherapy recovery, with our initial targeted indications being hemochromatosis and post-chemotherapy recovery.
Pluripotent stem cells are a type of stem cells that have the ability to undergo self-renewal and to give rise to various cell types of the tissues of the body. Based on pre-clinical studies, we believe that TELOMIR-1 may have the potential to protect stem cells in situ by reducing the overload of metals such as zinc and copper that accompany age-related inflammatory conditions and certain cancers by modulating pro-inflammatory cytokines such as IL-17. If demonstrated by future clinical trials and approved by the FDA and comparable foreign regulators, we believe TELOMIR-1 may protect the stem cells by elongating and stimulating the telomeres to sustain self-renewal of stem cells. Telomeres are repetitive DNA sequences at the end of chromosomes that protect the chromosomes from becoming frayed or tangled. Each time a cell divides, the telomeres become slightly shorter, and eventually they become so short that the cell can no longer divide, with the result being that the cell dies. Effectively, telomeres protect the ends of our chromosomes by forming a cap, much like the plastic tip on shoelaces, thereby allowing the chromosome to be replaced properly during cell division.
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TELOMIR-1 is currently under investigation to provide a potential therapeutic intervention against age-related inflammatory conditions such as hemochromatosis, as well as for post-chemotherapy recovery, by interrupting and preventing the IL-17 induced inflammatory pathways that create the systemic imbalance of cellular metals. Our pre-clinical studies suggest that TELOMIR-1 may inhibit the concentration and accumulation of metals such as zinc and copper in the serum that drive the hyperactivity of pro-inflammatory cytokines such as IL-17. Our studies suggest that TELOMIR-1 may achieve this outcome by selectively binding to metal ions in a dose dependent manner, slowing enzyme reactivity, and protecting and lengthening telomeres in the human chromosome. If demonstrated in clinical trials and approved by the FDA and comparable foreign regulators, we believe that TELOMIR-1 has potential as a non-toxic oral enzyme inhibitor that may regulate the overactivity of the enzymes caused by excessive metal reactivity.
We were organized as a Florida corporation in August 2021 for the purpose of pursuing the development and commercialization of TELOMIR-1 in the United States in human applications. We were originally incorporated under the name “Metallo Therapies Inc.” and changed our name to “Telomir Pharmaceuticals, Inc.” in October 2022. We are an early-stage company that had net losses of $0.14 million and $0.85 million for the years ended December 31, 2021 and 2022, respectively.
In Situ Therapeutic Treatment of Stem Cells
Stem cells have the potential to renew themselves. They can develop into many different cell types in the body during early and adult life. Pluripotent stem cells have the ability to differentiate into all of the cells of the adult body. Since pluripotent stem cells are undifferentiated, they do not have any tissue-specific characteristics that allow them to perform specialized functions. Given their unique regenerative abilities and limited quantities in the adult human body, in situ treatment and protection of stem cells may provide an important therapeutic mechanism for treatment of disease.
Metal Overload and Telomere Length
Research studies have demonstrated that metal overload in stem cells could severely impair the proliferation of pluripotent stem cells through excessive DNA damage. Furthermore, many pro-inflammatory cytokine-induced conditions create an imbalance of cellular metals such as zinc and copper. This metal imbalance may impact the length of telomeres in stem cells and impact their ability to sustain self-renewal.
Hemochromatosis
According to the CDC, hemochromatosis is a disorder in which the body builds up too much iron in the skin, heart, liver, pancreas, pituitary glands, and joints. This overload of iron is toxic to the body, and over time, the high levels of iron can damage tissues and organs and lead to conditions such as liver damage, liver cancer, heart problems, arthritis, and diabetes. Other conditions associated with high iron levels include inflammatory conditions, chronic kidney disease, and autoimmune disorders. Hemochromatosis is a life-long condition requiring regular treatment to avoid long-term serious effects with poor pharmacologic options. The most used treatment for hemochromatosis is phlebotomy, a procedure to remove some of the patient’s blood. Phlebotomy is relatively inexpensive, well accepted, and well tolerated, but it requires regular visits to health care professionals and blood draws and may not be appropriate for all patients. Additionally, iron chelators, which are molecules that bind to iron to help the body excrete it, are sometimes used, but they have limited use due to gastrointestinal and kidney toxicity issues. Iron chelators can be natural or synthetic and are used to treat iron overload, which can occur after regular blood transfusions. Despite the presence of these potential treatment options, we believe significant unmet need remains such that an innovative therapy achieving reduction in iron overload with a new profile could be subject to widespread use.
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We are pursuing TELOMIR-1 as a metal enzyme inhibitor that, if approved by the FDA and comparable foreign regulators, may selectively bind metal ions to inhibit pro-inflammatory cytokines such as IL-17 and protect telomeres and that aims to increase the average telomere length, or ATL, by selectively binding iron and reducing blood iron levels, therefore supporting the ability to treat hemochromatosis. On average, about 750,000 US patients express one or more iron overload symptoms. There are 2 types of hemochromatosis, with the following patient mix: 150,000 primary hemochromatosis and 65,000 secondary hemochromatosis confirmed diagnoses in the United States. Over 150,000 patients have sought treatment since 2018, with most receiving phlebotomy, which is the withdrawal of blood to bring iron to normal levels. At present, 99% of hemochromatosis patients receive phlebotomy, with a portion of patients also receiving iron chelators as a co-treatment. Note that in the last 12 months, there have been 76,000 confirmed diagnoses of hereditary hemochromatosis and approximately 1% of hemochromatosis patients received deferasirox or deferoxamine off-label for 12 weeks (1 year for primary).
Certain sub-groups of hemochromatosis patients may benefit from TELOMIR-1, in addition to phlebotomy, which is the current standard of care for the treatment of hemochromatosis, if contraindicated for this treatment method. Lastly, iron chelation is used off-label, poorly tolerated and has toxic long-term effects. In pre-clinical stage testing, TELOMIR-1 may have more effective metal complexing than Doxycycline, an FDA-approved metalloproteinases (“MMP”) inhibitor. However, pre-clinical data may prove inaccurate and is not necessarily indicative of future results. MMP inhibitors act as “brakes” for enzymes in our body. MMP enzymes sometimes become too active and break down compounds and structures they should not, such as the body’s tissues. MMP inhibitors are compounds that typically slow down or stop these overactive enzymes, preventing them from causing damage to our tissues. They act as a control switch to keep the body in balance and protect it from harm.
Post-Chemotherapy Recovery
Post-chemotherapy recovery from adverse effects of antineoplastic treatments is often important for cancer therapy success. While chemotherapy treatment can be highly effective for cancer, it can also come with many side effects, as chemotherapy drugs destroy both cancerous and healthy cells. We are investigating the use of TELOMIR-1 as a potential complementary treatment for patients receiving chemotherapy in the form of a twice daily, oral regimen to inhibit pro-inflammatory cytokines and to reduce blood iron levels, enabling potentially more effective adherence and improved outcomes. In exploratory early discovery studies, proof of concept was demonstrated, and the animal studies are pending. Post-chemotherapy recovery space contains several treatments that are used symptomatically based on the nature or severity of side effects.
We believe that post-chemotherapy recovery presents several potential unmet commercial needs for TELOMIR-1. There is potential to enable a more rapid recovery of patients receiving chemotherapy, improving adherence with chemotherapy regimens. Additionally, as current recovery management is based on severity and treated as needed, we believe that TELOMIR-1 could potentially be used as a preventative measure. As a complementary treatment, side effect reduction in post-chemotherapy is important to minimize patient burden while improving treatment outcomes.
Our Strategy
Our goal is to develop and commercialize new treatment options for treatment of age-related inflammatory conditions, with hemochromatosis as our initial clinical focus, and to thereafter expand the development of TELOMIR-1 to post-chemotherapy recovery as well as a broader range of other age-related inflammatory diseases and conditions such as osteoarthritis. The key elements of our strategy to achieve this goal include:
● | Advancing TELOMIR-1 through clinical development and approval for hemochromatosis. | |
● | Continuing pre-clinical development of TELOMIR-1 for post-chemotherapy recovery and across a range of inflammatory diseases associated with cellular aging. | |
● | Exploring strategic collaborations to maximize the value of TELOMIR-1. |
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Pre-Clinical Studies
To date, we have completed several pre-clinical proof-of-concept studies with respect to TELOMIR-1 that were designed to demonstrate that TELOMIR-1 is not mutagenic and has good biological and metal binding capabilities. These studies included an Ames test for the TELOMIR-1 compound and several Eurofins BioMap studies. Eurofins BioMAP studies are scientific experiments that help with understanding how different chemicals or drugs impact the human body. These in vitro studies use cells and tissues to see how they react when exposed to various substances. BioMAP studies may demonstrate the safety and efficacy of drugs and chemicals in treatment of diseases. They assist researchers in assessing whether a substance, at microscopic level, has a positive or negative impact on health of the subject by studying how it interacts within the cells or with other cells. The Ames test assesses whether a chemical or substance causes DNA mutations. Scientists use this test to figure out if a chemical might be harmful and could potentially cause cancer because DNA mutations are often linked to cancer.
The Eurofins in vitro studies showed that TELOMIR-1 was more active against malignant cells, colorectal cancer cells, and lung cancer cells than rapamycin. Rapamycin is a compound that has anti-tumor and immunosuppressive properties, and it was selected to compare against TELOMIR-1 because rapamycin and TELOMIR-1 both inhibit similar cytokines involved in immune responses. Several pro-inflammatory cytokines are common proteins that are affected by TELOMIR-1 and rapamycin. Rapamycin is also known by the brand names Rapamune and Sirolimus. It is a mammalian target of rapamycin (mTOR) inhibitor which works by slowing down cellular multiplication. mTOR inhibitors have been associated with anemia (a condition characterized by a low red blood cell count or low hemoglobin levels) due to a change in iron metabolism. Rapamycin is used to prevent organ transplant rejection and to treat certain types of cancer. mTORs regulates cell proliferation, autophagy, and apoptosis by participating in multiple signaling pathways in the body.
Doxycycline possesses anti-inflammatory properties that are in part attributed to its ability to chelate metal ions such as zinc, which are involved in the enzymatic processes related to inflammation. In particular, doxycycline has been shown to inhibit the TNF-α Converting Enzyme (TACE) as this enzyme requires zinc to function. Inhibition of TACE in turn leads to decreased systemic levels of the active TNF-α, which is implicated in inflammation and autoimmune diseases. This action contributes to the anti-inflammatory properties of doxycycline, which are beneficial in diseases such as rheumatoid arthritis and inflammatory skin conditions.
Similar to doxycycline, TELOMIR-1 is also a metal ion chelating drug, which underlies its ability to inhibit TACE by competing for the zinc that is required for its enzymatic activity. Both Doxycycline and TELOMIR-1inhibit the enzymatic activity of TACE which plays a key role in both acute and chronic inflammation.
Thus, doxycycline is a reasonable choice for comparison with TELOMIR-1 since, similar to doxycycline TELOMIR-1 is believed to exert its anti-inflammatory effects by inhibiting TACE in the same manner as doxycycline.
Other studies showed that, in comparison to Doxycycline, TELOMIR-1 was more active at metal complexing. Extensive analysis is being conducted on the potential of TELOMIR-1 to protect and treat stem cells and lower blood ferritin. We have also completed a variety of toxicology studies, and several others are ongoing or planned. Upon completion of the toxicology studies, we plan to submit to the FDA an Investigational New Drug application, IND for TELOMIR-1, focused on investigating TELOMIR-1 for the treatment of hemochromatosis. We may consider a second IND for post-chemotherapy recovery. All pre-clinical studies described in this prospectus were conducted with the assistance of third parties. For a summary of completed, ongoing, and planned pre-clinical studies and development activities, see the section entitled “Business—Pre-Clinical Studies.”
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Our Clinical Development Plan
Following completion of our pre-clinical development program, we plan to submit to the FDA an IND, focused on investigating TELOMIR-1 for the treatment of hemochromatosis. We may consider a second IND for post-chemotherapy recovery.
Our first IND application submission investigating TELOMIR-1 for the treatment of hemochromatosis is currently planned for the third quarter of 2024. If allowed to proceed by the FDA, a Phase I double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of TELOMIR-1 in 40-60 healthy male and female adult subjects will be initiated approximately 30 days post-IND submission. We have contracted with Frontage Laboratories Phase I clinic in New Jersey consisting of 160 beds across three units for normal volunteers. After the Phase I trial is complete, a Phase II trial in the hemochromatosis population is planned to commence after results and guidance from the FDA.
Our second IND application will likely focus on investigating TELOMIR-1 for the treatment of post-chemotherapy recovery and is planned for submission with guidance from the FDA. Additionally, osteoarthritis may be considered as a future contender with additional guidance from the FDA.
Our clinical development plans will depend on FDA acceptance of our IND applications. As appropriate and pursuant to discussions with the FDA, we may periodically adjust the timeline for certain filings and associated clinical trials. It is important to note that the process for conducting clinical trials is uncertain and there is no assurance that our clinical development activities will meet the planned timelines set forth above.
Intellectual Property
We license the U.S. patent rights for the use of TELOMIR-1 in human applications from MIRALOGX, LLC (“MIRALOGX”), an intellectual property development and holding company established by Jonnie R. Williams, Sr., the founder of our company and the sole inventor of TELOMIR-1. MIRALOGX has filed a Patent Cooperation Treaty (PCT) application, PCT/US2023/073106 on August 29, 2023. The application designated the U.S. and will enter U.S. national phase. The application, if granted and subject to payment of patent maintenance fees, would offer protection extending through at least August 29, 2043 in the U.S. The patent rights for TELOMIR-1 outside of the United States are not included in our current patent rights. Mr. Williams, our founder, does not hold any formal degrees in chemistry or certifications related to the development of pharmaceuticals; however, he developed extensive knowledge of tobacco alkaloid chemistry in the 1990’s through collaboration with industry experts during his development of techniques for preventing the formation of carcinogenic tobacco-specific nitrosamines (TSNAs) during the tobacco curing process. To better understand the mechanism by which TSNAs are formed, Mr. Williams collaborated closely with a leading expert in tobacco chemistry at the University of Kentucky, where he developed a working knowledge of tobacco alkaloid chemistry, which led to his development of patented curing technologies which would become the industry standard. This work led to him focusing on the therapeutic properties of tobacco alkaloids, and later to his design of novel small molecule therapeutics. He is a named inventor on 31 issued US patents and approximately 30 pending or published US patent applications, all of which are in the life sciences, a field that embraces the study of living organisms, including biology, botany, zoology, and biochemistry. Approximately 20 of his issued patents and 27 of his applications involve therapeutic treatment methods, and 4 issued patents and approximately 18 applications are directed to novel small molecules, principally involving alkaloid and cannabinoid chemistries. His work on TELOMIR-1 began in late 2020.
Our license from MIRALOGX is set forth in an Amended and Restated Exclusive License Agreement, dated August 11, 2023, between the Company and MIRALOGX, pursuant to which we obtained the exclusive perpetual right and license under the above-described patent rights to make, have made, use, and sell “Licensed Products” in the U.S. for human uses and pre-clinical studies and activities of any kind conducted in furtherance of obtaining regulatory approval or commercialization for human uses (the “Initial MIRALOGX License Agreement”). On November 10, 2023, we and MIRALOGX entered into the Amendment No. 1 to the Amended and Restated License Agreement, pursuant to which the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals, in addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and commercialization of veterinary, in addition to human, therapeutic treatments and uses (together with the “Initial MIRALOGX License Agreement, the “MIRALOGX License Agreement”). “Licensed Product” is defined in the agreement as a drug product containing as an active agent 2,4,6-tris(3,4-dihydro-2H-pyrrol-2-yl)pyridine or a pharmaceutically acceptable salt, ester, or solvate thereof. We also have the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement provides for the payment to MIRALOGX of an 8% royalty (payable quarterly) on our net sales of Licensed Products by us or our sublicensees and on non-royalty bearing milestone revenue. There are no up-front, execution, or milestone payments in the license agreement. Further, no payments have been made to date under the agreement. For a more detailed description of the MIRALOGX License Agreement, see the section entitled “Business—Intellectual Property.”
5 |
Summary Risk Factors
There are a number of risks that you should understand before making an investment decision regarding this offering. These risks are discussed more fully in the section entitled “Risk Factors” following this prospectus summary. If any of these risks actually occur, our business, financial condition, or results of operations would likely be materially and adversely affected. In such a case, the trading price of our common stock would likely decline, and you may lose all or part of your investment. These risks include, but are not limited to:
● | We are an early development-stage company with no revenues. | |
● | Management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in their audit report for the year ended December 31, 2022. | |
● | Because we have a limited operating history, you may not be able to accurately evaluate our operations. | |
● | We are dependent on additional financing for the continuation of our operations. | |
● | Our operating results may fluctuate, which could have a negative impact on our ability to grow our client base, establish sustainable revenues and succeed overall. | |
● | We have yet to achieve a profit and may not achieve a profit in the near future, if at all. | |
● | Certain of our executive officers, including our Chief Executive Officer and Chairman of our board of directors, Dr. Christopher Chapman, will not be employed by us on a full-time basis and will working for us on a part-time and as-needed basis. | |
● | Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with other companies. | |
● | Conflicts of interest may arise between us and MIRALOGX. | |
● | Our future success will largely depend on the success of TELOMIR-1 and any future product candidates, which development will require significant capital resources and years of clinical development effort. | |
● | We are dependent on the success of our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized. | |
● | Our business may be materially and adversely affected in the future by the evolving effects of the COVID-19 pandemic as a result of the current and potential future impacts on our commercialization efforts, supply chain, regulatory and clinical development activities, and other business operations, in addition to the impact of a global economic slowdown. | |
● | Results of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results. | |
● | Should we later determine it is in our best interest to develop a sales force we may be unable to effectively train and equip our sales force, therefore our ability to successfully commercialize our products may be harmed. | |
● | Our product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate revenue from new products. | |
● | If the price for any future approved products decreases or if government and other third-party payers do not provide coverage and adequate reimbursement levels, our revenue and prospects for profitability will suffer. | |
● | We expect to face intense competition, often from companies with greater resources and experience than we have. |
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● | Business interruptions could delay us in the process of developing our product candidates and could disrupt our product sales. | |
● | We have significant and increasing liquidity needs and may require additional funding. | |
● | Operating results may vary significantly in future periods. | |
● | If product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the commercialization of TELOMIR-1 and our product candidates. | |
● | We depend upon our key personnel and our ability to attract and retain employees. | |
● | Failure of our information technology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt the operation of our business. | |
● | Security breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing critical information or expose us to liability, which could adversely affect our business and our reputation. | |
● | Legislative or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved. | |
● | We expect additional federal and state legislative proposals for health care reform, which could limit the prices that can be charged for the products we develop and may limit our commercial opportunity. | |
● | We may acquire other companies which could divert our management’s attention, result in additional dilution to our shareholders and otherwise disrupt our operations and harm our operating results. | |
● | Clinical trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results of clinical trials are open to differing interpretations. | |
● | Any failure by us to comply with existing regulations could harm our reputation and operating results. | |
● | The regulatory approval processes with the FDA are lengthy and inherently unpredictable. | |
● | There is a high rate of failure for drug candidates proceeding through clinical trials. | |
● | Our existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates. | |
● | We maintain our cash at financial institutions, at times in balances that exceed federally insured limits. The failure of financial institutions could adversely affect our ability to pay operational expenses or make other payments. | |
● | We may not be able to adequately protect our product candidates or our proprietary technology in the marketplace. | |
● | If third parties claim that the Company’s intellectual property, products, processes, or anything else used by us infringes upon their intellectual property, our operating profits could be adversely affected. | |
● | Because of the speculative nature of investment risk, you may lose your entire investment. |
7 |
Implications of Being an Emerging Growth Company
As a company with less than $1.235 billion in annual gross revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in Section 2(a) of the Securities Act of 1933, as amended (the “Securities Act”). An emerging growth company may take advantage of specified reduced reporting and other requirements that are otherwise applicable generally to public companies. These provisions include:
● | we are required to present only two years of audited financial statements and related management’s discussion and analysis of financial condition and results of operations in the registration statement of which this prospectus is a part; | |
● | we are exempt from compliance with the requirement that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting; | |
● | we are exempt from compliance with any requirement that the Public Company Accounting Oversight Board (the “PCAOB”) has adopted regarding communication of critical accounting matters and may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; | |
● | we are exempt from the “say on pay,” “say when on pay,” and “say on golden parachute” non-binding advisory vote requirements; and | |
● | we can provide reduced disclosures about our executive compensation arrangements. |
We currently intend to take advantage of each of the exemptions described above. It is possible, therefore, that some investors will find our common stock less attractive, which may result in a less active trading market for our common stock and higher volatility in our stock price.
We may take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the completion of this offering or such an earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earliest of: (i) the last day of the first fiscal year in which our annual gross revenues are $1.235 billion or more; (ii) the date on which we have, during the previous three-year period, issued more than $1 billion in non-convertible debt securities; or (iii) the date on which we are deemed to be a “large accelerated filer,” which will occur as of the end of any fiscal year in which we (x) have an aggregate market value of our common stock held by non-affiliates of $700 million or more as of the last business day of our most recently completed second fiscal quarter, (y) have been required to file annual and quarterly reports under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), for a period of at least 12 months and (z) have filed at least one annual report pursuant to the Exchange Act.
In addition, emerging growth companies may take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We intend to take advantage of the benefits of this extended transition period. For risks related to our status as an emerging growth company, see “Risk Factors — Risks Related to Ownership of Our Common Stock — Taking advantage of the reduced disclosure requirements applicable to “emerging growth companies” may make our common stock less attractive to investors.”
Implications of Being a Smaller Reporting Company
We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of any fiscal year for so long as either: (i) the market value of our shares of common stock held by non-affiliates does not equal or exceed $250 million as of the prior June 30th; or (ii) our annual revenues did not equal or exceed $100 million during such completed fiscal year. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.
Reverse Stock Split
Effective December 11, 2023, we completed a reverse stock split of our outstanding common stock upon the filing of our Second Amended and Restated Articles of Incorporation with the Florida Secretary of State. No fractional shares were or will be issued in connection with the reverse stock split, and all such fractional shares resulting from the reverse stock split were and will be rounded up to the nearest whole number. Unless otherwise noted, the shares issuable upon the exercise of our outstanding warrants, and the exercise prices of such warrants, have been adjusted to reflect the reverse stock split. Unless otherwise noted, the share and per share information in this prospectus reflects the reverse stock split.
Corporate Information
Our corporate headquarters is located at 855 N Wolfe Street, Suite 601, Baltimore, Maryland 21205. Our telephone number is (737) 289-0835.
Our website address is www.telomirpharma.com. The information contained on, or that can be accessed through, our website is deemed not to be incorporated in this prospectus or to be part of this prospectus. You should not consider information contained on our website to be part of this prospectus.
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The Offering
Common stock offered by us | 1,000,000 shares. | |
Initial public offering price | The assumed initial public offering price is $7.00 per share. | |
Shares of common stock outstanding before this offering (1) | 28,609,814 shares. | |
Shares of common stock to be outstanding immediately after this offering | 29,609,814 shares (or 29,759,814 shares if the underwriters exercise the option to purchase additional shares from us in full. See “Over-allotment Option” below). | |
Over-allotment Option | We have granted the underwriters an option exercisable for a period of 45 days from the date of this prospectus to purchase from us in whole or in part and at any time or from time to time up to 150,000 additional shares of common stock, solely to cover overallotments, if any, at a purchase price equal to the initial public offering price less underwriting discounts and commissions. | |
Use of proceeds | We estimate that we will receive net proceeds from the sale of shares of our common stock in this offering of approximately $5.9 million, assuming an initial public offering price of $7.00 per share, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering to advance the clinical development of our programs, to fund our research and development activities, and for working capital and general corporate purposes. In order to advance our clinical development programs, we plan to use an estimated $3.2 million. Our management will have broad discretion in the application of the net proceeds from this offering and investors will be relying on the judgment of our management regarding the application of the proceeds. See “Use of Proceeds.” | |
Lock up | Our directors and officers, our initial stockholders holding an aggregate of 26,332,026 shares of our common stock (the “Initial Stockholders”), and other shareholders who beneficially own 3% or more of the outstanding shares of our common stock have agreed with not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any of our common stock or securities convertible into common stock for a period of 180 days (or 365 days for the Initial Stockholders), commencing on the date of this prospectus, except with the prior written consent of the underwriters. | |
Representative’s warrants | We have agreed to issue to the representative of the underwriters or its designees at the closing of this offering, warrants to purchase the number of shares of our common stock equal to 5.0% of the aggregate number of shares sold in this offering (the “Representative’s Warrants”). The Representative’s Warrants will be exercisable at any time and from time to time, in whole or in part, during the four-and-a-half-year period commencing six months after the commencement of sales in this offering. The exercise price of the Representative’s Warrants will equal 100% of the initial public offering price per share, subject to adjustments. The Representative’s Warrants provide for registration rights (including a one-time demand registration right and piggyback registration rights that expire 5 years from the commencement of sales of the offering) and customary anti-dilution provisions as permitted under FINRA Rule 5110(g)(8). The registration statement of which this prospectus is a part also covers the Representative’s Warrants and the shares of common stock issuable upon the exercise thereof. | |
Proposed Nasdaq Capital Market Symbol | We have applied to list our shares of common stock on Nasdaq under the symbol “TELO”. No assurance can be given that our listing will be approved by Nasdaq or that a trading market will be approved by Nasdaq or that a trading market will develop for the common stock. We will not proceed with this offering in the event the common stock is not approved for listing on Nasdaq. | |
Risk factors | Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 11 of this prospectus for a discussion of factors you should carefully consider before investing in our common stock. |
(1) | The number of shares of our common stock to be outstanding immediately after this is based on an aggregate of 28,609,814 shares of our common stock outstanding as of December 12, 2023, which excludes: |
● | 6,500,000 shares of our common stock reserved for future issuance under the Telomir Pharmaceuticals, Inc. 2023 Omnibus Incentive Plan, as well as any automatic increases in the number of shares of common stock reserved for future issuance under such plan: | |
● | 268,025 shares of our common stock to be issued upon the exercise of outstanding warrants at an exercise price of $15.42 per share; and | |
● | 2,506,035 shares of our common stock to be issued upon the exercise of outstanding warrants at an exercise price of $3.73 per share. |
Unless the context otherwise requires, the information presented in this prospectus assumes the following: |
● | that the shares of our common stock to be sold in this offering are sold at the assumed initial public offering price of $7.00 per share; | |
● | no exercise by the underwriters of their over-allotment option; and | |
● | no exercise by the Representative of the Representative’s Warrants. |
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Summary Financial Data
The following tables summarize our financial data as of the dates and for the periods presented. We have derived the summary statements of operations data for the years ended December 31, 2022 and 2021, and the balance sheet data as of December 31, 2022 and 2021, from our audited financial statements included elsewhere in this prospectus. We have derived the summary statement of operations data for the three months ended September 30, 2023 and 2022, and the balance sheet data as of September 30, 2023 and 2022, from our unaudited financial statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected in the future.
The following summary financial and other data should be read in conjunction with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included elsewhere in this prospectus.
Statement of Operations data:
Three Months Ended September 30, | Year Ended December 31 | |||||||||||||||
2023 | 2022 | 2022 | 2021 | |||||||||||||
Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
Operating costs: | ||||||||||||||||
General and administrative expenses | 102,191 | 3,750 | 20,941 | 11,639 | ||||||||||||
Related party travel costs | 589,400 | - | - | - | ||||||||||||
Research and development expenses | 262,562 | 229,747 | 833,206 | 126,492 | ||||||||||||
Total operating costs | 954,153 | 233,497 | 854,147 | 138,131 | ||||||||||||
Interest expense | (757,173 | ) | - | - | - | |||||||||||
Net loss | $ | (1,711,326 | ) | $ | (233,497 | ) | $ | (854,147 | ) | $ | (138,131 | ) |
Balance Sheet data:
September 30, | December 31, | December 31, | ||||||||||
2023 | 2022 | 2021 | ||||||||||
ASSETS | ||||||||||||
Current assets: | ||||||||||||
Cash | $ | 2,452 | $ | 1,419 | $ | - | ||||||
Deferred offering costs | 102,894 | 47,311 | - | |||||||||
Prepaid expenses | 963 | - | - | |||||||||
Due from related parties | 130,000 | - | - | |||||||||
Total other current assets | 236,309 | 48,730 | - | |||||||||
Deferred Financing Costs | 5,082,292 | - | - | |||||||||
Total assets | $ | 5,318,601 | $ | 48,730 | $ | - | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||||||
Current liabilities: | ||||||||||||
Trade accounts payable and accrued liabilities | $ | 496,027 | $ | 404,221 | $ | 18,735 | ||||||
Accrued Interest | 13,517 | - | - | |||||||||
Due to related parties | 1,293,070 | 581,787 | 119,396 | |||||||||
Related party line of credit | 1,337,914 | - | - | |||||||||
Total current liabilities | 3,140,528 | 986,008 | 138,131 | |||||||||
Total liabilities | 3,140,528 | 986,008 | 138,131 | |||||||||
Stockholders’ Equity (Deficit) | ||||||||||||
Preferred Stock, no par value, 100,000,000 shares authorized and none issued or outstanding. | - | - | - | |||||||||
Common Stock, no par value; 300,000,000 shares authorized, 27,097,294 and 26,829,269 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively. | - | - | - | |||||||||
Additional paid-in capital | 6,915,000 | 55,000 | 55,000 | |||||||||
Accumulated deficit | (4,736,927 | ) | (992,278 | ) | (138,131 | ) | ||||||
Stock subscription receivable | - | - | (55,000 | ) | ||||||||
Total stockholders’ equity (deficit) | 2,178,073 | (937,278 | ) | (138,131 | ) | |||||||
Total liabilities and stockholders’ deficit | $ | 5,318,601 | $ | 48,730 | $ | - |
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Investing in shares of our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, the section of this prospectus entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included elsewhere in this prospectus before investing in shares of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the following risks occur, our business, operating results and prospects could be materially harmed. In that event, the price of our common stock could decline, and you could lose part or all of your investment.
Risks Related to Our Operations and Financial Condition
We are an early development-stage company with no revenues.
As an early development-stage enterprise that is focused on the development of a pre-clinical pharmaceutical product, we have generated no revenue and have an accumulated deficit of $4.7 million through September 30, 2023, and $1.0 million through December 31, 2022. There can be no assurance that sufficient funds required to pursue our development program will be generated from operations or that funds will be available from external sources, such as debt or equity financings or other potential sources. The lack of additional capital resulting from the inability to generate cash flow from operations, or to raise capital from external sources would force us to substantially curtail or cease operations and would, therefore, have a material adverse effect on business. Furthermore, there can be no assurance that any such required funds, if available, will be available on attractive terms or that they will not have a significant dilutive effect on our existing stockholders.
We seek to overcome the circumstances that impact our ability to remain a going concern in the future through the growth of revenues with interim cash flow deficiencies being addressed through additional equity and debt financing. We anticipate raising additional funds through public or private financing, strategic relationships, or other arrangements in the near future to support our business operations; however, we may not have commitments from third parties for a sufficient amount of additional capital. We cannot be certain that any such financing will be available on acceptable terms, or at all, and our failure to raise capital when needed could limit our ability to continue operations. Our ability to obtain additional funding will determine our ability to continue as a going concern. Failure to secure additional financing in a timely manner and on favorable terms would have a material adverse effect on our financial performance, results of operations and stock price and require us to curtail or cease operations, sell off our assets, seek protection from our creditors through bankruptcy proceedings, or otherwise. Furthermore, additional equity financing may be dilutive to the holders of our common stock, and debt financing, if available, may involve restrictive covenants, and strategic relationships, if necessary, to raise additional funds, and may require that we relinquish valuable rights.
Management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in their audit report for the year ended December 31, 2022.
We anticipate that we will continue to report losses and negative cash flow for the foreseeable future. We have concluded that our historical recurring losses from operations and negative cash flows from operations as well as our dependence on debt and other financings raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the year ended December 31, 2022.
The consolidated financial statements of the Company do not include any adjustments that might result from the outcome of this uncertainty. These adjustments would likely include substantial impairment of the carrying amount of our assets and potential contingent liabilities that may arise if we are unable to fulfill various operational commitments. In addition, the value of our securities, including the subordinate voting shares included in this offering, would be greatly impaired. Our ability to continue as a going concern is dependent upon generating sufficient cash flow from operations and obtaining additional capital and financing. If our ability to generate cash flow from operations is delayed or reduced and we are unable to raise additional funding from other sources, we may be unable to continue in business.
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Because we have a limited operating history, you may not be able to accurately evaluate our operations.
We have had limited operations to date. Therefore, we have a limited operating history upon which to evaluate the merits of investing in our company. Potential investors should be aware of the difficulties normally encountered by new companies and the high rate of failure of such enterprises. The likelihood of success must be considered in light of the problems, expenses, difficulties, complications, and delays encountered in connection with the operations that we plan to undertake. These potential problems include, but are not limited to, unanticipated problems relating to the ability to generate sufficient cash flow to operate our business, and additional costs and expenses that may exceed current estimates. We expect to continue to incur significant losses into the foreseeable future. We recognize that if the effectiveness of our business plan is not forthcoming, we will not be able to continue business operations. There is no history upon which to base any assumption as to the likelihood that we will prove successful, and it is doubtful that we will generate any operating revenues or ever achieve profitable operations. If we are unsuccessful in addressing these risks, our business will most likely fail.
We are dependent on additional financing for the continuation of our operations.
Because we have generated no revenues and currently operate at a loss, we are completely dependent on the continued availability of financing in order to continue our business operations. There can be no assurance that financing sufficient to enable us to continue our operations will be available to us in the future.
We will need additional funds to complete further development of our business plan to achieve a sustainable level where ongoing operations can be funded out of revenues. We expect that the proceeds from this Offering will provide adequate resources to fund our operations and initial clinical development programs through January 2025. We will require further funding to fully implement our business plan to its fullest potential and achieve our growth plans. There is no assurance that any additional financing will be available or if available, on terms that will be acceptable to us.
Our failure to obtain future financing or to produce levels of revenue to meet our financial needs could result in our inability to continue as a going concern in the future and, as a result, our investors could lose their entire investment.
Our operating results may fluctuate, which could have a negative impact on our ability to grow our client base, establish sustainable revenues and succeed overall.
Our results of operations may fluctuate as a result of a number of factors, some of which are beyond our control including but not limited to:
● | general economic conditions in the geographies and industries where we sell our services and conduct operations; legislative policies where we sell our services and conduct operations; | |
● | the budgetary constraints of our customers; seasonality; | |
● | success of our strategic growth initiatives; | |
● | costs associated with the launching or integration of new or acquired businesses; timing of new product introductions by us, our suppliers and our competitors; product and service mix, availability, utilization and pricing; | |
● | the mix, by state and country, of our revenues, personnel, and assets; movements in interest rates or tax rates; | |
● | changes in, and application of, accounting rules; changes in the regulations applicable to us; and litigation matters. |
As a result of these factors, we may not succeed in our business, and we could go out of business.
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We have yet to achieve a profit and may not achieve a profit in the near future, if at all.
We have not yet produced any revenues or profit and may not in the near future, if at all. We cannot be certain that we will be able to realize sufficient revenue to achieve profitability. Further, many of our competitors have a significantly larger industry presence and revenue stream but have yet to achieve profitability. Our ability to continue as a going concern in the future is dependent upon raising capital from financing transactions, increasing revenue and keeping operating expenses below our revenue levels in order to achieve positive cash flows, none of which can be assured.
Certain of our executive officers, including our Chief Executive Officer and Chairman of our board of directors, Dr. Christopher Chapman, will not be employed by us on a full-time basis and will working for us on a part-time and as-needed basis.
Dr. Christopher Chapman, our Chief Executive Officer and Chairman of our board of directors, will not be employed by our company on a full-time basis. As intended to be provided in his employment agreement with our company, he is expected to work on a part-time and as-needed basis. Because he will not work full time for our company, instances may occur where he may not be immediately available to provide solutions to problems or address concerns that arise in the course of us conducting our business and thus adversely affect our business. In addition, he can become subject to conflicts of interest because he devotes part of his working time to other business endeavors and may have responsibilities to other entities. Although Dr. Chapman is aware of his duties and accountability to our company and to applicable laws and policies relating to corporate opportunity and conflicts of interest, such conflicts of interest may include deciding how much time to devote to our affairs, as well as what business opportunities should be presented to us.
Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with other companies.
Following this offering, Dr. Christopher Chapman, our Chief Executive Officer and Chairman of our board of directors, will continue to serve as the Executive Chairman of MIRA Pharmaceuticals, Inc. (“MIRA”) and as a director, President, and Chief Medical Officer of MyMD Pharmaceuticals, Inc. (“MyMD”). Further, each of Christos Nicholoudis, Brad Kroenig, Talhia Tuck, and Hugh McColl serve as members of the board of directors of MIRA and will continue to serve on our board of directors following this offering, and Mr. Nicholoudis also serves as our General Counsel and the General Counsel of MIRA. Although these persons are not full-time employees of MyMD or MIRA, it is possible that the amount of time that they expend on their work for other companies may adversely impact the amount of time that they can spend on their work for our company. These persons may also own or acquire shares of MyMD or MIRA common stock and options to purchase such common stock. Their respective positions at MyMD or MIRA, as applicable, and the ownership of any equity or equity awards of MyMD or MIRA, as applicable, creates, or may create the appearance of, conflicts of interest when these individuals are faced with decisions that could have different implications for MyMD or MIRA than the decisions have for us.
Conflicts of interest may arise between us and MIRALOGX.
MIRALOGX holds the patent rights to TELOMIR-1. MIRALOGX is a separate intellectual property development company owned by the Bay Shore Trust, which is an irrevocable trust established by the Company’s founder, Jonnie R. Williams, Sr., and in which Brian McNulty is the trustee. The Bay Shore Trust is also our largest stockholder. Additionally, our General Counsel and one of our directors, Christos Nicholoudis, performs certain consulting work for MIRALOGX through his law firm, The Law Firm of Christos Nicholoudis PLLC, on an as-needed basis. We have an exclusive license from MIRALOGX to develop and commercialize TELOMIR-1 in the U.S. for human and non-human applications. Although the interests of MIRALOGX are 100% owned by the Bay Shore Trust, and neither Mr. Williams nor Mr. Nicholoudis is an officer or director of MIRALOGX and Mr. Williams does not have voting or dispositive power over the shares of the Company held by Bay Shore Trust, our relationship with the Bay Shore Trust, Mr. Williams, or Mr. Nicholoudis may create, or may create the appearance of, conflicts of interest when we are faced with decisions that could have different implications for MIRALOGX than the decisions have for us. Furthermore, in light of the license agreement that we have with MIRALOGX, if a dispute were to arise between MIRALOGX and us relating to our past or future relationship with MIRALOGX or with respect to intellectual property matters, these potential conflicts of interest may make it more difficult for us to favorably resolve such disputes.
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Risks Relating to Our Business and Our Industry
Our future success will largely depend on the success of TELOMIR-1 and any future product candidates, which development will require significant capital resources and years of clinical development effort.
We currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development. Our business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization of our product candidates, principally TELOMIR-1. Investors need to be aware that substantial additional investments including pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before we are permitted to undertake clinical studies and market and commercialize our product candidates, if ever. It may be several years before we can commence clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States and other jurisdictions where we intend, if approved, to market our product candidates. Before obtaining regulatory approvals for any of our product candidates, we must demonstrate through pre-clinical testing and clinical trials that the product candidate is safe and effective for its specific application. This process can take many years and may include post- marketing studies and surveillance, which would require the expenditure of substantial resources. Of the large number of drugs in development for approval in the United States (and the rest of the world), only a small percentage will successfully complete the FDA regulatory approval financing to fund our planned research, development, and clinical programs, we cannot assure you that any of our product candidates will be successfully developed or commercialized.
We may be unable to formulate or scale up any or all of our product candidates. There is no guarantee that any of the product candidates will be or are able to be manufactured or produced in a manner to meet the FDA’s criteria for product stability, content uniformity and all other criteria necessary for product approval in the United States and other markets. Any of our product candidates may fail to achieve their specified endpoints in clinical trials.
Furthermore, product candidates may not be approved even if they achieve their specified endpoints in clinical trials. The FDA may disagree with our trial design and our interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for our clinical trials. The FDA may also approve a drug for fewer or more limited indications than we request or may grant approval contingent on the performance of costly post-approval clinical trials (i.e., Phase IV trials). In addition, the FDA may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product candidates.
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If we are unable to expand our pipeline and obtain regulatory approval for our product candidates within the timelines we anticipate, we will not be able to execute our business strategy effectively and our ability to substantially grow our revenues will be limited, which would have a material adverse impact on our long-term business, results of operations, financial condition, and prospects.
We are dependent on the success of our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.
Our success will depend on our ability to successfully commercialize our product candidates. Our ability to successfully commercialize our product candidates will depend on, among other things, our ability to:
● | successfully complete pre-clinical and other nonclinical studies and clinical trials; | |
● | receive regulatory approvals from the FDA; | |
● | produce, through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently large quantities of product candidates to permit successful commercialization; | |
● | obtain reimbursement from payers such as government health care programs and insurance companies and achieve commercially attractive levels of pricing; | |
● | secure acceptance of our product candidates from physicians, health care payers, patients, and the medical community; | |
● | create positive publicity surrounding our product candidates; | |
● | manage our spending as costs and expenses increase due to clinical trials and commercialization; and | |
● | obtain and enforce sufficient intellectual property for our product candidates. |
Our failure or delay with respect to any of the factors above could have a material adverse effect on our business, results of operations and financial condition.
Our business may be materially and adversely affected in the future by the evolving effects of the COVID-19 pandemic as a result of the current and potential future impacts on our commercialization efforts, supply chain, regulatory and clinical development activities, and other business operations, in addition to the impact of a global economic slowdown.
Our business could be materially and adversely affected in the future by the evolving effects of the COVID-19 pandemic. If we are unable to obtain adequate supplies of personal protective equipment due to shortages or encounter other challenges related to the evolving COVID-19 pandemic, we may have to place or may experience additional limitations on our in-person activities. In addition, our increased reliance on personnel working from home may negatively impact productivity or disrupt, delay or otherwise adversely impact our business. This could also increase our cybersecurity risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations. Impacts related to the COVID-19 pandemic could materially and adversely affect our business, our ability to generate sales of and revenues from our approved products, and our ability to advance the development of our products and product candidates, as described elsewhere in this “Risk Factors” section. The magnitude of such impacts will depend, in large part, on the ultimate duration and severity of the evolving effects of the COVID-19 pandemic.
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The effects of the COVID-19 pandemic continue to rapidly evolve. These effects have increased market volatility and could result in a significant long-term disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity. In addition, market corrections resulting from the effects of the COVID-19 pandemic could materially affect our business and the value of our common stock. The extent to which the evolving effects of the COVID-19 pandemic impact our business, our ability to generate sales of and revenues from our approved products, and our clinical development and regulatory efforts will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate duration and severity of the pandemic, government actions, such as travel restrictions, quarantines and social distancing requirements in the U.S. and in other countries, business closures or business disruptions and the effectiveness of actions taken in the U.S. and in other countries to contain and treat the disease. Accordingly, we do not yet know the full extent of potential delays or impacts on our business, sales of our products, our clinical and regulatory activities, our research programs, healthcare systems or the global economy as a whole. However, these effects could materially and adversely affect our business, financial condition, results of operations and growth prospects. In addition, to the extent the evolving effects of the COVID-19 pandemic adversely affect our business, financial condition, results of operations and growth prospects, they may also have the effect of heightening many of the other risks and uncertainties described elsewhere in this “Risk Factors” section. It is also possible that future global pandemics could also occur and materially and adversely affect our business, financial condition, results of operations and growth prospects.
Results of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.
Any positive results from future pre-clinical testing of our product candidates and potential future clinical trials may not necessarily be predictive of the results from Phase I, Phase II or Phase III clinical trials. In addition, our interpretation of results derived from clinical data or our conclusions based on our pre-clinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology companies have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks may be caused by the fact that pre-clinical and clinical data can be susceptible to varying interpretations and analyses. Furthermore, certain product candidates may perform satisfactorily in pre-clinical studies and clinical trials, but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate regulatory authorities in other countries. If we fail to produce positive results in our clinical trials for our product candidates, the development timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects, would be materially adversely affected.
We have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.
Our ability to generate revenues ultimately depends on our ability to sell our approved products and secure adequate third-party reimbursement. We currently have limited experience in marketing and selling our products. We currently do not have any products approved for sale in the United States or in any other country.
The commercial success of our product candidates will depend on a number of factors beyond our control, including the willingness of physicians to prescribe our products to patients, payers’ willingness and ability to pay for the drugs, the level of pricing achieved, patients’ response to our drugs and the ability of our marketing partners to generate sales. There can be no guarantee that we will be able to establish or maintain the personnel, systems, arrangements and capabilities necessary to successfully commercialize TELOMIR-1 or any product candidate approved by the FDA in the future. If we fail to establish or maintain successful marketing, sales and reimbursement capabilities or fail to enter into successful marketing arrangements with third parties, our product revenues may suffer.
Should we later determine it is in our best interest to develop a sales force we may be unable to effectively train and equip our sales force, therefore our ability to successfully commercialize our products may be harmed.
We will be required to expend significant time and resources to train our sales force to be credible, persuasive, and compliant with applicable laws in marketing TELOMIR-1 or our other product candidates to physicians for their approved uses. In addition, we must continue to train our sales force to ensure that a consistent and appropriate message about TELOMIR-1 or our other product candidates is being delivered to our potential customers. If we are unable to effectively train our sales force and equip them with effective materials, including medical and sales literature to help them inform and educate potential customers about the benefits of TELOMIR-1 and our product candidates and its proper administration, our efforts to successfully commercialize TELOMIR-1 and our product candidates could be jeopardized, which would negatively impact our ability to generate product revenues.
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We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing our growth and executing our growth strategy.
Our management and personnel, systems, and facilities currently in place may not be adequate to support our business plan and future growth. As a result, we may need to further expand certain areas of our organization.
Our need to effectively manage our operations, growth and various projects requires that we:
● | continue to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures; | |
● | attract and retain enough talented employees; | |
● | manage our clinical trials effectively; |
● | manage our external manufacturing operations with contract research organizations effectively and in a cost-effective manner; | |
● | manage our development efforts effectively while carrying out our contractual obligations to contractors and other third parties; and |
In addition, we may utilize the services of part-time outside consultants and contractors to perform several tasks for us, including tasks related to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions. Our growth strategy may entail expanding our use of consultants and contractors to implement these and other tasks going forward. If we are not able to effectively expand our organization by hiring new employees and expanding our use of consultants and contractors, we may be unable to successfully implement the tasks necessary to effectively execute on our planned research, development, manufacturing, and commercialization activities and, accordingly, may not achieve our research, development and commercialization goals.
Our product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate revenue from new products.
Even when product development is successful and regulatory approval has been obtained, our ability to generate sufficient revenue depends on the acceptance of our products by physicians and patients. We cannot assure you that our product candidates will achieve the expected level of market acceptance and revenue if and when they obtain the requisite regulatory approvals. The market acceptance of any product depends on a number of factors, including the indication statement and warnings required by regulatory authorities in the product label. Market acceptance can also be influenced by continued demonstration of efficacy and safety in commercial use, physicians’ willingness to prescribe the product, reimbursement from third-party payers such as government health care programs and private third-party payers, the price of the product, the nature of any post-approval risk, management activities mandated by regulatory authorities, competition, and marketing and distribution support. Further, an ineffective or inefficient distribution model at launch may lead to the inability to fulfill demand, and consequently a loss of revenue. Any factors preventing or limiting the market acceptance of our products could have a material adverse effect on our business, results of operations and financial condition.
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If the price for any future approved products decreases or if government and other third-party payers do not provide coverage and adequate reimbursement levels, our revenue and prospects for profitability will suffer.
Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payers to reimburse all or part of the costs associated with their prescription drugs. Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals generally must be obtained on a country-by-country basis. Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payers is critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower-cost therapeutic alternatives are already available or subsequently become available. Even if we obtain coverage for products we may market, the resulting reimbursement payment rates may require co-payments that patients find unacceptably high. Patients may not use our products if coverage is not provided, or reimbursement is inadequate to cover a significant portion of its cost.
In addition, the market for our products will depend significantly on access to third-party payers’ drug formularies or lists of medications for which third-party payers provide coverage and reimbursement. The industry competition to be included in such formularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payers may refuse to include a particular branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or other alternative is available, even if not approved for the indications for which our products are approved.
Third-party payers or governmental or commercial entities are developing increasingly sophisticated methods of controlling healthcare costs. The current environment is putting pressure on companies to price products below what they may feel is appropriate. Selling our products at less than an optimized price could impact our revenues and overall success as a company. It will be difficult to determine the optimized price for our products. In addition, in the U.S., no uniform policy of coverage and reimbursement for drug products exists among third-party payers. Therefore, coverage and reimbursement for our products may differ significantly from payer to payer. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payer separately, with no assurance that coverage will be obtained. If we are unable to obtain coverage of, and adequate payment levels for, products we may market to third-party payers, physicians may limit how much or under what circumstances they will prescribe or administer them, and patients may decline to purchase them. This in turn could affect our ability to successfully commercialize products we may market, and thereby adversely impact our profitability, results of operations, financial condition, and future success.
In addition, where we have chosen to collaborate with a third party on product candidate development and commercialization, our partner may elect to reduce the price of our products in order to increase the likelihood of obtaining reimbursement approvals. In many countries, products cannot be commercially launched until reimbursement is approved and the negotiation process in some countries can exceed 12 months. In addition, pricing and reimbursement decisions in certain countries can be affected by decisions taken in other countries, which can lead to mandatory price reductions and/or additional reimbursement restrictions across a number of other countries, which may thereby adversely affect our sales and profitability. If countries impose prices that are not sufficient to allow us or our partners to generate a profit, our partners may refuse to launch the product in such countries or withdraw the product from the market, which would adversely affect sales and profitability. Events, such as price decreases, government mandated rebates or unfavorable reimbursement decisions, could affect the pricing and reimbursement of TELOMIR-1 and our other product candidates and could have a material adverse effect on our business, reputation, results of operations and financial condition.
We expect to face intense competition, often from companies with greater resources and experience than we have.
The development and commercialization of drugs and medicines is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized biotechnology companies, as well as products and processes being developed by universities and other research institutions. Many of our competitors have developed, are developing, or will develop drugs and processes which may be competitive with our drug candidates. Competitive products include those that have already been approved by medicines regulators and accepted by the medical community and any new products that may enter the market. For some of our drug development programs / areas of interest, other treatment options or products are currently available, under development, and may become commercially available in the future. If any of our product candidates are approved for the diseases and conditions we are currently pursuing, they may compete with a range of medicines or therapeutic treatments that are either in development, will be developed in the future or currently marketed.
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Established companies may have a competitive advantage over us due to their size and experiences, financial resources, and institutional networks. Many of our competitors may have significantly greater financial, technical, and human resources than we do. Due to these factors, our competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before we are able to, which may limit our ability to develop or commercialize our drug candidates. Our competitors may also develop drugs or medicines that are safer, more effective, more widely used and less expensive than ours. These advantages could materially impact our ability to develop and, if approved, commercialize our product candidates successfully. Furthermore, some of these competitors may make acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain market share.
Moreover, as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially. Even if we are the first to obtain FDA approval of one of our product candidates, the future potential approval of generics could adversely affect the price we are able to charge, and the profitability of our product(s) will likely decline.
Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
These companies may compete with us in recruiting and retaining qualified scientific, management and commercial personnel, utilizing contract manufacturing facilities or contract research organizations (CROs), or establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to our research projects.
Problems in our manufacturing process, failure to comply with manufacturing regulations or unexpected increases in our manufacturing costs could harm our business, results of operations and financial condition.
The manufacturing of our product candidates necessitates compliance with cGMP and other regulatory requirements in jurisdictions internationally. We must ensure chemical consistency among our batches of products, including clinical batches and, if approved, marketing batches. Demonstrating such consistency may require typical manufacturing controls as well as clinical data. We must also ensure that our batches conform to complex release specifications. If we are unable to manufacture our product candidates in accordance with regulatory specifications, including cGMP, or if there are disruptions in our manufacturing process due to damage, loss or otherwise, or failure to pass regulatory inspections of our manufacturing facilities, we may not be able to meet current demand or supply sufficient product for use in clinical trials, and this may also harm our ability to commercialize our product candidates on a timely or cost-competitive basis, if at all.
We may fail to expand our manufacturing capability in time to meet market demand for our products and product candidates, and the FDA may refuse to accept our facilities or those of our contract manufacturers as being suitable for the production of our products and product candidates. Any problems in our manufacturing process could have a material adverse effect on our business, results of operations and financial condition.
In addition, before we can begin commercial manufacture of any product candidates for sale in the U.S., we must obtain FDA regulatory approval for the product, which requires a successful FDA inspection of our manufacturing facilities and those of our contract manufacturers, processes, and quality systems in addition to other product-related approvals. Although we may successfully navigate this pre-approval inspection process as it relates in the U.S., pharmaceutical manufacturing facilities are continuously subject to post-approval inspection by the FDA and foreign regulatory authorities. Due to the complexity of the processes used to manufacture our product candidates, we may be unable to initially or continue to pass federal, state or international regulatory inspections in a cost-effective manner. If we are unable to comply with manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products, total or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These possible sanctions would adversely affect our business, results of operations and financial condition.
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Business interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.
Our research and development activities are conducted through outside contractors and manufacturers. Loss of our contracted manufacturing facilities, stored inventory or laboratory facilities through fire, theft or other causes, or loss of our raw material, could have an adverse effect on our ability to continue product development activities and to conduct our business. Failure to supply our partners with commercial product may lead to adverse consequences, including the right of partners to take over responsibility for product supply. We currently do not have insurance coverage to compensate us for such business interruptions. Our contract manufacturers and suppliers provide that in their separate operations; however, such coverage may prove insufficient to fully compensate us for the damage to our business resulting from any significant property or casualty loss to those facilities.
We have significant and increasing liquidity needs and may require additional funding.
Our operations have consumed substantial amounts of cash since inception. For the nine months ended September 30, 2023, we reported a net operating cash outflow of $2.8 million and a net cash inflow from financing activities of $2.8 million. For the year ended December 31, 2022, we reported a net operating cash outflow of $0.5 million and a net cash inflow from investing activities of $0.5 million. For the year ended December 31, 2021, we reported a net operating cash outflow of $0.1 million and a net cash inflow from investing activities of $0.1 million.
Research and development, and general and administrative expenses, and cash used for operations will continue to be significant and may increase substantially in the future in connection with new research and development initiatives and continued product commercialization efforts. We may need to raise additional capital to fund our operations, continue to conduct clinical trials to support potential regulatory approval of marketing applications and to fund commercialization of our products.
The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:
● | the timing of FDA approval, if any, and approvals in international markets of our product candidates, if at all; | |
● | the timing and amount of revenue from sales of our products, or revenue from grants or other sources; | |
● | the rate of progress and cost of our clinical trials and other product development programs; | |
● | costs of establishing or outsourcing sales, marketing, and distribution capabilities; | |
● | costs and timing of completion of expanded in-house manufacturing facilities as well as any outsourced commercial manufacturing supply arrangements for our product candidates; | |
● | costs of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights associated with our product candidates; | |
● | the effect of competing technological and market developments; | |
● | personnel, facilities, and equipment requirements; and | |
● | the terms and timing of any additional collaborative, licensing, co-promotion, or other arrangements that we may establish. |
While we expect to fund our future capital requirements from several sources including existing cash balances, future cash flows from operations and the proceeds from equity offerings, we cannot assure you that any of these funding sources will be available to us on favorable terms, or at all. Further, even if we can raise funds from all of the above sources, the amounts raised may not be sufficient to meet our future capital requirements.
Operating results may vary significantly in future periods.
Our expenses and operating results have fluctuated in the past and our revenues, expenses, and operating results are likely to fluctuate significantly in the future. Our financial results are unpredictable and may fluctuate, for among other reasons, due to:
● | commercial sales of our products; |
● | our achievement of product development objectives and milestones; | |
● | clinical trial enrollment and expenses; | |
● | research and development expenses; and | |
● | the timing and nature of contract manufacturing and contract research payments. |
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A high portion of our costs are predetermined on an annual basis, due in part to our significant research and development costs. Thus, small declines in revenue could disproportionately affect financial results in a quarter. Because of these factors, our financial results in one or more future quarters may fail to meet the expectations of securities analysts or investors, which could cause our share price to decline.
If product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the commercialization of TELOMIR-1 and our product candidates.
Although we have never had any product liability claims or lawsuits brought against us, we face potential product liability exposure related to the testing of our product candidates in human clinical trials. We may face exposure to claims by an even greater number of persons when we begin to market and distribute our products commercially in the U.S., Europe and elsewhere. Now, and in the future, an individual may bring a liability claim against us alleging that TELOMIR-1 or one of our product candidates caused an injury. While we continue to take what we believe are appropriate precautions, we may be unable to avoid significant liability if any product liability lawsuit is brought against us. Large judgments have been awarded in class action or individual lawsuits based on drugs that had unanticipated side effects. If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
● | decreased demand for TELOMIR-1 and our product candidates if such product candidates are approved; | |
● | injury to our reputation; | |
● | withdrawal of clinical trial participants; | |
● | costs of related litigation; | |
● | substantial monetary awards to patients and others; | |
● | increased cost of liability insurance; | |
● | loss of revenue; and | |
● | the inability to successfully commercialize our products. |
Counterfeit versions of our products could harm our business.
Counterfeiting activities and the presence of counterfeit products in a number of markets and over the Internet continue to be a challenge for maintaining a safe drug supply for the pharmaceutical industry. Counterfeit products are frequently unsafe or ineffective and can be life-threatening. To distributors and users, counterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions to counterfeit drugs along with increased levels of counterfeiting could be mistakenly attributed to the authentic product, affect patient confidence in the authentic product and harm the business of companies such as ours. If our products were to be the subject of counterfeits, we could incur reputational and financial harm.
We depend upon our key personnel and our ability to attract and retain employees.
Our future growth and success depend on our ability to recruit, retain, manage, and motivate our employees. The inability to hire or retain experienced management personnel could adversely affect our ability to execute our business plan and harm our operating results. Due to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical, and managerial personnel. The competition for qualified personnel in the pharmaceutical field is intense. Due to this intense competition, we may be unable to continue to attract and retain the qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.
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Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA or foreign regulations, provide accurate information to FDA or other regulatory authorities, comply with applicable manufacturing standards, comply with other foreign, federal, and state laws and regulations, report information or data accurately or disclose unauthorized activities to us. Employee misconduct could also involve the improper use of information, including information obtained during clinical trials, or illegal appropriation of drug products, which could result in government investigations and serious harm to our reputation. The precautions we take to detect and prevent these prohibited activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.
We are subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition.
Our operations are subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), and other anti-corruption laws that apply in countries where we do business. The FCPA and these other laws generally prohibit us and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. We and our commercial partners operate in a number of jurisdictions that pose a high risk of potential FCPA violations, and we participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope, or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.
We are also subject to other laws and regulations governing our international operations, including regulations administered by the government of the U.S. and other countries in which we operate or plan to operate, including applicable export control regulations, economic sanctions on countries and persons, customs requirements, and currency exchange regulations, (collectively referred to as the “Trade Control laws”).
However, there is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the FCPA and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity, as well as our reputation. Likewise, any investigation of any potential violations of the FCPA, other anti-corruption laws or Trade Control laws by the U.S. or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition.
Our proprietary information, or that of our customers, suppliers, and business partners, may be lost or we may suffer security breaches.
In the ordinary course of our business, we will collect and store sensitive data, including valuable and commercially sensitive intellectual property, clinical trial data, our proprietary business information and that of our customers, suppliers and business partners, and personally identifiable information of our customers, clinical trial subjects and employees, and patients, on our networks, and with our third-party cloud service providers. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our security measures, our information technology and infrastructure, and that of our third parties, may be vulnerable to attacks by hackers or breached due to employee error, malfeasance, or other disruptions. Any breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost, or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, disrupt our operations, damage our reputation, and cause a loss of confidence in our products and our ability to conduct clinical trials, which could adversely affect our business and reputation and lead to delays in gaining regulatory approvals for TELOMIR-1 or other product candidates.
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Failure of our information technology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt the operation of our business.
Our business is increasingly dependent on critical, complex, and interdependent information technology (“IT”) systems, including internet-based systems, some of which are managed or hosted by third parties, to support business processes as well as internal and external communications. The size and complexity of our IT systems make us potentially vulnerable to IT system breakdowns, malicious intrusion, and computer viruses, which may result in the impairment of our ability to operate our business effectively.
We are continuously evaluating and, where appropriate, enhancing our IT systems to address our planned growth, including to support our planned manufacturing operations. There are inherent costs and risks associated with implementing the enhancements to our IT systems, including potential delays in access to, or errors in, critical business and financial information, substantial capital expenditures, additional administrative time and operating expenses, retention of sufficiently skilled personnel to implement and operate the enhanced systems, demands on management time, and costs of delays or difficulties in transitioning to the enhanced systems, any of which could harm our business and results of operations. In addition, the implementation of enhancements to our IT systems may not result in productivity improvements at a level that outweighs the costs of implementation, or at all. In addition, our systems and the systems of our third-party providers and collaborators are potentially vulnerable to data security breaches which may expose sensitive data to unauthorized persons or to the public. Such data security breaches could lead to the loss of confidential information, trade secrets or other intellectual property, could lead to the public exposure of personal information (including personally identifiable information or individually identifiable health information) of our employees, clinical trial patients, customers, business partners, and others, could lead to potential identity theft, or could lead to reputational harm. Data security breaches could also result in loss of clinical trial data or damage to the integrity of that data. In addition, the increased use of social media by our employees and contractors could result in inadvertent disclosure of sensitive data or personal information, including but not limited to, confidential information, trade secrets and other intellectual property.
Any such disruption or security breach, as well as any action by us or our employees or contractors that might be inconsistent with the rapidly evolving data privacy and security laws and regulations applicable within the United States and elsewhere where we conduct business, could result in enforcement actions by U.S. states, the U.S. federal government or foreign governments, liability or sanctions under data privacy laws, including healthcare laws such as HIPAA, that protect certain types of sensitive information, regulatory penalties, other legal proceedings such as but not limited to private litigation, the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation, which could harm our business and operations. Because of the rapidly moving nature of technology and the increasing sophistication of cybersecurity threats, our measures to prevent, respond to and minimize such risks may be unsuccessful.
Security breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing critical information or expose us to liability, which could adversely affect our business and our reputation.
In the ordinary course of our business, we, our vendors, and our third-party cloud service providers may collect and store sensitive data, including legally protected patient health information, credit card information, personally identifiable information about our employees and patients, intellectual property, and proprietary business information. We manage and maintain our applications and data utilizing cloud-based and on-site systems. These applications and data encompass a wide variety of business-critical information including research and development information, commercial information and business and financial information.
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The secure processing, storage, maintenance, and transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches, or interruptions due to employee error, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates. Any such virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. We have measures in place that are designed to prevent, and if necessary to detect and respond to such security incidents, breaches of privacy, and security mandates. However, in the future, any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as HIPAA in the United States and the General Data Protection Regulation in the European Union, or GDPR, government enforcement actions and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process samples, provide test results, share and monitor safety data, bill payers or patients, provide customer support services, conduct research and development activities, process and prepare company financial information, manage various general and administrative aspects of our business and may damage our reputation, any of which could adversely affect our business, financial condition and results of operations.
Legislative or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved.
Our ability to commercialize our future products successfully, alone or with collaborators, will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers and other third-party payers. The continuing efforts of the U.S., European, and foreign governments, insurance companies, managed care organizations and other payers for health care services to contain or reduce health care costs may adversely affect our ability to set prices for our products which we believe are fair, and our ability to generate revenues and achieve and maintain profitability.
Specifically, in both the U.S. and some foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our products profitably.
We expect additional federal and state legislative proposals for health care reform, which could limit the prices that can be charged for the products we develop and may limit our commercial opportunity.
The continuing efforts of government and other third-party payers to contain or reduce the costs of health care through various means may limit our commercial opportunity. It will be time-consuming and expensive for us to go through the process of seeking coverage and reimbursement from Medicare, Medicaid, and other governmental health programs and from private payers. Our products may not be considered cost-effective, and government and third-party private health insurance coverage and reimbursement may not be available to patients for any of our future products or sufficient to allow us to sell our products on a competitive and profitable basis. Our results of operations could be adversely affected by the Patient Protection and Affordable Care Act (the “ACA”), changes to the ACA, and by other health care reforms that may be enacted or adopted in the future. In addition, increasing emphasis on managed care in the U.S. will continue to put downward pressure on the pricing of pharmaceutical products. Cost-control initiatives could decrease the price that we or any potential collaborators could receive for any of our future products and could adversely affect our ability to generate revenue in the U.S. market and maintain profitability.
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We may acquire other companies which could divert our management’s attention, result in additional dilution to our shareholders and otherwise disrupt our operations and harm our operating results.
We may in the future seek to acquire businesses, products, or technologies that we believe could complement or expand our product offerings, enhance our technical capabilities or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attention of management and cause us to incur various expenses in identifying, investigating, and pursuing suitable acquisitions, whether or not they are consummated. If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and technologies successfully, effectively manage the combined business following the acquisition or realize anticipated cost savings or synergies. We also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:
● | incurrence of acquisition-related costs; | |
● | diversion of management’s attention from other business concerns; | |
● | unanticipated costs or liabilities associated with the acquisition; | |
● | harm to our existing business relationships with collaboration partners as a result of the acquisition; | |
● | harm to our brand and reputation; | |
● | the potential loss of key employees; | |
● | use of resources that are needed in other parts of our business; and | |
● | use of substantial portions of our available cash to consummate the acquisition. |
In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating results arising from the impairment assessment process. Acquisitions may also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results. In addition, if an acquired business fails to meet our expectations, our business, results of operations and financial condition may be adversely affected.
Risks Related to Development and Regulatory Approval of Our Product Candidates
Clinical trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results of clinical trials are open to differing interpretations.
Clinical trials are expensive, time consuming and difficult to design and implement. Regulatory agencies may analyze or interpret the results differently than us. Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidates are expected to continue for several years and may take significantly longer to complete. In addition, we, the FDA, or other regulatory authorities, including state and local authorities, or an Institutional Review Board, or IRB, with respect to a trial at its institution, may suspend, delay or terminate our clinical trials at any time, require us to conduct additional clinical trials, require a particular clinical trial to continue for a longer duration than originally planned, require a change to our development plans such that we conduct clinical trials for a product candidate in a different order, e.g., in a step-wise fashion rather than running two trials of the same product candidate in parallel, or the DEA could suspend or terminate the registrations and quota allotments we require in order to procure and handle controlled substances, for various reasons, including:
● | lack of effectiveness of any product candidate during clinical trials; | |
● | discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions, including those which cause confounding changes to the levels of other concomitant medications; | |
● | slower than expected rates of subject recruitment and enrollment rates in clinical trials; | |
● | difficulty in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason; | |
● | the evolving effects of the COVID-19 pandemic; | |
● | delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints; |
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● | inadequacy of or changes in our manufacturing process or product formulation; | |
● | delays in obtaining regulatory authorization to commence a trial, including “clinical holds” or delays requiring suspension or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced; | |
● | changes in applicable regulatory policies and regulation, including changes to requirements imposed on the extent, nature, or timing of studies; | |
● | delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites; | |
● | uncertainty regarding proper dosing; | |
● | delay or failure to supply product for use in clinical trials which conforms to regulatory specification; | |
● | unfavorable results from ongoing pre-clinical studies and clinical trials; | |
● | failure of our contract research organizations, or CROs, or other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable manner; |
● | failure by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security, and recordkeeping; | |
● | scheduling conflicts with participating clinicians and clinical institutions; |
● | failure to design appropriate clinical trial protocols; | |
● | insufficient data to support regulatory approval; | |
● | inability or unwillingness of medical investigators to follow our clinical protocols; or | |
● | difficulty in maintaining contact with patients during or after treatment, which may result in incomplete data. |
Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.
Any failure by us to comply with existing regulations could harm our reputation and operating results.
We are subject to extensive regulation by U.S. federal and state governments in each of the markets where we have product candidates progressing through the approval process.
We must also adhere to all regulatory requirements including FDA’s Good Laboratory Practice, Good Clinical Practice, and current Good Manufacturing Practices requirements (“cGMP”) pharmacovigilance requirements, advertising, and promotion restrictions, reporting and recordkeeping requirements. If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval cGMP requirements, then FDA could sanction us. Even if a drug is FDA-approved, regulatory authorities may impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials. TELOMIR-1, and any of our product candidates that may be approved in the U.S. in the future, will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission of safety and other post-market information, including both federal and state requirements in the U.S. In addition, manufacturers and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to GMP. As such, we, and our contract manufacturers (in the event contract manufacturers are appointed in the future) are subject to continual review and periodic inspections to assess compliance with GMP. Accordingly, we and others with whom we work must continue to spend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, quality control and quality assurance. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label.
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If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of the product, it may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may:
● | issue untitled or warning letters; | |
● | seek to enjoin our activities; | |
● | impose civil or criminal penalties; | |
● | suspend regulatory approval; | |
● | suspend any of our ongoing clinical trials; | |
● | refuse to approve pending applications or supplements to approved applications submitted by us; | |
● | impose restrictions on our operations, including by requiring us to enter into a Corporate Integrity Agreement or closing our contract manufacturers’ facilities, if any; or | |
● | seize or detain products or require a product recall. |
In addition, any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our product candidates. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our business and our operating results may be adversely affected.
Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business and damage our reputation. We expend significant resources on compliance efforts and such expenses are unpredictable and might adversely affect our results. Changing laws, regulations and standards might also create uncertainty, higher expenses and increase insurance costs. As a result, we intend to invest all reasonably necessary resources to comply with evolving standards, and this investment might result in increased management and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities.
We are subject to federal and state healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations could adversely affect our business and results of operations.
In the United States, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact our ability to sell our product candidates. If we are found to be in violation of any of these laws or any other federal or state regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion from federal health care programs and the restructuring of our operations. Any of these could have a material adverse effect on our business and financial results. Since many of these laws have not been fully interpreted by the courts, there is an increased risk that we may be found in violation of one or more of their provisions. Any action against us for violation of these laws, even if we ultimately are successful in our defense, will cause us to incur significant legal expenses and divert our management’s attention away from the operation of our business.
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We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we may receive for any approved product. There have been judicial challenges to certain aspects of the ACA and numerous legislative attempts to repeal and/or replace the ACA in whole or in part, and we expect there will be additional challenges and amendments to the ACA in the future. At this time, the full effect that the ACA will have on our business in the future remains unclear. An expansion in the government’s role in the U.S. healthcare industry may cause general downward pressure on the prices of prescription drug products, lower reimbursements, or any other product for which we obtain regulatory approval, reduce product utilization, and adversely affect our business and results of operations. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize products for which we may receive regulatory approval.
The regulatory approval processes with the FDA are lengthy and inherently unpredictable.
We are not permitted to market our drug candidates as medicines in the United States or other countries until we receive approval of a New Drug Application (“NDA”) from the FDA or in any foreign countries until we receive the approval from the regulatory authorities of such countries. Prior to submitting an NDA to the FDA for approval of our drug candidates we will need to have completed our pre-clinical studies and clinical trials and demonstrate that our products meet all applicable standards of identity, strength, quality, and purity throughout their expiration date. Successfully completing any clinical program and obtaining approval of an NDA is a complex, lengthy, expensive, and uncertain process, and the FDA (or other country medicines regulatory body) may delay, limit, or deny approval of product candidates for many reasons, including, among others, because:
● | an inability to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA; | |
● | results of clinical trials that may not meet the level of statistical or clinical significance required by the FDA; | |
● | disagreements with the FDA with respect to the number, design, size, conduct or implementation of clinical trials; | |
● | requirements by the FDA to conduct additional clinical trials; |
● | disapproval by the FDA of certain formulations, labeling or specifications of product candidates; | |
● | findings by the FDA that the data from pre-clinical studies and clinical trials are insufficient; |
● | findings by the FDA that our API or finished products do not meet all applicable standards of identity, strength, quality, and purity; | |
● | the FDA may disagree with the interpretation of data from pre-clinical studies and clinical trials; and | |
● | the FDA may change their approval policies or adopt new regulations. |
Any of these factors, many of which are beyond our control, could increase development time and / or costs or jeopardize our ability to obtain regulatory approval for our drug candidates.
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There is a high rate of failure for drug candidates proceeding through clinical trials.
Generally, there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinical trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, FDA may disagree with our interpretation of the data. In the event that we obtain negative results from clinical trials for product candidates or other problems related to potential chemistry, manufacturing and control issues or other hurdles occur and our product candidates are not approved, we may not be able to generate sufficient revenue or obtain financing to continue our operations, our ability to execute on our current business plan may be materially impaired, our reputation in the industry and in the investment community might be significantly damaged and the price of our common stock could decrease significantly. In addition, our inability to properly design, commence and complete clinical trials may negatively impact the timing and results of our clinical trials and ability to seek approvals for our drug candidates.
If we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended from participation in federal or state health care programs, which may adversely affect our business, financial condition, and results of operations.
In the United States, we are subject to various federal and state health care “fraud and abuse” laws, including anti-kickback laws, false claims laws and other laws intended to reduce fraud and abuse in federal and state health care programs, which could affect us particularly upon successful commercialization of our products in the U.S. The Medicare and Medicaid Patient Protection Act of 1987, or federal Anti-Kickback Statute, makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referral of business, including the purchase, order or prescription of a particular drug for which payment may be made under a federal health care program, such as Medicare or Medicaid. Under federal law, some arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback Statute. Although we seek to structure our business arrangements in compliance with all applicable requirements, it is often difficult to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices may be challenged under the federal Anti-Kickback Statute and Federal False Claims Act. Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and/or exclusion or suspension from federal and state health care programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions on behalf of the government under the federal False Claims Act as well as under the false claims laws of several states.
Many states have adopted laws similar to the federal anti-kickback statute, some of which apply to the referral of patients for health care services reimbursed by any source, not just governmental payers. There are ambiguities as to what is required to comply with these state requirements and if we fail to comply with an applicable state law requirement, we could be subject to penalties.
Neither the government nor the courts have provided definitive guidance on the application of fraud and abuse laws to our business. Law enforcement authorities are increasingly focused on enforcing these laws, and it is possible that some of our practices may be challenged under these laws. While we believe we have structured our business arrangements to comply with these laws, it is possible that the government could allege violations of, or convict us of violating, these laws. If we are found in violation of one of these laws, we could be required to pay a penalty and could be suspended or excluded from participation in federal or state health care programs, and our business, results of operations and financial condition may be adversely affected.
Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product candidates, limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already marketed.
If any of our product candidates prior to or after any approval for commercial sale, cause serious or unexpected side effects, or are associated with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:
● | regulatory authorities may interrupt, delay or halt clinical trials; |
● | regulatory authorities may deny regulatory approval of our product candidates; | |
● | regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, and/or impose restrictions on distribution in the form of a Risk Evaluation and Mitigation Strategy (“REMS”) in connection with approval or post-approval; | |
● | regulatory authorities may withdraw their approval, require more onerous labeling statements, impose a more restrictive REMS, or require us to recall any product that is approved; | |
● | we may be required to change the way the product is administered or conduct additional clinical trials; | |
● | our relationships with our collaboration partners may suffer; | |
● | we could be sued and held liable for harm caused to patients; or | |
● | our reputation may suffer. The reputational risk is heightened with respect to those of our product candidates that are being developed for pediatric indications. |
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We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants or if preliminary data demonstrate that our product candidates are unlikely to receive regulatory approval or unlikely to be successfully commercialized. Following receipt of approval for commercial sale of a product we may voluntarily withdraw or recall that product from the market if at any time we believe that its use, or a person’s exposure to it, may cause adverse health consequences or death. To date we have not withdrawn, recalled, or taken any other action, voluntary or mandatory, to remove an approved product from the market. In addition, regulatory agencies, IRBs, or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Although we have never been asked by a regulatory agency, IRB, or data safety monitoring board to discontinue a clinical trial temporarily or permanently, if we elect or are forced to suspend or terminate a clinical trial of any of our product candidates, the commercial prospects for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. Furthermore, any of these events may result in labeling statements such as warnings or contraindications. In addition, such events or labeling could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these products either by us or by our collaboration partners.
Risks Related to Our Reliance Upon Third Parties
Our existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
We may seek additional collaboration arrangements with pharmaceutical or biotechnology companies for the development or commercialization of our product candidates. We may, with respect to our product candidates, enter into new arrangements on a selective basis depending on the merits of retaining commercialization rights for ourselves as compared to entering into selective collaboration arrangements with leading pharmaceutical or biotechnology companies for each product candidate, both in the U.S. and internationally. To the extent that we decide to enter into collaboration agreements, we will face significant competition in seeking appropriate collaborators and the terms of any collaboration or other arrangements that we may establish may not be favorable to us.
Any existing or future collaboration that we enter may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding development, intellectual property, regulatory or commercialization matters can lead to delays in the development process or commercialization of the applicable product candidate and, in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority. Any such termination or expiration could harm our business reputation and may adversely affect us financially.
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We depend on a limited number of suppliers for materials and components required to manufacture our product candidates. The loss of these suppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity and adversely affect our business.
We depend on a limited number of suppliers for the materials and components required to manufacture our product candidates. As a result, we may not be able to obtain sufficient quantities of critical materials and components in the future. A delay or interruption by our suppliers may also harm our business, results of operations and financial condition. In addition, the lead time needed to establish a relationship with a new supplier can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new supplier. The time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional costs, diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our dependence on single-source suppliers exposes us to numerous risks, including the following: our suppliers may cease or reduce production or deliveries, raise prices or renegotiate terms; our suppliers may become insolvent or cease trading; we may be unable to locate a suitable replacement supplier on acceptable terms or on a timely basis, or at all; and delays caused by supply issues may harm our reputation, frustrate our customers and cause them to turn to our competitors for future needs.
We maintain our cash at financial institutions, at times in balances that exceed federally insured limits. The failure of financial institutions could adversely affect our ability to pay operational expenses or make other payments.
Our cash held in non-interest-bearing and interest-bearing accounts can at times exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limits. If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance limitations. In addition, even if account holders are ultimately made whole with respect to a future bank failure, account holders’ access to their accounts and assets held in their accounts may be substantially delayed. Any material loss that we may experience in the future or inability for a material time period to access our cash and cash equivalents could have an adverse effect on our ability to pay our operational expenses or make other payments, which could adversely affect our business.
Risks Related to Our Intellectual Property
We depend on rights to TELOMIR-1 that are or will be licensed to us. We do not own the intellectual property rights to TELOMIR-1 and any loss of our rights to it could prevent us from selling our product.
Within our present and future pipeline of treatments, TELOMIR-1 is in-licensed from another company. We do not currently own any intellectual property rights, including the patent application that underlies this license. Our rights to use TELOMIR-1 is subject to the negotiation of, continuation of and compliance with the terms of this license. Thus, the non-provisional patent application is not written by us or our attorneys, and we did not have control over the drafting and prosecution. The patent owner and our licensor might not have given the same attention to the drafting and prosecution of these patents and applications as we would have if we had been the owner of the patent application and had control over the drafting. We cannot be certain that drafting of the licensed patent application, or patent prosecution, by the licensor have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights.
Significant additional research and development activity, pre-clinical testing, and/or clinical testing TELOMIR-1 is required before we will have a chance to achieve a viable product for licensing or commercialization. Our business currently depends entirely on the successful development, regulatory approval, and licensing or commercialization of our product candidate, which may never occur.
Enforcement of our licensed patent application or defense of any claims asserting invalidity of these patents is often subject to the control or cooperation of our licensor. Legal action could be initiated against the owners of the intellectual property that we license and an adverse outcome in such legal action could harm our business because it might prevent such companies or institutions from continuing to license intellectual property that we may need to operate our business. In addition, such licensor may resolve such litigation in a way that benefits it but adversely affects our ability to have freedom to operate to develop and commercialize TELOMIR-1.
We may not be able to adequately protect our product candidates or our proprietary technology in the marketplace.
Our success will depend, in part, on our ability to obtain patents, protect our trade secrets and operate without infringing on the proprietary rights of others. We may rely upon a combination of patents, trade secret protection (i.e., know-how), trademarks, licenses, and confidentiality agreements to protect the intellectual property of our product candidates. The strengths of patents in the pharmaceutical field involve complex legal and scientific questions and can be uncertain. Where appropriate, we seek patent protection for certain aspects of our products and technology. However, patent protection for naturally occurring compounds is exceedingly difficult to obtain, defend and enforce. Filing, prosecuting and defending patents throughout the world would be prohibitively expensive, so our policy is to look to patent technologies with commercial potential in jurisdictions with significant commercial opportunities. However, patent protection may not be available for some of the products or technology we are developing. If we must spend significant time and money protecting, defending, or enforcing our patents, designing around patents held by others or licensing, potentially for large fees, patents or other proprietary rights held by others, our business, results of operations and financial condition may be harmed. We may not develop additional proprietary products that are patentable.
The patent positions of pharmaceutical products are complex and uncertain. Although we have sought and expect to continue to seek patent protection for our product candidates, their methods of use, and methods of manufacture, any, or all of them may not be subject to effective patent protection. If any of our products are approved and marketed for an indication for which we do not have an issued patent, our ability to use our patents to prevent a competitor from commercializing a non-branded version of our commercial products for that non-patented indication could be significantly impaired or even eliminated.
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Publication of information related to our product candidates by us, or others may prevent us from obtaining or enforcing patents relating to these products and product candidates. Furthermore, others may independently develop similar products, may duplicate our products, or may design around our patent rights. In addition, any of our issued patents may be opposed and/or declared invalid or unenforceable. If we fail to adequately protect our intellectual property, we may face competition from companies who attempt to create a generic product to compete with our product candidates. We may also face competition from companies who develop a substantially similar product to one of our product candidates that is not covered by any of our patents.
Many companies have encountered significant problems in protecting, defending and enforcing intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property rights, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.
Currently, we do not own the rights to the intellectual property and technology that will be used to commercially develop our initial product candidate, TELOMIR-1. MIRALOGX, which is a separate intellectual property development company owned by a trust established by the Company’s founder, holds the patent rights to TELOMIR-1, which are currently comprised of a pending non-provisional patent application. We have an exclusive, license from MIRALOGX to develop and commercialize TELOMIR-1 in the U.S. for human and non-human applications. The term of the license will continue through the date of the expiration of the last-to-expire licensed patent or, if later, the date of the expiration of the last strategic partnership/sublicensing agreement covering the licensed products. The licensed patent rights are expected to extend through 2043. We expect additional patent terms may be awarded, including additional patent terms based on the time for regulatory review of drug products. There are no up-front, execution, or milestone payments required under the license agreement. Further, no payments have been made to date under the agreement. We are also required to pay an 8% royalty on net sales or revenue in exchange for an exclusive, worldwide license to patent rights, and we may bring suit in our own name to enforce our patent rights under the license agreement. In the event we are unable to enforce our rights under the agreement or are unable to detect unauthorized use of our intellectual property, we may lose the benefit of the licensed rights used to commercially develop TELOMIR-1. MIRALOGX will control the prosecution of the patent applications for TELOMIR-1.
If third parties claim that the Company’s intellectual property, products, processes, or anything else used by us infringes upon their intellectual property, our operating profits could be adversely affected.
There is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the pharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights, or other intellectual property rights owned by third parties, and we cannot provide assurances that other companies will not, in the future, pursue such infringement claims against us, our commercial partners or any third-party proprietary technologies we have licensed. If we were found to infringe upon a patent or other intellectual property right, or if we failed to obtain or renew a license under a patent or other intellectual property right from a third party, or if a third party that we were licensing technologies from was found to infringe upon a patent or other intellectual property rights of another third party, we may be required to pay damages, including damages of up to three times the damages found or assessed, if the infringement is found to be willful, suspend the manufacture of certain products or reengineer or rebrand our products, if feasible, or we may be unable to enter certain new product markets. Any such claims could also be expensive and time consuming to defend and divert management’s attention and resources. Our competitive position could suffer as a result. In addition, if we have declined or failed to enter into a valid non-disclosure or assignment agreement for any reason, we may not own the invention or our intellectual property, and our products may not be adequately protected. Thus, we cannot guarantee that our product candidates, or our commercialization thereof, does not and will not infringe any third party’s intellectual property.
We have been granted a license to the right to develop TELOMIR-1 in the United States in human and non-human application, but we have not been granted a license to the rights to patents covering TELOMIR-1 in foreign jurisdictions.
We have been granted a license to the right to develop TELOMIR-1 in the United States but not in countries outside the United States, as MIRALOGX has retained all rights outside the United States and may license such rights to other parties. Accordingly, MIRALOGX potentially could develop a competing product for such jurisdictions outside of the United States.
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Risks Relating to our Common Stock
Because of the speculative nature of investment risk, you may lose your entire investment.
An investment in our securities carries a high degree of risk and should be considered as a speculative investment. We have a limited operating history, no revenues, have not paid dividends, and are unlikely to pay dividends in the immediate or near future. The likelihood of our success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the establishment of any business. An investment in our securities may result in the loss of an investor’s entire investment. Only potential investors who are experienced in high-risk investments and who can afford to lose their entire investment should consider an investment in our securities.
The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members.
As a reporting issuer, we will be subject to the reporting requirements of applicable securities legislation of the jurisdiction in which it is a reporting issuer, the listing requirements of Nasdaq and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on its systems and resources. Applicable securities laws will require us to, among other things, file certain annual and quarterly reports with respect to its business and results of operations. In addition, applicable securities laws require us to, among other things, maintain effective disclosure controls and procedures and internal control over financial reporting.
In order to maintain and, if required, improve its disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight are required. Specifically, due to the increasing complexity of its transactions, it is anticipated that we will improve our disclosure controls and procedures and internal control over financial reporting primarily through the continued development and implementation of formal policies, improved processes and documentation procedures, as well as the continued sourcing of additional finance resources. As a result, management’s attention may be diverted from other business concerns, which could harm our business and results of operations. To comply with these requirements, we may need to hire more employees in the future or engage outside consultants, which will increase its costs and expenses.
In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to continue to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us, which could adversely affect our business and financial results.
As a public company subject to these rules and regulations, we may find it more expensive for it to obtain director and officer liability insurance, and it may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on its Audit Committee and Compensation Committee, and qualified executive officers.
As a result of disclosure of information in filings required of a public company, our business and financial condition will become more visible, which may result in threatened or actual litigation, including by competitors and other third parties. If such claims are successful, our business and results of operations could be harmed, and even if the claims do not result in litigation or are resolved in its favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and harm its business and results of operations.
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We are an “emerging growth company” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies could make shares of our common stock less attractive to investors.
We are an “emerging growth company,” as defined in Section 2(a) of the Securities Act. For as long as we continue to be an emerging growth company, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies, including, but not limited to, not being required to have our independent registered public accounting firm audit our internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We could be an emerging growth company until the fifth anniversary of the fiscal year end date following the completion of this offering, however, our status would change more quickly if we have more than US$1.235 billion in annual revenue, if the market value of our shares of common stock held by non-affiliates equals or exceeds US$700 million as of June 30 of any year, or we issue more than US$1.0 billion of non-convertible debt over a three-year period before the end of that period.
Investors could find our shares less attractive if we choose to rely on these exemptions. If some investors find shares less attractive as a result of any choice to reduce future disclosure, there may be a less active trading market for our shares and our share price may be more volatile.
For as long as we are an “emerging growth company”, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. We could be an “emerging growth company” until the fifth anniversary of the fiscal year end date following the completion of this offering. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur the expense of remediation.
If we identify material weaknesses in our internal control over financial reporting, or if we are unable to comply with the requirements of Section 404 in a timely manner or assert that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting when required, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our securities could be negatively affected, and we could become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, which could require additional financial and management resources.
We are a “smaller reporting company” and, even if we no longer qualify as an emerging growth company, we may still be subject to reduced reporting requirements.
Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of any fiscal year for so long as either: (i) the market value of our shares of common stock held by non-affiliates does not equal or exceed $250 million as of the prior June 30th; or (ii) our annual revenues did not equal or exceed $100 million during such completed fiscal year. To the extent we take advantage of such reduced disclosure obligations, it may also make the comparison of our financial statements with other public companies difficult or impossible.
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Our management will have broad discretion over the use of the proceeds we receive in this offering and might not apply the proceeds in ways that increase the value of your investment.
Our management will have broad discretion over the use of our net proceeds from this offering and you will be relying on the judgment of our management regarding the application of these proceeds. Our management might not use our net proceeds in ways that ultimately increase the value of your investment. We expect to use the net proceeds from this offering to advance the clinical development of our programs, to fund our research and development activities and to fund working capital and for general corporate purposes. Our management might not be able to yield a significant return, if any, on any investment or use of these net proceeds. You will not have the opportunity to influence the decision on how to use the net proceeds from this offering.
If we fail to maintain compliance with Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading market for our shares and make obtaining future debt or equity financing more difficult for the Company.
We have applied to have shares of our common stock sold in this offering listed on the Nasdaq under the symbol “TELO”. However, there is no assurance that we will be able to continue to maintain our compliance with the Nasdaq continued listing requirements. If we fail to do so, our securities may be de-listed and cease trading on Nasdaq. As a result, selling our securities could be more difficult because smaller quantities of shares or warrants would likely be bought and sold, transactions could be delayed, and security analysts’ coverage of us may be reduced. In addition, in the event our securities are delisted, broker-dealers would face certain regulatory requirements which may discourage them from effecting transactions in the securities and further limit the liquidity of the securities. These factors could result in lower prices and larger spreads in the bid and ask prices for the securities. Such delisting from Nasdaq and continued or further declines in the share price of the securities could also greatly impair our ability to raise additional necessary capital through equity or debt financing and could significantly increase the ownership dilution to shareholders caused by our issuing equity in financing or other transactions.
If our shares were to be delisted from Nasdaq, they may become subject to the SEC’s “penny stock” rules.
Delisting from Nasdaq may cause the securities of the Company to become subject to the SEC’s “penny stock” rules. The SEC generally defines a penny stock as an equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, and that is not listed on a national securities exchange, such as Nasdaq subject to certain exemptions. Therefore, if shares of our common stock were to be delisted from Nasdaq, the securities of the Company could become subject to the SEC’s “penny stock” rules. These rules require, among other things, that any broker engaging in a purchase or sale of our securities provide its customers with: (i) a risk disclosure document, (ii) disclosure of market quotations, if any, (iii) disclosure of the compensation of the broker and its salespersons in the transaction, and (iv) monthly account statements showing the market values of our securities held in the customer’s accounts. A broker would be required to provide the bid and offer quotations and compensation information before effecting the transaction. This information must be contained in the customer’s confirmation. Generally, brokers are less willing to effect transactions in penny stocks due to these additional delivery requirements. These requirements may make it more difficult for shareholders to purchase or sell the shares of our common stock. Since the broker, not us, prepares this information, we would not be able to assure that such information is accurate, complete or current.
You will experience immediate and substantial dilution as a result of this offering and may experience additional dilution in the future.
If you purchase shares in this offering, the value of your shares based on our actual book value will immediately be less than the price you paid. This reduction in the value of your equity is known as dilution. This dilution occurs in large part because our existing stockholders paid less than the assumed public offering price when they acquired their shares of common stock. Based upon the issuance and sale of 1,000,000 shares of common stock by us in this offering at an assumed public offering price of $7.00 per share, you will incur immediate dilution of in the net tangible book value per share. If the underwriters exercise their over-allotment option, or if outstanding warrants to purchase shares of our common stock are exercised, investors will experience additional dilution. For more information, see “Dilution”.
There is no existing market for our securities and we do not know if one will develop to provide you with adequate liquidity.
Prior to this offering, there has not been a public market for our securities. We cannot assure you that an active trading market for shares of our common stock will develop following this offering, or if it does develop, it may not be maintained. You may not be able to sell your shares of our common stock quickly or at the market price if trading in our securities is not active. The initial public offering price for the shares of common stock offered hereby will be determined by negotiations between us and the underwriter and may not be indicative of prices that will prevail in the trading market.
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Some provisions of Florida law and our amended and restated articles of incorporation and amended and restated bylaws that will be in effect immediately prior to the completion of this offering may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our shareholders, and may prevent attempts by our shareholders to replace or remove our current management.
Upon the closing of this offering, our status as a Florida corporation and the anti-takeover provisions of the Florida Business Corporation Act, which we sometimes refer to as the FBCA, may discourage, delay or prevent a change in control even if a change in control would be beneficial to our shareholders.
The control share acquisition statute, Section 607.0902 of the FBCA, generally provides that in the event a person acquires voting shares of the company in excess of 20% of the voting power of all of our issued and outstanding shares, such acquired shares will not have any voting rights unless such rights are restored by the holders of a majority of the votes of each class or series entitled to vote separately, excluding shares held by the person acquiring the control shares or any of our officers or employees who are also directors of the company. Certain acquisitions of shares are exempt from these rules, such as shares acquired pursuant to the laws of intestate succession or pursuant to a gift or testamentary transfer, pursuant to a merger or share exchange effected in compliance with the FBCA if we are a party to the agreement, or pursuant to an acquisition of our shares if the acquisition has been approved by our board of directors before the acquisition. The control share acquisition statute generally applies to any “issuing public corporation,” which means a Florida corporation which has:
● | One hundred or more shareholders; |
● | Its principal place of business, its principal office, or substantial assets within Florida; and |
● | Either (i) more than 10% of its shareholders are resident in Florida; (ii) more than 10% of its shares are owned by residents of Florida; or (iii) one thousand shareholders are resident in Florida. |
The affiliated transaction (or so-called “business combination”) statute, Section 607.0901 of the FBCA, provides that we may not engage in certain mergers, consolidations, sales of assets, issuances of stock, reclassifications, recapitalizations, and other affiliated transactions with any “interested shareholder” for a period of three years following the time that such shareholder became an interested shareholder, unless:
● | Prior to the time that such shareholder became an interested shareholder, our board of directors approved either the affiliated transaction or the transaction which resulted in the shareholder becoming an interested shareholder; or |
● | Upon consummation of the transaction that resulted in the shareholder becoming an interested shareholder, the interested shareholder owned at least 85% of our voting shares outstanding at the time the transaction commenced; or |
● | At or subsequent to the time that such shareholder became an interested shareholder, the affiliated transaction is approved by our board of directors and authorized at an annual or special meeting of shareholders, and not by written consent, by the affirmative vote of at least two-thirds of the outstanding voting shares which are not owned by the interested shareholder. |
An “interested shareholder” is generally defined as any person who is the beneficial owner of more than 15% of our outstanding voting shares.
The voting requirements set forth above do not apply to a particular affiliated transaction if one or more conditions are met, including, but not limited to, the following: if the affiliated transaction has been approved by a majority of our disinterested directors; if we have not had more than 300 shareholders of record at any time during the three years preceding the date the affiliated transaction is announced; if the interested shareholder has been the beneficial owner of at least 80% of our outstanding voting shares for at least three years preceding the date the affiliated transaction is announced; or if the consideration to be paid to the holders of each class or series of voting shares in the affiliated transaction meets certain requirements of the statute with respect to form and amount, among other things.
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Both the control share acquisition statute and the affiliated transactions statute may have the effect of discouraging or preventing certain change of control or takeover transactions involving us.
In addition, our amended and restated articles of incorporation and amended and restated bylaws that will be in effect immediately prior to the completion of this offering contain provisions that may make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our shareholders, including transactions in which shareholders might otherwise receive a premium for their shares. These provisions include:
● | nothing in our amended and restated articles of incorporation precludes future issuances without shareholder approval of the authorized but unissued shares of our common stock; |
● | advance notice procedures apply for shareholders to nominate candidates for election as directors or to bring matters before an annual meeting of shareholders; |
● | a special meeting of shareholders can only be called by our chairman of the board of directors, our chief executive officer, our president (in the absence of a chief executive officer), a majority of our board of directors or the holders of 10% or more of all of our votes entitled to be cast on any issue proposed to be considered at the special meeting of shareholders; |
● | no provision in our amended and restated articles of incorporation or amended and restated bylaws provides for cumulative voting, which limits the ability of minority shareholders to elect director candidates; |
● | directors will only be able to be removed for cause; |
● | our amended and restated articles of incorporation authorizes undesignated preferred stock, the terms of which may be established and shares of which may be issued, without the approval of the holders of our capital stock; and |
● | certain litigation against us can only be brought in Florida. |
These provisions could discourage, delay or prevent a transaction involving a change in control of our company. These provisions could also discourage proxy contests and make it more difficult for you and other shareholders to elect directors of your choosing and cause us to take corporate actions other than those you desire. See “Description of Capital Stock.”
Our amended and restated bylaws that will be in effect immediately prior to the completion of this offering designates the state courts located within the state of Florida as the exclusive forum for substantially all disputes between us and our shareholders and the federal district courts as the exclusive forum for Securities Act claims, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.
Our amended and restated bylaws that will be in effect immediately prior to the completion of this offering provide that, unless we consent in writing to the selection of an alternative forum, the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our shareholders, (iii) any action arising pursuant to any provision of the FBCA, our amended and restated articles of incorporation or our amended and restated bylaws, or (iv) any other action asserting a claim that is governed by the internal affairs doctrine shall be a state court located within the state of Florida (or, if a state court located within the state of Florida does not have jurisdiction, the federal district court for the Middle District of Florida); provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act, or to any claim for which the federal courts have exclusive jurisdiction. Our amended and restated bylaws that will be in effect immediately prior to the completion of this offering also provide that, unless we consent in writing to the selection of an alternative forum, the U.S. federal district courts shall be the exclusive forum for the resolution of any claims arising under the Securities Act. Under the Securities Act, federal and state courts have concurrent jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act, and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Accordingly, there is uncertainty as to whether a court would enforce such a forum selection provision as written in connection with claims arising under the Securities Act.
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By becoming a shareholder in our company, you will be deemed to have notice of and have consented to the provisions of our amended and restated bylaws related to choice of forum. The choice of forum provisions in our amended and restated bylaws may limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us. Additionally, the enforceability of choice of forum provisions in other companies’ governing documents has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against us, a court could find the choice of forum provisions contained in our amended and restated bylaws to be inapplicable or unenforceable in such action. If so, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.
Securities or industry analysts may not regularly publish reports on us, which could cause the price of our securities or trading volumes to decline.
The trading market for our securities could be influenced by research and reports that industry and/or securities analysts may publish us, our business, the market or our competitors. We do not have any control over these analysts and cannot be assured that such analysts will cover us or provide favorable coverage. If any of the analysts who may cover our business change their recommendation regarding our securities adversely, or provide more favorable relative recommendations about our competitors, the price of our securities would likely decline. If any analysts who may cover our business were to cease coverage or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our securities or trading volumes to decline.
We will likely conduct further offerings of our equity securities in the future, in which case your proportionate interest may become diluted.
We will likely be required to conduct equity offerings in the future to finance our current projects or to finance subsequent projects that we decide to undertake. If our common stock shares are issued in return for additional funds, the price per share could be lower than that paid by our current shareholders. We anticipate continuing to rely on equity sales of our common stock shares in order to fund our business operations. If we issue additional common stock shares or securities convertible into shares of our common stock, your percentage interest in us could become diluted.
We may issue shares of preferred stock in the future, which could make it difficult for another company to acquire us or could otherwise adversely affect holders of our common stock, which could depress the price of our common stock.
Our certificate of incorporation authorizes us to issue one or more series of preferred stock. Our board of directors will have the authority to determine the preferences, limitations and relative rights of the shares of preferred stock and to fix the number of shares constituting any series and the designation of such series, without any further vote or action by our shareholders. Our preferred stock could be issued with voting, liquidation, dividend and other rights superior to the rights of our common stock. The potential issuance of preferred stock may delay or prevent a change in control of us, discouraging bids for our common stock at a premium to the market price, and materially adversely affect the market price and the voting and other rights of the holders of our common stock.
We have never declared or paid any cash dividends or distributions on our capital stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future.
We have never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings, if any, to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
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The declaration, payment and amount of any future dividends will be made at the discretion of the board of directors, and will depend upon, among other things, the results of our operations, cash flows and financial condition, operating and capital requirements, and other factors as the board of directors considers relevant. There is no assurance that future dividends will be paid, and, if dividends are paid, there is no assurance with respect to the amount of any such dividend.
The net proceeds to us from the sale of shares of common stock by us in this offering will be approximately $5.9 million, assuming an initial public offering price of $7.00 per share, and after deducting underwriting discounts and commissions and estimated offering expenses.
We intend to use the net proceeds from this offering as follows:
● | approximately $3.0 million to advance our clinical development programs, including: | ||
○ | approximately $2.0 million to fund our pre-clinical animal toxicology studies and CMC activities, | ||
○ | approximately $0.3 million for expenses associated with our initial IND application, and | ||
○ | approximately $0.7 million for expenses relating to our Phase I clinical trials for TELOMIR-1; and | ||
● | the remaining amounts to fund working capital and general corporate purposes. |
Based on our current operating plan, we believe that the net proceeds of this offering, together with our existing cash and cash equivalents, will be sufficient to fund our operations and our planned development and research activities through at least January 2025.
We cannot specify with certainty the particular uses of the net proceeds that we will receive from this offering or the amounts we actually spend on the uses set forth above. Pending the use of proceeds from this offering as described above, we plan to invest the net proceeds that we receive in this offering in short-term and intermediate-term interest-bearing obligations, investment-grade investments, certificates of deposit or direct or guaranteed obligations of the U.S. government. Our management will have broad discretion in the application of the net proceeds from this offering and investors will be relying on the judgment of our management regarding the application of the proceeds.
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We have never declared or paid dividends on our capital stock. We currently intend to retain all available funds and future earnings, if any, for use in the operation of our business and do not anticipate paying any dividends on our common stock in the foreseeable future. Investors should not purchase our common stock with the expectation of receiving dividends.
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The following table sets forth our cash and cash equivalents, as well as our total capitalization, as of September 30, 2023 (after giving effect to the 1-for-2.05 reverse stock split that occurred on December 11, 2023):
● | on an actual basis; | |
● | on a pro forma basis giving effect to the following: (i) the incurrence of, in the aggregate, an additional $0.5 million in debt from September 30, 2023 through November 30, 2023, and (ii) the conversion of an aggregate of $3.1 million of outstanding debt into 1,512,478 shares of common stock, as described below, on November 30, 2023; and | |
● | on a pro forma as adjusted basis to give effect to our issuance and sale of 1,000,000 shares of our common stock in this offering (assuming no exercise of the underwriters’ overallotment option) at an assumed initial public offering price of $7.00 per share, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. |
You should read this table together with our financial statements and related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” that are included elsewhere in this prospectus.
Actual | Pro Forma(1) | Pro Forma As Adjusted (2) | ||||||||||
(unaudited) | (unaudited) | (unaudited) | ||||||||||
Cash | $ | 2,452 | $ | 2,452 | $ | 5,875,666 | ||||||
Debt | ||||||||||||
Related party line of credit | $ | 1,337,914 | $ | - | $ | - | ||||||
Due to related parties | 1,293,070 | 525 | 525 | |||||||||
Stockholders’ deficit: | ||||||||||||
Preferred Stock, no par value, 100,000,000 shares authorized and none issued or outstanding, actual, pro forma, and pro forma as adjusted | - | - | - | |||||||||
Common Stock, no par value; 300,000,000 shares authorized, 28,609,814 issued and outstanding, actual and pro forma; 300,000,000 shares authorized and 29,609,814 shares issued and outstanding pro forma as adjusted | - | - | - | |||||||||
Additional paid-in capital | 6,915,000 | 10,015,579 | 15,888,793 | |||||||||
Accumulated deficit | (4,736,927 | ) | (4,736,927 | ) | (4,736,927 | ) | ||||||
Total stockholders’ deficit | 2,178,073 | 5,278,652 | 11,151,866 | |||||||||
Total capitalization | $ | 4,809,057 | $ | 5,279,177 | $ | 11,152,391 |
(1) | Includes the conversion on November 30, 2023 of (i) $1.7 million of outstanding debt due to MIRALOGX LLC into 837,841 shares of common stock, and (ii) $1.4 million of outstanding debt due to the Bay Shore Trust into 674,637 shares of common stock, each such conversion made at a conversion price of $2.05 per share (after giving effect to the 1-for-2.05 reverse stock split that occurred on December 11, 2023). See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources.” |
(2) | A $1.00 increase or decrease in the assumed initial public offering price per share of our common stock would increase or decrease each of cash, additional paid-in-capital and total capitalization on a pro forma as adjusted basis by approximately $0.92 million, assuming the number of shares of our common stock offered by us remains the same and after deducting the estimated underwriting discounts and commissions and offering expenses payable by us. |
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If you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference between the public offering price per share of our common stock and the pro forma net tangible book value per share of our common stock immediately after this offering. Dilution in pro forma net tangible book value per share to new investors represents the difference between the amount per share paid by purchasers of shares of our common stock in this offering and the pro forma net tangible book value per share of our common stock immediately after completion of this offering.
Net tangible book value per share is determined by dividing our total tangible assets less our total liabilities and common stock in stockholders’ equity (deficit) by the number of shares of our common stock outstanding. Our historical net tangible book value (deficit) as of September 30, 2023, was approximately $2.1 million, or $0.04 per share. Our pro forma net tangible book value as of September 30, 2023 was approximately $2.0 million, or $0.03 per share, adjusted to give effect to the following: (i) the incurrence of, in the aggregate, an additional $0.5 million in debt from September 30, 2023 through November 30, 2023, and (ii) the conversion of an aggregate of $3.1 million of outstanding debt into 1,512,478 shares of common stock on November 30, 2023. After giving effect to the sale by us of shares of our common stock in this offering at the assumed public offering price of $7.00 per share, and after deducting underwriting discounts and commissions, and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of September 30, 2023, would have been approximately $8.0 million, or $0.27 per share. This represents an immediate increase in pro forma net tangible book value of $0.23 per share to our existing stockholders and an immediate dilution in pro forma net tangible book value of $6.73 per share to investors purchasing shares of our common stock in this offering. The following table illustrates this dilution:
Public offering price per share of common stock | $ | 7.00 | ||||||
Pro forma net tangible book value per share as of September 30, 2023 | $ | 0.03 | ||||||
Increase per share attributable to new investors purchasing shares of common stock in this offering | 0.23 | |||||||
Pro forma as adjusted net tangible book value per share immediately after this offering | 0.27 | |||||||
Dilution in pro forma as adjusted net tangible book value per share to new common stock investors in this offering | $ | 6.73 |
The following table presents, on a pro forma as adjusted basis as of September 30, 2023, after giving effect to (i) the incurrence of, in the aggregate, an additional $0.5 million in debt from September 30, 2023 through November 30, 2023, and (ii) the conversion of an aggregate of $3.1 million of outstanding debt into 1,512,478 shares of common stock on November 30, 2023, and (iii) the sale by us of 1,000,000 shares of our common stock in this offering at the assumed offering price of $7.00 per share, the difference between the directors, officers and their affiliates and the new investors purchasing shares of our common stock in this offering with respect to the number of shares of our common stock purchased from us, the total consideration paid or to be paid to us, and the average price per share paid or to be paid to us by such persons during the last five years and new investors, before deducting underwriting discounts and commissions and estimated offering expenses payable by us:
Shares Purchased | Total Consideration | Average Price | ||||||||||||||||||
Number | Percent | Amount | Percent | Per Share | ||||||||||||||||
($ in millions) | ||||||||||||||||||||
Directors, officers and their affiliates | % | $ | % | $ | ||||||||||||||||
New investors | % | % | ||||||||||||||||||
Total | % | $ | % |
If the underwriters exercise in full their option to purchase 150,000 additional shares of our common stock from us in this offering, the pro forma as adjusted net tangible book value (deficit) per share after this offering would be $0.30 per share and the dilution to new investors in this offering would be $6.70 per share. If the underwriters exercise such option in full, the number of shares held by new investors will increase to approximately 1,150,000 shares of our common stock, or approximately 3.74% of the total number of shares of our common stock outstanding after this offering.
A $1.00 increase (decrease) in the assumed public offering price of $7.00 per share would increase (decrease) the pro forma as-adjusted net tangible book value per share by $0.03, and the dilution per share to new investors in this offering by $0.97, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.
In addition, we may choose to raise additional capital due to market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity, as common stock, or other securities that are convertible into our common stock, such as convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis provide information which our management believes is relevant to an assessment and understanding of our results of operations and financial condition. You should read the following discussion and analysis of our results of operations and financial condition together with our financial statements and related notes and other information included elsewhere in this prospectus.
In addition to historical financial information, this discussion contains forward-looking statements based upon our current expectations that involve risks and uncertainties. Our actual results could differ materially from such forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” included elsewhere in this prospectus. Additionally, our historical results are not necessarily indicative of the results that may be expected for any period in the future.
Overview
We are a pre-clinical-stage pharmaceutical company focused on the development and commercialization of TELOMIR-1, a novel small molecule being developed to function as an oral in situ therapeutic treatment for human stem cells. Our initial focus will be on treatments to inhibit the production of pro-inflammatory cytokines, such as IL-17, by oral administration of TELOMIR-1 as a therapeutic treatment for stem cells in situ. Our goal is to advance the clinical development of TELOMIR-1 in the United States for the treatment of age-related inflammatory conditions such as hemochromatosis and osteoarthritis, as well as in post-chemotherapy recovery, with our initial targeted indications being hemochromatosis and post-chemotherapy recovery.
We had net losses of $3.7 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively. We had net losses of $0.9 million and $0.1 million for the years ended December 31, 2022 and December 31, 2021, respectively.
Reverse Stock Split
Effective December 12, 2023, we completed a reverse stock split of our outstanding common stock upon the filing of our Second Amended and Restated Articles of Incorporation with the Florida Secretary of State. No fractional shares were or will be issued in connection with the reverse stock split, and all such fractional shares resulting from the reverse stock split were and will be rounded up to the nearest whole number. The shares issuable upon the exercise of our outstanding warrants, and the exercise prices of such warrants, have been adjusted to reflect the reverse stock split. Unless otherwise noted, the share and per share information in this prospectus reflects the reverse stock split.
Supply Chain Disruption / COVID-19 Business Update
Due to the residual impact of the global COVID-19 pandemic, we have taken measures to secure our research and development activities, while work in laboratories and facilities has been organized to reduce the risk of COVID-19 transmission. The extent of the impact of the COVID-19 pandemic on our business, operations and clinical development timelines and plans remains uncertain, and will depend on certain developments, including the duration and spread of the outbreak and its impact on our clinical trials, CROs, manufacturing process, supply chain, and other third parties with whom we do business, as well as its impact on regulatory authorities and our key scientific and management personnel. While we are experiencing limited financial impacts at this time, given the global economic slowdown, the overall disruption of global supply chains and the other risks and uncertainties associated with the pandemic, our business, financial condition, and results of operations ultimately could be materially adversely affected. Some of our suppliers have experienced delays in securing critical raw materials; while this has not materially impacted their services, we have observed delays in certain activities. Therefore, we continue to closely monitor the COVID-19 pandemic as we evolve our business continuity plans, clinical development plans and response strategy.
Components of our Results of Operations
Research and Development Expenses
Research and development expenses represent costs incurred to conduct research and development of our product candidate. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:
● | contracted research and manufacturing; | |
● | consulting arrangements; and | |
● | other expenses incurred to advance the Company’s research and development activities. |
Our operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities. We expect research and development expenses will increase in the future as we advance TELOMIR-1 into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development costs.
The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates.
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General and Administrative Expenses
General and administrative expenses consist of administrative functions, as well as fees paid for legal, consulting fees and facilities costs not otherwise included in research and development expense. Legal costs include general corporate legal fees and patent costs. We expect to incur additional expenses as a result of becoming a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services.
Results of Operations for nine months ended September 30, 2023 and 2022
Nine Months Ended September 30, | ||||||||
2023 | 2022 | |||||||
Revenues | $ | - | $ | - | ||||
Operating costs: | ||||||||
General and administrative expenses | 204,902 | 11,150 | ||||||
Related Party Travel costs | 1,288,000 | - | ||||||
Research and development expenses | 1,370,522 | 355,901 | ||||||
Total operating costs | 2,863,424 | 367,051 | ||||||
Interest Expense | (881,225 | ) | - | |||||
Net loss | $ | (3,744,649 | ) | $ | (367,051 | ) |
General and Administrative Expenses. We incurred general and administrative expenses of $0.2 million and $0.01 million during the nine months September 30, 2023 and September 30, 2022, respectively. General and administrative expenses consisted of consulting fees, office and rent expenses.
Related Party Travel Costs. We incurred $1.3 million in related party travel costs during the nine months ended September 30, 2023. There was no such expense incurred during the same period ended September 30, 2022. Related party travel costs consisted of a shared lease and use of an airplane with an entity under common control. The increase in related party travel costs is due to CRO and vendor site visits, plus IPO related efforts.
Research and Development Expenses. We incurred research and development expenses of $1.4 million and $0.4 million during the nine months ended September 30, 2023 and September 2022, respectively. The increase in research and development expenses during 2023 compared to 2022 is due to the expansion of pre-clinical programs during 2023.
Major components of research and development expenses during 2023 is as follows:
R&D Category | Expense | |||
Toxicology | $ | 0.5 million | ||
Pre-clinical research | $ | 0.5 million | ||
R&D consultants | $ | 0.4 million |
Interest expense. We recognized $0.9 million in interest expense during the nine months ended September 30, 2023. There was no such expense during the same period ended September 30, 2022. Interest expense during 2023 was composed of debt issuance costs related to a line of credit financing.
Results of Operations for years ended December 31, 2022 and 2021
Year ended December 31, | ||||||||
2022 | 2021 | |||||||
Revenues | $ | - | $ | - | ||||
Operating costs: | ||||||||
General and administrative expenses | 20,941 | 11,639 | ||||||
Research and development expenses | 833,206 | 126,492 | ||||||
Total operating costs | 854,147 | 138,131 | ||||||
Net loss | $ | (854,147 | ) | $ | (138,131 | ) |
General and Administrative Expenses. We incurred general and administrative expenses of $0.02 million and $0.01 million during the year ended December 31, 2022 and December 31, 2021, respectively. General and administrative expenses consisted of consulting fees, office and rent expenses.
Research and Development Expenses. We incurred research and development expenses of $0.8 million and $0.1 million during the year ended December 31, 2022 and December 31, 2021, respectively. The increase in research and development expenses during 2022 compared to 2021 is due to the expansion of pre-clinical programs during 2022 as our contract research organizations (“CROs”) began substantive pre-clinical efforts on TELOMIR-1.
Major components of research and development expenses during 2022 is as follows:
R&D Category | Expense | |||
Toxicology | $ | 0.2 million | ||
Pre-clinical research | $ | 0.4 million | ||
R&D consultants | $ | 0.2 million |
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Liquidity and Capital Resources
Sources of Liquidity
Since the Company’s inception in August 2021, we have financed our operations primarily through an unsecured line of credit with a major shareholder and an affiliated company and through a private placement of shares of our common stock that occurred during the first quarter 2023. We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources of debt and equity financing, including the proceeds from our anticipated initial public offering. We may enter into new licensing and commercial partnership agreements.
On June 15, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder, Jonnie R. Williams, Sr., and under which various of his family members are beneficiaries. Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), we have the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our initial public offering (“IPO”). Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in its assets, operations, or prospects. The Bay Share Note, together with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty. The Bay Shore Note will accrue interest at a rate equal to 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note is unsecured. As of November 30, 2023, the total amount outstanding under the Bay Shore Note was $1.4 million. The total amount outstanding was converted into 674,637 shares of our common stock on November 30, 2023 at a conversion rate of $2.05 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023) pursuant to a conversion agreement.
Since January 1, 2023, MIRALOGX, an intellectual property development and holding company owned by Bay Shore Trust, and The Starwood Trust, a separate trust established by our founder, have advanced funds on behalf of Bayshore Trust to our company in order to fund operating activities. The total amount advanced and outstanding as of November 30, 2023, was $1.7 million. These advances were converted into 837,841 shares of our common stock on November 30, 2023 at a conversion rate of $2.05 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023) pursuant to a conversion agreement.
In consideration of the loan facility provided by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant on June 15, 2023 giving the Bay Shore Trust the right to purchase up to 2,439,024 shares of common stock at an exercise price of $3.73 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023), which warrant will expire five years after the date of grant
As of September 30, 2023 and December 31, 2022, we had cash of $0.002 million and $0.001 million, respectively. In total, we have raised $1.0 million in 2023 through the issuance of equity. Substantially all our equity capital has been raised at $3.73 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023). We used $0.5 million in operating activities during the year ended December 31, 2022, compared to $0.1 million in operating activities during the year ended December 31, 2021. We expect that our existing cash and available line of credit, before our anticipated initial public offering, will be sufficient to finance our planned level of operations through April 2024.
Prior to commercializing or monetizing our product candidates, we anticipate that additional capital will be required to support ongoing activities and further phases of development. Should that be required, our available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional funding. In addition, there can be no assurance that additional funding, when and if required, will be available at commercially favorable terms, if at all.
Accordingly, we may need to raise additional capital, which may be available to us through a variety of sources, including:
● | public equity markets; | |
● | private equity financings; | |
● | commercialization agreements and collaborative arrangements; |
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● | sale of product royalty; | |
● | grants and new license revenues; | |
● | bank loans; and | |
● | public or private debt. |
Additional funding, capital, or loans (including, without limitation, milestone, or other payments from potential commercialization agreements) may be unavailable on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain technologies and drug formulations or potential markets, any of which could have a material adverse effect on us, our financial condition, and our results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities or exercise of warrants and options, the issuance of such securities would result in ownership dilution to existing stockholders.
If we are unable to attract additional funds on commercially acceptable terms, it may adversely affect our ability to achieve our development and commercialization goals, which could have a material and adverse effect on our business, results of operations and financial condition.
Cash Flows
The following table provides information regarding our cash flows for the periods presented:
Nine Months Ended September 30, 2023 | Year Ended December 31, 2022 | Period from August 2021 (Inception) to December 31, 2021 | ||||||||||
Net cash provided by (used in): | ||||||||||||
Operating activities | $ | (2,772,581 | ) | $ | (468,661 | ) | $ | (119,396 | ) | |||
Financing activities | 2,773,614 | 470,080 | 119,396 | |||||||||
Net change in cash | $ | 1,033 | $ | 1,419 | $ | - |
Net Cash Used in Operating Activities
The cash used in operating activities resulted primarily from our net losses and changes in components of accounts payable and accrued liabilities.
From August 2021 (inception) to December 31, 2021, operating activities used $0.12 million of cash, primarily due to a net loss of $0.14 million, offset by a $0.02 million in accounts payable and accrued liabilities. Accounts payable and accrued liabilities was composed of research and development payables and accrued rent expense.
For year ended December 31, 2022, operating activities used $0.47 million of cash, primarily due to a net loss of $0.85 million, offset by a $0.38 million change in accounts payable. Accounts payable was composed of research and development payables and rent expenses.
For the nine months ended September 30, 2023, operating activities used $2.3 million of cash, primarily due to a net loss of $3.8 million, offset by a $0.1 million change in accounts payable and $0.9 million in amortization of debt issuance costs. Accounts payable was composed of research and development payables, rent and legal expenses.
Net Cash Provided by Financing Activities
From August 2021 (inception) to December 31, 2021, financing activities provided $0.12 million of cash, resulting from $0.12 million in amounts due to a related party. Related party advances were used to pay research and development payables.
For year ended December 31, 2022, financing activities provided $0.47 million of cash, resulting from $0.46 million in amounts due to a related party, $0.06 million in collection of stock subscription receivable, offset by a $0.05 million in deferred offering costs.
For the nine months ended September 30, 2023, financing activities provided $2.8 million of cash, resulting from $0.9 million in issuance of warrants, net of deferred offering costs, offset by $1.9 million in advances to affiliates.
Future Funding Requirements
To date, we have not generated any revenue from product sales. We do not expect to generate revenue from product sales unless and until we successfully complete pre-clinical and clinical development of, receive regulatory approval for, and commercialize a program and we do not know when, or if at all, that will occur. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the pre-clinical activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any programs, we expect to incur significant expenses related to product sales, marketing, and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Further, upon the completion of this offering, we expect to incur additional costs associated with operating as a public company. The timing and amount of our operating expenditure will depend largely on the factors set out above. For more information, see the section titled “Risk Factors-Risks Related to Our Operations and Financial Condition.”
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Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including, but not limited to:
■ the rate of progress in the development of our TELOMIR-1 program and other development programs;
■ the scope, progress, results and costs of pre-clinical studies and clinical trials for any other current and future programs;
■ the number and characteristics of programs and technologies that we develop or may in-license;
■ the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our programs for which we receive marketing approval;
■ the costs necessary to obtain regulatory approvals, if any, for any approved products in the United States and other jurisdictions, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where approval is obtained;
■ the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
■ the continuation of our existing licensing arrangements and entry into new collaborations and licensing arrangements;
■ the costs we incur in maintaining business operations;
■ the costs of hiring additional clinical, quality control, manufacturing and other scientific personnel;
■ the costs adding operational, financial and management information systems and personnel;
■ the costs associated with being a public company;
■ the revenue, if any, received from commercial sales of our programs for which we receive marketing approval;
■ the effect of competing technological and market developments; and
■ the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for programs.
Identifying potential programs, product candidates, conducting pre-clinical studies and clinical trials is a time consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our programs, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
Recently Issued and Adopted Accounting Pronouncements
On January 1, 2022, we adopted Accounting Standards Codification (“ASC”) Topic 842 ASC Topic 842, which is intended to improve financial reporting about leasing transactions. Under the standard, organizations that lease assets, referred to as “Lessees” shall recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. In addition, the standard requires disclosures including financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. We do not expect that the adoption of Topic 842 will materially impact our Company’s operations.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under Generally Accepted Accounting Principles (GAAP) and SEC rules.
Quantitative and Qualitative Disclosures about Market Risk
We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate risks and inflation risks. Periodically, we maintain deposits in accredited financial institutions in excess of the FDIC federally insured limits. We deposit our cash in financial institutions that we believe have high credit quality and have not experienced any losses on such accounts and do not believe we are exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Interest Rate Risk
Our cash consists of cash in readily available checking accounts. We may also invest in short-term money market fund investments. Such interest-earning instruments carry a degree of interest rate risk; however, historical fluctuations in interest income have not been significant.
Inflation Risk
Inflation generally affects us by increasing our cost of labor and research and development contract costs. We do not believe inflation has had a material effect on our results of operations during the periods presented.
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Overview
We are a pre-clinical-stage pharmaceutical company focused on the development and commercialization of TELOMIR-1, a novel small molecule being developed to function as an oral in situ therapeutic treatment for human stem cells. Based on our pre-clinical studies and if approved by the FDA and comparable foreign regulators, we believe that TELOMIR-1 may effectively serve as a metal enzyme inhibitor of essential metals such as zinc and copper. These essential metals play an important role in the production and function of many enzymatic reactions and the modulation of key cellular pathways. In particular, zinc is essential to the function of pro-inflammatory cytokines such as Interleukin-17, or IL-17, that play a role in a host of age-related inflammatory conditions such as hemochromatosis and osteoarthritis as well as in post-chemotherapy health problems. IL-17 is a type of pro-inflammatory cytokine, and while the pro-inflammatory properties of IL-17 are key to its host-protective capacity, unrestrained IL-17 signaling is associated with immunopathology, inflammatory disease and cancer progression. Our initial focus will be on treatments to inhibit the production of pro-inflammatory cytokines, such as IL-17, by oral administration of TELOMIR-1 as a therapeutic treatment for stem cells in situ. To the best of our knowledge, there is no approved oral IL-17 inhibitor. Our goal is to advance the clinical development of TELOMIR-1 in the United States for the treatment of age-related inflammatory conditions such as hemochromatosis and osteoarthritis, as well as in post-chemotherapy recovery, with our initial targeted indications being hemochromatosis and post-chemotherapy recovery.
Pluripotent stem cells are a type of stem cells that have the ability to undergo self-renewal and to give rise to various cell types of the tissues of the body. Based on pre-clinical studies, we believe that TELOMIR-1 may have the potential to protect stem cells in situ by reducing the overload of metals such as zinc and copper that accompany age-related inflammatory conditions and certain cancers by modulating pro-inflammatory cytokines such as IL-17. If demonstrated in clinical trials and approved by the FDA and comparable foreign regulators, we believe that TELOMIR-1 may protect the stem cells by elongating and stimulating the telomeres to sustain self-renewal of stem cells. Telomeres are repetitive DNA sequences at the end of chromosomes that protect the chromosomes from becoming frayed or tangled. Each time a cell divides, the telomeres become slightly shorter, and eventually they become so short that the cell can no longer divide, with the result being that the cell dies. Effectively, telomeres protect the ends of our chromosomes by forming a cap, much like the plastic tip on shoelaces, thereby allowing the chromosome to be replaced properly during cell division.
TELOMIR-1 is currently under investigation to provide a potential therapeutic intervention against age-related inflammatory conditions such as hemochromatosis, as well as for post-chemotherapy recovery, by interrupting and preventing the IL-17 induced inflammatory pathways that create the systemic imbalance of cellular metals. Our pre-clinical studies suggest that TELOMIR-1 may inhibit the concentration and accumulation of metals such as zinc and copper in the serum that drive the hyperactivity of pro-inflammatory cytokines such as IL-17. Our studies suggest that TELOMIR-1 may achieve this outcome by selectively binding to metal ions in a dose dependent manner, slowing enzyme reactivity, and protecting and lengthening telomeres in the human chromosome. We believe that TELOMIR-1 has potential as a non-toxic oral enzyme inhibitor that may regulate the overactivity of the enzymes caused by excessive metal reactivity.
To date, we have completed several pre-clinical proof-of-concept studies with respect to TELOMIR-1 that were designed to demonstrate that TELOMIR-1 is not mutagenic and has good biological and metal binding capabilities. These studies included an Ames test for the TELOMIR-1 compound and several Eurofins BioMap studies.
We were organized as a Florida corporation in August 2021 for the purpose of pursuing the development and commercialization of TELOMIR-1 in the United States in human applications. We were originally incorporated under the name “Metallo Therapies Inc.” and changed our name to “Telomir Pharmaceuticals, Inc.” in October 2022. Our rights to develop and commercialize TELOMIR-1 are licensed to us under a license agreement with MIRALOGX under which we have the exclusive right to develop and commercialize TELOMIR-1 for human and non-human applications in the United States. See “—Intellectual Property.”
We are an early-stage company that had net losses of $3.9 million for the nine months ended September 30, 2023, $0.85 million for the year ended December 31, 2022, and $0.14 million for the year ended December 31, 2021.
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In Situ Therapeutic Treatment of Stem Cells
Stem cells have the potential to renew themselves. They can develop into many different cell types in the body during early and adult life. Pluripotent stem cells have the ability to differentiate into all of the cells of the adult body. Since pluripotent stem cells are undifferentiated, they do not have any tissue-specific characteristics that allow them to perform specialized functions. Given their unique regenerative abilities and limited quantities in the adult human body, in situ treatment and protection of stem cells may provide an important therapeutic mechanism for treatment of disease.
Metal Overload and Telomere Length
Research studies have demonstrated that metal overload in stem cells could severely impair the proliferation of pluripotent stem cells through excessive DNA damage. Furthermore, many pro-inflammatory cytokine-induced conditions create an imbalance of cellular metals such as zinc and copper. This metal imbalance may impact the length of telomeres in stem cells and impact their viability and survival.
Hemochromatosis
According to the Centers for Disease Control (“CDC”), hemochromatosis is a disorder in which the body builds up too much iron in the skin, heart, liver, pancreas, pituitary glands, and joints. This overload of iron is toxic to the body, and over time, the high levels of iron can damage tissues and organs and lead to conditions such as liver damage, liver cancer, heart problems, arthritis, and diabetes. Hemochromatosis is most commonly hereditary and caused by certain variants in the HFE gene. In the U.S., about 1 in 300 non-Hispanic white persons have hereditary hemochromatosis, with lower rates among other races and ethnicities. Hemochromatosis can also result in persons who need multiple blood transfusions, which can lead to excess iron build up in a condition also referred to as “iron overload.” Other conditions associated with high iron levels include inflammatory conditions, chronic kidney disease, and autoimmune disorders.
Hemochromatosis is a life-long condition requiring regular treatment to avoid long-term serious effects with poor pharmacologic options. The most used treatment for hemochromatosis is phlebotomy, a procedure to remove some of the patient’s blood. Phlebotomy is relatively inexpensive, well accepted, and well tolerated, but it requires regular visits to health care professionals and blood draws and may not be appropriate for all patients. Additionally, iron chelators are sometimes used, but they have limited use due to gastrointestinal and kidney toxicity issues. Despite the presence of these potential treatment options, we believe significant unmet need remains such that an innovative therapy achieving reduction in iron overload with a new profile could be subject to widespread use.
If approved by the FDA and comparable foreign regulators, we are pursuing TELOMIR-1 as a metal enzyme inhibitor that may selectively bind metal ions to inhibit pro-inflammatory cytokines such as IL-17 and protect telomeres and that aims to increase the average telomere length, or ATL, by selectively binding iron and reducing blood iron levels, therefore supporting the ability to treat hemochromatosis. On average, about 750,000 US patients express one or more iron overload symptoms. There are 2 types of hemochromatosis, with the following patient mix: 150,000 primary hemochromatosis and 65,000 secondary hemochromatosis confirmed diagnoses in the United States. Over 150,000 patients have sought treatment since 2018, with most receiving phlebotomy, which is the withdrawal of blood to bring iron to normal levels. At present, 99% of hemochromatosis patients receive phlebotomy, with a portion of patients also receiving iron chelators as a co-treatment. Note that in the last 12 months, there have been 76,000 confirmed diagnoses of hereditary hemochromatosis and approximately 1% of hemochromatosis patients received deferasirox or deferoxamine off-label for 12 weeks (1 year for primary). Certain sub-groups of hemochromatosis patient may benefit from TELOMIR-1 in addition to phlebotomy, which is the current standard of care for the treatment of hemochromatosis if contraindicated for this treatment method. Lastly, iron chelation is used off-label, poorly tolerated and has toxic long-term effects. In pre-clinical stage testing, TELOMIR-1 is potentially has more effective metal complexing than Doxycycline, an FDA-approved MMP inhibitor. However, pre-clinical data may prove inaccurate and is not necessarily indicative of future results.
Post-Chemotherapy Recovery
Post-chemotherapy recovery from adverse effects of antineoplastic treatments is often important for cancer therapy success. While chemotherapy treatment can be highly effective for cancer, it can also come with many side effects, as chemotherapy drugs destroy both cancerous and healthy cells. According to a study published in the British Journal of Clinical Pharmacology1, of approximately 650,000 patients who use chemotherapy each year, only a fraction use drugs for side effects. Side effects and toxicity of chemotherapy lead to reduced compliance, and therefore treating chemotherapy side effects can increase compliance. Common barriers center around the complexity of post-chemotherapy side effects, obtaining reimbursement without significant outcomes, avoiding pauses, and/or delays in treatment due to side effects.
We are investigating the use of TELOMIR-1 as a potential complementary treatment for patients receiving chemotherapy in the form of a twice daily, oral regimen to inhibit pro-inflammatory cytokines and to reduce blood iron levels, potentially enabling more effective adherence and improved outcomes. In exploratory early discovery studies, proof of concept was demonstrated, and the animal studies are pending. Post-chemotherapy recovery space contains several treatments that are used symptomatically based on the nature or severity of side effects.
Post-chemotherapy recovery may present several potential unmet commercial needs for TELOMIR-1. There is potential to enable a more rapid recovery of patients receiving chemotherapy, improving adherence with chemotherapy regimens. Additionally, as current recovery management is based on severity and treated as needed, we believe that TELOMIR-1 could potentially be used as a preventative measure. As a complementary treatment, side effect reduction in post-chemotherapy is important to minimize patient burden while improving treatment outcomes.
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Our Strategy
Our goal is to develop and commercialize new treatment options for treatment of age-related inflammatory conditions such as hemochromatosis as our initial clinical focus and to thereafter expand the development of TELOMIR-1 to post-chemotherapy recovery as well as broader range of other age-related inflammatory diseases and conditions such as osteoarthritis. The key elements of our strategy to achieve this goal include:
● | Advancing TELOMIR-1 through clinical development and approval for hemochromatosis. Our product candidate, TELOMIR-1, is in pre-clinical studies. Existing treatment options for hemochromatosis have significant limitations, and, if approved, we believe TELOMIR-1 may represent a major therapeutic advancement for patients. | |
● | Explore the potential of TELOMIR-1 for Post-Chemotherapy Recovery. TELOMIR-1 may represent a major therapeutic advancement for post-chemotherapy patients. Our product candidate, TELOMIR-1, may have the potential in post-chemotherapy recovery. | |
● | Continuing pre-clinical development of TELOMIR-1 across a range of inflammatory diseases associated with cellular aging. Given the impact of telomere cap regrowth on a variety of age-related inflammatory diseases, we intend to explore TELOMIR-1’s broader potential, as we believe TELOMIR-1 may have potential in several inflammatory diseases, such as osteoarthritis, associated with a range of metabolic and geriatric related conditions. | |
● | Exploring strategic collaborations to maximize the value of TELOMIR-1. We plan to explore collaborations opportunistically to maximize the value of TELOMIR-1. We intend to retain significant economic and commercial rights to our programs. |
Completed Proof-of-Concept and Pre-Clinical Studies
The Ames Test - Computational Mutagenicity
The use of in silico (computational) tools to predict toxicity has increased significantly and has become well-established not only in the pharmaceutical industry, but also in the chemical and cosmetic industries. This is specifically reflected in the area of potential genotoxic impurities and finalization in 2015 of the ICH M7 guidance, which was the first regulatory document that supports use of in silico tools as an initial surrogate for conducting in vitro or in vivo testing (ICH M7_Sept 5, 2015). The purpose of the M7 guidance is to aid in the identification and characterization of impurities with mutagenic risk and to outline the control strategy for the various classes (Class 1-5) of compounds in order to limit potential carcinogenic risk to humans. According to ICH M7, “the absence of structural alerts from two complementary quantitative structure activity relationship (“(Q)SAR”) methodologies (expert rule-based and statistical) is sufficient to conclude that the impurity is of no mutagenic concern, and no further testing is recommended.
The primary endpoint of concern in the ICH M7 guidance is DNA reactive mutagenicity, with the Ames bacterial mutagenicity assay being the preferred assay for this endpoint. The structure based in silico evaluations demonstrate reasonable ability to differentiate mutagens from non-mutagens with generally high concordance when compared with Ames assay results (Sutter et al, 2013).
The primary purpose of this study was to evaluate the bacterial mutagenicity of three potential drug candidates by testing the structures in at least two complementary in silico software programs, followed by expert review of the in silico data. The emphasis of the overall computational assessment of toxicity was placed on the potential for DNA reactive mutagenicity, in accordance with the ICH M7 guidance.
In rule-based systems, TELOMIR-1 was predicted non-reactive (no mutagenic concern. Therefore, according to ICH M7 criteria with negative predictions in two complementary in silico systems, it is considered non-mutagenic (Class 5).
The Ames Test - Computational Mutagenicity study was not powered for statistical significance.
BioMap Studies
The BioMAP® Platform provides an unbiased, target-agnostic and data-driven approach to understanding the effect of mono- or combination therapies on human disease models and translational biomarkers. Validated with clinically approved drugs and known test agents, the BioMAP Platform is powered by human primary cultures or co-cultures stimulated to recapitulate specific disease states and qualified with clinically approved and investigative test agents, a Reference Database of over 4,500+ molecules, data analytics, and expert interpretation to provide clients with actionable insights.
System Name | Icon | Human Cell Types | Stimulation | Disease/Tissue Relevance | Biomarker Readouts | System Description | ||||||
3C | ![]() |
Venular endothelial cells | TNFα, IL-1β, IFNγ | Cardiovascular Disease, Chronic Inflammation | CCL2/MCP-1, CD106/VCAM-1, CD141/Thrombomodulin, CD142/Tissue Factor, CD54/ICAM-1, CD62E/E-Selectin, CD87/uPAR, CXCL8/IL-8, CXCL9/MIG, HLA-DR, Proliferation, SRB | The 3C system models Th1 type vascular inflammation and is an anti-angiogenic environment that promotes monocyte and T cell adhesion and recruitment. The 3C system is relevant for chronic inflammatory diseases, vascular inflammation and restenosis. | ||||||
4H | ![]() |
Venular endothelial cells | IL-4, Histamine | Autoimmunity, Allergy, Asthma | CCL26/Eotaxin-3, CCL2/MCP-1, CD106/VCAM-1, CD62P/P-Selectin, CD87/uPAR, SRB, VEGFR2 | The 4H system models Th2 type vascular inflammation and is a pro-angiogenic environment that promotes mast cell, basophil, eosinophil, T and B cell recruitment. The 4H system is relevant for diseases where Th2-type inflammatory conditions play a role such as allergy, asthma, and ulcerative colitis. | ||||||
LPS | ![]() |
Venular endothelial cells, Peripheral blood mononuclear cells | TLR4 ligand | Chronic Inflammation, Cardiovascular Disease | CCL2/MCP-1, CD106/VCAM-1, CD141/Thrombomodulin, CD142/Tissue Factor, CD40, CD62E/E-Selectin, CD69, CXCL8/IL-8, IL-1 alpha, M-CSF, sPGE2, SRB, sTNF-alpha | The LPS system models Th1 type chronic inflammation and monocyte activation responses. The LPS system is relevant to chronic inflammatory conditions where monocytes play a key role including atherosclerosis, restenosis, rheumatoid arthritis, and metabolic diseases. | ||||||
SAg | ![]() |
Venular endothelial cells, Peripheral blood mononuclear cells | TCR ligands (1X) | Chronic Inflammation, Autoimmune Disease | CCL2/MCP-1, CD38, CD40, CD62E/E-Selectin, CD69, CXCL8/IL-8, CXCL9/MIG, PBMC Cytotoxicity, Proliferation, SRB | The SAg system models Th1 type chronic inflammation and T cell effector responses related to T cell proliferation and activation in the context of the vascular endothelium. Modeling chronic inflammation of the Th1 type and T cell effector responses, the SAg systemis relevant for T-cell driven inflammatory conditions including organ transplantation, rheumatoid arthritis, psoriasis, Crohn’s disease and hematological oncology. | ||||||
BT | ![]() |
Peripheral blood mononuclear cells, B cells | α-lgM, TCR ligands (0.001X, sub-mitogenic levels) | Asthma, Oncology, Autoimmunity, Allergy | B cell Proliferation, PBMC Cytotoxicity, Secreted lgG, sIL-17A, sIL-17F, sIL-2, sIL-6, sTNF-alpha | The BT system models the T cell dependent B cell proliferation, activation and class switching that occurs in the germinal centers of secondary lympnoid organs. The BT system is relevant for indications in which B cell activation and antibody production have been implicated including systemic lupus erythematosus (SLE), hematological oncology, autoimmune indications, asthma and allergy. | ||||||
BF4T | ![]() |
Bronchial epithelial cells, Dermal fibroblasts | IL-4, TNFα | Fibrosis, Lung Inflammation, Asthma, Allergy | CCL26/Eotaxin-3, CCL2/MCP-1, CD106/VCAM-1, CD54/ICAM-1, CD90, CXCL8/IL-8, IL-1 alpha, Keratin 8/18, MMP-1, MMP-3, MMP-9, PAI-I, SRB, tPA, uPA | The BF4T system models Th1 type lung inflammation and is an environment that promotes the recruitment of eosinophils, mast cells and basophils as well as effector memory T cells. The BF4T system is relevant for allergy and asthma, pulmonary fibrosis, as well as COPD exacerbations. | ||||||
BE3C | ![]() |
Bronchial epithelial cells | IL-1β, IFNγ, TNFα | COPD, Lung Inflammation | CD54/ICAM-1, CD87/uPAR, CXCL10/IP-10, CXCL11/I-TAC, CXCL8/IL-8, CXCL9/MIG, EGFR, HLA-DR, IL-1 alpha, Keratin 8/18, MMP-1, MMP-9, PAI-I, SRB, tPA, uPA | The BE3C system models Th1 type lung inflammation and is an environment that promotes monocyte and T cell adhesion and recruitment. The BE3C system is relevant for sarcoidosis and pulmonary responses to respiratory infections. | ||||||
CASM3C | ![]() |
Coronary artery smooth muscle cells | IL-1β, IFNγ, TNFα | Cardiovascular Inflammation, Restenosis | CCL2/MCP-1, CD106/VCAM-1, CD141/Thrombomodulin, CD142/Tissue Factor, CD87/uPAR, CXCL8/IL-8, CXCL9/MIG, HLA-DR, IL-6, LDLR, M-CSF, PAI-I, Proliferation, Serum Amyloid A, SRB | The CASM3C system models Th1 type vascular inflammation and is an environment that promotes monocyte and T cell recruitment. The CASm3C system is relevant for chronic inflammatory diseases, vascular inflammation and restenosis. | ||||||
HDF3CGF | ![]() |
Dermal fibroblasts | IFNγ, TNFα, IL-1β, EGF, bFGF, PDGF-BB | Fibrosis, Chronic Inflammation | CCL2/MCP-1, CD106/VCAM-1, CD54/ICAM-1, Collagen I, Collagen III, CXCL 10/IP-10, CXCL11/1-TAC, CXCL8/IL-8, CXCL9/MIG, EGFR, M-CSF, MMP-1, PAI-I, Proliferation_72hr, SRB, TIMP-1, TIMP-2 | The HDF3CGF system models wound healing and matrix/tissue remodeling in the context of Th1-type inflammation. The HDF3CGF system is relevant for various diseases including fibrosis, rheumatoid arthritis, psoriasis as well as stromal biology in tumors. | ||||||
KF3CT | ![]() |
Keratinocytes, Dermal fibroblasts | IL-1β, IFNγ, TGFβ, TNFα | Dermatitis, Psoriasis | CCL2/MCP-1, CD54/ICAM-1, CXCL 10/IP-10, CXCL8/IL-8, CXCL9/MIG, IL-1 alpha, MMP-9, PAI-I, SRB, TIMP-2, uPA | The KF3CT system models model Th1 type cutaneous inflammation and is an environment that promotes monocyte and T cell adhesion and recruitment. The KF3CT system is relevant for cutaneous responses to tissue damage caused by mechanical, chemical, or infectious agents as well as certain states of psoriasis and dermatitis. | ||||||
MyoF | ![]() |
Lung fibroblasts | TGFβ, TNFα | Wound Healing, Matrix Remodeling, Fibrosis, Chronic Inflammation | Alpha-SM Actin, bFGF, CD106/VCAM-1, Collagen I, Collagen III, Collagen IV, CXCL8/IL-8, Decorin, MMP-1, PAI-I, SRB, TIMP-1 | The MyoF system models general myofibroblast differentiation and tissue remodeling relevant for multiple fibrotic diseases. Biomarker readouts capture impacts on translationally relevant matrix remodeling, tissue repair and inflammation related responses in fibrotic tissue. | ||||||
Mphg | ![]() |
Macrophages, Venular endothelial cells | TLR2 ligand | Chronic Inflammation, Restenosis, Cardiovascular Disease | CCL2/MCP-1, CCL3/MIP-1 alpha, CD106/VCAM-1, CD40, CD62E/E-Selectin, CD69, CXCL8/IL-8, IL-1 alpha, M-CSF, sIL-10, SRB, SRB, SRB-Mphg | The /Mphg system models Th1 type chronic inflammation and macrophage activation responses. The /Mphg system is relevant to inflammatory conditions where monocytes play a key role including atherosclerosis, restenosis, rheumatoid arthritis, and other chronic inflammatory conditions. |
https://www.eurofinsdiscovery.com/solution/biomap-platform
This study was conducted with the assistance of Eurofins, a third-party vendor.
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Eurofins BioMap® Diversity PLUS
BioMap® Diversity PLUS panel of human primary cell-based systems designed to model complex human tissue and diseases. The studies below with BioMap were conducted to investigate the anti-cancer activities versus Rapamycin. The BT system models the T cell proliferation activation and is relevant for indications in which B cell activation and antibody production have been implicated including autoimmune disorders. Rapamycin is selected to compare against TELOMIR-1 because rapamycin and TELOMIR-1 both inhibit similar cytokines involved in the immune responses. The common proteins affected between TELOMIR-1 and rapamycin are several pro-inflammatory cytokines.
The studies were not powered for statistical significance. They had no relationship to hemochromatosis. This study was conducted with the assistance of Eurofins, a third-party vendor.
BT | ![]() |
Peripheral blood mononuclear cells, B cells | α-lgM, TCR ligands (0.001X, sub-mitogenic levels) | Asthma, Oncology, Autoimmunity, Allergy | B cell Proliferation, PBMC Cytotoxicity, Secreted lgG, sIL-17A, sIL-17F, sIL-2, sIL-6, sTNF-alpha | The BT system models the T cell dependent B cell proliferation, activation and class switching that occurs in the germinal centers of secondary lympnoid organs. The BT system is relevant for indications in which B cell activation and antibody production have been implicated including systemic lupus erythematosus (SLE), hematological oncology, autoimmune indications, asthma and allergy. |
BioMAP® Diversity PLUS® Data Analysis Report: TELOMIR-1 versus Rapamycin
Biological and Disease Relevance Activity | Decreased Activity | Increase Activity | Modulated Activity | |||
Inflammation-related activities | VCAM-1, ITAC, Psel, SAA, MCP-1, IL6, MIG, Eot3 | sPGE2 | sTNFa, IL8 | |||
Immunomodulatory activities | HLA-DR, sIgG, sIL-2, CD38, sIL-6, CD40, sIL-17A, sIL17F, sIL-10 | CD69 | ||||
Tissue Remodeling Activities | TIMP1, PAI-I, CoI-III, CoI-IV | |||||
Hemostasis-related activities | TM | TF | ||||
Other activities | LDLR |
The study showed that TELOMIR-1 is an antiproliferative (suppress malignant cells) to human primary endothelial cells and fibroblasts vs Rapamycin.
This study was conducted with the assistance of Eurofins, a third-party vendor.
BioMAP® panels consist of human primary cell-based systems designed to model different aspects of the human body in an in vitro format. Rapamycin was approved in 1999 to prevent rejection of transplanted organs. There are approximately 1,073 clinical trials including rapamycin located on clinicaltrials.gov.
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BioMAP® Colorectal Cancer (CRC) Data Report: TELOMIR-1 vs. Rapamycin
Biological and Disease Relevance Activity | Decreased Activity | Increase Activity | Modulated Activity | |||
Inflammation-related activities | sTNFa, VCAM-1, IP-10, MCP-1, MIG | |||||
Matrix remodeling activities | TIMP2, CoI-I, COL-IV, MMP9 | CoI-III | ||||
Angiogenesis-related activities | PAI-I, tPA, uPA | sVegF | ||||
Tumor-related activities | CEACAM5, Keratin 20 | |||||
Immune-related activities | sIFNg, sGranB, sIL-10, sIL-2, sIL-6, CD40, CD69, sIL17-A |
In the Colorectal Cancer study, TELOMIR-1 was not cytotoxic at the concentrations tested in this study and was broadly active in the BioMAP Colorectal Cancer Panel with 32 activities versus Rapamycin.
TELOMIR-1 impacted inflammation-related, matrix remodeling, angiogenesis-related, tumor-related, and immune-related activities.
This study was conducted with the assistance of Eurofins, a third-party vendor.
BioMAP® Non-small Cell Lung Carcinoma (NSCLC) Data Report: TELOMIR-1 vs. Rapamycin
Biological and Disease Relevance Activity | Decreased Activity | Increase Activity | Modulated Activity | |||
Inflammation-related activities | sTNFa, VCAM-1, sMDC | IP-10 | ||||
Matrix remodeling activities | EGFR, CoI-III, HGF | |||||
Angiogenesis-related activities | uPA | tPA | sVegF | |||
Immune-related activities | sIL-4, sIFNg, sGranB, sIL-10, sIL-2, sIL17-A | sIL-13 |
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In the NSCLC study, TELOMIR-1 was active with 24 annotated readouts, 17 of which were in the StroNSCLC system, impacting inflammation-related, matrix remodelling, angiogenesis-related, and immune-related activities.
The Eurofins in vitro studies showed that TELOMIR-1 was more active against malignant cells, colorectal cancer cells, and lung cancer cells than rapamycin. Other studies showed that versus Doxycycline TELOMIR-1 was more active at metal complexing.
This study was conducted with the assistance of Eurofins, a third-party vendor.
TELOMIR-1 complexing ability compared to doxycycline study
Metal Complexing of TELOMIR-1 vs Doxycycline
Drug | Metal | Metal | LogK1 | K1 | ||||||||
TELOMIR-1 | Pb (II) | Lead | 4.2 | 15,849 | ||||||||
TELOMIR-1 | Cd (II) | Calcium | 4.62 | 41,687 | ||||||||
TELOMIR-1 | Zn (II) | Zinc | 5.0 | 91,201 | ||||||||
TELOMIR-1 | Co (II) | Cobalt | 5.0 | 398,107 | ||||||||
TELOMIR-1 | Ni (II) | Nickel | 6.6 | 3,981,072 | ||||||||
Doxycycline | Zn (II) | Zinc | 4.7 | 50,119 |
K1 = stability constant (also called formation constant or binding constant) that represents the strength of association of compound with metal ion. The K1 measures the strength of the interaction between the TELOMIR and each metal when they come together to form the complex. TELOMIR-1 complexing ability compared to doxycycline and Zinc complexing ability. TELOMIR-1 is a good overall metal chelator. Results indicate TELOMIR-1 is potentially more effective than Doxycycline in Zinc complexing or binding.
This study was not powered for statistical significance. This study started in Q1 2023 and was completed in Q2 2023.
This study was conducted with the assistance of the University of North Carolina - Wilmington, a third party vendor.
Extensive analysis is being conducted on the potential of TELOMIR-1 to protect and treat stem cells and lower blood ferritin. We have also completed a variety of toxicology studies, and several others are ongoing or planned. Upon completion of the toxicology studies, we plan to submit to the FDA an IND for TELOMIR-1, focused on investigating TELOMIR-1 for the treatment of hemochromatosis. We may consider a second IND for post-chemotherapy recovery.
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(Source: Rini, D. John Hopkins School of Medical Arts)
In silico Affinity Studies
Subject to approval by the FDA and comparable foreign regulators, our pre-clinical studies demonstrate that TELOMIR-1 may uniquely and selectively bind critical metals to interrupt enzyme function, and may return cellular metals like zinc, copper and, iron to homeostasis. TELOMIR-1 may selectively affect the key cytokine-driven inflammatory processes that drive the concentration and accumulation of zinc, copper and iron in the serum that affects diseases like hemochromatosis and cancer. However, pre-clinical data may prove inaccurate and is not necessarily indicative of future results and drug safety and efficacy is within the sole authority of the FDA and comparable foreign regulators. If approved by the FDA or applicable foreign regulatory bodies, we believe that TELOMIR-1 may have the potential to be a therapeutic intervention against hemochromatosis and cancer by interrupting and preventing the enzymatic actions that create the systemic imbalance of cellular metals that allows elevated reactive oxygen species to oxidize and erode the protective DNA telomere caps.
The graphic on the left below represents the structure of TELOMIR-1. Fe2+ (iron) is embedded in the structure (orange) and is attracted by the nitrogen (blue) in each of the 5-member rings and 1 six-member ring.
The graphic on the right below represents is Fe2+ (iron) and the other molecules binding to the nitrogen (blue).
Source: InSilicoTrials; Insilico Affinity Computations Between TELOMIR-1 and DIEN to Fe2+ ions in Water Solution.
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This in silico study, conducted in the third quarter of 2023, aimed to investigate the affinity of TELOMIR-1 for Fe2+.The results of the affinity tests show that TELOMIR-1 has a higher affinity to Fe2+ in comparison to Diethylenetriamine (“DIEN”), but for 1 micromolar Fe2+ more than 10 micro molar of TELOMIR-1 is needed to form an effective complex. Additionally, Fe2+ is the bound form of iron in the human body; the majority of biological iron in the free state occurs in the Fe3+ (Ferric) state, and in the context of Hemochromatosis the excess iron is in the ferric form, hence the chelating agents currently used primarily target Fe3+. This was a computerized computation; therefore, serum was not used. Water is a complex substance that can mix with various substances, especially certain charged molecules including iron complexes, in many different ways. Currently, scientists have ways to study and understand these interactions, ranging from basic calculations to very detailed ones that look at tiny molecular details. To make sure these methods are accurate, scientists need a standard test to compare it with. Accordingly, we decided to use a database called NIST SRD 46 (A Critically Selected Stability Constants of Metal Complexes database) to get information about how well iron sticks to various molecules and find one that has similar binding properties to our drug, TELOMIR-1. We narrowed our search down to diethylenetriamine (DIEN). We picked DIEN with a pH of 6.33, or energy value of 36.11 kJ/mol, as our benchmark. This study was conducted with the assistance of InSilicoTrials, a third-party vendor.
Completed Pre-Clinical Toxicology Studies
The table below lists the type, species, purpose and results of our completed pre-clinical toxicology studies. Each of these studies began during the first quarter of 2023 and were completed during the third quarter of 2023. This study was conducted with the assistance of Frontage Laboratories, Inc., a third-party vendor.
Type of Study | Species (in vitro studies) |
Purpose | Results | |||
Metabolite Identification | CD-1 mouse, SD-rat, Beagle dog, Cynomolgus monkey and human | To determine the metabolic pathways of TELOMIR-1 across species | TELOMIR-1 showed little/no metabolism by CYP enzymes. | |||
TELOMIR-1 Reaction Phenotyping Using Liver S9 | Mouse, rat, monkey and human liver | Identification of the Enzymes Involved in the Metabolism of TELOMIR-1 Using Hepatic S9 Fraction | The compound does not appear to be a substrate of cytochrome P450 enzymes. There was little/no metabolism of TELOMIR-1 in dog S9, consistent with the fact that the dog lacks aldehyde oxidase activity. | |||
Cytochrome P450 (CYP) reaction phenotyping | Human | To evaluate the potential of TELOMIR-1 to be a victim of drug-drug interactions | TELOMIR-1 was extensively metabolized in mouse, rat, monkey, dog, and human hepatocytes. | |||
Cytochrome P450 (CYP) inhibition | Human | To evaluate the potential of TELOMIR-1 to cause drug-drug interactions as a perpetrator | TELOMIR-1 (up to 100 µM) did not inhibit any of the tested CYP enzymes. | |||
Plasma protein binding | CD-1 mouse, SD rat, Beagle dog, Cynomolgus monkey and human | To know the unbound fraction of TELOMIR-1 in plasma | Not highly Protein Bound | |||
Maximum Tolerated Dose and 7 Day Repeat-Dose Toxicity/Toxicokinetic Study in Rats | Sprague Dawley Rats | To evaluate and characterize the toxicokinetic and toxicity of TELOMIR-1 and to estimate the MTD of TELOMIR-1 following | The MTD following 7 days of repeated administration of TELOMIR-1 at dose levels of 50, 200, and 750 mg/kg/day in rats was determined to be ≥ 750 mg/kg/day | |||
Maximum Tolerated Dose and 7 Day Repeat-Dose Toxicity/Toxicokinetic Study in Dogs | Beagle Dogs | To evaluate and characterize the toxicokinetic and toxicity of TELOMIR-1 and to estimate the MTD of TELOMIR- | there were no treatment-related clinical observations, body weights, clinical pathology and anatomic gross pathology findings up to 7.5 mg/kg/day. | |||
SafetyScreen44 TM | N/A | To evaluate, in Enzyme, and Radioligand Binding assays, the activity of TELOMIR-1 | No significant results noted |
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Ongoing and Planned Pre-Clinical Proof-of Concept Studies
The following is a description of the ongoing and planned pre-clinical proof-of-concept studies that we are conducting or anticipate conducting with respect to TELOMIR-1:
Efficacy of TELOMIR-1 in reducing ferritin in aged mice: A third-party vendor will complete a tolerability assessment, ferritin assay optimization, whole blood Methylation assay optimization, efficacy assessment with ferritin assay, and whole blood DNA methylation assay in 24-month-old mice, which have been shown to bioaccumulate hepatic ferritin compared with young mice. This was not powered for statistical significance.
The study began on August 22, 2023 and will progress over nine weeks as shown below. This study was conducted with the assistance of Frontage Laboratories, Inc., a third-party vendor.
Assay development to detect plasma concentration of rat and dog ferritin: The sample analysis for rat to measure concentrations of rat ferritin from rat plasma samples will be done by using ELISA assay (LS Bio commercial kit cat# LS-F36491). The sample analysis for dog to measure concentrations of dog ferritin from dog plasma samples will be done by using ELISA assay (LS Bio commercial kit cat# LS-F11494). This was not powered for statistical significance. This study started in June 2023; results are anticipated December 2023. This study is being conducted with the assistance of Evotec, a third-party vendor.
In Vitro stem cell therapy study: This study is expected to start in December 2023; Results are anticipated Q2 of 2024, which will consist of cell line selection, telomere length determination, cell proliferation/renewal determination, cell death determination, R&D cell bank.
a. Cell line selection: Based on the literature highlighting their appropriateness for telomere and aging research, a third-party collaborator will acquire three vials for each cell line: Primary human umbilical vein endothelial cell, non-immortalized human fibroblast, and the human BM-derived mesenchymal stem cell line.
b. Telomere length determination: A quantitative polymerase chain reaction (qPCR) kit will be employed to treat and assess the absolute telomere length of the cells. As part of the R&D analytical method development, assay performance will be determined to ensure the assay meets the linearity, selectivity, and precision attributes.
qPCR is the accumulation of amplification product is measured as the reaction progresses, in real time, with product quantification after each cycle.
c. Cell Proliferation/renewal determination: The cells will be exposed to different concentrations of TELOMIR-1 at varying time intervals. Multiple analytical attributes, including repeatability and linearity, will be evaluated to assess the experimental outcomes.
d. Cell death determination: Cellular apoptosis and necrosis are recognized as distinctive indicators of telomere shortening in stem cells and other cell types. The assay’s performance will be evaluated to ascertain repeatability and linearity criteria compliance.
e. R&D cell bank: It is of utmost importance to preserve the original cell vial to ensure consistent cell line behavior throughout the development of analytical assays and subsequent Good Manufacturing Practice (GMP) analytical testing. This approach aims to maintain the integrity and stability of the cell strain throughout the experimental procedures.
This study will not be powered for statistical significance. This study will be conducted with the assistance of Frontage Laboratories, Inc., a third-party vendor.
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Planned Pre-Clinical Toxicology Studies
The table below lists the type, species, and purpose, of additional planned pre-clinical toxicology designed to demonstrate that TELOMIR-1 will be not toxic before starting human clinical trials. Each of these studies are expected to begin during the fourth quarter of 2023 and be completed during the second quarter of 2024. These studies will be conducted with the assistance of third-party vendors.
Type of Study | Species | Purpose | ||
In Vivo Micronucleus Study in Rats Using Bone Marrow | Sprague Dawley Rat | To assess the potential of TELOMIR-1 and/or its metabolites to induce micronuclei (MN) in bone marrow reticulocytes (RETs) of male and female Sprague Dawley | ||
hERG (Manual Patch-Clamp) | N/A | To detect the risk of the protein product of the human-Ether-a-go-go -Related Gene (hERG) is an ion channel which plays an integral role in the repolarization and relaxation of the myocardium. | ||
Cardiovascular Study Dog (Telemetry) | Beagle Dog | Cardiovascular analysis: ECG and Blood Pressure will be monitored continuously in conscious animals in their home cage for a minimum 1 hour of baseline (prior to dosing) and a minimum 24 hours after dosing. | ||
Respiratory Study Rat | Sprague Dawley Rat | Plethysmography: Animals will be place in a whole-body plethysmograph and allowed to stabilize for a minimum of 1 hour prior to administration of the control or test article. | ||
Neurobehavioral Evaluation Rats | Sprague Dawley Rat | Functional observational battery will occur pre-dose and 1 time point (txmax) post-dose. Motor activity conducted following functional observational battery using opto-varimax boxes. | ||
28-Day Dog Study | Beagle Dog | to evaluate the toxicity and toxicokinetic profile following oral gavage administration of TELOMIR-1 to male and female Beagle dogs | ||
28-Day Rat Study | Sprague Dawley Rat | The objectives of this study are to evaluate the toxicity and toxicokinetic profile following oral gavage administration of TELOMIR-1 to male and female Sprague Dawley rats. |
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These are IND enabling studies with the purpose of demonstrating there are no animal toxicity issues before dosing in humans.
CMC Activities
The table below identifies our ongoing chemistry, manufacturing, and controls activities relating to TELOMIR-1. We started the analytical development and manufacturing of TELOMIR-1 in the first quarter of 2023. By the fourth quarter of 2023, we anticipate our suppliers will be developing TELOMIR-1 at scale and manufactured under cGMP conditions, expanding on earlier non-GMP volumes of TELOMIR-1 for use in our advanced testing programs. We plan to work closely with our suppliers to generate sufficient volumes of cGMP-grade TELOMIR-1 materials for the planned pre-clinical toxicity programs, expanded animal testing in human clinical trials expected to be performed in 2024, if the FDA approves our clinical trial design. This study is being conducted with the assistance of Frontage Laboratories, Inc., a third-party vendor.
Chemistry, Manufacturing, and Controls | ||
Status | Planned/In process Activity | |
Drug Substance Preparation | ● Analytical Development
○ Method Development ■Assay/impurity ■ Dissolution ○ Method Validation (cleaning method)
● Drug Excipient Compatibility ● Formulation Development and Prototypes ● Lead Formulation Stability ● Scale-up Demo Batch Manufacturing ● R&D Demo Batch Stability ● Method Validation
■Assay/impurity ■Dissolution
● GMP Manufacturing ● Release Testing ● GMP Stability Study |
Our Clinical Development Plan
Regulatory Submissions
Following the completion of pre-clinical development program as described above, we plan to submit to the FDA an IND, focused on investigating TELOMIR-1 for the treatment of hemochromatosis. We may consider a second IND for post-chemotherapy recovery.
Our first IND application submission investigating TELOMIR-1 for the treatment of hemochromatosis is currently planned for the third quarter of 2024. If allowed to proceed by the FDA, a Phase I double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of TELOMIR-1 in 40-60 healthy male and female adult subjects will be initiated approximately 30 days post-IND submission. We have contracted with Frontage Laboratories Phase I clinic in New Jersey consisting of 160 beds across three units for normal volunteers. After the Phase I trial is complete, a Phase II trial in the hemochromatosis population is planned to commence after results and guidance from the FDA.
Our second IND application will likely focus on investigating TELOMIR-1 for the treatment of post-chemotherapy recovery and is planned for submission with guidance from the FDA.
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Our clinical development plans will depend on FDA acceptance of our IND applications. As appropriate and pursuant to discussions with the FDA, we may periodically adjust the timeline for certain filings and associated clinical trials. It is important to note that the process for conducting clinical trials is uncertain and there is no assurance that our clinical development activities will meet the planned timelines set forth above.
Manufacture of Product for Clinical Development Activities
Anthem, a leading CDMO, has been developing a large-scale synthesis protocol for us and will be supplying quantities of TELOMIR-1 needed for our pre-clinical and clinical development activities. We are currently in discussions with Frontage to have TELOMIR-1 formulated into solid oral dosage forms for clinical trials.
Market Opportunity
TELOMIR-1, if approved, is expected to initially compete in the hemochromatosis market. TELOMIR-1, if approved, may have the potential to secondarily compete in the post-chemotherapy recovery market.
Disease Epidemiology – Patient Targets
The target patient pool for TELOMIR-1 will vary depending on which indication is under review. The initial target patient pool relates to hemochromatosis. Hemochromatosis is largely an inherited condition. The secondary category, post-treatment recovery, is a derivative of broader oncology epidemiology and treatment seeking behaviors.
Potential Market in Hemochromatosis
Patients with two mutated copies of the HFE gene (C282Y and H63D) are at the greatest risk for developing hemochromatosis, alongside patients with a family history of hemochromatosis. As a result, approximately 13 million U.S. patients carry mutations for hemochromatosis but only a fraction of them has symptoms, and not every symptomatic patient develops hemochromatosis. On average, about 750,000 US patients express one or more iron overload symptoms. There are 2 types of hemochromatosis, with the following patient mix: 150,000 primary hemochromatosis, and 65,000 secondary hemochromatosis confirmed diagnoses in the United States. Today, we estimate that over 150,000 patients have sought treatment since 2018, with most receiving phlebotomy, which is the withdrawal of blood to bring iron to normal levels. At present, 99% of hemochromatosis patients receive phlebotomy, with a portion of patients also receiving iron chelators as a co-treatment. Note that in the last 12 months, there have been 76,000 confirmed diagnoses of hereditary hemochromatosis and approximately 1% of hemochromatosis patients received deferasirox or deferoxamine off-label for 12 weeks (1 year for primary). The chart below outlines the epidemiological flow for hemochromatosis.
SOURCES
1. Bacon BR, Adams PC, Kowdley KV, Powell LW, Tavill AS; American Association for the Study of Liver Diseases. Diagnosis and management of hemochromatosis: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology. 2011;54(1):328-343. doi:10.1002/hep.24330
2. Gurrin, Lyle C., et al. “The natural history of serum iron indices for HFE C282Y homozygosity associated with hereditary hemochromatosis.” Gastroenterology 135.6 (2008): 1945-1952.
3. P360 Scripts and Claims Database, retrieved on October 3, 2022.
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Potential Market in Post-Chemotherapy
Patients undergoing chemotherapy irrespective of type of cancer are at risk. That said, older patients aged 65+ and above, have a higher risk of developing post-chemotherapy side effects such as digestive issues, sleep and memory issues, fatigue, and body aches. Other risk factors include the presence of metabolic conditions, dose levels of chemotherapy medication, blood count, and BMI.US CDC health data estimates that 650,000 patients receive chemotherapy annually in the US, with 45% experiencing severe side effects and 40% having more moderate side effects. Thus, ~158,000 patients were diagnosed with the adverse effects of chemotherapy (antineoplastic and immunosuppressive drugs. Today, Neulasta is given to patients undergoing chemotherapy as a “catch-all” therapeutic to help manage side effects. Neulasta is typically given to patients after chemotherapy for recovery. 95,000 patients with chemotherapy side effects got Neulasta over the last 12 months while 5,500 patients with immunosuppressive therapy side effects got Jakafi, also used for myelofibrosis and polycythemia vera. Given existing compliance levels around the use of Neulasta (~70%), we believe that adding TELOMIR-1 may boost overall compliance levels higher especially if levels of side effects are reduced.
SOURCES
1. Bacon BR, Adams PC, Kowdley KV, Powell LW, Tavill AS; American Association for the Study of Liver Diseases. Diagnosis and management of hemochromatosis: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology. 2011;54(1):328-343. doi:10.1002/hep.24330
2. Gurrin, Lyle C., et al. “The natural history of serum iron indices for HFE C282Y homozygosity associated with hereditary hemochromatosis.” Gastroenterology 135.6 (2008): 1945-1952.
3. P360 Scripts and Claims Database, retrieved on October 3, 2022.
Competition
We are subject to competition from pharmaceutical and biotechnology companies and academic and research institutions.
TELOMIR-1 will face competition in its initial target indication, hemochromatosis, as well as in its potential second target indication, post-chemotherapy recovery. Below we discuss the known competitors by target indication.
● | Hemochromatosis: The current standard of care is phlebotomy, which typically costs $80 - $300/visit in community health facilities or offered for free at blood banks. Based on historical treatment data, phlebotomy serves more than 95% of hemochromatosis patients, as there are no FDA-approved indications. Each year, about 70,000 patients receive phlebotomy in healthcare facilities, excluding the blood banks (that provide the service for free). Patients who use it continue to embrace it given the lack of clinical options, its broad accessibility and low treatment cost. However, this option is not available to patients with hemophilia and other blood disorders. About 5% of patients are treated with iron chelators such as Exjade and Jadenu (and associated generics). This option is more expensive with pricing for Exjade at $532/day and Jadenu at $517/day. The last treatment option, deferasirox / deferoxamine was used with only 7,000 patients (2018-2022) based on IQVIA claims and scripts data. Future clinical options for treating hemochromatosis exist and remain limited. For example, 2 molecules are pre-clinical, 2 in Phase I, 1 in Phase II, and 1 is in Phase III. |
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SOURCE
1. Citeline, Pharma Projects, and Trial Trove Database Results for “hemochromatosis”, retrieved on September 23, 2022.
● | Post-Chemo Recovery: The current standard of care involves prescribing a small set of compounds designed to reduce patient discomfort from side effects. Filgrastim, pegfilgrastim, sargramostim are some examples of prescribed medication. These medications stimulate the growth of healthy white blood cells and granulocytes by subcutaneous injection. However, prices are high and can cost around $4,000-6,400 per dose of injection. Jakafi, a tyrosine kinase inhibitor is used in polycythemia vera and graft-versus-host disease. Pricing for Jakafi is $16,200 per bottle, with a $270 wholesale acquisition cost (WAC) unit price. Thus, given cost, only a portion of the high-risk patients are given the script; these are usually patients who are older than 65, and with a weakened immune system and low white blood cell count. Patients who use the class of medication do so to reduce post-treatment infection risk, even if they suffer from fevers and aches because of usage. The development pipeline of competing assets is robust but targeted at specific side effects such as iron deficiency or thrombotic constraints. |
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SOURCE
1. Citeline, Pharma Projects, and Trial Trove Database Results for “hemochromatosis”, retrieved on September 23, 2022.
Intellectual Property
We license the U.S. patent rights for the use of TELOMIR-1 in human applications from MIRALOGX, an intellectual property development and holding company established by Jonnie R. Williams, Sr., the founder of our company and the sole inventor of TELOMIR-1. MIRALOGX is owned by the Bay Shore Trust, an irrevocable trust established by Mr. Williams. MIRALOGX filed a Patent Cooperation Treaty (PCT) application, PCT/US2023/073106 on August 29, 2023 for TELOMIR-1. The PCT application, which is titled, “ANTI-INFLAMMATORY COMPOUNDS, PHARMACEUTICAL COMPOSITIONS, AND METHODS OF TREATING HEMOCHROMATOSIS, AND OTHER DISORDERS,” covers, among other things, the TELOMIR-1 compound and methods of treating hemochromatosis, hyperammonemia, or a disorder associated with chronic inflammation or a cancer, by administering the compound to humans. The PCT application designated the U.S. and will enter U.S. national phase. The application, if granted and subject to payment of patent maintenance fees, would offer protection extending through at least August 29, 2043, in the U.S. The patent rights for TELOMIR-1 outside of the United States are not included in our current patent rights. Mr. Williams, our founder, does not hold any formal degrees in chemistry or certifications related to the development of pharmaceuticals; however, he developed extensive knowledge of tobacco alkaloid chemistry in the 1990’s through collaboration with industry experts during his development of techniques for preventing the formation of carcinogenic tobacco-specific nitrosamines (TSNAs) during the tobacco curing process. To better understand the mechanism by which TSNAs are formed, Mr. Williams collaborated closely with a leading expert in tobacco chemistry at the University of Kentucky, where he developed a working knowledge of tobacco alkaloid chemistry, which led to his development of patented curing technologies which would become the industry standard. This work led to him focusing on the therapeutic properties of tobacco alkaloids, and later to his design of novel small molecule therapeutics. He is a named inventor on 31 issued US patents and approximately 30 pending or published US patent applications, all of which are in the life sciences, a field that embraces the study of living organisms, including biology, botany, zoology, and biochemistry. Approximately 20 of his issued patents and 27 of his applications involve therapeutic treatment methods, and 4 issued patents and approximately 18 applications are directed to novel small molecules, principally involving alkaloid and cannabinoid chemistries. His work on TELOMIR-1 began in late 2020.
Our license from MIRALOGX is set forth in the Initial MIRALOGX License Agreement, as amended on November 10, 2023, by the Amendment No. 1 to the Amended and Restated License Agreement, pursuant to which the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals, in addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and commercialization of veterinary, in addition to human, therapeutic treatments and uses (together with the “Initial MIRALOGX License Agreement, the “MIRALOGX License Agreement”). “Licensed Product” is defined as a drug product containing as an active agent 2,4,6-tris(3,4-dihydro-2H-pyrrol-2-yl)pyridine or a pharmaceutically acceptable salt, ester, or solvate thereof. We also have the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement provides for the payment to MIRALOGX of an 8% royalty (payable quarterly) on our net sales of Licensed Products by us or our sublicensees and on non-royalty bearing milestone revenue, with the royalty obligation ceasing upon the later of the expiration of the last-to-expire licensed patent or the expiration of the last strategic partnership/sublicensing agreement entered into by us. There are no up-front, execution, or milestone payments required under the license agreement. Further, no payments have been made to date under the agreement. The agreement provides for a perpetual license and does not contain a provision that permits MIRALOGX to terminate the agreement. The MIRALOGX License Agreement provides that MIRALOGX will have sole control over the filing, prosecution, maintenance, and management of the licensed patent rights, provided that we will be responsible for the cost of prosecuting, maintaining, and managing the licensed patents. The agreement grants to us the primary right, but not the obligation, to enforce the licensed patent rights.
Besides relying on patents, we will also rely on trade secrets, proprietary know-how and continuing innovation to develop and maintain our competitive position, especially when we do not believe that patent protection is appropriate or can be obtained. We will seek protection of these trade secrets, proprietary know-how and any continuing innovation, in part, through confidentiality and proprietary information agreements. However, these agreements may not provide meaningful protection for, or adequate remedies to protect, our technology in the event of unauthorized use or disclosure of information. Furthermore, our trade secrets may otherwise become known to, or be independently developed by, our competitors. We may in the future seek appropriate patent protection for technology in our research and development programs to the extent not licensed from MIRALOGX or another third party, where applicable, and their uses by filing patent applications in the appropriate jurisdiction. We intend for these patent applications to cover, where possible, claims for compositions of matter, medical uses, processes for preparation and formulations.
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We currently use TELOMIR and TELOMIR-1 as unregistered trademarks, and we intend to rely on such trademarks and trade names and service marks, as well as our domain names and logos, as appropriate, to distinguish, build, and market our brand.
Regulation
The U.S. Food and Drug Administration (FDA) and comparable regulatory authorities in state and local jurisdictions impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing, and distribution of drugs. These agencies and other federal, state, and local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, sampling and export and import of our drug candidates.
U.S. Government Regulation
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications (NDAs), withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
The process required by the FDA before a drug may be marketed in the United States generally involves the following:
● | completion of pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice (“GLP”) regulations; | |
● | submission to the FDA of an Investigational New Drug (“IND”) application, which must become effective before human clinical trials may begin; | |
● | approval by an independent Institutional Review Board (“IRB”), at each clinical site before each trial may be initiated; | |
● | performance of adequate and well-controlled human clinical trials in accordance with good clinical practices (“GCP”) requirements to establish the safety and efficacy of the proposed drug product for each indication; | |
● | demonstration that the API and finished product are manufactured under cGMP conditions and meet all applicable standards of identity, strength, quality, and purity; | |
● | submission to the FDA of an NDA; | |
● | satisfactory completion of an FDA advisory committee review, if applicable; |
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● | satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements and to assure that the facilities, methods, and controls are adequate to preserve the drug’s identity, strength, quality, and purity; | |
● | FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to commercial marketing or sale of the drug in the United States; and | |
● | compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”) or to conduct a post-approval study. |
Pre-clinical studies
Before testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events (“AEs”) and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies. An IND sponsor must submit the results of the pre-clinical studies, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.
An IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed to proceed by the FDA before human clinical trials may begin. Some long-term pre-clinical testing, such as animal tests of reproductive AEs and carcinogenicity, may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions before that time related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.
Clinical trials
The clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by, or under control of, the trial sponsor, in accordance with GCPs, which include the requirement that all research patients provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Information about most clinical trials must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website. Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.
Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined:
● | Phase I clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the drug. |
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● | Phase II clinical trials involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. | |
● | Phase III clinical trials generally involve a larger number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing. |
Post-approval trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow up. In certain instances, the FDA may mandate the performance of Phase IV clinical trials as a condition of approval of an NDA or a Biologics License Application (“BLA”).
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if significant adverse events (“SAEs”) occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time, or the FDA may impose other sanctions on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk. Similarly, an IRB can refuse, suspend, or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.
Concurrently with clinical trials, companies usually complete additional pre-clinical studies and must also develop additional information about the physical characteristics of the drug or biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency, and purity of the final biological product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.
Marketing Approval
Assuming successful completion of the required clinical testing, the results of the pre-clinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee.
The review process typically takes twelve months from the date the NDA is submitted to the FDA. The FDA conducts a preliminary review of all NDAs within the first 60 days after submission to determine whether they are sufficiently complete to permit substantive review before accepting them for “filing.” The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information and may be subject to an additional application user fee. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged, or held meets standards designed to assure the product’s continued safety, quality and purity. Under the current guidelines in effect in the Prescription Drug User Fee Act (PDUFA), the FDA has a goal to review and act on the submission within ten months from the completion of the preliminary review of a standard NDA for a new molecular entity.
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The FDA also may require submission of a REMS plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries, or other risk minimization tools.
The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP requirements.
After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical trials or pre-clinical studies in order for FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
Post-approval requirements
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA review and approval. There also are continuing annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.
Properties
Our administrative and accounting office is located in Tampa, Florida. We currently share space with MIRA Pharmaceuticals, Inc., another pharmaceutical development company, under a lease of approximately 2,279 square feet of office space under a lease that is due to expire on March 31, 2024. We share the office and costs in Tampa with two other companies. Our corporate headquarters and executive offices are in Baltimore, Maryland. Our Baltimore location, which comprises approximately 150 square feet, is under a lease that is due to expire on November 30, 2023. We believe that this facility will be sufficient for our current and planned operations, although we may require additional office and laboratory space in Baltimore for our planned operations as we progress our programs.
Employees and Human Capital Resources
As of September 30, 2023, we had 2 full-time employees and 4 part-time employees, of which one of our part-time employees is engaged in research and development. None of our employees is represented by a labor union or are covered by a collective bargaining agreement. We consider our relationship with our employees to be satisfactory. In addition, we utilize the services of contractors and part-time outside consultants to support our organization’s needs. We expect to continue to build our team to ensure we can effectively execute our development plans.
Legal Proceedings
There are no material proceedings to which any director or officer, or any associate of any such director or officer, is a party that is adverse to our Company or any of our subsidiaries or has a material interest adverse to our Company or any of our subsidiaries. No director or executive officer has been a director or executive officer of any business which has filed a bankruptcy petition or had a bankruptcy petition filed against it during the past ten years. No current director or executive officer has been convicted of a criminal offense or is the subject of a pending criminal proceeding during the past ten years. No current director or executive officer has been the subject of any order, judgment or decree of any court permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities during the past ten years. No current director or officer has been found by a court to have violated a federal or state securities or commodities law during the past ten years. From time to time, we may be named in claims arising in the ordinary course of business.
We anticipate that we will expend significant financial and managerial resources in the defense of our intellectual property rights in the future if we believe that our rights have been violated. We also anticipate that we will expend significant financial and managerial resources to defend against claims that our products and services infringe upon the intellectual property rights of third parties.
Corporation Information
Our corporate headquarters is located at 855 N Wolfe Street, Suite 601, Baltimore, Maryland 21205. Our telephone number is (737) 289-0835.
Our website address is www.telomirpharma.com. The information contained on, or that can be accessed through, our website is deemed not to be incorporated in this prospectus or to be part of this prospectus. You should not consider information contained on our website to be part of this prospectus.
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Executive Officers, Directors, and Key Advisors
The following table sets forth information about our current executive officers and directors, including their ages as of September 30, 2023. With respect to our directors, each biography includes information regarding the experience, qualifications, attributes, or skills that caused our board of directors to determine that such person should serve as a director of our company.
Name | Age | Position | ||
Christopher Chapman, Jr., MD | 70 | Chief Executive Officer and Chairman | ||
Nathen Fuentes, CPA | 41 | Chief Financial Officer, Treasurer, and Secretary | ||
Christos Nicholoudis, Esq. | 33 | General Counsel and Director | ||
Michael Jerman, CPA | 57 | Director | ||
Brad Kroenig | 44 | Director | ||
Craig Eagle, MD | 56 | Director | ||
Talhia Tuck | 45 | Director | ||
Hugh McColl III | 63 | Director | ||
Dr. Michael Roizen | 77 | Key Advisor |
The following is a brief biography of each of our current executive officers and directors:
Executive Officers and Directors
Christopher Chapman, Jr., MD was appointed to serve as our Chief Executive Officer and Chairman effective November 2022. He also currently serves as the Executive Chairman of MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA), a publicly traded pre-clinical pharmaceutical development company (“MIRA”), a position he has held since April 2023. As Executive Chairman of MIRA, Dr. Chapman’s duties include those that are customarily associated with the position of Chairman of our board of directors, as well as oversight of the regulatory affairs and drug development activities of the company. Dr. Chapman has also served as one of MIRA’s directors since November 1, 2021 and served as a consultant with respect to regulatory affairs and drug development from November 1, 2021 until he began serving as MIRA’s Executive Chairman in April 2023. Dr. Chapman also serves as the President, Chief Medical Officer, and a director of MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a publicly traded clinical-stage pharmaceutical development company (“MyMD”). Dr. Chapman previously served as President and Chief Medical Officer of MyMD Pharmaceuticals (Florida), Inc. (“MyMD Florida”) effective as of November 1, 2020. MyMD Florida is the predecessor by merger of MYMD. Prior to joining MyMD Florida and since 1999, Dr. Chapman has also served as the Chief Executive Officer of Chapman Pharmaceutical Consulting, Inc., a consulting organization that provides support to pharmaceutical and biotechnology companies in North America, Europe, Japan, India and Africa on issues such as product safety, pharmacovigilance, medical devices, clinical trials and regulatory issues. Dr. Chapman served as Director, Medical Affairs, Drug Safety and Medical Writing Departments at Quintiles (currently known as IQVIA), from 1995 to 2003, where he grew the division from no employees to forty employees, including eight board certified physicians, four RNs, two pharmacists, eight medical writers and supporting staff. Dr. Chapman has also served on the board of directors of Rock Creek Pharmaceuticals, Inc. (formerly, Star Scientific, Inc.) from 2007 to 2016, including as a member of the Audit Committee from 2007 to 2014, chairperson of the Compensation Committee from 2007 to 2014, and chairperson of the Executive Search Committee from 2007 to 2014. Dr. Chapman is an experienced executive and global medical expert and has extensive experience in providing monitoring and oversight for ongoing clinical trials including both adult and pediatric subjects. Dr. Chapman is also the founder of the Chapman Pharmaceutical Health Foundation, an IRS Section 501(c)(3) nonprofit organization established to solicit public funds and to support healthcare needs such as AIDS, diabetes, hypertension, lupus, sickle cell anemia, malaria and tuberculosis, which was organized in 2006. Dr. Chapman earned an Executive Certificate in Nonprofit Financial Stewardship from the Harvard Kennedy School in 2020. Dr. Chapman received his M.D. degree from Georgetown University in Washington, D.C. in 1987, and completed his internship in Internal Medicine, a residency in Anesthesiology and a fellowship in Cardiovascular and Obstetric Anesthesiology at Georgetown. We believe Dr. Chapman is qualified to serve as one of our directors due to his executive experience in the pharmaceutical and biotechnology industries, as well as his medical expertise. Dr. Chapman’s recent publications include two poster presentations: 1)British Society of Immunology, Liverpool, UK, December 5-8, 2022 Pharmacology and clinical profile of MYMD-1® (isomyosamine), an oral, selective, next-generation, TNF-alpha inhibitor that crosses the blood brain barrier and 2) Society of Toxicology, Nashville, TN, March 19-22, 2023, A Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNF-α, MYMD-1® (Isomyosamine), Significantly Reduced the Inflammation and Disease Severity in Murine Model of Collagen Antibody Induced Arthritis. Additionally, Dr. Chapman published a manuscript in Drug Research, “A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects” (Brager, J., Chapman, C., Dunn, L., & Kaplin, A. (2023). A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects. Drug research, 73(2), 95–104. https://doi.org/10.1055/a-1962-6834).
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Nathen Fuentes, CPA, joined our company as our Chief Financial Officer, Treasurer, and Secretary on September 21, 2023. Prior to serving as our Chief Financial Officer, Treasurer, and Secretary, Mr. Fuentes has worked for mid-market private equity sponsored companies within the specialty healthcare industry, including with Emergence Health Holdings as the Chief Financial Officer from May 2023 to September 2023; as the Chief Financial Officer of Divergent Dental Group from July 2022 to May 2023; the Chief Financial Officer of Family First Homecare from 2019 to July 2022; and as the Chief Financial Officer and Partner of Dermatology Medical Partners from 2017 to 2019. He also served as the Controller of Glytec from 2013 to 2017, as an Experienced Associate at PricewaterhouseCoopers from 2012 to 2013 and held various managerial positions with homebuilding companies prior to his experience with PricewaterhouseCoopers. Mr. Fuentes has experience leading acquisition and organic growth initiatives within highly levered environments while managing investor relations, human resources, finance, accounting, and revenue cycle functions. Mr. Fuentes earned his Bachelor of Science in marketing from the University of Florida and his Masters of Science in accounting from Fairfield University. Mr. Fuentes is a Certified Public Accountant.
Christos Nicholoudis joined our company as a director and as our General Counsel on August 11, 2023. He was initially appointed under an agreement between our company and our largest stockholder, the Bay Shore Trust, to serve as the designated representative of the Bay Shore Trust on our board of directors. He has also served as a director of MIRA Pharmaceuticals, Inc., (Nasdaq: MIRA) since April 2023. Mr. Nicholoudis was also named General Counsel of MIRA in April 2023, although he is not deemed to be an executive officer of that company. Mr. Nicholoudis is an attorney who has practiced with his own firm, The Law Firm of Christos Nicholoudis PLLC, since February 2022, where he handles a wide range of legal matters including contract work, personal injury, real estate, wills trusts and estates and criminal law. Prior to that, from July of 2019 to February of 2022, Mr. Nicholoudis was employed by the State of Florida as a Public Defender for the 12th Judicial Circuit and from July 2012 to February of 2020, Mr. Nicholoudis owned and operated a restaurant franchise under Cortez Roadhouse, LLC. Mr. Nicholoudis is a 2012 graduate of Cornell University’s School of Hotel Administration where he received a B.S. in hospitality and a 2017 graduate of Stetson College of Law where he received his J.D. degree. He is admitted to the bar in New York, Florida, Texas, and Washington D.C. We believe that Mr. Nicholoudis is qualified to serve as one of our directors based on his legal experience and training and his diverse business management experience.
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Michael Jerman, CPA joined our company as a director in November 2023. He also serves as a member of the board of directors of Inhibitor Therapeutics, Inc. (OTC:INTI). Mr. Jerman has served as the managing partner at Hollywell Partners, a professional accounting and finance consulting firm, since May 2019, and has provided chief financial officer and other services to multiple private equity-backed companies in the energy, SaaS, and manufacturing industries. Prior to his role with Hollywell Partners, he was a Director with PwC in the US and UK from January 2007 to August of 2019 and was a Captain with the United States Air Force from July 2003 to June 2015. He has led global public and private client engagements in the industries of retail and consumer, energy, utilities and mining, and transportation and logistics. Mr. Jerman has significant experience in client equity and debt offerings, business combinations inclusive of public listing and reporting requirements, initial valuations and ongoing goodwill impairment analyses, share-based awards, restructuring, and global taxes, as well as stakeholder management, specifically with board and management presentation experience to include annual and quarterly requirements, fee negotiations, technical accounting and finance discussions, and fraud and non-compliance investigations. Mr. Jerman has specialized in rapid project mobilization and deployment of skilled resources for emergency issues, design, and implementation of small to large scale assurance requirements and advisory projects. Mr. Jerman’s additional experience includes leading PwC’s data acquisition methods and tools, client acquisitions and systems implementations to include new SOX-compliant control plan implementations across multiple systems, leading co-sourced internal audit projects, and time spent driving PwC’s lean efficiency initiatives. Mr. Jerman was a member of the PwC national office within the SEC PCAOB quality group supporting Europe and the EMEA regions with complex accounting and audit consultations. He earned a B.S. in accounting from the University of South Florida, an M.S. in accounting from the University of Tampa, and an M.B.A. from the University of Oxford.
Brad Kroenig joined our company as director in November 2022. Since November 2021, he has also served as a member of the Board of Directors of MIRA Pharmaceuticals, Inc., (Nasdaq: MIRA) a publicly traded early pre-clinical-stage pharmaceutical company focused on the development and commercialization of a new molecular synthetic THC analog. Since 2000, Mr. Kroenig’s principal occupation has been serving as one of the world’s leading fashion models. Mr. Kroenig was the face of Ralph Lauren, The Gap, Tommy Hilfiger, Chanel, Fendi, Peter Millar, and many other top brands. Models.com ranked him the #1 male model in the world from 2004 to 2006, and Vogue magazine ranked him the #3 male model of all time. Mr. Kroenig also serves as a business and strategy consultant for many private firms and early-stage companies, where as a part of his consulting business he advises companies regarding building management teams and managing relationships with investors. Mr. Kroenig is an experienced investor and business executive with significant experience in collaborating with executive-level and cross-functional teams, analyzing business situations, and developing and implementing practical investor strategies. Mr. Kroenig attended Florida International University on a NCAA Division I soccer scholarship. We believe that Mr. Kroenig’s business experience in the modeling industry as a business executive qualifies him to serve as one of our directors.
Craig Eagle, MD joined our company as a director in November 2022. He has also served as a director of MyMD since April 16, 2021. Dr. Eagle is currently the Chief Medical Officer of Guardant Health, Inc. since 2021. Previously, Dr. Eagle was Vice President of Oncology for Genentech, where he oversaw the medical programs across Genentech’s oncology portfolio. Prior to his current role, Dr. Eagle worked in several positions at Pfizer from 2009 to 2019, including as the oncology business lead in the United Kingdom and Canada, the global lead for Oncology Strategic Alliances and Partnerships based in New York, and as the head of the Oncology Therapeutic Area Global Medical and Outcomes Group, including the U.S. oncology medical business. Through his multiple roles at Pfizer, Dr. Eagle delivered significant business growth and was involved in multiple strategic acquisitions and divestitures. In addition, while at Pfizer, Dr. Eagle oversaw extensive oncology clinical trial programs, multiple regulatory and payer approvals across Pfizer’s oncology portfolio, health outcomes assessments and scientific collaborations with key global research organizations like the National Cancer Institute (NCI), and the European Organization for Research and Treatment of Cancer (EORTC), and led worldwide development of several compounds including celecoxib, aromasin, irinotecan, dalteparin and ozagomicin. Dr. Eagle currently serves as a member of the board of directors and chair of the Science and Policy Committee of Pierian Biosciences, a privately held life sciences company. Dr. Eagle attended Medical School at the University of New South Wales, Sydney, Australia and received his general internist training at Royal North Shore Hospital in Sydney. He completed his hemato-oncology and laboratory hematology training at Royal Prince Alfred Hospital in Sydney and was granted Fellowship in the Royal Australasian College of Physicians (FRACP) and the Royal College of Pathologists Australasia (FRCPA). After his training, Dr. Eagle performed basic research at the Royal Prince of Wales hospital to develop a new monoclonal antibody to inhibit platelets before moving into the pharmaceutical industry. Dr. Eagle’s qualifications to sit on our board of directors include his long and successful career in the international pharmaceutical industry, his senior executive experience in areas such as business growth, strategic alliances and mergers and acquisition transactions, his experience as a member of both public and private company boards in the healthcare and life science industries, and his wealth of oncology experience, including leading and participating in scientific research, regulatory, pricing and re-imbursement negotiations for compounds in therapeutic areas.
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Talhia Tuck joined our company as a director in November 2022. She has also served as a director of MIRA since November 1, 2021. She has worked in the higher education field for over a decade, including her most recent position as an Admissions and Recruitment Counselor for Georgetown Law School in 2023. From 2019 to 2023, Ms. Tuck was a Project Director with Georgetown Law School’s Center for Innovations in Community Safety, formerly the Innovative Policing Program, which identifies new approaches to long-standing issues in policing. Ms. Tuck served as an Associate Director of Admissions at Georgetown University from 2016-2019, where she evaluated applications for the undergraduate schools and chaired several admissions committees. Prior to 2016, Ms. Tuck worked in the investment relations and communications field as Vice President for Communications and Investor Relations at Star Scientific, Inc. (OTC: STSC) where she was responsible for coordinating communications with shareholders, the financial community, and the media. She also has experience in the legal industry, as she participated in the Ropes & Gray New Alternatives Program as a Fellow at the Office of the State’s Attorney for Montgomery County, Maryland, and subsequently worked in the Corporate Department at Ropes & Gray LLP in Washington, D.C. Prior to attending law school, Ms. Tuck was a journalist with MSNBC, NBC News, ABC News, and the CBS affiliate, WINK-TV, and worked as an admissions officer for Harvard College at Harvard University. She also served as a financial analyst at Goldman Sachs in the Investment Management Division from July 2000 until April 2001. We believe that Ms. Tuck’s experience in public policy and investment relations qualifies her to serve as one of our directors. She received her A.B. degree from Harvard College, cum laude, and received her J.D. degree from Harvard Law School. We believe that Ms. Tuck’s experience in public policy and investment relations qualifies her to serve as one of our directors.
Hugh McColl III joined our company as a director in November 2022. He has served as a director of MIRA Pharmaceuticals, Inc., (Nasdaq: MIRA) since November 1, 2021. Mr. McColl has served as Co-Managing Member of Collwick Capital LLC, a fund of funds, since 2010 and Managing Member of McColl Brothers Lockwood LLC, a family investment office, since 2006. Since June 2015, he has served as a Senior Advisor at Brown Brothers Harriman Capital Partners where he assists in sourcing, investment evaluation, transaction execution, and providing post-investment, value-added oversight to portfolio companies. Before co-founding Collwick Capital LLC, Mr. McColl spent 14 years in the hedge fund industry, where he was a private investments portfolio manager for Round Table Investment Management and McColl Brothers Lockwood LLC, served as the Chief Operating Officer for M&M Partners LLC and was the Chief Executive Officer for McColl Partners LLC. Mr. McColl has served on the boards of directors of Heritage Brands Inc. since 2019 and Fintag Holdings Inc. since 2022. Mr. McColl received a B.S. degree in Business Administration from the University of North Carolina at Chapel Hill in 1982 and an MBA degree from the University of Virginia Darden School of Business in 1987. We believe that Mr. McColl’s investment management and executive experience qualifies him to serve as a member of our board of directors. We believe that Mr. McColl’s investment management and executive experience qualifies him to serve as a member of our board of directors.
Key Advisor
Dr. Michael Roizen has served as an advisor to the Company since November 30, 2023. Since 2007, Dr. Roizen has served as the Chief Wellness Officer of the Cleveland Clinic, including as the Chief Wellness Officer Emeritus since February 2019 and the Wellness Institute Chair since June 2007. He is also a professor of medicine at the Cleveland Clinic Lerner College of Medicine. Dr. Roizen developed the “RealAge” concept and has authored or coauthored five number one New York Times best sellers. He has over 165 peer-reviewed publications and 100 medical chapters, 14 U.S. patents, has founded several of his own companies, served on FDA advisory committees for 16 years, and chaired an FDA advisory committee. He received a B.A. degree from Williams College in 1967 in chemistry and economics, and he attended the University of California, San Francisco School of Medicine and performed his residency at Harvard’s Beth Israel Deconess Medical Center. He spent 9 years on the faculty at the University of California, San Francisco, served as the chair of the Department of Anesthesia and Critical Care and Pain Management at the University of Chicago for 16 years, and served as the Dean of the School of Medicine and Vice President for Biomedical Sciences at SUNY Upstate.
Board Composition
Our business and affairs are managed under the direction of our board of directors, which currently consists of seven members. The number of directors is determined by our board of directors, subject to the terms of our amended and restated articles of incorporation and bylaws that will become effective upon the completion of this offering. Upon the completion of this offering, our board of directors will continue to consist of seven members, and our directors will be elected for one-year terms.
Family Relationships
There are no family relationships among any of our directors and executive officers.
Director Independence
Our board of directors has undertaken a review of the independence of each director. Based on information provided by each director concerning his or her background, employment, and affiliations, our board of directors has determined that Michael Jerman, Talhia Tuck, Dr. Craig Eagle, and Hugh McColl III do not have any relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and are independent directors under the Nasdaq Listing Rules.
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In making these determinations, our board of directors considered the current and prior relationships that each non-employee director has with our company and all other facts and circumstances our board of directors deemed relevant in determining their independence, including the transactions described in the section of this prospectus titled “Certain Relationships and Related Party Transactions.”
Committees of the Board of Directors
Our board of directors will establish an audit committee, a compensation committee, and a nominating and corporate governance committee prior to the completion of this offering. The functions of these committees are described below. Members will serve on these committees until their resignation or until otherwise determined by our board of directors. Our board of directors may establish other committees as it deems necessary or appropriate from time to time.
Audit Committee
Our board of directors will establish an audit committee, and we anticipate that Michael Jerman, Hugh McColl III, and Bradley Kroenig will be the members of the committee, with Michael Jerman serving as the chair of the audit committee. Each member of the committee will meet the requirements for independence under the listing standards of Nasdaq and SEC rules and regulations, including Rule 10A-3(b)(1) under the Exchange Act. Each member of our audit committee will also meet the financial literacy requirements of the listing standards of Nasdaq. In addition, our board of directors has determined that Mr. Jerman is an audit committee financial expert within the meaning of Item 407(d) of Regulation S-K under the Securities Act.
The audit committee’s main purpose is to oversee our corporate accounting and financial reporting process. Our audit committee will be responsible for, among other things:
● | selecting a qualified firm to serve as the independent registered public accounting firm to audit our financial statements; | |
● | helping to ensure the independence and performance of the independent registered public accounting firm; | |
● | discussing the scope and results of the audit with the independent registered public accounting firm, and reviewing, with management and the independent registered public accounting firm, our interim and year-end results of operations; | |
● | developing procedures for employees to submit concerns anonymously about questionable accounting or audit matters; | |
● | reviewing our policies on risk assessment and risk management; | |
● | reviewing related party transactions; | |
● | reviewing and pre-approving, as required, all audit and all permissible non-audit services to be performed by the independent registered public accounting firm; and | |
● | assisting our board of directors in monitoring the performance of our internal audit function. |
Our audit committee will operate under a written charter that satisfies the applicable rules and regulations of the SEC and the listing standards of Nasdaq, a copy of which will be available on our website at www.telomirpharma.com.
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Compensation Committee
Our board of directors will establish a compensation committee and we anticipate that Talhia Tuck, Michael Jerman, and Craig Eagle will be the members of this committee, with Talhia Tuck serving as the chair of the compensation committee. Each member of the committee will meet the requirements for independence under the listing standards of Nasdaq and SEC rules and regulations. Each member of our compensation committee will also be a non-employee director, as defined pursuant to Rule 16b-3 promulgated under the Exchange Act, or Rule 16b-3. In arriving at these determinations, our board of directors will examine all factors relevant to determining whether any compensation committee member has a relationship to us that is material to that member’s ability to be independent from management in connection with carrying out such member’s duties as a compensation committee member.
The compensation committee’s main purpose is to review and recommend policies relating to compensation and benefits of our officers and employees. Our compensation committee will be responsible for, among other things:
● | reviewing, approving, and determining, or making recommendations to our board of directors regarding, the compensation and compensation arrangements of our executive officers; | |
● | administering our equity compensation plans; | |
● | reviewing and approving, or making recommendations to our board of directors regarding, incentive compensation and equity compensation plans; and | |
● | establishing and reviewing general policies relating to compensation and benefits of our employees. |
Our compensation committee will operate under a written charter that satisfies the applicable rules and regulations of the SEC and the listing standards of Nasdaq, a copy of which will be available on our website.
Nominating and Corporate Governance Committee
Our board of directors will establish a nominating and corporate governance committee, and we anticipate that Talhia Tuck, Bradley Kroenig, and Craig Eagle will be the members of this committee, with Talhia Tuck serving as the chair of the nominating and corporate governance committee. Each member of the committee will meet the requirements for independence under the listing standards of Nasdaq and SEC rules and regulations.
Our nominating and corporate governance committee will be responsible for, among other things:
● | identifying, evaluating, and selecting, or making recommendations to our board of directors regarding, nominees for election to our board of directors and its committees; | |
● | developing and overseeing the annual evaluation of our board of directors and of its committees; | |
● | considering and making recommendations to our board of directors regarding the composition of our board of directors and its committees; | |
● | overseeing our corporate governance practices; and | |
● | making recommendations to our board of directors regarding corporate governance guidelines. |
Our nominating and corporate governance committee will operate under a written charter that satisfies the applicable listing standards of Nasdaq, a copy of which will be available on our website.
Compensation Committee Interlocks and Insider Participation
None of the members of our compensation committee is a current or former executive officer or employee of our company. None of our executive officers serves as a member of the compensation committee of any entity that has one or more executive officers serving on our compensation committee.
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Risk Oversight
One of the key functions of our board of directors is informed oversight of our risk management process. Our board of directors administers this oversight function directly through our board of directors as a whole, and through various standing committees of our board of directors that address risks inherent in their respective areas of oversight. In particular, our board of directors is responsible for monitoring and assessing strategic risk exposure, including risks associated with cybersecurity and data protection, and our audit committee has the responsibility to consider our major financial risk exposures and the steps our management has taken to monitor and control these exposures, including guidelines and policies to govern the process by which risk assessment and management is undertaken. Our audit committee will review legal, regulatory, and compliance matters that could have a significant impact on our financial statements. Our nominating and corporate governance committee will monitor the effectiveness of our corporate governance practices, including whether they are successful in preventing illegal or improper liability-creating conduct. Our compensation committee will assess and monitor whether any of our compensation policies and programs has the potential to encourage excessive risk taking. While each committee is responsible for evaluating certain risks and overseeing the management of such risks, our entire board of directors will be regularly informed through committee reports about such risks.
Board Diversity
Our nominating and corporate governance committee will be responsible for reviewing with the board of directors, on an annual basis, the appropriate characteristics, skills, and experience required for the board of directors as a whole and its individual members. Although our board of directors does not have a formal written diversity policy with respect to the evaluation of director candidates, in its evaluation of director candidates, our nominating and corporate governance committee will consider factors including, without limitation, issues of character, integrity, judgment, potential conflicts of interest, other commitments, and diversity, and with respect to diversity, such factors as gender, race, ethnicity, experience, and area of expertise, as well as other individual qualities and attributes that contribute to the total diversity of viewpoints and experience represented on the board of directors.
The nominating and corporate governance committee will ensure compliance with the new rule by Nasdaq for board diversity (the “Nasdaq Diversity Rule”), on or before the date required under the Nasdaq Diversity Rule. The Nasdaq Diversity Rule requires, assuming our shares of common stock are listed on the Nasdaq Capital Market and that we are a smaller reporting company, that we will have at least two directors serving on our board of directors, at least one of which identifies as female and the second of which identifies as female, underrepresented minority or LGBTQ+, by December 31, 2026, unless our board of directors is comprised of five or less directors.
Code of Business Conduct and Ethics
Prior to the completion of this offering, our board of directors will adopt a code of business conduct and ethics applicable to all of our directors, officers (including our principal executive officer, principal financial officer, and principal accounting officer) and all global employees in accordance with applicable federal securities laws and corporate governance rules of the Nasdaq Capital Market. Our code of business conduct and ethics will be available on our website. Any amendments to the code of business conduct and ethics, or waivers of its requirements, will, if required, be disclosed on our website.
Corporate Governance Guidelines
Prior to the completion of this offering, our board of directors will adopt corporate governance guidelines, a copy of which will be available on our website.
Director Compensation
We did not provide any cash or equity compensation to any of our directors during the year ended December 31, 2022, in their capacity as directors, and we have not yet adopted a compensation program for our directors.
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This section discusses the material components of the executive compensation program for the following persons: (i) all persons serving as our principal executive officers during 2022 and (ii) the most highly compensated of our other executive officers who received compensation during 2022 of at least $100,000 and who were executive officers on December 31, 2022. We refer to these persons as our “named executive officers” elsewhere in this prospectus. Our “named executive officers” and their positions are as follows:
● | Christopher Chapman, Jr., MD, Chief Executive Officer and Chairman; and | |
● | James A. McNulty, CPA, Former Chief Financial Officer and Treasurer. |
Summary Compensation Table
The following table shows the compensation paid by us during the 2022 and 2021 fiscal years to our named executive officers. As indicated below, there was no compensation paid to any named executive officer of our company during 2021 or 2022. For a description of the compensation program for our named executive officers following 2022, see “—Executive Compensation Arrangements” below.
Name and principal position | Year | Salary | Bonus | Stock Awards | Option Awards | All Other Compensation | Total ($) | |||||||||||||||||||||
Christopher Chapman, Jr., MD | 2022 | $ | - | - | - | - | - | $ | - | |||||||||||||||||||
Chief Executive Officer and Chairman | 2021 | $ | - | - | - | - | - | $ | - | |||||||||||||||||||
James A. McNulty, CPA (1) | 2022 | $ | - | - | - | - | - | $ | - | |||||||||||||||||||
Former Chief Financial Officer and Treasurer | 2021 | $ | - | - | - | - | - | $ | - |
(1) | Mr. McNulty served as our Chief Financial Officer and Treasurer until the appointment of Mr. Nathen Fuentes as the Chief Financial Officer and Treasurer effective September 21, 2023. |
Executive Compensation Arrangements
Below is a more detailed summary of the elements of our current executive compensation program as it relates to our named executive officers.
Employment Agreements
Christopher Chapman, Jr., MD
We entered into an employment agreement with Dr. Chapman, effective as of the date of the closing of this initial public offering, pursuant to which Dr. Chapman will serve as our Chief Executive Officer and Chairman of our board of directors. Under his employment agreement, Dr. Chapman will agree to work part-time and on an as-needed basis with respect to the affairs of our company. Dr. Chapman’s employment agreement provides that his employment will be on an at-will basis and can be terminated by either Dr. Chapman or us at any time for cause. Under the agreement, Dr. Chapman will receive an initial base salary of $275,000 per year beginning on the closing of this offering. In the event that Dr. Chapman’s employment is terminated by our company without “Cause” or is terminated by Dr. Chapman for “Good Reason”, Dr. Chapman will be entitled to severance compensation in the form of salary continuation for a period of three months (subject to Dr. Chapman executing and delivering a customary general release in favor of the company). “Cause” is defined in the agreement to include dishonesty, misappropriation, willful misconduct, breach of the agreement, and other customary matters. “Good Reason” is defined to include a material adverse change in Dr. Chapman’s compensation or duties and level of responsibility. The employment agreement also contains customary confidentiality and invention-assignment covenants to which Dr. Chapman is subject. Beginning in 2023, in lieu of health insurance coverage and 401k benefits, we have agreed to pay Dr. Chapman’s life insurance policy premium in an amount up to $2,215 per quarter.
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Nathen Fuentes, CPA
We entered into an amended and restated employment agreement on December 11, 2023, with Mr. Fuentes which amended and restated his original employment agreement, which was effective September 21, 2023, pursuant to which Mr. Fuentes serves as our Chief Financial Officer, Treasurer, and Secretary. Under his employment agreement, Mr. Fuentes has agreed to devote his full business time and effort to the business affairs of the Company. Mr. Fuentes’s employment agreement provides that his employment will be on an at-will basis and can be terminated by either Mr. Fuentes or our company at any time for cause. Under the agreement, Mr. Fuentes will receive an initial base salary of $165,000 per year, however, should the Company complete the initial public offering prior to September 21, 2024, such salary shall be retroactively adjusted to equal $250,000 for his first full year of employment only. Additional bonuses and adjustments to Mr. Fuentes’s salary may be made by our board of directors in its sole discretion. In the event that his employment is terminated by our company without “Cause” or is terminated by Mr. Fuentes for “Good Reason”, Mr. Fuentes will be entitled to severance compensation in the form of salary continuation for a period of three months (subject to Mr. Fuentes executing and delivering a customary general release in favor of the company). “Cause” is defined in the agreement to include dishonesty, misappropriation, willful misconduct, breach of the agreement, and other customary matters. “Good Reason” is defined to include a material adverse change in Mr. Fuentes’s compensation or duties and level of responsibility. The employment agreement also contains customary confidentiality and invention-assignment covenants to which Mr. Fuentes is subject.
Base Salaries
The base salaries of our employed executive officers are specified in their respective employment agreements, as summarized above.
Bonuses
We did not pay any bonuses to any of our named executive officers during 2022 or during the first three quarters of 2023. Our employment agreements with our executive officers provide that bonuses may be granted to our executive officers in the discretion of our board of directors.
Equity Compensation
Through the date of this prospectus, none of our officers, directors, or employees have received any equity compensation.
Retirement Plans
We do not currently maintain any retirement plans for our employees.
Outstanding Equity Awards at Fiscal Year-End
There were no stock options granted and outstanding as of December 31, 2022.
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2023 Omnibus Incentive Plan
Our board of directors has adopted, and our stockholders have approved, the Telomir Pharmaceuticals, Inc. 2023 Omnibus Incentive Plan (the “2023 Omnibus Plan”) which will be effective upon the completion of this offering. The 2023 Omnibus Plan will authorize the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to our employees and any of our parent and subsidiary corporations’ employees, and the grant of non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to our employees, directors, and consultants and any of our future subsidiary corporations’ employees and consultants. The following is a summary of certain terms and conditions of the 2023 Omnibus Plan. This summary is qualified in its entirety by reference to the 2023 Omnibus Plan attached as an exhibit to the registration statement of which this prospectus forms a part.
Administration
The 2023 Omnibus Plan is administered by our board of directors or our compensation committee, or any other committee or subcommittee or one or more of our officers to whom authority has been delegated (collectively, the “Administrator”). The Administrator has the authority to interpret the 2023 Omnibus Plan and award agreements entered into with respect to the 2023 Omnibus Plan; to make, change and rescind rules and regulations relating to the 2023 Omnibus Plan; to make changes to, or reconcile any inconsistency in, the 2023 Omnibus Plan or any award agreement covering an award; and to take any other actions needed to administer the 2023 Omnibus Plan.
Eligibility
The Administrator may designate any of the following as a participant under the 2023 Omnibus Plan: any officer or employee, or individuals engaged to become an officer or employee, of our company or our affiliates; and consultants of our company or our affiliates, and our directors, including our non-employee directors.
Types of Awards
The 2023 Omnibus Plan permits the Administrator to grant stock options, stock appreciation rights (“SARs”), performance shares, performance units, shares of common stock, restricted stock, restricted stock units (“RSUs”), cash incentive awards, dividend equivalent units, or any other type of award permitted under the 2023 Omnibus Plan. The Administrator may grant any type of award to any participant it selects, but only our employees or our subsidiaries’ employees may receive grants of incentive stock options within the meaning of Section 422 of the Internal Revenue Code. Awards may be granted alone or in addition to, in tandem with, or (subject to the repricing prohibition described below) in substitution for any other award (or any other award granted under another plan of our company or any affiliate, including the plan of an acquired entity).
Shares Reserved Under the 2023 Omnibus Incentive Plan
The 2023 Omnibus Plan will provide that 6,500,000 shares of our common stock are reserved for issuance under the 2023 Omnibus Plan, all of which may be issued pursuant to the exercise of incentive stock options. The number of shares available for issuance under our 2023 Omnibus Plan will also include an annual increase on the first day of each fiscal year after the completion of this offering equal to 1.0% of the outstanding shares of all class of our common stock as of the last day of the immediately preceding fiscal year or such other amount as our board of directors may determine.
The number of shares reserved for issuance under the 2023 Omnibus Plan will be reduced on the date of the grant of any award by the maximum number of shares, if any, with respect to which such award is granted. However, an award that may be settled solely in cash will not deplete the 2023 Omnibus Plan’s share reserve at the time the award is granted. If (a) an award expires, is canceled, or terminates without issuance of shares or is settled in cash, (b) the Administrator determines that the shares granted under an award will not be issuable because the conditions for issuance will not be satisfied, (c) shares are forfeited under an award, (d) shares are issued under any award and we reacquire them pursuant to our reserved rights upon the issuance of the shares, (e) shares are tendered or withheld in payment of the exercise price of an option or as a result of the net settlement of outstanding stock appreciation rights or (f) shares are tendered or withheld to satisfy federal, state or local tax withholding obligations, then those shares are added back to the reserve and may again be used for new awards under the 2023 Omnibus Plan. However, shares added back to the reserve pursuant to clauses (d), (e) or (f) in the preceding sentence may not be issued pursuant to incentive stock options.
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Options
The Administrator may grant stock options and determine all terms and conditions of each stock option, which include the number of stock options granted, whether a stock option is to be an incentive stock option or non-qualified stock option, and the grant date for the stock option. However, the exercise price per share of common stock may never be less than the fair market value of a share of common stock on the date of grant and the expiration date may not be later than 10 years after the date of grant. Stock options will be exercisable and vest at such times and be subject to such restrictions and conditions as are determined by the Administrator, including with respect to the manner of payment of the exercise price of such stock options.
Stock Appreciation Rights
The Administrator may grant SARs, which represent the right of a participant to receive cash in an amount, or common stock with a fair market value, equal to the appreciation of the fair market value of a share of common stock during a specified period of time. The 2023 Omnibus Plan provides that the Administrator will determine all terms and conditions of each SAR, including, among other things: (a) whether the SAR is granted independently of a stock option or relates to a stock option, (b) the grant price, which may never be less than the fair market value of our common stock as determined on the date of grant, (c) a term that must be no later than 10 years after the date of grant, and (d) whether the SAR will settle in cash, common stock or a combination of the two.
Performance and Stock Awards
The Administrator may grant awards of shares of common stock, restricted stock, RSUs, performance shares or performance units. Restricted stock means shares of common stock that are subject to a risk of forfeiture or restrictions on transfer, which may lapse upon the achievement or partial achievement of performance goals (as described below) or upon the completion of a period of service. An RSU grants the participant the right to receive cash or shares of common stock the value of which is equal to the fair market value of one share of common stock, to the extent performance goals are achieved or upon the completion of a period of service. Performance shares give the participant the right to receive shares of common stock to the extent performance goals are achieved. Performance units give the participant the right to receive cash or shares of common stock valued in relation to a unit that has a designated dollar value or the value of which is equal to the fair market value of one or more shares of common stock, to the extent performance goals are achieved.
The Administrator will determine all terms and conditions of the awards including (a) whether performance goals must be achieved for the participant to realize any portion of the benefit provided under the award, (b) the length of the vesting or performance period and, if different, the date that payment of the benefit will be made, (c) with respect to performance units, whether to measure the value of each unit in relation to a designated dollar value or the fair market value of one or more shares of common stock, and (d) with respect to performance shares, performance units, and RSUs, whether the awards will settle in cash, in shares of common stock (including restricted stock), or in a combination of the two.
Cash Incentive Awards
The Administrator may grant cash incentive awards. An incentive award is the right to receive a cash payment to the extent one or more performance goals are achieved. The Administrator will determine all terms and conditions of a cash incentive award, including, but not limited to, the performance goals (described below), the performance period, the potential amount payable, and the timing of payment. While the 2023 Omnibus Plan permits cash incentive awards to be granted under the 2023 Omnibus Plan, we may also make cash incentive awards outside of the 2023 Omnibus Plan.
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Performance Goals
For purposes of the 2023 Omnibus Plan, the Administrator may establish objective or subjective performance goals which may apply to any performance award. Such performance goals may include, but are not limited to, one or more of the following measures with respect to our company or any one or more of our subsidiaries, affiliates, or other business units: net sales; cost of sales; gross income; gross revenue; revenue; operating income; earnings before taxes; earnings before interest and taxes; earnings before interest, taxes, depreciation and amortization; earnings before interest, taxes, depreciation, amortization and exception items; income from continuing operations; net income; earnings per share; diluted earnings per share; total stockholder return; fair market value of a share of common stock; cash flow; net cash provided by operating activities; net cash provided by operating activities less net cash used in investing activities; ratio of debt to debt plus equity; return on stockholder equity; return on invested capital; return on average total capital employed; return on net capital employed; return on assets; return on net assets employed before interest and taxes; operating working capital; average accounts receivable (calculated by taking the average of accounts receivable at the end of each month); average inventories (calculated by taking the average of inventories at the end of each month); economic value added; succession planning; manufacturing return on assets; manufacturing margin; and customer satisfaction. Performance goals may also relate to a participant’s individual performance. The Administrator reserves the right to adjust any performance goals or modify the manner of measuring or evaluating a performance goal.
Dividend Equivalent Units
The Administrator may grant dividend equivalent units. A dividend equivalent unit gives the participant the right to receive a payment, in cash or shares of common stock, equal to the cash dividends or other distributions that we pay with respect to a share of common stock. We determine all terms and conditions of a dividend equivalent unit award, except that dividend equivalent units may not be granted in connection with a stock option or SAR, and dividend equivalent unit awards granted in connection with another award cannot provide for payment until the date such award vests or is earned, as applicable.
Other Stock-Based Awards
The Administrator may grant to any participant shares of unrestricted stock as a replacement for other compensation to which such participant is entitled, such as in payment of director fees, in lieu of cash compensation, in exchange for cancellation of a compensation right or as a bonus.
Transferability
Awards are not transferable, including to any financial institution, other than by will or the laws of descent and distribution, unless the Administrator allows a participant to (a) designate in writing a beneficiary to exercise the award or receive payment under the award after the participant’s death, (b) transfer an award to a former spouse as required by a domestic relations order incident to a divorce, or (c) transfer an award without receiving any consideration.
Adjustments
If (a) we are involved in a merger or other transaction in which our shares of common stock are changed or exchanged; (b) we subdivide or combine shares of common stock or declare a dividend payable in shares of common stock, other securities, or other property (other than stock purchase rights issued pursuant to a stockholder rights agreement); (c) we effect a cash dividend that exceeds 10% of the fair market value of a share of common stock or any other dividend or distribution in the form of cash or a repurchase of shares of common stock that our board of directors determines is special or extraordinary, or that is in connection with a recapitalization or reorganization; or (d) any other event occurs that in the Administrator’s judgment requires an adjustment to prevent dilution or enlargement of the benefits intended to be made available under the 2023 Omnibus Plan, then the Administrator will, in a manner it deems equitable, adjust any or all of (1) the number and type of shares subject to the 2023 Omnibus Plan and which may, after the event, be made the subject of awards; (2) the number and type of shares of common stock subject to outstanding awards; (3) the grant, purchase, or exercise price with respect to any award; and (4) the performance goals of an award. In any such case, the Administrator may also provide for a cash payment to the holder of an outstanding award in exchange for the cancellation of all or a portion of the award, subject to the terms of the 2023 Omnibus Plan.
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The Administrator may, in connection with any merger, consolidation, acquisition of property or stock, or reorganization, authorize the issuance or assumption of awards upon terms and conditions we deem appropriate without affecting the number of shares of common stock otherwise reserved or available under the 2023 Omnibus Plan.
Change of Control
Upon a change of control (as defined in the 2023 Omnibus Plan), the successor or surviving corporation may agree to assume some or all outstanding awards or replace them with the same type of award with similar terms and conditions, without the consent of any participant, subject to the following requirements:
● | Each award that is assumed must be appropriately adjusted, immediately after such change of control, to apply to the number and class of securities that would have been issuable to a participant upon the consummation of such change of control had the award been exercised, vested, or earned immediately prior to such change of control, and other appropriate adjustment to the terms and conditions of the award may be made. | |
● | If the securities to which the awards relate after the change of control are not listed and traded on a national securities exchange, then (a) each participant must be provided the option to elect to receive, in lieu of the issuance of such securities, cash in an amount equal to the fair value of the securities that would have otherwise been issued, and (b) no reduction may be taken to reflect a discount for lack of marketability, minority, or any similar consideration, for purposes of determining the fair value of such securities. | |
● | If a participant is terminated from employment without cause, or due to death or disability, or the participant resigns employment for good reason (as defined in any award or other agreement between the participant and our company or an affiliate) within two years following the change of control, then upon such termination, all of the participant’s awards in effect on the date of such termination will vest in full or be deemed earned in full. |
If the purchaser, successor, or surviving entity does not assume the awards or issue replacement awards, then immediately prior to the change of control date, unless the Administrator otherwise determines:
● | Each stock option or SAR then held by a participant will become immediately and fully vested, and all stock options and SARs will be cancelled on the change of control date in exchange for a cash payment equal to the excess of the change of control price of the shares of common stock over the purchase or grant price of such shares under the award. | |
● | Unvested restricted stock and RSUs (that are not performance awards) will vest in full. | |
● | All performance shares, performance units and cash incentive awards for which the performance period has expired will be paid based on actual performance, and all such awards for which the performance period has not expired will be cancelled in exchange for a cash payment equal to the amount that would have been due under such awards, valued assuming achievement of target performance goals at the time of the change of control, prorated based on the number of full months elapsed in the performance period. | |
● | All unvested dividend equivalent units will vest (to the same extent as the award granted in tandem with such units) and be paid. | |
● | All other unvested awards will vest and any amounts payable will be paid in cash. |
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Term of Plan
Unless earlier terminated by our board of directors, the 2023 Omnibus Plan will terminate on, and no further awards may be granted, after the tenth (10th) anniversary of its effective date.
Termination and Amendment of Plan
Our board of directors or the Administrator may amend, alter, suspend, discontinue, or terminate the 2023 Omnibus Plan at any time, subject to the following limitations:
● | Our board of directors must approve any amendment to the 2023 Omnibus Plan if we determine such approval is required by prior action of our board of directors, applicable corporate law, or any other applicable law; | |
● | Stockholders must approve any amendment to the 2023 Omnibus Plan, which may include an amendment to materially increase the number of shares reserved under the 2023 Omnibus Plan, if we determine that such approval is required by Section 16 of the Exchange Act, the Code, the listing requirements of any principal securities exchange or market on which the shares are then traded, or any other applicable law; and | |
● | Stockholders must approve any amendment to the 2023 Omnibus Plan that would diminish the protections afforded by the participant award limits or repricing and backdating prohibitions. |
Amendment, Modification, Cancellation and Disgorgement of Awards
Subject to the requirements of the 2023 Omnibus Plan, the Administrator may modify or amend any award or waive any restrictions or conditions applicable to any award or the exercise of the award, or amend, modify, or cancel any terms and conditions applicable to any award, in each case, by mutual agreement of the Administrator and the participant or any other person that may have an interest in the award, so long as any such action does not increase the number of shares of common stock issuable under the 2023 Omnibus Plan.
We do not need to obtain participant (or other interested party) consent for any such action (a) that is permitted pursuant to the adjustment provisions of the 2023 Omnibus Plan; (b) to the extent we deem the action necessary to comply with any applicable law or the listing requirements of any principal securities exchange or market on which our common stock is then traded; (c) to the extent we deem the action is necessary to preserve favorable accounting or tax treatment of any award for us; or (d) to the extent we determine that such action does not materially and adversely affect the value of an award or that such action is in the best interest of the affected participant or any other person as may then have an interest in the award.
The Administrator can cause a participant to forfeit any award, and require the participant to disgorge any gains attributable to the award, if the participant engages in any action constituting, as determined by the Administrator in its discretion, cause for termination, or a breach of a material company policy, any award agreement or any other agreement between the participant and us or one of our affiliates concerning noncompetition, nonsolicitation, confidentiality, trade secrets, intellectual property, nondisparagement or similar obligations.
Any awards granted under the 2023 Omnibus Plan, and any shares of common stock issued or cash paid under an award, will be subject to any recoupment or clawback policy that we adopt, or any recoupment or similar requirement otherwise made applicable by law, regulation or listing standards to us.
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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
The following is a description of transactions within the last three years to which we have been a party, in which the amount involved exceeded or will exceed $120,000, and in which any of our executive officers, directors or holders of more than 5% of our voting securities, or an immediate family member thereof, had or will have a direct or indirect material interest. We believe the terms obtained or consideration that we paid or received, as applicable, in connection with the transactions described below were comparable to terms available or amounts that would be paid or received, as applicable, in arm’s-length transactions with unrelated third parties.
Line of Credit and Promissory Note with the Bay Shore Trust
On June 15, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder, Jonnie R. Williams, Sr., and under which various of his family members are beneficiaries (the “Bay Shore Trust”). Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), we have the right to borrow up to an aggregate of $5,000,000 from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our initial public offering. Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in our assets, operations, or prospects. The Bay Share Note, together with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty. The Bay Shore Note will accrue interest at a rate equal to 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note is unsecured. As of November 30, 2023, the total amount outstanding under the Bay Shore Note was $1.4 million. The total amount outstanding was converted into 674,637 shares of our common stock on November 30, 2023 at a conversion rate of $2.05 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023) pursuant to a conversion agreement.
In consideration of the loan facility provided by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant on June 15, 2023, giving the Bay Shore Trust the right to purchase up to 2,439,025 shares of common stock at an exercise price of $3.73 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023), which warrant will expire five years after the date of grant. Upon issuance, the warrant met the criteria to be classified as equity based on an analysis under Accounting Standards Codification (480) ASC 480, “Distinguishing Liabilities from Equity” and will be measured at fair value, resulting in an initial fair value of approximately $5.95 million upon issuance of the warrant using Black-Scholes valuation techniques.
Transactions with MIRALOGX LLC
Since January 1, 2023, MIRALOGX and The Starwood Trust, a separate Trust established by our founder, have advanced funds on behalf of Bayshore Trust to our company in order to fund operating activities. The total amount advanced and outstanding as of November 30, 2023, was $1.7 million. These advances were converted into 837,841 shares of our common stock on November 30, 2023 at a conversion rate of $2.05 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023) pursuant to a conversion agreement.
On July 31, 2023, we entered into the Initial MIRALOGX License Agreement with MIRALOGX, which is an intellectual property development and holding company established by our founder and the inventor of TELOMIR-1, Jonnie R. Williams, Sr. See “Business– Intellectual Property”. MIRALOGX is wholly owned by the Bay Shore Trust, and Mr. Williams does not have voting or dispositive power over the shares of the Company held by Bay Shore Trust, and Mr. Williams is not an officer or director of the Bay Shore Trust. On November 10, 2023, we entered into an amendment to the Initial MIRALOGX License Agreement, pursuant to which we acquired the license to the non-human applications of the “Licensed Products.” See “—Intellectual Property.”
We are also a party to an Agreement for Shared Lease Costs, dated April 1, 2023, with MIRALOGX and MIRA Pharmaceuticals, Inc., under which we have agreed to pay our pro rata share of the operating usage costs owing by MIRALOGX under an aircraft lease agreement between MIRALOGX and Supera Aviation I LLC (“Supera Aviation”) based on our usage of the leased aircraft each month. No amounts are payable by us under this agreement unless and to the extent we choose to utilize the leased aircraft, and we may discontinue the use of the aircraft and terminate this agreement at any time. Supera Aviation is a company owned by Starwood Trust, a trust established by Mr. Williams. Since April 1, 2023, the Company has incurred $698,600 in expenses under the aircraft lease agreement.
Review and Approval of Related Party Transactions
Prior to the completion of this offering, our board of directors will adopt a written policy regarding the review and approval of related party transactions. Our audit committee charter provides that the audit committee shall review and approve or disapprove any related party transactions, which are transactions between us and related persons in which the aggregate amount involved exceeds or may be expected to exceed $120,000 and in which a related person has or will have a direct or indirect material interest. Upon the completion of this offering, our policy regarding transactions between us and related persons will provide that a related person is defined as a director, executive officer, nominee for director or greater than 5% beneficial owner of our common stock, in each case since the beginning of the most recently completed year, and any of their immediate family members.
Certain of the foregoing disclosures are summaries of certain provisions of our related party agreements and are qualified in their entirety by reference to all of the provisions of such agreements. Because these descriptions are only summaries of the applicable agreements, they do not necessarily contain all of the information that you may find useful. Copies of certain of the agreements have been filed as exhibits to the registration statement of which this prospectus is a part and are available electronically on the website of the SEC at www.sec.gov.
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The following table sets forth information as of December 5, 2023 (the “Beneficial Ownership Date”) with respect to the beneficial ownership of our common stock (i) immediately prior to this offering and (ii) as adjusted to reflect the sale of 1,000,000 shares of our common stock in this offering, in each case by:
● | each of our named executive officers; | |
● | each of our directors; | |
● | all of our current directors and executive officers as a group; and | |
● | each person known by us to be the beneficial owner of more than 5% of the outstanding shares of our common stock. |
We have determined beneficial ownership in accordance with the rules of the SEC, and thus it represents sole or shared voting or investment power with respect to our securities. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of common stock subject to options or warrants held by that person that are currently exercisable or exercisable within 60 days of the Beneficial Ownership Date are deemed outstanding but are not deemed outstanding for computing the percentage ownership of any other person. Unless otherwise indicated below, to our knowledge, the persons and entities named in the table have sole voting and sole investment power with respect to all shares that they beneficially owned, subject to community property laws where applicable. The information does not necessarily indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Securities Act.
In the table below, the applicable percentage ownership relating to shares beneficially owned prior to this offering is based on shares of our common stock outstanding as of the Beneficial Ownership Date. The applicable percentage ownership relating to shares beneficially owned after this offering is based on 28,609,814 shares of our common stock outstanding (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023) and assumes that the underwriters do not exercise their option to purchase additional shares of common stock from us. Unless otherwise indicated in the footnotes to the table below, the address of each beneficial owner listed in the table below is 900 West Platt Street Suite 200, Tampa, Florida 33606.
(1) | Includes (i) 5,406,431 shares held by the Bay Shore Trust, (ii) 1,853,659 shares held by the Celeste J. Williams Lifetime QTIP Trust, (iii) 24,391 shares held directly by Mr. McNulty, and (iv) 2,439,025 shares issuable pursuant to a warrant held by the Bay Shore Trust that is immediately exercisable. As trustee for both the Bay Shore Trust and Celeste J. Williams Lifetime QTIP Trust, Mr. McNulty has sole voting and dispositive power over the shares held by each trust, and, as a result is deemed to have beneficial ownership (as determined under Section 13(d) of the Exchange Act) of the securities held by each trust. Mr. Jonnie R. Williams, Sr., our founder and the settlor of the Bay Shore Trust, does not have voting or dispositive power over the shares held by the Bay Shore Trust. | |
(5) | Consists of (i) 585,366 shares held directly by Mr. O’Donnell Jr. and (ii) 1,365,854 shares held by the Rachel Jean Williams 2021 Irrevocable Trust. As trustee of the Rachel Jean Williams 2021 Irrevocable Trust, Mr. O’Donnell Jr. has sole voting and dispositive power over the shares held by the trust, and, as a result is deemed to have beneficial ownership (as determined under Section 13(d) of the Exchange Act) of the securities held by the trust. |
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The following is a description of the material terms of our amended and restated articles of incorporation and our amended and restated bylaws to be in effect upon the completion of this offering. The following description is a summary, does not purport to be complete and is qualified in its entirety by reference to our second amended and restated articles of incorporation and amended and restated bylaws, which are filed as exhibits to the registration statement of which this prospectus is a part and are incorporated by reference into this prospectus.
After giving effect to the filing of our Second Amended and Restated Articles of Incorporation and the 1-for-2.05 reverse stock split that we completed on December 11, 2023, the total number of shares of common stock our company is authorized to issue is presently 300,000,000 shares, no par value. The total number of shares of preferred stock our company is authorized to issue is 100,000,000 shares, no par value.
Corporate Governance
We are a corporation organized under the laws of the state of Florida and are governed by the Florida Business Corporation Act, which we sometimes refer to as the FBCA, our amended and restated articles of incorporation and our amended and restated bylaws.
Common Stock
Holders of shares of our common stock are entitled to one vote for each share held on all matters submitted to a vote of shareholders. Accordingly, holders of a majority of the shares of our common stock entitled to vote in any election of directors may elect all of the directors standing for election. Holders of shares of our common stock are entitled to receive proportionately any dividends if and when such dividends are declared by our board of directors, subject to any preferential dividend rights of outstanding preferred stock. Upon the liquidation, dissolution or winding up of the company, the holders of our common stock are entitled to receive ratably net assets available after the payment of all debts and other liabilities and subject to the prior rights of holders of any outstanding preferred stock. The rights, preferences, and privileges of holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.
Preferred Stock
Under the terms of our amended and restated articles of incorporation, which we sometimes refer to as the articles, the board of directors is authorized to designate and issue up to 100,000,000 shares of preferred stock in one or more series without shareholder approval. Our board of directors will have discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock.
It is not possible to state the actual effect of the issuance of any shares of preferred stock upon the rights of holders of our common stock until the board of directors determines the specific rights of the holders of the preferred stock. However, these effects might include:
● | restricting dividends on the common stock; |
● | diluting the voting power of the common stock; |
● | impairing the liquidation rights of the common stock; and |
● | delaying or preventing a change in control of the company. |
Upon completion of this offering, there will be no shares of preferred stock outstanding, and, at present, we have no plans to issue any shares of preferred stock.
Dividends and Other Distributions
The holders of our common stock will be entitled to receive proportionately any cash or stock dividends if and when such dividends are declared by the board of directors, subject to any preferential dividend rights of outstanding preferred stock. In the event of the dissolution or liquidation of the company, after the full preferential rights, if any, on any outstanding preferred stock has been paid to or set aside for the holders of such preferred stock, the holders of our common stock will be entitled to receive proportionately all of our remaining assets.
The declaration and payment of any dividend will be subject to the discretion of our board of directors, subject to applicable laws. The time and amount of any dividend will depend on a number of factors, including our financial condition, results of operations, capital requirements, contractual restrictions, general business conditions, and any other factors that our board of directors may deem relevant.
We currently intend to retain all available funds and any future earnings for general corporate purposes, including working capital, operating expenses, and capital expenditures, and do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future. See “Dividend Policy.”
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Number and Election of Directors
Our board of directors consists of seven members. The holders of common stock and any other class of stock of our company, to the extent they shall have the right to vote, shall retain the right to elect and remove all members of the board of directors.
Quorum/Voting
At all meetings of our board of directors, a majority of the total number of directors constitutes a quorum. If there is a quorum, a vote of the majority of the directors present at the meeting is considered an act of our board of directors.
Removal of Directors
Our amended and restated articles provide that any director may be removed from office, but only for cause by the affirmative vote of not less than a majority of our shareholders entitled to vote in the election of directors. “Cause” is construed to exist only if the director whose removal is proposed has been convicted of a felony or has been adjudged to be liable for willful misconduct in the performance of his or her duties to us in a matter which has a material adverse effect on our business.
Vacancies on the Board of Directors
A vacancy on our board of directors may be filled by a vote of a majority of the remaining members of the board of directors, even if less than a quorum, at any meeting of the board of directors. A person so elected by the board of directors to fill a vacancy shall hold office for the remainder of the full term of the director for which the vacancy was created or occurred and until such director’s successor shall have been duly elected and qualified.
Voting by Shareholders
Each holder of our common stock is entitled to one vote per share for the election of directors and for all other corporate purposes.
Amendment of Articles
The FBCA allows us to amend our amended and restated articles at any time to add or change a provision that is required or permitted to be included in the articles of incorporation or to delete a provision that is not required to be included in the articles of incorporation. Our board of directors can propose one or more amendments for submission to shareholders and may condition its submission of the proposed amendment on any basis if it provides certain notice and includes certain information regarding the proposed amendment in that notice. The provisions in our articles that require a greater voting requirement than provided in the FBCA may only be amended by the same vote required to take action under that voting requirement.
Amendment of Bylaws
Our bylaws may be amended or repealed, and new bylaws may be adopted by our shareholders at any annual or special meetings at which a quorum is present. The bylaws may also be amended or repealed, and new bylaws may be adopted by our board of directors by affirmative vote of a majority of the number of directors present at any meeting at which a quorum is in attendance. Notwithstanding the foregoing, pursuant to our articles, the provisions of our bylaws that require a greater voting requirement than provided in the FBCA may only be amended by the same vote required to take action under that voting requirement.
Anti-Takeover Effects of Various Provisions of Florida Law, Our Amended and Restated Articles of Incorporation and Our Bylaws
Provisions of Florida law have certain anti-takeover effects. Our amended and restated articles of incorporation and bylaws also contain provisions that may have similar effects.
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Florida Anti-Takeover Statutes
The control share acquisition statute, Section 607.0902 of the FBCA, generally provides that in the event a person acquires voting shares of the company in excess of 20% of the voting power of all of our issued and outstanding shares, such acquired shares will not have any voting rights unless such rights are restored by the holders of a majority of the votes of each class or series entitled to vote separately, excluding shares held by the person acquiring the control shares or any of our officers or employees who are also directors of the company. Certain acquisitions of shares are exempt from these rules, such as shares acquired pursuant to the laws of intestate succession or pursuant to a gift or testamentary transfer, pursuant to a merger or share exchange effected in compliance with the FBCA if we are a party to the agreement, or pursuant to an acquisition of our shares if the acquisition has been approved by our board of directors before the acquisition. The control share acquisition statute generally applies to any “issuing public corporation,” which means a Florida corporation which has:
● | One hundred or more shareholders; | |
● | Its principal place of business, its principal office, or substantial assets within Florida; and | |
● | Either (i) more than 10% of its shareholders are resident in Florida; (ii) more than 10% of its shares are owned by residents of Florida; or (iii) one thousand shareholders are resident in Florida. |
The affiliated transaction (or so-called “business combination”) statute, Section 607.0901 of the FBCA, provides that we may not engage in certain mergers, consolidations, sales of assets, issuances of stock, reclassifications, recapitalizations, and other affiliated transactions with any “interested shareholder” for a period of three years following the time that such shareholder became an interested shareholder, unless:
● | Prior to the time that such shareholder became an interested shareholder, our board of directors approved either the affiliated transaction or the transaction which resulted in the shareholder becoming an interested shareholder; or | |
● | Upon consummation of the transaction that resulted in the shareholder becoming an interested shareholder, the interested shareholder owned at least 85% of our voting shares outstanding at the time the transaction commenced; or | |
● | At or subsequent to the time that such shareholder became an interested shareholder, the affiliated transaction is approved by our board of directors and authorized at an annual or special meeting of shareholders, and not by written consent, by the affirmative vote of at least two-thirds of the outstanding voting shares which are not owned by the interested shareholder. |
An “interested shareholder” is generally defined as any person who is the beneficial owner of more than 15% of our outstanding voting shares.
The voting requirements set forth above do not apply to a particular affiliated transaction if one or more conditions are met, including, but not limited to, the following: if the affiliated transaction has been approved by a majority of our disinterested directors; if we have not had more than 300 shareholders of record at any time during the three years preceding the date the affiliated transaction is announced; if the interested shareholder has been the beneficial owner of at least 80% of our outstanding voting shares for at least three years preceding the date the affiliated transaction is announced; or if the consideration to be paid to the holders of each class or series of voting shares in the affiliated transaction meets certain requirements of the statute with respect to form and amount, among other things.
No Cumulative Voting
The FBCA provides that shareholders do not have the right to cumulate votes in the election of directors unless the articles of incorporation provide otherwise. Our articles do not provide for cumulative voting.
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Advance Notice Requirements for Shareholder Proposals and Director Nominations; Calling a Special Meeting
Our amended and restated bylaws provide that shareholders seeking to bring business before an annual meeting must provide timely notice of their proposal in writing to the corporate secretary. To be timely, a shareholder’s notice must have been received on or before December 31 of the year immediately preceding the annual meeting; provided, however, that in the event that the date of the annual meeting is on or after May 1 in any year, notice by the shareholder to be timely must be received not later than the close of business on the day which is determined by adding to December 31 of the year immediately preceding such annual meeting the number of days starting with May 1 and ending on the date of the annual meeting in such year. The amended and restated bylaws also specify requirements as to the form and content of a shareholder’s notice. These provisions may impede shareholders’ ability to bring matters before an annual meeting of shareholders or make nominations for directors at an annual meeting of shareholders.
Our amended and restated bylaws also provide that a special meeting of shareholders can only be called by our chairman of the board of directors, our chief executive officer, our president (in the absence of a chief executive officer), a majority of our board of directors or the holders of 10% or more of all of our votes entitled to be cast on any issue proposed to be considered at the special meeting of shareholders.
Authorized But Unissued Shares
Our authorized but unissued shares of common stock and preferred stock will be available for future issuance without shareholder approval. We could use these additional shares for a variety of corporate purposes, including future public offerings to raise additional capital, acquisitions of other businesses or entities and issuances under employee benefit plans. Additionally, we could issue a series of preferred stock that could, depending on its terms, impede the completion of a merger, tender offer or other takeover attempt. Our board of directors will make any determination to issue such shares based on its judgment as to the best interests of us and our shareholders. The board of directors, in so acting, could issue preferred stock having terms that could discourage an acquisition attempt through which an acquiror may be able to change the composition of the board of directors, including a tender offer or other transaction that some, or a majority, of our shareholders might believe to be in their best interests or in which shareholders might receive a premium over the then-current market price of the common stock.
Exclusive Jurisdiction
Our amended and restated bylaws provide that, unless we consent in writing to the selection of an alternative forum, the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our shareholders, (iii) any action arising pursuant to any provision of the FBCA, our amended and restated articles of incorporation or our amended and restated bylaws, or (iv) any other action asserting a claim that is governed by the internal affairs doctrine shall be a state court located within the state of Florida (or, if a state court located within the state of Florida does not have jurisdiction, the federal district court for the Middle District of Florida); provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act, or to any claim for which the federal courts have exclusive jurisdiction. Our bylaws also provide that, unless we consent in writing to the selection of an alternative forum, the U.S. federal district courts shall be the exclusive forum for the resolution of any claims arising under the Securities Act. Any person or entity purchasing or otherwise acquiring any interest in our securities shall be deemed to have notice of and consented to these provisions. Although we believe these provisions benefit us by providing increased consistency in the application of law for the specified types of actions and proceedings, the provisions may have the effect of discouraging lawsuits against us or our directors and officers. We note that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Please also see the section titled “Risk Factors—Risks Related to Ownership of our Common Stock—Our bylaws that will be in effect immediately prior to the completion of this offering designates the state courts located within the state of Florida as the exclusive forum for substantially all disputes between us and our shareholders and the federal district courts as the exclusive forum for Securities Act claims, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.”
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Preemptive Rights
No holder of our common stock has any preemptive or subscription rights to acquire shares of our capital stock.
Liability and Indemnification of Officers and Directors
Our amended and restated articles of incorporation and bylaws provide that we shall indemnify any and all persons whom we shall have power to indemnify under the FBCA to the fullest extent permitted by law.
Section 607.0831 of the FBCA, provides that a director is not personally liable for monetary damages to the corporation or any other person for any statement, vote, decision to take or not to take action, or any failure to take any action, as a director, unless (1) the director breached or failed to perform his or her duties as a director and (2) the director’s breach of, or failure to perform, those duties constitutes (a) a violation of the criminal law, unless the director had reasonable cause to believe his or her conduct was lawful or had no reasonable cause to believe his or her conduct was unlawful, (b) a transaction from which the director derived an improper personal benefit, either directly or indirectly, (c) a circumstance under which the liability provisions of Section 607.0834 of the FBCA are applicable, (d) in a proceeding by or in the right of the corporation to procure a judgment in its favor or by or in the right of a shareholder, conscious disregard for the best interest of the corporation, or willful or intentional misconduct, or (e) in a proceeding by or in the right of someone other than the corporation or a shareholder, recklessness or an act or omission which was committed in bad faith or with malicious purpose or in a manner exhibiting wanton and willful disregard of human rights, safety, or property. A judgment or other final adjudication against a director in any criminal proceeding for a violation of the criminal law estops that director from contesting the fact that his or her breach, or failure to perform, constitutes a violation of the criminal law; but does not estop the director from establishing that he or she had reasonable cause to believe that his or her conduct was lawful or had no reasonable cause to believe that his or her conduct was unlawful.
Under Section 607.0851 of the FBCA, a corporation has power to indemnify any person who is a party to any proceeding (other than an action by, or in the right of the corporation), because he or she is or was a director or officer of the corporation against liability incurred in connection with such proceeding, including any appeal thereof, if he or she acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The termination of any proceeding by judgment, order, settlement or conviction or upon a plea of nolo contendere or its equivalent shall not, of itself, create a presumption that the person did not act in good faith and in a manner which he or she reasonably believed to be in, or not opposed to, the best interests of the corporation or, with respect to any criminal action or proceeding, has reasonable cause to believe that his or her conduct was unlawful.
For purposes of the indemnification provisions of the FBCA, “director” or “officer” means an individual who is or was a director or officer, respectively, of a corporation or who, while a director or officer of the corporation, is or was serving at the corporation’s request as a director or officer, manager, partner, trustee, employee, or agent of another domestic or foreign corporation, limited liability company, partnership, joint venture, trust, employee benefit plan, or another enterprise or entity and the terms include, unless the context otherwise requires, the estate, heirs, executors, administrators, and personal representatives of a director or officer.
In addition, under Section 607.0851 of the FBCA, a corporation has the power to indemnify any person, who was or is a party to any proceeding by or in the right of the corporation to procure a judgment in its favor by reason of the fact that the person is or was a director or officer, against expenses and amounts paid in settlement not exceeding, in the judgment of the board of directors, the estimated expense of litigating the proceeding to conclusion, actually and reasonably incurred in connection with the defense or settlement of such proceeding, including any appeal thereof. Such indemnification shall be authorized if such person acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the corporation, except that no indemnification shall be made under this subsection in respect of any claim, issue, or matter as to which such person shall have been adjudged to be liable unless, and only to the extent that, the court in which such proceeding was brought, or any other court of competent jurisdiction, shall determine upon application that, despite the adjudication of liability but in view of all circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which such court shall deem proper.
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Section 607.0852 of the FBCA provides that a corporation must indemnify an individual who is or was a director or officer who was wholly successful, on the merits or otherwise, in the defense of any proceeding to which the individual was a party because he or she is or was a director or officer of the corporation against expenses incurred by the individual in connection with the proceeding.
Section 607.0853 of the FBCA provides that a corporation may, before final disposition of a proceeding, advance funds to pay for or reimburse expenses incurred in connection with the proceeding by an individual who is a party to the proceeding because that individual is or was a director or an officer if the director or officer delivers to the corporation a signed written undertaking of the director or officer to repay any funds advanced if (a) the director or officer is not entitled to mandatory indemnification under Section 607.0852; and (b) it is ultimately determined under Section 607.0854 or Section 607.0855 (as described below) that the director or officer has not met the relevant standard of conduct described in Section 607.0851 or the director or officer is not entitled to indemnification under Section 607.0859 (as described below).
Section 607.0854 of the FBCA provides that, unless the corporation’s articles of incorporation provide otherwise, notwithstanding the failure of a corporation to provide indemnification, and despite any contrary determination of the board of directors or of the shareholders in the specific case, a director or officer of the corporation who is a party to a proceeding because he or she is or was a director or officer may apply for indemnification or an advance for expenses, or both, to a court having jurisdiction over the corporation which is conducting the proceeding, or to a circuit court of competent jurisdiction. Our amended and restated articles of incorporation do not provide any such exclusion. After receipt of an application and after giving any notice it considers necessary, the court may order indemnification or advancement of expenses upon certain determinations of the court.
Section 607.0855 of the FBCA provides that, unless ordered by a court under Section 607.0854, a corporation may not indemnify a director or officer under Section 607.0851 unless authorized for a specific proceeding after a determination has been made that indemnification is permissible because the director or officer has met the relevant standard of conduct set forth in Section 607.0851.
Section 607.0857 of the FBCA also provides that a corporation shall have the power to purchase and maintain insurance on behalf of and for the benefit of any person who is or was a director or officer of the corporation against any liability asserted against the person and incurred by him or her in any such capacity or arising out of his or her status as such, whether or not the corporation would have the power to indemnify or advance expenses to the individual against such liability under the provisions of Section 607.0857.
Section 607.0858 of the FBCA provides that the indemnification provided pursuant to Section 607.0851 and Section 607.0852, and the advancement of expenses provided pursuant to Section 607.0853, are not exclusive. A corporation may, by a provision in its articles of incorporation, bylaws, or any agreement, or by vote of shareholders or disinterested directors, or otherwise, obligate itself in advance of the act or omission giving rise to a proceeding to provide any other or further indemnification or advancement of expenses to any of its directors or officers.
Section 607.0859 of the FBCA provides that, unless ordered by a court under the provisions of Section 607.0854 of the FBCA, a corporation may not indemnify a director or officer under Section 607.0851 or Section 607.0858, or advance expenses to a director or officer under Section 607.0853 or Section 607.0858, if a judgment or other final adjudication establishes that his or her actions, or omissions to act, were material to the cause of action so adjudicated and constitute: (a) willful or intentional misconduct or a conscious disregard for the best interests of the corporation in a proceeding by or in the right of the corporation to procure a judgment in its favor or in a proceeding by or in the right of a shareholder; (b) a transaction in which a director or officer derived an improper personal benefit; (c) a violation of the criminal law, unless the director or officer had reasonable cause to believe his or her conduct was lawful or had no reasonable cause to believe his or her conduct was unlawful; or (d) in the case of a director, a circumstance under which the liability provisions of Section 607.0834 are applicable (relating to unlawful distributions).
These provisions may have the practical effect in certain cases of eliminating the ability of shareholders to collect monetary damages from our directors and officers. We believe that these provisions are necessary to attract and retain qualified persons to serve as our directors and officers. There is currently no pending material litigation or proceeding involving any of our directors, officers or employees for which indemnification is sought.
Transfer Agent and Registrar
American Stock Transfer (also known as Equiniti) will be the transfer agent and registrar for our common stock. The transfer agent’s address is 6201 15th Avenue, Brooklyn, NY 11219.
Listing
We have applied to list our common stock on the Nasdaq Capital Market under the symbol “TELO”.
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SHARES ELIGIBLE FOR FUTURE SALE
Prior to this offering, there was no public market for our common stock, and there can be no assurance that a significant public market for our common stock will develop or be sustained after this offering. Future sales of substantial amounts of our common stock in the public market (including securities convertible into or redeemable, exchangeable, or exercisable for shares of common stock) or the perception that such sales may occur or the availability of such shares for sale in the public market, after this offering could adversely affect the prevailing market price of our common stock. Furthermore, because all of our common stock outstanding prior to the completion of this offering (including securities convertible into or redeemable, exchangeable, or exercisable for shares of our common stock) will be subject to the contractual and legal restrictions on resale described below, the sale of a substantial amount of common stock in the public market after these restrictions lapse could materially adversely affect the prevailing market price of our common stock and our ability to raise equity capital in the future.
If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the lock-up and other legal restrictions on resale discussed in this prospectus lapse, the trading price of our common stock could decline. Based on shares of common stock outstanding as of December 12, 2023, upon the completion of this offering we will have outstanding a total of 29,609,814 shares of common stock. Of these shares, only the shares of common stock sold in this offering by us, plus any shares sold upon exercise of the underwriters’ option to purchase additional shares, will be freely tradable without restriction in the public market immediately following this offering.
The lock-up agreements pertaining to this offering will expire 180 days from the date of this prospectus (or 365 days for initial holders of our common stock that hold 26,332,026 shares in the aggregate), subject to earlier release of all or a portion of the shares subject to such agreements by the representatives of the underwriters in this offering in their sole discretion. After the lock-up agreements expire, based upon the number of shares of common stock, on an as-converted basis, outstanding as of December 12, 2023, up to an additional 26,658,594 shares of common stock will be eligible for sale in the public market. Approximately 5.98% of these additional shares are beneficially held by directors, executive officers and their affiliates and will be subject to certain limitations of Rule 144 under the Securities Act of 1933, as amended, or the Securities Act.
In addition, shares of common stock that are reserved for future issuance under our existing equity compensation plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements and Rule 144 and Rule 701 under the Securities Act. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline. Additionally, the number of shares of our common stock reserved for issuance under the 2023 Omnibus Plan will automatically increase on January 1 of each year following our initial public offering by 1% of outstanding shares or such lesser number as is determined by our board of directors.
All of the shares of common stock sold in this offering will be freely transferable without restriction or further registration under the Securities Act by persons other than “affiliates,” as that term is defined in Rule 144 under the Securities Act.
Generally, the balance of our outstanding shares of common stock will be deemed “restricted securities” within the meaning of Rule 144 under the Securities Act, subject to the limitations and restrictions that are described below. Common stock purchased by our affiliates will be “restricted securities” under Rule 144. Restricted securities may be sold in the public market only if they are registered under the Securities Act or if they qualify for an exemption from registration under Rule 144 or Rule 701 under the Securities Act, which rules are summarized below.
As a result of the lock-up agreements described below and subject to the provisions of Rule 144 or Rule 701, shares of our common stock will be available for sale in the public market as follows:
● | beginning on the date of this prospectus, all 1,000,000 shares of our common stock sold in this offering will be immediately available for sale in the public market; | |
● | beginning 180 days after the date of this prospectus, 326,568 additional shares of common stock become eligible for sale in the public market, of which no shares would be held by affiliates and subject to the volume and other restrictions of Rule 144, as described below; and | |
● | beginning 365 days after the date of this prospectus, 26,332,026 additional shares of common stock become eligible for sale in the public market, of which 1,710,892 shares would be held by affiliates and subject to the volume and other restrictions of Rule 144, as described below. |
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Lock-up Agreements
In connection with this offering, we, our directors, our executive officers, our initial stockholders holding an aggregate of 26,332,026 shares of our common stock (the “Initial Stockholders”), and other holders of more than 3% of our issued and outstanding shares of common stock outstanding as of December 12, 2023 have agreed, subject to certain exceptions, with the underwriters not to dispose of or hedge any shares of our common stock or securities convertible into or exchangeable for shares of common stock during the period from the date of the lock-up agreement continuing through the date 180 days (365 days in the case of the Initial Stockholders) after the closing date of this offering, except with the prior written consent of the representative of the underwriters and certain other exceptions. The representative of the underwriters has advised us that they have no current intent or arrangement to release any of the shares subject to the lock-up agreements prior to the expiration of the lock-up period. See “Underwriting”.
Following the lock-up periods set forth in the agreements described above, and assuming that the representative of the underwriters does not release any parties from these agreements, all of the shares of our common stock that are restricted securities or are held by our affiliates as of the date of this prospectus will be eligible for sale in the public market in compliance with Rule 144 under the Securities Act.
Rule 144
In general, under Rule 144 as in effect on the date of this prospectus, beginning 90 days after completion of this offering, a person (or persons whose common stock is required to be aggregated) who is an affiliate and who has beneficially owned our common stock for at least six months is entitled to sell in any three-month period a number of shares that does not exceed the greater of:
● | 1% of the number of shares of our common stock then outstanding, which will equal approximately 296,098 shares immediately after completion of this offering; or | |
● | the average weekly trading volume in our common stock during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such a sale. |
Sales by our affiliates under Rule 144 are also subject to manner of sale provisions and notice requirements and to the availability of current public information about us. An “affiliate” is a person that directly, or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with, an issuer.
Under Rule 144, a person (or persons whose shares are aggregated) who is not deemed to have been an affiliate of ours at any time during the 90 days preceding a sale, and who has beneficially owned the shares proposed to be sold for at least six months (including the holding period of any prior owner other than an affiliate), would be entitled to sell those shares subject only to availability of current public information about us, and after beneficially owning such shares for at least 12 months, would be entitled to sell an unlimited number of shares without restriction. To the extent that our affiliates sell their shares of common stock, other than pursuant to Rule 144 or a registration statement, the purchaser’s holding period for the purpose of effecting a sale under Rule 144 commences on the date of transfer from the affiliate.
Regulation S
Regulation S under the Securities Act provides that securities owned by any person may be sold without registration in the United States, provided that the sale is effected in an “offshore transaction” and no “directed selling efforts” are made in the United States (as these terms are defined in Regulation S) and subject to certain other conditions. In general, this means that our shares may be sold in some manner outside the United States without requiring registration in the United States.
Rule 701
In general, under Rule 701 as in effect on the date of this prospectus, any of our employees, directors, officers, consultants, or advisors who purchased shares from us in reliance on Rule 701 in connection with a compensatory stock or option plan or other written agreement before the effective date of this offering, or who purchase shares from us after that date upon the exercise of options granted before that date, are eligible to resell such shares 90 days after the effective date of this offering in reliance upon Rule 144. If such person is not an affiliate, such sale may be made subject only to current public information provisions of Rule 144. If such a person is an affiliate, such sale may be made under Rule 144 without compliance with the holding period requirement, but subject to the other Rule 144 restrictions described above.
Equity Incentive Plans
Following the completion of this offering, we intend to file one or more registration statements on Form S-8 under the Securities Act to register all shares of common stock issued or issuable under the 2023 Omnibus Plan. Any such Form S-8 registration statements will automatically become effective upon filing. Accordingly, shares registered under such registration statements will be available for sale in the open market following the expiration of the lock-up period. We expect that the initial registration statements on Form S-8 will cover approximately 6,500,000 shares of our common stock. Shares issued under the 2023 Omnibus Plan after the effective date of the applicable Form S-8 registration statement will be eligible for resale in the public market without restriction, subject to Rule 144 limitations applicable to affiliates and the lock-up agreements described above. See “Executive Compensation — Executive Compensation Arrangements — Equity Compensation”, and “Executive Compensation Plan” for a description of the 2023 Omnibus Plan.
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MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS FOR NON-U.S.
HOLDERS OF OUR COMMON STOCK
The following discussion is a summary of the material U.S. federal income tax consequences to non-U.S. holders (as defined below) of the ownership and disposition of shares of our common stock issued pursuant to this offering but is not intended to be a complete analysis of all potential tax consequences. The effects of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local or non-U.S. tax laws are not discussed. This discussion is based on the U.S. Internal Revenue Code of 1986, as amended (the “Code”), final, temporary, and proposed Treasury Regulations, judicial decisions, and published rulings and administrative pronouncements of the U.S. Internal Revenue Service (the “IRS”), in each case as in effect as of the date of this prospectus. These authorities may change or be subject to differing interpretations, and any such change or differing interpretation may be applied retroactively in a manner that could adversely affect a non-U.S. holder of our common stock. We have not sought and will not seek any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a contrary position to that discussed below regarding the tax consequences of the ownership and disposition of our common stock.
This discussion is limited to a non-U.S. holder that holds our common stock as a “capital asset” within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all U.S. federal income tax consequences relevant to a non-U.S. holder’s particular circumstance, including the impact of the alternative minimum tax, the special tax accounting rules in Section 451(b) of the Code or the Medicare surtax on net investment income provided by Section 1411 of the Code. In addition, it does not address consequences relevant to Non-U.S. Holders subject to special rules, including, without limitation:
● | U.S. expatriates and former citizens or long-term residents of the United States; | |
● | persons holding shares of our common stock as part of a straddle, or other risk reduction strategy or as part of a conversion transaction or other integrated investment; | |
● | banks, insurance companies, and other financial institutions; | |
● | brokers, dealers, or certain electing traders in securities that use a mark-to-market method of tax accounting for their securities positions; | |
● | “controlled foreign corporations”, “passive foreign investment companies”, as defined in Sections 957 and Section 1297 of the Code, respectively, and corporations that accumulate earnings to avoid U.S. federal income tax under Section 531 and 532 of the Code; | |
● | partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes and other pass-through entities (and investors in such entities); | |
● | tax-exempt organizations or governmental organizations; | |
● | persons deemed to sell our common stock under the constructive sale provisions of the Code; | |
● | tax-qualified retirement plans; and | |
● | “qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities all of the interests of which are held by qualified foreign pension funds. |
If an entity treated as a partnership for U.S. federal income tax purposes holds our common stock, the tax treatment of a partner in the partnership will depend on the status of the partner, the activities of the partnership, and certain determinations made at the partner level. Partnerships holding our common stock and the partners in such partnerships should consult their tax advisors regarding the U.S. federal income tax consequences to them.
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THIS DISCUSSION IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT TAX ADVICE. INVESTORS SHOULD CONSULT THEIR TAX ADVISORS WITH RESPECT TO THE APPLICATION OF THE U.S. FEDERAL INCOME TAX LAWS TO THEIR PARTICULAR SITUATIONS AS WELL AS ANY TAX CONSEQUENCES OF THE PURCHASE, OWNERSHIP, AND DISPOSITION OF SHARES OF OUR COMMON STOCK ARISING UNDER THE U.S. FEDERAL ESTATE OR GIFT TAX LAWS OR UNDER THE LAWS OF ANY STATE, LOCAL, OR NON-U.S. TAXING JURISDICTION OR UNDER ANY APPLICABLE INCOME TAX TREATY.
Definition of a Non-U.S. Holder
For purposes of this discussion, a “non-U.S. holder” is any beneficial owner of our common stock that is an individual, corporation, estate or trust and is not a “U.S. person.” A U.S. person is any person that, for U.S. federal income tax purposes, is or is treated as any of the following:
● | an individual who is a citizen or resident of the United States; | |
● | a corporation created or organized under the laws of the United States, any state thereof, or the District of Columbia; | |
● | an estate, the income of which is subject to U.S. federal income tax regardless of its source; or | |
● | a trust that (1) is subject to the primary supervision of a U.S. court and the control of one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code), or (2) has a valid election in effect to be treated as a United States person for U.S. federal income tax purposes. |
Distributions
As described in the section entitled “Dividend Policy,” we do not anticipate declaring or paying dividends to holders of our common stock in the foreseeable future. However, if we do make distributions of cash or property on our common stock, such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a nontaxable return of capital and first be applied against and reduce a Non-U.S. Holder’s adjusted tax basis in its common stock, but not below zero, and any excess will be treated as capital gain and will be treated as described below under “— Sale or Other Taxable Disposition”.
Subject to the discussion below on effectively connected income, dividends paid to a Non-U.S. Holder of our common stock will be subject to U.S. federal withholding tax at a rate of 30% of the gross amount of the dividends (or such lower rate specified by an applicable income tax treaty, provided the Non-U.S. Holder furnishes a valid IRS Form W-8BEN or W-8BEN-E (or other applicable documentation) certifying qualification for the lower treaty rate of withholding). A Non-U.S. Holder that does not timely furnish the required documentation, but that qualifies for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS. Non-U.S. Holders should consult their tax advisors regarding their entitlement to benefits under any applicable income tax treaty.
If dividends paid to a Non-U.S. Holder are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States (and, if required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment in the United States to which such dividends are attributable), the Non-U.S. Holder will be exempt from the U.S. federal withholding tax described above. To claim the exemption, the non-U.S. holder must furnish to the applicable withholding agent a valid IRS Form W-8ECI, certifying that the dividends are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States.
Any such effectively connected dividends will be subject to U.S. federal income tax on a net income basis at the rates applicable to U.S. persons. A Non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on such effectively connected dividends, as adjusted for certain items. Non-U.S. Holders should consult their tax advisors regarding any applicable tax treaties that may provide for different rules.
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Sale or Other Taxable Disposition
Subject to the discussion below under “— Information Reporting and Backup Withholding” and “— Additional Withholding Tax Under FATCA”, a Non-U.S. Holder will not be subject to U.S. federal income tax on any gain realized upon the sale or other taxable disposition of our common stock unless:
● | the gain is effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States (and, if required by an applicable income tax treaty, the non-U.S. holder maintains a permanent establishment in the United States to which such gain is attributable);or | |
● | the non-U.S. holder is a nonresident alien individual present in the United States for 183 days or more during the taxable year of the disposition and certain other requirements are met; |
Gain described in the first bullet point above generally will be subject to U.S. federal income tax on a net income basis at the rates applicable to U.S. persons. A non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on such effectively connected gain, as adjusted for certain items.
Gain described in the second bullet point above will be subject to U.S. federal income tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty), which may be offset by U.S. source capital losses of the non-U.S. Holder (even though the individual is not considered a resident of the United States), provided the Non-U.S. Holder has timely filed U.S. federal income tax returns with respect to such losses.
Non-U.S. Holders should consult their tax advisors regarding potentially applicable income tax treaties that may provide for different rules.
Information Reporting and Backup Withholding
Information returns are required to be filed with the IRS in connection with any dividends on our common stock paid to a non-U.S. holder whether or not withholding is required. Copies of the information returns reporting such interest, dividends, and withholding may also be made available to the tax authorities in the country in which a non-U.S. holder resides under the provisions of an applicable income tax treaty. Payments of dividends on our common stock will not be subject to backup withholding, provided the applicable withholding agent does not have actual knowledge or reason to know the beneficial owner is a United States person and the Non-U.S. Holder either certifies its non-U.S. status, such as by furnishing a valid IRS Form W-8BEN, W-8BEN-E or W-8ECI, or other applicable documentation, or otherwise establishes an exemption. Proceeds of the sale or other taxable disposition of our common stock within the United States or conducted through certain U.S.-related brokers generally will not be subject to backup withholding or information reporting, if the applicable withholding agent receives the certification described above and does not have actual knowledge or reason to know that such beneficial owner is a United States person, or otherwise establishes an exemption. Proceeds of a disposition of our common stock conducted through a non-U.S. office of a non-U.S. broker generally will not be subject to backup withholding or information reporting.
Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund or a credit against a non-U.S. Holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS.
Additional Withholding Tax Under FATCA
Sections 1471 to 1474 of the Code (such sections commonly referred to as the Foreign Account Tax Compliance Act, or “FATCA”) and the Treasury Regulations and administrative guidance thereunder impose a 30% withholding tax on certain types of payments made to a “foreign financial institution” or a “non-financial foreign entity” (each as defined in the Code), including, in some cases, when such foreign financial institution or non-financial foreign entity acts as an intermediary, unless (1) the foreign financial institution has entered into an agreement with the U.S. government to withhold on certain payments and to undertake certain diligence and reporting obligations regarding U.S. account holders (including certain account holders that are non-U.S. entities with U.S. owners), (2) the non-financial foreign entity either certifies it does not have any “substantial United States owners” (as defined in the Code) or furnishes identifying information regarding each substantial United States owner, or (3) the foreign financial institution or non-financial foreign entity otherwise qualifies for an exemption from these rules. Foreign financial institutions located in jurisdictions that have an intergovernmental agreement with the United States governing FATCA may be subject to different rules.
Under the applicable Treasury Regulations and administrative guidance, withholding under FATCA generally applies to payments of dividends on our common stock. While withholding under FATCA would have applied also to payments of gross proceeds from the sale or other disposition of stock on or after January 1, 2019, recently proposed Treasury Regulations eliminate FATCA withholding on payments of gross proceeds entirely. Taxpayers generally may rely on these proposed Treasury Regulations until final Treasury Regulations are issued.
Prospective investors should consult their tax advisors regarding the potential application of withholding under FATCA to their investment in our common stock.
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Kingswood Investments, division of Kingswood Capital Partners LLC is acting as representative of the underwriters (the “Representative”) of the offering. We have entered into an underwriting agreement (the “underwriting agreement”) with the Representative. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriters named below, and the underwriters have agreed, severally and not jointly, to purchase from us, the number of shares of common stock set forth opposite the underwriter’s name in the following table at the initial public offering price per share less underwriting discounts and commissions, as set forth on the cover page of this prospectus.
Underwriter | Number of Shares | |||
Kingswood Investments, division of Kingswood Capital Partners, LLC | 1,000,000 | |||
Total | 1,000,000 |
The underwriters are committed to purchase all of the shares offered by us other than those shares covered by the over-allotment option described below, if they purchase any shares. The obligations of the underwriters may be terminated upon the occurrence of certain events specified in the underwriting agreement. Furthermore, pursuant to the underwriting agreement, the underwriters’ obligations are subject to customary conditions, representations and warranties contained in the underwriting agreement, such as receipt by the underwriters of officers’ certificates and legal opinions.
We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act, or to contribute to payments the underwriters may be required to make in respect of those liabilities.
The underwriters are offering the shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions contained in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.
Over-Allotment Option
We have granted the underwriters an option to purchase from us up to an additional 150,000 shares of our common stock, solely to cover over-allotments, if any, at the public offering price, less the underwriting discounts and commissions. The underwriters may exercise this option, in whole or in part, for our common stock, any time during the 45-day period from the date of this prospectus. If this option is exercised in full, the total price to the public will be $563,500 and the total net proceeds before expenses to us will be $7,486,500.
Underwriting Discount, Commissions and Expenses
The following table shows the per share of common stock and total underwriting discounts and commissions to be paid to the underwriters. Such amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares, assuming an initial public offering price of $7.00 per share.
Per Share | Total Without Exercise of Over- Allotment Option | Total With Exercise in Over- Allotment Option | ||||||||||
Public offering price (1) | $ | 7.00 | $ | 7,000,000 | $ | 8,050,000 | ||||||
Underwriting discount and commissions | $ | 0.49 | $ | 490,000 | $ | 563,500 | ||||||
Proceeds, before expenses, to us | $ | 6.51 | $ | 6,510,000 | $ | 7,486,500 |
(1) | Assuming an initial public offering price of $7.00 per share. |
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The Representative has advised us that they propose initially to offer the shares to the public at the public offering price set forth on the cover page of this prospectus and to dealers at that price less a concession not in excess of 0.28% per share. After the initial public offering, the public offering price, concession and discount may be changed.
We have also agreed to pay all of the expenses relating to the offering, including, but not limited to, (a) all filing fees and communication expenses relating to the registration of the shares of common stock to be sold in this offering with the Securities and Exchange Commission; (b) all fees and expenses relating to the listing of the shares on the Nasdaq Capital Market and such other exchanges as the Company and Representative together determine, including any fees charged by DTC; (c) all fees, expenses and disbursements relating to the registration or qualification of the shares under “blue sky” or securities laws. of such states of the United States of America and other jurisdictions designated by the Representative, including the reasonable fees and expenses of the Representative’s blue sky counsel; (d) all fees, expenses and disbursements relating to the registration, qualification or exemption of the shares under the securities laws of such foreign jurisdictions designated by the Representative; (e) the costs of mailing and printing the underwriting documents (including the Underwriting Agreement, any Blue Sky Surveys and, if appropriate, any Agreement Among Underwriters, Selected Dealers’ Agreement, Underwriters’ Questionnaire and Power of Attorney), registration statements, prospectuses and all amendments, supplements and exhibits thereto and as many preliminary and final prospectuses as the Representative may reasonably deem necessary; (f) transfer and/or stamp taxes, if any, payable upon our transfer of the shares to the Underwriters; (g) the fees and expenses of the Company’s accountants; (h) all filing fees and communication expenses associated with the review of the offering by FINRA; (i) expenses incurred by the Underwriters for any roadshow for the offering up to $10,000; (j) the costs associated with bound volumes of the offering materials in an aggregate amount not to exceed $5,000; (k) the fees of counsel to the underwriters in an amount not to exceed $150,000; (l) fees and expenses of the transfer agent for our common stock; and (m) the costs of preparing, printing and delivering certificates representing the common stock issued in this offering.
We have paid a $25,000 expense advance to the Representative, which shall be applied against actual out-of-pocket-accountable expenses, which will be returned to us to the extent such out-of-pocket accountable expenses are not actually incurred in accordance with FINRA Rule 5110(f)(2)(C). We have agreed to pay to the Representative 0.5% of the gross proceeds of the offering for non-accountable expenses, payable upon the closing of the offering.
We estimate that the total expenses of the offering payable by us, excluding the total underwriting discount, and including the above-referenced advance to the Representative, will be approximately $603,207.
Discretionary Accounts
The underwriters do not intend to confirm sales of the shares offered hereby to any accounts over which they have discretionary authority.
Representative’s Warrants
We have agreed to issue to the Representative or its designees at the closing of this offering warrants to purchase the number of common stock equal to 5.0% of the aggregate number of shares sold in this offering. The warrants will be exercisable at any time and from time to time, in whole or in part, during the four-and-a-half-year period commencing six months from the commencement of sales in this offering. The warrants will be exercisable at a per share price equal to 100% of the initial public offering price per share in the offering. The Warrants provide for registration rights (including a one-time demand registration right at our expense and piggyback registration rights that expire 5 years from the commencement of sales of this offering) and customary anti-dilution provisions as permitted under FINRA Rule 5110(g)(8).
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The warrants have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to Rule 5110(e)(1) of FINRA. The Representative (or permitted assignees under Rule 5110(e)(2)(B)) will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities underlying these warrants, nor will they engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the warrants or the underlying securities for a period of 180 days from the date of this prospectus. The warrants and shares of common stock issuable upon exercise of the warrants are being registered as a part of the registration statement of which this prospectus forms a part and will be freely tradable upon the declaration of the effectiveness of such registration statement by the SEC.
The exercise price and number of shares of common stock issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, extraordinary cash dividend or recapitalization, reorganization, merger or consolidation.
Right of First Refusal
Subject to the closing of this offering and certain conditions set forth in the underwriting agreement, for a period of twelve (12) months after the closing of the offering, the Representative shall have a right of first refusal to act as sole investment banker, sole bookrunner and/or sole placement agent, at the discretion of the Representative, for any and all future public and private equity offerings, including all equity-linked financings, undertaken during such period by us, or any of our successors or subsidiaries.
Tail Period
The Representative shall be entitled to a cash fee equal to seven percent (7%) of the gross proceeds received by the Company from the sale of any equity, debt and/or equity derivative instruments to any investor actually introduced by the Representative to the Company during the period beginning on July 27, 2023 and ending on the later of (i) July 27, 2024 or (ii) the final closing, if any, of the Offering (the “Engagement Period”), in connection with any public or private financing or capital raise (each a “Tail Financing”), and such Tail Financing is consummated at any time during the Engagement Period or within the twelve (12) month period following the expiration or termination of the Engagement Period (the “Tail Period”), provided that such Tail Financing is by a party actually introduced to the Company first by the Representative during the Engagement Period.
Lock-Up Agreements
Our officers and directors, our initial stockholders holding an aggregate of 26,332,026 shares of our common stock (the “Initial Stockholders”), and other holders of more than 3% of the issued and outstanding shares of common stock of the Company have agreed not to, without the prior written consent of the Representative, directly or indirectly, offer to sell, sell, pledge or otherwise transfer or dispose of any shares of our common stock (or enter into any transaction or device that is designed to, or could be expected to, result in the transfer or disposition by any person at any time in the future of shares of our common stock, enter into any swap or other derivatives transaction that transfers to another, in whole or in part, any of the economic benefits or risks of ownership of shares of common stock, make any demand for or exercise any right or cause to be filed a registration statement, including any amendments thereto, with respect to the registration of any of the shares of common stock or securities convertible into or exercisable or exchangeable for shares of common stock or any other of our securities or publicly disclose the intention to do any of the foregoing, subject to customary exceptions, for periods of 180 days (or 365 days for the Initial Stockholders) from the date of this prospectus.
No Sales of Similar Securities
We have agreed not to offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase or otherwise transfer or dispose of, directly or indirectly, any shares of common stock or any securities convertible into or exercisable or exchangeable for shares of common stock or enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of shares of our common stock, whether any such transaction is to be settled by delivery of shares of common stock or such other securities, in cash or otherwise, without the prior written consent of the Representative, for a period of 180 days from the date of this prospectus.
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Electronic Offer, Sale, and Distribution of Securities
A prospectus in electronic format may be made available on the websites maintained by one or more of the underwriters or selling group members. The Representative may agree to allocate a number of shares of common stock to underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated by the underwriters and selling group members that will make internet distributions on the same basis as other allocations. Other than the prospectus in electronic format, the information on these websites is not part of, nor incorporated by reference into, this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us, and should not be relied upon by investors.
Listing
We have applied to have shares of our common stock listed on the Nasdaq Capital Market under the symbol “TELO”. No assurance can be given that such application will be approved. If the application is not approved, we will not proceed with this offering.
Determination of Offering Price
Before this offering, there has been no public market for shares of our common stock. Accordingly, the public offering price will be negotiated between us and the underwriter. Among the factors to be considered in these negotiations are:
● | the information set forth in this prospectus and otherwise available to the underwriter; | |
● | the prospects for our Company and the industry in which we operate; | |
● | an assessment of our management; | |
● | our past and present financial and operating performance; | |
● | our prospects for future earnings; | |
● | financial and operating information and market valuations of publicly traded companies engaged in activities similar to ours; | |
● | the prevailing conditions of United States securities markets at the time of this offering; and | |
● | other factors deemed relevant. |
Neither we nor the underwriter can assure investors that an active trading market will develop for shares of our common stock, or that the shares will trade in the public market at or above the initial public offering price.
Stabilization
In connection with this offering, the underwriter may engage in stabilizing transactions, over-allotment transactions, syndicate-covering transactions, penalty bids, and purchases to cover positions created by short sales.
● | Stabilizing transactions permit bids to purchase securities so long as the stabilizing bids do not exceed a specified maximum and are engaged in for the purpose of preventing or retarding a decline in the market price of the securities while the offering is in progress. |
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● | Over-allotment transactions involve sales by the underwriter of securities in excess of the number of securities the underwriter is obligated to purchase. This creates a syndicate short position which may be either a covered short position or a naked short position. In a covered short position, the number of securities over-allotted by the underwriter is not greater than the number of securities that they may purchase in the over-allotment option. In a naked short position, the number of securities involved is greater than the number of securities in the over-allotment option. The underwriter may close out any short position by exercising their over-allotment option and/or purchasing securities in the open market. | |
● | Syndicate covering transactions involves purchases of securities in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of securities to close out the short position, the underwriter will consider, among other things, the price of securities available for purchase in the open market as compared with the price at which they may purchase securities through exercise of the over-allotment option. If the underwriter sells more securities than could be covered by exercise of the over-allotment option and, therefore, have a naked short position, the position can be closed out only by buying securities in the open market. A naked short position is more likely to be created if the underwriter is concerned that after pricing there could be downward pressure on the price of the securities in the open market that could adversely affect investors who purchase in the offering. |
● | Penalty bids permit the underwriter to reclaim a selling concession from a syndicate member when the securities originally sold by that syndicate member are purchased in stabilizing or syndicate covering transactions to cover syndicate short positions. |
These stabilizing transactions, over-allotment transactions, syndicate covering transactions, and penalty bids may have the effect of raising or maintaining the market price of our securities or preventing or retarding a decline in the market price of our securities. As a result, the price of our securities in the open market may be higher than it would otherwise be in the absence of these transactions. Neither we nor the underwriter make any representation or prediction as to the effect that the transactions described above may have on the price of our securities. These transactions may be affected on the Nasdaq Stock Market, in the over-the-counter market or otherwise and, if commenced, may be discontinued at any time.
Passive Market Making
In connection with this offering, underwriter, and selling group members may engage in passive market making transactions in our securities on the Nasdaq Stock Market in accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement of offers or sales of the shares and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid, then that bid must then be lowered when specified purchase limits are exceeded.
Other Relationships
The underwriters and their respective affiliates are full service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage and other financial and non-financial activities and services. Certain of the underwriters and their respective affiliates have provided, and may in the future provide, a variety of these services to us and to persons and entities with relationships with us, for which they received or will receive customary fees and expenses.
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SELLING RESTRICTIONS
Other than in the United States, no action has been taken by us or the underwriter that would permit a public offering of the securities offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.
European Economic Area
In relation to each member state of the European Economic Area that has implemented the Prospectus Directive (each, a relevant member state), with effect from and including the date on which the Prospectus Directive is implemented in that relevant member state (the relevant implementation date), an offer of shares described in this prospectus may not be made to the public in that relevant member state other than:
● | to any legal entity which is a qualified investor as defined in the Prospectus Directive; |
● | to fewer than 100 or, if the relevant member state has implemented the relevant provision of the 2010 PD Amending Directive, 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the relevant Dealer or Dealers nominated by us for any such offer; or |
● | in any other circumstances falling within Article 3(2) of the Prospectus Directive, |
● | provided that no such offer of shares shall require us or any underwriter to publish a prospectus pursuant to Article 3 of the Prospectus Directive. |
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For purposes of this provision, the expression an “offer of securities to the public” in any relevant member state means the communication in any form and by any means of sufficient information on the terms of the offer and the shares to be offered so as to enable an investor to decide to purchase or subscribe for the shares, as the expression may be varied in that member state by any measure implementing the Prospectus Directive in that member state, and the expression “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in the relevant member state) and includes any relevant implementing measure in the relevant member state. The expression 2010 PD Amending Directive means Directive 2010/73/EU.
The sellers of the shares have not authorized and do not authorize the making of any offer of shares through any financial intermediary on their behalf, other than offers made by the underwriters with a view to the final placement of the shares as contemplated in this prospectus. Accordingly, no purchaser of the shares, other than the underwriters, is authorized to make any further offer of the shares on behalf of the sellers or the underwriters.
United Kingdom
This prospectus is only being distributed to, and is only directed at, persons in the United Kingdom that are qualified investors within the meaning of Article 2(1)(e) of the Prospectus Directive that are also (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (each such person being referred to as a “relevant person”). This prospectus and its contents are confidential and should not be distributed, published or reproduced (in whole or in part) or disclosed by recipients to any other persons in the United Kingdom. Any person in the United Kingdom that is not a relevant person should not act or rely on this document or any of its contents.
Canada
The securities may be sold in Canada only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.
Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.
Pursuant to section 3A.3 of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI33-105 regarding underwriter conflicts of interest in connection with this offering.
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The validity of the shares of common stock offered hereby will be passed upon for us by Foley & Lardner LLP, Tampa, Florida. Lucosky Brookman LLP has acted as counsel for the underwriters with respect of this offering.
The financial statements of Telomir Pharmaceuticals, Inc. as of and for the years ended December 31, 2022 and 2021 included in this prospectus have been audited by Cherry Bekaert LLP, an independent registered public accounting firm, appearing elsewhere herein, given on the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of common stock offered by this prospectus. This prospectus, which constitutes a part of the registration statement, does not contain all the information set forth in the registration statement. The rules and regulations of the SEC allow us to omit certain information from this prospectus that is included in the registration statement. Statements made in this prospectus concerning the contents of any contract, agreement, or other document are summaries of all material information about the documents summarized but are not complete descriptions of all terms of these documents. If we filed any of these documents as an exhibit to the registration statement, you may read the document itself for a complete description of its terms.
You may read and copy the registration statement, including the related exhibits and schedules, and any document we file with the SEC without charge at the SEC’s public reference room at 100 F Street, N.E., Room 1580, Washington, DC 20549. You may also obtain copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Room 1580, Washington, DC 20549. You may call the SEC at 1-800-SEC-0330 for further information on the public reference room. The SEC also maintains an Internet website that contains reports and other information regarding issuers that file electronically with the SEC. Our filings with the SEC are also available to the public through the SEC’s website at http://www.sec.gov.
Upon completion of this offering, we will become subject to the information reporting requirements of the Exchange Act, and we will file periodic reports, proxy statements and other information with the SEC. These periodic reports, and other information are available for inspection and copying at the website of the SEC referred to above. You may access our annual reports on Form 10-K, quarterly reports on Form 10-Q, reports on Form 8-K and amendments to those reports filed pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free of charge at our website as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC. The information contained in, or that can be accessed through, our website is not incorporated by reference in, and is not part of, this prospectus. A copy of the registration statement and the exhibits filed therewith may be inspected without charge at the public reference room maintained by the SEC, located at 100 F Street, NE, Washington, DC 20549, and copies of all or any part of the registration statement may be obtained from that office. Please call the SEC at 1-800-SEC-0330 for further information about the public reference room. The SEC also maintains a website that contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC. The address of the website is www.sec.gov.
We maintain a corporate website at www.telomirpharma.com. Information contained in, or that can be accessed through, our website does not constitute a part of this prospectus. We have included our website address in this prospectus solely as an inactive textual reference. We will post on our website any materials required to be so posted on such website under applicable corporate or securities laws and regulations.
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Telomir Pharmaceuticals, Inc. Financial Statements
As of and For the Years Ended December 31, 2022 and 2021
Telomir Pharmaceuticals, Inc. Condensed Financial Statements
As of September 30, 2023 and December 31, 2022
For the Nine Months Ended September 30, 2023 and 2022
F-1 |
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
Telomir Pharmaceuticals, Inc.
Tampa, Florida
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Telomir Pharmaceuticals, Inc. (the “Company”) as of December 31, 2021 and 2022, and the related statements of operations, stockholders’ equity (deficit), and cash flows for the year ended December 31, 2022 and for the period from August 26, 2021 (Inception) through December 31, 2021, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the year ended December 31, 2022 and for the period from August 26, 2021 through December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has recurring losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s evaluations of the events and conditions and management’s plans regarding those matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
We have served as the Company’s auditor since 2023.
/s/ Cherry Bekaert LLP | |
Tampa, Florida | |
August 14, 2023, except for the last paragraph of Note 7, and its related effects to the financial statements, which is as of December 11, 2023. |
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Telomir Pharmaceuticals, Inc.
DECEMBER 31, 2022 AND december 31, 2021
December 31, | December 31, | |||||||
2022 | 2021 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash | $ | 1,419 | $ | - | ||||
Deferred offering costs | 47,311 | - | ||||||
Total other current assets | 48,730 | - | ||||||
Total assets | $ | 48,730 | $ | - | ||||
LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
Current liabilities: | ||||||||
Trade accounts payable | $ | 404,221 | $ | 18,735 | ||||
Due to related party | 581,787 | 119,396 | ||||||
Total current liabilities | 986,008 | 138,131 | ||||||
Total liabilities | 986,008 | 138,131 | ||||||
Stockholders’ Deficit | ||||||||
Preferred Stock, no par value, 100,000,000 shares authorized and none issued or outstanding. | - | - | ||||||
Common Stock, no par value; 300,000,000 shares authorized, 26,829,269 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively. | - | - | ||||||
Accumulated deficit | (992,278 | ) | (138,131 | ) | ||||
Additional Paid in Capital | 55,000 | 55,000 | ||||||
Stock subscription receivable | - | (55,000 | ) | |||||
Total stockholders’ deficit | (937,278 | ) | (138,131 | ) | ||||
Total liabilities and stockholders’ deficit | $ | 48,730 | $ | - |
The accompanying notes to the financial statements are an integral part of these statements.
F-3 |
Telomir Pharmaceuticals, Inc.
YEAR ended December 31, 2022 and period ended DECEMBER 31, 2021
Year ended December 31, | ||||||||
2022 | 2021 | |||||||
Revenues | $ | - | $ | - | ||||
Operating costs: | ||||||||
General and administrative expenses | 20,941 | 11,639 | ||||||
Research and development expenses | 833,206 | 126,492 | ||||||
Total operating costs | 854,147 | 138,131 | ||||||
Net loss | $ | (854,147 | ) | $ | (138,131 | ) |
The accompanying notes to the financial statements are an integral part of these statements.
F-4 |
Telomir Pharmaceuticals, Inc.
Statements of stockholders’ DEFICIT
YEARS ended DECEMBER 31, 2022, and DECEMBER 31, 2021
Common Stock | Additional Paid-In | Stock Subscription | Accumulated | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Receivable | Deficit | Deficit | |||||||||||||||||||
Balances, January 1, 2021 | $ | - | $ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||||
Issuance of founders’ shares | 26,829,269 | - | 55,000 | (55,000 | ) | - | - | |||||||||||||||||
Net loss | - | - | - | - | (138,131 | ) | (138,131 | ) | ||||||||||||||||
Balances, December 31, 2021 | 26,829,269 | - | 55,000 | (55,000 | ) | (138,131 | ) | (138,131 | ) | |||||||||||||||
Collection of stock subscription receivable | - | - | - | 55,000 | - | 55,000 | ||||||||||||||||||
Net loss | - | - | - | - | (854,147 | ) | (854,147 | ) | ||||||||||||||||
Balances, December 31, 2022 | 26,829,269 | $ | - | $ | 55,000 | $ | - | $ | (992,278 | ) | $ | (937,278 | ) |
The accompanying notes to the financial statements are an integral part of these statements.
F-5 |
Telomir Pharmaceuticals, Inc.
YEARS ended DECEMBER 31, 2022, and DECEMBER 31, 2021
Year Ended December 31, | ||||||||
2022 | 2021 | |||||||
Cash flows from Operating activities | ||||||||
Net loss | $ | (854,147 | ) | $ | (138,131 | ) | ||
Adjustments to reconcile net loss to net cash from operations | ||||||||
Change in operating assets and liabilities: | ||||||||
Accounts payable and accrued liabilities | 385,486 | 18,735 | ||||||
Net cash flows from operating activities | $ | (468,661 | ) | $ | (119,396 | ) | ||
Financing activities: | ||||||||
Collection of stock subscription receivable | 55,000 | - | ||||||
Deferred offering costs | (47,311 | ) | - | |||||
Advances from related party | 462,391 | 119,396 | ||||||
Net cash flows from financing activities | 470,080 | 119,396 | ||||||
Net change in cash | 1,419 | - | ||||||
Cash, beginning of period | - | - | ||||||
Cash, end of period | $ | 1,419 | $ | - |
The accompanying notes to the financial statements are an integral part of these statements.
F-6 |
Telomir Pharmaceuticals, Inc.
notes to the financial statements
DECEMBER 31, 2022 and december 31, 2021
Note 1. Description of business and summary of significant accounting policies
Overview
Telomir Pharmaceuticals, Inc. (“Telomir” or the “Company” and formerly known as Metallo Therapies, Inc.) was formed in August 2021 and is a Florida-based early pre-clinical stage biopharmaceutical company that is developing its product candidate, TELOMIR-1, a novel small molecule being developed to function as an oral in situ therapeutic treatment for human stem cells. Based on the Company’s pre-clinical studies and if approved by the FDA and comparable foreign regulators, the Company believes that TELOMIR-1 may effectively serve as a metal enzyme inhibitor of essential metals such as zinc and copper. These essential metals play an important role in the production and function of many enzymatic reactions and the modulation of key cellular pathways. In particular, zinc is essential to the function of pro-inflammatory cytokines such as Interleukin-17, or IL-17, that play a role in a host of age-related inflammatory conditions such as hemochromatosis and osteoarthritis as well as in post-chemotherapy health problems.
As such, TELOMIR-1 is under investigation to potentially provide a therapeutic intervention against age-related inflammatory conditions such as hemochromatosis, as well as for post-chemotherapy recovery, by interrupting and preventing the IL-17 induced inflammatory pathways that create the systemic imbalance of cellular metals.
Substantive operations began in late 2021 and the Company’s Investigative New Drug application is anticipated to be filed with the U.S. Food and Drug Administration (“FDA”) in fourth quarter 2023 for hemochromatosis and first quarter 2024 for post-chemotherapy recovery. A non-provisional patent application is pending for Telomir-1 as a new molecular entity and its therapeutic uses. See Note 3, regarding this patent.
The accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America (“GAAP”).
As used herein, the Company’s Common Stock, no par value per share, is referred to as the “Common Stock” and the Company’s preferred stock, no par value per share, is referred to as the “Preferred Stock”.
Pending transactions
The Company is in the process of preparing for an initial public offering (IPO) and expects to be listed under the NASDAQ symbol “TELO.” The transaction is expected to be complete in the second half of 2023. The Company incurred $0.05 million of legal costs, as of December 31, 2022, associated with the offering, which have been recorded as deferred offering costs in the accompanying balance sheets. There were no deferred offering costs during 2021. These deferred offering costs will be derecognized as a reduction in offering proceeds when the offering closes. However, there can be no guarantees that the Company will be successful in completing the proposed transaction and ultimately listing on the NASDAQ.
Income taxes
The Company is a C corporation. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred tax assets are recognized for temporary differences that will result in deductible amounts in future years and for loss carryovers. A valuation allowance is recognized regarding deferred tax assets, if any, if it is more likely than not that some portion of the deferred tax asset will not be realized.
Research and development expenses
Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract research organizations and consultants, who conduct research and development activities on behalf of the Company.
F-7 |
Use of estimates
The preparation of financial statements in accordance with generally accepted accounting principles in the United States of America requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from such estimates and such differences could be material.
Cash
The Company maintains cash balances with financial institutions that management believes are of high credit quality. The Company’s cash account at times may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk from its cash account.
Income taxes
The Company is a C corporation. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred tax assets are recognized for temporary differences that will result in deductible amounts in future years and for loss carryovers. A valuation allowance is recognized regarding deferred tax assets, if any, if it is more likely than not that some portion of the deferred tax asset will not be realized. At December 31, 2022 deferred tax assets are comprised primarily of net operating loss carryforwards and IRC Section 174 qualified research expenditures totaling approximately $0.06 million and $0.2 million respectively. At December 31, 2021, deferred tax assets consisted of net operating loss carryforwards of approximately $0.04 million The Company has recorded a full valuation allowance against its deferred tax assets generated by net operating loss carryforwards as it has determined that such amounts may not be recognizable, given the historical losses of the Company to date. As of December 31, 2022, the Company has a cumulative federal net operating loss carryforward of approximately $0.2 million. The net operating loss carryforwards have no expiry date.
Note 2. Liquidity and capital resources
As of December 31, 2022, the Company had cash of approximately $0.01 million. The Company used approximately $0.5 million of cash in operations during the year ended December 31, 2022 and had stockholders’ deficit of approximately $0.9 million, versus stockholders’ deficit of approximately $0.1 million at December 31, 2021.
Historically, the Company has been primarily engaged in developing Telomir-1. During these activities, the Company sustained substantial losses. The Company’s ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on the Company’s ability to obtain significant additional external funding in the near term. Since inception, the Company has financed its operations through related party financings-see Note 4. Additional sources of financing may be sought by the Company. However, there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.
The Company expects to be able to fund operations through the anticipated IPO, or through the first quarter of 2024, with available borrowings from a related party line of credit (Note 4). Should actual cash expenditures exceed management’s budget, the Company may be forced to curtail operations along with implementing other cost-saving measures, such as a reduction in staff, reducing the use of outside professional service providers, or significantly modifying or delaying the development of our product candidates. Because of these factors, substantial doubt about the Company’s ability to continue as a going concern exists.
Note 3. License agreement, related party
On November 29 2022, (the “Effective Date”), the Company and MIRALOGX LLC (“MIRALOGX”), entered into an exclusive, worldwide license to commercially develop Telomir-1 in the United States and its territories. MIRALOGX, which is a separate intellectual property development company owned by a trust established by the Company’s founder, holds the patent rights to Telomir-1, which are currently comprised of a pending non-provisional patent application. The term of the license from MIRALOGX will continue through the date of the expiration of the last-to-expire licensed patent or, if later, the date of the expiration of the last strategic partnership/sublicensing agreement covering the licensed products. The patent rights are expected to extend through 2043, and additional patent terms may be awarded, including additional patent terms based on the time taken for regulatory review of drug products.
The exclusive license agreement requires that Telomir pay an 8% royalty on net sales or revenue in exchange for an exclusive, worldwide license to patent rights. The agreement also provides that Telomir may bring suit in its own name to enforce patent rights. MIRALOGX will control the prosecution of the patent applications for Telomir-1. Telomir is required to be kept informed by MIRALOGX of patent prosecution activities and may select identified countries for patent protection. Telomir is to reimburse MIRALOGX for patent prosecution and maintenance costs.
F-8 |
Note 4. Related party transactions
Due to related party – During the year ended December 31, 2022, and period ended December 31, 2021, the Company received working capital advances from companies under common control. These advances are due on demand and are non-interest bearing. Amounts due to related parties as of December 31, 2022, and 2021, is $0.6 million and $0.1 million, respectively.
License agreement - See Note 3.
Shared management- Historically, the Company has shared management with related parties on an as-needed basis, to collaborate and pool resources efficiently. This arrangement has resulted in cost savings and expertise-sharing while maintaining distinct operations and identities for each entity. The Company intends on reducing these shared resources post IPO.
Shared jet use- On April 1, 2023 the Company entered into an Agreement For Shared Lease Costs with MIRALOGX, LLC, (the “Shared Agreement”) who is a related party. Under the Shared Agreement, the Company agrees to make monthly contributions or payments in accordance with its monthly use of shared aircraft toward rent payments. There is no minimum cost requirement under the agreement.
Note 5. Lease
The Company has leased an office in Baltimore, Maryland, as its corporate headquarters. This Baltimore office lease began in December 2022 for 12 months. This space is approximately 127 square feet and has remaining base rent of $0.01 million payable through November 2023. Rent is payable in monthly installments and is subject to yearly price increases.
Accounting standards
On January 1, 2022, the Company adopted Accounting Standards Codification (“ASC”) Topic 842 ASC Topic 842, which is intended to improve financial reporting about leasing transactions. Under the standard, organizations that lease assets, referred to as “Lessees” shall recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. In addition, the standard requires disclosures including financial statements to assess the amount, timing and uncertainty of cash flows arising from leases.
The Company made an accounting policy election to account for leases with an initial term of 12 months or less similar to existing guidance for operating leases today. The Company recognized those lease payments in the Condensed Statements of Operations on a straight-line basis over the lease term. Under the new standard, the Company’s lease liability is based on the present value of such payments and the related right-of-use asset will generally be based on the lease liability.
Note 6. Stockholders’ equity
Capital stock
The Company has the authority to issue 400,000,000 shares of capital stock, consisting of 300,000,000 shares of Common Stock and 100,000,000 shares of undesignated preferred stock, whose rights and privileges will be defined by the Board of Directors when a series of preferred stock is designated.
F-9 |
Note 7 – Subsequent events
The Company has evaluated subsequent events through August 12, 2023, in connection with the preparation of these financial statements, which is the date the financial statements were available to be issued.
Private placement
During 2023, the Company sold 268,025 shares of Common Stock at $3.73 per share, net of offering costs of $0.1 million, resulting in net proceeds of $0.9 million.
Warrants
During 2023, the Company issued to the 2023 private placement investors a common stock warrant for the right to purchase up to 268,025 shares of common stock at an exercise price of $15.42 per share. The Company also issued to the placement agent a common stock warrant for the right to purchase up to 67,007 shares of common stock at an exercise price of $3.73 per share. Both issuances of warrants are immediately vested and will be exercisable any time until the day that is one year plus ninety days from the date an Investigational New Drug filing is made with the Food and Drug Administration.
Bay Shore Line of Credit
On June 15, 2023, the Company entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by the Company’s founder, Jonnie R. Williams, Sr., and under which various of his family members are beneficiaries. Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), the Company has the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of the Company’s IPO. The Company’s right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in its assets, operations, or prospects. The Bay Share Note, together with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty. The Bay Shore Note will accrue interest at a rate equal 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note is unsecured. The Bay Shore Note paid off related party balances owed to The Starwood Trust, a separate trust established by our founder, in which we had an outstanding balance of $0.5 million as of the date of the Bay Shore Note (which outstanding balance was retired with an advance under the Bay Shore Note).
In consideration of the loan facility provided by the Bay Shore Trust, the Company issued to the Bay Shore Trust a common stock purchase warrant on June 15, 2023 giving the Bay Shore Trust the right to purchase up to 2,439,025 shares of common stock at an exercise price of $3.73 per share, which warrant will expire five years after the date of grant. Upon issuance, the warrant met the criteria to be classified as equity based on an analysis under Accounting Standards Codification (480) ASC 480, “Distinguishing Liabilities from Equity” and will be measured at fair value, resulting in an initial fair value of approximately $5.95 million upon issuance of the warrant using Black-Scholes valuation techniques.
Reverse Stock Split
Effective December 11, 2023, the Company completed a reverse stock split of its outstanding common stock upon the filing of the Company’s Second Amended and Restated Articles of Incorporation with the Florida Secretary of State. No fractional shares were or will be issued in connection with the reverse stock split, and all such fractional shares resulting from the reverse stock split were and will be rounded up to the nearest whole number. The shares issuable upon the exercise of our outstanding warrants, and the exercise prices of such warrants, have been adjusted to reflect the reverse stock split. Unless otherwise noted, the share and per share information in this prospectus reflects the reverse stock split.
F-10 |
Telomir Pharmaceuticals, Inc.
September 30, 2023 (unaudited) and DECEMBER 31, 2022
September 30, | December 31, | |||||||
2023 | 2022 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash | $ | 2,452 | $ | 1,419 | ||||
Deferred offering costs | 102,894 | 47,311 | ||||||
Prepaid expenses | 963 | - | ||||||
Due from related parties | 130,000 | - | ||||||
Total other current assets | 236,309 | 48,730 | ||||||
Deferred Financing Costs | 5,082,292 | - | ||||||
Total assets | $ | 5,318,601 | $ | 48,730 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
Current liabilities: | ||||||||
Trade accounts payable and accrued liabilities | $ | 496,027 | $ | 404,221 | ||||
Accrued Interest | 13,517 | - | ||||||
Due to related parties | 1,293,070 | 581,787 | ||||||
Related party line of credit | 1,337,914 | - | ||||||
Total current liabilities | 3,140,528 | 986,008 | ||||||
Total liabilities | 3,140,528 | 986,008 | ||||||
Stockholders’ Equity (Deficit) | ||||||||
Preferred Stock, no par value, 100,000,000 shares authorized and none issued or outstanding. | - | - | ||||||
Common Stock, no par value; 300,000,000 shares authorized, 27,097,294 and 26,829,269 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively. | - | - | ||||||
Additional paid-in capital | 6,915,000 | 55,000 | ||||||
Accumulated deficit | (4,736,927 | ) | (992,278 | ) | ||||
Total stockholders’ equity (deficit) | 2,178,073 | (937,278 | ) | |||||
Total liabilities and stockholders’ deficit | $ | 5,318,601 | $ | 48,730 |
The accompanying notes to the financial statements are an integral part of these statements.
F-11 |
Telomir Pharmaceuticals, Inc.
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
Three and Nine MONTHS ended September 30, 2023 and September 30, 2022
Three
Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
Operating costs: | ||||||||||||||||
General and administrative expenses | 102,191 | 3,750 | 204,902 | 11,150 | ||||||||||||
Related party travel costs | 589,400 | - | 1,288,000 | - | ||||||||||||
Research and development expenses | 262,562 | 229,747 | 1,370,522 | 355,901 | ||||||||||||
Total operating costs | 954,153 | 233,497 | 2,863,424 | 367,051 | ||||||||||||
Interest expense | (757,173 | ) | - | (881,225 | ) | - | ||||||||||
Net loss | $ | (1,711,326 | ) | $ | (233,497 | ) | $ | (3,744,649 | ) | $ | (367,051 | ) |
The accompanying notes to the financial statements are an integral part of these statements.
F-12 |
Telomir Pharmaceuticals, Inc.
CONDENSED Statements of stockholders’ DEFICIT (UNAUDITED)
THREE and Nine MONTHS ended September 30, 2023, and september 30, 2022
Common Stock | Additional Paid-In | Stock Subscription | Accumulated | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Receivable | Deficit | Deficit | |||||||||||||||||||
Balances, July 1, 2022 | 26,829,269 | $ | - | $ | 55,000 | $ | (55,000 | ) | $ | (271,685 | ) | $ | (271,685 | ) | ||||||||||
Net loss | - | - | - | - | (233,497 | ) | (233,497 | ) | ||||||||||||||||
Balances, September 30, 2022 | 26,829,269 | $ | - | $ | 55,000 | $ | (55,000 | ) | $ | (505,182 | ) | $ | (505,182 | ) |
Common Stock | Additional Paid-In | Stock Subscription | Accumulated | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Receivable | Deficit | Equity | |||||||||||||||||||
Balances, July 1, 2023 | 27,097,294 | $ | - | $ | 6,915,000 | $ | - | $ | (3,025,601 | ) | $ | 3,889,399 | ||||||||||||
Net loss | - | - | - | - | (1,711,326 | ) | (1,711,326 | ) | ||||||||||||||||
Balances, September 30, 2023 | 27,097,294 | $ | - | $ | 6,915,000 | $ | - | $ | (4,736,927 | ) | $ | 2,178,073 |
Common Stock | Additional Paid-In | Stock Subscription | Accumulated | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Receivable | Deficit | Deficit | |||||||||||||||||||
Balances, January 1, 2022 | 26,829,269 | - | $ | 55,000 | $ | (55,000 | ) | $ | (138,131 | ) | $ | (138,131 | ) | |||||||||||
Net loss | - | - | - | - | (367,051 | ) | (367,051 | ) | ||||||||||||||||
Balances, September 30, 2022 | 26,829,269 | $ | - | $ | 55,000 | $ | (55,000 | ) | $ | (505,182 | ) | $ | (505,182 | ) |
Common Stock | Additional Paid-In | Stock Subscription | Accumulated | Total Stockholders’ (Deficit) | ||||||||||||||||||||
Shares | Amount | Capital | Receivable | Deficit | Equity | |||||||||||||||||||
Balances, January 1, 2023 | 26,829,269 | $ | - | $ | 55,000 | $ | - | $ | (992,278 | ) | $ | (937,278 | ) | |||||||||||
Issuance of common stock, net | 268,025 | - | 910,000 | - | - | 910,000 | ||||||||||||||||||
Issuance of Warrants | - | - | 5,950,000 | - | - | 5,950,000 | ||||||||||||||||||
Net loss | - | - | - | - | (3,744,649 | ) | (3,744,649 | ) | ||||||||||||||||
Balances, September 30, 2023 | 27,097,294 | $ | - | $ | 6,915,000 | $ | - | $ | (4,736,927 | ) | $ | 2,178,073 |
The accompanying notes to the financial statements are an integral part of these statements.
F-13 |
Telomir Pharmaceuticals, Inc.
CONDENSED statements of cash flows (UNAUDITED)
Nine MONTHS ended September 30, 2023, and september 30, 2022
Nine Months Ended September 30, | ||||||||
2023 | 2022 | |||||||
Cash flows from Operating activities | ||||||||
Net loss | $ | (3,744,649 | ) | $ | (367,051 | ) | ||
Adjustments to reconcile net loss to net cash from operations | ||||||||
Non-cash interest expense | 13,517 | - | ||||||
Amortization of debt issuance costs | 867,708 | |||||||
Change in operating assets and liabilities: | ||||||||
Accounts payable and accrued expenses | 91,806 | 154,181 | ||||||
Prepaid expenses | (963 | ) | - | |||||
Net cash flows used in operating activities | $ | (2,772,581 | ) | $ | (212,870 | ) | ||
Financing activities: | ||||||||
Payment of deferred offering costs | (55,583 | ) | - | |||||
Related party receivables | (130,000 | ) | ||||||
Net borrowings to related party | 711,283 | 219,200 | ||||||
Net borrowings under related party line of credit | 1,337,914 | - | ||||||
Proceeds from sale of common stock, less offering costs | 910,000 | - | ||||||
Net cash flows provided by financing activities | 2,773,614 | 219,200 | ||||||
Net change in cash | 1,033 | 6,330 | ||||||
Cash, beginning of period | 1,419 | - | ||||||
Cash, end of period | $ | 2,452 | $ | 6,330 | ||||
Cash paid for interest | - | - |
The accompanying notes to the financial statements are an integral part of these statements.
F-14 |
Telomir Pharmaceuticals, Inc.
SUPPLEMENTAL CASH FLOW INFORMATION
Non-cash Operating, Financing and Investing Activities:
The Company recorded the fair value of a total of 2,439,025 warrants issued to Bay Shore Trust during the nine months ended September 30, 2023 totaling approximately $5.95 million to deferred finance costs.
F-15 |
Telomir Pharmaceuticals, Inc.
notes to the CONDENSED financial statements
September 30, 2023 (UNAUDITED) and december 31, 2022
Note 1. Description of business and summary of significant accounting policies
Overview
Telomir Pharmaceuticals, Inc. (“Telomir” or the “Company” and formerly known as Metallo Therapies, Inc.) was formed in August 2021 and is a Florida-based early pre-clinical stage biopharmaceutical company that is developing its product candidate, TELOMIR-1, a novel small molecule being developed to function as an oral in situ therapeutic treatment for human stem cells. Based on the Company’s pre-clinical studies and if approved by the FDA and comparable foreign regulators, Telomir Pharmaceuticals, Inc. believes that TELOMIR-1 may effectively serve as a metal enzyme inhibitor of essential metals such as zinc and copper. These essential metals play an important role in the production and function of many enzymatic reactions and the modulation of key cellular pathways. In particular, zinc is essential to the function of pro-inflammatory cytokines such as Interleukin-17, or IL-17, that play a role in a host of age-related inflammatory conditions such as hemochromatosis and osteoarthritis as well as in post-chemotherapy health problems
As such, TELOMIR-1 is under investigation to potentially provide a therapeutic intervention against age-related inflammatory conditions such as hemochromatosis, as well as for post-chemotherapy recovery, by interrupting and preventing the IL-17 induced inflammatory pathways that create the systemic imbalance of cellular metals.
Substantive operations began in late 2021 and the Company’s Investigative New Drug application is anticipated to be filed with the U.S. Food and Drug Administration (“FDA”) in second quarter 2024 for hemochromatosis. A non-provisional patent application is pending for TELOMIR-1 as a new molecular entity and its therapeutic uses. See Note 3 regarding this patent.
The accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America (“GAAP”). In the opinion of management, all adjustments considered necessary for the fair presentation of the financial statements for the periods presented have been included. The results of operations for the nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for future periods.
As used herein, the Company’s Common Stock, no par value per share, is referred to as the “Common Stock” and the Company’s preferred stock, no par value per share, is referred to as the “Preferred Stock”.
Pending transactions
The Company is in the process of preparing for an Initial Public Offering (IPO) and expects to be listed under the NASDAQ symbol “TELO.” The transaction is expected to be complete in the second half of 2023. The Company incurred $0.1 million of legal costs as of September 30, 2023 associated with the offering, which have been recorded as deferred offering costs in the accompanying condensed balance sheets. These deferred offering costs will be derecognized as a reduction in offering proceeds when the offering closes. However, there can be no guarantees that the Company will be successful in completing the proposed transaction and ultimate listing on the NASDAQ.
Income taxes
The Company is a C corporation. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred tax assets are recognized for temporary differences that will result in deductible amounts in future years and for loss carryovers. A valuation allowance is recognized regarding deferred tax assets, if any, if it is more likely than not that some portion of the deferred tax asset will not be realized.
F-16 |
Research and development expenses
Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract research organizations and consultants, who conduct research and development activities on behalf of the Company.
Use of estimates
The preparation of financial statements in accordance with generally accepted accounting principles in the United States of America requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from such estimates and such differences could be material.
Cash
The Company maintains cash balances with financial institutions that management believes are of high credit quality. The Company’s cash account at times may exceed federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk from its cash account.
Fair Value of Financial Instruments
The Company measures the fair value of financial instruments in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company considers the carrying amount of deferred offering costs to approximate fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value:
Level 1 – quoted prices in active markets for identical assets or liabilities.
Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable.
Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions).
Note 2. Liquidity and capital resources
As of September 30, 2023, the Company had cash of approximately $0.002 million. The Company used approximately $2.7 million of cash in operations during the nine months ended September 30, 2023 and had stockholders’ equity of approximately $2.2 million at September 30, 2023, versus stockholders’ deficit of approximately $0.9 million at December 31, 2022.
Historically, the Company has been primarily engaged in developing TELOMIR-1. During these activities, the Company sustained substantial losses. The Company’s ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on the Company’s ability to obtain significant additional external funding in the near term. Since inception, the Company has financed its operations through related party financings-see Note 4. Additional sources of financing may be sought by the Company. However, there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.
The Company expects to be able to fund operations through the anticipated IPO, or through the first quarter of 2024, with available borrowings from a related party line (Note 4). During the nine months ended September 30, 2023, the Company raised approximately $1.0 million to finance its research and development and working capital needs, through a private placement (the “2023 Private Placement”) of the Company’s common stock. Should actual cash expenditures exceed management’s budget, the Company may be forced to curtail operations along with implementing other cost-saving measures, such as a reduction in staff, reducing the use of outside professional service providers, or significantly modifying or delaying the development of our product candidates. Because of these factors, substantial doubt about the Company’s ability to continue as a going concern exists.
F-17 |
Note 3. License agreement, related party
The Company licenses the U.S. patent rights for the use of TELOMIR-1 in human applications from MIRALOGX, LLC (“MIRALOGX”), an intellectual property development and holding company established by Jonnie R. Williams, Sr., the founder of the Company and the sole inventor of TELOMIR-1.
On August 11, 2023, (the “Effective Date”), the Company and MIRALOGX entered into an Amended and Restated Exclusive License Agreement, under which the Company has the exclusive perpetual right and license under the above-described patent rights to make, have made, use, and sell “Licensed Products” in the U.S. for human uses and preclinical studies and activities of any kind conducted in furtherance of obtaining regulatory approval or commercialization for human uses (the “MIRALOGX License Agreement”). The Company has the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement provides for the payment to MIRALOGX of an 8% royalty (payable quarterly) on the Company’s net sales of Licensed Products by the Company or its sublicensees and on non-royalty bearing milestone revenue. There are no up-front, execution, or milestone payments in the license agreement. Further, no payments have been made to date under the agreement.
The term of the license from MIRALOGX will continue through the date of the expiration of the last-to-expire licensed patent or, if later, the date of the expiration of the last strategic partnership/sublicensing agreement covering the licensed products. The patent rights are expected to extend through 2043, and additional patent terms may be awarded, including additional patent terms based on the time taken for regulatory review of drug products.
The agreement also provides that Telomir may bring suit in its own name to enforce patent rights. MIRALOGX will control the prosecution of the patent applications for TELOMIR-1. Telomir is required to be kept informed by MIRALOGX of patent prosecution activities and may select identified countries for patent protection. Telomir is to reimburse MIRALOGX for patent prosecution and maintenance costs
Note 4. Related party transactions
Due from related parties- During the nine months ended September 30, 2023, the Company provided working capital advances to companies under common control. These advances are due on demand and are non-interest bearing. Amounts due from related parties as of September 30, 2023 were $0.13 million. There was no such advances made during the year ended 2022.
Due to related parties- During the year ended December 31, 2022 and the nine months ended September 30, 2023, the Company received working capital advances from companies under common control. These advances are due on demand and are non-interest bearing. Amounts due to related parties as of September 30, 2023 and December 31, 2022 were $1.3 million and $0.6 million, respectively.
Related party line of credit- During the nine months ended September 30, 2023, the Company received advances from a line of credit from Bay Shore Trust, which totaled $1.3 million. There was no line of credit during 2022.
Bay Shore Trust Line of Credit
On June 15, 2023, the Company entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by the Company’s founder, Jonnie R. Williams, Sr., and under which various of his family members are beneficiaries. Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), the Company has the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of the Company’s IPO. The Company’s right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in its assets, operations, or prospects. The Bay Share Note, together with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty. The Bay Shore Note will accrue interest at a rate equal 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note is unsecured.
F-18 |
In consideration of the loan facility provided by the Bay Shore Trust, the Company issued to the Bay Shore Trust a common stock purchase warrant on June 15, 2023 giving the Bay Shore Trust the right to purchase up to 2,439,025 shares of common stock at an exercise price of $3.73 per share, which warrant will expire five years after the date of grant. Pursuant to a registration rights agreement, the Company has granted to Bay Shore Trust the right to require the Company, at any time after one year following the Company’s IPO, to register for resale the shares issuable upon the exercise of the warrant, with such registration rights being in the form of demand and “piggyback” registration rights that are subject to customary limitations and restrictions. Upon issuance, the warrant met the criteria to be classified as equity based on an analysis under Accounting Standards Codification (480) ASC 480, “Distinguishing Liabilities from Equity” and was measured at fair value, resulting in an initial fair value of approximately $5.95 million upon issuance of the warrant, using Black-Scholes valuation techniques.
License agreement - See Note 3.
Related Party Travel Costs- On April 1, 2023 the Company entered into an Agreement For Shared Lease Costs (the “Shared Agreement”) with MIRALOGX, LLC, a related party. Under the Shared Agreement, the Company agrees to make monthly contributions or payments in accordance with its use of shared aircraft toward rent payments. During the nine months ended September 30, 2023, the Company incurred $1.29 million, for travel-related expenses to the related party for rental charges and airplane-related expenses.
Shared management- Historically, the Company has shared management with related parties on an as-needed basis, to collaborate and pool resources efficiently. This arrangement has resulted in cost savings and expertise-sharing while maintaining distinct operations and identities for each entity. The Company intends to reduce these shared resources post-IPO.
Leases
The Company’s corporate headquarters is in Baltimore, Maryland, which includes a lease for office space. This lease began in November 2021 and was amended in April 2023. This space is approximately 550 square feet and has a remaining base rent of $0.009 million payable through April 2024. Rent is payable in monthly installments and is subject to yearly price increases.
Variable lease costs
Variable lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor. Variable lease costs related to the aircraft include usage expenses, which includes pilot expenses, jet fuel and general flight expenses.
Beginning August 1, 2023, the Company’s accounting and administrative staff began sharing office space with a related party in Tampa, Florida. As of September 30, 2023, there is no formal agreement, pending a revised lease agreement from the landlord. As such, the Company has agreed to split the cost of the Tampa lease pending an executed lease. During the nine months ended September 30, 2023, this variable least cost related to the Tampa, Florida space totaled $0.0045 million.
The components of lease expense were as follows:
Nine months ended September 30, | ||||||||
Lease Costs | 2023 | 2022 | ||||||
Operating lease cost | ||||||||
Operating lease | $ | 7,416 | $ | - | ||||
Variable lease costs | 1,292,545 | - | ||||||
Total lease cost | $ | 1,299,961 | $ | - |
F-19 |
Note 5. Stockholders’ equity
Capital stock
The Company has the authority to issue 400,000,000 shares of capital stock, consisting of 95,000,000 shares of Common Stock and 100,000,000 shares of undesignated preferred stock, whose rights and privileges will be defined by the Board of Directors when a series of preferred stock is designated.
Private placement Warrants
During the nine months ended September 30, 2023, the Company issued to the 2023 Private Placement investors a common stock warrant the right to purchase up to 268,025 shares of common stock at an exercise price of $15.42 per share. The Company also issued to the placement agent a common stock warrant the right to purchase up to 67,007 shares of common stock at an exercise price of $3.73 per share. Both issuances of warrants are immediately vested and will be exercisable any time until the day that is one year plus ninety days from the date an Investigational New Drug filing is made with the Food and Drug Administration.
Bay Shore Trust warrants
In consideration of the line of credit provided by the Bay Shore Trust, the Company issued to the Bay Shore Trust a common stock purchase warrant on June 15, 2023 giving the Bay Shore Trust the right to purchase up to 2,439,025 shares of common stock at an exercise price of $3.73 per share. This warrant will expire five years after the date of grant.
The fair value of the warrants were estimated on the grant date using the Black-Scholes valuation model and level 3 inputs based on assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate, which resulted in $5.95 million of deferred financing costs. This cost was recorded as deferred financing costs and additional paid in capital on the accompanying condensed balance sheet and is amortized straight-line over the term of the line of credit (which is 24 months). Associated amortization of deferred finance costs is recorded to interest expense on the condensed income statement of operations.
Key assumptions used to value warrants during the nine months ended September 30, 2023 are as follows:
Expected price volatility | 78.08 | % | ||
Risk-free interest rate | 3.91 | % | ||
Fair Market Value of underlying Common Stock | $ | 1.190 | ||
Weighted average expected life in years | 5 years | |||
Dividend yield | - |
F-20 |
Note 6 – Employment Agreement
Employment Agreement
Nathen Fuentes
On September 21, 2023 (the “Effective Date”), the Company entered into an employment agreement with Mr. Nathen Fuentes pursuant to which Mr. Fuentes serves as the Company’s Chief Financial Officer, Treasurer and Secretary on a full-time basis. Mr. Fuentes’ employment agreement provides that his employment will be on an at-will basis and can be terminated by either Mr. Fuentes or the Company at any time and for any reason. Under the agreement, Mr. Fuentes will receive an initial base salary of $0.165 million per year. At the time of the Company’s IPO, Mr. Fuentes will be entitled to a one-time bonus to effectively adjust his annual base compensation to $0.25 million annually, retroactively to the date of the Effective Date. Mr. Fuentes will also receive a cash bonus of $0.025 million at the time of the IPO. In addition, Mr. Fuentes will be granted 200,000 options to purchase common stock at the IPO offering price, which vest as follows; i) 100,000 vest at 6 months post-IPO, 50,000 vest at first anniversary of IPO, and remaining 50,000 vest six months after first anniversary of IPO. In the event that Mr. Fuentes’ employment is terminated by the company without “Cause” or is terminated by Mr. Fuentes for “Good Reason”, Mr. Fuentes will be entitled to severance compensation in the form of salary continuation for a period of three months (subject to Mr. Fuentes executing and delivering a customary general release in favor of the company).
Note 7 – Subsequent events
The Company has evaluated subsequent events through November 2, 2023, in connection with the preparation of these financial statements, which is the date the financial statements were available to be issued.
Reverse Stock Split
Effective December 11, 2023, the Company completed a reverse stock split of its outstanding common stock upon the filing of the Company’s Second Amended and Restated Articles of Incorporation with the Florida Secretary of State. No fractional shares were or will be issued in connection with the reverse stock split, and all such fractional shares resulting from the reverse stock split were and will be rounded up to the nearest whole number. The shares issuable upon the exercise of our outstanding warrants, and the exercise prices of such options and warrants, have been adjusted to reflect the reverse stock split. Unless otherwise noted, the share and per share information in this prospectus reflects the reverse stock split.
F-21 |
1,000,000 Shares
Common Stock
Telomir Pharmaceuticals, Inc.
Prospectus
Kingswood Investments
division of Kingswood Capital Partners, LLC
Until [●], 2023 (the 25th day after the date of this prospectus), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.
[●], 2023
[Alternate Page for Resale Prospectus]
The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell, and it is not soliciting an offer to buy, these securities in any state where the offer or sale is not permitted.
Subject to completion, dated [●], 2023
PROSPECTUS
6,203,696 Shares
of Common Stock
TELOMIR PHARMACEUTICALS, INC.
This prospectus relates to up to 6,203,696 shares of common stock, no par value, of Telomir Pharmaceuticals, Inc. that may be sold from time to time by the selling stockholders named in this prospectus.
The selling stockholders may sell shares from time to time in the open market, through privately negotiated transactions or a combination of these methods, at market prices prevailing at the time of sale or at negotiated prices. The Selling Securityholder may offer shares to or through underwriters, dealers or other agents, directly to investors or through any other manner permitted by law, on a continued or delayed basis. We will bear all costs, expenses and fees in connection with the registration of the shares offered by this prospectus, and the Selling Securityholder will bear all incremental selling expenses, including commissions and discounts, brokerage fees and other similar selling expenses they incur in sale of the shares. See “Plan of Distribution”.
By separate prospectus (the “IPO Prospectus”), we have registered an aggregate of 1,000,000 shares of common stock which we are offering for sale to the public through our underwriters, excluding any shares issuable upon exercise by the underwriters’ of their over-allotment option.
The 6,203,696 shares of common stock offered by the selling stockholders is defined herein as the “Resale Shares.”
We have applied to list our shares of common stock for trading on the Nasdaq Capital Market, subject to official notice of issuance, under the symbol “TELO”. No assurance can be given that our application will be approved. The consummation of this offering is conditioned on obtaining Nasdaq approval. The Resale Shares offered by the selling stockholders are part of and conditioned on the closing of our initial public offering.
We are an “emerging growth company” as defined in the federal securities laws, and, as such, are subject to reduced public company reporting requirements. See “Prospectus Summary — Implications of Being an Emerging Growth Company”.
Investing in our securities is highly speculative and involves a significant degree of risk. See “Risk Factors” beginning on page 11 of this prospectus for a discussion of information that should be considered before making a decision to purchase our securities.
Sales of the shares of our common stock registered in this prospectus and the IPO Prospectus will result in two offerings taking place concurrently, which might affect price, demand, and liquidity of our common stock.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is [●], 2023.
Alt-1 |
[Alternate Page for Resale Prospectus]
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of the Resale Shares.
The selling stockholders will pay any underwriting discounts and commissions and expenses incurred by them for brokerage, accounting, tax or legal services or any other expenses incurred by them in disposing of the shares. We will bear all other costs, fees and expenses incurred in effecting the registration of the shares covered by this prospectus, including, without limitation, all registration and filing fees and fees and expenses of our counsel and our accountants.
Alt-2 |
[Alternate Page for Resale Prospectus]
SELLING STOCKHOLDERS
This prospectus covers the possible resale by the selling stockholders identified in the table below of up to 6,203,696 shares of our common stock (the “Resale Shares”). The transactions by which the selling stockholders acquired their securities from us were exempt under the registration provisions of the Securities Act.
The selling stockholders may sell some, all, or none of the Resale Shares. Unless otherwise indicated in the footnotes to the table below, no selling stockholder has had any material relationship with us or any of our affiliates within the past three years other than as a security holder.
We have prepared the following table based on written representations and information furnished to us by or on behalf of the selling stockholders. Unless otherwise indicated in the footnotes to the table below, we believe that (i) none of the selling stockholders are broker-dealers or affiliates of broker-dealers, and (ii) no selling stockholder has direct or indirect agreements or understandings with any person to distribute their Resale Shares. To the extent any selling stockholder identified below is, or is affiliated with, a broker-dealer, it could be deemed, individually, but not severally, to be an “underwriter” within the meaning of the Securities Act. Information about the selling stockholders may change over time.
The table below lists the selling stockholders and other information regarding the beneficial ownership of the shares of common stock by each of the selling stockholders. The second column lists the number of shares of common stock beneficially owned by each selling stockholder, based on its ownership of Resale Shares as of December 12, 2023.
The third column lists the shares of common stock being offered by this prospectus by the selling stockholders.
The fourth column assumes the sale of all of the shares offered by the selling stockholders pursuant to this prospectus.
Selling Stockholder | Number of Shares Beneficially Owned Before Offering | Percentage of Shares Beneficially Owned Before this Offering | Number of Shares Being Offered | Number of Shares Beneficially Owned After Offering | Percentage of Shares Beneficially Owned After Offering (%) | |||||||||||||||
Dr. Francis O’Donnell, Jr. | 585,366 | 2.05 | % | 585,366 | - | * | ||||||||||||||
Rachel Jean Williams 2021 Irrevocable Trust | 1,365,854 | 4.77 | % | 1,365,854 | - | * | ||||||||||||||
Bay Shore Trust | 5,406,431 | 18.90 | % | 2,439,025 | 2,967,406 | 10.02 | % | |||||||||||||
MIRALOGX LLC | 1,325,646 | 4.63 | % | 1,325,646 | - | * | ||||||||||||||
Supera Aviation I, LLC | 487,805 | 1.71 | % | 487,805 | - | * |
*Less than 1%
(1) | Applicable percentage ownership after to this offering is based on 28,609,814 shares of common stock deemed to be outstanding as of December 12, 2023, after giving effect to the Company’s 1-for-2.05 reverse stock split of its outstanding common stock effective as of December 11, 2023. |
Alt-3 |
[Alternate Page for Resale Prospectus]
PLAN OF DISTRIBUTION
We are registering the Resale Shares to permit the resale of the Resale Shares by the selling stockholders from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale of the Resale Shares. We will pay all expenses (other than discounts, commissions, and transfer taxes, if any) relating to the registration of the Resale Shares in the registration statement of which this prospectus forms a part.
The selling stockholders may sell all or a portion of the Resale Shares beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers, or agents. If the Resale Shares are sold through underwriters or broker-dealers, the selling stockholders will be responsible for any underwriter discounts or commissions and any applicable transfer taxes. The Resale Shares may be sold in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions,
● | on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale; |
● | in the over-the-counter market; |
● | in transactions otherwise than on these exchanges or systems or in the over-the-counter market; |
● | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
● | block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
● | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
● | an exchange distribution in accordance with the rules of the applicable exchange; |
● | privately negotiated transactions; |
● | short sales; |
● | in transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such securities at a stipulated price per security; |
● | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
● | a combination of any such methods of sale; or |
● | any other method permitted pursuant to applicable law |
The selling stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus. The selling stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus.
Broker-dealers engaged by the selling stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.
In connection with the sale of the securities or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The selling stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The selling stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each selling stockholder has informed us that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.
Alt-4 |
[Alternate Page for Resale Prospectus]
LEGAL MATTERS
The validity of the common stock covered by this prospectus will be passed upon by Foley & Lardner LLP.
Alt-5 |
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The following table sets forth all the costs and expenses, other than underwriting discounts and commissions, to be paid by us in connection with the sale of the shares of common stock being registered hereby. All amounts shown below are estimates, except the SEC registration fee, the FINRA filing fee and the Nasdaq listing fee:
Amount | ||||
SEC registration fee | $ | 8,547 | ||
FINRA filing fee | 2,660 | |||
Nasdaq entry and listing fee | 50,000 | |||
Printing expenses | 10,000 | |||
Legal fees and expenses | 400,000 | |||
Accounting fees and expenses | 50,000 | |||
Transfer agent and registrar fees and expenses | 7,000 | |||
Miscellaneous expenses | 75,000 | |||
Total | $ | 603,207 |
Item 14. Indemnification of Directors and Officers
Telomir Pharmaceuticals, Inc. is incorporated under the laws of the state of Florida. Section 607.0831 of the Florida Business Corporation Act, as amended (the “FBCA”), provides that a director is not personally liable for monetary damages to the corporation or any other person for any statement, vote, decision to take or not to take action, or any failure to take any action, as a director, unless (1) the director breached or failed to perform his or her duties as a director and (2) the director’s breach of, or failure to perform, those duties constitutes (a) a violation of the criminal law, unless the director had reasonable cause to believe his or her conduct was lawful or had no reasonable cause to believe his or her conduct was unlawful, (b) a transaction from which the director derived an improper personal benefit, either directly or indirectly, (c) a circumstance under which the liability provisions of Section 607.0834 of the FBCA are applicable, (d) in a proceeding by or in the right of the corporation to procure a judgment in its favor or by or in the right of a shareholder, conscious disregard for the best interest of the corporation, or willful or intentional misconduct, or (e) in a proceeding by or in the right of someone other than the corporation or a shareholder, recklessness or an act or omission which was committed in bad faith or with malicious purpose or in a manner exhibiting wanton and willful disregard of human rights, safety, or property. A judgment or other final adjudication against a director in any criminal proceeding for a violation of the criminal law estops that director from contesting the fact that his or her breach, or failure to perform, constitutes a violation of the criminal law; but does not estop the director from establishing that he or she had reasonable cause to believe that his or her conduct was lawful or had no reasonable cause to believe that his or her conduct was unlawful.
Under Section 607.0851 of the FBCA, a corporation has power to indemnify any person who is a party to any proceeding (other than an action by, or in the right of the corporation), because he or she is or was a director or officer of the corporation against liability incurred in connection with such proceeding, including any appeal thereof, if he or she acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The termination of any proceeding by judgment, order, settlement or conviction or upon a plea of nolo contendere or its equivalent shall not, of itself, create a presumption that the person did not act in good faith and in a manner which he or she reasonably believed to be in, or not opposed to, the best interests of the corporation or, with respect to any criminal action or proceeding, has reasonable cause to believe that his or her conduct was unlawful.
For purposes of the indemnification provisions of the FBCA, “director” or “officer” means an individual who is or was a director or officer, respectively, of a corporation or who, while a director or officer of the corporation, is or was serving at the corporation’s request as a director or officer, manager, partner, trustee, employee, or agent of another domestic or foreign corporation, limited liability company, partnership, joint venture, trust, employee benefit plan, or another enterprise or entity and the terms include, unless the context otherwise requires, the estate, heirs, executors, administrators, and personal representatives of a director or officer.
In addition, under Section 607.0851 of the FBCA, a corporation has the power to indemnify any person, who was or is a party to any proceeding by or in the right of the corporation to procure a judgment in its favor by reason of the fact that the person is or was a director or officer, against expenses and amounts paid in settlement not exceeding, in the judgment of the board of directors, the estimated expense of litigating the proceeding to conclusion, actually and reasonably incurred in connection with the defense or settlement of such proceeding, including any appeal thereof. Such indemnification shall be authorized if such person acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the corporation, except that no indemnification shall be made under this subsection in respect of any claim, issue, or matter as to which such person shall have been adjudged to be liable unless, and only to the extent that, the court in which such proceeding was brought, or any other court of competent jurisdiction, shall determine upon application that, despite the adjudication of liability but in view of all circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which such court shall deem proper.
II-1 |
Section 607.0852 of the FBCA provides that a corporation must indemnify an individual who is or was a director or officer who was wholly successful, on the merits or otherwise, in the defense of any proceeding to which the individual was a party because he or she is or was a director or officer of the corporation against expenses incurred by the individual in connection with the proceeding.
Section 607.0853 of the FBCA provides that a corporation may, before final disposition of a proceeding, advance funds to pay for or reimburse expenses incurred in connection with the proceeding by an individual who is a party to the proceeding because that individual is or was a director or an officer if the director or officer delivers to the corporation a signed written undertaking of the director or officer to repay any funds advanced if (a) the director or officer is not entitled to mandatory indemnification under Section 607.0852; and (b) it is ultimately determined under Section 607.0854 or Section 607.0855 (as described below) that the director or officer has not met the relevant standard of conduct described in Section 607.0851 or the director or officer is not entitled to indemnification under Section 607.0859 (as described below).
Section 607.0854 of the FBCA provides that, unless the corporation’s articles of incorporation provide otherwise, notwithstanding the failure of a corporation to provide indemnification, and despite any contrary determination of the board of directors or of the shareholders in the specific case, a director or officer of the corporation who is a party to a proceeding because he or she is or was a director or officer may apply for indemnification or an advance for expenses, or both, to a court having jurisdiction over the corporation which is conducting the proceeding, or to a circuit court of competent jurisdiction. Our amended and restated articles of incorporation do not provide any such exclusion. After receipt of an application and after giving any notice it considers necessary, the court may order indemnification or advancement of expenses upon certain determinations of the court.
Section 607.0855 of the FBCA provides that, unless ordered by a court under Section 607.0854, a corporation may not indemnify a director or officer under Section 607.0851 unless authorized for a specific proceeding after a determination has been made that indemnification is permissible because the director or officer has met the relevant standard of conduct set forth in Section 607.0851.
Section 607.0857 of the FBCA also provides that a corporation shall have the power to purchase and maintain insurance on behalf of and for the benefit of any person who is or was a director or officer of the corporation against any liability asserted against the person and incurred by him or her in any such capacity or arising out of his or her status as such, whether or not the corporation would have the power to indemnify or advance expenses to the individual against such liability under the provisions of Section 607.0857.
Section 607.0858 of the FBCA provides that the indemnification provided pursuant to Section 607.0851 and Section 607.0852, and the advancement of expenses provided pursuant to Section 607.0853, are not exclusive. A corporation may, by a provision in its articles of incorporation, bylaws or any agreement, or by vote of shareholders or disinterested directors, or otherwise, obligate itself in advance of the act or omission giving rise to a proceeding to provide any other or further indemnification or advancement of expenses to any of its directors or officers.
Section 607.0859 of the FBCA provides that, unless ordered by a court under the provisions of Section 607.0854 of the FBCA, a corporation may not indemnify a director or officer under Section 607.0851 or Section 607.0858, or advance expenses to a director or officer under Section 607.0853 or Section 607.0858, if a judgment or other final adjudication establishes that his or her actions, or omissions to act, were material to the cause of action so adjudicated and constitute: (a) willful or intentional misconduct or a conscious disregard for the best interests of the corporation in a proceeding by or in the right of the corporation to procure a judgment in its favor or in a proceeding by or in the right of a shareholder; (b) a transaction in which a director or officer derived an improper personal benefit; (c) a violation of the criminal law, unless the director or officer had reasonable cause to believe his or her conduct was lawful or had no reasonable cause to believe his or her conduct was unlawful; or (d) in the case of a director, a circumstance under which the liability provisions of Section 607.0834 are applicable (relating to unlawful distributions).
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Our amended and restated articles of incorporation and bylaws provide that we shall indemnify any and all persons whom it shall have power to indemnify under the FBCA to the fullest extent permitted by law.
The underwriting agreement for this offering will provide that the underwriters indemnify us against certain civil liabilities that may be incurred in connection with this offering, including certain liabilities under the Securities Act of 1933.
We also maintain director and officer liability insurance against certain claims and liabilities which may be made against our former, current or future directors and officers. In addition, we have individual indemnification agreements with our directors.
Item 15. Recent Sales of Unregistered Securities
In the preceding three years, we have issued and sold the following securities that were not registered under the Securities Act:
1. | In September 2021, in connection with the incorporation of our company, we issued to our founders, who were comprised of 35 accredited investors, an aggregate of 26,829,269 shares of our common stock in exchange for initial capital contributions in the aggregate amount of $55,000. | |
2. | From January 2023 to March 2023, we undertook a private placement solely to accredited investors pursuant to which we issued and sold an aggregate of 268,025 shares of our common stock at a price of $3.73 per share, for an aggregate purchase price of approximately $1.0 million to 10 investors. In addition, each investor received one warrant for each share of common stock purchased in the offering, exercisable any time until the day that is one year plus 90 days from the date an IND filing is made with the FDA, at an exercise price equal to $15.42 per share. |
3. | On June 15, 2023, we granted to Bay Shore Trust a warrant to purchase up to 2,439,025 shares of our common stock at an exercise price of $3.73 per share in consideration of making a credit facility available to the Company. | |
4. | On November 30, 2023, in connection with the conversion of debt into shares of our common stock pursuant to a conversion agreement entered into separately by us with each of the Bay Shore Trust and MIRALOGX LLC, we issued to Bay Shore Trust and MIRALOGX LLC an aggregate total of 1,512,478 shares of common stock at a conversion price of $2.05 per share. |
We claimed exemption from registration under the Securities Act of 1933, as amended, or the Securities Act, for the sale and issuance of securities in the transactions described in paragraphs 1, 2, 3, and 4 above by virtue of Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder as a transaction not involving any public offering. All the purchasers of unregistered securities for which we relied on Section 4(a)(2) and/or Regulation D represented that they were accredited investors as defined in Rule 501(a) under the Securities Act. We claimed such exemption on the basis that (a) the purchasers in each case represented that they intended to acquire the securities for investment only and not with a view to the distribution thereof and that they either received adequate information about the registrant or had access, through employment or other relationships, to such information and (b) appropriate legends were affixed to the stock certificates issued in such transactions.
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Item 16. Exhibits and Financial Statement Schedules
(A) | Exhibits. |
INDEX TO EXHIBITS
* | To be filed by amendment. |
^ | Previously filed. |
+ | Denotes management contract or compensatory plan or arrangement. |
(B) Financial Statement Schedules.
Not applicable.
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Item 17. Undertakings
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended.
(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement.
(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Tampa, Florida, on this 14th day of December 2023.
TELOMIR Pharmaceuticals, Inc. | ||
By: | /s/ Dr. Christopher Chapman, Jr. | |
Dr. Christopher Chapman, Jr. | ||
Chief Executive Officer |
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature first appears below constitutes and appoints each of Christopher Chapman and Nathen Fuentes, and each of them individually, his or her true and lawful attorneys-in-fact and agents, with full powers of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any or all amendments (including post effective amendments) to this registration statement and any subsequent registration statement filed pursuant to Rule 462 under the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, and hereby ratifying and confirming all that either of the said attorneys-in-fact and agents, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed below by the following persons in the capacities and on the dates indicated.
Signature | Title | Date | ||
/s/ Dr. Christopher Chapman, Jr. | Chief Executive Officer and Chairman | December 14, 2023 | ||
Dr. Christopher Chapman, Jr. | (Principal Executive Officer) | |||
/s/ Nathen Fuentes, CPA | Chief Financial Officer | December 14, 2023 | ||
Nathen Fuentes, CPA | (Principal Financial Officer and Principal Accounting Officer) | |||
* | Director | December 14, 2023 | ||
Dr. Craig Eagle | ||||
* | General Counsel and Director | December 14, 2023 | ||
Christos Nicholoudis, Esq. | ||||
* | Director | December 14, 2023 | ||
Michael Jerman, CPA | ||||
* | Director | December 14, 2023 | ||
Brad Kroenig | ||||
/s/ Talhia Tuck | Director | December 14, 2023 | ||
Talhia Tuck | ||||
* | Director | December 14, 2023 | ||
Hugh McColl III |
*By: | /s/ Dr. Christopher Chapman, Jr. | |
Dr. Christopher Chapman, Jr. | ||
Attorney-in-Fact |
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Exhibit 3.1
SECOND AMENDED AND RESTATED
ARTICLES OF INCORPORATION
OF
TELOMIR PHARMACEUTICALS, INC.
(Pursuant to Sections 607.1007 and 607.1003
of the Florida Business Corporation Act)
Telomir Pharmaceuticals, Inc., a corporation organized and existing under and by virtue of the provisions of the Florida Business Corporation Act (the “FBCA”),
DOES HEREBY CERTIFY:
1. That this Corporation is named Telomir Pharmaceuticals, Inc. (the “Corporation”) and was originally incorporated in the State of Florida on August 26, 2021, as amended by the Amended and Restated Articles of Incorporation filed with the State of Florida on October 10, 2022, and that these Second Amended and Restated Articles of Incorporation shall amend, restate and supersede in their entirety any and all prior Amended and Restated Articles of Incorporation, Articles of Incorporation, and any Articles of Amendment or Certificates of Designation thereto, filed with the State of Florida from the date of the Corporation’s original incorporation through the date hereof.
2. That these Second Amended and Restated Articles of Incorporation have been approved by the Board of Directors and shareholders of the Corporation in the manner and by the vote required by the FBCA. These Second Amended and Restated Articles of Incorporation contain amendments that require shareholder approval. These Second Amended and Restated Articles of Incorporation were approved by the shareholders pursuant to a written consent in lieu of a meeting dated December 8, 2023, and the votes cast for the amendments by the shareholders were sufficient for approval.
That the existing Amended and Restated Articles of Incorporation of this Corporation have been further amended and restated in their entirety to read as follows:
First: The name of this corporation is Telomir Pharmaceuticals, Inc. (the “Corporation”).
Second: The address of the principal office of the Corporation is 855 N Wolfe Street, Suite 601, Baltimore, Maryland 21205. The mailing address of the Corporation is 900 West Platt Street Suite #200, Tampa, Florida 33606. The address of the Corporation’s registered office is 900 West Platt Street, Suite #200, in the City of Tampa, County of Hillsborough 33606. The name of the registered agent at such address is James A McNulty.
Third: The nature of the business or purposes to be conducted or promoted is to engage in any lawful act or activity for which corporations may be organized under the Florida Business Corporation Act (the “FBCA”).
Fourth: The total number of shares of all classes of stock which the Corporation shall have authority to issue is (i) Three Hundred Million (300,000,000) shares of Common Stock, no par value (“Common Stock”), and (ii) One Hundred Million (100,000,000) shares of Preferred Stock, no par value (“Preferred Stock”).
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Effective immediately upon the Effective Time (as defined below), each 2.05 shares of the Corporation’s Common Stock issued and outstanding immediately prior to the Effective Time shall automatically and without any further action by any shareholder or the Corporation be combined into one (1) validly issued, fully paid and non-assessable share of Common Stock (the “Reverse Stock Split”). No fractional shares of Common Stock shall be issued in connection with the Reverse Stock Split. Rather, fractional shares created as a result of the Reverse Stock Split shall be rounded up to the next largest whole number, such that, in lieu of fractional shares, each shareholder who otherwise would be entitled to receive a fractional share of Common Stock as a result of the Reverse Stock Split shall instead be entitled to receive one (1) share of Common Stock. Each certificate that immediately prior to the Effective Time represented shares of Common Stock (“Old Certificates”) shall thereafter represent that number of shares of Common Stock into which the shares of Common Stock represented by the Old Certificate shall have been combined, subject to the treatment of fractional shares as described above.
The following is a statement of the designations and the powers, privileges and rights, and the qualifications, limitations or restrictions thereof in respect of each class of capital stock of the Corporation.
A. COMMON STOCK
1. Dividends and Distributions. Subject to the rights, if any, of the holders of any outstanding shares of Preferred Stock, the Board of Directors of the Corporation may, in its sole discretion, out of funds legally available for the payment of dividends and at such times and in such manner as determined by the Board of Directors, declare and pay dividends or other distributions on the Common Stock.
2. Liquidation Rights. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, after there shall have been paid to or set aside for the holders of Preferred Stock the full preferential amounts, if any, to which they are entitled, the holders of outstanding shares of Common Stock shall be entitled to receive pro rata, according to the number of shares held by each, the remaining net assets of the Corporation available for distribution.
3. Voting Rights. Except as otherwise provided by the FBCA, and except as may be determined by the Board of Directors with respect to Preferred Stock pursuant to Section B of this Article Fourth, only the holders of Common Stock shall be entitled to vote for the election of directors of the Corporation and for all other corporate purposes. Upon any such vote the holders of Common Stock shall, except as otherwise provided by law, be entitled to one vote for each share of Common Stock held by them respectively. The number of authorized shares of Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of shares of capital stock of the Corporation representing a majority of the votes represented by all outstanding shares of capital stock of the Corporation entitled to vote, irrespective of the provisions of Section 607.1004 of the FBCA.
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B. PREFERRED STOCK
1. Series and Variations Between Series. Pursuant to Section 607.0602 of the FBCA, the Board of Directors of the Corporation is hereby expressly authorized, without the approval of the shareholders of the Corporation, to (a) provide for the classification and reclassification of any unissued shares of Preferred Stock and determine the preferences, limitations, and relative rights thereof and (b) issue Preferred Stock in one or more series, all within the limitations set forth in Section 607.0601 of the FBCA. The authority of the Board of Directors of the Corporation with respect to each series of Preferred Stock shall include, but not be limited to, determination of the following:
(1) the number of shares constituting such series and the distinctive designation of that series;
(2) the dividend rate, if any, on the shares of such series, whether dividends shall be cumulative, and, if so, from which date or dates, and the relative rights of priority, if any, of payment of dividends on shares of that series;
(3) whether such series shall have voting rights, in addition to the voting rights provided by law, and, if so, the terms of such voting rights;
(4) whether such series shall have conversion privileges and, if so, the terms and conditions of conversion, including provision for adjustment of the conversion rate upon such events as the Board of Directors shall determine;
(5) whether or not the shares of such series shall be redeemable, and, if so, the terms and conditions of such redemption, including the date or dates upon or after which they shall be redeemable and the amount per share payable in case of redemption, which amount may vary under different conditions and at different redemption dates;
(6) whether such series shall have a sinking fund for the redemption or purchase of shares of the series, and, if so, the terms and amount of such sinking fund;
(7) the rights of the shares of such series in the event of voluntary or involuntary dissolution or winding up of the Corporation, and the relative rights of priority, if any, of payment of shares of that series; and
(8) any other preferences and relative, participating, optional or other special rights, and qualifications, limitations or restrictions of such series.
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C. NO PREEMPTIVE RIGHTS
No holder of shares of any class of capital stock of the Corporation shall have any preferential or preemptive right to subscribe to or acquire (1) unissued or treasury shares of the Corporation of any class, (2) securities of the Corporation convertible into or carrying a right to acquire or subscribe to shares of any class or (3) any other obligations, warrants, rights to subscribe to shares or other securities of the Corporation of any class, in each case whether now or hereafter authorized.
Fifth: Subject to any additional vote required by these Second Amended and Restated Articles of Incorporation or the bylaws of the Corporation as then in effect (the “Bylaws”), in furtherance and not in limitation of the powers conferred by statute, the Board of Directors is expressly authorized to make, repeal, alter, amend and rescind any or all of the Bylaws of the Corporation.
Sixth: Each director will serve until the next annual meeting at which such director’s successor is duly elected and qualified or until such director’s earlier death, resignation or removal.
Subject to any additional vote required by these Second Amended and Restated Articles of Incorporation, the number of the directors, the staggering terms of the directors and the classification of the Board of Directors shall be determined in the manner set forth in the Bylaws of the Corporation. Each director shall be entitled to one vote on each matter presented to the Board of Directors.
Seventh: Any director may be removed from office, but only for Cause (as defined below) by the affirmative vote of holders of at least a majority of the voting power of the then outstanding shares of stock entitled to vote for the election of directors (or, if a director is elected by a voting group of shareholders, at least a majority of the voting power of the then outstanding shares of stock of the voting group of shareholders that elected the director to be removed). As used herein, “Cause” shall exist only if the director whose removal is proposed (1) has been convicted of a felony by a court of competent jurisdiction and such conviction is no longer subject to direct appeal or (2) has been adjudged by a court of competent jurisdiction to be liable for willful misconduct in the performance of his or her duties to the Corporation in a matter which has a material adverse effect on the business of the Corporation and such adjudication is no longer subject to direct appeal.
Eighth: Any vacancy occurring in the Board of Directors, including a vacancy created by the removal of a director or an increase in the number of directors, shall be filled by the affirmative vote of a majority of the directors then in office, although less than a quorum of the Board of Directors; provided, however, that if the vacant office was held by a director elected by a voting group of shareholders, only the remaining directors elected by that voting group shall fill the vacancy. A director elected by directors to fill a vacant office pursuant to this Article Eighth shall be deemed to be a director elected by the same voting group of shareholders that elected the director(s) who voted to fill the vacancy. Any director elected pursuant to this Article Eighth shall serve until the next meeting of the shareholders at which directors are elected or, if then permitted by the FBCA, the next election of the class for which such director shall have been chosen, and until such director’s successor is duly elected and qualified or until such director’s earlier death, resignation or removal.
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Ninth: Elections of directors need not be by written ballot unless the Bylaws of the Corporation shall so provide.
Tenth: Meetings of shareholders may be held within or without the State of Florida, as the Bylaws of the Corporation may provide. The books of the Corporation may be kept outside the State of Florida at such place or places as may be designated from time to time by the Board of Directors or in the Bylaws of the Corporation.
Eleventh: To the fullest extent permitted by law, a director of the Corporation shall not be personally liable to the Corporation or its shareholders for monetary damages for breach of fiduciary duty as a director. If the FBCA or any other law of the State of Florida is amended after approval by the shareholders of this Article Eleventh to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the FBCA as so amended.
Any repeal or modification of the foregoing provisions of this Article Eleventh by the shareholders of the Corporation shall not adversely affect any right or protection of a director of the Corporation existing at the time of, or increase the liability of any director of the Corporation with respect to any acts or omissions of such director occurring prior to, such repeal or modification.
Twelfth: To the fullest extent permitted by applicable law, the Corporation is authorized to provide indemnification of (and advancement of expenses to) directors, officers and agents of the Corporation (and any other persons to which FBCA permits the Corporation to provide indemnification) through Bylaw provisions, agreements with such agents or other persons, vote of shareholders or disinterested directors or otherwise, in excess of the indemnification and advancement otherwise provided by the FBCA.
Any amendment, repeal or modification of the foregoing provisions of this Article Twelfth shall not (a) adversely affect any right or protection of any director, officer or other agent of the Corporation existing at the time of such amendment, repeal or modification or (b) increase the liability of any director of the Corporation with respect to any acts or omissions of such director, officer or agent occurring prior to, such amendment, repeal or modification.
Thirteenth: Notwithstanding any other provision of these Second Amended and Restated Articles of Incorporation or any provision in the Bylaws of the Corporation: (1) any provisions in these Second Amended and Restated Articles of Incorporation that require a greater voting requirement than provided in the FBCA may only be amended by the same vote required to take action under the voting requirement then in effect; and (2) any provisions in the Bylaws of the Corporation that require a greater voting requirement than provided in the FBCA may only be amended by the same vote required to take action under the voting requirement then in effect.
* * *
3. That the foregoing amendment and restatement was approved by the holders of the requisite number of shares of this Corporation in accordance with the FBCA.
4. That these Second Amended and Restated Articles of Incorporation, which restate and integrate and further amend the provisions of this Corporation’s prior Second Amended and Restated Articles of Incorporation, has been duly adopted in accordance with the FBCA.
5. That these Second Amended and Restated Articles of Incorporation shall be effective as of 11:59 pm, Eastern Time, on December 11, 2023 (the “Effective Time”).
[Signature Page Follows]
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IN WITNESS WHEREOF, these Second Amended and Restated Articles of Incorporation have been executed by a duly authorized officer of this Corporation on this 11th day of December, 2023.
By: | /s/ Nathen Fuentes | |
Name: | Nathen Fuentes | |
Its: | Chief Financial Officer |
Exhibit 3.2
AMENDED AND RESTATED BYLAWS
OF
TELOMIR PHARMACEUTICALS, INC. (a Florida corporation)
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Article 1
OFFICES
Telomir Pharmaceuticals, Inc. (the “Corporation”) may have such principal and other business offices, either within or without the State of Florida, as the Board of Directors may designate or as the business of the Corporation may require from time to time.
Article 2
SHAREHOLDERS
Section 2.1 Annual Meeting. The annual meeting of the shareholders shall be held at such time and on such date as may be fixed by or under the authority of the Board of Directors. In fixing a meeting date for any annual meeting of shareholders, the Board of Directors may consider such factors as it deems relevant within the good faith exercise of its business judgment. At each annual meeting of shareholders, the shareholders shall elect directors and transact only such other business that is properly brought before the meeting in accordance with Section 2.14 of these Bylaws. If the election of directors shall not be held on the date fixed as herein provided for any annual meeting of shareholders, or any adjournment thereof, the Board of Directors shall cause the election to be held at a special meeting of shareholders as soon thereafter as is practicable.
Section 2.2 Special Meetings. Special meetings of the shareholders may be called only by the Chairman of the Board, the Chief Executive Officer, the President (in the absence of the Chief Executive Officer) or a majority of the Board of Directors, and shall be called by the Corporation in the event that the holders of not less than ten percent (10%) of all of the votes entitled to be cast on any issue proposed to be considered at the proposed special meeting sign, date, and deliver to the Secretary one or more written demands for the meeting describing one or more purposes for which it is to be held. The Corporation shall give notice of such a special meeting within sixty (60) days after the date that the demands are delivered to the Corporation.
Section 2.3 Place of Meeting. The Board of Directors may designate any place, either within or without the State of Florida, as the place of meeting for any annual meeting of shareholders or for any special meeting of shareholders. The Board of Directors, in its sole discretion, may determine that the annual meeting of shareholders or a special meeting of shareholders shall not be held at any place, but shall instead be held solely by means of remote communication as provided under Sections 607.0701, 607.0702 and 607.0709 of the Florida Business Corporation Act, as it may be amended from time to time, or any successor legislation thereto (the “Act”). If no designation is made, the place of meeting shall be the Corporation’s principal office.
Section 2.4 Notice of Meeting.
(a) Content and Delivery.
(i) Notice of the place, if any, date, time, and means of remote communication, if any, of each annual and special meeting of shareholders shall be given by the Corporation not less than ten (10) nor more than sixty (60) days before the date of the meeting. Notices of special meetings shall also specify the purpose or purposes for which the meeting has been called. Unless otherwise required by the Act or the Corporation’s articles of incorporation (the “Articles of Incorporation”):
(A) Notice of a shareholders’ meeting need be given only to shareholders entitled to vote at the meeting; and
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(B) Notices of annual meetings need not specify the purpose or purposes for which the meeting has been called.
(ii) Notices to shareholders must be in writing and may be communicated in person, by electronic means (in a manner authorized by the shareholder), or by mail or other method of delivery, in each case, by or at the direction of the Board of Directors, the Chairman of the Board, the Chief Executive Officer, the President, the Secretary, or the officer or persons calling the meeting. If mailed, the notice shall be effective when deposited in the United States mail addressed to the shareholder at the shareholder’s address as it appears in the Corporation’s shareholder records, with postage thereon prepaid.
(b) Notice of Adjourned Meetings. If an annual or special meeting of shareholders is adjourned to a different date, time or place, or to add or modify the terms of participation by remote communication, the Corporation shall not be required to give notice of the new date, time, place or terms of participation by remote communications if the new date, time, place or terms of participation by remote communications is announced at the meeting before adjournment; provided, however, that if a new record date for an adjourned meeting is or must be fixed, the Corporation shall give notice of the adjourned meeting to persons who are shareholders as of the new record date who are entitled to notice of the meeting.
(c) No Notice Under Certain Circumstances. Notwithstanding the other provisions of this Section 2.4, no notice of a meeting of shareholders need be given to a shareholder if: (i) an annual report and proxy statement for two consecutive annual meetings of shareholders, or (ii) all, and at least two, checks in payment of dividends or interest on securities during a twelve-month period have been sent by first-class, United States mail, addressed to the shareholder at his or her address as it appears on the share transfer books of the Corporation, and returned undeliverable. The obligation of the Corporation to give notice of a shareholders’ meeting to any such shareholder shall be reinstated once the Corporation has received a new address for such shareholder for entry on its share transfer books.
Section 2.5 Waiver of Notice.
(a) Written Waiver. A shareholder may waive any notice required by the Act or these Bylaws before or after the date and time stated for the meeting in the notice. The waiver shall be in writing and signed by the shareholder entitled to the notice, and be delivered to the Corporation for inclusion in the minutes or filing with the corporate records. Neither the business to be transacted at nor the purpose of any regular or special meeting of shareholders need be specified in any written waiver of notice.
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(b) Waiver by Attendance. A shareholder’s attendance at a meeting, whether physical or remote, in person or by proxy, waives objection to all of the following: (i) lack of notice or defective notice of the meeting, unless the shareholder at the beginning of the meeting objects to holding the meeting or transacting business at the meeting; and (ii) consideration of a particular matter at the meeting that is not within the purpose or purposes described in the meeting notice, unless the shareholder objects to considering the matter when it is presented.
Section 2.6 Fixing of Record Date.
(a) General. The Board of Directors may fix in advance a date as the record date for the purpose of determining shareholders entitled to notice of a shareholders’ meeting, entitled to vote, or take any other action. In no event may a record date fixed by the Board of Directors be (i) a date preceding the date upon which the resolution fixing the record date is adopted or (ii) a date more than seventy (70) days before the date of meeting or action requiring a determination of shareholders.
(b) Special Meeting. The record date for determining shareholders entitled to demand a special meeting shall be the close of business on the date the first shareholder delivers his or her demand to the Corporation.
(c) Absence of Board Determination for Shareholders’ Meeting. If the Board of Directors does not determine the record date for determining shareholders entitled to notice of and to vote at an annual or special meeting of shareholders, such record date shall be the close of business on the day before the first notice with respect thereto is delivered to shareholders.
(d) Adjourned Meeting. A record date for determining shareholders entitled to notice of or to vote at a shareholders’ meeting is effective for any adjournment of the meeting unless the Board of Directors fixes a new record date, which it must do if the meeting is adjourned to a date more than 120 days after the date fixed for the original meeting.
Section 2.7 Shareholders’ List for Meetings.
(a) Preparation and Availability. After a record date for a meeting of shareholders has been fixed, the Corporation shall prepare an alphabetical list of the names of all of the shareholders entitled to notice of the meeting (and, if the Board of Directors fixes a different record date to determine the shareholders entitled to vote at the meeting, an alphabetical list of the names of all shareholders entitled to vote at the meeting). The list shall be arranged by class or series of shares, if any, and show the address of and number of shares held by each shareholder. Such list shall be available for inspection by any shareholder for a period of ten days prior to the meeting or such shorter time as exists between the record date and the meeting date, and continuing through the meeting, at the Corporation’s principal office, at a place identified in the meeting notice in the city where the meeting will be held, on the Internet as an electronic list, or at the office of the Corporation’s transfer agent or registrar, if any. A shareholder or his or her agent or attorney may, on written demand, inspect the list, subject to the requirements of the Act, during regular business hours and at his or her expense, during the period that it is available for inspection pursuant to this Section 2.7. The Corporation shall make the shareholders’ list available at the meeting and any shareholder or his or her agent or attorney may inspect the list at any time during the meeting or any adjournment thereof.
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(b) Prima Facie Evidence. The shareholders’ list is prima facie evidence of the identity of shareholders entitled to examine the shareholders’ list or to vote at a meeting of shareholders.
(c) Failure to Comply. If the requirements of this Section 2.7 have not been substantially complied with, or if the Corporation refuses to allow a shareholder or his or her agent or attorney to inspect the shareholders’ list before or at the meeting, on the demand of any shareholder, in person or by proxy, who failed to get such access, the meeting shall be adjourned until such requirements are complied with.
(d) Validity of Action Not Affected. Refusal or failure to prepare or make available the shareholders’ list shall not affect the validity of any action taken at a meeting of shareholders.
Section 2.8 Conduct of Meetings by Remote Communication. The Board of Directors may adopt guidelines and procedures for shareholders and proxy holders not physically present at an annual or special meeting of shareholders to participate in the meeting, be deemed present in person, vote, communicate and read or hear the proceedings of the meeting substantially concurrently with such proceedings, all by means of remote communication. The Board of Directors may adopt procedures and guidelines for the conduct of an annual or special meeting solely by means of remote communication rather than holding the meeting at a designated place.
Section 2.9 Quorum.
(a) What Constitutes a Quorum. Shares entitled to vote as a separate voting group may take action on a matter at a meeting only if a quorum of those shares exists with respect to that matter. If the Corporation has only one class of stock outstanding, such class shall constitute a separate voting group for purposes of this Section 2.9. Except as otherwise provided in the Act, a majority of the votes entitled to be cast on the matter shall constitute a quorum of the voting group for action on that matter. After a quorum has been established at a shareholders’ meeting, the subsequent withdrawal of shareholders, so as to reduce the number of shares entitled to vote at the meeting below the number required for a quorum, shall not affect the validity of any action taken at the meeting or any adjournment thereof.
(b) Presence of Shares. Once a share is represented for any purpose at a meeting, other than for the purpose of objecting to holding the meeting or transacting business at the meeting, it is considered present for purposes of determining whether a quorum exists for the remainder of the meeting and for any adjournment of that meeting unless a new record date is or must be set for the adjourned meeting.
(c) Adjournment in Absence of Quorum. Where a quorum is not present, the holders of a majority of the shares represented and who would be entitled to vote at the meeting if a quorum were present may adjourn such meeting from time to time.
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Section 2.10 Voting Entitlement of Shares.
(a) Unless the Corporation’s Articles of Incorporation or the Act provide otherwise, each outstanding share, regardless of class, is entitled to one vote on each matter submitted to a vote at a meeting of shareholders. Only shares are entitled to vote.
(b) The shares of the Corporation are not entitled to vote if they are owned, directly or indirectly, by a second corporation, domestic or foreign, and the first corporation owns, directly or indirectly, a majority of shares entitled to vote for directors of the second corporation.
(c) This Section 2.10 does not limit the power of the Corporation to vote any shares, including its own shares, held by it in a fiduciary capacity.
(d) Redeemable shares are not entitled to vote on any matter, and shall not be deemed to be outstanding, after notice of redemption is mailed to the holders thereof and a sum sufficient to redeem such shares has been deposited with a bank, trust company, or other financial institution upon an irrevocable obligation to pay the holders the redemption price upon surrender of the shares.
(e) Shares standing in the name of another corporation, domestic or foreign, may be voted by such officer, agent, or proxy as the bylaws of the corporate shareholder may prescribe or, in the absence of any applicable provision, by such person as the Board of Directors of the corporate shareholder may designate. In the absence of any such designation or in case of conflicting designation by the corporate shareholder, the chairman of the board, the president, any vice president, the secretary, and the treasurer of the corporate shareholder, in that order, shall be presumed to be fully authorized to vote such shares.
(f) Shares held by an administrator, executor, guardian, personal representative, or conservator may be voted by him or her, either in person or by proxy, without a transfer of such shares into his or her name. Shares standing in the name of a trustee may be voted by him or her, either in person or by proxy, but no trustee shall be entitled to vote shares held by him or her without a transfer of such shares into his name or the name of his or her nominee.
(g) Shares held by or under the control of a receiver, a trustee in bankruptcy proceedings, or an assignee for the benefit of creditors may be voted by him or her without the transfer thereof into his or her name.
(h) If a share or shares stand of record in the names of two or more persons, whether fiduciaries, members of a partnership, joint tenants, tenants in common, tenants by the entirety, or otherwise, or if two or more persons have the same fiduciary relationship respecting the same shares, unless the Secretary of the Corporation is given notice to the contrary and is furnished with a copy of the instrument or order appointing them or creating the relationship wherein it is so provided, then acts with respect to voting have the following effect:
(i) If only one votes, in person or in proxy, his or her act binds all;
(ii) If more than one vote, in person or by proxy, the act of the majority so voting binds all;
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(iii) If more than one vote, in person or by proxy, but the vote is evenly split on any particular matter, each faction is entitled to vote the share or shares in question proportionally;
(iv) If the instrument or order so filed shows that any such tenancy is held in unequal interest, a majority or a vote evenly split for purposes of this subsection shall be a majority or a vote evenly split in interest;
(v) The principles of this subsection shall apply, insofar as possible, to execution of proxies, waivers, consents, or objections and for the purpose of ascertaining the presence of a quorum;
(vi) Subject to Section 2.10(i), nothing herein contained shall prevent trustees or other fiduciaries holding shares registered in the name of a nominee from causing such shares to be voted by such nominee as the trustee or other fiduciary may direct. Such nominee may vote shares as directed by a trustee or their fiduciary without the necessity of transferring the shares to the name of the trustee or other fiduciary.
(i) The Corporation may establish a procedure by which the beneficial owner of shares that are registered in the name of a nominee is recognized by the Corporation as the shareholder. The extent of this recognition may be determined in the procedure. The procedure may set forth (a) the types of nominees to which it applies; (b) the rights or privileges that the Corporation recognizes in a beneficial owner; (c) the manner in which the procedure is selected by the nominee; (d) the information that must be provided when the procedure is selected; (e) the period for which selection of the procedure is effective; and (f) other aspects of the rights and duties created.
Section 2.11 Vote Required.
(a) Matters Other Than Election of Directors. If a quorum exists, except in the case of the election of directors, action on a matter shall be approved if the votes cast favoring the action exceed the votes cast opposing the action, unless the Act or the Corporation’s Articles of Incorporation require a greater number of affirmative votes.
(b) Election of Directors.
(i) Each shareholder who is entitled to vote at an election of directors has the right to vote the number of shares owned by him or her for as many persons as there are directors to be elected. Shareholders do not have a right to cumulate their votes for directors.
(ii) Unless otherwise provided in the Corporation’s Articles of Incorporation, each director to be elected shall be elected by a plurality of the votes cast by the shares entitled to vote in the election of directors at an annual meeting or special meeting of shareholders at which a quorum is present.
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Section 2.12 Conduct of Meeting. The Chairman of the Board, and in his or her absence, the Vice Chairman (if any), and in his or her absence, the Chief Executive Officer, and in his or her absence, the President, and in his or her absence, a Vice President, and in his or her absence, any person chosen by the shareholders present shall call a shareholders’ meeting to order and shall act as presiding officer of the meeting, and the Secretary of the Corporation shall act as secretary of all meetings of the shareholders, but, in the absence of the Secretary, the presiding officer may appoint any other person to act as secretary of the meeting. The presiding officer of the meeting shall have broad discretion in determining the order of business at a shareholders’ meeting. The presiding officer’s authority to conduct the meeting shall include, but in no way be limited to, recognizing shareholders entitled to speak, calling for the necessary reports, stating questions and putting them to a vote, calling for nominations, and announcing the results of voting. The presiding officer also shall take such actions as are necessary and appropriate to preserve order at the meeting. The rules of parliamentary procedure need not be observed in the conduct of shareholders’ meetings; however, meetings shall be conducted in accordance with accepted usage and common practice with fair treatment to all who are entitled to take part.
Section 2.13 Proxies.
(a) Appointment. At all meetings of shareholders, a shareholder or attorney- in-fact for a shareholder may vote the shareholder’s shares in person or by proxy. If an appointment form expressly provides, any proxy holder may appoint, in writing, a substitute to act in his or her place. A shareholder or attorney-in-fact for a shareholder may appoint a proxy to vote or otherwise act for the shareholder by signing an appointment form or by electronic transmission. As provided by Section 607.0722 of the Act, any type of electronic transmission appearing to have been, or containing or accompanied by such information or obtained under such procedures to reasonably ensure that the electronic transmission was, transmitted or authorized by such person is a sufficient appointment, subject to the verification requested by the Corporation under Section 2.15 of these Bylaws and Section 607.0724 of the Act. The appointment may be signed by any reasonable means, including, but not limited to, facsimile or electronic signature. Any copy, facsimile transmission or other reliable reproduction of the writing or electronic transmission of the appointment may be substituted or used in lieu of the original writing or electronic transmission for any purpose for which the original writing or electronic transmission could be used if the copy, facsimile transmission or other reproduction is a complete reproduction of the entire original writing or electronic transmission.
(b) When Effective. An appointment of a proxy is effective when received by the Secretary or other officer or agent of the Corporation authorized to tabulate votes. An appointment is valid for up to eleven (11) months unless a longer or shorter period is expressly provided in the appointment form. An appointment of a proxy is revocable by the shareholder unless the appointment form conspicuously states that it is irrevocable and the appointment is coupled with an interest.
Section 2.14 Advance Notice of Shareholder Nominations and Proposals.
(a) Annual Meetings. At a meeting of the shareholders, only such nominations of persons for the election of directors and such other business shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting, nominations or such other business must be:
(i) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board of Directors;
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(ii) otherwise properly brought before the meeting by or at the direction of the Board of Directors; or
(iii) otherwise properly brought before an annual meeting by a shareholder who is a shareholder of record of the Corporation at the time such notice of meeting is delivered, who is entitled to vote at the meeting, and who complies with the procedures set forth in this Section 2.14.
In addition, any proposal of business (other than the nomination of persons for election to the Board of Directors) must be a proper matter for shareholder action.
For business (including, but not limited to, director nominations) to be properly brought before an annual meeting by a shareholder pursuant to Section 2.14(a)(iii), the shareholder or shareholders of record intending to propose the business (the “Proposing Shareholder”) must have given timely notice thereof pursuant to this Section 2.14(a), in writing to the Secretary of the Corporation even if such matter is already the subject of any notice to the shareholders or Public Disclosure from the Board of Directors. To be timely, a Proposing Shareholder’s notice for an annual meeting must be delivered to or mailed and received at the Corporation’s principal office on or before December 31 of the year immediately preceding the annual meeting; provided, however, that in the event that the date of the annual meeting is on or after May 1 in any year, notice by the shareholder to be timely must be so received not later than the close of business on the day which is determined by adding to December 31 of the year immediately preceding such annual meeting the number of days starting with May 1 and ending on the date of the annual meeting in such year. In no event shall the Public Disclosure of an adjournment or postponement of an annual meeting commence a new notice time period (or extend any notice time period). For the purposes of this Section 2.14, “Public Disclosure” shall mean a disclosure made in a press release reported by the Dow Jones News Services, The Associated Press, or a comparable national news service or in a document filed by the Corporation with the Securities and Exchange Commission pursuant to Sections 13, 14, or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
(b) Shareholder Nominations. For the nomination of any person or persons for election to the Board of Directors pursuant to Section 2.14(a)(iii) or Section 2.14(d), a Proposing Shareholder’s notice to the Secretary shall set forth or include:
(i) the name, age, business address, and residence address of each nominee proposed in such notice;
(ii) the principal occupation or employment of each such nominee;
(iii) the class and number of shares of capital stock of the Corporation which are owned of record and beneficially by each such nominee (if any);
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(iv) such other information concerning each such nominee as would be required to be disclosed in a proxy statement soliciting proxies for the election of such nominee as a director in an election contest (even if an election contest is not involved) or that is otherwise required to be disclosed, under Section 14(a) of the Exchange Act;
(v) a written questionnaire with respect to the background and qualification of such proposed nominee (which questionnaire shall be provided by the Secretary upon written request) and a written statement and agreement executed by each such nominee acknowledging that such person:
(A) consents to being named in the Corporation’s proxy statement as a nominee and to serving as a director if elected; and
(B) makes the following representations: (1) that the director nominee has read and agrees to adhere to the Corporation’s corporate governance guidelines, code of conduct and ethics, and any other of the Corporation’s policies or guidelines applicable to directors, including with regard to securities trading; (2) that the director nominee is not and will not become a party to any agreement, arrangement or understanding with, and has not given any commitment or assurance to, any person or entity as to how such person, if elected as a director of the Corporation, will act or vote on any issue or question (a “Voting Commitment”) that has not been disclosed to the Corporation or any Voting Commitment that could limit or interfere with such person’s ability to comply, if elected as a director of the Corporation, with such person’s fiduciary duties under applicable law; and (3) that the director nominee is not and will not become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with respect to any direct or indirect compensation, reimbursement, or indemnification that has not been disclosed to the Corporation in connection with such person’s nomination for director or service as a director; and
(vi) as to the Proposing Shareholder:
(A) the name and address of the Proposing Shareholder as they appear on the Corporation’s books and of the beneficial owner, if any, on whose behalf the nomination is being made;
(B) the class and number of shares of the Corporation which are owned by the Proposing Shareholder (beneficially and of record) and owned by the beneficial owner, if any, on whose behalf the nomination is being made, as of the date of the Proposing Shareholder’s notice, and a representation that the Proposing Shareholder will notify the Corporation in writing of the class and number of such shares owned of record and beneficially as of the record date for the meeting within five business days after the record date for such meeting;
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(C) a description of any agreement, arrangement or understanding with respect to such nomination between or among the Proposing Shareholder or the beneficial owner, if any, on whose behalf the nomination is being made and any of their affiliates or associates, and any others (including their names) acting in concert with any of the foregoing, and a representation that the Proposing Shareholder will notify the Corporation in writing of any such agreement, arrangement, or understanding in effect as of the record date for the meeting within five business days after the record date for such meeting;
(D) a description of any agreement, arrangement or understanding (including any derivative or short positions, profit interests, options, hedging transactions, and borrowed or loaned shares) that has been entered into as of the date of the Proposing Shareholder’s notice by, or on behalf of, the Proposing Shareholder or the beneficial owner, if any, on whose behalf the nomination is being made and any of their affiliates or associates, the effect or intent of which is to mitigate loss to, manage risk or benefit of share price changes for, or increase or decrease the voting power of such person or any of their affiliates or associates with respect to shares of stock of the Corporation, and a representation that the Proposing Shareholder will notify the Corporation in writing of any such agreement, arrangement, or understanding in effect as of the record date for the meeting within five business days after the record date for such meeting;
(E) a representation that the Proposing Shareholder is a holder of record of shares of the Corporation entitled to vote at the meeting and intends to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice; and
(F) a representation whether the Proposing Shareholder intends to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to approve the nomination and/or otherwise to solicit proxies from shareholders in support of the nomination.
The Corporation may require any proposed nominee to furnish such other information as it may reasonably require to determine the eligibility of such proposed nominee to serve as an independent director of the Corporation or that could be material to a reasonable shareholder’s understanding of the independence, or lack thereof, of such nominee.
(c) Other Shareholder Proposals. For all business other than director nominations, a Proposing Shareholder’s notice to the Secretary shall set forth as to each matter the Proposing Shareholder proposes to bring before the annual meeting:
(i) a brief description of the business desired to be brought before the annual meeting;
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(ii) the reasons for conducting such business at the annual meeting;
(iii) the text of any proposal or business (including the text of any resolutions proposed for consideration and in the event that such business includes a proposal to amend these Bylaws, the language of the proposed amendment);
(iv) any substantial interest (within the meaning of Item 5 of Schedule 14A under the Exchange Act) in such business of such shareholder and the beneficial owner (within the meaning of Section 13(d) of the Exchange Act), if any, on whose behalf the business is being proposed;
(v) any other information relating to such shareholder and beneficial owner, if any, on whose behalf the proposal is being made, required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the proposal and pursuant to and in accordance with Section 14(a) of the Exchange Act and the rules and regulations promulgated thereunder;
(vi) a description of all agreements, arrangements or understandings between or among such shareholder, the beneficial owner, if any, on whose behalf the proposal is being made, any of their affiliates or associates, and any other person or persons (including their names) in connection with the proposal of such business and any material interest of such shareholder, beneficial owner, or any of their affiliates or associates, in such business, including any anticipated benefit therefrom to such shareholder, beneficial owner, or their affiliates or associates; and
(vii) the information required by Section 2.14(b)(vi) above.
(d) Special Meetings of Shareholders. Only such business shall be conducted at a special meeting of shareholders as shall have been brought before the meeting pursuant to the Corporation’s notice of meeting. Nominations of persons for election to the Board of Directors may be made at a special meeting of shareholders called by the Board of Directors at which directors are to be elected pursuant to the Corporation’s notice of meeting:
(i) by or at the direction of the Board of Directors; or
(ii) provided that the Board of Directors has determined that directors shall be elected at such meeting, by any shareholder of the Corporation who is a shareholder of record at the time the notice provided for in this Section 2.14(d) is delivered to the Secretary of the Corporation, who is entitled to vote at the meeting, and upon such election and who complies with the notice procedures set forth in this Section 2.14.
In the event the Corporation calls a special meeting of shareholders for the purpose of electing one or more directors to the Board of Directors, any such shareholder entitled to vote in such election of directors may nominate a person or persons (as the case may be) for election to such position(s) as specified in the Corporation’s notice of meeting, if such shareholder delivers a shareholder’s notice that complies with the requirements of Section 2.14(b) to the Secretary at the Corporation’s principal office not earlier than the close of business on the 120th day prior to such special meeting and not later than the close of business on the later of: (x) the 90th day prior to such special meeting; or (y) the tenth (10th) day following the date of the first Public Disclosure of the date of the special meeting and of the nominees proposed by the Board of Directors to be elected at such meeting. In no event shall the Public Disclosure of an adjournment or postponement of a special meeting commence a new time period (or extend any notice time period).
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(e) Effect of Noncompliance. Only such persons who are nominated in accordance with the procedures set forth in this Section 2.14 shall be eligible to be elected at any meeting of shareholders of the Corporation to serve as directors, and only such other business shall be conducted at a meeting as shall be brought before the meeting in accordance with the procedures set forth in this Section 2.14. If any proposed nomination or other business was not made or proposed in compliance with this Section 2.14, then, except as otherwise required by law, the chair of the meeting shall have the power and duty to declare that such nomination shall be disregarded or that such proposed other business shall not be transacted. Notwithstanding anything in these Bylaws to the contrary, unless otherwise required by law, if a Proposing Shareholder intending to propose business or make nominations at an annual meeting or propose a nomination at a special meeting pursuant to this Section 2.14 does not provide the information required under this Section 2.14 to the Corporation, including the updated information required by Section 2.14(b)(vi)(B), Section 2.14(b)(vi)(C) and Section 2.14(b)(vi)(D) within five (5) business days after the record date for such meeting or the Proposing Shareholder (or a qualified representative of the Proposing Shareholder) does not appear at the meeting to present the proposed business or nominations, such business or nominations shall not be considered, notwithstanding that proxies in respect of such business or nominations may have been received by the Corporation.
(f) Rule 14a-8. This Section 2.14 shall not apply to a proposal proposed to be made by a shareholder if the shareholder has notified the Corporation of the shareholder’s intention to present the proposal at an annual or special meeting only pursuant to and in compliance with Rule 14a-8 under the Exchange Act and such proposal has been included in a proxy statement that has been prepared by the Corporation to solicit proxies for such meeting.
Section 2.15 Acceptance of Instruments Showing Shareholder Action. If the name signed on a vote, consent, waiver, or proxy appointment corresponds to the name of a shareholder, the Corporation, if acting in good faith, may accept the vote, consent, waiver, or proxy appointment and give it effect as the act of a shareholder. If the name signed on a vote, consent, waiver, or proxy appointment does not correspond to the name of a shareholder, the Corporation, if acting in good faith, may accept the vote, consent, waiver, or proxy appointment and give it effect as the act of the shareholder if any of the following apply:
(a) The shareholder is an entity and the name signed purports to be that of an officer or agent of the entity;
(b) The name signed purports to be that of an administrator, executor, guardian, personal representative, or conservator representing the shareholder and, if the Corporation requests, evidence of fiduciary status acceptable to the Corporation is presented with respect to the vote, consent, waiver, or proxy appointment;
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(c) The name signed purports to be that of a receiver or trustee in bankruptcy, or assignee for the benefit of creditors of the shareholder and, if the Corporation requests, evidence of this status acceptable to the Corporation is presented with respect to the vote, consent, waiver, or proxy appointment;
(d) The name signed purports to be that of a pledgee, beneficial owner, or attorney-in-fact of the shareholder and, if the Corporation requests, evidence acceptable to the Corporation of the signatory’s authority to sign for the shareholder is presented with respect to the vote, consent, waiver, or proxy appointment; or
(e) Two or more persons are the shareholder as co-tenants or fiduciaries and the name signed purports to be the name of at least one of the co-owners and the person signing appears to be acting on behalf of all co-owners.
The Corporation may reject a vote, consent, waiver, or proxy appointment if the Secretary or other officer or agent of the Corporation who is authorized to tabulate votes, acting in good faith, has reasonable basis for doubt about the validity of the signature on it or about the signatory’s authority to sign for the shareholder.
Article 3
BOARD OF DIRECTORS
Section 3.1 General Powers, Number and Qualifications. All corporate powers shall be exercised by or under the authority of, and the business and affairs of the Corporation managed under the direction of, the Board of Directors. The Board of Directors shall consist of not less than three (3) directors. Subject to the foregoing, the exact number of directors shall be established from time to time by resolution of the Board of Directors. If the terms of the directors are staggered or classified under Section 3.5 of these Bylaws, any increase or decrease in the number of directors shall be allocated proportionately among the classes. Any decrease in the number of directors shall not prematurely shorten the term of any incumbent director. Directors must be natural persons who are eighteen (18) years of age or older, but need not be residents of the State of Florida or shareholders of the Corporation.
Section 3.2 Term of Office. The term of each director shall expire at the next annual meeting of shareholders following his or her election or until his or her successor is elected and qualifies, unless their terms are staggered or classified under Section 3.5.
Section 3.3 Removal. A director may be removed from office only as provided in the Corporation’s Articles of Incorporation at a meeting called for that purpose.
Section 3.4 Resignation. A director may resign at any time by delivering written notice to the Board of Directors or its Chairman or Vice Chairman (if any), or to the Corporation. A director’s resignation is effective when the notice is delivered unless the notice specifies a later effective date.
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Section 3.5 Staggered Terms for Directors/Classification of the Board of Directors. The Board of Directors may, by the Corporation’s Articles of Incorporation, or by amendment to these Bylaws adopted by a vote of the shareholders, be divided into one, two or three classes with the number of directors in each class being as nearly equal as possible; the term of office of those of the first class to expire at the annual meeting next ensuing; of the second class one year thereafter; at the third class two years thereafter; and at each annual election held after such classification and election, directors shall be chosen for a full term, as the case may be, to succeed those whose terms expire. If the directors have staggered terms, then any increase or decrease in the number of directors shall be so apportioned among the classes as to make all classes as nearly equal in number as possible.
Section 3.6 Vacancies. Any vacancy occurring on the Board of Directors shall be filled as provided in the Corporation’s Articles of Incorporation.
Section 3.7 Compensation. The Board of Directors, irrespective of any personal interest of any of its members, may establish reasonable compensation of all directors for services to the Corporation as directors or may delegate such authority to an appropriate committee. The Board of Directors also shall have authority to provide for or delegate authority to an appropriate committee to provide for reasonable pensions, disability or death benefits, and other benefits or payments, to directors, officers and employees and to their families, dependents, estates or beneficiaries on account of prior services rendered to the Corporation by such directors, officers and employees.
Section 3.8 Chairman of the Board and Vice Chairman. The Board of Directors may elect a director as the Chairman of the Board and, if it has done so, the Board of Directors may also elect another director as the Vice Chairman. The Chairman of the Board shall, when present, preside at all meetings of the shareholders and of the Board of Directors, may call meetings of the shareholders and the Board of Directors, shall advise and counsel with the management of the Corporation, and shall perform such other duties as set forth in these Bylaws and as determined by the Board of Directors. In the absence of the Chairman of the Board, the Vice Chairman shall, when present, preside at all meetings of the shareholders and of the Board of Directors. Except as provided in this Section 3.8, neither the Chairman of the Board nor the Vice Chairman shall be an officer or an employee of the Corporation by virtue of his or her election and service as Chairman of the Board or Vice Chairman; provided, however, the Chairman or Vice Chairman may be an officer of the Corporation. The Chairman may use the title Chairman or Chairman of the Board interchangeably.
Section 3.9 Regular Meetings. The Board of Directors may provide the date, time and place, either within or without the State of Florida, for the holding of regular meetings of the Board of Directors without notice. Such meetings may also be remotely held as provided by Section 3.14(d).
Section 3.10 Special Meetings. Special meetings of the Board of Directors may be called by or at the request of the Chairman of the Board, the Vice Chairman (if any), the Chief Executive Officer, the President or any two (2) directors. The person or persons calling the meeting may fix any place, either within or without the State of Florida, as the place for holding any special meeting of the Board of Directors, and if no other place is fixed, the place of the meeting shall be the Corporation’s principal office. Such meetings may also be remotely held as provided by Section 3.14(d).
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Section 3.11 Notice. Special meetings of the Board of Directors must be preceded by at least two days’ notice of the date, time, and place of the meeting. The notice need not describe the purpose of the special meeting. The Corporation may give notice of a regular or special meeting of the Board of Directors by electronic means to each director who consents to such electronic means of notice in the manner authorized by that director.
Section 3.12 Waiver of Notice. Notice of a meeting of the Board of Directors need not be given to any director who signs a waiver of notice either before or after the meeting. Attendance of a director at a meeting shall constitute a waiver of notice of such meeting and waiver of any and all objections to the place of the meeting, the time of the meeting, or the manner in which it has been called or convened, except when a director states, at the beginning of the meeting or promptly upon arrival at the meeting, any objection to the transaction of business because the meeting is not lawfully called or convened.
Section 3.13 Quorum and Voting. A majority of the total number of directors shall constitute a quorum for the transaction of business at any meeting of the Board of Directors. If a quorum is present when a vote is taken, the affirmative vote of a majority of directors present is the act of the Board of Directors. A director who is present at a meeting of the Board of Directors or a committee of the Board of Directors when corporate action is taken is deemed to have assented to the action taken unless: (a) he or she objects at the beginning of the meeting (or promptly upon his or her arrival) to holding it or transacting specified business at the meeting; or (b) he or she votes against or abstains from the action taken.
Section 3.14 Conduct of Meetings.
(a) Presiding Officer. The Chairman of the Board, and in his or her absence, the Vice Chairman (if any), and in his or her absence, the Chief Executive Officer, and in his or her absence, the President, and in his or her absence, any director chosen by the directors present, shall call meetings of the Board of Directors to order and shall act as presiding officer of the meeting.
(b) Minutes. The Secretary of the Corporation shall act as secretary of all meetings of the Board of Directors but in the absence of the Secretary, the presiding officer may appoint any other person present to act as secretary of the meeting. Minutes of any regular or special meeting of the Board of Directors shall be prepared and distributed to each director.
(c) Adjournments. A majority of the directors present, whether or not a quorum exists, may adjourn any meeting of the Board of Directors to another time and place. Notice of any such adjourned meeting shall be given to the directors who are not present at the time of the adjournment and, unless the time and place of the adjourned meeting are announced at the time of the adjournment, to the other directors.
(d) Participation by Conference Call or Similar Means. The Board of Directors may permit any or all directors to participate in a regular or a special meeting by, or conduct the meeting through the use of, any means of communication by which all directors participating may simultaneously hear each other during the meeting, including virtual meetings. A director participating in a meeting by this means is deemed to be present in person at the meeting.
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Section 3.15 Committees. The Board of Directors, by resolution adopted by a majority of all of the directors then in office, may establish from among its members one or more committees (which may include, by way of example and not as a limitation, an executive committee, a compensation committee, an audit committee and a nominating and corporate governance committee) each of which, to the extent provided in such resolution and in any charter adopted by the Board of Directors for any committee, shall have and may exercise all the authority of the Board of Directors, except that no such committee shall have the authority to:
(a) approve, recommend to shareholders or propose to shareholders actions required by the Act to be approved by shareholders;
(b) fill vacancies on the Board of Directors or any committee thereof;
(c) adopt, amend, or repeal these Bylaws; or
(d) authorize or approve the reacquisition of shares unless pursuant to a general formula or method, or within limits, prescribed by the Board of Directors.
Each committee must have one or more members, who shall serve at the pleasure of the Board of Directors. The Board of Directors, by resolution adopted in accordance with this Section 3.15, may designate one or more directors as alternate members of any such committee, who may act in the place and stead of any absent member or members at any meeting of such committee. The Board of Directors may adopt a charter for any such committee specifying requirements with respect to committee chairs and membership, responsibilities of the committee, the conduct of meetings and business of the committee and such other matters as the Board may designate. In the absence of a committee charter or a provision of a committee charter governing such matters, the provisions of these Bylaws which govern meetings, notice and waiver of notice, and quorum and voting requirements of the Board of Directors apply to committees and their members as well.
Section 3.16 Action Without Meeting. Any action required or permitted by the Act to be taken at a meeting of the Board of Directors or a committee thereof may be taken without a meeting if the action is taken by all members of the Board or of the committee. The action shall be evidenced by one or more written consents describing the action taken, signed by each director or committee member and retained by the Corporation. Such action shall be effective when the last director or committee member signs the consent, unless the consent specifies a different effective date. A consent signed under this Section 3.16 has the effect of a vote at a meeting and may be described as such in any document.
Article 4
OFFICERS
Section 4.1 Number. The principal officers of the Corporation shall be a Chief Executive Officer, a President, a Chief Financial Officer, the number of Vice Presidents as authorized from time to time by the Board of Directors and a Secretary, each of whom shall be elected by the Board of Directors. Such other officers and assistant officers as may be deemed necessary may be elected or appointed by the Board of Directors. The Board of Directors may also authorize any duly appointed officer to appoint one or more officers or assistant officers. Any two or more offices may be held by the same person.
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Section 4.2 Election and Term of Office. The officers of the Corporation to be elected by the Board of Directors shall be elected annually by the Board of Directors at the first meeting of the Board of Directors held after each annual meeting of the shareholders. If the election of officers shall not be held at such meeting, such election shall be held as soon thereafter as is practicable. Each officer shall hold office until his or her successor shall have been duly elected or until his or her prior death, resignation, or removal.
Section 4.3 Removal. The Board of Directors may remove any officer and, unless restricted by the Board of Directors, an officer may remove any officer or assistant officer appointed by that officer, at any time, with or without cause and notwithstanding the contract rights, if any, of the officer removed. The appointment of an officer does not of itself create contract rights.
Section 4.4 Resignation. An officer may resign at any time by delivering notice to the Corporation. The resignation shall be effective when the notice is delivered, unless the notice specifies a later effective date and the Corporation accepts the later effective date. If a resignation is made effective at a later date and the Corporation accepts the future effective date, the pending vacancy may be filled before the effective date but the successor may not take office until the effective date.
Section 4.5 Vacancies. A vacancy in any principal office because of death, resignation, removal, disqualification, or otherwise, shall be filled as soon thereafter as practicable by the Board of Directors for the unexpired portion of the term.
Section 4.6 Chief Executive Officer. The Chief Executive Officer shall be the principal executive officer of the Corporation and, subject to the control of the Board of Directors, shall in general supervise and control all of the business and affairs of the Corporation. The Chief Executive Officer shall have authority, subject to such rules as may be prescribed by the Board of Directors, to appoint such agents and employees of the Corporation as he or she shall deem necessary, to prescribe their powers, duties and compensation, and to delegate authority to them. Such agents and employees shall hold office at the discretion of the Chief Executive Officer. He or she shall have authority to sign, execute and acknowledge, on behalf of the Corporation, all deeds, mortgages, bonds, stock certificates, contracts, leases, reports and all other documents or instruments necessary or proper to be executed in the course of the Corporation’s regular business, or which shall be authorized by resolution of the Board of Directors; and, except as otherwise provided by law or the Board of Directors, he or she may authorize the President or any Vice President or other officer or agent of the Corporation to sign, execute and acknowledge such documents or instruments in his or her place and stead. In general, he or she shall perform all duties incident to the office of Chief Executive Officer and such other duties as may be prescribed by the Board of Directors from time to time. In the absence or disability of the Chairman of the Board, or when that position is vacant, the Chief Executive Officer shall, when present, preside at all meetings of the shareholders and of the Board of Directors.
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Section 4.7 President. The President shall be the Chief Executive Officer if that position is not filled by another individual and shall have the powers and perform the duties incident to that particular position. If the Chief Executive Officer position is filled by another individual, the President shall assist the Chief Executive Officer in exercising general supervision over the business and affairs of the Corporation, and shall perform such other duties and have such authority as from time to time may be delegated or assigned to him or her by the Chief Executive Officer or by the Board of Directors. The President shall have authority, subject to the authority of the Chief Executive Officer and to such rules as may be prescribed by the Board of Directors, to appoint such agents and employees of the Corporation as he or she shall deem necessary, to prescribe their powers, duties and compensation, and to delegate authority to them. Such agents and employees shall hold office at the discretion of the President. He or she shall have authority to sign, execute and acknowledge, on behalf of the Corporation, all deeds, mortgages, bonds, stock certificates, contracts, leases, reports and all other documents or instruments necessary or proper to be executed in the course of the Corporation’s regular business, or which shall be authorized by the Chief Executive Officer or by resolution of the Board of Directors; and, except as otherwise provided by law, the Chief Executive Officer or the Board of Directors, he or she may authorize any Vice President or other officer or agent of the Corporation to sign, execute and acknowledge such documents or instruments in his or her place and stead.
Section 4.8 Chief Financial Officer. The Chief Financial Officer shall responsible for the financial operations of the Corporation, including the maintenance of financial records, the preparation and reporting of financial results and related tax returns, the co-ordination of the reporting practices of the Corporation with outside auditors, the negotiation of credit arrangements with the Corporations’ lenders and investors and related budgeting, tax-planning and forecasting functions. Subject to the further direction from time to time from the Board of Directors, the Chief Executive Officer or the President, the Chief Financial Officer shall have the authority to execute documentation on behalf of the Corporation and shall have such other powers and perform such other duties incident to the position as well as such other duties as may be delegated or assigned by the Chief Executive Officer, the President or the Board of Directors.
Section 4.9 Vice Presidents. In the absence or disability of the President, the Vice President (or in the event there be more than one Vice President, the Vice Presidents in the order and with the status designated by the Board of Directors, or in the absence of any designation, then in the order of their election) shall perform the duties of the President, and when so acting, shall have all the powers of and be subject to all the restrictions upon the President. Any Vice President may sign, with the Secretary or Assistant Secretary, certificates for shares of the Corporation; and shall perform such other duties and have such authority as from time to time may be delegated or assigned to him or her by the Chief Executive Officer, the President or the Board of Directors. The execution of any instrument of the Corporation by any Vice President shall be conclusive evidence, as to third parties, of his or her authority to act in the stead of the President. The Board of Directors may designate any Vice President as being senior in rank or degree of responsibility and may accord such a Vice President an appropriate title designating his or her senior rank, such as (in order of seniority) “Executive Vice President” or “Senior Vice President.” The Board of Directors may assign a certain Vice President responsibility for a designated group, division or function of the Corporation’s business and add an appropriate descriptive designation to his or her title.
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Section 4.10 The Secretary. The Secretary shall: (a) keep minutes of the meetings of the shareholders and of the Board of Directors (and of committees thereof) in one or more books provided for that purpose (including records of actions taken by the shareholders or the Board of Directors (or committees thereof) without a meeting); (b) see that all notices are duly given in accordance with the provisions of these Bylaws or as required by the Act; (c) be custodian of the corporate records and of the seal of the Corporation (if any) and see that the seal of the Corporation (if any) is affixed to all documents the execution of which on behalf of the Corporation under its seal is duly authorized; (d) maintain or cause an authorized agent to maintain a record of the shareholders of the Corporation, in a form that permits preparation of a list of the names and addresses of all shareholders, by class or series of shares and showing the number and class or series of shares held by each shareholder; (e) sign with the Chief Executive Officer, the President or a Vice President, certificates for shares of the Corporation, the issuance of which shall have been authorized by resolution of the Board of Directors; (f) have general charge of the stock transfer books of the Corporation; and (g) in general perform all duties incident to the office of Secretary and have such other duties and exercise such authority as from time to time may be delegated or assigned by the Chief Executive Officer, the President or the Board of Directors.
Section 4.11 Assistant Secretaries. There shall be such number of Assistant Secretaries as the Board of Directors may from time to time authorize. The Assistant Secretaries may sign with the Chief Executive Officer, the President or a Vice President certificates for shares of the Corporation the issuance of which shall have been authorized by a resolution of the Board of Directors. The Assistant Secretaries, in general, shall perform such duties and have such authority as shall from time to time be delegated or assigned to them by the Secretary or by the Chief Executive Officer, the President or the Board of Directors.
Section 4.12 Other Assistants and Acting Officers. The Board of Directors shall have the power to appoint, or to authorize any duly appointed officer of the Corporation to appoint, any person to act as assistant to any officer, or as agent for the Corporation in his or her stead, or to perform the duties of such officer whenever for any reason it is impracticable for such officer to act personally, and such assistant or acting officer or other agent so appointed by the Board of Directors or an authorized officer shall have the power to perform all the duties of the office to which he or she is so appointed to be an assistant, or as to which he or she is so appointed to act, except as such power may be otherwise defined or restricted by the Board of Directors or the appointing officer.
Section 4.13 Salaries. The salaries of the principal officers shall be fixed from time to time by the Board of Directors or by a duly authorized committee thereof, and no officer shall be prevented from receiving such salary by reason of the fact that he or she is also a director of the Corporation.
Article 5
CONTRACTS, CHECKS AND DEPOSITS
Section 5.1 Contracts. The Board of Directors may authorize any officer or officers, or any agent or agents to enter into any contract or execute or deliver any instrument in the name of and on behalf of the Corporation, and such authorization may be general or confined to specific instances. In the absence of other designation, all deeds, mortgages, and instruments of assignment or pledge made by the Corporation shall be executed in the name of the Corporation by the Chief Executive Officer, the President or a Vice President; the Secretary or an Assistant Secretary (if any), when necessary or required, shall attest and affix the corporate seal, if any, thereto; and when so executed no other party to such instrument or any third party shall be required to make any inquiry into the authority of the signing officer or officers.
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Section 5.2 Checks, Drafts, etc. All checks, drafts or other orders for the payment of money, notes, or other evidences of indebtedness issued in the name of the Corporation, shall be signed by such officer or officers, agent or agents of the Corporation and in such manner as shall from time to time be determined by or under the authority of a resolution of the Board of Directors.
Section 5.3 Deposits. All funds of the Corporation not otherwise employed shall be deposited from time to time to the credit of the Corporation in such banks, trust companies, or other depositaries as may be selected by or under the authority of a resolution of the Board of Directors.
Article 6
SHARE CERTIFICATES; DIVIDENDS AND DISTRIBUTIONS
Section 6.1 Form and Content of Share Certificates.
(a) Shares may but need not be represented by certificates. Unless the Act or another Florida statute expressly provides otherwise, the rights and obligations of shareholders are identical whether or not their shares are represented by certificates.
(b) At a minimum, each share certificate must state on its face:
(i) The name of the issuing corporation and that the Corporation is organized under the laws of the State of Florida;
(ii) The name of the person to whom issued; and
(iii) The number and class of shares and the designation of the series, if any, the certificate represents.
(c) If the shares being issued are of different classes of shares or different series within a class, the designations, relative rights, preferences, and limitations applicable to each class and the variations in rights, preferences, and limitations determined for each series (and the authority of the Board of Directors to determine variations for future series) must be summarized on the front or back of each certificate. Alternatively, each certificate may state conspicuously on its front or back that the Corporation will furnish the shareholder a full statement of this information on request and without charge.
(d) Each share certificate:
(i) Must be signed (either manually or in facsimile) by an officer or officers designated by the Board of Directors; and
(ii) May bear the corporate seal or its facsimile.
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(e) If the person who signed (either manually or in facsimile) a share certificate no longer holds office when the certificate is issued, the certificate is nevertheless valid.
Section 6.2 Shares Without Certificates.
(a) The Board of Directors may authorize the issue of some or all of the shares of any or all of its classes or series without certificates. The authorization does not affect shares already represented by certificates until they are surrendered to the Corporation.
(b) Within a reasonable time after the issue or transfer of shares without certificates, the Corporation shall send the shareholder a written statement of the information required on certificates by the Act.
Section 6.3 Restriction on Transfer of Shares and Other Securities.
(a) The Corporation’s Articles of Incorporation, these Bylaws, an agreement among shareholders, or an agreement between shareholders and the Corporation may impose restrictions on the transfer or registration of transfer of shares of the Corporation. A restriction does not affect shares issued before the restriction was adopted unless the holders of such shares are parties to the restriction agreement or voted in favor of the restriction.
(b) A restriction on the transfer or registration of transfer of shares is valid and enforceable against the holder or a transferee of the holder if the restriction is authorized by this Section 6.3, and effected in compliance with the provisions of the Act, including having a proper purpose as referred to in the Act.
Section 6.4 Distributions to Shareholders.
(a) The Board of Directors may authorize, and the Corporation may make, distributions to its shareholders subject to any limitations in the and the Act.
(b) If the Board of Directors does not fix the record date for determining shareholders entitled to a distribution (other than one involving a purchase, redemption, or other acquisition of the Corporation’s shares), it is the date the Board of Directors authorizes the distribution.
Article 7
SEAL
The Board of Directors may provide for a corporate seal for the Corporation.
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Article 8
INDEMNIFICATION
Section 8.1 Indemnification. The Corporation shall, to the fullest extent permitted or required by the Act, including any amendments thereto (but in the case of any such amendment, only to the extent such amendment permits or requires the Corporation to provide broader indemnification rights than prior to such amendment), indemnify its Directors and Officers against any and all Liabilities, and advance any and all reasonable Expenses, incurred thereby in connection with any Proceeding to which any such Director or Officer is a Party or in which such Director or Officer is deposed or called to testify as a witness because he or she is or was a Director or Officer of the Corporation, whether or not such person continues to serve in such capacity at the time the obligation to indemnify against Liabilities or advance Expenses is incurred or paid. The rights to indemnification granted hereunder shall not be deemed exclusive of any other rights to indemnification against Liabilities or the advancement of Expenses which a Director or Officer may be entitled under any written agreement, Board of Director resolution, vote of shareholders, the Act or otherwise. The Corporation may, but shall not be required to, supplement the foregoing rights to indemnification against Liabilities and advancement of Expenses by the purchase of insurance on behalf of any one or more of its Directors or Officers whether or not the Corporation would be obligated to indemnify or advance Expenses to such Director or Officer under this Article 8. For purposes of this Article 8, the term “Directors” includes former directors and any directors who are or were serving at the request of the Corporation as directors, officers, employees, or agents of another Corporation, partnership, joint venture, trust, or other enterprise, including, without limitation, any employee benefit plan (other than in the capacity as agents separately retained and compensated for the provision of goods or services to the enterprise, including, without limitation, attorneys-at-law, accountants, and financial consultants), whether or not such person continues to serve in such capacity at the time the obligation to indemnify against Liabilities or advance Expenses is incurred or paid. All other capitalized terms used in this Article 8 and not otherwise defined herein shall have the meaning set forth in Section 607.0850 of the Act (or successor provision). The provisions of this Article 8 are intended solely for the benefit of the indemnified parties described herein, their heirs and personal representatives and shall not create any rights in favor of third parties. No amendment to or repeal of this Article 8 shall diminish the rights of indemnification provided for herein to any person who serves or served as a Director or Officer at any time prior to such amendment or repeal.
Section 8.2 No Subrogation. The indemnification provided for by these Bylaws will be personal in nature and the Corporation will not have any liability under this Article 8 to any insurer or any person, corporation, partnership, trust or association or other entity (other than heirs, executors or administrators) by reason of subrogation, assignment, or succession by any other means to the claim of any person indemnified pursuant to these Bylaws.
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Article 9
EXCLUSIVE JURISDICTION
Section 9.1 Florida Courts. Unless the Corporation consents in writing to the selection of an alternative forum, the sole and exclusive forum for (a) any derivative action or proceeding brought on behalf of the Corporation, (b) any action asserting a claim of breach of a fiduciary duty owed by any current or former directors, officers or other employees of the Corporation to the Corporation or the Corporation’s shareholders, (c) any action arising pursuant to any provision of the Act or the Corporation’s Articles of Incorporation or these Bylaws (as either may be amended from time to time), or (d) any other action asserting a claim governed by the internal affairs doctrine, shall be a state court located within the state of Florida (or, if a state court located within the state of Florida does not have jurisdiction, the federal district court for the Middle District of Florida); provided that, the provisions of this Section 9.1 will not apply to suits brought to enforce any liability or duty created by the Securities Exchange Act or 1934, as amended, or to any other claim for which the U.S. federal courts have exclusive jurisdiction.
Section 9.2 U.S. Federal Courts. Unless the Corporation consents in writing to the selection of an alternative forum, the U.S. federal district courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action against the Corporation or any director, officer, other employee or agent of the Corporation arising under the Securities Act of 1933, as amended.
Section 9.3 Deemed Notice and Consent. Any person or entity purchasing or otherwise acquiring any interest in any security of the Corporation shall be deemed to have notice of and consented to the provisions of this Article 9. This Article 9 shall be enforceable by any party to a complaint covered by the provisions of this Article 9.
Article 10
AMENDMENTS
As provided in the Corporation’s Articles of Incorporation, any provisions in these Bylaws that require a greater voting requirement than provided in the Act may only be amended by the shareholders by the same vote required to take action under the voting requirement then in effect.
Article 11
MISCELLANEOUS
Section 11.1 Application of Florida Law. Whenever any provision of these Bylaws is inconsistent with any provision of the Act, as they may be amended from time to time, then in such instance, Florida law shall prevail.
Section 11.2 Fiscal Year. The fiscal year of the Corporation shall be determined by resolution of the Board of Directors.
Section 11.3 Conflicts with the Corporation’s Articles of Incorporation. In the event that any provision contained in these Bylaws conflicts with any provision of the Corporation’s Articles of Incorporation, as amended from time to time, the provisions of the Corporation’s Articles of Incorporation shall prevail and be given full force and effect, to the full extent permissible under the Act.
Section 11.4 Partial Invalidity. If any provision of these Bylaws shall, for any reason, be held by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of these Bylaws, and these Bylaws shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein.
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Exhibit 4.2
THIS WARRANT AND THE SECURITIES REPRESENTED BY THIS WARRANT HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT, AND UPON DELIVERY OF AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT THE PROPOSED TRANSFER IS EXEMPT FROM THE SECURITIES ACT.
THIS WARRANT AND THE SHARES ISSUABLE UPON THE EXERCISE OF THIS WARRANT ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER AND A MARKET STANDOFF PROVISION AS SET FORTH IN THE SUBSCRIPTION AGREEMENT PURSUANT TO WHICH THIS WARRANT WAS ISSUED, COPIES OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE COMPANY. SUCH TRANSFER RESTRICTIONS AND MARKET STANDOFF PROVISION ARE BINDING ON PERMITTED TRANSFEREES OF THIS WARRANT.
COMMON STOCK PURCHASE WARRANT
To purchase shares of common stock, no par value, of
TELOMIR PHARMACEUTICALS, INC.
Dated: June , 2023
THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, the Bay Shore Trust (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date of this Warrant and on or prior to the close of business on the date that is fifth (5th) anniversary of the date of this Warrant (the “Termination Date”) but not thereafter and subject to Section 11 below (the “Exercise Period”), to subscribe for and purchase from TELOMIR PHARMACEUTICALS, INC., a Florida corporation (the “Company”), up to FIVE MILLION (5,000,000) shares (the “Warrant Shares”) of common stock, no par value, of the Company (the “Common Stock”). The purchase price of one share of Common Stock under this Warrant shall be $1.82 (the “Exercise Price”), payable in cash. This Warrant may be exercised in whole or in part at any time prior to the Termination Date. The Exercise Price and the number of Warrant Shares for which the Warrant is exercisable shall be subject to adjustment as provided herein. The term “Holder” shall refer to the Holder identified above or any subsequent transferee of this Warrant.
1. Authorization of Warrant Shares. The Company represents and warrants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant, be duly authorized, validly issued, fully paid and nonassessable.
2. Exercise of Warrant. Except as provided in Section 3 herein and subject to Section 11, exercise of the purchase rights represented by this Warrant may be made at any time on or after the date of this Warrant and on or prior to the close of business on the Termination Date by (i) surrendering this Warrant, with the Notice of Exercise Form attached hereto completed and duly executed, to the offices of the Company (or such other office or agency (including the transfer agent, if applicable) of the Company as it may designate by notice in writing to the registered Holder at the address of such Holder appearing on the books of the Company), and (ii) delivering to the Company payment of the Exercise Price by wire transfer of immediately available funds or cashier’s check drawn on a United States bank. The Holder exercising his, her or its purchase rights in accordance with the preceding sentence shall be entitled to receive a certificate for the Warrant Shares so purchased, which certificate will bear a legend substantially similar to the legend set forth on this Warrant. Certificates for shares purchased hereunder shall be issued and delivered to the Holder within five (5) business days after the date on which this Warrant shall have been exercised as aforesaid. This Warrant shall be deemed to have been exercised and such certificate or certificates shall be deemed to have been issued, and the Holder shall be deemed to no longer hold this Warrant with respect to such shares and to have become a holder of record of such shares for all purposes, in each case, as of the date the Warrant has been exercised by payment to the Company of the Exercise Price for such shares and all taxes required to be paid by the Holder, if any, pursuant to Section 4 prior to the issuance of such shares, have been paid.
3. No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price.
4. Charges, Taxes and Expenses. Issuance of certificates for Warrant Shares shall be made without charge to the Holder for any issue tax or other incidental expense in respect of the issuance of such certificate, all of which taxes and expenses shall be paid by the Company, and such certificates shall be issued in the name of the Holder; provided, however, that the Holder shall pay any applicable transfer taxes.
5. No Rights as Stockholder until Exercise. This Warrant does not entitle the Holder to any voting rights or other rights as a stockholder of the Company prior to the exercise hereof. Upon the surrender of this Warrant and the payment of the aggregate Exercise Price, the Warrant Shares so purchased shall be and be deemed to be issued to such Holder as the record owner of such shares as of the close of business on the later of the date of such surrender or payment, and this Warrant shall no longer be issuable with respect to such Warrant Shares.
6. Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that, upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in the case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it, and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.
7. Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall be a Saturday, Sunday or legal holiday, then such action may be taken or such right may be exercised on the next succeeding day not a Saturday, Sunday or legal holiday.
8. Adjustments and Termination of Rights. The purchase price per Warrant Share and the number of Warrant Shares purchasable hereunder are subject to adjustment from time to time as follows:
(a) Reclassification, Recapitalization, etc. If the Company at any time shall, by reclassification of securities, recapitalization, automatic conversion, or other similar event affecting the number or character of outstanding shares of Common Stock, or otherwise, change any of the securities as to which purchase rights under this Warrant exist into the same or a different number of securities of any other class or classes, this Warrant shall thereafter represent the right to acquire such number and kind of securities as would have been issuable as the result of such change with respect to the securities that were subject to the purchase rights under this Warrant immediately prior to such reclassification or other change.
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(b) Split, Subdivision or Combination of Shares. If the Company at any time while this Warrant remains outstanding and unexpired shall split, subdivide or combine the securities as to which purchase rights under this Warrant exist, the Exercise Price shall be proportionately decreased in the case of a split or subdivision or proportionately increased in the case of a combination.
(c) Stock Dividends. If the Company at any time while this Warrant is outstanding and unexpired shall pay a dividend with respect to Common Stock payable in shares of Common Stock, then the Exercise Price shall be adjusted, from and after the date of determination of the shareholders entitled to receive such dividend or distribution, to that price determined by multiplying the Exercise Price in effect immediately prior to such date of determination by a fraction (i) the numerator of which shall be the total number of shares of Common Stock outstanding immediately prior to such dividend or distribution, and (ii) the denominator of which shall be the total number of shares of Common Stock outstanding immediately after such dividend or distribution.
(d) Adjustment of Number of Warrant Shares. Upon each adjustment in the Exercise Price pursuant to Sections 8(b) or 8(c) hereof, the number of Warrant Shares purchasable hereunder shall be adjusted to the product obtained by multiplying the number of Warrant Shares purchasable immediately prior to such adjustment in the Exercise Price by a fraction (i) the numerator of which shall be the Exercise Price immediately prior to such adjustment, and (ii) the denominator of which shall be the Exercise Price immediately after such adjustment.
9. Notice of Adjustments, Notices. If the Exercise Price or number or type of securities issuable hereunder shall be adjusted pursuant to Section 8 hereof, the Company shall issue and provide to the Holder, as holder of this Warrant, a certificate signed by an officer of the Company setting forth, in reasonable detail, the event requiring the adjustment, the amount of the adjustment, the method by which such adjustment was calculated and the Exercise Price and number of Warrant Shares purchasable hereunder after giving effect to such adjustment.
10. Authorized Shares. The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company will take all such reasonable action as may be necessary to ensure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation.
11. Early Termination. Notwithstanding anything to the contrary set forth in this Warrant Agreement, in the event of a proposed Company Sale, the Company shall give written notice to the Holder that the Company proposes to enter into a Company Sale (a “Sale Notice”). Such notice shall be provided no less than fifteen (15) calendar days prior to the anticipated closing date of the Company Sale. In the event that the Company does not receive a Notice of Exercise within fifteen (15) days after delivering the Sale Notice, then this Warrant will automatically terminate and be of no further force and effect as of the closing date of the Company Sale. Each Warrant not exercised on or before the date of consummation of a Company Sale shall become void, and all rights thereunder and in respect thereof under this Agreement shall cease at the close of business on such date. “Company Sale” means (i) a sale or transfer of more than fifty percent (50%) or more of the outstanding shares of Common Stock of the Company by the holders thereof to transferees that are not affiliates of the respective transferors, (ii) the sale or disposition of all or substantially all of the Company’s assets, (iii) any merger, consolidation, or other business combination of the Company with an entity that is not an affiliate of the Company, or (iv) any other transaction or reorganization that the Board of Directors of the Company believes in good faith is in the nature of a transaction described in the foregoing clauses of this sentence.
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12. Miscellaneous.
(a) Jurisdiction. This Warrant shall constitute a contract under the laws of the State of Florida, without regard to its conflict of law, principles or rules.
(b) Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant will have restrictions upon resale imposed by state and federal securities laws and as set forth in the Subscription Agreement pursuant to which this Warrant was issued.
(c) Notices. All notices, requests, consents and other communications provided for herein shall be in writing and shall be effective upon delivery in person or five business days after being mailed by certified or registered mail, return receipt requested, postage pre-paid, addressed as follows:
(i) If to the Holder to the address of the Holder as shown on the books of the Company; or
(ii) If to the Company:
TELOMIR PHARMACEUTICALS, INC.
900 W PLATT ST., SUITE 200
TAMPA, FLORIDA 33606
Attention: Chief Executive Officer
or at such other address as the Holder or the Company, as applicable, may hereafter provide to the other in accordance with the provisions of this paragraph.
(d) Successors and Assigns; No Assignment. This Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors of the Company. The Holder may assign this Warrant without the prior written consent of the Company.
(e) Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company and the Holder.
(f) Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.
(g) Headings. The headings used in this Warrant are for convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.
[signature follows]
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IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized.
TELOMIR PHARMACEUTICALS, INC. | ||
By: | ||
Chief Executive Officer |
NOTICE OF EXERCISE
To: TELOMIR PHARMACEUTICALS, INC.
(1) The undersigned hereby elects to purchase _____ of the Warrant Shares of TELOMIR PHARMACEUTICALS, INC. pursuant to the terms of the attached Warrant. Capitalized terms used but not otherwise defined herein shall have the meanings set forth in the attached Warrant.
(2) The undersigned tenders herewith payment of the Exercise Price in full, together with all applicable transfer taxes, if any. Payment shall take the form of lawful money of the United States.
(3) Please issue a certificate or certificates representing said Warrant Shares in the name of the undersigned. The Warrant Shares shall be delivered to the following:
_______________________________
_______________________________
_______________________________
(4) Accredited Investor. The undersigned is an “accredited investor” as defined in Regulation D under the Securities Act of 1933, as amended.
PURCHASER | ||
By: | ||
Name: | ||
Title: | ||
Dated: |
Exhibit 10.1
TELOMIR PHARMACEUTICALS, INC.
2023 OMNIBUS INCENTIVE PLAN
1. Purposes and Effective Date.
(a) Purposes. The Telomir Pharmaceuticals, Inc. 2023 Omnibus Incentive Plan has two complementary purposes: (i) to attract and retain outstanding individuals to serve as officers, directors, employees, and consultants and (ii) to increase shareholder value. The Plan will provide participants incentives to increase shareholder value by offering the opportunity to acquire shares of the Company’s common stock, receive monetary payments based on the value of such common stock, or receive other incentive compensation, on the potentially favorable terms that this Plan provides.
(b) Effective Date. This Plan was adopted and approved by the Board and stockholders of the Company effective December 8, 2023 (the “Effective Date”) and reflects the Company’s 1-for-2.05 reverse stock split of its issued and outstanding common stock that became effective on December 11, 2023. This Plan will terminate as provided in Section 15.
2. Definitions. Capitalized terms used and not otherwise defined in this Plan or in any Award agreement have the following meanings:
(a) “Act” means the Securities Act of 1933, as amended from time to time. Any reference to a specific provision of the Act shall include any successor provision thereto.
(b) “Administrator” means the Board or the Committee; provided that, to the extent the Board or the Committee has delegated authority and responsibility as an Administrator of the Plan to one or more committees or officers of the Company as permitted by Section 3(b), the term “Administrator” shall also mean such committee, committees, officer or officers.
(c) “Affiliate” has the meaning ascribed to such term in Rule 12b-2 under the Exchange Act. Notwithstanding the foregoing, for purposes of determining those individuals to whom an Option or a Stock Appreciation Right may be granted, the term “Affiliate” means any entity that, directly or through one or more intermediaries, is controlled by or is under common control with, the Company within the meaning of Code Sections 414(b) or (c); provided that, in applying such provisions, the phrase “at least 20 percent” shall be used in place of “at least 80 percent” each place it appears therein.
(d) “Applicable Exchange” means the Nasdaq Stock Market, the New York Stock Exchange or such other exchange or automated trading system on which the Stock is principally traded at the applicable time.
(e) “Award” means a grant of Options, Stock Appreciation Rights, Performance Shares, Performance Units, Stock, Restricted Stock, Restricted Stock Units, an Incentive Award, Dividend Equivalent Units or any other type of award permitted under this Plan. Any Award granted under this Plan shall be provided or made in such manner and at such time as complies with the applicable requirements of Code Section 409A to avoid a plan failure described in Code Section 409A(a)(1), including, without limitation, deferring payment to a specified employee or until a specified distribution event, as provided in Code Section 409A(a)(2), and the provisions of Code Section 409A are incorporated into this Plan to the extent necessary for any Award that is subject to Code Section 409A to comply therewith.
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(f) “Beneficial Owner” means a Person, with respect to any securities which:
(i) such Person or any of such Person’s Affiliates has the right to acquire (whether such right is exercisable immediately or only after the passage of time) pursuant to any agreement, arrangement or understanding, or upon the exercise of conversion rights, exchange rights, rights, warrants or options, or otherwise; provided, however, that a Person shall not be deemed the Beneficial Owner of, or to beneficially own, securities tendered pursuant to a tender or exchange offer made by or on behalf of such Person or any of such Person’s Affiliates until such tendered securities are accepted for purchase;
(ii) such Person or any of such Person’s Affiliates, directly or indirectly, has the right to vote or dispose of or has “beneficial ownership” of (as determined pursuant to Rule 13d-3 of the General Rules and Regulations under the Act), including pursuant to any agreement, arrangement or understanding; provided, however, that a Person shall not be deemed the Beneficial Owner of, or to beneficially own, any security under this clause (ii) as a result of an agreement, arrangement or understanding to vote such security if the agreement, arrangement or understanding: (A) arises solely from a revocable proxy or consent given to such Person in response to a public proxy or consent solicitation made pursuant to, and in accordance with, the applicable rules and regulations under the Act and (B) is not also then reportable on a Schedule l3D under the Act (or any comparable or successor report); or
(iii) are beneficially owned, directly or indirectly, by any other Person with which such Person or any of such Person’s Affiliates has any agreement, arrangement or understanding for the purpose of acquiring, holding, voting (except pursuant to a revocable proxy as described in clause (ii) above) or disposing of any voting securities of the Company.
(g) “Board” means the Board of Directors of the Company.
(h) “Cause” shall have the same meaning as set forth in a Participant’s employment agreement or individual Award with the Company, or, if the Participant does not have an employment agreement with the Company (or the Participant’s individual Award does not otherwise define the term), “Cause” shall mean a good faith finding by the Company that the Participant has (i) failed, neglected, or refused to perform the lawful employment duties related to the Participant’s position or as from time to time assigned to the Participant (other than due to disability within the meaning of Code Section 22(e)(3)); (ii) committed any willful, intentional, or grossly negligent act having the effect of injuring the interest, business, or reputation of the Company or any Affiliate; (iii) violated or failed to comply in any material respect with the Company’s or an Affiliate’s published rules, regulations, or policies, as in effect or amended from time to time, to the extent applicable to the Participant; (iv) committed an act constituting a felony or misdemeanor involving moral turpitude, fraud, theft, or dishonesty; (v) misappropriated or embezzled any property of the Company or an Affiliate (whether or not an act constituting a felony or misdemeanor); or (vi) breached any material provision of any applicable confidentiality, non-compete, non-solicit, general release, covenant not-to-sue, or other agreement with the Company or any Affiliate.
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(i) “Change of Control” means, unless specified otherwise in an Award agreement, the occurrence of any of the following:
(i) any Person (other than (A) the Company or any of its subsidiaries, (B) a trustee or other fiduciary holding securities under any employee benefit plan of the Company or any of its subsidiaries, (C) an underwriter temporarily holding securities pursuant to an offering of such securities, or (D) a corporation owned, directly or indirectly, by the shareholders of the Company in substantially the same proportions as their ownership of stock in the Company (“Excluded Persons”)) is or becomes the Beneficial Owner, directly or indirectly, of securities of the Company (not including in the securities beneficially owned by such Person any securities acquired directly from the Company or its Affiliates after the Effective Date, pursuant to express authorization by the Board that refers to this exception) representing fifty percent (50%) or more of either the then outstanding shares of common stock of the Company or the combined voting power of the Company’s then outstanding voting securities; or
(ii) the following individuals cease for any reason to constitute a majority of the number of directors of the Company then serving: (A) individuals who, on the Effective Date, constituted the Board and (B) any new director (other than a director whose initial assumption of office is in connection with an actual or threatened election contest, including but not limited to a consent solicitation, relating to the election of directors of the Company, as such terms are used in Rule 14a-11 of Regulation 14A under the Act) whose appointment or election by the Board or nomination for election by the Company’s shareholders was approved by a vote of at least two-thirds (2/3) of the directors then still in office who either were directors on the Effective Date, or whose appointment, election or nomination for election was previously so approved (collectively the “Continuing Directors”); provided, however, that individuals who are appointed to the Board pursuant to or in accordance with the terms of an agreement relating to a merger, consolidation, or share exchange involving the Company (or any direct or indirect Subsidiary of the Company) shall not be Continuing Directors for purposes of this Agreement until after such individuals are first nominated for election by a vote of at least two-thirds (2/3) of the then Continuing Directors and are thereafter elected as directors by the shareholders of the Company at a meeting of shareholders held following consummation of such merger, consolidation, or share exchange; and, provided further, that in the event the failure of any such persons appointed to the Board to be Continuing Directors results in a Change of Control, the subsequent qualification of such persons as Continuing Directors shall not alter the fact that a Change of Control occurred; or
(iii) the consummation of a merger, consolidation or share exchange of the Company with any other corporation or the issuance of voting securities of the Company in connection with a merger, consolidation or share exchange of the Company (or any direct or indirect Subsidiary of the Company), in each case, which requires approval of the shareholders of the Company, other than (A) a merger, consolidation or share exchange which would result in the voting securities of the Company outstanding immediately prior to such merger, consolidation or share exchange continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or any parent thereof) at least fifty percent (50%) of the combined voting power of the voting securities of the Company or such surviving entity or any parent thereof outstanding immediately after such merger, consolidation or share exchange, or (B) a merger, consolidation or share exchange effected to implement a recapitalization of the Company (or similar transaction) in which no Person (other than an Excluded Person) is or becomes the Beneficial Owner, directly or indirectly, of securities of the Company (not including in the securities beneficially owned by such Person any securities acquired directly from the Company or its Affiliates after the Effective Date, pursuant to express authorization by the Board that refers to this exception) representing twenty percent (20%) or more of either the then outstanding shares of common stock of the Company or the combined voting power of the Company’s then outstanding voting securities; or
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(iv) the consummation of a plan of complete liquidation or dissolution of the Company or a sale or disposition by the Company of all or substantially all of the Company’s assets (in one transaction or a series of related transactions within any period of twenty-four (24) consecutive months), in each case, which requires approval of the shareholders of the Company, other than a sale or disposition by the Company of all or substantially all of the Company’s assets to an entity at least seventy-five percent (75%) of the combined voting power of the voting securities of which are owned by Persons in substantially the same proportions as their ownership of the Company immediately prior to such sale.
Notwithstanding the foregoing, no “Change of Control” shall be deemed to have occurred if there is consummated any transaction or series of integrated transactions immediately following which the record holders of the common stock of the Company immediately prior to such transaction or series of transactions continue to own, directly or indirectly, in the same proportions as their ownership in the Company, an entity that owns all or substantially all of the assets or voting securities of the Company immediately following such transaction or series of transactions.
Notwithstanding the foregoing, if an Award is considered deferred compensation subject to the provisions of Code Section 409A, and if a payment under such Award is triggered upon a “Change of Control,” then the foregoing definition shall be deemed amended as necessary to comply with Code Section 409A.
(j) “Code” means the Internal Revenue Code of 1986, as amended. Any reference to a specific provision of the Code includes any successor provision and the regulations promulgated under such provision.
(k) “Committee” means the Compensation Committee of the Board, any successor committee thereto or such other committee of the Board that is designated by the Board with the same or similar authority. The Committee shall consist only of Non-Employee Directors (not fewer than two (2)) to the extent necessary for the Plan and Awards to comply with Rule 16b-3 promulgated under the Exchange Act.
(l) “Company” means Telomir Pharmaceuticals, Inc., a Florida corporation, or any successor thereto.
(m) “Director” means a member of the Board.
(n) “Disability” means, unless otherwise defined in the applicable Award agreement, a finding of disability under the long-term disability plan sponsored by the Company or an Affiliate in which the Participant participates. Notwithstanding the foregoing, for Awards that are subject to Section 409A of the Code, Disability shall mean that a Participant is disabled under Section 409A(a)(2)(C)(i) or (ii) of the Code.
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(o) “Dividend Equivalent Unit” means the right to receive a payment, in cash or Shares, equal to the cash dividends or other cash distributions paid with respect to a Share.
(p) “Effective Date” has the meaning in Section 1(b).
(q) “Exchange Act” means the Securities Exchange Act of 1934, as amended. Any reference to a specific provision of the Exchange Act includes any successor provision and the regulations and rules promulgated under such provision.
(r) “Fair Market Value” means a price that is based on the opening, closing, actual, high or low sale price, or the arithmetic mean of selling prices of, a Share, on the Applicable Exchange on the applicable date, the preceding trading day, the next succeeding trading day, or the arithmetic mean of selling prices on all trading days over a specified averaging period weighted by volume of trading on each trading day in the period that is within 30 days before or 30 days after the applicable date, as determined by the Administrator in its discretion; provided that, if an arithmetic mean of prices is used to set a grant price or an exercise price for an Option or Stock Appreciation Right, the commitment to grant the applicable Award based on such arithmetic mean must be irrevocable before the beginning of the specified averaging period in accordance with Treasury Regulation 1.409A-1(b)(5)(iv)(A). The method of determining Fair Market Value with respect to an Award shall be determined by the Administrator and may differ depending on whether Fair Market Value is in reference to the grant, exercise, vesting, settlement, or payout of an Award; provided that, if the Administrator does not specify a different method, the Fair Market Value of a Share as of a given date shall be the closing sale price as of the trading day immediately preceding the date as of which Fair Market Value is to be determined or, if there shall be no such sale on such date, the next preceding day on which such a sale shall have occurred. If the Stock is not traded on an established stock exchange, the Administrator shall determine in good faith the Fair Market Value in whatever manner it considers appropriate but based on objective criteria. Notwithstanding the foregoing, in the case of the sale of Shares on the Applicable Exchange, the actual sale price shall be the Fair Market Value of such Shares.
(s) “Incentive Award” means the right to receive a cash payment to the extent Performance Goals are achieved (or other requirements are met), and shall include “Annual Incentive Awards” as described in Section 10 and “Long-Term Incentive Awards” as described in Section 11.
(t) “Incentive Stock Option” means an Option that is intended to qualify as an “incentive stock option” within the meaning of Section 422 of the Code.
(u) “Non-Employee Director” means a Director who is not also an employee of the Company or its Subsidiaries and, to the extent necessary for Awards to comply with Rule 16b-3 under the Exchange Act, who otherwise meets the definition of “Non-Employee Director” in Rule 16b-3(b)(3) under the Exchange Act.
(v) “Nonqualified Stock Option” means an Option that is not intended to qualify as an Incentive Stock Option.
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(w) “Option” means the right to purchase a Share at a stated price for a specified period of time.
(x) “Participant” means an individual selected by the Administrator to receive an Award.
(y) “Performance Goals” means any objective or subjective goals the Administrator establishes with respect to an Award. A Performance Goal may, but is not required to, relate to one or more of the following with respect to the Company or any one or more Subsidiaries, Affiliates or other business units: basic earnings per common share for the Company on a consolidated basis; diluted earnings per common share for the Company on a consolidated basis; total shareholder return; fair market value of shares; net sales; cost of sales; gross profit; selling, general and administrative expenses; operating income; earnings before interest and the provision for income taxes (EBIT); earnings before interest, the provision for income taxes, depreciation, and amortization (EBITDA); net income; accounts receivable; return on equity; return on assets; return on invested capital; return on sales; economic value added, or other measure of profitability that considers the cost of capital employed; free cash flow; net cash provided by operating activities; net increase (decrease) in cash and cash equivalents; customer satisfaction; market share; and/or quality. Unless otherwise determined by the Administrator, the relevant measurement of performance as to each Performance Goal shall be computed in accordance with generally accepted accounting principles, if applicable. The Administrator reserves the right to adjust Performance Goals, or modify the manner of measuring or evaluating a Performance Goal, for any reason the Administrator determines is appropriate, including but not limited to by excluding the effects of (i) charges for reorganizing and restructuring, (ii) discontinued operations, (iii) asset write-downs, (iv) gains or losses on the disposition of a business, (v) mergers, acquisitions or dispositions, and (vi) extraordinary, unusual and/or non-recurring items of gain or loss. The inclusion in an Award agreement of specific adjustments or modifications shall not be deemed to preclude the Administrator from making other adjustments or modifications, in its discretion, as described herein, unless the Award agreement provides that the adjustments or modifications described in such agreement shall be the sole adjustments or modifications. The Administrator may establish other Performance Goals not listed in this Plan. Where applicable, the Performance Goals may be expressed, without limitation, in terms of attaining a specified level of the particular criterion or the attainment of an increase or decrease (expressed as absolute numbers or a percentage) in the particular criterion or achievement in relation to a peer group or other index. The Performance Goals may include a threshold level of performance below which no payment will be made (or no vesting will occur), levels of performance at which specified payments will be paid (or specified vesting will occur), and a maximum level of performance above which no additional payment will be made (or at which full vesting will occur).
(z) “Performance Shares” means the right to receive Shares to the extent Performance Goals are achieved (or other requirements are met).
(aa) “Performance Unit” means the right to receive a cash payment and/or Shares valued in relation to a unit that has a designated dollar value or the value of which is equal to the Fair Market Value of one or more Shares, to the extent Performance Goals are achieved (or other requirements are met).
(bb) “Person” means any individual, firm, partnership, corporation or other entity, including any successor (by merger or otherwise) of such entity, or a group of any of the foregoing acting in concert.
(cc) “Plan” means this Telomir Pharmaceuticals, Inc. 2023 Omnibus Incentive Plan as it may be amended from time to time.
(dd) “Restricted Stock” means Shares that are subject to a risk of forfeiture or restrictions on transfer, or both a risk of forfeiture and restrictions on transfer, which may lapse upon the achievement or partial achievement of Performance Goals or upon the completion of a period of service, or both.
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(ee) “Restricted Stock Unit” means the right to receive a cash payment and/or Shares the value of which is equal to the Fair Market Value of one Share.
(ff) “Section 16 Participants” means Participants who are subject to the provisions of Section 16 of the Exchange Act.
(gg) “Share” means a share of Stock.
(hh) “Stock” means the common stock, no par value, of the Company.
(ii) “Stock Appreciation Right” or “SAR” means the right to receive a cash payment, and/or Shares with a Fair Market Value, equal to the appreciation of the Fair Market Value of a Share during a specified period of time.
(jj) “Subsidiary” means any corporation, limited liability company or other limited liability entity in an unbroken chain of entities beginning with the Company if each of the entities (other than the last entities in the chain) owns the stock or equity interest possessing more than fifty percent (50%) of the total combined voting power of all classes of stock or other equity interests in one of the other entities in the chain.
3. Administration.
(a) Administration. In addition to the authority specifically granted to the Administrator in this Plan, the Administrator has full discretionary authority to administer this Plan, including but not limited to the authority to: (i) interpret the provisions of this Plan or any agreement covering an Award; (ii) prescribe, amend and rescind rules and regulations relating to this Plan; (iii) correct any defect, supply any omission, or reconcile any inconsistency in the Plan, any Award or any agreement covering an Award in the manner and to the extent it deems desirable to carry this Plan or such Award into effect; and (iv) make all other determinations necessary or advisable for the administration of this Plan. All Administrator determinations shall be made in the sole discretion of the Administrator and are final and binding on all interested parties.
(b) Delegation to Other Committees or Officers. To the extent applicable law permits, the Board may delegate to another committee of the Board, or the Committee may delegate to a subcommittee of the Committee or to one or more officers of the Company, any or all of their respective authority and responsibility as an Administrator of the Plan; provided that no such delegation is permitted with respect to Stock-based Awards made to Section 16 Participants at the time any such delegated authority or responsibility is exercised unless the delegation is to another committee of the Board consisting entirely of Non-Employee Directors. If the Board or the Committee has made such a delegation, then all references to the Administrator in this Plan include such other committee, subcommittee or one or more officers to the extent of such delegation.
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(c) No Liability; Indemnification. No member of the Board or the Committee, and no officer or member of any other committee to whom a delegation under Section 3(b) has been made, will be liable for any act done, or determination made, by the individual in good faith with respect to the Plan or any Award. The Company will indemnify and hold harmless each such individual as to any acts or omissions, or determinations made, in each case done or made in good faith, with respect to this Plan or any Award to the maximum extent that the law and the Company’s By-Laws permit.
4. Eligibility. The Administrator may designate any of the following as a Participant from time to time, to the extent of the Administrator’s authority: any officer or other employee of the Company or its Affiliates; any individual that the Company or an Affiliate has engaged to become an officer or employee; any consultant or advisor who provides services to the Company or its Affiliates; or any Director, including a Non-Employee Director. The Administrator’s designation of, or granting of an Award to, a Participant will not require the Administrator to designate such individual as a Participant or grant an Award to such individual at any future time. The Administrator’s granting of a particular type of Award to a Participant will not require the Administrator to grant any other type of Award to such individual.
5. Types of Awards. Subject to the terms of this Plan, the Administrator may grant any type of Award to any Participant it selects, but only employees of the Company or a Subsidiary may receive grants of Incentive Stock Options. Awards may be granted alone or in addition to, in tandem with, or (subject to the prohibition on repricing set forth in Section 15(e)) in substitution for any other Award (or any other award granted under another plan of the Company or any Affiliate, including the plan of an acquired entity).
6. Shares Reserved under this Plan.
(a) Plan Reserve. Subject to adjustment as provided in Section 17, as of the Effective Date, an aggregate of 6,500,000 Shares are reserved for issuance under this Plan, all of which may be issued pursuant to the exercise of Incentive Stock Options. The aggregate number of Shares reserved for issuance under this Plan shall be increased annually on the first day of each fiscal year of the Company after the Effective Date, commencing on the first day of the Company’s first fiscal year following the completion by the Company of an underwritten initial public offering, by a number of Shares equal to 1.0% of the number of outstanding shares of all classes of the Company’s common stock as of the last day of the immediately preceding fiscal year or such other number of Shares as the Board may determine. The Shares reserved for issuance may be either authorized and unissued Shares or Shares reacquired at any time and now or hereafter held as treasury stock. The aggregate number of Shares reserved under this Section 6(a) shall be depleted on the date of grant of an Award by the maximum number of Shares, if any, that may be issuable under an Award as determined at the time of grant. Notwithstanding the foregoing, an Award that may be settled solely in cash shall not cause any depletion of the Plan’s Share reserve at the time such Award is granted.
(b) Replenishment of Shares Under this Plan. To the extent (i) an Award lapses, expires, terminates or is cancelled without the issuance of Shares under the Award (whether due currently or on a deferred basis) or is settled in cash, (ii) it is determined during or at the conclusion of the term of an Award that all or some portion of the Shares with respect to which the Award was granted will not be issuable on the basis that the conditions for such issuance will not be satisfied, (iii) Shares are forfeited under an Award (except as described below), (iv) Shares are issued under any Award and the Company subsequently reacquires them pursuant to rights reserved upon the issuance of the Shares, or (v) Shares are tendered or withheld in payment of the exercise price of an Option or as a result of the net settlement of an outstanding Stock Appreciation Right or (vi) Shares are tendered or withheld to satisfy federal, state or local tax withholding obligations, then such Shares shall be recredited to the Plan’s reserve and may again be used for new Awards under this Plan, but Shares recredited to the Plan’s reserve pursuant to clause (iv), (v) or (vi) may not be issued pursuant to Incentive Stock Options.
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(c) Non-Employee Director Award Limitation. Subject to adjustment as provided in Section 7, the maximum number of Shares that may be granted during any fiscal year to any individual Non-Employee Director, in his or her capacity as a Non-Employee Director, shall not exceed that number of Shares that has a grant date fair value of, when added to any cash compensation received by such Non-Employee Director, $300,000.
7. Options. Subject to the terms of this Plan, the Administrator will determine all terms and conditions of each Option, including but not limited to: (a) whether the Option is an Incentive Stock Option that meets the requirements of Code Section 422, or a Nonqualified Stock Option that does not meet the requirements of Code Section 422; (b) the grant date, which may not be any day prior to the date that the Administrator approves the grant; (c) the number of Shares subject to the Option; (d) the exercise price, which may never be less than the Fair Market Value of the Shares subject to the Option as determined on the date of grant, (e) the terms and conditions of vesting and exercise; (f) the term, except that an Option must terminate no later than ten (10) years after the date of grant; and (g) the manner of payment of the exercise price. In all other respects, the terms of any Incentive Stock Option should comply with the provisions of Code Section 422 except to the extent the Administrator determines otherwise. If an Option that is intended to be an Incentive Stock Option fails to meet the requirements thereof, the Option shall automatically be treated as a Nonqualified Stock Option to the extent of such failure. To the extent permitted by the Administrator, and subject to such procedures as the Administrator may specify, the payment of the exercise price of Options may be made by (w) delivery of cash or other Shares or other securities of the Company (including by attestation) having a then Fair Market Value equal to the purchase price of such Shares, (x) by delivery (including by fax) to the Company or its designated agent of an executed irrevocable option exercise form together with irrevocable instructions to a broker-dealer to sell or margin a sufficient portion of the Shares and deliver the sale or margin loan proceeds directly to the Company to pay for the exercise price, (y) by surrendering the right to receive Shares otherwise deliverable to the Participant upon exercise of the Award having a Fair Market Value at the time of exercise equal to the total exercise price, or (z) by any combination of the methods set forth in clauses (w), (x) and/or (y). Except to the extent otherwise set forth in an Award agreement, a Participant shall have no rights as a holder of Stock as a result of the grant of an Option until the Option is exercised, the exercise price and applicable withholding taxes are paid and the Shares subject to the Option are issued thereunder.
8. Stock Appreciation Rights. Subject to the terms of this Plan, the Administrator will determine all terms and conditions of each SAR, including but not limited to: (a) whether the SAR is granted independently of an Option or relates to an Option; (b) the grant date, which may not be any day prior to the date that the Administrator approves the grant; (c) the number of Shares to which the SAR relates; (d) the grant price, which may never be less than the Fair Market Value of the Shares subject to the SAR as determined on the date of grant; (e) the terms and conditions of exercise or maturity, including vesting; (f) the term, provided that an SAR must terminate no later than ten (10) years after the date of grant; and (g) whether the SAR will be settled in cash, Shares or a combination thereof.
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9. Performance and Stock Awards. Subject to the terms of this Plan, the Administrator will determine all terms and conditions of each award of Shares, Restricted Stock, Restricted Stock Units, Performance Shares or Performance Units, including, but not limited to:
(a) the number of Shares and/or units to which such Award relates; (b) whether, as a condition for the Participant to realize all or a portion of the benefit provided under the Award, one or more Performance Goals must be achieved during such period as the Administrator specifies; (c) the length of the vesting and/or performance period and, if different, the date on which payment of the benefit provided under the Award will be made; (d) with respect to Performance Units, whether to measure the value of each unit in relation to a designated dollar value or the Fair Market Value of one or more Shares; and (e) with respect to Restricted Stock Units and Performance Units, whether to settle such Awards in cash, in Shares (including Restricted Stock), or in a combination of cash and Shares; provided that no dividends or Dividend Equivalent Units shall be paid on Performance Shares or Performance Units prior to their vesting.
10. Annual Incentive Awards. Subject to the terms of this Plan, the Administrator will determine all terms and conditions of an Annual Incentive Award, including but not limited to the Performance Goals, performance period, the potential amount payable, and the timing of payment; provided that the Administrator must require that payment of all or any portion of the amount subject to the Annual Incentive Award is contingent on the achievement or partial achievement of one or more Performance Goals during the period the Administrator specifies, although the Administrator may specify that all or a portion of the Performance Goals subject to an Award are deemed achieved upon a Participant’s death, Disability, or such other circumstances as the Administrator may specify; and provided further that any performance period applicable to an Annual Incentive Award must relate to a period of at least one year.
11. Long-Term Incentive Awards. Subject to the terms of this Plan, the Administrator will determine all terms and conditions of a Long-Term Incentive Award, including, but not limited to, the Performance Goals, performance period (which must be more than one year), the potential amount payable, and the timing of payment; provided that the Administrator must require that payment of all or any portion of the amount subject to the Long-Term Incentive Award is contingent on the achievement or partial achievement of one or more Performance Goals during the period the Administrator specifies, although the Administrator may specify that all or a portion of the Performance Goals subject to an Award are deemed achieved upon a Participant’s death, Disability or retirement (as defined by the Administrator), or such other circumstances as the Administrator may specify.
12. Dividend Equivalent Units. Subject to the terms of this Plan, the Administrator will determine all terms and conditions of each award of Dividend Equivalent Units, including but not limited to whether: (a) such Award will be granted in tandem with another Award; (b) payment of the Award will be made concurrently with dividend payments or credited to an account for the Participant which provides for the deferral of such amounts until a stated time; (c) the Award will be settled in cash or Shares; and (d) as a condition for the Participant to realize all or a portion of the benefit provided under the Award, one or more Performance Goals must be achieved during such period as the Administrator specifies; provided that Dividend Equivalent Units may not be granted in connection with an Option or Stock Appreciation Right; and provided further that no Dividend Equivalent Unit granted in tandem with another Award shall include vesting provisions more favorable to the Participant than the vesting provisions, if any, to which the tandem Award is subject; and provided further that no Dividend Equivalent Unit relating to another Award shall provide for payment with respect such other Award prior to its vesting.
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13. Other Stock-Based Awards. Subject to the terms of this Plan, the Administrator may grant to a Participant shares of unrestricted Stock as replacement for other compensation to which the Participant is entitled, such as in payment of director fees, in lieu of cash compensation, in exchange for cancellation of a compensation right, or as a bonus.
14. Transferability. Awards are not transferable other than by will or the laws of descent and distribution, unless and to the extent the Administrator allows a Participant to:
(a) designate in writing a beneficiary to exercise the Award or receive payment under the Award after the Participant’s death; (b) transfer an Award to the former spouse of the Participant as required by a domestic relations order incident to a divorce; or (c) transfer an Award; provided, however, that with respect to clause (c) above the Participant may not receive consideration for such a transfer of an Award.
15. Termination and Amendment of Plan; Amendment, Modification or Cancellation of Awards.
(a) Term of Plan. Unless the Board earlier terminates this Plan pursuant to Section 15(b), this Plan will terminate on, and no further Awards may be granted under this Plan after, the tenth (10th) anniversary of the Effective Date.
(b) Termination and Amendment. The Board or the Administrator may amend, alter, suspend, discontinue or terminate this Plan at any time, subject to the following limitations:
(i) the Board must approve any amendment of this Plan to the extent the Company determines such approval is required by: (A) prior action of the Board, (B) applicable corporate law, or (C) any other applicable law;
(ii) shareholders must approve any amendment of this Plan to the extent the Company determines such approval is required by: (A) Section 16 of the Exchange Act, (B) the Code, (C) the listing requirements of any principal securities exchange or market on which the Shares are then traded, or (D) any other applicable law; and
(iii) shareholders must approve any of the following Plan amendments: (A) an amendment to materially increase any number of Shares specified in Section 6(a) or the limits set forth in Section 6(b)(except as permitted by Section 17), or (B) an amendment that would diminish the protections afforded by Section 15(e).
(c) Amendment, Modification, Cancellation and Disgorgement of Awards.
(i) Except as provided in Section 15(e) and subject to the requirements of this Plan, the Administrator may modify, amend or cancel any Award; provided that, except as otherwise provided in the Plan or the Award agreement, any modification or amendment that materially diminishes the rights of the Participant, or the cancellation of an Award, shall be effective only if agreed to by the Participant or any other person(s) as may then have an interest in such Award, but the Administrator need not obtain Participant (or other interested party) consent for the modification, amendment or cancellation of an Award pursuant to the provisions of subsection (ii) or Section 17 or as follows: (A) to the extent the Administrator deems such action necessary to comply with any applicable law or the listing requirements of any principal securities exchange or market on which the Shares are then traded; (B) to the extent the Administrator deems necessary to preserve favorable accounting or tax treatment of any Award for the Company; or (C) to the extent the Administrator determines that such action does not materially and adversely affect the value of an Award or that such action is in the best interest of the affected Participant (or any other person(s) as may then have an interest in the Award). Notwithstanding the foregoing, unless determined otherwise by the Administrator, any such amendment shall be made in a manner that will enable an Award intended to be exempt from Code Section 409A to continue to be so exempt, or to enable an Award intended to comply with Code Section 409A to continue to so comply.
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(ii) Notwithstanding anything to the contrary in an Award agreement, the Administrator shall have full power and authority to terminate or cause the Participant to forfeit the Award, and require the Participant to disgorge to the Company any gains attributable to the Award, if the Participant engages in any action constituting, as determined by the Administrator in its discretion, Cause for termination, or a breach of any Award agreement or any other agreement between the Participant and the Company or an Affiliate concerning noncompetition, nonsolicitation, confidentiality, trade secrets, intellectual property, nondisparagement or similar obligations.
(iii) Any Awards granted pursuant to this Plan, and any Stock issued, or cash paid pursuant to an Award, shall be subject to any recoupment or clawback policy that is adopted by, or any recoupment or similar requirement otherwise made applicable by law, regulation or listing standards to, the Company from time to time.
(d) Survival of Authority and Awards. Notwithstanding the foregoing, the authority of the Board and the Administrator under this Section 15 and to otherwise administer the Plan with respect to then-outstanding Awards will extend beyond the date of this Plan’s termination. In addition, termination of this Plan will not affect the rights of Participants with respect to Awards previously granted to them, and all unexpired Awards will continue in force and effect after termination of this Plan except as they may lapse or be terminated by their own terms and conditions.
(e) Repricing and Backdating Prohibited. Notwithstanding anything in this Plan to the contrary, and except for the adjustments provided for in Section 17, at such time as the Company’s common stock is listed on the Nasdaq Stock Market or New York Stock Exchange, neither the Administrator nor any other person may (i) amend the terms of outstanding Options or SARs to reduce the exercise or grant price of such outstanding Options or SARs; (ii) cancel outstanding Options or SARs in exchange for Options or SARs with an exercise or grant price that is less than the exercise or grant price of the original Options or SARs; or (iii) cancel outstanding Options or SARs with an exercise or grant price above the current Fair Market Value of a Share in exchange for cash or other securities. In addition, the Administrator may not make a grant of an Option or SAR with a grant date that is effective prior to the date the Administrator takes action to approve such Award.
(f) Foreign Participation. To assure the viability of Awards granted to Participants employed or residing in foreign countries, the Administrator may provide for such special terms as it may consider necessary or appropriate to accommodate differences in local law, tax policy, accounting or custom. Moreover, the Administrator may approve such supplements to, or amendments, restatements or alternative versions of, this Plan as it determines is necessary or appropriate for such purposes. Any such amendment, restatement, or alternative versions that the Administrator approves for purposes of using this Plan in a foreign country will not affect the terms of this Plan for any other country. In addition, all such supplements, amendments, restatements or alternative versions must comply with the provisions of Section 15(b)(ii).
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16. Taxes.
(a) Withholding. In the event the Company or one of its Affiliates is required to withhold any Federal, state or local taxes or other amounts in respect of any income recognized by a Participant as a result of the grant, vesting, payment or settlement of an Award or disposition of any Shares acquired under an Award, the Company may deduct (or require an Affiliate to deduct) from any payments of any kind otherwise due the Participant cash, or with the consent of the Administrator, Shares otherwise deliverable or vesting under an Award, to satisfy such tax or other obligations. Alternatively, the Company or its Affiliate may require such Participant to pay to the Company or its Affiliate, in cash, promptly on demand, or make other arrangements satisfactory to the Company or its Affiliate regarding the payment to the Company or its Affiliate of the aggregate amount of any such taxes and other amounts. If Shares are deliverable upon exercise or payment of an Award, then the Administrator may permit a Participant to satisfy all or a portion of the Federal, state and local withholding tax obligations arising in connection with such Award by electing to (i) have the Company or its Affiliate withhold Shares otherwise issuable under the Award, (ii) tender back Shares received in connection with such Award or (iii) deliver other previously owned Shares, in each case having a Fair Market Value equal to the amount to be withheld; provided that the amount to be withheld in Shares may not exceed the total maximum statutory tax withholding obligations associated with the transaction to the extent needed for the Company and its Affiliates to avoid an accounting charge. If an election is provided, the election must be made on or before the date as of which the amount of tax to be withheld is determined and otherwise as the Administrator requires. In any case, the Company and its Affiliates may defer making payment or delivery under any Award if any such tax may be pending unless and until indemnified to its satisfaction.
(b) No Guarantee of Tax Treatment. Notwithstanding any provisions of this Plan to the contrary, the Company does not guarantee to any Participant or any other Person with an interest in an Award that (i) any Award intended to be exempt from Code Section 409A shall be so exempt, (ii) any Award intended to comply with Code Section 409A or Code Section 422 shall so comply, or (iii) any Award shall otherwise receive a specific tax treatment under any other applicable tax law, nor in any such case will the Company or any Affiliate be required to indemnify, defend or hold harmless any individual with respect to the tax consequences of any Award.
17. Adjustment and Change of Control Provisions.
(a) Adjustment of Shares. If (i) the Company shall at any time be involved in a merger or other transaction in which the Shares are changed or exchanged; (ii) the Company shall subdivide or combine the Shares or the Company shall declare a dividend payable in Shares, other securities (other than stock purchase rights issued pursuant to a shareholder rights agreement) or other property; (iii) the Company shall effect a cash dividend the amount of which, on a per Share basis, exceeds ten percent (10%) of the Fair Market Value of a Share at the time the dividend is declared, or the Company shall effect any other dividend or other distribution on the Shares in the form of cash, or a repurchase of Shares, that the Board determines by resolution is special or extraordinary in nature or that is in connection with a transaction that the Company characterizes publicly as a recapitalization or reorganization involving the Shares; or (iv) any other event shall occur, which, in the case of this clause (iv), in the judgment of the Administrator necessitates an adjustment to prevent dilution or enlargement of the benefits or potential benefits intended to be made available under this Plan, then the Administrator shall, in such manner as it may deem equitable to prevent dilution or enlargement of the benefits or potential benefits intended to be made available under this Plan, adjust any or all of: (A) the number and type of Shares subject to this Plan (including the number and type of Shares described in Sections 6(a) and 6(c)) and which may after the event be made the subject of Awards; (B) the number and type of Shares subject to outstanding Awards; (C) the grant, purchase, or exercise price with respect to any Award; and (D) the Performance Goals of an Award. In any such case, the Administrator may also (or in lieu of the foregoing) make provision for a cash payment to the holder of an outstanding Award in exchange for the cancellation of all or a portion of the Award (without the consent of the holder of an Award) in an amount determined by the Administrator effective at such time as the Administrator specifies (which may be the time such transaction or event is effective). However, in each case, with respect to Awards of Incentive Stock Options, no such adjustment may be authorized to the extent that such authority would cause this Plan to violate Code Section 422(b). Further, the number of Shares subject to any Award payable or denominated in Shares must always be a whole number. In any event, previously granted Options or SARs are subject to only such adjustments as are necessary to maintain the relative proportionate interest the Options and SARs represented immediately prior to any such event and to preserve, without exceeding, the value of such Options or SARs.
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Without limitation, in the event of any reorganization, merger, consolidation, combination or other similar corporate transaction or event, whether or not constituting a Change of Control (other than any such transaction in which the Company is the continuing corporation and in which the outstanding Stock is not being converted into or exchanged for different securities, cash or other property, or any combination thereof), the Administrator may substitute, on an equitable basis as the Administrator determines, for each Share then subject to an Award and the Shares subject to this Plan (if the Plan will continue in effect), the number and kind of shares of stock, other securities, cash or other property to which holders of Stock are or will be entitled in respect of each Share pursuant to the transaction.
(b) Issuance or Assumption. Notwithstanding any other provision of this Plan, and without affecting the number of Shares otherwise reserved or available under this Plan, in connection with any merger, consolidation, acquisition of property or stock, or reorganization, the Administrator may authorize the issuance or assumption of awards under this Plan upon such terms and conditions as it may deem appropriate.
(c) Effect of Change of Control.
(i) In order to preserve a Participant’s rights under an Award in the event of a Change of Control, the Administrator in its discretion may, at the time an Award is made or at any time thereafter, take one or more of the following actions: (a) provide for the acceleration of any time period, or the deemed achievement of any Performance Goals, relating to the exercise or realization of the Award; (b) provide for the purchase or cancellation of the Award for an amount of cash or other property that could have been received upon the exercise or realization of the Award had the Award been currently exercisable or payable (or the cancellation of Awards in exchange for no payment to the extent that no cash or other property would be received upon the exercise or realization of the Award in such circumstances); (c) adjust the terms of the Award in the manner determined by the Administrator to reflect the Change of Control; (d) cause the Award to be assumed, or new right substituted therefor, by another entity; or (e) make such other provision as the Administrator may consider equitable and in the best interests of the Company.
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(ii) Except to the extent the Participant has in effect an employment or similar agreement with the Company or any Affiliate or is subject to a policy that provides for a more favorable result to the Participant upon a Change of Control, in the event that the Company’s legal counsel or accounting advisor determines that any payment, benefit or transfer by the Company under this Plan or any other plan, agreement, or arrangement to or for the benefit of the Participant (in the aggregate, the “Total Payments”) would be subject to the tax (“Excise Tax”) imposed by Code Section 4999 but for this subsection (d), then, notwithstanding any other provision of this Plan to the contrary, the Total Payments shall be delivered either (i) in full or (ii) in an amount such that the value of the aggregate Total Payments that the Participant is entitled to receive shall be One Dollar ($1.00) less than the maximum amount that the Participant may receive without being subject to the Excise Tax, whichever of clause (i) or (ii) results in the receipt by the Participant of the greatest benefit on an after-tax basis (taking into account applicable federal, state and local income taxes and the Excise Tax). In the event that clause (ii) results in a greater after-tax benefit to the Participants, payments or benefits included in the Total Payments shall be reduced or eliminated by applying the following principles, in order: (A) the payment or benefit with the higher ratio of the parachute payment value to present economic value (determined using reasonable actuarial assumptions) shall be reduced or eliminated before a payment or benefit with a lower ratio; (B) the payment or benefit with the later possible payment date shall be reduced or eliminated before a payment or benefit with an earlier payment date; and (C) cash payments shall be reduced prior to non-cash benefits; provided that if the foregoing order of reduction or elimination would violate Code Section 409A, then the reduction shall be made pro rata among the payments or benefits included in the Total Payments (on the basis of the relative present value of the parachute payments).
(d) Certain Modifications. Notwithstanding anything contained in this Section 17, the Board may, in its sole and absolute discretion, amend, modify or rescind the provisions of this Section 17 if it determines that the operation of this Section 17 may prevent a transaction in which the Company, a Subsidiary or any Affiliate is a party from receiving desired tax treatment, including without limitation requiring that each Participant receive a replacement or substitute Award issued by the surviving or acquiring corporation.
18. Stock Transfer Restrictions and Repurchase Right.
(a) Restriction on Transfer. Shares issued under the Plan may not be sold or otherwise disposed of except as permitted by the Company. As a condition to the receipt of Shares hereunder, the Participant (or individual entitled to receive Shares following the Participant’s death) may be required to execute a stockholder’s agreement or other agreement required by the Board.
(b) Restrictions; Legends. All Shares delivered under the Plan shall be subject to such restrictions as the Company may deem advisable, and the Company may cause a legend or legends to be put on any certificates for shares to make appropriate references to such restrictions.
(c) Right to Purchase Shares. Pursuant to the provisions of this Section 18(c), the Company shall have the right (the “Purchase Right”), but not the obligation, to purchase all, but not less than all, of the Shares acquired by the Participant under this Plan upon the occurrence of any of the following events (a “Trigger Date”):
(i) the Participant’s separation from employment or service from the Company and its Affiliates, or
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(ii) the Participant’s attempted or purported sale, assignment, exchange, disposition, distributions, transfer, pledge, encumbrance, hypothecation or other disposition or alienation of Shares acquired under the Plan without the Company’s prior written consent.
The purchase price (the “Purchase Price”) for the Shares subject to such Purchase Right shall be the Fair Market Value of the Shares on the applicable Trigger Date, unless (A) the Participant’s employment has been terminated for Cause, (B) the Company determines that the Participant’s employment could have been terminated for Cause, or (C) the Participant breaches any restrictive covenants set forth in any agreement by and between the Participant and the Company or any of its Subsidiaries, then in each case the purchase price shall be the lower of (x) the Fair Market Value of the Shares on the applicable Trigger Date and (y) the cost paid by the Participant to acquire the Shares.
The Company may exercise its Purchase Right by giving written notice thereof to the Participant within one (1) year after the Trigger Date (the one (1)-year period in each case, the “Call Period”) of the number of Shares with respect to which the Purchase Right is being exercised, and the Company intends that such date shall not be earlier than the first date on which the Purchase Price can be set without changing the accounting treatment for the acquisition of the Shares being repurchased from an equity-based accounting treatment to a liability-based accounting treatment (as contemplated by FASB ASC Topic 718 or any successor thereto). The Company shall promptly determine the Purchase Price for the Shares subject to the Purchase Right and shall notify the Participant of such determination. The Company may elect to pay all or any portion of such Purchase Price in cash; provided that if the Company does not elect to pay the entire Purchase Price in cash, the Company shall, at a minimum, pay to the Participant at least ten percent (10%) of the Purchase Price in cash, and shall deliver to the Participant a promissory note with a principal amount equal to the remainder of the Purchase Price, which promissory note shall provide that: (A) the principal shall be paid in no more than five (5) equal annual installments commencing one (1) year from the delivery of such promissory note, (B) interest on the unpaid principal amount shall accrue at an annual rate equal to the prime interest rate interest charged by the principal bank with which the Company conducts business as determined on the date the promissory note is issued, and shall be payable together with and in addition to each principal payment, and (C) the Company shall have the right, without penalty, to prepay all or any portion of the principal and accrued interest owing thereunder at any time.
Upon the delivery of the payment and/or the promissory note described herein by the Company, the Participant shall take all actions necessary, and execute all related documents specified by the Company as being reasonably necessary to consummate the sale of the Shares to the Company, and, by accepting an award under this Plan, the Participant appoints the Company’s Secretary as his or her true and lawful attorney-in-fact to exercise and deliver all such instruments, documents and writings, and to take all such actions as shall be required to consummate the sale of the Shares to the Company as contemplated in this Section. Such power is a special Power of Attorney coupled with an interest, is irrevocable, and shall run with the shares to any subsequent owners thereof.
(d) Termination Upon Initial Public Offering. The Company’s right to exercise its repurchase rights under Section 18(c) shall terminate upon the closing of the Company’s first underwritten public offering of equity securities pursuant to an effective registration statement under the Act.
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19. Drag-Along Rights.
(a) If the Board or a group of shareholders that, in the aggregate, owns a majority of the voting power of the Company, receives an offer in a transaction or series of transactions pursuant to which a third party proposes to acquire all of the equity securities of the Company (a “Drag-Along Transaction”), any shareholder or any group of shareholders of the Company that, in the aggregate, owns a majority of the voting power of the Company (collectively, the “Drag- Along Shareholder”) shall have the right, at its option, to require the other shareholders of the Company, including any Participant who acquires Shares under this Plan (each such shareholder, a “Dragged Shareholder,” and collectively with any other Dragged Shareholder, the “Dragged Shareholders”), and each Dragged Shareholder hereby agrees, whether such Drag- Along Transaction is structured as a transfer of equity securities, merger, consolidation, combination, reorganization, recapitalization, reclassification or otherwise, to transfer all of such Dragged Shareholder’s equity securities on substantially the same terms and conditions as are applicable to the Drag-Along Shareholder; provided that the price per share for each equity security to be sold in such Drag-Along Transaction shall be determined by first allocation a portion of the aggregate consideration to be paid by the buyer(s) in such Drag-Along Transaction to the holders of the Series A Preferred Stock in the amount of any accrued but unpaid dividends thereon and then allocation the remainder of such aggregate consideration to the equity securities to be sold in such Drag-Along Transaction ratably on an as-converted basis.
(b) Each Dragged Shareholder shall reasonably cooperate in, and shall take all actions requested by the Drag-Along Shareholder that are reasonably necessary or desirable to consummate, the Drag-Along Transaction, including: (i) to the extent applicable, voting its equity securities (or executing and delivering any written consents in lieu thereof) in favor of the Drag- Along Transaction and all actions deemed reasonably necessary by the Drag- Along Shareholder in connection with the Drag-Along Transaction; (ii) if applicable, taking all actions necessary to cause the Board to approve the Drag-Along Transaction; and (iii) entering into definitive agreements as are customary for the nature of the proposed Drag-Along Transaction and any ancillary agreements with respect thereto, and using commercially reasonable efforts (including indemnification obligations on a ratable basis) to cause the transactions contemplated by such definitive agreements and ancillary agreements to be consummated.
(c) Without limitation of the foregoing, each shareholder waives any dissenters, appraisal or other similar rights it may have in connection with any sale of the Company under applicable law that is approved or instituted pursuant to this Section 19.
(d) The Drag-Along Shareholder shall provide written notice of such Drag-Along Transaction to each Dragged Shareholder (a “Drag-Along Transaction Notice”). The Drag-Along Transaction Notice shall identify the proposed transferee, the consideration for which a transfer is proposed to be made and all other material terms and conditions of the Drag-Along Transaction. Each Dragged Shareholder shall be required to participate in the Drag-Along Transaction on the terms and conditions set forth in the Drag-Along Transaction Notice.
(e) Notwithstanding anything to the contrary in this Section 19, there shall be no liability on the part of the Drag-Along Shareholder to the Company or the Dragged Shareholders if the Drag-Along Transaction is not consummated for whatever reason, regardless of whether the Drag-Along Shareholder has delivered a Drag-Along Transaction Notice. The decision to effect a Drag-Along Transaction is in the sole and absolute discretion of the Drag-Along Shareholder.
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(f) The foregoing shall not affect the rights of the Company or the Administrator under Section 17 (or elsewhere) of this Plan.
20. Miscellaneous.
(a) Other Terms and Conditions. The Administrator may provide in any Award agreement such other provisions (whether or not applicable to the Award granted to any other Participant) as the Administrator determines appropriate to the extent not otherwise prohibited by the terms of the Plan.
(b) Employment and Service. The issuance of an Award shall not confer upon a Participant any right with respect to continued employment or service with the Company or any Affiliate, or the right to continue as a Director. Unless determined otherwise by the Administrator, for purposes of the Plan and all Awards, the following rules shall apply:
(i) a Participant who transfers employment between the Company and its Affiliates, or between Affiliates, will not be considered to have terminated employment;
(ii) a Participant who ceases to be a Non-Employee Director because he or she becomes an employee of the Company, or an Affiliate shall not be considered to have ceased service as a Director with respect to any Award until such Participant’s termination of employment with the Company and its Affiliates;
(iii) a Participant who ceases to be employed by the Company or an Affiliate and immediately thereafter becomes a Non-Employee Director, a non-employee director of an Affiliate, or a consultant to the Company or any Affiliate shall not be considered to have terminated employment until such Participant’s service as a director of, or consultant to, the Company and its Affiliates has ceased; and
(iv) a Participant employed by an Affiliate will be considered to have terminated employment when such entity ceases to be an Affiliate.
Notwithstanding the foregoing, for purposes of an Award that constitutes “nonqualified deferred compensation” subject to Code Section 409A, if a Participant’s termination of employment or service triggers the payment of such nonqualified deferred compensation under such Award, then the Participant will be deemed to have terminated employment or service upon his or her “separation from service” within the meaning of Code Section 409A. Notwithstanding any other provision in this Plan or an Award to the contrary, if any Participant is a “specified employee” within the meaning of Code Section 409A as of the date of his or her “separation from service” within the meaning of Code Section 409A, then, to the extent required to avoid the imposition of additional taxes under Code Section 409A, any payment of nonqualified deferred compensation made to the Participant on account of such separation from service shall not be made before a date that is six (6) months after the date of the separation from service.
(c) No Fractional Shares. No fractional Shares or other securities may be issued or delivered pursuant to this Plan, and the Administrator may determine whether cash, other securities or other property will be paid or transferred in lieu of any fractional Shares or other securities, or whether such fractional Shares or other securities or any rights to fractional Shares or other securities will be canceled, terminated, or otherwise eliminated.
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(d) Unfunded Plan; Awards Not Includable for Benefits Purposes. This Plan is unfunded and does not create, and should not be construed to create a trust or separate fund with respect to this Plan’s benefits. This Plan does not establish any fiduciary relationship between the Company and any Participant or other person. To the extent any person holds any rights by virtue of an Award granted under this Plan, such rights are no greater than the rights of the Company’s general unsecured creditors. Income recognized by a Participant pursuant to an Award shall not be included in the determination of benefits under any employee pension benefit plan (as such term is defined in Section 3(2) of the Employee Retirement Income Security Act of 1974, as amended) or group insurance or other benefit plans applicable to the Participant which are maintained by the Company or any Affiliate, except as may be provided under the terms of such plans or determined by resolution of the Board.
(e) Requirements of Law and Securities Exchange. The granting of Awards and the issuance of Shares in connection with an Award are subject to all applicable laws, rules and regulations and to such approvals by any governmental agencies or national securities exchanges as may be required. Notwithstanding any other provision of this Plan or any award agreement, the Company has no liability to deliver any Shares under this Plan or make any payment unless such delivery or payment would comply with all applicable laws and the applicable requirements of any securities exchange or similar entity, and unless and until the Participant has taken all actions required by the Company in connection therewith. The Company may impose such restrictions on any Shares issued under the Plan as the Company determines necessary or desirable to comply with all applicable laws, rules and regulations or the requirements of any national securities exchanges.
(f) Governing Law; Venue. This Plan, and all agreements under this Plan, will be construed in accordance with and governed by the laws of the State of Florida, without reference to any conflict of law principles. Any legal action or proceeding with respect to this Plan, any Award or any award agreement, or for recognition and enforcement of any judgment in respect of this Plan, any Award or any award agreement, may only be brought and determined in a court sitting in the State of Florida.
(g) Limitations on Actions. Any legal action or proceeding with respect to this Plan, any Award or any award agreement, must be brought within one (1) year after the day the complaining party first knew or should have known of the events giving rise to the complaint.
(h) Construction. Whenever any words are used herein in the masculine, they shall be construed as though they were used in the feminine in all cases where they would so apply; and wherever any words are used in the singular or plural, they shall be construed as though they were used in the plural or singular, as the case may be, in all cases where they would so apply. Titles of sections are for general information only, and this Plan is not to be construed with reference to such titles. The title, label or characterization of an Award in an award agreement or in the Company’s public filings or other disclosures shall not be determinative as to which specific Award type is represented by the award agreement. Instead, the Administrator may determine which specific type(s) of Award(s) is (are) represented by any award agreement, at the time such Award is granted or at any time thereafter. Except to the extent otherwise provided in the applicable award agreement, in the case of any Award that includes a “series of installment payments” (within the meaning of Section 1.409A-2(b)(2)(iii) of the Treasury Regulations), the Award holder’s right to the series of installment payments shall be treated as a right to a series of separate payments and not as a right to a single payment.
(i) Severability. If any provision of this Plan or any award agreement or any Award (a) is or becomes or is deemed to be invalid, illegal or unenforceable in any jurisdiction, or as to any person or Award, or (b) would cause this Plan, any award agreement or any Award to violate or be disqualified under any law the Administrator deems applicable, then such provision should be construed or deemed amended to conform to applicable laws, or if it cannot be so construed or deemed amended without, in the determination of the Administrator, materially altering the intent of this Plan, award agreement or Award, then such provision should be stricken as to such jurisdiction, person or Award, and the remainder of this Plan, such award agreement and such Award will remain in full force and effect.
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Exhibit 10.2
TELOMIR PHARMACEUTICALS, INC.
2023 OMNIBUS INCENTIVE PLAN
STOCK OPTION AWARD
[PARTICIPANTID]
[FIRSTNAME] [LASTNAME]
You have been granted an option (your “Option”) to purchase shares (“Shares”) of Common Stock of Telomir Pharmaceuticals, Inc. (the “Company”) under the Telomir Pharmaceuticals, Inc. 2023 Omnibus Incentive Plan, as amended and restated (the “Plan”), effective as of the Grant Date, with the following terms and conditions:
● | The tenth (10th) anniversary of the Grant Date; | |
● | 12 months after your termination of employment or service as a result of death or disability (as determined by the Administrator); | |
● | Your termination of employment or service for Cause; or | |
● | 90 days after your termination of employment or service for any other reason, provided that if you die during this 90-day period, the exercise period will be extended until 12 months after the date of your death. |
If the date this Option terminates as specified above falls on a day on which the stock market is not open for trading or on a date on which you are prohibited by Company policy (such as an insider trading policy) from exercising the Option, the termination date shall be automatically extended to the first available trading day following the original termination date, but not beyond the tenth (10th) anniversary of the Grant Date. | |
Manner of Exercise: | You may exercise your Option only to the extent vested and only if it has not terminated. To exercise your Option, you must complete the “Notice of Stock Option Exercise” form provided by the Company and return it to the address or send it via facsimile or email as indicated on the form, or use the equity platform or other exercise procedure prescribed by the Company. The exercise will not be completed until you pay the total exercise price and all applicable withholding taxes due as a result of the exercise to the Company and, to the extent prescribed by the Company, until you have executed a joinder agreement to any stockholders agreement or similar agreement maintained by the Company and provided any investment representation required by the Company.
If someone else wants to exercise your Option after your death, that person must contact the Company and prove to the Company’s satisfaction that he or she is entitled to do so.
Your ability to exercise your Option may be restricted by the Company if required by applicable law.
No fractional Shares shall be issued pursuant to the grant or exercise of this Option. The Administrator shall determine whether the cash value of such fraction shall be paid or whether the fraction shall be canceled for no consideration. |
Market Stand-Off:
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In connection with any underwritten public offering by the Company of its equity securities pursuant to an effective registration statement filed under the Securities Act of 1933, as amended, you agree that you shall not directly or indirectly sell, make any short sale of, loan, hypothecate, pledge, offer, grant or sell any option or other contract for the purchase of, purchase any option or other contract for the sale of, or otherwise dispose of or transfer or agree to engage in any of the foregoing transactions with respect to, any Shares acquired under this Stock Option Award without the prior written consent of the Company. Such restriction shall be in effect for such period of time following the date of the final prospectus for the offering as may be determined by the Company. In no event, however, shall such period exceed one hundred eighty (180) days. |
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Miscellaneous: | ● | Neither the Plan nor the grant of the Option shall constitute or be evidence of any agreement or understanding, express or implied, that you have a right to continue as an employee of the Company or any of its Affiliates for any period of time, or at any particular rate of compensation. |
● | The Plan and this Option constitute the entire understanding of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements between you and the Company with respect to the subject matter hereof. You expressly warrant that you are not accepting this Option in reliance on any promises, representations, or inducements other than those contained herein. |
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● | By accepting the grant of your Option, you agree not to sell any Shares acquired in connection with your Option other than as set forth in the Plan and at a time when applicable laws, Company policies or an agreement between the Company and its underwriters do not prohibit a sale. | |
● | As a condition of the granting of your Option, you agree, for yourself and your legal representatives or guardians, that this Stock Option Award shall be interpreted by the Committee and that any interpretation by the Committee of the terms of this Stock Option Award or the Plan and any determination made by the Committee pursuant to this Stock Option Award or the Plan shall be final, binding and conclusive. | |
● | Subject to the terms of the Plan, the Committee may modify or amend this Stock Option Award without your consent as permitted by Section 15(c) of the Plan or: (i) to the extent such action is deemed necessary by the Committee to comply with any applicable law or the listing requirements of any principal securities exchange or market on which Shares are then traded; (ii) to the extent the action is deemed necessary by the Committee to preserve favorable accounting or tax treatment of any award for the Company; or (iii) to the extent the Committee determines that such action does not materially and adversely affect the value of this Stock Option Award or that such action is in the best interest of you or any other person who may then have an interest in this Stock Option Award. | |
● | This Stock Option Award may be executed in counterparts. |
Your Option is granted under and governed by the terms and conditions of the Plan, including provisions of the Plan relating to the right of the Company to repurchase Shares issued pursuant to the Plan. The terms of the Plan to the extent not stated herein are expressly incorporated herein by reference and in the event of any conflict between this Option and the Plan, the terms of the Plan shall govern, control and supersede over the provisions of this Option. Capitalized terms used in this Option and not defined shall have the meanings given in the Plan.
BY ACCEPTING THIS STOCK OPTION AWARD, YOU AGREE TO ALL OF THE TERMS AND CONDITIONS DESCRIBED HEREIN AND IN THE PLAN. YOU ALSO ACKNOWLEDGE RECEIPT OF THE PLAN.
TELOMIR PHARMACEUTICALS, INC. | OPTIONEE | ||
By: | |||
[EXECUTIVE] | [OPTIONEE] | ||
[POSITION] | |||
Date: |
4 |
TELOMIR PHARMACEUTICALS, INC.
NOTICE OF STOCK OPTION EXERCISE
Your completed form should be delivered to: _________________________, ____________________________.
Phone: _________________ Fax: ____________________ Email: _____________________
Incomplete forms may cause a delay in processing your option exercise.
OPTIONEE INFORMATION
Please complete the following. PLEASE WRITE YOUR FULL LEGAL NAME SINCE THIS NAME MAY BE ON YOUR SHARES.
Name: ______________________________________________________________________
Street Address: _______________________________________________________________
City: _____________________ State: _________________ Zip Code: _______________
Work Phone #: (_____) - _______- ________ Home Phone #: (_____) - _______- __________
Social Security #: ______ - _____ - _______
DESCRIPTION OF OPTION(S) BEING EXERCISED
Please complete the following for each option that you wish to exercise.
Grant Date | Exercise Price Per Share | Number of Option Shares Being Purchased | Total Exercise Price (multiply Exercise Price Per Share by Number of Option Shares Being Purchased) | |||||||
| $ | $ | ||||||||
$ | $ | |||||||||
$ | $ | |||||||||
$ | $ | |||||||||
$ | $ | |||||||||
Aggregate Exercise Price | $ |
5 |
Exhibit 10.3
INDEMNIFICATION AGREEMENT
This Indemnification Agreement (the Indemnification Agreement”) is made and entered into as of [●], [●], by and between TELOMIR PHARMACEUTICALS, INC., a Florida corporation (the “Company”), and ________________________, an individual (“Indemnitee”).
WHEREAS, it is essential to the Company to retain and attract qualified directors and officers;
WHEREAS, Indemnitee is a director and/or officer of the Company or one or more of its subsidiaries;
WHEREAS, the Company and Indemnitee recognize the risk of litigation and other claims being asserted against directors and officers of public companies;
WHEREAS, the Second Amended and Restated Articles of Incorporation (the “Articles”) of the Company authorizes the Company to indemnify and advance expenses to its directors and officers to the full extent permitted by law, and Indemnitee has been serving and continues to serve as a director and/or officer of the Company in part in reliance upon the Articles; and,
WHEREAS, in recognition of (1) Indemnitee’s need for substantial protection against personal liability; (2) the Company’s need to induce Indemnitee’s continued service to the Company in an effective manner; and (3) Indemnitee’s reliance on the Articles, and to provide Indemnitee with specific contractual assurance that the protection contained in the Articles will be available to Indemnitee (regardless of, among other things, any amendment to or restatement of the Articles or any changes in the composition of the Company’s Board of Directors or any Change in Control or business combination in which the Company participates), the Company wishes to provide in this Indemnification Agreement for the indemnification of and the advancing of expenses to Indemnitee to the full extent (whether partial or complete) permitted by law and as set forth in this Indemnification Agreement and, if insurance is obtained, for the coverage of Indemnitee under the Company’s directors’ and officers’ liability insurance policies.
NOW, THEREFORE, in consideration of the premises, the mutual promises, covenants and conditions herein contained, Indemnitee continuing to serve the Company directly, or at its request, to serve another enterprise, and for other good and valuable considerations, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:
1. | Certain Definitions. In addition to the words and terms elsewhere defined in this Indemnification Agreement, certain capitalized words and terms used herein shall have the meanings given to them by the definitions and descriptions in this Section 1, unless the context or use indicates another or different meaning or intent, and such definitions shall be equally applicable to both the singular and plural forms of any of the capitalized words and terms herein defined. The following words and terms are defined terms under this Indemnification Agreement: |
a. | Change in Control. “Change in Control” shall be deemed to have occurred if (i) any “person” (as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (“Exchange Act”)), other than a trustee or other fiduciary holding securities under an employee benefit plan of the Company or a corporation owned directly or indirectly by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company, is or becomes the “beneficial owner” (as defined in Rule 13-d-3 under the Exchange Act), directly or indirectly, of securities of the Company representing 20% or more of the total voting power represented by the Company’s then outstanding Voting Securities (unless such change in beneficial ownership results solely from a reduction in the aggregate number of outstanding shares of Voting Securities); (ii) during any period of two consecutive years, not including any period prior to the execution of this Indemnification Agreement, individuals who at the beginning of such period constitute the Board of Directors of the Company (and any new director whose election by the Board of Directors or nomination for election by the Company’s stockholders was approved by a vote of at least two-thirds (2/3) of the directors then still in office who either were directors at the beginning of the period or whose election or nomination for election was previously so approved), cease for any reason to constitute a majority thereof; or (iii) the stockholders of the Company approve a merger or consolidation of the Company with any other corporation, other than a merger or consolidation which would result in the Voting Securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into Voting Securities of the surviving entity) at least 80% of the total voting power represented by the Voting Securities of the Company or such surviving entity outstanding immediately after such merger or consolidation, or (iv) the stockholders of the Company approve a plan of complete liquidation of the Company or an agreement for the sale or disposition by the Company of (in one transaction or a series of transactions) all or substantially all the Company’s assets. | |
b. | Claim. “Claim” means any threatened, pending or completed action, suit, proceeding or alternative dispute resolution, or any inquiry or investigation, whether instituted by the Company or any other person or party, that Indemnitee, in good faith, reasonably determines might lead to the institution of any such action, suit, proceeding or alternative dispute resolution, whether civil, criminal, administrative, arbitrative, investigative or other, and whether made pursuant to federal, state or other law. | |
c. | Expenses. “Expenses” means all expenses, including attorneys’ fees and all other costs, expenses and obligations paid or incurred in connection with investigating, defending, being a witness in or participating in (including on appeal), or preparing to defend, be a witness in or participate in any Claim relating to any Indemnifiable Event. Expenses also shall include (i) Expenses incurred in connection with any appeal resulting from any Claim, including without limitation the premium, security for, and other costs relating to any cost bond, supersedeas bond, or other appeal bond or its equivalent, and (ii) for purposes of Section 4 only, Expenses incurred by Indemnitee in connection with the interpretation, enforcement or defense of Indemnitee’s rights under this Agreement, by litigation or otherwise. Expenses, however, shall not include amounts paid in settlement of any threatened or pending Claim by Indemnitee or the amount of judgments or fines against Indemnitee. |
d. | Indemnifiable Event. “Indemnifiable Event” means any event or occurrence, whether on or after the date of this Agreement, related to the fact that Indemnitee is or was a director, officer, employee, trustee or agent of the Company or any subsidiary of the Company, or is or was serving at the request of the Company as a director, officer, member, manager, employee, trustee, agent or fiduciary of another corporation, limited liability company, partnership, joint venture, employee benefit plan, trust or other entity or enterprise, or by reason of anything done or not done by Indemnitee in any such capacity. | |
e. | Independent Legal Counsel. “Independent Legal Counsel” means an attorney or firm of attorneys, selected in accordance with the provisions of this Agreement, who is experienced in matters of corporation law and who shall not have otherwise been retained by or performed services within the last three years for (i) the Company or Indemnitee (other than with respect to matters concerning the rights of Indemnitee under this Indemnification Agreement or of other indemnities under similar indemnification agreements) or (ii) any other party to the Claim giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term “Independent Legal Counsel” shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement. | |
f. | “Losses.” “Losses” means any and all Expenses, damages, losses, liabilities, judgments, fines, penalties (whether civil, criminal or other), ERISA excise taxes, amounts paid or payable in settlement, including any interest, assessments, and all other charges paid or payable in connection with investigating, defending, being a witness in or participating in (including on appeal), or preparing to defend, be a witness or participate in, any Claim. | |
g. | Qualified Director. “Qualified Director” means a director who, at the time action is to be taken under this Agreement: |
i. | is not and was not a party to the Claim in respect of which indemnification is sought by Indemnitee; | |
ii. | is not a director as to whom a transaction is a director’s conflict of interest transaction, which transaction is challenged in such Claim; and | |
iii. | does not have a material relationship with a director who is disqualified by virtue of not meeting the requirements of subparagraph (i) or subparagraph (ii) of this definition. |
h. | Reviewing Party. “Reviewing Party” means: |
i. | if there are two or more Qualified Directors, by the Board Directors by a majority vote of all of the Qualified Directors, a majority of whom shall for such purposes constitute a quorum, or by a majority of the members of a committee of two or more Qualified Directors appointed by such a vote; or |
ii. | by Independent Legal Counsel: (1) selected in the manner prescribed by paragraph (h)(i) of this definition; or (2) if there are fewer than two Qualified Directors, selected by the Board of Directors. |
i. | Voting Securities. “Voting Securities” means any securities of the Company which vote generally in the election of directors. |
2. | Basic Indemnification Arrangement. |
a. | In the event Indemnitee was, is or becomes a party to or witness or other participant in, or is threatened to be made a party to or witness or other participant in, a Claim by reason of (or arising in part out of) an Indemnifiable Event, the Company shall indemnify Indemnitee to the full extent permitted by the Articles and the Florida Business Corporation Act as soon as practicable but in any event no later than thirty days after written demand is presented to the Company, against any and all Losses (including all interest, assessments and other charges paid or payable in connection with or in respect of such Losses) related to or arising from such a Claim including, without limitation, Claims brought by or in the right of the Company, Claims brought by third parties, and Claims in which the Indemnitee is solely a witness. | |
b. | Indemnitee shall have the right to advancement by the Company, prior to the final disposition of any Claim by final adjudication to which there are no further rights of appeal, of any and all Expenses actually and reasonably paid or incurred by Indemnitee in connection with any Claim arising out of an Indemnifiable Event. Without limiting the generality or effect of the foregoing, within two business days of such request by Indemnitee, the Company shall, in accordance with such request, (a) pay such Expenses on behalf of Indemnitee, (b) advance to Indemnitee funds in an amount sufficient to pay such Expenses, or (c) reimburse Indemnitee for such Expenses. In connection with any request for payment of expenses advanced to Indemnitee by the Company pursuant to this Section 2 (“Expense Advances”), Indemnitee shall not be required to provide any documentation or information to the extent that the provision thereof would undermine or otherwise jeopardize attorney-client privilege. | |
c. | Notwithstanding the foregoing, (i) the obligations of the Company under this Section 2 shall be subject to the condition that the Reviewing Party shall not have determined (in a written opinion to the Board of Directors in any case in which Independent Legal Counsel is involved) that Indemnitee would not be permitted to be indemnified under applicable law, and (ii) the obligation of the Company to make an Expense Advance pursuant to this Section 2 shall be subject to the condition that, if, when and to the extent that the Reviewing Party determines that Indemnitee would not be permitted to be so indemnified under applicable law, the Company shall be entitled to be reimbursed by Indemnitee (who hereby agrees to reimburse the Company) for all such amounts theretofore paid; provided, however, that if Indemnitee has commenced or thereafter commences legal proceedings in a court of competent jurisdiction to secure a determination that Indemnitee should be indemnified under applicable law, any determination made by the Reviewing Party that Indemnitee would not be permitted to be indemnified under applicable law shall not be binding and Indemnitee shall not be required to reimburse the Company for any Expense Advance until a final judicial determination is made with respect thereto (as to which all rights of appeal therefrom have been exhausted or lapsed). Indemnitee’s obligation to reimburse the Company for Expense Advances shall be unsecured and no interest shall be charged thereon. |
d. | If there has not been a Change in Control (or if there has been a Change in Control which has been approved by a majority of the Company’s Board of Directors who were directors immediately prior to such Change in Control), the Reviewing Party shall be, if there are two or more Qualified Directors, the Board Directors by a majority vote of all of the Qualified Directors, a majority of whom shall for such purposes constitute a quorum, or by a majority of the members of a committee of two or more Qualified Directors appointed by such a vote, or by Independent Legal Counsel selected by the Board of Directors or such committee. If there has been such a Change in Control (other than a Change in Control which has been approved by a majority of the Company’s Board of Directors who were directors immediately prior to such Change in Control), the Reviewing Party shall be the Independent Legal Counsel referred to in Section 3 hereof and contemplated by the definition of Review Party. If there has been no determination by the Reviewing Party or if the Reviewing Party determines that Indemnitee substantively would not be permitted to be indemnified in whole or in part under applicable law, Indemnitee shall have the right to commence litigation in any court in the State of Florida having subject matter jurisdiction thereof and in which venue is proper seeking an initial determination by the court or challenging any such determination by the Reviewing Party or any aspect thereof, including the legal or factual bases therefor, and the Company hereby consents to service of process and to appear in any such proceeding. Any determination by the Reviewing Party otherwise shall be conclusive and binding on the Company and Indemnitee. |
3. | Change in Control. The Company agrees that if there is a Change in Control of the Company (other than a Change in Control which has been approved by a majority of the Company’s Board of Directors who were directors immediately prior to such Change in Control) then with respect to all matters thereafter arising concerning the rights of Indemnitee to indemnity payments and Expense Advances under the Articles, this Indemnification Agreement or any other agreement or Company Bylaws now or hereafter in effect relating to Claims for Indemnifiable Events, the Company shall seek legal advice only from Independent Legal Counsel selected by Indemnitee and approved by the Company in the manner contemplated by this Agreement (which approval shall not be unreasonably withheld). Such counsel, among other things, shall render its written opinion to the Company and Indemnitee as to whether and to what extent the Indemnitee would be permitted to be indemnified under applicable law. The Company agrees to pay the reasonable fees of the Independent Legal Counsel referred to above and to fully indemnify such counsel against any and all expenses (including attorneys’ fees), claims, liabilities and damages arising out of or relating to this Indemnification Agreement or its engagement pursuant hereto. |
4. | Indemnification for Additional Expenses. The Company shall indemnify Indemnitee against any and all Expenses and, if requested by Indemnitee, shall (within two business days of such request) advance such Expenses to Indemnitee which are incurred by Indemnitee in connection with any action brought by Indemnitee for (i) indemnification or advance payment of Expenses by the Company under this Indemnification Agreement or any other agreement, the Articles or Company Bylaw now or hereafter in effect relating to Claims for Indemnifiable Events, and/or (ii) recovery under any directors’ and officers’ liability insurance policies maintained by the Company regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification, advance Expense payment or insurance recovery, as the case may be. |
5. | Partial Indemnity, Etc. If Indemnitee is entitled under any provision of this Indemnification Agreement to indemnification by the Company for some or a portion of the Losses related to a Claim but not, however, for the total amount thereof, the Company shall nevertheless indemnify Indemnitee for the portion thereof to which Indemnitee is entitled. Moreover, notwithstanding any other provision of this Indemnification Agreement, to the extent that Indemnitee has been successful on the merits or otherwise in defense of any or all Claims relating in whole or in part to an Indemnifiable Event or in defense of any issue or matter therein, including dismissal without prejudice, Indemnitee shall be indemnified against all Expenses incurred in connection therewith. |
6. | Exception to Right of Indemnification. Notwithstanding any provision in this Indemnification Agreement, the Company shall not be obligated to: |
a. | indemnify or advance funds to Indemnitee for Expenses or Losses with respect to proceedings initiated by Indemnitee, including any proceedings against the Company or its directors, officers, employees or other indemnitees and not by way of defense, except where the Company has joined in or the Board of Directors has consented to the initiation of such proceedings. | |
b. | indemnify Indemnitee if a final decision by a court of competent jurisdiction determines that such indemnification is prohibited by applicable law. | |
c. | indemnify Indemnitee for the disgorgement of profits arising from purchase or sale by Indemnitee of securities of the Company in violation of Section 16(b) of the Exchange Act, or any similar successor statute. |
7. | Notification and Defense of Claims. |
a. | Notification of Claims. Indemnitee shall notify the Company in writing as soon as practicable of any Claim which could relate to an Indemnifiable Event or for which Indemnitee could seek Expense Advances, including a brief description (based upon information then available to Indemnitee) of the nature of, and the facts underlying, such Claim. The failure by Indemnitee to timely notify the Company hereunder shall not relieve the Company from any liability hereunder unless the Company’s ability to participate in the defense of such claim was materially and adversely affected by such failure. |
b. | Defense of Claims. The Company shall be entitled to participate in the defense of any Claim relating to an Indemnifiable Event at its own expense and, except as otherwise provided below, to the extent the Company so wishes, it may assume the defense thereof with counsel reasonably satisfactory to Indemnitee (the consent to which shall not be unreasonably withheld by Indemnitee). After notice from the Company to Indemnitee of its election to assume the defense of any such Claim, the Company shall not be liable to Indemnitee under this Agreement or otherwise for any Expenses subsequently directly incurred by Indemnitee in connection with Indemnitee’s defense of such Claim other than reasonable costs of investigation or as otherwise provided below. Indemnitee shall have the right to employ its own legal counsel in such Claim, but all Expenses related to such counsel incurred after notice from the Company of its assumption of the defense shall be at Indemnitee’s own expense; provided, however, that if (i) Indemnitee’s employment of its own legal counsel has been authorized by the Company, (ii) Indemnitee has reasonably determined that there may be a conflict of interest between Indemnitee and the Company in the defense of such Claim, (iii) after a Change in Control, Indemnitee’s employment of its own counsel has been approved by the Independent Counsel or (iv) the Company shall not in fact have employed counsel to assume the defense of such Claim, then Indemnitee shall be entitled to retain its own separate counsel (but not more than one law firm plus, if applicable, local counsel in respect of any such Claim) and all Expenses related to such separate counsel shall be borne by the Company. |
8. | Presumption in Favor of Indemnitee; Burden of Proof. In connection with any determination by the Reviewing Party or otherwise as to whether Indemnitee is entitled to be indemnified hereunder, there shall exist a rebuttable presumption that Indemnitee has met the applicable standard(s) of conduct and is, therefore, entitled to indemnification pursuant to this Indemnification Agreement, and the burden of proof shall be on the Company to establish that Indemnitee has not met such applicable standard(s) of conduct and is not so entitled to indemnification. |
9. | No Other Presumptions. For purposes of this Indemnification Agreement, the termination of any claim, action, suit or proceeding, by judgment, order, settlement (whether with or without court approval) or conviction, or upon a plea of nolo contendere, or its equivalent, shall not create a presumption that (i) Indemnitee did not meet any particular standard of conduct; or (ii) Indemnitee did not have any particular belief; or, (iii) that a court has determined that indemnification is not permitted by applicable law. In addition, neither the failure of the Reviewing Party to have made a determination as to whether Indemnitee has met any particular standard of conduct or had any particular belief, nor an actual determination by the Reviewing Party that Indemnitee has not met such standard of conduct or did not have such belief, prior to the commencement of legal proceedings by Indemnitee to secure a judicial determination that Indemnitee should be indemnified under applicable law shall be a defense to Indemnitee’s claim or create a presumption that Indemnitee has not met any particular standard of conduct or did not have any particular belief. |
10. | Nonexclusivity, Etc. The rights of Indemnitee hereunder will be in addition to any other rights Indemnitee may have under the Articles, any Company Bylaw, the Florida Business Corporation Act or any other contract or otherwise (collectively, “Other Indemnity Provisions”); provided, however, that (a) to the extent that Indemnitee otherwise would have any greater right to indemnification under any Other Indemnity Provision, Indemnitee will be deemed to have such greater right hereunder and (b) to the extent that any change is made to any Other Indemnity Provision which permits any greater right to indemnification than that provided under this Agreement as of the date hereof, Indemnitee will be deemed to have such greater right hereunder. |
11. | Liability Insurance. If the Company obtains directors’ and officers’ liability insurance, then, to the extent the Company maintains an insurance policy or policies providing directors’ and officers’ liability insurance, Indemnitee shall be covered by such policy or policies, in accordance with its or their terms, to the maximum extent of the coverage available for any Company director or officer. |
12. | Period of Limitations. No legal action shall be brought and no cause of action shall be asserted by or in the right of the Company against Indemnitee or Indemnitee’s spouse, heirs, executors or personal or legal representatives after the expiration of two years from the date of accrual of such cause of action, and any claim or cause of action of the Company shall be extinguished and deemed released unless asserted by the timely filing of a legal action within such two year period; provided, however, that if any shorter period of limitations is otherwise applicable to any such cause of action, such shorter period shall govern. |
13. | Amendments, Etc. No supplement, modification or amendment of this Indemnification Agreement shall be binding unless executed in writing by both of the parties hereto. No waiver of any of the provisions of this Indemnification Agreement shall be deemed or shall constitute a waiver of any other provisions hereof (whether or not similar) nor shall such waiver constitute a continuing waiver. |
14. | Subrogation. In the event of payment under this Indemnification Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers required and shall do everything that may be necessary to secure such rights, including the execution of such documents necessary to enable the Company effectively to bring suit to enforce such rights. To the extent Indemnitee has been indemnified by the Company hereunder and later receives payments from any insurance carrier covering the same Losses so indemnified by the Company hereunder, Indemnitee shall immediately reimburse the Company hereunder for all such amounts received from the insurer. Notwithstanding anything contained herein to the contrary, Indemnitee shall not be entitled to recover amounts under this Indemnification Agreement which, when added to the amount of indemnification payments made to, or on behalf of, Indemnitee, under the Articles or Company Bylaws, in the aggregate exceed the Losses actually and reasonably incurred by Indemnitee (“Excess Amounts”). To the extent the Company has paid Excess Amounts to Indemnitee, Indemnitee shall be obligated to immediately reimburse the Company for such Excess Amounts. |
15. | No Duplication of Payments. The Company shall not be liable under this Indemnification Agreement to make any payment in respect of any Losses to the extent Indemnitee has otherwise actually received payment (under any insurance policy, the Articles or Company Bylaws or otherwise) of the amounts otherwise indemnifiable hereunder. |
16. | Right of Individual Attorney. Except as specifically provided in this Agreement, the Company shall not restrict the right of Indemnitee to be represented by and indemnified against the fees and expenses of the attorney of Indemnitee’s choice hereunder. |
17. | Allowance for Compliance with SEC Requirements. Indemnitee acknowledges that the Securities and Exchange Commission (“SEC”) has expressed the opinion that indemnification of directors and officers from liabilities under the Securities Act of 1933, as amended (the “Securities Act”) is against public policy as expressed in the Securities Act and is, therefore, unenforceable. Indemnitee hereby agrees that it will not be a breach of this Indemnification Agreement for the Company to undertake with the SEC in connection with the registration for sale of any stock or other securities of the Company from time to time that, in the event a claim for indemnification against liabilities under the Securities Act (other than the payment by the Company of expenses incurred or paid by a director or officer of the Company in the successful defense of any action, suit or proceeding) is asserted in connection with such securities being registered, the Company will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of competent jurisdiction the question of whether or not such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. Indemnitee further agrees that such submission to a court of competent jurisdiction shall not be a breach of this Indemnification Agreement. |
18. | Binding Effect. This Indemnification Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors; assigns, including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the business and/or assets of the Company; spouses; heirs; executors and personal and legal representatives. The Company shall require and cause any successor (whether direct or indirect by purchase, merger, consolidation or otherwise) to all, substantially all or a substantial part of the business and/or assets of the Company, by written agreement in form and substances satisfactory to Indemnitee, expressly to assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place |
19. | Severability. The provisions of this Indemnification Agreement shall be severable in the event that any of the provisions hereof (including any provision within a single section, paragraph or sentence) is held by a court of competent jurisdiction to be invalid, void or otherwise unenforceable in any respect, and the validity and enforceability of any such provision in every other respect and of the remaining provisions hereof shall not be in any way impaired and shall remain enforceable to the full extent permitted by law. |
20. | Governing Law. This Indemnification Agreement shall be governed by and construed and enforced in accordance with the laws of the State of Florida applicable to contracts made and to be performed in such state without giving effect to the principles of conflicts of laws. |
21. | Counterparts. This Indemnification Agreement may be executed in two or more fully or partially executed counterparts each of which shall be deemed an original binding and the signer thereof against the other signing parties, but all counterparts together shall constitute one and the same instrument. Executed signature pages may be removed from counterpart agreements and attached to one or more fully executed copies of this Agreement. |
22. | Notice. Indemnitee shall, as a condition precedent to his right to be indemnified under this Indemnification Agreement, give to the Company notice in writing as soon as practicable of any claim made against him for which indemnity will or could be sought under this Indemnification Agreement. Notice to the Company shall be directed to the Company at its headquarters located at 900 West Platt Street, Suite 200, Tampa, FL, 33606, Attention: General Counsel (or such other address as the Company shall designate in writing to Indemnitee). Notice shall be deemed received three days after the date of postmark if sent by prepaid mail, properly addressed. In addition, Indemnitee shall give the Company such information and cooperation as it may reasonably require within Indemnitee’s power. |
23. | Duration. All agreements and obligations of the Company contained herein shall continue during the period that Indemnitee is a director or officer of the Company (or is serving at the request of the Company as a director, officer, employee, member, trustee or agent of another entity) and shall continue thereafter (i) so long as Indemnitee may be subject to any possible Claim relating to an Indemnifiable Event (including any rights of appeal thereto) and (ii) throughout the pendency of any proceeding (including any rights of appeal thereto) commenced by Indemnitee to enforce or interpret his or her rights under this Agreement, even if, in either case, he or she may have ceased to serve in such capacity at the time of any such Claim or proceeding. |
[Remainder of this page intentionally left blank; signatures to follow]
IN WITNESS WHEREOF, the parties hereto have executed this Indemnification Agreement as of the date first above written.
TELOMIR PHARMACEUTICALS, INC. | ||
By: | ||
Name: | ||
Title: | ||
“INDEMNITEE” | ||
Exhibit 10.6
First Amended and
Restated Employment
Agreement
This First Amended and Restated Employment Agreement (this “Agreement”) is made and entered into as of December 11, 2023 (the “Effective Date”), by and between TELOMIR Pharmaceuticals, Inc. (the “Company”) and Nathen Fuentes (“Employee”). This Agreement amends and restates, and supersedes in its entirety, that certain Employment Agreement, dated September 21, 2023, by and among the Company and Employee.
In consideration of the mutual promises and covenants set forth herein, and other good and valuable consideration, the sufficiency of which is hereby acknowledged, the Company and Employee hereby agree as follows:
1. | Position of Employment. |
a. | The Company here employs the Employee in the position of Chief Financial Officer, Treasurer, and Secretary, and, in that position, Employee shall report to the Company’s Chief Executive Officer. Employee’s duties shall include (i) the duties customarily associated with the positions of Chief Financial Officer, Treasurer, and Secretary, including serving as the Company’s principal financial and accounting officer, and (ii) such other reasonable related duties as the Company or its Board of Directors may assign to Employee from time to time (including service to subsidiaries of the Company for no additional consideration). The Company retains the right to change Employee’s title, duties, and reporting relationships as may be determined to be in the best interests of the Company; provided, however, that any such change shall be consistent with Employee’s training, experience, and qualifications. |
b. | The terms and conditions of the Employee’s employment shall, to the extent not addressed or described in this Agreement, be governed by the Company’s Board of Directors. In addition, the Company in its discretion may adopt a formal Policies and Procedures Manual for all employees to adhere to. In the event of a conflict between this Agreement, the Board of Directors, and/or the future implementation of a Policies and Procedures Manual and/or existing practices, the terms of this Agreement shall govern. |
c. | Employee shall devote Employee’s full business time and effort to the business and affairs of the Company. The Company acknowledges that Employee is currently engaged in activities and consultancies in addition to Employee’s employment relationship with the Company, and that Employee may establish additional outside relationships and activities without approval by the Company so long as they do not unreasonably interfere with Employee’s duties hereunder. |
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2. | Term of Employment. Employee’s employment hereunder shall continue until terminated in accordance with this Section 2 (the “Term of Employment”). The parties acknowledge, subject to the provisions of this Section 2, that Employee’s employment with the Company is on an at- will basis, and either Company or Employee may therefore terminate the Employee’s employment, with or without cause, at any time and for any reason upon the terms and conditions specified in this Section 2 below. |
a. | This Agreement and Employee’s employment hereunder may be terminated at any time and for any reason not constituting a Termination With Cause (as defined below) upon thirty (30) days’ prior written notice by the Company to Employee (a “Termination Without Cause”). |
b. | This Agreement and Employee’s employment hereunder may be terminated at any time immediately for Cause (as defined below) upon written notice to Employee specifying in reasonable detail the acts or omissions constituting Cause (a “Termination With Cause”). |
c. | Employee may terminate Employee’s employment hereunder at any time and for any reason upon no less than thirty (30) days’ prior written notice to the Company. |
d. | Employee shall have the right to resign from employment for “Good Reason” if: (i) there is a material adverse change or material diminution in Employee’s duties, responsibilities, functions, reporting lines, or title with Company, (ii) there is a material reduction in the compensation payable to Employee hereunder, or (iii) there is a material breach of the provisions of this Agreement by the Company. Employee cannot terminate Employee’s employment for Good Reason unless Employee has provided written notice to the Company of the existence of the circumstances providing grounds for termination for Good Reason within fifteen (15) days of the initial existence of such grounds, and if curable, Company has had at least thirty (30) days from the date on which such notice is provided to cure such circumstances (and has failed to cure such circumstances within such period). If not curable, or if Company has not, within such thirty (30) day period, cured the circumstances providing grounds for termination for Good Reason, and Employee does not terminate Employee’s own employment for Good Reason within ten (10) days after the expiration of Company’s cure period in the preceding sentence, Employee will be deemed to have waived Employee’s right to terminate for Good Reason with respect to such grounds. A resignation that is effected in accordance with this paragraph is referred to as a “Good Reason Resignation.” |
e. | In the event of a Termination Without Cause or a Good Reason Resignation, the Employee shall be paid Employee’s normal monthly Base Salary (as defined below) for a period of three (3) months following the effective date of termination of employment, which shall constitute Employee’s full and complete entitlement to severance compensation. However, the right to receive such severance compensation is conditioned upon Employee signing (and not revoking), by the twenty-first (21st) day after Employee’s last day of payment, a general release of all claims in a form provided by the Company releasing all claims against the Company and its officers, directors, stockholders, and affiliates (provided that such release shall exclude Employee’s right to receive severance compensation hereunder). The Company will also execute a mutual release. |
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f. | As used herein, the term “Cause” shall mean (i) commission of a willful act of dishonesty in the course of Employee’s duties hereunder or misappropriation of funds, theft, or embezzlement by Employee of Company funds or property, (ii) conviction by a court of competent jurisdiction of, or plea of no contest to, a crime constituting a felony or conviction in respect of, or plea of no contest to, any act involving fraud, dishonesty or moral turpitude, (iii) Employee’s gross or willful misconduct (whether or not directly related to the Company or its business) or illegal conduct that impairs the performance of Employee’s duties or that is injurious to the Company, including without limitation injurious to the reputation of the Company, (iv) Employee’s performance under the influence of controlled substances (other than those taken pursuant to a medical doctor’s orders), or continued habitual intoxication, during working hours, (v) Employee’s personal misconduct or refusal or material failure to timely perform Employee’s duties and responsibilities or to timely carry out the lawful directives of Company, which, if capable of being cured shall not have been cured, within thirty (30) days after Company shall have advised Employee in writing of its intention to terminate Employee’s employment; provided, that such right to cure shall not apply to any subsequent act or omission of a substantially similar nature or type, or (vi) Employee’s material non-compliance with the terms of this Agreement or any Company policy, which, if capable of being cured, shall not have been cured within thirty (30) days after Company shall have advised Employee in writing of its intention to terminate Employee’s employment for such reason. |
g. | Notwithstanding any provision of this Agreement to the contrary, the obligations and commitments under Sections 5 through 10 of this Agreement shall survive and continue in full force and effect in accordance with their terms notwithstanding any termination of Employee’s employment for any reason or termination of this Agreement for any reason. |
3. | Compensation. The Company shall pay Employee an initial base salary of $165,000 per annum beginning on the Effective Date, provided, however, that if the Effective Date is a date other than the first day of such month, Employee’s Base Salary will be prorated based on the number of days then remaining during such month and continuing for the remaining Term of Employment as defined in Section 2 herein. The Employee’s Base Salary shall be paid monthly after the deduction of appropriate federal, state, and local withholding taxes. Upon the completion of the Company’s initial public offering, Employee will be entitled to a one-time bonus to effectively adjust his annual base compensation to $250,000 annually retroactively to the date of his initial employment with the Company, and will remain at that amount until the first anniversary of his initial employment. Bonus Compensation may be paid to Employee in the discretion of the Company’s Board of Directors, including at its annual review of Employee’s compensation. |
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4. | Expenses. The Company will reimburse Employee for all reasonable out-of-pocket travel and other expenses incurred by Employee during the Term of Employment in providing services hereunder, subject to any requirements or conditions as may be set forth in any expense reimbursement policy or procedures as may be adopted from time to time by the Company. Until the Company initiates a group health plan, Employee will be reimbursed for COBRA costs, or other individual plan costs. |
5. | Disclosure of Inventions. During the Term of Employment, Employee shall promptly disclose in confidence to the Company all inventions, improvements, designs, original works of authorship, formulas, processes, compositions of matter, computer software programs, databases, mask works and trade secrets made or discovered by Employee that: (i) are related to, expand, continue and/or advance the Company’s Proprietary Assets or the potential manufacture, formulation, use, efficacy or safety thereof; and/or (ii) are made or discovered as a direct result of the performance of services hereunder (the “Inventions”). The Company’s “Proprietary Assets” are defined as all discoveries, product candidates, molecules, processes, potential therapies, and/or technologies that the Company treats as proprietary and/or a trade secret. Employee is hereby given written notice that, as of the date hereof, the Company’s Proprietary Assets include the compound referred to as “MIRA1a,” which is described in patent filings. For clarity, regardless of written notice, the Company’s Proprietary Assets will include any and all Inventions made or discovered by Employee during the Term of Employment provided the Invention is made or discovered pursuant to subparagraph (i) or (ii) above. |
6. | Work for Hire; Assignment of Inventions. Employee acknowledges and agrees that any copyrightable works prepared within the scope of involvement with the Company are “works for hire” under the United States Copyright Act and that the Company will be considered the author and owner of such copyrightable works. Employee agrees that all Inventions that: (i) are developed using equipment, supplies facilities or trade secrets of the Company, (ii) result from work performed for the Company, or (iii) relate to any of the Company’s Proprietary Assets will be the sole and exclusive property of, and are hereby irrevocably assigned by Employee to, the Company. |
7. | Assignment of Other Rights. In addition to the foregoing assignment of Inventions to the Company, Employee hereby irrevocably transfers and assigns to the Company: (i) all worldwide patents, patent applications, copyrights, mask works, trade secrets and other intellectual property rights in any Invention within the scope of involvement with the Company; and (ii) any and all “Moral Rights” (as defined below) that Employee may have in or with respect to any Invention within the scope of involvement with the Company. Employee also hereby forever waives and agrees never to assert any and all Moral Rights he may have in or with respect to any Invention, even after termination of involvement with the Company. “Moral Rights” mean any rights to claim authorship of an Invention, to object to or prevent the modification of any Invention, or to withdraw from circulation or control the publication or distribution of any Invention, and any similar right, existing under judicial or statutory law of any country in the world, or under any treaty, regardless of whether or not such right is denominated or generally referred to as a “moral right.” |
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8. | Assistance. Employee agrees to assist the Company in every proper way to obtain for the Company and enforce patents, copyrights, mask work rights, trade secret rights and other legal protections for the Company’s Inventions in any and all countries. Employee will execute any documents that the Company may reasonably request for use in obtaining or enforcing such patents, copyrights, mask work rights, trade secrets and other legal protections. Employee’s obligations under this paragraph will continue beyond the termination of this Agreement, provided that the Company will compensate Employee at a reasonable rate after such termination for time or expenses actually spent at the Company’s request on such assistance. Employee appoints the Chief Executive Officer of the Company as attorney-in-fact to execute documents on Employee’s behalf for this purpose upon Employee’s review and approval of such documents. |
9. | Proprietary Information. Employee understands that Employee’s participation in this Agreement with the Company creates a relationship of confidence and trust with respect to any information (including Trade Secrets) that may be disclosed to Employee by or on behalf of the Company that relates to the businesses, assets, or financial position of the Company or to the business, assets, or financial positions of any affiliate, customer or supplier of the Company or any other party with whom the Company agrees to hold information of such party in confidence (the “Proprietary Information”). Such Proprietary Information includes, but is not limited to, Inventions, marketing plans, product plans, business strategies, financial information, forecasts, personnel information, customer lists, domain names or any other material information, which is not generally available to the public. |
10. | Confidentiality. At all times, both during the Term of Employment and at all times thereafter, Employee will keep and hold all Proprietary Information in strict confidence and trust. Employee will not use or disclose any Proprietary Information without the prior written consent of the Company, except as may be necessary to perform Employee’s duties for the benefit of the Company. Upon termination of Employee’s involvement with the Company, Employee will promptly deliver to the Company all documents and materials of any nature pertaining to Employee’s work with the Company. Employee will not take with Employee any documents or materials or copies thereof containing any Proprietary Information. As used herein, the term “Trade Secret” means any technical or nontechnical data, formula, pattern, compilation, program, device, method, technique, drawing, process, financial data, financial plan, product plan, list of actual or potential customers or suppliers, or other information similar to any of the foregoing, which (i) derives economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by other persons who can derive economic value from its disclosure or use; and (ii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy. Employee shall keep all Trade Secrets of the Company for as long as the Company maintains them as a trade secret. In addition to the requirements set forth above, Employee agrees that the restrictions in this Agreement regarding the use or disclosure of Proprietary Information, including, without limitation, the restrictions in this Agreement regarding the use or disclosure of Trade Secrets, shall be in addition to any restrictions imposed by law in the absence of contract. |
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11. | No Breach of Other Agreement. Employee represents that Employee’s performance of all the terms of this Agreement will not breach any agreement with any former or current employer or other party. Employee represents that Employee will not bring with Employee to the Company or use in the performance of Employee’s duties for the Company any documents or materials or intangibles of a former employer or third party that are not generally available to the public or have not been legally transferred to the Company. |
12. | Injunctive Relief. Employee understands that in the event of a breach or threatened breach of this Agreement by Employee, the Company may suffer irreparable harm and will therefore be entitled to injunctive relief to enforce this Agreement. |
13. | Governing Law; Severability. This Agreement will be governed by and construed in accordance with the laws of the State of Florida, without giving effect to that body of laws pertaining to conflict of law. If any provision of this Agreement is determined by any court or arbitrator of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such provision will be enforced to the maximum extent possible given the intent of the parties hereto. If such clause or provision cannot be so enforced, such provision shall be stricken from this Agreement and the remainder of this Agreement shall be enforced as if such invalid, illegal or unenforceable clause or provision had (to the extent not enforceable) never been contained in this Agreement. Notwithstanding the foregoing, if the value of this Agreement based upon the substantial benefit of the bargain for any party is materially impaired, which determination as made by the presiding court or arbitrator of competent jurisdiction shall be binding, then this Agreement will not be enforceable against such affected party and both parties agree to renegotiate such provision(s) in good faith. |
14. | Counterparts. This Agreement may be executed in any number of counterparts, each of which when so executed and delivered will be deemed an original, and all of which together shall constitute one and the same agreement. Counterparts may be delivered via facsimile, electronic mail (including .pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes. |
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15. | Entire Agreement. This Agreement and the documents referred to herein or referencing this Agreement constitute the entire agreement and understanding of the parties with respect to the subject matter of this Agreement, and supersede all prior understandings and agreements, whether oral or written, between or among the parties hereto with respect to the specific subject matter hereof and Employee’s employment with the Company. |
16. | Amendment and Waiver. This Agreement may be amended only by a written agreement executed by each of the parties hereto. No amendment of or waiver of, or modification of any obligation under this Agreement will be enforceable unless set forth in a writing signed by the party against which enforcement is sought. |
IN WITNESS WHEREOF, the Company has caused this First Amended and Restated Employment Agreement to be signed by its officer pursuant to the authority of its Board, and the Employee has executed this First amended and Restated Employment Agreement, as of the day and year first written above.
TELOMIR PHARMACEUTICALS, INC. | ||
/s/ Dr. Chris Chapman | ||
By: | Dr. Chris Chapman | |
Title: | Chief Executive Officer | |
/s/ Nathen Fuentes | ||
Nathen Fuentes, individually |
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Exhibit 10.8
FLORIDA DOCUMENTARY STAMP TAX IN THE AMOUNT $2,450.00 HAS BEEN PAID OR WILL BE PAID DIRECTLY TO THE FLORIDA DEPARTMENT OF REVENUE.
PROMISSORY NOTE AND LOAN AGREEMENT
Tampa, FL | |
$5,000,000 | June 15, 2023 |
FOR VALUE RECEIVED AND IN CONSIDERATION OF THE LOAN, Telomir Pharmaceuticals, Inc., a Florida corporation (the “Borrower”), hereby promises to pay to the order of George Cappy, as Trustee of the Bay Shore Trust (the “Lender”), the principal sum of Five Million and No/100 Dollars ($5,000,000.00) (the “Commitment Amount”), or such lesser amount thereof as may be borrowed from the Lender and then outstanding, together with interest thereon from the date of this Promissory Note and Loan Agreement (this “Note”). Interest on any amounts advanced pursuant to this Note (each such amount, an “Advance”) shall accrue and be paid in the manner set forth in Section 4 of this Note. Subject to the provisions of Section 10 hereof, the outstanding principal of, and any and all accrued and unpaid interest with respect to, this Note shall be due and payable by the Borrower on June 15, 2025 (the “Maturity Date”).
1. Loan Commitment; Borrowing Procedure. Subject to the terms and conditions set forth herein, Lender agrees to make one or more Advances to the Borrower in an aggregate original principal amount up to the Commitment Amount (the “Loan”). Subject in all cases to the provisions of Section 2, at any time and from time to time from and after the date hereof and through and including the Maturity Date, during normal business hours, upon not less than three (3) business days prior written notice, the Borrower may deliver to the Lender a written request for an Advance (each, an “Advance Request”). On the date set forth in the applicable Advance Request (which date shall be not less than five (5) business days after the date of such Advance Request), the Lender shall (subject to the provisions of Section 2) disburse to the Borrower the full amount set forth in the applicable Advance Request. Any amounts so disbursed will be advanced to the Borrower as a loan and shall be evidenced by, and subject to, the terms and conditions of this Note. Any Advances made by the Lender to the Borrower pursuant to this Note may be repaid by the Borrower (together with any and all interest accrued thereon) at any time without penalty or premium in accordance with the terms hereof. Amounts repaid hereunder may not be reborrowed.
2. Limitations on Borrowing. The Lender shall not have any obligation to make, nor be required to make, any Advances or other extension of credit to the Borrower hereunder if (a) an Event of Default (as defined below) has occurred or (b) Borrower has consummated an initial public offering of its common stock resulting in its common stock trading on a stock exchange or in the over-the-counter market and the Borrower becoming subject to the periodic filing and other obligations under the federal securities law. In no event shall the Lender be obligated to make any Advances or other extension of credit to the Borrower in excess of the Commitment Amount.
3. Payments Generally. All payments shall be made to the Lender in immediately available funds and in lawful money of the United States of America at the principal office of the Lender, or at such other place as Lender may from time to time designate in writing to the Borrower. Each payment of any amounts owed hereunder shall be applied to the then outstanding obligations under this Note in the following order of priority: first, to any fees or other amounts then due hereunder, second, to any accrued and unpaid interest with respect to this Note, and, third, to the outstanding principal of this Note. The Borrower hereby unconditionally waives (a) any rights to presentment, demand, protest or (except as expressly required hereby) notice of any kind, and (b) any rights of rescission, setoff, counterclaim, suretyship or defense to payment under this Note or otherwise that the Borrower may have or claim against the Lender.
4. Calculation and Payment of Interest. This Note (inclusive of all Advances made hereunder) will bear interest on the outstanding principal amount thereof at a fixed rate as follows: (i) up to and including June 14, 2024 (the “Initial Period”), an interest rate equal to seven percent (7.0%) per annum, simple interest and (ii) after the Initial Period and up to and including the date on which this Note is paid in full, an interest rate equal to ten percent (10.0%) per annum, simple interest. Interest shall be calculated based on a year consisting of 365 days and the actual number of days elapsed. Interest shall accrue on a quarterly basis and shall be due and payable on the Maturity Date.
5. Payment of Principal. Unless earlier accelerated in accordance with the provisions hereof following the occurrence of an Event of Default, the unpaid principal balance of this Note (inclusive of all Advances), together with all accrued and unpaid interest, fees and other amounts due hereunder, shall be due and payable in full on the Maturity Date.
6. Prepayments. The Borrower may prepay all or any portion of the outstanding obligations of this Note (including any and all Advances) at any time without penalty or premium.
7. Representations and Warranties of the Borrower. In connection with the transactions provided for herein, the Borrower hereby represents and warrants to the Lender that:
7.1 Organization, Good Standing and Qualification. The Borrower is a corporation duly organized, validly existing and in good standing under the laws of the State of Florida and has all requisite corporate power and authority to carry on its business as now conducted. The Borrower is duly qualified to transact business and is in good standing in each jurisdiction in which the failure to so qualify would have a material adverse effect on its business or properties.
7.2 Authorization. All corporate action has been taken on the part of the Borrower, its officers, directors and shareholders necessary for the authorization, execution and delivery of this Note. The Borrower has taken all corporate action required to make all the obligations of the Borrower reflected herein the valid and enforceable obligations they purport to be.
7.3 Compliance with Other Instruments. The authorization, execution and delivery of this Note will not constitute or result in a material default or violation of any law or regulation applicable to the Borrower or any material term or provision of the Borrower’s current Articles of Incorporation or bylaws, or any material agreement or instrument by which it is bound or to which its properties or assets are subject.
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8. Representations and Warranties of the Lender. In connection with the transactions provided for herein, the Lender hereby represents and warrants to the Borrower that:
8.1 Authorization. This Note constitutes the Lender’s valid and legally binding obligation, enforceable in accordance with its terms, except as may be limited by (i) applicable bankruptcy, insolvency, reorganization or similar laws relating to or affecting the enforcement of creditors’ rights and (ii) laws relating to availability of specific performance, injunctive relief or other equitable remedies.
8.2 Purchase Entirely for Own Account. The Lender acknowledges that this Note is issued to the Lender in reliance upon the Lender’s representation to the Borrower that the Note will be acquired for investment for the Lender’s own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that such Lender has no present intention of selling, granting any participation in, or otherwise distributing the same. By executing this Note, the Lender further represents that the Lender does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participations to such person or to any third person, with respect to this Note.
8.3 Disclosure of Information. The Lender acknowledges that it has received all the information it considers necessary or appropriate for deciding whether to acquire this Note. The Lender further represents that it has had an opportunity to ask questions and receive answers from the Borrower regarding the terms and conditions of the offering of this Note.
8.4 Investment Experience. The Lender is an investor in securities of companies in the development stage and acknowledges that it is able to fend for itself, can bear the economic risk of its investment, and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment in this Note. If other than an individual, the Lender also represents it has not been organized solely for the purpose of acquiring this Note.
8.5 Accredited Investor. The Lender is an “accredited investor” within the meaning of Rule 501 of Regulation D, as presently in effect, as promulgated by the Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended (the “Act”).
8.6 Restricted Securities. The Lender understands that this Note is characterized as a “restricted security” under the federal securities laws inasmuch as it is being acquired from the Borrower in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Act, only in certain limited circumstances. In this connection the Lender represents that it is familiar with Rule 144 as promulgated by the SEC under the Act, as presently in effect (“Rule 144”), and understands the resale limitations imposed thereby and by the Act.
8.7 Further Limitations on Disposition. Without in any way limiting the representations and warranties set forth above, the Lender further agrees not to make any disposition of all or any portion of this Note unless and until the transferee has agreed in writing for the benefit of the Borrower to be bound by this Section and:
(a) There is then in effect a registration statement under the Act covering such proposed disposition and such disposition is made in accordance with such registration statement; or
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(b) (i) The Lender shall have notified the Borrower of the proposed disposition and shall have furnished the Borrower with a detailed statement of the circumstances surrounding the proposed disposition and (ii) if other than an individual, Lender shall not make any disposition to any of the Borrower’s competitors as such is in good faith determined by the Borrower.
9. Warrant.
10. In connection with the issuance of this Note, the Borrower has issued to Lender a warrant to purchase shares of Borrower’s common stock.
11. Defaults and Remedies.
11.1 Events of Default. Each of the following events shall be considered an “Event of Default” with respect to this Note:
(a) The Borrower shall default in the payment of any part of the principal, interest or other amounts owed to Lender pursuant to this Note, in each case after the same shall become due and payable hereunder, whether at the Maturity Date or at a date fixed for prepayment or by acceleration or otherwise;
(b) Any representation or warranty made by the Borrower herein is determined to have been false, misleading or erroneous in any material respect when made;
(c) The Borrower shall fail to comply in any material respect with any covenant, agreement or other obligation contained in this Note (other than the obligation to pay amounts owed hereunder, which shall be governed by the provisions of Section 10.1(a)) in a timely manner, and such failure shall remain uncured for a period of more than ten (10) days after the Borrower receives notice of the same;
(d) The Borrower shall make an assignment for the benefit of creditors, or shall admit in writing its inability to pay its debts as they become due, or shall file a voluntary petition for bankruptcy, or shall file any petition or answer seeking for itself any reorganization, arrangement, composition, readjustment, dissolution or similar relief under any present or future statute, law or regulation, or shall file any answer admitting the material allegations of a petition filed against the Borrower in any such proceeding, or shall seek or consent to or acquiesce in the appointment of any trustee, receiver or liquidator of the Borrower, or of all of any substantial part of the properties of the Borrower, or the Borrower or its managers or members shall take any action looking to the dissolution or liquidation of the Borrower; or
(e) There shall have occurred a material adverse change in the assets, operations or prospects of the Borrower, in each case taken as a whole.
11.2 Remedies. Upon the occurrence and during the continuation of an Event of Default under Section 10.1, the entire unpaid principal and accrued and unpaid interest on this Note shall, without presentment, demand, protest or notice of any kind, all of which are hereby expressly waived, be forthwith due and payable (a) immediately upon the occurrence of any Event of Default described in Section 10.1(d) and (b) at the option and upon the declaration of the Lender upon the occurrence of any other Event of Default. Upon the occurrence and during the continuation of an Event of Default under Section 10.1, the Lender may, immediately and without expiration of any period of grace, enforce payment of all amounts due and owing under this Note and exercise any and all other remedies granted to it hereunder.
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12. Miscellaneous.
12.1 Successors and Assigns. Except as otherwise provided herein, the terms and conditions of this Note shall inure to the benefit of and be binding upon the respective successors and assigns of the parties; provided, however that the Borrower may not assign its obligations under this Note without the written consent of the Lender. Nothing in this Note, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations or liabilities under or by reason of this Note, except as expressly provided in this Note.
12.2 Governing Law. This Note shall be governed by and construed under the laws of the State of Florida, without regard to its conflict of laws principles. EACH OF THE Borrower AND THE LENDER hereby consent to the jurisdiction of any court located in Sarasota or hillsborough counties, florida, waive any objection to jurisdiction and venue of any action instituted against ANY OF THEM in such forum as provided above and AGREE NOT TO ASSERT ANY DEFENSE BASED ON LACK OF JURISDICTION OR VENUE IN SUCH FORUM.
12.3 Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Note.
12.4 Notices. All notices and other communications given or made pursuant hereto shall be in writing and shall be deemed effectively given: (i) upon personal delivery to the party to be notified, (ii) when sent by confirmed electronic mail or facsimile if sent during normal business hours of the recipient; if not, then on the next business day, (iii) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (iv) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt.
12.5 Expenses. If any action at law or in equity is necessary to enforce or interpret the terms of this Note, the prevailing party shall be entitled to reasonable attorneys’ fees, costs and necessary disbursements in addition to any other relief to which such party may be entitled.
12.6 Severability. If one or more provisions of this Note are held to be unenforceable under applicable law, such provision shall be excluded from this Note and the balance of the Note shall be interpreted as if such provision were so excluded and shall be enforceable in accordance with its terms.
12.7 Further Assurance. From time to time, the Borrower shall execute and deliver to Lender such additional documents and shall provide such additional information to the Lender as Lender may reasonably require to carry out the terms of this Note, and any agreements executed in connection herewith.
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12.8 Waiver of Jury Trial. TO THE EXTENT EACH MAY LEGALLY DO SO, EACH PARTY HERETO HEREBY EXPRESSLY WAIVES ANY RIGHT TO TRIAL BY JURY OF ANY CLAIM, DEMAND, ACTION, CAUSE OF ACTION OR PROCEEDING ARISING UNDER OR WITH RESPECT TO THIS NOTE, OR IN ANY WAY CONNECTED WITH, OR RELATED TO, OR INCIDENTAL TO, THE DEALING OF THE PARTIES HERETO WITH RESPECT TO THIS NOTE, OR THE TRANSACTIONS RELATED THERETO, IN EACH CASE WHETHER NOW EXISTING OR HEREAFTER ARISING, AND IRRESPECTIVE OF WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE. TO THE EXTENT EACH MAY LEGALLY DO SO, EACH PARTY HERETO HEREBY AGREES THAT ANY SUCH CLAIM, DEMAND, ACTION OR PROCEEDING SHALL BE DECIDED BY A COURT TRIAL WITHOUT A JURY AND THAT EITHER PARTY HERETO MAY FILE AN ORIGINAL COUNTERPART OR A COPY OF THIS AGREEMENT WITH ANY COURT AS WRITTEN EVIDENCE OF THE CONSENT OF ANY OTHER PARTY HERETO TO THE WAIVER OF ITS RIGHT TO TRIAL BY JURY.
12.9 Entire Agreement; Amendments and Waivers. This Note and the other documents delivered pursuant hereto constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof and thereof. Any term of this Note may be amended and the observance of any term may be waived (either generally or in a particular instance and either retroactively or prospectively), with the written consent of the Borrower and the Lender. Any waiver or amendment effected in accordance with this Section shall be binding upon each future holder of all such securities, and the Borrower.
12.10 Florida Documentary Stamp Tax. The Borrower shall pay any and all Florida documentary stamp taxes that may be due with respect to this Note.
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IN WITNESS WHEREOF, the parties have executed this Promissory Note and Loan Agreement as of the date first above written.
BORROWER: | ||
TELOMIR PHARMACEUTICALS, INC. | ||
By: | /s/ Christopher Chapman | |
Christopher Chapman | ||
Chief Executive Officer | ||
LENDER: | ||
/s/ George Cappy | ||
George Cappy, as Trustee of the Bay Shore Trust |
Exhibit 10.9
AGREEMENT FOR SHARED
LEASE COSTS
This Agreement for Shared Lease Costs (the “Agreement”) is made, effective as of April 1, 2023 by and among MIRALOGX LLC. (“ MIRALOGX”), MIRA Pharmaceuticals, Inc. (“MIRA” ) and Telomir Pharmaceuticals, Inc. (“Telomir”), all with a mailing address of 900 West Platt Street, Suite 200, Tampa, Florida 33606.
RECITALS
WHEREAS, MIRALOGX has entered into an Aircraft Dry Lease Agreement dated and effective as of April 1, 2023 (the “Lease”) in the form attached hereto as Exhibit A; and
WHEREAS, MIRA and Telomir hereby agree and elect to share use of the aircraft subject to the Lease (the “ Aircraft”) as needed and provided by MIRALOGX; and
WHEREAS, MIRA and Telomir hereby agree to make monthly contribution/payment in accordance with their monthly use of the Aircraft toward the Rent payments due under the Lease as defined in Annex A of the Lease in consideration of the right to use the Aircraft during the term of the Lease.
NOW, THEREFO RE, in consideration of the foregoing, and the other promises contained herein, the parties, intending to be legally bound hereby, agree as follows:
1. | MIRA and Telomir hereby mutually covenant and agree that each of them shall make payment of their pro rata portion of the Rent payments due under the Lease, based upon their respective actual usage of the Aircraft during the term thereof. For purposes of clarity, the portion of the Rent payments to be made by MIRA and Telomir hereunder is based on actual use of the Aircraft, and no payments are due unless and to the extent that the Aircraft is actually used by the subject party during the applicable month. |
2. | MIRA and Telomir shall each transmit payment of their allocated portion of the Rent due under the Lease to MIRALOGX, as shown on a monthly invoice from MIRALOGX, on or before the fifteenth day of each month during the term of the Lease. MIRALOGX shall be responsible for making payment to the LESSOR in accordance with the terms of the Lease. |
3. | Each of MIRA and Telomir is under no obligation to use the Aircraft and may discontinue such use at any time, in which case such party will have no further obligations under this Agreement. |
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date aforementioned.
MIRA Pharmaceuticals, Inc. | ||
By: | /s/ Michelle Yanez | |
Name: | Michelle Yanez | |
Title: | CFO | |
Telomir Pharmaceuticals, Inc. | ||
By: | /s/ James McNulty | |
Name: | James McNulty | |
Title: | CFO | |
MIRALOGX LLC | ||
By: | /s/ Jonnie R. Williams | |
Name: | Jonnie R. Williams | |
Title: | Manager |
Exhibit 10.10
DEBT Conversion Agreement
This Debt Conversion Agreement (this “Agreement”) is entered into effective as of November 30, 2023 (the “Effective Date”) by and between MIRALOGX LLC, a Florida limited liability company with its principal executive office located at 900 West Platt Street, Suite 200, Tampa, Florida 33606 (“MIRALOGX”), and Telomir Pharmaceuticals, Inc., a Florida corporation with its principal executive office located at 855 N Wolfe Street, Suite 601, Baltimore, Maryland 21205 (“Telomir”); MIRALOGX and Telomir together the “Parties” to this Agreement.
W I T N E S S E T H
WHEREAS, MIRALOGX has advanced funds to Telomir in order to fund operating activities in an aggregate amount of $1,717,574 (the “Debt”); and
WHEREAS, the Parties have mutually agreed to effect a conversion of the Debt into fully paid and non-assessable shares of common stock, no par value, of Telomir (the “Common Stock”) at a conversion price of $1.00 per share.
NOW, THEREFORE, in consideration of the premises stated herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, it is hereby agreed that:
1. Recitals. The foregoing recitals are true and correct and are incorporated herein by reference.
2. Conversion. Telomir and MIRALOGX hereby agree that the Debt is hereby converted as of the Effective Date into an aggregate of 1,717,574 shares of Telomir Common Stock (the “Conversion Shares”). From and after the Effective Date, MIRALOGX shall for all purposes be deemed to have owned the Conversion Shares, and the entire $1,717,574 of the Debt shall be deemed paid in full and extinguished.
3. Representations and Warranties of Telomir. Telomir hereby makes the following representations and warranties to MIRALOGX as of the Effective Date (which representations and warranties shall survive the Effective Date):
a. Telomir is a duly organized, validly existing and in good standing corporation under the laws of the State of Florida, with all requisite power and authority to own, operate and conduct its business as now being conducted.
b. All corporate action on the part of Telomir necessary for the authorization, execution, delivery and performance of this Agreement has been taken. This Agreement constitutes the valid and legally binding obligation of Telomir, enforceable in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies.
c. The Conversion Shares received hereunder are, and will be upon the issuance thereof, validly issued, fully paid, and non-assessable.
4. Representations and Warranties of MIRALOGX. MIRALOGX represents, warrants, covenants and agrees (which representations, warranties, covenants, and agreements shall be and be deemed to be continuing and survive the Effective Date) as follows:
a. MIRALOGX is an “Accredited Investor” as defined in Rule 501 of Regulation D promulgated under the Securities Act of 1933, as amended (the “Act”). MIRALOGX has been advised and understands that (i) there are substantial limitations under applicable securities laws on the transferability of the Conversion Shares; (ii) the Conversion Shares have not been and will not be registered under the Act; (iii) there is no public market for the Conversion Shares, and there may never be a public market for such shares; and (iv) Telomir has not covenanted to make “current public information” available for purposes of Rule 144 under the Act. Accordingly, it may be impossible for MIRALOGX to liquidate the investment in the Conversion Shares.
b. MIRALOGX is accepting the Conversion Shares for its own account, for investment purposes only, and without a view towards the sale or distribution thereof.
c. MIRALOGX has sufficient knowledge and experience in financial and business matters to evaluate the merits and risk of conversion of the Debt and acceptance of the Conversion Shares. MIRALOGX is able to bear the economic risks of this conversion and at the present time could afford a complete loss of any and all value received hereunder.
d. MIRALOGX believes it has received all the information it considers necessary or appropriate for deciding whether to acquire the Telomir Shares. In addition, MIRALOGX represents and warrants that Telomir has made available for inspection by MIRALOGX various documents connected with Telomir’s business and has not refused in any way to permit MIRALOGX to inspect any document requested to be inspected by MIRALOGX. MIRALOGX further represents that it has had an opportunity to ask questions and receive satisfactory answers from representatives of Telomir regarding the terms and conditions of this conversion, the Telomir Shares, the present and anticipated future financial condition of Telomir, and the present and anticipated business, properties, prospects and financial condition of Telomir.
5. Miscellaneous.
a. Governing Law; Venue. This Agreement shall be construed and interpreted according to the laws of the State of Florida without reference to the rules of conflicts of law. All disputes arising out of or relating to this Agreement will be resolved exclusively in the state or federal courts located in Hillsborough County, Florida, and the Parties hereto hereby consent to the jurisdiction of such courts for this purpose.
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b. Notices. All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given when hand delivered, including, without limitation, by Federal Express or other delivery service, or telecopied (transmission confirmed), or when mailed, certified or registered mail, with postage prepaid addressed to the Party at its last known address, or to such other person or address as the Party to receive such notice may have designated from time to time by notice in writing pursuant hereto.
c. Entire Agreement. This Agreement embodies the entire agreement and understanding between the Parties hereto and supersedes all prior agreements and understandings related to the subject matter hereof.
d. Binding Effect. This Agreement shall be binding upon and shall inure to the benefit of the Parties hereto and their respective heirs, successors and assigns.
e. Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original as against any Party whose signature appears thereon, and all of which together shall constitute one and the same agreement. The Parties agree that this Agreement may be executed by each Party signing one original and providing a facsimile (fax) or scanned copy of the signature page to the Party, provided that the Party agrees that the fax or scanned signature shall be treated as if it were an original signature, and no Party shall contest the validity of this Agreement based on the use of fax or scanned signatures.
f. Assignment. Neither this Agreement nor any rights or obligations hereunder may be assigned or delegated by any Party without the prior written consent of the other Party.
g. Construction. The captions in this Agreement are inserted only as a matter of convenience and in no way affect the terms or intent of any provision of this Agreement. All phrases, pronouns, and other variations thereof shall be deemed to refer to the masculine, feminine, neuter, singular, or plural, as the actual identity of the organization, person, or persons may require. No provision of this Agreement shall be construed against any Party hereto by reason of the extent to which such Party or its counsel participated in the drafting hereof.
[Signature Page to Immediately Follow]
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IN WITNESS WHEREOF, the undersigned have executed this Agreement effective as of the Effective Date.
Telomir Pharmaceuticals, Inc. | ||
By: | /s/ Nathen Fuentes | |
Nathen Fuentes, Chief Financial Officer |
MIRALOGX LLC | ||
By: | /s/ Brian McNulty | |
Print Name: | Brian McNulty | |
Title: | Trustee of the Bay Shore Trust, sole member of MIRALOGX LLC |
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Exhibit 10.11
DEBT Conversion Agreement
This Debt Conversion Agreement (this “Agreement”) is entered into effective as of November 30, 2023 (the “Effective Date”) by and between the Bay Shore Trust (“Bay Shore Trust”), and Telomir Pharmaceuticals, Inc., a Florida corporation with its principal executive office located at 855 N Wolfe Street, Suite 601, Baltimore, Maryland 21205 (“Telomir”); Bay Shore Trust and Telomir together the “Parties” to this Agreement.
W I T N E S S E T H
WHEREAS, Bay Shore Trust has advanced funds to Telomir pursuant to a line of credit in an aggregate amount of $1,383,005 (the “Debt”); and
WHEREAS, the Parties have mutually agreed to effect a conversion of the Debt into fully paid and non-assessable shares of common stock, no par value, of Telomir (the “Common Stock”) at a conversion price of $1.00 per share.
NOW, THEREFORE, in consideration of the premises stated herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, it is hereby agreed that:
1. Recitals. The foregoing recitals are true and correct and are incorporated herein by reference.
2. Conversion. Telomir and the Bay Shore Trust hereby agree that the Debt is hereby converted as of the Effective Date into an aggregate of 1,383,005 shares of Telomir Common Stock (the “Conversion Shares”). From and after the Effective Date, the Bay Shore Trust shall for all purposes be deemed to have owned the Conversion Shares, and the entire $1,383,005 of the Debt shall be deemed paid in full and extinguished.
3. Representations and Warranties of Telomir. Telomir hereby makes the following representations and warranties to the Bay Shore Trust as of the Effective Date (which representations and warranties shall survive the Effective Date):
a. Telomir is a duly organized, validly existing and in good standing corporation under the laws of the State of Florida, with all requisite power and authority to own, operate and conduct its business as now being conducted.
b. All corporate action on the part of Telomir necessary for the authorization, execution, delivery and performance of this Agreement has been taken. This Agreement constitutes the valid and legally binding obligation of Telomir, enforceable in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies.
c. The Conversion Shares received hereunder are, and will be upon the issuance thereof, validly issued, fully paid, and non-assessable.
4. Representations and Warranties of the Bay Shore Trust. The Bay Shore Trust represents, warrants, covenants and agrees (which representations, warranties, covenants, and agreements shall be and be deemed to be continuing and survive the Effective Date) as follows:
a. The Bay Shore Trust is an “Accredited Investor” as defined in Rule 501 of Regulation D promulgated under the Securities Act of 1933, as amended (the “Act”). The Bay Shore Trust has been advised and understands that (i) there are substantial limitations under applicable securities laws on the transferability of the Conversion Shares; (ii) the Conversion Shares have not been and will not be registered under the Act; (iii) there is no public market for the Conversion Shares, and there may never be a public market for such shares; and (iv) Telomir has not covenanted to make “current public information” available for purposes of Rule 144 under the Act. Accordingly, it may be impossible for the Bay Shore Trust to liquidate the investment in the Conversion Shares.
b. The Bay Shore Trust is accepting the Conversion Shares for its own account, for investment purposes only, and without a view towards the sale or distribution thereof.
c. The Bay Shore Trust has sufficient knowledge and experience in financial and business matters to evaluate the merits and risk of conversion of the Debt and acceptance of the Conversion Shares. The Bay Shore Trust is able to bear the economic risks of this conversion and at the present time could afford a complete loss of any and all value received hereunder.
d. The Bay Shore Trust believes it has received all the information it considers necessary or appropriate for deciding whether to acquire the Telomir Shares. In addition, the Bay Shore Trust represents and warrants that Telomir has made available for inspection by the Bay Shore Trust various documents connected with Telomir’s business and has not refused in any way to permit the Bay Shore Trust to inspect any document requested to be inspected by the Bay Shore Trust. The Bay Shore Trust further represents that it has had an opportunity to ask questions and receive satisfactory answers from representatives of Telomir regarding the terms and conditions of this conversion, the Telomir Shares, the present and anticipated future financial condition of Telomir, and the present and anticipated business, properties, prospects and financial condition of Telomir.
5. Miscellaneous.
a. Governing Law; Venue. This Agreement shall be construed and interpreted according to the laws of the State of Florida without reference to the rules of conflicts of law. All disputes arising out of or relating to this Agreement will be resolved exclusively in the state or federal courts located in Hillsborough County, Florida, and the Parties hereto hereby consent to the jurisdiction of such courts for this purpose.
b. Notices. All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given when hand delivered, including, without limitation, by Federal Express or other delivery service, or telecopied (transmission confirmed), or when mailed, certified or registered mail, with postage prepaid addressed to the Party at its last known address, or to such other person or address as the Party to receive such notice may have designated from time to time by notice in writing pursuant hereto.
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c. Entire Agreement. This Agreement embodies the entire agreement and understanding between the Parties hereto and supersedes all prior agreements and understandings related to the subject matter hereof.
d. Binding Effect. This Agreement shall be binding upon and shall inure to the benefit of the Parties hereto and their respective heirs, successors and assigns.
e. Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original as against any Party whose signature appears thereon, and all of which together shall constitute one and the same agreement. The Parties agree that this Agreement may be executed by each Party signing one original and providing a facsimile (fax) or scanned copy of the signature page to the Party, provided that the Party agrees that the fax or scanned signature shall be treated as if it were an original signature, and no Party shall contest the validity of this Agreement based on the use of fax or scanned signatures.
f. Assignment. Neither this Agreement nor any rights or obligations hereunder may be assigned or delegated by any Party without the prior written consent of the other Party.
g. Construction. The captions in this Agreement are inserted only as a matter of convenience and in no way affect the terms or intent of any provision of this Agreement. All phrases, pronouns, and other variations thereof shall be deemed to refer to the masculine, feminine, neuter, singular, or plural, as the actual identity of the organization, person, or persons may require. No provision of this Agreement shall be construed against any Party hereto by reason of the extent to which such Party or its counsel participated in the drafting hereof.
[Signature Page to Immediately Follow]
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IN WITNESS WHEREOF, the undersigned have executed this Agreement effective as of the Effective Date.
Telomir Pharmaceuticals, Inc. | ||
By: | /s/ Nathen Fuentes | |
Nathen Fuentes, Chief Financial Officer |
Bay Shore Trust | ||
By: | /s/ Brian McNulty | |
Print Name: | Brian McNulty | |
Title: | Trustee |
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Exhibit 14.1
TELOMIR PHARMACEUTICALS, INC.
CODE OF ETHICS AND CONDUCT
In accordance with the requirements of the Securities and Exchange Commission (the “SEC”) and the Initial Listing Standards of the Nasdaq Stock Exchange (“Nasdaq”), the Board of Directors (the “Board”) of Telomir Pharmaceuticals, Inc. (the “Company”) has adopted this Code of Ethics and Conduct (the “Code”) to encourage:
● | Honest and ethical conduct, including fair dealing and the ethical handling of actual or apparent conflicts of interest; | |
● | Full, fair, accurate, timely and understandable disclosure; | |
● | Compliance with applicable governmental laws, rules and regulations; | |
● | Prompt internal reporting of any violations of law or the Code; | |
● | Accountability for adherence to the Code, including fair process by which to determine violations; | |
● | Consistent enforcement of the Code, including clear and objective standards for compliance; | |
● | Protection for persons reporting any such questionable behavior; | |
● | The protection of the Company’s legitimate business interests, including its assets and corporate opportunities; and | |
● | Confidentiality of information entrusted to directors, officers and employees by the Company and its customers. |
All directors, officers and employees of the Company (each a “Covered Party” and, collectively, the “Covered Parties”) are expected to be familiar with the Code and to adhere to the principles and procedures set forth below.
This Code is not intended to be a comprehensive rulebook and cannot address every situation that you may face. If you feel uncomfortable about a situation or have any doubts about whether it is consistent with the Company’s ethical standards, seek help. We encourage you to contact your supervisor for help first. If your supervisor cannot answer your question or if you do not feel comfortable contacting your supervisor, contact the Company’s Chief Financial Officer or another senior executive of the Company.
I. | Conflicts of Interest |
A conflict of interest occurs when the private interests of a Covered Party interfere, or appear to interfere, with the interests of the Company as a whole.
For example, a conflict of interest can arise when a Covered Party takes actions or has personal interests that may make it difficult to perform his or her Company duties objectively and effectively. A conflict of interest may also arise when a Covered Party, or a member of his or her immediate family, receives improper personal benefits as a result of his or her position at the Company.
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Conflicts of interest can also occur indirectly. For example, a conflict of interest may arise when a Covered Party is also an executive officer, a major shareholder or has a material interest in a company or organization doing business with the Company.
Each Covered Party has an obligation to conduct the Company’s business in an honest and ethical manner, including the ethical handling of actual or apparent conflicts of interest between personal and professional relationships. Any situation that involves, or may reasonably be expected to involve, a conflict of interest with the Company, should be disclosed promptly to the Company’s Chief Executive Officer, Chief Financial Officer or the Board.
This Code does not attempt to describe all possible conflicts of interest that could develop. Other common conflicts from which Covered Parties must refrain are set out below:
● | Covered Parties may not engage in any conduct or activities that are inconsistent with the Company’s best interests or that disrupt or impair the Company’s relationship with any person or entity with which the Company has or proposes to enter into a business or contractual relationship. | |
● | Covered Parties may not accept compensation, in any form, for services performed for the Company from any source other than the Company. | |
● | No Covered Party may take up any management or other employment position with, or have any material interest in, any firm or company that is in direct or indirect competition with the Company. |
II. | Disclosures |
The information in the Company’s public communications, including in all reports and documents filed with or submitted to the SEC, must be full, fair, accurate, timely and understandable.
To ensure the Company meets this standard, all Covered Parties (to the extent they are involved in the Company’s disclosure process) are required to maintain familiarity with the disclosure requirements, processes and procedures applicable to the Company commensurate with their duties. Covered Parties are prohibited from knowingly misrepresenting, omitting or causing others to misrepresent or omit, material facts about the Company to others, including the Company’s independent auditors, governmental regulators and self-regulatory organizations.
III. | Compliance with Laws, Rules and Regulations |
The Company is obligated to comply with all applicable laws, rules and regulations. It is the personal responsibility of each Covered Party to adhere to the standards and restrictions imposed by these laws, rules and regulations in the performance of his or her duties for the Company.
The Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer or Controller (or persons performing similar functions) of the Company (together, the “Senior Financial Officers”) are also required to promote compliance by all employees with the Code and to abide by Company standards, policies and procedures.
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IV. | Insider Trading |
Trading on inside information is a violation of federal securities law. Covered Parties in possession of material non-public information about the Company or companies with whom we do business must abstain from trading or advising others to trade in the respective company’s securities from the time that they obtain such inside information until adequate public disclosure of the information. Material information is information of such importance that it can be expected to affect the judgment of investors as to whether or not to buy, sell, or hold the securities in question. To use non-public information for personal financial benefit or to “tip” others, including family members, who might make an investment decision based on this information is not only unethical but also illegal. Covered Parties who trade stock based on insider information can be personally liable for damages totaling up to three times the profit made or loss avoided by the respective Covered Party. You are required to read carefully and observe our Insider Trading Policy, as amended from time to time. Please contact the Company’s Chief Financial Officer for a copy of the Insider Trading Policy or with any questions you may have about insider trading laws.
V. | Reporting, Accountability and Enforcement |
The Company promotes ethical behavior at all times and encourages Covered Parties to talk to supervisors, managers and other appropriate personnel, including the officers, outside counsel for the Company and the Board or the relevant committee thereof, when in doubt about the best course of action in a particular situation. All Covered Persons have a duty to report suspected violations of laws, rules, regulations or the Code. If you know of or suspect such a violation, immediately report the conduct to your supervisor or other appropriate Company personnel, Board or relevant committee thereof. All reports of known or suspected violations of the law or this Code will be handled sensitively and with discretion. The Company and any others assisting in the investigation will protect your confidentiality to the extent possible, consistent with applicable laws, regulations and the Company’s need to investigate your concern.
The Audit Committee of the Board or other appropriate officer or body shall investigate and determine, or shall designate appropriate persons to investigate and determine, the legitimacy of such reports. The Audit Committee or other appropriate officer or body will then determine the appropriate disciplinary action. Such disciplinary action includes, but is not limited to, reprimand, termination with cause, and possible civil and criminal prosecution.
To encourage reporting of any and all violations, the Company will not tolerate retaliation for reports and assisting in investigating reports made in good faith. Retaliation or retribution against any Covered Party for a report or assistance in investigating a report made in good faith of any suspected violation of laws, rules, regulations or this Code is cause for appropriate disciplinary action.
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VI. | Corporate Opportunities |
All Covered Parties owe a duty to the Company to advance the legitimate interests of the Company when the opportunity to do so arises. Covered Parties are prohibited from directly or indirectly (a) taking personally for themselves opportunities that are discovered through the use of Company property, information or positions; (b) using Company property, information or positions for personal gain; or (c) competing with the Company for business opportunities; provided, however, if the Company’s disinterested directors of the Board determine that the Company will not pursue an opportunity that relates to the Company’s business, a Covered Party may do so, after notifying the disinterested directors of the Board of intended actions in order to avoid any appearance of conflict of interest.
VII. | Confidentiality |
In carrying out the Company’s business, Covered Parties may learn confidential or proprietary information about the Company, its customers, distributors, suppliers or joint venture partners. Confidential or proprietary information includes all non-public information relating to the Company, or other companies, that would be harmful to the relevant company or useful or helpful to competitors if disclosed.
Covered Parties must maintain the confidentiality of all information so entrusted to them, except when disclosure is authorized or legally mandated. Covered Parties must safeguard confidential information by keeping it secure, limiting access to those who have a need to know in order to do their job, and avoiding discussion of confidential information in public areas such as planes, elevators, and restaurants and on mobile phones. This prohibition includes, but is not limited to, inquiries made by the press, analysts, investors or others. Covered parties also may not use such information for personal gain. These confidentiality obligations continue even after employment with the Company ends.
VIII. | Fair Dealing |
Each Covered Party should endeavor to deal fairly with fellow employees and with the Company’s customers, service providers, suppliers and competitors. No Covered Party should take unfair advantage of anyone through manipulation, concealment, abuse of privileged information, misrepresentation of material facts, or any unfair dealing practice.
IX. | Protection and Proper Use of Company Assets |
All Covered Parties should protect the Company’s assets and ensure their efficient use. Theft, carelessness and waste have a direct impact on the Company’s profitability. All Company assets should be used only for legitimate business purposes. The obligation of employees to protect the Company’s assets includes its proprietary information. Proprietary information includes intellectual property such as trade secrets, patents, trademarks and copyrights, as well as business, marketing and service plans, engineering and manufacturing ideas, designs, databases, records, salary information and any unpublished financial data and reports.
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X. | Waivers |
Any waiver of this Code for our directors, executive officers or other principal financial officers may be made only by our Board or a duly authorized committee thereof and will be disclosed to the public as required by law or the rules of Nasdaq, when applicable. Waivers of this Code for other employees may be made only by our Chief Executive Officer or Chief Financial Officer and will be reported to our Audit Committee.
XI. | Accuracy of Business Records |
All financial books, records and accounts must accurately reflect transactions and events, and conform both to generally accepted accounting principles (GAAP) and to the Company’s system of internal controls. No entry may be made that intentionally hides or disguises the true nature of any transaction. Covered Parties should therefore attempt to be as clear, concise, truthful and accurate as possible when recording any information.
XII. | Gifts and Favors |
The purpose of business gifts and entertainment in a commercial setting is to create goodwill and sound working relationships, not to gain unfair advantage with customers. Covered Parties must act in a fair and impartial manner in all business dealings. Gifts and entertainment should further the business interests of the Company and not be construed as potentially influencing business judgment or creating an obligation.
Gifts must not be lavish or in excess of the generally accepted business practices of one’s country and industry. Gifts of cash or cash equivalents are never permitted. Requesting or soliciting personal gifts, favors, entertainment or services is unacceptable. Covered Parties should contact the officers, outside counsel for the Company and the Board or the relevant committee thereof to discuss if they are not certain that a gift is appropriate.
The Foreign Corrupt Practices Act prohibits giving anything of value, directly or indirectly, to officials of foreign governments or foreign political candidates in order to obtain or retain business. It is strictly prohibited to make illegal payments to government officials of any country. In addition, the promise, offer or delivery to an official or employee of the U.S. government of a gift, favor or other gratuity in violation of these rules would not only violate Company policy but could also be a criminal offense. State and local governments, as well as foreign governments, may have similar rules.
XIII. | Antitrust Laws and Competition |
The purpose of antitrust laws is to preserve fair and open competition and a free market economy, which are goals that the Company fully supports. Covered Parties must not directly or indirectly enter into any formal or informal agreement with competitors that fixes or controls prices, divides or allocates markets, limits the production or sale of products, boycotts certain suppliers or customers, eliminates competition or otherwise unreasonably restrains trade.
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XIV. | Political Contributions |
Covered Parties may participate in the political process as individuals on their own time. However, Covered Parties must make every effort to ensure that they do not create the impression that they speak or act on behalf of the Company with respect to political matters. Company contributions to any political candidate or party or to any other organization that might use the contributions for a political candidate or party are prohibited. A Covered Party may not receive any reimbursement from corporate funds for a personal political contribution.
XV. | Discrimination and Harassment |
The Company is an equal opportunity employer and will not tolerate illegal discrimination or harassment of any kind. The Company is committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, sexual orientation, disability, veteran status, or any other basis prohibited by applicable law. Examples include derogatory comments based on a person’s protected class and sexual harassment and unwelcome sexual advances. Similarly, offensive or hostile working conditions created by such harassment or discrimination will not be tolerated.
XVI. | Environmental Protection |
The Company is committed to managing and operating its assets in a manner that is protective of human health and safety and the environment. It is our policy to comply with both the letter and the spirit of the applicable health, safety and environmental laws and regulations and to attempt to develop a cooperative attitude with government inspection and enforcement officials. Covered Parties are encouraged to report conditions that they perceive to be unsafe, unhealthy or hazardous to the environment.
XVII. | Personal Conduct and Social Media Policy |
Covered Parties should take care when presenting themselves in public settings, as well as online and in web-based forums or networking sites. Each Covered Party is encouraged to conduct himself or herself in a responsible, respectful, and honest manner at all times. The Company understands that Covered Parties may wish to create and maintain a personal presence online using various forms of social media. However, in so doing Covered Parties should include a disclaimer that the views expressed therein do not necessarily reflect the views of the Company. Covered Parties should be aware that that even after a posting is deleted, certain technology may still make that content available to readers.
Covered Parties are prohibited from using or disclosing confidential, proprietary, sensitive or trade secret information of the Company, its partners, vendors, consultants or other third parties with which the Company does business. Harassment of other directors, officers or employees will also not be tolerated. A Covered Party may not provide any content to Company social media sites that may be construed as political lobbying or solicitation of contributions, or use the sites to link to any sites sponsored by or endorsing political candidates or parties, or to discuss political campaigns, political issues or positions on any legislation or law.
XVIII. | No Rights Created |
This Code is a statement of certain fundamental principles, policies and procedures that govern the Company’s Covered Parties in the conduct of the Company’s business. It is not intended to and does not create any rights in any employee, customer, client, visitor, supplier, competitor, shareholder or any other person or entity. It is the Company’s belief that the policy is robust and covers most conceivable situations.
Approved by the Telomir Pharmaceuticals, Inc. Board of Directors on December 8, 2023.
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Exhibit 21.1
List of Subsidiaries of Telomir Pharmaceuticals, Inc.
Legal Name | Jurisdiction |
None | Not applicable |
Exhibit 23.1
Consent of Independent Accountants
We hereby consent to the incorporation by reference in this Registration Statement and Prospectus of Telomir Pharmaceuticals, Inc., of our report dated August 14, 2023, with respect to our audits of the financial statements of Telomir Pharmaceuticals, Inc. as of December 31, 2022 and 2021 and for each of the years in the two-year period ended December 31, 2022. We also consent to the reference to us under the heading “Experts” in such Registration Statement and Prospectus.
/s/ Cherry Bekaert LLP
Tampa, Florida
November 14, 2023
Exhibit 99.1
TELOMIR PHARMACEUTICALS, INC.
AUDIT COMMITTEE CHARTER
The Board of Directors (the “Board”) of Telomir Pharmaceuticals, Inc. (the “Company”) has established a standing Audit Committee (the “Committee”) pursuant to Section 607.0825 of the Florida Business Corporation Act (“FBCA”) and for the purposes described in this charter of the Committee (the “Committee Charter”).
I. | Purpose of the Committee |
The purpose of the Committee is to assist the Board in its oversight and monitoring of:
● | the integrity of the Company’s financial statements and other financial information provided by the Company to its shareholders; | |
● | the Company’s system of internal control over financing reporting; | |
● | the Company’s compliance with legal and regulatory requirements; | |
● | the independent registered public accountants (the “Auditors”), including their independence and qualifications; and | |
● | the performance of the Company’s internal audit function and the Auditors. |
The Committee shall also prepare the audit committee report for inclusion in the Company’s annual proxy statement as required by the applicable rules and regulations of the United States Securities and Exchange Commission (the “SEC”). In the course of fulfilling its purpose, the Committee may maintain free and open communication between the Board, the Company’s Auditors and the financial management of the Company. In addition, the Committee shall promote with the Company’s management, an environment of high integrity and control consciousness.
II. | Organization |
Members of the Committee shall be appointed by the Board. The Committee shall consist of at least three members of the Board, each of whom shall be independent in accordance with the requirements of Rule 10A-3 of the Securities Exchange Act of 1934 and the rules of the Nasdaq Stock Exchange, and otherwise meet the qualifications set forth herein.
All members of the Committee shall have a basic understanding of finance and accounting and be able to read and understand fundamental financial statements, including the Company’s balance sheet, income statement and cash flow statement. At least one member of the Committee shall have accounting or related financial management expertise or be considered an “audit committee financial expert” as defined in Item 407 of Regulation S-K.
The chair of the Committee (the “Chair”) shall be designated by the full Board or, if it does not do so, the Committee members shall elect a Chair by vote of a majority of the full Committee. No member of the Committee may serve simultaneously on the audit committee of more than two other public companies. The members of the Committee shall serve until their successors are appointed and qualified, or until such member’s earlier resignation or removal. The Board may remove any member from the Committee at any time with or without cause.
The Committee may form and delegate authority to subcommittees when appropriate, as permitted by the charter and bylaws of the Company and consistent with the FBCA. The Committee shall have the authority to engage independent counsel and other advisors, as the Committee deems necessary to carry out its duties. The Committee shall determine and receive appropriate funding from the Company for payment of compensation to any independent counsel or other advisors engaged by the Committee and ordinary administrative expenses of the Committee that are necessary or appropriate in carrying out its duties.
III. | Structure and Meetings |
The Chair will preside at each meeting, and in consultation with the other members of the Committee, will set the frequency and length of each meeting and the agenda of items to be addressed at each meeting; provided, that the Committee shall meet no less frequently than quarterly. If a Chair is not designated or present, the members of the Committee may designate a chair of the meeting by majority vote of the Committee membership. To the extent beneficial to the Committee, the Chair, or in such person’s absence the chair of the meeting, may circulate an agenda for each meeting in advance of the meeting.
The Committee should meet privately in executive session at least annually with management, the Auditors, and as a committee to discuss any matters that the Committee or any of these groups believe should be discussed. In addition, the Committee, or at least its Chair, should communicate with management and the Auditors quarterly to review the Company’s financial statements and significant findings based upon the Auditors’ limited review procedures.
A majority of the members of the Committee shall constitute a quorum for the transaction of business. The Committee may act only upon the approval of a majority of its members. The action of the Committee at a meeting at which a quorum is present shall be the act of the Committee. The Committee may act in writing by the unanimous consent of its members.
IV. | Duties and Responsibilities |
In carrying out its purpose, the Committee shall maintain the flexibility to react to changing conditions and may adopt such policies and procedures as it shall deem appropriate to fulfill its oversight and monitoring responsibilities. The Committee shall also undertake such other tasks as may be delegated to it, from time-to-time, by the Board. Specific duties and responsibilities of the Committee are as follows:
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Financial Statements
1. | Review and discuss with management and the Auditors: |
● | the Company’s annual audited financial statements and quarterly unaudited financial statements, including Management’s Discussion and Analysis of Financial Condition and Results of Operations. This review must be prior to filing of the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, respectively with the SEC; | |
● | the Auditors’ audit of the annual financial statements and their report thereon; | |
● | the accompanying management letter and any reports with respect to interim periods; | |
● | any material changes to the Company’s accounting principles and practices used in preparing the financial statements to be filed with the SEC; | |
● | any significant changes required in the Auditors’ audit plan; | |
● | any difficulties or disputes with management encountered during the course of the audit; and | |
● | other matters related to the conduct of the audit that are to be communicated to the Committee under the auditing standards of the Public Company Accounting Oversight Board (the “PCAOB”). |
2. | Review and discuss the Company’s earnings press releases, including the use of non-GAAP financial measures, prior to public disclosure. |
3. | Discuss with the Auditors the financial statements and audit findings, including any significant adjustments, management judgements and accounting estimates, significant new accounting policies and disagreements with management and any other matters required to be discussed by the rules and regulations of the PCAOB and SEC. |
4. | Review disclosures made by the Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”) regarding significant deficiencies or material weaknesses in the design or operation of the Company’s internal controls over financial reporting that are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information and any fraud that involves management or other employees that have a significant role in the Company’s internal control over financial reporting. The Committee shall also review disclosures made by the CEO and CFO regarding the effectiveness of the Company’s disclosure controls and procedures. |
Independent Auditors
5. | Have the sole authority and responsibility to appoint, determine the compensation of, retain, and oversee the work of the Auditors (including resolution of disagreements between management and the Auditors regarding financial reporting) for the purpose of preparing or issuing an audit report or related work. The Committee shall also have the sole authority to propose and approve the discharge of the Auditors when circumstances warrant. The Auditors shall report directly to the Committee. |
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6. | Pre-approve all audit and permissible non-audit services to be provided to the Company by the Auditors. The Committee shall have the sole authority to approve the hiring and firing of the Auditors and all fees and terms of audit and non-audit engagements with the Auditors, in each case as may be permissible and compatible with the Auditors independence. |
7. | Review annually the independence and performance of the Auditors. |
8. | Review and discuss with the Auditors all significant relationships that could impair the Auditors’ independence including, but not limited to, review of the Auditors’ formal written statement delineating all relationships between the Auditors and the Company. |
9. | Review the Auditors’ audit plan, and discuss scope, staffing, locations, reliance upon management, and internal audit and general audit approach. |
10. | Review with the Auditors and management the opinion to be issued by the Auditors on the financial statements and the disclosures to be included in the Company’s annual report on Form 10-K. |
11. | Review with the Auditors and management the quarterly financial statements to be included in the Company’s quarterly report on Form 10-Q. |
12. | Prior to releasing the year-end earnings, discuss the results of the audit with the Auditors. |
13. | Consider the Auditors’ judgments about the quality and appropriateness of the Company’s accounting principles as applied in its financial reporting and discuss with the Auditors the scope of their annual audit and key risk areas. |
14. | Obtain and review, at least annually, a report by the Auditors describing the Auditors’ internal quality-control procedures and any material issues raised by the most recent internal quality-control review, peer review, PCAOB review, or any other investigation by governmental or professional authorities. |
15. | Review and approve the Company’s hiring of employees of the Auditors who were engaged on the Company’s account. |
Internal Audit
16. | Review the appointment and replacement of the senior internal auditing employee. |
17. | Appoint, determine the compensation, evaluate the scope, and oversee the work of any consultants or accountants retained for internal auditing purposes. |
18. | Review the significant reports to management prepared by the internal auditing department (including reports of any consultants or accountants retained for internal auditing purposes) and management’s responses. |
19. | Review the audit plan, scope of work, progress, and results of the internal auditing department. |
20. | Discuss with the Auditors and management the internal audit department responsibilities, budget and staffing and any recommended changes in the planned scope of the internal audit. |
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Information Technology and Cybersecurity
21. | Provide oversight of policies, procedures, plans, and execution intended to provide security, confidentiality, availability, and integrity of the Company’s information. |
22. | Oversee the quality and effectiveness of the Company’s policies and procedures with respect to its information technology systems, including privacy, network security and data security. |
23. | Review and provide oversight on the policies and procedures of the Company in preparation for responding to any material incidents. |
24. | Periodically review with management the Company’s disaster recovery capabilities. |
25. | Oversee the Company’s management of risks related to its information technology systems and processes, including privacy, network security and data security, and any internal audits of such systems and processes. |
26. | Periodically review risk assessments from management with respect to cybersecurity, including the adequacy and effectiveness of the Company’s internal controls regarding cybersecurity, emerging cybersecurity developments and trends, and the Company’s strategy to mitigate cybersecurity risks. |
27. | Oversee the Company’s information technology senior management team relating to budgetary priorities based, in part, on assessing risk associated with various perceived threats. |
28. | Review the Company’s information technology strategy or programs relating to new technologies, applications, and systems. |
29. | Perform such other functions as may be necessary or appropriate in the efficient and lawful discharge of the foregoing. |
Complaints
30. | Establish and monitor procedures for the receipt, retention and treatment of complaints received by the Company regarding accounting, internal accounting controls or auditing matters, including procedures for the confidential, anonymous submission by employees of the Company of concerns regarding questionable accounting or auditing matters. The Committee shall review and take such action, as they deem necessary or appropriate, with respect to complaints or concerns received from employees or others on accounting, internal accounting controls or auditing matters. |
Reporting Matters
31. | Annually prepare a report to shareholders of the Company as required by the SEC. The report should be included in the Company’s annual proxy statement on Schedule 14A. |
32. | Maintain minutes of meetings, ensuring that the minutes document all significant issues that have been discussed during the meetings with the Auditors, management and legal counsel, and all decisions made by the audit committee outside of their formal meetings, such as approval of the Auditors’ fees or approval of non-audit services. |
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Reports by Attorneys
33. | Review, make appropriate investigations and responses, and take such other actions, as the Committee deems necessary or appropriate and in compliance with applicable laws and regulations, with respect to any reports from any attorneys of evidence of a material violation of securities law or breach of fiduciary duty or similar violation by the Company or any of its agents. Additionally, the Committee shall review periodically with the Company’s outside securities counsel those legal and regulatory matters that may have a material impact on the Company’s financial statements or otherwise materially affect compliance policies and programs in the Committee’s areas of responsibility. |
Related Party Transactions
34. | Approve, if the duty is not delegated to a comparable body of the Board, all material related party transactions, which refers to transactions required to be disclosed under Item 404 of Regulation S-K of the Exchange Act. |
General Duties
35. | Work with the Nominating & Governance Committee to perform an annual self-assessment of the performance of the Committee. |
36. | Review this Charter at least annually and thereafter report any recommended modifications thereto to the Board for consideration and, if appropriate, adoption thereof. |
37. | Review with the Company’s CEO on a periodic basis the status of any material pending orders, significant changes in current projects, and any other matters that could significantly affect the Company’s financial status. |
38. | Perform any other activities consistent with this Committee Charter, the Company’s by-laws, and governing law, as the Committee or the Board deems necessary or appropriate. |
V. | Disclosure of Committee Charter |
This Committee Charter will be made available on the Company’s website.
Approved by the Telomir Pharmaceuticals, Inc. Board of Directors on December 8, 2023.
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Exhibit 99.2
telomir PHARMACEUTICALS, INC.
NOMINATING & GOVERNANCE COMMITTEE CHARTER
The Board of Directors (the “Board”) of Telomir Pharmaceuticals, Inc. (the “Company”) has established a standing Nominating & Governance Committee (the “Committee”) pursuant to Section 607.0825 of the Florida Business Corporation Act (“FBCA”) and for the purposes described in this charter of the Committee (the “Committee Charter”).
I. Purpose
The primary objectives of the Committee are to assist the Board by: (i) identifying and screening individuals qualified to become Board members and recommending to the Board a group of director nominees for the next annual meeting of the Company’s stockholders; (ii) ensuring that the Audit, Compensation, and Nominating & Governance Committees of the Board shall have the benefit of qualified and experienced “independent” directors; and (iii) overseeing and making recommendations concerning the Company’s corporate governance.
II. Organization
The Committee shall consist of at least three members of the Board each of whom shall be independent in accordance with the requirements of the rules of the Nasdaq Stock Exchange, and otherwise meet the qualifications set forth herein. Prior to appointing any member of the Committee, the Board shall affirmatively determine that such individual is independent under the rules of the Nasdaq Stock Exchange and, in making such determination, consider all factors specifically relevant to determining whether a director has a relationship to the Company that is material to that director’s ability to be independent from management in connection with the duties of a Committee member, including, but not limited to: (A) the source of compensation of such director, including any consulting, advisory, or other compensatory fee paid by the Company to such director; and (B) whether such director is affiliated with the Company, a subsidiary of the Company, or an affiliate of a subsidiary of the Company. The Board shall appoint the members of the Committee, who shall serve until their successors are appointed and qualified, or until such member’s earlier resignation or removal.
Notwithstanding the above, one director of the Company who is not independent in accordance with the requirements of the rules of the Nasdaq Stock Exchange, but is not a current officer or employee or an immediate family member of such person, may be appointed to the Committee, if the Board, under exceptional and limited circumstances, determines that membership on the Committee by the individual is required by the best interests of the Company and its stockholders, and the Board discloses, in the next annual meeting proxy statement (or in its next annual report filed with the SEC on Form 10-K if the Company does not file an annual proxy statement) subsequent to such determination, the nature of the relationship and the reasons for that determination. A director appointed to the Committee pursuant to this exception may not serve for a period in excess of two years.
The chair of the Committee (the “Chair”) may be designated by the full Board or, if it does not do so, the Committee members shall elect a Chair by vote of a majority of the full Committee. The Board may remove any member from the Committee at any time with or without cause.
The Committee may form and delegate authority to subcommittees when appropriate, as permitted by the charter and bylaws of the Company and consistent with the FBCA. The Committee shall have the authority to engage independent counsel and other advisors as the Committee deems necessary to carry out its duties. The Committee shall determine and receive appropriate funding from the Company for payment of compensation to any independent counsel or other advisors engaged by the Committee and ordinary administrative expenses of the Committee that are necessary or appropriate in carrying out its duties.
III. Structure and Meetings
The Chair will preside at each meeting, and in consultation with the other members of the Committee, will set the frequency and length of each meeting and the agenda of items to be addressed at each meeting; provided, that the Committee shall meet no less frequently than annually. If a Chair is not designated or present, the members of the Committee may designate a chair of the meeting by majority vote of the Committee membership. To the extent beneficial to the Committee, the Chair, or in such person’s absence the chair of the meeting, may circulate an agenda for each meeting in advance of the meeting.
The Committee may invite to its meetings any director, member of management of the Company, and such other persons as it deems appropriate in order to carry out its responsibilities; provided, however, that the Chairman of the Board and Chief Executive Officer of the Company (to the extent the latter is a director) shall each be entitled ex officio to attend, but not vote at, meetings of the Committee unless the Committee shall determine that their attendance is not appropriate.
IV. Duties and Responsibilities
The Committee shall: (i) make recommendation to the full Board on the size and composition of the Board; (ii) review possible candidates for Board membership, including candidates validly nominated by stockholders, consistent with the Board’s criteria for selecting new directors; (iii) annually recommend a slate of nominees to the Board with respect to election at the annual meeting of the Company’s stockholders; (iv) oversee evaluation of the Board and its directors, which may include developing and recommending an annual self-assessment process; (v) recommend to the Board director nominees to fill vacancies on the Board as necessary; (vi) develop and recommend to the Board a set of corporate governance principles applicable to the Company; (vii) review and make recommendations to the Board regarding corporate governance matters including, but not limited to, amendments to the charter and by-laws, as necessary and appropriate; (viii) develop procedures for the Committee’s consideration of director candidates nominated by the stockholders of the Company and administer such process; (ix) review stockholder proposals and recommend proposed responses by the Company including, but not limited to, responses for inclusion in the Company proxy statement; (x) oversee the Company’s management of operational risk and contingency planning for business continuity in areas other than information technology and cybersecurity; and (xi) develop and implement short- and long-term strategies to enhance and support each of the foregoing. The Committee may also make recommendations to the Board with respect to committee member qualifications, committee member appointments and removals, committee structure and operations, charters for other committees of the Company, and committee reporting to the Board. The Committee will annually review and reassess the adequacy of this Committee Charter and recommend any proposed changes to the Board for approval. The Committee shall regularly review and monitor compliance with the Company’s corporate governance guidelines, Conduct of Business Policy, Code of Ethics for Directors, the Principal Executive Officer, and Senior Financial Officers, and policies concerning trading in the Company’s securities, and make recommendations concerning such policies and guidelines to the Board. The Committee shall conduct an annual performance assessment of the Committee.
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V. Other Committee Responsibilities
The Committee shall maintain minutes of meetings, ensuring that the minutes document all significant issues that have been discussed during the meetings, and all decisions made by the Committee. The minutes of the Committee meetings will be presented to the Board for review at their Board meetings. The Chair of the Committee will provide additional comments to the Board as deemed appropriate.
VI. Disclosure of Committee Charter
This Committee Charter will be made available on the Company’s website.
Approved by the Telomir Pharmaceuticals, Inc. Board of Directors on December 8, 2023.
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Exhibit 99.3
TELOMIR PHARMACEUTICALS, INC.
COMPENSATION COMMITTEE CHARTER
The Board of Directors (the “Board”) of Telomir Pharmaceuticals, Inc. (the “Company”) has established a standing Compensation Committee (the “Committee”) pursuant to Section 607.0825 of the Florida Business Corporation Act (“FBCA”) and for the purposes described in this charter of the Committee (the “Committee Charter”).
I. | Purpose of the Committee |
The primary purpose of the Committee is to assist the Board in discharging its responsibilities in respect of compensation of the Company’s chief executive officer (the “CEO”) and other named executive officers (the “Named Executive Officers”). In addition, the Committee is charged with overall responsibility for approving and evaluating all incentive and equity compensation plans, policies, and programs of the Company as they affect the CEO, the Named Executive Officers, and other executive officers, and significant Company compensation matters and policies generally.
II. | Organization |
The Committee shall consist of at least three members of the Board, each of whom shall be independent in accordance with the requirements of the rules of the Nasdaq Stock Exchange (including those additional independence requirements specific to compensation committee membership) and otherwise meet the qualifications set forth herein. Prior to appointing any member of the Committee, the Board shall affirmatively determine that such individual is independent under the rules of the Nasdaq Stock Exchange and, in making such determination, consider all factors specifically relevant to determining whether a director has a relationship to the Company which is material to that director’s ability to be independent from management in connection with the duties of a Committee member, including, but not limited to: (A) the source of compensation of such director, including any consulting, advisory, or other compensatory fee paid by the Company to such director; (B) whether such director is affiliated with the Company, a subsidiary of the Company, or an affiliate of a subsidiary of the Company. The Board shall appoint the members of the Committee, who shall serve until their successors are appointed and qualified, or until such member’s earlier resignation or removal.
Notwithstanding the above, one director of the Company who is not independent in accordance with the rules of the Nasdaq Stock Exchange (including those additional independence requirements specific to compensation committee membership), but is not a current officer or employee or an immediate family member of such person, may be appointed to the Committee, if the Board, under exceptional and limited circumstances, determines that membership on the Committee by the individual is required by the best interests of the Company and its shareholders, and the Board discloses, in the next annual meeting proxy statement (or in its next annual report filed with the SEC on Form 10-K if the Company does not file an annual proxy statement) subsequent to such determination, the nature of the relationship and the reasons for that determination. A director appointed to the Committee pursuant to this exception may not serve for in excess of two years.
The chair of the Committee (the “Chair”) may be designated by the full Board or, if it does not do so, the Committee members shall elect a Chair by vote of a majority of the full Committee. The Board may remove any member from the Committee at any time with or without cause. The Committee may form and delegate authority to subcommittees when appropriate, as permitted by the charter and bylaws of the Company and consistent with the FBCA.
III. | Structure and Meetings |
The Chair will preside at each meeting, and in consultation with the other members of the Committee, will set the frequency and length of each meeting and the agenda of items to be addressed at each meeting; provided, that the Committee shall meet no less frequently than twice annually. If a Chair is not designated or present, the members of the Committee may designate a chair of the meeting by majority vote of the Committee membership. To the extent beneficial to the Committee, the Chair, or in such person’s absence the chair of the meeting, may circulate an agenda for each meeting in advance of the meeting. The CEO shall not be present during any voting or deliberations by the Committee on his or her compensation.
IV. | Duties and Responsibilities |
The Committee shall have the power and authority of the Board to perform the following duties and to fulfill the following responsibilities:
a. | on an annual basis, develop written guidelines and review the performance of the CEO, review and approve documented corporate goals relevant to the compensation of the CEO, evaluate and deliver a written assessment of the performance of the CEO in light of these goals and objectives, and set the compensation of the CEO based on this evaluation; |
b. | with the assistance of the CEO, annually review and approve corporate goals relevant to the compensation of Named Executive Officers and set the compensation of the Named Executive Officers, including without limitation any benefits packages; and annually review the Company’s overall employee benefits program; |
c. | produce an annual report on executive compensation for inclusion in the Company’s proxy statement, in accordance with applicable rules and regulations; |
d. | review and approve the Company’s cash incentive compensation or bonus plans and equity-based plans for Named Executive Officers, other Company officers, and (in the aggregate) other Company employees, establish criteria for the granting of cash and equity-based awards to the Company’s officers and other employees, and review and approve the granting of equity-based awards in accordance with such criteria; |
e. | review director compensation levels and practices, considering the results of the most recent stockholder advisory vote on incentive compensation, and recommend, from time to time, changes in such compensation levels and practices to the Board with equity ownership in the Company encouraged; |
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f. | review the Company’s incentive compensation arrangements to determine whether they encourage excessive risk, and evaluate compensation policies and practices that could mitigate any such risk; |
g. | develop and annually assess the effectiveness of retention and succession plans for the Company’s Chief Executive Officer, and review and approve retention and succession plans developed by the Company’s senior officers related to other important Company employees; |
h. | annually review and assess the adequacy of this Committee Charter and recommend any proposed changes to the Board for approval; |
i. | make recommendations to the Board with respect to (i) Committee member qualifications, (ii) Committee member appointments and removals, (iii) Committee structure and operations, and (iv) Committee reporting to the Board; and |
j. | perform an annual self-assessment of the performance of the Committee. |
V. | Committee Resources |
The Committee may, in its sole discretion, retain, or obtain the advice of a compensation consultant, independent legal counsel, or other adviser. The Committee shall be directly responsible for the appointment, compensation, and oversight of the work of any compensation consultant, independent legal counsel, or other adviser retained by the Committee. The Company shall provide for appropriate funding, as determined by the Committee, for payment of reasonable compensation to a compensation consultant, independent legal counsel, or any other adviser retained by the Committee.
The Committee may select a compensation consultant, legal counsel, or other adviser to the Committee only after taking into consideration all relevant factors, including the following: (i) the provision of other services to the Company by the person that employs the compensation consultant, legal counsel, or other adviser; (ii) the amount of fees received from the Company by the person that employs the compensation consultant, legal counsel, or other adviser, as a percentage of the total revenue of the person that employs the compensation consultant, legal counsel, or other adviser; (iii) the policies and procedures of the person that employs the compensation consultant, legal counsel, or other adviser that are designed to prevent conflicts of interest; (iv) any business or personal relationship of the compensation consultant, legal counsel, or other adviser with a member of the Committee; (v) any stock of the Company owned by the compensation consultant, legal counsel, or other adviser; and (vi) any business or personal relationship of the compensation consultant, legal counsel, other adviser, or the person employing the adviser, with an executive officer of the Company.
VI. | Other Committee Responsibilities |
The Committee shall maintain minutes of meetings, ensuring that the minutes document all significant issues that have been discussed during the meetings, and all decisions made by the Committee. The minutes of the Committee meetings will be presented to the Board for review at their Board meetings. The Chair of the Committee will provide additional comments to the Board as deemed appropriate.
VII. | Disclosure of Committee Charter |
This Committee Charter will be made available on the Company’s website.
Approved by the Telomir Pharmaceuticals, Inc. Board of Directors on December 8, 2023.
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Exhibit 99.4
TELOMIR PHARMACEUTICALS, INC.
CORPORATE GOVERNANCE GUIDELINES
The Board of Directors (the “Board”) of Telomir Pharmaceuticals, Inc. (the “Company”) has adopted the following Corporate Governance Guidelines (the “Guidelines”) to assist the Board in the exercise of its responsibilities and to serve the interests of the Company and its stockholders. These Guidelines should be interpreted in the context of all applicable laws and the Company’s articles of incorporation, bylaws and other corporate governance documents. These Guidelines acknowledge the leadership exercised by the Board’s standing committees and their chairs and are intended to serve as a flexible framework within which the Board may conduct its business and not as a set of legally binding obligations. The Guidelines are subject to modification from time to time by the Board as the Board may deem appropriate and in the best interests of the Company and its stockholders or as required by applicable laws and regulations.
I. | THE BOARD |
A. | Independence of the Board |
Except as otherwise permitted by the applicable Nasdaq Stock Market LLC (“Nasdaq”) rules, the Board will be comprised of a majority of directors who qualify as independent directors (the “Independent Directors”) as required under Nasdaq rules.
B. | Separate Sessions of Independent Directors |
The Independent Directors will meet in executive session without non-Independent Directors or management present on a regularly scheduled basis, but no less than twice per year.
C. | Lead Director |
If the Chairperson of the Board is a member of management or does not otherwise qualify as an Independent Director, the Independent Directors may elect from among themselves a lead director. The lead director’s responsibilities include, but are not limited to: presiding over all meetings of the Board at which the Chairperson of the Board is not present, including any executive sessions of the Independent Directors; approving Board meeting schedules and agendas; and acting as the liaison between the Independent Directors on the one hand and the Chief Executive Officer and Chairperson of the Board on the other. At such times as the Chairperson of the Board is an Independent Director, the Chairperson of the Board may serve as lead director. The Board may modify its leadership structure in the future as it deems appropriate.
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D. | Director Qualification Standards and Additional Selection Criteria |
In evaluating the suitability of individual candidates (both new candidates and current Board members), the Nominating and Corporate Governance Committee, in recommending candidates for election, and the Board, in approving (and, in the case of vacancies, appointing) such candidates, may take into account many factors, including, but not limited to: personal and professional integrity, ethics and values; experience in corporate management, such as serving as an officer or former officer of a publicly held company; strong finance experience; relevant social policy concerns; experience relevant to the Company’s industry; experience as a board member or executive officer of another publicly held company; relevant academic expertise or other proficiency in an area of the Company’s operations; diversity of expertise and experience in substantive matters pertaining to the Company’s business relative to other board members; diversity of background and perspective, including, but not limited to, with respect to age, gender, race, place of residence and specialized experience, gender identification or identification as an underrepresented minority or as LGBTQ+, practical and mature business judgment, including, but not limited to, the ability to make independent analytical inquiries; and any other relevant qualifications, attributes or skills. The Board evaluates each individual in the context of the Board as a whole, with the objective of assembling a group that can best perpetuate the success of the business and represent stockholder interests through the exercise of sound judgment using its diversity of experience and background in these various areas. In determining whether to recommend a director for re-election, the Nominating and Corporate Governance Committee may also consider the director’s past attendance at meetings and participation in and contributions to the activities of the Board.
E. | Director Orientation and Continuing Education |
Management will provide an orientation process for new directors, including background material on the Company and its business. As appropriate, management will provide opportunities for additional educational sessions for directors on matters relevant to the Company and its business.
F. | Service on Other Boards |
The Board does not believe that its members should be prohibited from serving on boards and/or committees thereof of other organizations and has not adopted any guidelines limiting such activities. However, the Nominating and Corporate Governance Committee may take into account the nature of and time involved in a director’s service on other boards and/or committees thereof in evaluating the suitability of individual director candidates and current directors. Prior to accepting any position on the board of directors or committees of the board of directors of any organization, whether for-profit or not-for-profit, current directors should notify the Nominating and Corporate Governance Committee. The Nominating and Corporate Governance Committee shall review the proposed board and/or committee membership to ensure compliance with applicable laws and policies.
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Service on other boards and/or committees should be consistent with the Company’s conflict of interest policies.
G. | Directors Who Resign or Materially Change Their Current Positions with Their Own Company or Become Aware of Circumstances that May Adversely Reflect upon the Director or the Company |
When a director, including any director who is currently an officer or employee of the Company, resigns or materially changes his or her position with his or her employer or becomes aware of circumstances that may adversely reflect upon the director or the Company, such director should notify the Nominating and Corporate Governance Committee of such circumstances. The Nominating and Corporate Governance Committee will consider the circumstances, and may in certain cases recommend that the Board request that the director submit his or her resignation from the Board if, for example, continuing service on the Board by the individual is not consistent with the criteria deemed necessary for continuing service on the Board.
H. | Term Limits |
As each director is periodically subject to election by stockholders, the Board does not believe it is in the best interests of the Company to establish term limits at this time. Additionally, such term limits may cause the Company to lose the contribution of directors who have been able to develop, over a period of time, increasing insight into the Company’s business and therefore can provide an increasingly significant contribution to the Board.
I. | Director Responsibilities |
The business and affairs of the Company will be managed by or under the direction of the Board, including through one or more of its committees. Each director is expected to spend the time and effort necessary to properly discharge his or her responsibilities. These include:
● | exercising their business judgment in good faith; | |
● | acting in what they reasonably believe to be the best interest of all stockholders; | |
● | becoming and remaining well-informed about the Company’s business and operations and general business and economic trends affecting the Company; and | |
● | ensuring that the business of the Company is conducted so as to further the long-term interests of its stockholders. |
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J. | Compensation |
The Board believes that director compensation should fairly pay directors for work required in a business of the Company’s size and scope, and that compensation should align directors’ interests with the long-term interests of stockholders. The Compensation Committee will review and make recommendations to the Board regarding the cash and equity compensation of directors. The Company’s executive officers do not receive additional compensation for their service as directors.
Except as otherwise permitted by the applicable Nasdaq rules, members of the Audit Committee and Compensation Committee may not directly or indirectly receive any compensation from the Company other than their directors’ compensation, including any compensation for service on committees of the Board and the receipt of equity incentive awards.
K. | Stock Ownership |
The Company encourages directors to own shares of the Company’s stock. However, the number of shares of the Company’s stock owned by any director is a personal decision and, at this time, the Board has chosen not to adopt a policy requiring ownership by directors of a minimum number of shares.
L. | Board Access to Senior Management |
The Board will have complete access to Company management in order to ensure that directors can ask any questions and receive all information necessary to perform their duties. Directors should exercise judgment to ensure that their contact with management does not distract managers from their jobs or disturb the business operations of the Company. Any meetings or contacts that a director wishes to initiate may be arranged through the Chief Executive Officer or the Chairperson of the Board, or if neither is available or neither is appropriate, directly by the director. To the extent appropriate, such contact, if in writing, should be copied to the Chief Executive Officer of the Company.
M. | Board Access to Third-Party Advisors |
The Board committees may hire third-party advisors as set forth in their applicable charters. The Board as a whole shall have access to any third-party advisor retained by the Company, and the Board may hire any third-party advisor it considers necessary to discharge its responsibilities.
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N. | Board and Committee Self-Evaluations |
The Board and its committees conduct periodic self-assessments under applicable Nasdaq rules to determine whether the Board and its committees are functioning effectively. The Nominating and Corporate Governance Committee will oversee such self-evaluations.
II. | BOARD MEETINGS |
A. | Frequency of Meetings |
The Board will meet as often as it deems necessary or advisable in order to perform its responsibilities. In addition, special meetings may be called from time to time as determined by the needs of the business. It is the responsibility of the directors to attend meetings.
B. | Director Attendance |
A director is expected to spend the time and effort necessary to properly discharge his or her responsibilities. Accordingly, a director is expected to regularly prepare for and attend meetings of the Board and all committees on which the director serves (including separate meetings of the non-management directors and the Independent Directors), with the understanding that, on occasion, a director may be unable to attend a meeting. A director who is unable to attend a meeting of the Board or a committee of the Board is expected to notify the Chairperson of the Board or the Chairperson of the appropriate committee in advance of such meeting, and, whenever possible, participate in such meeting via teleconference in the case of an in-person meeting. It is expected that directors will attend the Company’s annual meeting of stockholders.
C. | Attendance of Non-Directors |
The Board encourages the Chairperson of the Board or of any committee to invite Company management and outside advisors or consultants from time to time to participate in Board and/or committee meetings to (i) provide insight into items being discussed by the Board which involve the manager, advisor or consultant, (ii) make presentations to the Board on matters which involve the manager, advisor or consultant, and (iii) bring managers with high potential into contact with the Board. Attendance of non-directors at Board meetings is at the discretion of the Board.
D. | Advance Receipt of Meeting Materials |
Information regarding the topics to be considered at a meeting is essential to the Board’s understanding of the business and the preparation of the directors for a productive meeting. To the extent feasible, the meeting agenda and any written materials relating to each Board meeting will be distributed to the directors sufficiently in advance of each meeting to allow for meaningful review of such agenda and materials by the directors. Directors are expected to have reviewed and be prepared to discuss all materials distributed in advance of any meeting.
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III. | COMMITTEE MATTERS |
The Board currently has three (3) standing committees: (i) the Audit Committee, (ii) the Compensation Committee and (iii) the Nominating and Corporate Governance Committee. Each committee will perform its duties as assigned by the Board in compliance with the Company’s bylaws and the committee’s charter. It is the responsibility of the directors to attend the meetings of the committees on which they serve.
IV. | SUCCESSION PLANNING |
The Board (and/or a committee delegated by the Board) will (i) work on a periodic basis with the Chief Executive Officer to evaluate the Company’s succession plans upon the Chief Executive Officer’s retirement and in the event of an unexpected occurrence, and (ii) periodically review the performance of the Chief Executive Officer.
V. | Interested Persons’ Communications With The Board |
To help foster input and insight from the Company’s stockholders and other interested parties (collectively, “Interested Parties”), Interested Parties may communicate with, or otherwise make his or her concerns known directly to, the Chairperson of the Board, the non-management directors or any specified individual director by addressing such communications to the intended recipient by name or position in care of: Telomir Pharmaceuticals, Inc., 900 West Platt Street Suite 200, Tampa, Florida 33606 to the attention of the Secretary. The Secretary will forward such communications to the appropriate party.
* * * * *
Approved by the Telomir Pharmaceuticals, Inc. Board of Directors on December 8, 2023.
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Exhibit 99.5
TELOMIR PHARMACEUTICALS, INC.
Insider Trading Policy
This policy applies to all employees at every level of the Company and its subsidiaries, including the directors of the Company.
Overview
Given that the common stock of the Telomir Pharmaceuticals, Inc. (the “Company”) is traded on the Nasdaq Capital Market, there are certain important restrictions and limitations imposed on you under the federal securities laws. Any violation of these restrictions may subject the Company and yourself to serious criminal and civil liabilities and sanctions. Such a violation would also severely damage the Company’s reputation and business relationships.
Prohibition Against Trading on or Disclosing Material Nonpublic Information
It is the policy of the Company that all employees, officers and directors who become aware of any material information relating to the Company that has not been made available to the general public by press release, a filing with the United States Securities and Exchange Commission or otherwise, and their immediate family members and other individuals in their household as well as entities controlled by them (such as trusts, partnerships and corporations), are prohibited from directly or indirectly purchasing or selling (or offering to purchase or sell) Company stock. In addition, it is the Company’s policy that all employees, officers and directors, and their immediate family members and other individuals in their household as well as entities controlled by them, are prohibited from directly or indirectly disclosing (i.e., tipping) such information to any other person who may trade in Company stock.
It is difficult to describe exhaustively what constitutes “material” information, but you should assume that any information, positive or negative, which might affect the Company’s stock price or otherwise might be of significance to an investor in determining whether to purchase, sell or hold Company stock would be “material.” Such information includes, without limitation:
● | information regarding the Company’s product candidate(s) and the Company’s development programs, clinical trials, FDA communications, and regulatory status and activities; | |
● | earnings information (favorable or unfavorable), including annual, quarterly or monthly financial results and any guidance or projections relating to future earnings performance (which can include any confirmations of guidance); | |
● | pending or proposed material acquisitions or dispositions of businesses and/or assets, mergers, tender offers or joint ventures; | |
● | developments regarding significant customers, vendors or other suppliers (including the acquisition or loss of an important contract) or new products or service offerings; |
● | a change in auditors or an auditor notification that the Company may no longer rely on an auditor’s audit report; | |
● | a change in executive management of the Company; | |
● | a significant change in compensation policy; | |
● | financings and other events regarding the Company’s securities (e.g., stock or debt repurchase plans, calls of securities for redemption, stock splits, changes in dividend policy, changes to the rights of security holders, public or private offerings of securities, or defaults on debt or senior securities); | |
● | pending or threatened significant litigation or a change in the status of significant litigation; or | |
● | bankruptcies or receiverships involving the Company or third parties with whom the Company has a significant relationship (including brand partners, vendors or other suppliers). |
This list is merely illustrative and not exhaustive. If you are unsure whether information is considered “nonpublic” or “material,” you should consult with the Company’s Compliance Officer or assume that the information is material and nonpublic. The Company’s “Compliance Officer” for this purpose is the Company’s General Counsel or such other officer as may be designated by the Company’s Board of Directors for purposes of this policy.
These prohibitions on purchasing or selling Company stock will be in effect through 4:00 p.m., E.T., on the business day following the day the Company makes such information available to the general public. For example, if you are aware of information that could be considered “material” and the Company makes a public disclosure through a filing with the United States Securities and Exchange Commission or a press release (like an earnings release) on a Tuesday, you are prohibited from purchasing or selling Company stock until 4:00 p.m., E.T, on Wednesday.
It is also the policy of the Company that employees, officers and directors who become aware of any material nonpublic information in the course of their employment or service with the Company relating to any other company, including the Company’s business partners, customers, vendors and suppliers, may not directly or indirectly trade in that company’s securities (or disclose such information to any other person who can trade in that company’s securities) until the information becomes public.
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Applicability of Policy to Transactions under Company Benefit Plans
The insider trading prohibition includes transactions under any of the benefit plans adopted by the Company or its affiliates (including the 401(k) plan and any future dividend reinvestment or similar plan) from time to time to the extent the transactions involve a voluntary investment in or sale of Company stock, including elections to participate in a plan or allocate contributions to any such plan’s Company stock fund, changes in those contribution elections or payroll deductions in connection therewith, and transfers into and out of any such Company stock funds, while in possession of material nonpublic information. The prohibition on insider trading does not, however, apply to (a) automatic purchases pursuant to any of the benefit plans adopted by the Company from time to time (provided that changes in the amounts of these automatic purchases may not be made while in possession of material nonpublic information); (b) automatic payroll deductions, pursuant to a contribution election made when an individual was not aware of material nonpublic information, to purchase Company stock pursuant to Company benefit plans that may be in effect from time to time; (c) award payouts by the Company to employees or directors under any equity-based compensation plans; (d) exercises of stock options or other equity awards where the employee or director pays the exercise price in cash and does not fund the exercise price with the sale of Company stock; or (e) exercises of tax withholding rights pursuant to which employees or directors elect to have the Company withhold shares subject to an option, restricted stock unit or other equity award to satisfy tax withholding requirements.
Prohibition on Derivatives and Hedging Transactions
Investing in Company stock provides an opportunity to share in the future growth of the Company. Investment in the Company and sharing in the growth of the Company, however, does not mean short-range speculation based on fluctuations in the market. These activities may put the personal gain of an individual in conflict with the best interests of the Company and its shareholders. Consequently, trading in puts, calls and other derivative securities on stock of the Company is prohibited at all times. In addition, the purchase of financial instruments (including prepaid variable forward contracts, equity swaps, collars and exchange funds) or otherwise engaging in transactions that are designed to or have the effect of hedging or offsetting any decrease in the market value of the Company’s stock are also prohibited at all times. Anyone may, of course, exercise options and other equity based awards granted to them by the Company and, subject to the restrictions discussed in this policy and other applicable Company policies and any governing plans, arrangements or agreements which apply to such options or other equity based awards, sell shares acquired through the exercise of options or other equity based awards.
Confidentiality
Serious problems could be caused for the Company by unauthorized disclosure of internal information about the Company, whether or not for the purpose of facilitating improper trading in the Company’s stock. It is the policy of the Company that all employees, officers and directors must keep strictly confidential all material nonpublic information that such persons learn regarding the Company (and all material nonpublic information that such persons learn in the course of their employment or service with the Company relating to any other company). It is also the policy of the Company that you should not discuss internal Company matters or developments with anyone outside of the Company, except as required in your performance of regular employment duties. Similarly you should not discuss Company affairs in public or quasi-public areas where your conversation may be overheard (i.e., restaurants, restrooms, elevators, etc.).
These prohibitions apply specifically, but not exclusively, to inquiries about the Company that may be made by the financial press, investment analysts or others in the financial community. It is important that all such communications on behalf of the Company be through an appropriately designated officer under carefully controlled circumstances. Unless an employee, officer or director is expressly authorized to answer financial questions, he or she must refuse to comment, and instead refer the inquirer to the Company’s Compliance Officer.
* * * * *
If you have any doubts as to your responsibilities under this policy, seek clarification and guidance from the Company’s Compliance Officer before you act. Do not try to resolve uncertainties on your own.
Telomir Pharmaceuticals, Inc. expects the strictest compliance with these procedures by all personnel at every level. In fact, failure to observe them may result in serious legal difficulties for the offender, as well as the Company. A failure to comply may also result in grounds for dismissal with cause.
Addendums A and B are attached for Section 16 officers, directors and other designated “insiders.”
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Telomir PHARMACEUTICALS, INC.
Insider
Trading Policy
Addendum
A for
Section 16 Officers, Directors and Other Designated “Insiders”
As a Section 16 officer, director or designated “insider” of the Company you agree to strictly comply with all of the restrictions and limitations contained in the Telomir Pharmaceuticals, Inc. Insider Trading Policy (the “Policy”) as supplemented by this Addendum A.
Window Periods
In addition to the prohibitions set forth in the Policy, you understand that you may only purchase or sell Company stock during four “window periods” occurring throughout the year (unless you are then in possession of material nonpublic information concerning the Company, in which case you cannot purchase or sell shares even during a window period). These window periods begin at 4:00 p.m., E.T., on the business day after the Company issues a press release announcing, or otherwise publicly announces, its quarterly or annual financial results. Each window period will last until 10 days before the last day of the calendar quarter.
You further understand that, from time to time, the Company, through its Board of Directors, Compliance Officer or other appropriate officer, may not open a window period, or may close a window period after initially opening it, because of material developments that have not yet been disclosed to the public. You agree that you will not purchase or sell Company stock during any window period if you have received notice from the Company that the window period is not going to be opened or that the window period is closed. In addition, you agree that you will not disclose to others that the Company has decided not to open, or to close, a window period.
The window periods do not apply to purchases or sales of Company stock that are made pursuant to Rule 10b5-1 Trading Plans that have been adopted in accordance with the Company’s Rule 10b5-1 Trading Plan Guidelines (which are attached as Addendum B). In addition, as set forth in the Policy, the window periods (and the general prohibition on insider trading) do not apply to (a) automatic purchases pursuant to any of the benefit plans adopted by the Company from time to time (provided that changes in the amounts of these automatic purchases may not be made while in possession of material nonpublic information); (b) automatic payroll deductions, pursuant to a contribution election made when an individual was not aware of material nonpublic information, to purchase Company stock pursuant to Company benefit plans that may be in effect from time to time; (c) award payouts by the Company to employees or directors under any equity-based compensation plans; (d) exercises of stock options or other equity awards where the employee or director pays the exercise price in cash and does not fund the exercise price with the sale of Company stock; or (e) exercises of tax withholding rights pursuant to which employees or directors elect to have the Company withhold shares subject to an option, restricted stock unit or other equity award to satisfy tax withholding requirements.
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Pre-Clearance
You further understand that, as an “insider” of the Company, it is the policy of the Company that you are required to pre-clear ALL of your contemplated transactions in the Company’s stock with the Company’s Compliance Officer (including, without limitation, open market and other purchases and sales; exercises of stock options, including cashless exercises, and exercises of other equity awards; gifts; trust transfers; entering into a Rule 10b5-1 Trading Plan in accordance with the Company’s Rule 10b5-1 Trading Plan Guidelines; and transactions under any of the benefit plans adopted by the Company from time to time to the extent the transactions involve a voluntary investment in or sale of Company stock). The pre-clearance policy also applies to transactions in Company stock by your spouse, minor children and other individuals who share your home, as well as entities controlled by you (such as trusts, partnerships and corporations). The pre-clearance policy does not apply to (1) automatic purchases of Company stock or payroll deductions to purchase Company stock under Company benefit plans that may be in effect from time to time, pursuant to an election made in accordance with the pre-clearance policy and when an individual was not aware of material nonpublic information; or (2) award payouts by the Company to employees or directors under any equity-based compensation plans; or (3) purchases or sales of Company stock that are made pursuant to Rule 10b5-1 Trading Plans that have been adopted in accordance with the Company’s Rule 10b5-1 Trading Plan Guidelines.
The Company’s “Compliance Officer” is the Company’s General Counsel or such other officer that is designated by the Company’s Board of Directors.
Clearance of a transaction does not constitute a recommendation by the Company or any of its employees or agents that you should engage in the subject transaction. Decisions regarding requests for pre-clearance are made at the discretion of the Company’s Compliance Officer (or, if the party requesting clearance is the Company’s Compliance Officer, the Company’s Chief Executive Officer), who may consult with outside legal counsel and other professionals in determining whether to grant any request for pre-clearance. Clearance of a transaction is valid for a five business day period only. If the transaction order is not placed within that five business day period, pre-clearance for the transaction must be obtained again from the Company’s Compliance Officer (or Chief Executive Officer, as applicable). Even if the Compliance Officer has granted a request for clearance, if corporate developments subsequently occur that could create an issue for the Company or you if the transaction were to be completed, then the clearance of the transaction, if it has not already occurred, could be withdrawn. If clearance of a contemplated transaction is denied, the fact of such denial must be keep confidential by you.
Prohibition on Margin Accounts and Pledges
Stock held in a margin account may be sold by the broker without the customer’s consent if the customer fails to meet a margin call. Similarly, stock pledged as collateral for a loan may be sold in foreclosure if the borrower defaults on the loan. Because a margin sale or foreclosure sale may occur at a time when the customer or borrower is aware of material nonpublic information or otherwise is not permitted to trade in Company stock, you further understand that you are prohibited from holding Company stock in a margin account or pledging Company stock as collateral for a loan.
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The undersigned hereby certifies and states that he or she has carefully read the Telomir Pharmaceuticals, Inc. Insider Trading Policy (the “Policy”), that he or she agrees to strictly comply with all of the restrictions and limitations contained in the Policy as supplemented by this Addendum A, that he or she understands that neither the window period policy nor the pre-clearance policy constitutes protection from liability for the undersigned in the event the undersigned effects a transaction in Company stock while in possession of material nonpublic information, and that the Company and all of its employees and agents assume no liability for the consequences of any such transaction.
Signature | |
Print Name | |
Title |
PLEASE
RETURN THIS SIGNED CERTIFICATE TO THE COMPANY’S
COMPLIANCE OFFICER AS SOON AS POSSIBLE.
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Telomir PHARMACEUTICALS, INC.
Rule 10b5-1 Trading Plan Guidelines
Addendum
B to Insider Trading Policy for
Section 16 Officers, Directors and Other Designated “Insiders”
These Rule 10b5-1 Trading Plan Guidelines are applicable to any Company director, executive officer or employee designated to be an “insider” (those individuals who are subject to both the Company’s Insider Trading Policy and Addendum A to that Policy):
1. Every Rule 10b5-1 Trading Plan must be in writing.
2. Every Rule 10b5-1 Trading Plan must be entered into in good faith and not as part of a plan or scheme to evade the provisions of Rule 10b-5 or Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
3. Every Rule 10b5-1 Trading Plan must be entered into during a Company “window period” that is not closed (both as described in the Company’s insider trading policies).
4. Every Rule 10b5-1 Trading Plan must also be entered into when the particular Company insider is not otherwise aware of any material nonpublic information about the Company.
5. Every Rule 10b5-1 Trading Plan must provide for a period of at least thirty (30) days between the establishment of a Rule 10b5-1 Trading Plan and the first trade to occur pursuant thereto.
6. Every Rule 10b5-1 Trading Plan must fully comply with all requirements of Rule 10b5-1 of the Exchange Act, including, without limitation, the requirement that the Rule 10b5-1 Trading Plan either (a) expressly specify the amount, price and date of the sales (or purchases) of the Company’s stock to be effected; (b) provide a formula, algorithm or computer program for determining when to sell (or purchase) the Company’s stock, the quantity to sell (or purchase) and the price; or (c) delegate decision-making authority with regard to these transactions to someone without any material nonpublic information about the Company.
7. Every Rule 10b5-1 Trading Plan must ensure that the Company insider fully complies with his or her Section 16 of the Exchange Act obligations.
8. Every Rule 10b5-1 Trading Plan must fully comply with Rule 144 of the Securities Act of 1933, as amended, including, without limitation, the Form 144 filing requirements and the volume limitations for every “rolling” three-month period.
9. Every Rule 10b5-1 Trading Plan must provide that prior to any early termination of the plan the Company insider has consulted with, and received the approval of, the Company’s Compliance Officer (or, if the applicable insider is the Company’s Compliance Officer, the Company’s Chief Executive Officer).
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10. Every Rule 10b5-1 Trading Plan must be approved in advance by the Company’s Compliance Officer (or, if the applicable insider is the Company’s Compliance Officer, the Company’s Chief Executive Officer).
11. Any modification or amendment to an approved Rule 10b5-1 Trading Plan must be approved in advance by the Company’s Compliance Officer (or, if the applicable insider is the Company’s Compliance Officer, the Company’s Chief Executive Officer), must be entered into during a Company “window period” that is not closed (both as described in the Company’s insider trading policies) and must also be entered into when the particular Company insider is not otherwise aware of any material nonpublic information about the Company.
12. While a Rule 10b5-1 Trading Plan is in effect for a Company insider, such Company insider must conduct all trading transactions in Company stock under the Rule 10b5-1 Trading Plan (unless sales are conducted under an effective Company filed registration statement).
* * * * *
Note: Notwithstanding any approval of a Rule 10b5-1 Trading Plan, the Company and all of its employees and agents assume no liability for the consequences of any transaction made pursuant to any such Rule 10b5-1 Trading Plan.
If you have any doubts as to your responsibilities under these guidelines, seek clarification and guidance from the Company’s Compliance Officer before you act. Do not try to resolve uncertainties on your own.
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telomir PHARMACEUTICALS, INC.
Insider Trading Policy
Checklist for
Section 16 Officers, Directors and Other Designated “Insiders”
You should ask the following questions and take the following actions before making any purchase, sale or other transfer of shares of Company stock:
1. Have I previously adopted a Rule 10b5-1 Trading Plan in accordance with the Company’s Rule 10b5-1 Trading Plan Guidelines or have I previously entered into a Company benefit plan that provides for automatic purchases or sales of Company stock or payroll deductions to purchase Company stock in accordance with the Company’s Insider Trading Policy? If “yes,” then stop here – you can trade pursuant to the terms of your Rule 10b5-1 Plan or those benefit plan(s). If “no,” then go to question 2.
2. Are we inside a window period? If “no,” then stop here – you cannot trade in Company stock. If “yes,” then go to question 3.
3. If we are inside a window period, have I received notification that the window has not been opened or has been closed? If “yes,” then stop here – you cannot trade in Company stock. If “no,” then go to question 4.
4. Do I have material nonpublic “inside” information about the Company? If “yes,” then stop here – you cannot trade in Company stock. If “no,” then go to question 5.
5. Have I purchased any Company stock (or has anyone purchased any Company stock with respect to which I am deemed a “beneficial owner”) within the last six months? If “yes,” then you cannot sell stock, but you may buy stock subject to the pre-clearance procedures discussed in question 7.
6. Have I sold any Company stock (or has anyone sold any Company stock with respect to which I am deemed a “beneficial owner”) within the last six months? If “yes,” then you cannot buy stock, but you may sell stock subject to the pre-clearance procedures discussed in question 7.
7. Have I pre-cleared my transaction with the Company’s Compliance Officer? If “no,” then you must do so by contacting the Compliance Officer and completing the pre-clearance review. You must affirmatively hear back from the Compliance Officer for pre-clearance to be effective; no response does not mean that you have been pre-cleared. If “yes,” then go to question 8.
8. You should request that a transaction confirmation be promptly sent to the Company so that the appropriate Form 4 may be timely filed with the SEC (the Form 4 must be filed with the SEC within two business days of the transaction).
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Exhibit 99.6
TELOMIR PHARMACEUTICALS, INC.
Related Person Transaction Policy and Procedures
I. | POLICY |
Telomir Pharmaceuticals, Inc. (the “Company”) recognizes that related person transactions present a heightened risk of conflicts of interest (or the perception thereof) and therefore the Company has adopted this policy (this “Policy”) pursuant to which all Related Person Transactions (as defined below) shall be subject to approval or ratification in accordance with the procedures set forth in this Policy.
For the purposes of this Policy, a “Related Person Transaction” is a transaction, arrangement or relationship (or any series of similar transactions, arrangements or relationships) in which the Company (including any of its subsidiaries) was, is or will be a participant, in which any Related Person (as defined below) had, has or will have a direct or indirect material interest and the amount involved exceeds $120,000 (or, to the extent the Company qualifies as a “smaller reporting company” pursuant to the rules of the Securities and Exchange Commission, the amount involves the lesser of $120,000 or 1% of the average of the Company’s total assets at year-end for the last two completed fiscal years).
II. | PROCEDURES |
A. Identification of Related Person Transactions
The Company will review all known transactions, arrangements and relationships in which the Company and a Related Person are participants to determine whether such transactions, arrangements and relationships constitute Related Person Transactions. The Company’s finance team is primarily responsible for developing and implementing processes and procedures to obtain information regarding Related Persons with respect to potential Related Person Transactions and then determining, based on the facts and circumstances, whether such potential Related Person Transactions do, in fact, constitute Related Person Transactions requiring compliance with this Policy. In addition, any potential Related Person Transaction that is proposed to be entered into by the Company must be reported to the Company’s Chief Financial Officer or such person performing duties similar to those performed by a Chief Financial Officer, or his or her designee, by both the Related Person and the person at the Company responsible for such potential Related Person Transaction.
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B. Audit Committee Approval
If the Company’s finance team determines that a transaction or relationship is a Related Person Transaction, then the Chief Financial Officer, or such person performing duties similar to those performed by a Chief Financial Officer, shall present to the Audit Committee (the “Committee”) of the Board of Directors (the “Board”) of the Company each such Related Person Transaction, including all relevant known facts and circumstances relating thereto. With the exception of pre-approved transactions as described below, the Committee shall review the relevant known facts and circumstances of each Related Person Transaction, (other than pre-approved transactions as described below) and either approve or decline to approve the Related Person Transaction. In connection with its review, the Committee shall consider if the transaction is on terms comparable to those that could be obtained in arm’s length dealings with an unrelated third party, whether the transaction arose in the ordinary course of business, the extent of the Related Person’s interest in the transaction, and shall also take into account any conflicts of interest and/or corporate opportunity provisions of the Company’s Code of Business Conduct and Ethics (the “Code”). If advance Committee approval of a Related Person Transaction requiring the Committee’s approval is not feasible, then the transaction may be preliminarily entered into by the Company upon prior approval of the transaction by the Chair of the Committee subject to ratification of the transaction by the Committee no later than the Committee’s next regularly scheduled meeting; provided that if ratification shall not be forthcoming, all reasonable efforts shall be made to amend the terms of the transaction, which is thereafter approved or ratified by the Committee, or otherwise all reasonable efforts shall be made to to cancel or annul such transaction. If a transaction was not initially determined to be a Related Person Transaction, then upon such determination, the transaction should be presented to the Committee for ratification at the Committee’s next regularly scheduled meeting; provided, that if ratification shall not be forthcoming, shall be made to amend the terms of the transaction, which is thereafter approved or ratified by the Committee, or otherwise all reasonable efforts shall be made to cancel or annul such transaction.
Management shall update the Committee as to any material changes to any approved or ratified Related Person Transaction and shall provide a status report of all then current Related Person Transactions at least annually at a regularly scheduled meeting of the Committee.
No director should participate in the approval or ratification of a Related Person Transaction for which he or she is a Related Person or otherwise has an interest.
C. Pre-Approved Transactions
The Committee has reviewed and considered each of the following types of Related Person Transactions, which shall be deemed to be approved or ratified, as applicable, under this Policy:
1. | Compensation |
(a) | to an executive officer or director of the Company if the compensation is required to be reported in the Company’s proxy statement pursuant to Item 402 of Regulation S-K; or | |
(b) | to an executive officer of the Company, if such compensation would have been required to be reported under Item 402 as compensation earned for services to the Company if the executive was a “named executive officer” in the proxy statement and such compensation has been approved, or recommended to the Board for approval, by the Compensation Committee of the Board.1 |
1 This exclusion is only applicable if the executive officer is not an immediate family member of another Related Person.
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2. | Transactions that are in the Company’s ordinary course of business and where the interest of the Related Person arises only |
(a) | from the Related Person’s position as a director of another corporation or organization that is a party to the transaction; or | |
(b) | from the direct or indirect ownership by such Related Person and all other Related Persons, in the aggregate, of less than a 10% equity interest in another person (other than a partnership) which is a party to the transaction; or | |
(c) | from both such positions described in (a) and such ownership described in (b); or | |
(d) | from the Related Person’s position as a limited partner in a partnership in which the Related Person and all other Related Persons, in the aggregate, have an interest of less than 10%, and the Related Person is not a general partner of and does not have another position in the partnership. |
3. | Transactions that are in the Company’s ordinary course of business and where the interest of the Related Person arises solely from the ownership of a class of equity securities in the Company and all holders of such class of equity securities of the Company will receive the same benefit on a pro rata basis. | |
4. | Transactions where the rates or charges involved in the transactions are determined by competitive bids. | |
5. | Transactions where a Related Person purchases or sells any securities of the Company at the same per share price sold in a public offering approved by the Board or a committee of the Board. | |
6. | Indebtedness transactions involving a Related Person who qualifies as a Related Person solely because he/she/it is the beneficial owner of more than 5% of any class of the Company’s voting securities or is the immediate family member of a beneficial owner of more than 5% of any class of the Company’s voting securities. |
D. Disclosure
Related Person Transactions are to be disclosed in the Company’s applicable filings as required by the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and related rules and regulations thereunder. Furthermore, any Related Person Transaction is expected to be disclosed to the Board of Directors.
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E. Other Agreements
Management shall assure that all Related Person Transactions are not in violation of and are approved in accordance with any requirements of the Company’s financing or other material agreements.
F. Interpretation
This Policy is intended to comply with Item 404 of Regulation S-K. Notwithstanding anything herein to the contrary, this Policy shall be interpreted in such a manner as to comply with Item 404 of Regulation S-K. In the event that a Related Person Transaction would constitute a conflict of interest or a corporate opportunity under the Code, the provisions of the Code also shall apply to such Related Person Transaction. Any such Related Person Transaction may not be approved hereunder unless it is also approved in accordance with the provisions of the Code and disclosed to the public to the extent required by law or the rules of the principal market on which the Company’s common stock is traded.
III. | DEFINITIONS |
For purposes of this Policy, a “Related Person” is:
1. | any person who, at any time during the specified period for which disclosure is required, was a director or executive officer of the Company or a nominee to become a director of the Company; | |
2. | any person or entity who/that, when a transaction in which such person or entity had a direct or indirect material interest occurred or existed was known to be the beneficial owner of more than 5% of any class of the Company’s voting securities; | |
3. | any immediate family member of any of the foregoing persons, which means any child, stepchild, parent, stepparent, spouse, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law or sister-in-law of the director, executive officer, nominee or more than 5% beneficial owner, and any person (other than a tenant or employee) sharing the same household of such director, executive officer, nominee or more than 5% beneficial owner. |
* * * * *
Approved by the Telomir Pharmaceuticals, Inc. Board of Directors on December 8, 2023.
Page 4 of 4 |
Exhibit 107
Calculation of Filing Fee Table
Form S-1
(Form Type)
TELOMIR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)
Table 1: Newly Registered Securities
Security Type | Security Class Title | Fee Calculation or Carry Forward Rule | Maximum Aggregate Offering Price (1)(2) | Fee Rate | Amount of Registration Fee | |||||||||||||
Fees Previously Paid | Equity | Common stock, no par value (3) | 457(o) | $ | 13,800,000 | 0.00014760 | $ | 2,037 | ||||||||||
Equity | Underwriter Warrants (4) | 457(g) | — | — | — | |||||||||||||
Fees Previously Paid | Equity | Common stock issuable upon exercise of Underwriter Warrants (5) | 457(o) | 600,000 | 0.00014760 | 89 | ||||||||||||
Secondary Offering | Equity | Common stock, no par value | 43,500,000 | 0.00014760 | 6,421 | |||||||||||||
Total Offering Amounts | $ | 57,900,000 | $ | 8,547 | ||||||||||||||
Total Fees Previously Paid | $ | 2,126 | ||||||||||||||||
Total Fee Offsets | $ | — | ||||||||||||||||
Net Fee Due | $ | 6,421 |
(1) | Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rule 457(o) of the Securities Act of 1933, as amended. Includes shares to be sold upon exercise of the underwriters’ option to purchase additional shares. | |
(2) | Pursuant to Rule 416, the securities being registered hereunder include such indeterminate number of additional securities as may be issued after the date hereof as a result of stock splits, stock dividends or similar transactions. | |
(3) | Includes shares of common stock which may be issued on exercise of a 45-day option granted to the underwriters to cover over-allotments. | |
(4) | No fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended. | |
(5) | As estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o), the proposed maximum aggregate offering price of the Underwriter Warrants is $833,333, which is equal to 5.0% of the aggregate number of shares of common stock sold in this offering, excluding the overallotment option, at an exercise price equal to 100% of the public offering price per share. |