As filed with the Securities and Exchange Commission on January 21, 2022
Registration No. 333-______
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM F-1
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
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MAINZ BIOMED N.V.
(Exact name of registrant as specified in its charter)
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The Netherlands |
8731 |
Not Applicable |
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(State or other jurisdiction of
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(Primary Standard Industrial
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(I.R.S. Employer
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Mainz Biomed N.V.
Robert Koch Strasse 50
55129 Mainz
Germany
Telephone: 0049 6131 5542860
(Address of principal executive offices, including zip code, and telephone number, including area code)
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Vcorp Services, LLC
25 Robert Pitt Drive, Suite 204
Monsey, NY 10952
Telephone:
(Name, address, including zip code, and telephone number, including area code, of agent of service)
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Copies to:
William Rosenstadt, Esq.
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Benjamin Tan, Esq.
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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, 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 of 1933, 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 of 1933, 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 of 1933, 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 an emerging growth company as defined in Rule 405 of the Securities Act of 1933.
Emerging growth company ☒
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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. ☐
CALCULATION OF REGISTRATION FEE
Title of each class of securities to be registered |
Amount
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Proposed
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Proposed maximum aggregate offering price |
Amount of registration fee |
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Ordinary Shares |
1,725,000 |
(1) |
$ |
23.725 |
$ |
40,925,625 |
(1) |
$ |
3,798 |
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(1) Consists of (i) 1,500,000 Ordinary Shares, with a par value of €0.01 per share, and (ii) 225,000 Ordinary Shares subject to the underwriter’s option to purchase additional shares.
(2) Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(a) and Rule 457(c) under the Securities Act of 1933, as amended. The maximum price per share and the maximum aggregate offering price are based on the average of the $25.41 (high) and $22.04 (low) sale price of the Registrant’s Ordinary Shares as reported on The Nasdaq Stock Market LLC on January 20, 2022, which date is within five business days prior to filing this Registration Statement.
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.
The information contained in this preliminary prospectus is not complete and may be changed. Neither we nor the underwriter can 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 these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY PROSPECTUS |
SUBJECT TO COMPLETION |
DATED JANUARY 21, 2022 |
1,500,000 Ordinary Shares
Mainz Biomed N.V.
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This is a firm commitment public offering of 1,500,000 ordinary shares of Mainz Biomed N.V.. Our ordinary shares are traded on the Nasdaq Capital Market under the symbol “MYNZ.” The last reported sale price of our ordinary shares on January 20, 2022 as reported on Nasdaq, was $23.75 per share, which is the per share offering price we have assumed for purposes of this preliminary prospectus.
We are an “emerging growth company” under the federal securities laws and have elected to comply with certain reduced public company reporting requirements.
Investing in our ordinary shares involves a high degree of risk. You should carefully consider the matters described under the caption “Risk Factors” beginning on page 14.
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.
Per
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Total |
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Public offering price |
$ |
$ |
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Underwriter discounts and commissions(1) |
$ |
$ |
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Proceeds to us, before expenses(2) |
$ |
$ |
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(1) The underwriter, Boustead Securities, LLC, will receive compensation in addition to the discounts and commissions. See “Underwriting” for a description of compensation payable to the underwriter.
(2) The total estimated expenses related to this offering are set forth in the section entitled “Expenses Relating to this Offering.”
We have granted a 45-day option to the underwriter to purchase up to additional 225,000 ordinary shares to cover over-allotments, if any.
The underwriter expects to deliver the ordinary shares on or about , 2022.
Boustead Securities, LLC
The date of this prospectus is , 2022
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES |
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F-1 |
You should rely only on the information contained in this prospectus, any amendment or supplement to this prospectus or any free writing prospectus prepared by or on our behalf. Neither we nor the underwriter have authorized any other person to provide you with different or additional information. Neither we nor the underwriter take responsibility for, nor can we provide assurance as to the reliability of, any other information that others may provide. The underwriter is not 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 of this prospectus or such other date stated in this prospectus, and our business, financial condition, results of operations and/or prospects may have changed since those dates.
Except as otherwise set forth in this prospectus, neither we nor the underwriter have taken any action to permit a public offering of these securities outside the United States or to permit the possession or distribution of this prospectus outside the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating to the offering of these securities and the distribution of this prospectus outside the United States.
Unless the context otherwise requires, in this prospectus, the term(s) “we”, “us”, “our”, “Company”, “our company”, “our business” and “Mainz Biomed” refer to Mainz Biomed N.V.
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The following summary highlights, and should be read in conjunction with, the more detailed information contained elsewhere in this prospectus. You should read carefully the entire document, including our historical financial statements and related notes, to understand our business, the ordinary shares and the other considerations that are important to your investment decision. You should pay special attention to the “Risk Factors” section beginning on page 14.
Our Company
We are a molecular genetics cancer diagnostic company formed in 2021 to acquire PharmGenomics GmbH (“PharmGenomics“) with the purpose of commercializing their product portfolio in Europe and the United States. PharmGenomics, a German DIN EN ISO 13485-certified manufacturer of in-vitro diagnostic (“IVD”) tests with its own molecular genetic laboratory, has developed several IVD tests for the European market since it was founded in 2008.
Our portfolio consists of the following products and product candidates:
• ColoAlert, a colorectal cancer (“CRC”) screening stool DNA (“deoxyribonucleic acid”) test licensed from ColoAlert AS and sold in Europe,
• PancAlert, a product candidate in an early stage of research for a pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction (“PCR”)-based multiplex detection of molecular-genetic biomarkers in stool samples,
• GenoStrip, a proposed platform technology in an early stage of research to detect pathogens in environments on a molecular genetic basis where a qualitative evaluation must be made in a short-time period and
• Legacy Research-Use-Only (“RUO”) and IVD tests, such as the GenoChips and the HumaSense product line, that we intend to license to third parties, sell or discontinue within the coming 18 months as well as third-party laboratory testing that we plan to discontinue.
About the Industry
The cancer industry can be divided into a diagnostics segment focused on detecting cancers, and a therapeutic segment focused on treating them. We are focused on the diagnostic aspect of the cancer industry.
For most cancer, early detection is lifesaving and for CRC, in particular, the symptoms are unclear and removal of cancer by surgery in the early stage is easy compared to treatment at a late stage. Screening of CRC is both lifesaving and cost saving. We compete with other entities developing and offering diagnostic tests to detect the presence of cancers. Our core product is a CRC screening stool DNA test, and we are in the early stages of researching a similar test for pancreatic cancer.
CRC refers to malignant tumors in the colon or rectum. These tumors usually develop from benign polyps which, over time degenerate and become cancerous. Because of the high survival rates in case of early detection, regular and accurate screening is essential.
According to the American Cancer Society, CRC is the third most-commonly diagnosed cancer but the second leading cause of cancer death in the world.1 According to an article in BMJ Journals, global cases of CRC are expected to increase by 60% to more than 2.2 million new cases and 1.1 million deaths by 2030.2
Industry Arc forecasts that the CRC diagnostic and therapeutic markets will be $31.2 billion in 2025, up from $26.2 billion in 2019, representing a compound annual growth rate (“CAGR”) of 3.0%.3 Factors that add to the rising prevalence of tumors that lead to CRC include unhealthy eating habits, both in the choice of foods and the timing of meals, and an increasing geriatric population in many nations.
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1 American Cancer Society, CA — A cancer journal for clinicians, Volume 71, issue3
2 BMJ Journals, Global patterns and trends in colorectal cancer incidents and mortality, Volume 66, Issue 4
3 https://www.industryarc.com/Report/15559/colorectal-cancer-market.html
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A recent report by Fact.MR projects the global CRC diagnostics market to register an expansion at a CAGR of 8.5% from 2017 to 2022. Revenues from the global CRC diagnostics market are expected to surpass $2 billion by the end of 2022.4
Products and Product Candidates
We strive to make the diagnosis of various diseases more effective by using the latest genetic diagnostic technologies. Enabling earlier detection of these diseases allows for earlier and better therapy for affected individuals. In addition to offering the CRC screening test, ColoAlert, we are currently developing two product candidates, PancAlert and GenoStrip. We aim to use known and existing biomarkers (concepts) in applicable and reliable diagnostic tools.
ColoAlert
We offer a CRC screening test, ColoAlert. We believe that molecular genetic stool tests like ColoAlert increase the low participation rate in CRC screening and shift the detection of CRC to an earlier point of time which, in turn, increases the likelihood of successful treatment of the cancer. ColoAlert is currently offered primarily in German-speaking countries due to the geographical location of our offices and facilities. In Germany alone, more than 31 million people are older than the suggested screening age of 50, resulting in a total available market of over 10 million tests per year, based on a screening interval of three years. Over 5 million of them are privately insured and eligible for complete reimbursement.
ColoAlert is a multitarget test in which the stool sample is analyzed for genetic anomalies as well as for the presence of hidden blood, which is often called occult blood. The genetic markers were chosen to complement the diagnostic accuracy of the occult blood test and lead to an increased clinical added value.
We target individuals covered by national CRC screening programs. Most screening programs recommend CRC screening starting at age 50. However, a trend exists to further lower the screening age. For example, the FDA recently recommended CRC screening starting at age 45.
We license the ColoAlert test from a Norwegian research and development company, ColoAlert AS, pursuant to an exclusive licensing agreement dated January 1, 2019. Pursuant to the terms of our license, we pay ColoAlert AS 50% of the net profit that we generate from the ColoAlert test, in addition to a protection fee of €5 per test sold. The licensing agreement has no fixed term but will be terminated if the quarterly fee paid to ColoAlert AS is less than €25,000 for each of the quarters ending on or prior to December 31, 2022 and €250,000 per quarter thereafter. On February 11, 2021, we obtained an option exercisable for three years to acquire the intellectual property for the ColoAlert test for (i) either a one-time cash payment of €2,000,000 or a €4,000,000 payment in ordinary shares at the valuation of our most recent financing plus (ii) a lifetime royalty payment of €3 per ColoAlert test sold. If we opt to make the one-time payment in cash, ColoAlert AS has the right to require us to pay the €2,000,000 in ordinary shares at the valuation of our most recent financing.
In the European Union, ColoAlert is a CE-IVD registered product under the current In-Vitro Diagnostics Directive 98/79 /EC (“IVD-D”). Starting on May 26, 2022, IVD products in the European Union will be regulated by the In-Vitro Diagnostics Regulation, EU 2017/746 (“IVD-R”), which replaces the IVD-D. We are currently evaluating the necessary steps to meet the upcoming regulations for our ColoAlert product. ColoAlert is currently validated on the Roche LightCycler 480 II and Roche Lightcycler 2.0. Mainz BioMed is planning to validate the test on additional real time PCR instruments used in many laboratories worldwide to allow a potential faster market penetration.
We offer ColoAlert Basic, which consists of the above-described biomarker panel with results obtained in 9 workdays, and ColoAlert Plus, which also includes the detection of the hemoglobin-haptoglobin while delivering results within five workdays.
We manufacture the ColoAlert IVD test kits at our facility in Mainz, Germany.
In January 2022, we entered into a Technology Rights Agreement related a portfolio of novel mRNA biomarkers developed at the Université de Sherbrooke (the “UdeS Biomarkers”. Pursuant to the agreement, we acquired an exclusive unilateral option to acquire an exclusive license to the UdeS Biomarkers in exchange for a payment of €10,000 and an agreement to pay for the prosecution and maintenance of certain intellectual property relating to the UdeS Biomarkers. The option to license the technology is for one year, which period can be extended at our sole discretion for six additional months (the “Option Period”).
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4 https://www.factmr.com/report/70/colorectal-cancer-diagnostics-market
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The UdeS Biomarkers are five gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting CRC lesions including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to this deadly disease. In a UdeS sponsored study evaluating these biomarkers,5 study results achieved overall sensitivities of 75% for AA and 95% for CRC, respectively, for a 96% specificity outcome.
We have a license during the Option Period to use the UdeS Biomarkers to further analyze their sensitivity and specificity. Depending on positive results from these further studies, we intend to exercise the option to license the UdeS Biomarkers for future integration into ColoAlert. If we exercise the option, we will pay the licensor a royalty on all products incorporating the UdeS Biomarkers and we will pay for the prosecution and maintenance of patents relating to the UdeS Biomarkers.
Below is a typical process flow for the use of ColoAlert for Germany.
Typical process flow:
1. The patient is informed about the risk of CRC.
2. The physician discusses with the patient about the need for a CRC test.
3. The physician provides a kit to the patient or the patient receives the kit shipped from the laboratory partner.
4. The patient collects the sample and ships the collected sample to the testing clinical laboratory.
5. The clinical laboratory tests the sample and provides the result to the ordering physician.
6. The ordering physician informs the patient about the results and decides on next steps.
PancAlert
We are in the early stages of developing PancAlert, a stool-based screening test for the detection of pancreatic cancer. According to the Global Cancer Observatory, pancreatic cancer was diagnosed in over 460,000 patients worldwide in 2018.6 Due to the asymptomatic early stages, in most cases this disease is detected too late, making pancreatic cancer one of the most lethal malignant neoplasms with over 430,000 annual deaths in 2018 according to the Global Cancer Observatory.7
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5 Herring, E.; Tremblay, É.; McFadden, N.; Kanaoka, S.; Beaulieu, J.-F. Multitarget Stool mRNA Test for Detecting Colorectal Cancer Lesions Including Advanced Adenomas. Cancers 2021, 13, 1228. https://doi.org/10.3390/cancers13061228
6 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.
7 https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21492 — Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.
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Our goal is to make PancAlert the world’s first pancreatic cancer screening test based on Real-Time PCR-based multiplex detection of molecular-genetic biomarkers in stool samples. The most promising candidates for disease-specific biomarkers to date are KRAS, mBMP3, NDRG4, and GNAS codon 201. In addition, the platform technology used will enable simple integration of further biomarkers if indicated. The analysis of the results will be additionally facilitated by a specialized IT solution. Although we have conducted some in house clinical trials, we do not expect this to become a commercially available product in the near future, if at all. If further clinical studies show promising results, we intend to start developing an IVD-R and FDA approvable product for the European and U.S. market.
As we are in the early stages of development and have only commenced preclinical trials, we cannot be sure that at this time that PancAlert will ever receive the necessary governmental approvals for us to offer an actual product or that it will be commercially viable if we do. If we do create a commercially viable product, it may not be in the near-term, and our revenues may be wholly reliant on ColoAlert until we do.
GenoStrip
We are in the early stage of developing a rapid and easy to use molecular lateral-flow test that we call GenoStrip. We intend to develop the GenoStrip technology as a platform technology which combines the advantages of highly precise molecular genetics and the easy-to-handle usage of a customized lateral-flow-dipstick to provide molecular results in as little as 20 minutes, depending on the sample preparation method amplification system used. The target sequences (DNA or RNA( Ribonucleic acid)) are amplified either way in single or multiplex amplification reactions.
If successful, the GenoStrip technology could be modified for various applications where qualitative evaluations have to be made within a short time frame, as for instance in the case of COVID-19 diagnosis, and other respiratory viruses, as well as pathogens causing sexually transmitted diseases or the detection of mutated or deleted genes.
As we are in the early stages of development and have only commenced preclinical trials, we cannot be sure that at this time that GenoStrip will ever receive the necessary governmental approvals for us to offer an actual product or that it will be commercially viable if we do. If we do create a commercially viable product, it may not be in the near-term, and our revenues may be wholly reliant on ColoAlert until we do.
Legacy Diagnostic Products and Services
We currently sell several genetic diagnostic products, which we manufacture, to clinical laboratories, mostly in Germany. Some of these products were CE-IVD registered while others are RUO products. Due to the high cost of meeting the new IVD-R regulatory requirements starting in May 2022, we have decided to license out, sell off or discontinue those products. Additionally, we have provided third-party laboratory testing services that we also intend to discontinue.
Competitive Advantages & Operational Strengths
We face competition from providers of more traditional CRC screening diagnostics, such as colonoscopies, as well as other manufacturers of non-invasive stool- or blood-based tests. We believe the primary competitive factors for ColoAlert include but are not limited to:
• Accuracy: End-users want as accurate a result as possible without worrying about costs, hassle and time associated with false-negative and false-positive results. A report by Professor Dollinger found ColoAlert to have a specificity of 92%, above the 90% specificity requirement set by the European CRC screening guidelines, and has a sensitivity of 85%. Sensitivity defines how often a test correctly generates a positive result for the condition being tested. Specificity is the ability of the test to correctly identify those without the disease (true negative rate). Since that report, we have updated the occult blood test component of ColoAlert in a way that we believe will increase sensitivity and specificity. In January 2022, we entered into a Technology Rights Agreement by which we have a unilateral option to exclusively license certain biomarkers developed ay the Université de Sherbrooke with the goal of further increasing the sensitivity and specificity of ColoAlert.
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• Time-to-result: The faster the results of a diagnostic test are known; the sooner treatment may begin or the end user can gain ease of mind. Due to ColoAlert’s simplicity of the testing procedure, the result turn-around time between the patient’s decision and delivery of the test report can be as low as three days in Germany, which we believe is significantly shorter than most other tests.
• Ease of use: As many people will delay or avoid getting an invasive diagnostic test, such as a colonoscopy, the easier it is to take such a test the higher the participation rates will be, which could mean more detection of cancer at earlier stages and higher rates of survival. ColoAlert is less invasive than traditional colonoscopies, requiring neither the drinking of barium (oral or suppository) the night prior to the test, nor prior fasting, and does not require a trip to a clinic or the administration of anesthesia. Compared to blood-based tests, stool tests can be performed at home and do not require the patient to visit their physician.
• Executive team: Our leadership team and advisors have extensive experience developing and commercializing innovative diagnostic products globally. We have strong relationships with government organizations and universities in Europe.
• Research and Development: We are confident that we have organized a strong team to front our research and development. Our research and development efforts have been supported by a grant of up to approximately €440,000 from the German Federal Ministry of Research and Education for the development of PancAlert, a non invasive product candidate to detect pancreatic cancers, and a grant of up to approximately €205,000 from the European Fund for Economic and Regional Development for the development of GenoStrip, a product candidate for a rapid and easy to use molecular lateral-flow test.
Strategy
We intend to make ColoAlert the global CRC screening market leader by providing the best performance of an early detection, less invasive test at an affordable cost. To fulfil this goal efficiently, our sales strategy is primarily based on collaborations with large laboratory chains. This distribution strategy, which we plan to replicate with PancAlert and GenoStrip if they ever become commercial products, is chosen because laboratories typically have a large customer base of physicians as well as a strong sales team. This can increase awareness of ColoAlert within the physician community in a cost-effective manner. At the same time, it offers the opportunity for accelerated product rollouts in foreign markets, as large laboratory chains operate across Europe or worldwide and successful products are often distributed within the laboratory chain. Laboratory partners benefit from the introduction and distribution of ColoAlert especially from the increased medical added value, the positioning as innovation leaders and from, we believe, significantly higher margins compared to conventional stool tests such as FIT. In December 2021, one of the laboratory chains in our distribution network, GANZIMMUN Diagnostics AG, found the association with ColoAlert so beneficial that they have agreed to offer ColoAlert as a co-branded product. We believe that this distribution approach also provides a strong business differentiation in the United States from the Cologuard, a test offered by Exact Sciences Corporation. Cologuard is performed exclusively in Exact Sciences’ in-house laboratories and therefore other laboratories currently do not have access to a multitarget stool test. By providing the ColoAlert test kits, other laboratories can also offer highly sensitive, non-invasive CRC screening to their affiliated physicians and their patients.
To introduce ColoAlert into the United States and potentially other markets like China, extensive regulatory studies are required. We are actively exploring the required regulatory path for the United States.
Therefore, we intend to use the proceeds from this offering to:
• Prepare and execute a clinical study in Europe related to the UdeS Biomarkers to measure their sensitivity and specificity in detection of CRC and AA.
• Prepare and execute a comprehensive clinical and regulatory strategy to achieve market authorization from the FDA to use ColoAlert as a screening test for CRC in the United States;
• Expand the commercial opportunity of our ColoAlert product in Europe by expanding our commercial team and partnerships; and
• Continue research and development of PancAlert and GenoStrip.
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Expansion of ColoAlert in Europe
There are currently circa 440 medical care centers with a laboratory focus in Germany, of which one-fifth has a molecular genetic laboratory in house and are therefore in the core target group.8 Approximately 50% of the market share is held by five laboratory chains (Sonic, Limbach, Synlab, Amedes and LADR). We plan on securing additional partner laboratories to market, as we did by adding GANZIMMUN Diagnostics AG to our distribution network in December 2021, and to sell our ColoAlert product through sales representatives. Partner laboratories, once part of our distribution network, will receive support from us for the proper administration of the product in the client’s clinical laboratory. This validation process for new IVD products is being performed daily by other diagnostic companies in Germany (e.g. Roche, Abbott, Siemens). If needed, we will also provide co-branded marketing materials.
We primarily sell the ColoAlert IVD test kits to German clinical reference laboratories. The reference laboratories provide the patient kits and accompanying marketing materials to their affiliated physicians and educate them about the clinical advantages of ColoAlert. The laboratories perform the diagnostic analysis and report the results to the physicians.
We initiated a pilot program to allow patients to use the ColoAlert website to order a patient kit online directly from us. The collected samples are sent by the patient directly to our own clinical laboratory. We plan to conduct joint marketing activities with the reference labs to connect patients and physicians supported by the newly established online portal www.gemeinsam-gegen-darmkrebs.de (currently in beta status).
Our primary market is currently Germany, and we intend to expand to other German-speaking countries. After the rollout in the German-speaking region, we intend to launch ColoAlert in other Western European markets, particularly in the United Kingdom, with its innovation-friendly National Health Service (“NHS”), followed by countries such as Spain or in Scandinavia.
In the coming year, we seek to expand the current European sales team with strong diagnostic sales experience. The sales team will focus on sales of our ColoAlert test to clinical laboratories that perform diagnostics tests ordered by physicians. To ensure that the clinical laboratory sales teams approach the primary care physician with the highest possible efficiency and effectiveness inside their respective laboratory network, we are planning to conduct training for sales representatives, seminars for physicians and joint marketing campaigns to expand our product awareness. We will also look into partnering with third parties or outsourcing parts of the sales organization that directly visit with physicians.
Entry into the U.S. Market
We plan to employ a product and marketing strategy in the United States that is substantially similar to what we use in Europe. Prior to employing these strategies, we will seek to sell the ColoAlert test as a test kit to clinical laboratories that are certified by the Secretary of the Department of Health and Human Services under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA labs”) requiring FDA market authorization, or as a laboratory developed test offered by the Mainz BioMed clinical laboratory governed under US Centers for Medicare and Medicaid Services (“CMS”). We plan to explore the required clinical and regulatory path to submit ColoAlert to the FDA to achieve a CRC screening claim for asymptomatic patients who are at average risk for CRC, aged 45 to 80.
We expect to conduct extensive clinical trials considering the desired CRC screening claims. The duration of the study will be defined by the required number of patients to be enrolled. Cologuard, the main competitor in the United States, has performed multiple large studies which took several years to execute followed by a PMA submission. In addition, we will evaluate achieving claims for early identification of cancerous polyps and advanced adenomas. In preparation for our clinical trials, we appointed a Vice President of Regulatory Affairs to oversee the process and as well as our application to the FDA to achieve a CRC screening claim.
During this market preparation period, market conditions may change, existing competitors may improve their products or new competitors may become commercially active which may force us to adjust our future commercial strategy if the FDA eventually authorizes the product. We may consider manufacturing our ColoAlert test kits as private label products to be sold to labs. In this case, we likely would not undertake any marketing efforts in the United States to promote it to physicians and patients but expect our business partner to take on this obligation.
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8 https://www.g-f-v.org/node/1233 or Schöneberg, K., Wilke, P., Klotz, S., Venzke, O. & Wulff, M. (2017). Branchenanalyse Laboranalytik. Hans Huber.
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Competition
Our principal product, ColoAlert, competes with other methods of CRC screening, such as the colonoscopy or the FIT test. The current standard for a CRC screening test is the colonoscopy, although we also compete with non-invasive CRC screening tests. In addition to these widespread, traditional screening tests, we also compete with companies that provide or are developing novel CRC screening tests.
Colonoscopy
The colonoscopy was established over 50 years ago and is used by countless physicians worldwide. The colonoscopy is an invasive procedure in which the inner wall of the intestine is examined by a physician using an endoscope. Preparation requires patients to undergo bowel cleansing at least the day prior to the procedure. Colonoscopy is a painful process and associated with risk of punctuating the colon. An experienced scopeist will perform the process with less pain and higher detection rate. The average detection rate of colonoscopy is approximately 95%.
Due to the cumbersome process, the compliance rate for colonoscopy in Germany even after a consultation with a physician is a mere 16%.9
Occult blood tests
With Fecal Immunochemical Tests (“FITs”), a patient’s stool sample can be examined for hidden, or occult, blood in a laboratory which can be a symptom of CRC. Unfortunately, occult blood is often only present in the later stages of the disease. There is no need for patients to prepare prior to sample collection, which leads to a high patient acceptance.
According to IKK Südwest, when coordinated by a centralized invitation to screening, participation rates can get as high as 73%.10 Since this method can only provide an indirect indication of CRC via fecal blood, the sensitivity normally hovers around 65% with a false-positive rate around 5% per an article published by the American Gastroenterological Association.11 Since this method depends on the presence of a blood signal and many tumors do not bleed in the early stages, many affected individuals are only diagnosed in later stages of the disease which leads to lower than 5-year survival rates and higher treatment costs.
Entities Providing Screening Tests
We compete with other entities that offer other non-invasive screening tests. Most of our current and potential competitors in Europe and the United States have significantly greater financial, technical, manufacturing, marketing, and other resources than we have and consequently may have better and more competitive products, services, marketing or distribution. Most of our competitors have more extensive customer bases and broader customer and industry relationships than we do. In addition, many of these companies have longer operating histories and greater name recognition than we do. Our competitors may be in a stronger position to respond quickly to new technologies and may be able to design, develop, market and sell their products more effectively.
Entities producing or developing CRC screening tests with which we compete include:
• Exact Sciences: The most established of the entities that we compete with is Exact Sciences, a publicly-traded molecular diagnostic company focusing on the early detection of various cancers, which manufactures Cologuard and conducts the analysis of the tests. Cologuard is also a stool-based CRC screening test, and it achieves a sensitivity of 92% and a specificity of 87% per a study published in the New England Journal of Medicine.12 The average reimbursement is about $500,13 which is equivalent to approximately $166 annually when used in the recommended three-year screening interval. Exact Sciences is currently
____________
9 Riens B et al (2011) Versorgungsatlas/Krebsfrüherkennung
10 IKK Südwest. IKK Südwest in Zahlen: https://www.ikk-suedwest.de/ueber-uns/daten-und-fakten/ikk-suedwest-in-zahlen/
11 Giess et al. Gastroenterology 154/2018
12 (Imperiale et al (2014) N Engl J Med 2014; 370)
13 https://investor.exactsciences.com/investor-relations/press-releases/press-release-details/2015/Exact-Sciences-Additional-Update-on-CMS-Reimbursement-for-Cologuard/default.aspx or https://www.businesswire.com/news/home/20151202005242/en/CMS-Corrects-2016-Reimbursement-Rate-for-Cologuard%C2%AE#:~:text=(Nasdaq%3A%20EXAS)%20announced%20that,NLA)%20for%20Cologuard%20at%20%24493.21.
7
pursuing the goal of further expanding the market share it has gained in the United States, broadening its relationships with relevant health care provider and building a diversified product portfolio in the oncology screening space through targeted acquisitions.
• Epigenomics AG, which focuses on the development of blood tests for cancer detection. The CRC test “Epi proColon”, one of its two approved products approved in the United States and the European Union, is a blood-based test that achieves a sensitivity of 68% with a specificity of 80%.14
• Novigenix SA, a Swiss company specializing in the development of immuno-transcriptomics solutions. Novigenix’s LITOseek Platform is designed to provide information for early cancer detection, disease progression and therapy selection. For CRC screening, Novigenix has developed the Colox blood test, which is currently available on the Swiss market. it achieved a sensitivity of 78% and a specificity of 92% in a clinical study.15
• Agena Biosciences Inc., a U.S. company active in the field of genetic diagnostics. The company’s core product is its proprietary MassArray platform. This offers laboratory customers the possibility to provide rapid and broad genetic analysis. From the large number of panels, the UltraSeek Colon Panel initially shows competitive potential. This is used for the investigation of disease progression and resistance of CRC. As this product is not suitable for CRC screening, it is not yet a direct competitor to ColoAlert, but could be relevant through a future product variation.
• Schebo AG, a German company, has developed a Tumor M2-PK, (Pyruvatekinase M2) based test, a biomarker that is only expressed in tumor tissue in adult humans. M2-PK can be detected in stool as well as in EDTA blood plasma and thus serves as an indicator of cancer. In a clinical study, in the regular combination with an occult blood test, it showed a high sensitivity of over 90%, while its specificity was below 70%.
• CellMaxLife, a liquid biopsy company focused on blood sample-based cancer screening. The company has no available products on the market yet, but is currently working on the development of the CRC screening test “FirstSight”, which screens patients’ blood sample for circulating gastrointestinal epithelial cells (CECs) and somatic mutations of cell-free tumor DNA (ctDNA).
• GRAIL, Inc., which develops products based on next-generation sequencing (NGS) for the early detection of cancer. The blood-based screening test “Galleri” is the company’s current core product. According to the company, this test can detect over 50 types of cancer. The list price for screening with Galleri is $959. GRAIL recommends using Galleri only in combination with conventional screening methods.
• Guardant Health, Inc., a California-based company that aims to improve early cancer detection based on liquid biopsy. The product “Guardant Reveal” is a blood test used to control residual disease and recurrence after CRC. Guardant Reveal was launched in the U.S. market in the start of 2021. Alongside the other products Guardant360, Guardant360 CDx and GuardantOMNI, Guardant Reveal contributes to the development of the LUNAR screening program, which will be used in the future for cancer screening of asymptomatic patients.
• Thrive, a subsidiary of Exact Sciences Corp., is researching a holistic cancer screening based on a liquid biopsy. The test is currently under development and has not yet received marketing approval.
We might not be able to compete successfully in our market, particularly as we seek to enter the United States and commercialize ColoAlert. We expect that some of the screening tests currently being developed will be commercially available in the United States by the time we obtain FDA approval for ColoAlert, if at all. If our competitors introduce new diagnostic tests that compete with or surpass the accuracy, price or ease of use of our products, we may be unable to satisfy existing customers or attract new customers at the prices and levels that would allow us to generate attractive rates of return on our investment. Increased competition could result in price reductions and revenue shortfalls, loss of customers and loss of market share, which could harm our business, prospects, financial condition and operating results.
____________
14 https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130001B.pdf
15 https://novigenix.com/wp-content/uploads/2018/02/Tableau-comparatif-novigenix-colox-ENGLISH.pdf
8
Customers
Our current customers are primarily laboratories in Germany, including some of the largest chains in Germany, that offer our ColoAlert test to physicians for use with their patients. Although no customer accounted for more than 10% of our revenues in our prior fiscal year, our revenues are substantially derived from our relationships with those laboratories that use our products. To increase revenues and because a deterioration of our relationship with those or a portion of those laboratories that currently use our products would adversely affect our results of operations and financial condition, we are actively seeking to expand our customer base in Europe, and intend to do so in the United States depending upon the progress of an application with the FDA for approval of ColoAlert.
Implications of Being an Emerging Growth Company
We qualify as and elect to be an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include, but not limited to:
• reduced disclosure about the emerging growth company’s executive compensation arrangements in our periodic reports, proxy statements and registration statements; and
• an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002.
We may take advantage of these provisions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual gross revenue, have more than $700 million in market value of our shares of common stock held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.
Implications of Being a Foreign Private Issuer
We are a foreign private issuer within the meaning of the rules under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As such, we are exempt from certain provisions applicable to United States domestic public companies. For example:
• we are not required to provide as many Exchange Act reports or provide periodic and current reports as frequently, as a domestic public company;
• for interim reporting, we are permitted to comply solely with our home country requirements, which are less rigorous than the rules that apply to domestic public companies;
• we are not required to provide the same level of disclosure on certain issues, such as executive compensation;
• we are exempt from provisions of Regulation FD aimed at preventing issuers from making selective disclosures of material information;
• we are not required to comply with the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; and
• we are not required to comply with Section 16 of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and establishing insider liability for profits realized from any “short-swing” trading transaction.
Summary Risk Factors
An investment in our ordinary shares involves a high degree of risk. If any of the factors below or in the section entitled “Risk Factors” occurs, our business, financial condition, liquidity, results of operations and prospects could be materially and adversely affected.
• We are an early revenue stage company and have incurred operating losses since inception, and we do not know when we will attain profitability. An investment in our securities is highly risky and could result in a complete loss of your investment if we are unsuccessful in our business plans.
9
• Terms of subsequent financings may adversely impact your investment.
• Our inability to manage growth could harm our business.
• We substantially depend upon our management.
• In September 2021, we acquired all of the equity interests of PharmGenomics, and the combined company may not perform as we expect.
• Failure of our internal controls over financial reporting could harm our business and financial results.
• You may face difficulties protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited because we are incorporated under the laws of the Netherlands, a substantial portion of our assets are in the European Union and a majority of our directors and executive officers reside outside the United States.
• Changes to trade policy, tariffs, and import/export regulations may have a material adverse effect on our business, financial condition, and results of operations.
• We may fail to generate sufficient revenue from our relationships with our clients or laboratory partners to achieve and maintain profitability.
• Our success depends heavily on our ColoAlert screening tests.
• Sales of our diagnostic tests could be adversely impacted by the reluctance of physicians to adopt the use of our tests and by the availability of competing diagnostic tests.
• We may not succeed in establishing, maintaining and strengthening ColoAlert and other brands associated with Mainz Biomed’s products, which would materially and adversely affect acceptance of our diagnostic tests, and our business, revenues and prospects.
• We might decide not to incorporate the UdeS Biomarkers after we conclude additional studies on such biomarkers.
• We may face technology transfer challenges and expenses in adding new tests to our portfolio and in expanding our reach into new geographical areas.
• If third party payors do not provide reimbursement, breach, rescind or modify their contracts or reimbursement policies or delay payments for our tests, or we are unable to successfully renegotiate reimbursement contracts, our commercial success could be compromised.
• We may depend on possible future collaborations to develop and commercialize many of our diagnostic test candidates and to provide the manufacturing, regulatory compliance, sales, marketing and distribution capabilities required for the success of our business.
• If we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could create undue competition and pricing pressures. There is no certainty that any future patent applications will result in the issuance of patents or that issued patents, if we receive any, will be deemed enforceable.
• Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.
• Results of FDA required studies may not create desired clinical performance resulting in follow-on studies delaying the launch of the product in the US.
• Our business is subject to various complex laws and regulations. We could be subject to significant fines and penalties if we or our partners fail to comply with these laws and regulations.
10
• We will have to maintain facilities, or maintain relationships with third party laboratories, for the manufacture and use of diagnostic tests. Our ability to provide services and pursue our research and development and commercialization efforts may be jeopardized if these facilities were to be harmed or rendered inoperable.
• We anticipate being required to obtain regulatory approval of our diagnostic test products to enter new markets.
• We are required to comply with national, regional and local laws governing the privacy of health information, and any failure to comply with these laws could result in material criminal and civil penalties.
• The market price of our ordinary shares may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
• You may experience dilution of your ownership interests if we issue additional ordinary shares or preferred shares.
• Volatility in our ordinary shares price may subject us to securities litigation.
• We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.
• If we are, or were to become, a passive foreign investment company (a “PFIC”) for U.S. federal income tax purposes, U.S. investors in our ordinary shares would be subject to certain adverse U.S. federal income tax consequences.
11
Offering Summary
Ordinary Shares Offered: |
(excluding the underwriter’s over-allotment option). |
|
Assumed Public Offering Price: |
$23.75 per ordinary share, the closing price of our ordinary shares on the Nasdaq Capital Market on January 20, 2022. |
|
Over-Allotment: |
We have granted the underwriter a 45-day option (commencing from the date of this prospectus) to purchase up to an additional 225,000 ordinary shares at the public offering price to cover over-allotments, if any. |
|
Shares Outstanding After the Offering: |
13,510,000 (or 13,735,000 if the underwriter exercises its over-allotment option in full) |
|
Use of Proceeds: |
We intend to use the net proceeds from this offering for research and development (primarily for the further development of ColoAlert, PancAlert and Genostrip), clinical studies for FDA approval of ColoAlert, marketing and sales and for general corporate purposes. |
|
Underwriter: |
Boustead Securities, LLC |
|
Market for our Ordinary Shares: |
There is currently no market for our ordinary shares. We intend to apply to have our ordinary shares listed on the Nasdaq Capital Market under the symbol “MYNZ”. The offering that we are conducting with the prospectus will not close unless the Nasdaq Capital Market has approved our ordinary shares for listing. |
|
Risk Factors: |
See “Risk Factors” for a discussion of the factors you should consider before deciding to invest in our securities. |
Shares outstanding after the offering is based on 12,010,000 ordinary shares that are outstanding as of the date of this prospectus and the shares sold in this offering and excludes up to 3,885,000 ordinary shares underlying warrants that are outstanding as of the date hereof, up to 1,539,650 ordinary shares underlying options that we granted under the 2021 Omnibus Incentive Plan.
12
Summary Financial Data
The following tables summarize our financial data. We derived the summary financial statement data for the years ended December 31, 2020 and 2019 set forth below from the audited financial statements of PharmGenomics GmbH, which is considered for accounting purposes to be our predecessor entity, and from the unaudited financial statements of PharmGenomics GmbH for the three and six months ended June 30, 2021 and 2020 contained in this prospectus. Mainz Biomed N.V. was not formed as of December 31, 2020 and to date has had no operations. Our financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. Our historical results are not necessarily indicative of the results that may be expected in the future. You should read the information presented below together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our financial statements, the notes to those statements and the other financial information contained in this prospectus and the unaudited consolidated pro forma information appearing elsewhere in this prospectus.
Summary of Operations in U.S. Dollars
Six Months Ended
|
Years Ended
|
|||||||||||||||
2021 |
2020 |
2020 |
2019 |
|||||||||||||
Revenues |
$ |
417,311 |
|
$ |
166,701 |
|
$ |
493,565 |
|
$ |
281,393 |
|
||||
Cost of Revenues |
|
240,954 |
|
|
152,285 |
|
|
370,480 |
|
|
342,664 |
|
||||
GROSS PROFIT (LOSS) |
|
176,357 |
|
|
14,416 |
|
|
123,085 |
|
|
(61,271 |
) |
||||
|
|
|
|
|
|
|
|
|||||||||
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
||||||||
Research and Development |
|
160,531 |
|
|
144,434 |
|
|
311,851 |
|
|
250,316 |
|
||||
Sales and marketing |
|
70,979 |
|
|
51,575 |
|
|
110,380 |
|
|
181,460 |
|
||||
General and administrative |
|
199,481 |
|
|
179,438 |
|
|
374,569 |
|
|
428,862 |
|
||||
Total operating expenses |
|
430,991 |
|
|
375,343 |
|
|
796,800 |
|
|
860,638 |
|
||||
Operating loss |
|
(254,634 |
) |
|
(360,927 |
) |
|
(673,715 |
) |
|
(921,909 |
) |
||||
|
|
|
|
|
|
|
|
|||||||||
OTHER INCOME/(EXPENSE) |
|
(7,087 |
) |
|
20,866 |
|
|
86,820 |
|
|
(35,146 |
) |
||||
|
|
|
|
|
|
|
|
|||||||||
NET LOSS |
$ |
(261,721 |
) |
$ |
(340,061 |
) |
|
(586,895 |
) |
|
(957,055 |
) |
||||
|
|
|
|
|
|
|
|
|||||||||
Foreign Currency Translation |
|
82,963 |
|
|
(29,550 |
) |
|
(224,656 |
) |
|
22,166 |
|
||||
|
|
|
|
|
|
|
|
|||||||||
TOTAL COMPREHENSIVE LOSS |
$ |
(178,758 |
) |
$ |
(369,611 |
) |
$ |
(811,551 |
) |
$ |
(934,889 |
) |
Balance Sheet in U.S. Dollars (audited)
As of
|
As of December 31, 2020 |
|||||||
Cash |
$ |
195,165 |
|
$ |
122,568 |
|
||
Total Current Assets |
|
281,607 |
|
|
186,398 |
|
||
Total Assets |
|
734,472 |
|
|
673,270 |
|
||
Total Current Liabilities |
|
672,051 |
|
|
701,954 |
|
||
Long Term Debt |
|
2,058,839 |
|
|
2,265,431 |
|
||
Total Liabilities |
|
3,146,548 |
|
|
3,414,825 |
|
||
Working Capital (Deficit) |
$ |
(390,444 |
) |
$ |
(515,556 |
) |
||
Total Stockholders’ Deficit |
|
(2,412,076 |
) |
|
(2,741,550 |
) |
13
An investment in our ordinary shares carries a significant degree of risk. You should carefully consider the following risks, as well as the other information contained in this prospectus, including our historical financial statements and related notes included elsewhere in this prospectus, before you decide to purchase the ordinary shares. Any one of these risks and uncertainties has the potential to cause material adverse effects on our business, prospects, financial condition and operating results which could cause actual results to differ materially from any forward-looking statements expressed by us and a significant decrease in the value of our ordinary shares. Refer to “Special Note Regarding Forward-Looking Statements”.
We may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause. These potential risks and uncertainties may not be a complete list of the risks and uncertainties facing us. There may be additional risks and uncertainties that we are presently unaware of, or presently consider immaterial, that may become material in the future and have a material adverse effect on us. You could lose all or a significant portion of your investment due to any of these risks and uncertainties.
Risks Related to Our Business Generally
We are an early revenue stage company and have incurred operating losses since inception, and we do not know when we will attain profitability. An investment in our securities is highly risky and could result in a complete loss of your investment if we are unsuccessful in our business plans.
We are an early-stage company. Since inception, we have incurred operating losses and negative cash flow, and we expect to continue to incur losses and negative cash flow in the future. Our net losses for the years ended December 31, 2020 and December 31, 2019 were approximately $586,895 and $957,055, respectively, and our net losses for the six months ended June 30, 2021 were $263,618. Ultimately, our ability to generate sufficient operating revenue to earn a profit depends upon our success in developing and marketing or licensing our diagnostic tests and technology. Any failure to do so could result in the possible closure of our business or force us to seek additional capital through loans or additional sales of our equity securities to continue business operations, which could dilute the value of any securities you hold or could result in the loss of your entire investment.
Terms of subsequent financings may adversely impact your investment.
We intend to engage in common equity, debt, or preferred stock financing in the future. Your rights and the value of your investment in our securities could be reduced as a result of any such financing. Interest on debt securities could increase costs and negatively impacts operating results. Preferred shares could be issued in series from time to time with such designation, rights, preferences, and limitations as needed to raise capital. The terms of preferred shares could be more advantageous to those investors than to the holders of ordinary shares. In addition, if we need to raise more equity capital from the sale of ordinary shares, institutional or other investors may negotiate terms at least as, and possibly more, favorable than the terms of your investment. Ordinary shares which we sell could be sold into the nascent public market for our ordinary shares which could adversely affect the market price of our ordinary shares.
Our inability to manage growth could harm our business.
We have added, and expect to continue to add, additional personnel in the areas of sales and marketing, research & development, laboratory operations, finance, quality assurance and compliance. As we build our commercialization efforts and expand research and development activities, our operating expenses and capital requirements have also increased, and we expect that they will continue to increase, significantly. Our ability to manage our growth effectively requires us to forecast expenses accurately, and to properly forecast and expand operational and testing facilities, if necessary, to expend funds to improve our operational, financial and management controls, reporting systems and procedures. As we move forward in commercializing our tests and developing our test portfolio, we will also need to effectively manage our growing manufacturing, laboratory operations and sales and marketing needs. If we are unable to manage our anticipated growth effectively, our business could be harmed.
14
Risks that we face in undertaking this expansion include:
• training new personnel;
• forecasting production and revenue;
• expanding our marketing efforts;
• controlling expenses and investments in anticipation of expanded operations;
• establishing and maintaining relationships with new customers and partners;
• implementing and enhancing administrative infrastructure, systems and processes;
• Unforeseen delays in the development of new products;
• Unforeseen delays in regulatory approvals;
• Unforeseen test performance that we may experience performing FDA studies; and
• addressing new markets.
We intend to continue to hire additional personnel. Competition for individuals with relevant experience can be intense, and we may not be able to attract, assimilate, train or retain additional highly qualified personnel in the future. The failure to attract, integrate, train, motivate and retain these additional employees could seriously harm our business and prospects.
We substantially depend upon our management.
Our success depends largely on the skills, experience and performance of key members of our management who are critical to directing and managing our growth and development in the future. Our success substantially depends upon our senior management’s ability to lead our company, implement successful corporate strategies and initiatives, develop key relationships, including relationships with collaborators and business partners, and successfully commercialize products and services. While our management has significant experience developing diagnostic products, we have considerably less experience in commercializing these products or services. The efforts of our management will be critical as we develop our technologies and seek to commercialize our tests and other products and services.
In September 2021, we acquired all of the equity interests of PharmGenomics, and the combined company may not perform as we expect.
On September 20, 2021, we acquired all of the equity interests of PharmGenomics, the entity that licenses ColoAlert. The combined company may not perform as we expect. Risks associated with the combined company include:
• integrating businesses is a difficult, expensive, and time-consuming process. Although we have not had historically substantial operations, the Chief Science Officer and the Chief Operating Officer of the combined company come from the legacy Mainz Biomed side of the acquisition whereas the non-executive employees of the combined company come from the legacy PharmGenomics side of the transaction. Failure to integrate successfully our businesses with the business and operations of PharmGenomics could lead to inefficiencies, the loss of staff, decreased revenue and ineffective marketing campaigns or research and development; and
• the success of the combined company also depends upon relationships with third parties and any deterioration of the relationship with PharmGenomics’ pre-existing reference laboratories platform could adversely affect the combined company’s business, financial condition, and results of operations.
Failure of our internal controls over financial reporting could harm our business and financial results.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting for external purposes in accordance with accounting principles generally accepted in the United States. Internal control over financial reporting includes maintaining records that in reasonable detail accurately
15
and fairly reflect our transactions; providing reasonable assurance that transactions are recorded as necessary for preparation of our financial statements; providing reasonable assurance that receipts and expenditures of our assets are made in accordance with management authorization; and providing reasonable assurance that unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements would be prevented or detected on a timely basis. Because of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement of our financial statements would be prevented or detected. Our growth and entry into new diagnostic tests, technologies and markets will place significant additional pressure on our system of internal control over financial reporting. Any failure to maintain an effective system of internal control over financial reporting could limit our ability to report our financial results accurately and timely or to detect and prevent fraud.
You may face difficulties protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited because we are incorporated under the laws of the Netherlands, a substantial portion of our assets are in the European Union and a majority of our directors and executive officers reside outside the United States.
We are constituted under the laws of the Netherlands. A majority of our officers, and directors, reside outside the United States. In addition, a substantial portion of their assets and our assets are located outside of the United States. As a result, you may have difficulty serving legal process within the United States upon us or any of these persons. You may also have difficulty enforcing, both in and outside of the United States, judgments you may obtain in U.S. courts against us or these persons in any action, including actions based upon the civil liability provisions of U.S. Federal or state securities laws. Furthermore, there is substantial doubt as to the enforceability in the Netherlands against us or against any of our directors, officers and the expert named in this prospectus who are not residents of the United States, in original actions or in actions for enforcement of judgments of U.S. courts, of liabilities based solely upon the civil liability provisions of the U.S. federal securities laws. In addition, shareholders in Dutch corporations may not have standing to initiate a shareholder derivative action in U.S. federal courts.
As a result, our public shareholders may have more difficulty in protecting their interests through actions against us, our management, our directors or our major shareholders than would shareholders of a corporation incorporated in a jurisdiction in the United States.
Global economic conditions could materially adversely impact demand for our products and services.
Our operations and performance depend significantly on economic conditions. Global financial conditions continue to be subject to volatility arising from international geopolitical developments and global economic phenomenon, as well as general financial market turbulence and natural phenomena such as the COVID-19 pandemic. Uncertainty about global economic conditions could result in
• customers postponing purchases of our products and services in response to tighter credit, unemployment, negative financial news and/or declines in income or asset values and other macroeconomic factors, which could have a material negative effect on demand for our products and services; and
• third-party suppliers being unable to produce components for our products in the same quantity or on the same timeline or being unable to deliver such parts and components as quickly as before or subject to price fluctuations, which could have a material adverse effect on our production or the cost of such production; and accordingly, on our business, results of operations or financial condition.
Access to public financing and credit can be negatively affected by the effect of these events on German, Dutch, European, U.S. and global credit markets. The health of the global financing and credit markets may affect our ability to obtain equity or debt financing in the future and the terms at which financing or credit is available to us. These instances of volatility and market turmoil could adversely affect our operations and the trading price of our ordinary shares.
Changes to trade policy, tariffs, and import/export regulations may have a material adverse effect on our business, financial condition, and results of operations.
Changes in laws and policies governing foreign trade could adversely affect our business. As a result of recent and future policy changes, there may be greater restrictions and economic disincentives on international trade. Such changes have the potential to adversely impact the global and local economies, our industry and global demand for our products and, as a result, could have a material adverse effect on our business, financial condition and results of operations.
16
Fluctuations in currency exchange rates may significantly impact our results of operations.
A substantial percentage of our operations are conducted in Europe. As a result, we are exposed to an exchange rate risk between the U.S. and the Euro. The exchange rates between these currencies in recent years have fluctuated significantly and may continue to do so in the future. An appreciation of the Euro against the U.S. dollar could increase the relative cost of our products outside of Europe, which could lead to decreased sales. Conversely, to the extent that we are required to pay for goods or services in U.S. dollars, the depreciation of the Euro dollar against the U.S. dollar would increase the cost of such goods and services.
We do not hedge our currency exposure and, therefore, we incur currency transaction risk whenever we enter into either a purchase or sale transaction using a currency other than the Euro. Given the volatility of exchange rates, we might not be able to effectively manage our currency transaction risks, and volatility in currency exchange rates might have a material adverse effect on our business, financial condition or results of operations.
Risks Related to Our Technology and Business Strategy
We may fail to generate sufficient revenue from our relationships with our clients or laboratory partners to achieve and maintain profitability.
We believe our commercial success depends upon our ability to successfully market and sell our products and solutions, to continue to expand our current relationships and to develop new relationships with customers, physicians, and laboratories. The demand for our existing and future services may decrease for a number of reasons, including, but is not limited to, the development by competitors of new products, and increased competition from companies that offer similar products and solutions. In addition to reducing our revenue, if our laboratory partners or clients decide to decrease or discontinue their partnerships or relationships with us, and their use of our knowledge and interpretation-based solutions, this may reduce our access to research and patient data that facilitates the incorporation of newly developed information about rare diseases into our data repository.
Our success depends heavily on our ColoAlert screening tests.
For the foreseeable future, our ability to generate revenues will depend almost entirely on the commercial success of our colon cancer screening test. The commercial success and our ability to generate revenues will depend on a variety of factors, including the following:
• patient acceptance of and demand for our tests;
• acceptance of our test in the medical community;
• successful sales, marketing, and educational programs;
• the amount and nature of competition from other colon cancer screening products and procedures;
• the ease of use of our ordering process for physicians;
• maintaining and defending intellectual property and trade secrets, and our ability to establish and maintain adequate commercial manufacturing, distribution, sales and laboratory testing capabilities; and
• The potential of being sued by competitors to avoid or delay market entry in certain geographic markets.
If we are unable to develop and maintain substantial sales of our tests or if we are significantly delayed or limited in doing so, our business prospects, financial condition and results of operation would be adversely affected.
Sales of our diagnostic tests could be adversely impacted by the reluctance of physicians to adopt the use of our tests and by the availability of competing diagnostic tests.
Physicians and hospitals may be reluctant to try a new diagnostic test due to the high degree of risk associated with the application of new technologies and diagnostic test in the field of human medicine, especially if the new test differs from the current standard of care for detecting cancer in patients. For example, CRC prevention strategies, such as FIT and colonoscopies, are well known in the patient group aged over 50 years, while ColoAlert and similar diagnostic
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tests are not vastly known by physicians or patients. We will need to expend significant sums of money to market our products to increase the public’s awareness. If our products do not achieve an adequate level of acceptance, we may not generate enough revenues to become profitable or the profitability may occur much later.
Competing tests for the initial diagnosis, reoccurrence diagnosis and optimal treatment of cancer are being manufactured and marketed by other companies. To compete with other diagnostic tests, particularly any that sell at lower prices, our tests will have to provide medically significant advantages or be more cost effective. Even if we can overcome physician reluctance and compete with products that are currently on the market, our competitors may succeed in developing new, safer, more accurate or more cost-effective diagnostic tests that could render our diagnostic tests and technologies obsolete or non-competitive.
We may not succeed in establishing, maintaining and strengthening ColoAlert and other brands associated with Mainz Biomed’s products, which would materially and adversely affect acceptance of our diagnostic tests, and our business, revenues and prospects.
Our business and prospects heavily depend on our ability to develop, maintain and strengthen the ColoAlert brand and the brands of our future products. Any failure to develop, maintain and strengthen these brands may materially and adversely affect our ability to sell our products. Most of our sales are to clinical reference laboratories or routine diagnostic laboratories. Those laboratories are generally more focused on taking orders than on marketing the products that they sell. We need to educate these reference laboratories and the general public as to why we believe our products are superior. If we are not able to establish, maintain and strengthen our brands, we may lose the opportunity to build our customer base.
We expect that our ability to develop, maintain and strengthen our brands will depend heavily on the success of our marketing efforts. We intend to use proceeds from this offering for marketing of our products, but we might not be successful in such expanded marketing. Due to the specifics of the market in which we operate, the investment in customer acquisition will be high and the uptake is likely slow until a critical mass is reached. To further promote our brand, we may be required to change our marketing practices, which could result in substantially increased advertising expenses, including the need to use traditional media such as television, radio and print. If we do not develop and maintain strong brands, our business, prospects, financial condition and operating results will be materially and adversely impacted.
We might decide not to incorporate the UdeS Biomarkers after we conclude additional studies on such biomarkers.
On January 4, 2022, we acquired an option to license the UdeS Biomarkers. Our decision to exercise such option will depend, among other factors, on the results of further studies that we intend to conduct on the UdeS biomarkers and the analysis as to whether the incorporation of such biomarkers will improve our ColoAlert product. If we conclude such studies and decide not exercise such option, we will have expended such funds without improving our ColoAlert product and we will have no recourse to such expended funds.
Product liability, warranty, personal injury, property damage and recall claims may materially affect our financial condition and damage our reputation.
We are engaged in a business that exposes us to claims for product liability and warranty claims in the event our products actually or allegedly fail to perform as expected or the use of our products results, or is alleged to result, in property damage, personal injury or death. Any judgment or settlement for personal injury or wrongful death claims could be more than our assets and, even if not justified, could prove expensive to contest.
Although we maintain product and general liability insurance of the types and in the amounts that we believe are customary for the industry, we are not fully insured against all such potential claims. We may experience legal claims in excess of our insurance coverage or claims that are not covered by insurance, either of which could adversely affect our business, financial condition and results of operations. Adverse determination of material product liability and warranty claims made against us could have a material adverse effect on our financial condition and harm our reputation. In addition, if any of our products or components in our products are, or are alleged to be, defective, we may be required to participate in a recall of that product or component. Any such recall and other claims could be costly to us and require substantial management attention.
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We may face technology transfer challenges and expenses in adding new tests to our portfolio and in expanding our reach into new geographical areas.
Our plan for expanding our business includes developing and acquiring additional tests or additional biomarkers that can be transferred into our current and future diagnostic product portfolio and distributed in our target markets. Due to differences in the hardware and software platforms available at different laboratories for running molecular tests, we may need to adjust the configuration of the reagents and there may be changes to the related software in order for the tests to be performed on particular hardware platforms. Making any such adjustments could take a considerable amount of time and expense, and there will be no assurance that we will succeed in running our tests on the hardware and software that we may encounter in different laboratories. To manage this issue, we may license or acquire our own instrument system and software from another company that has a platform that will be compatible with our tests. This may include additional licenses and license fees needed for reagents or components required hereto as well.
If third party payors do not provide reimbursement, breach, rescind or modify their contracts or reimbursement policies or delay payments for our tests, or we are unable to successfully renegotiate reimbursement contracts, our commercial success could be compromised.
Physicians and patients might not order our tests unless third party payors, such as managed care organizations as well as government payors, pay a substantial portion of the test price. Reimbursement by a payor may depend on a number of factors, including a payor’s determination that tests using our technologies are not experimental or investigational, and that they are medically necessary, cost-effective, supported by peer-reviewed publications and included in clinical practice guidelines. There is uncertainty concerning third-party payor reimbursement of any test incorporating new technology.
Reimbursement is based in most countries on reimbursement codes, which differ from country to country. Currently, ColoAlert is reimbursed as a polymerase chain reaction (“PCR”) test in Germany for privately insured patients if an authorized medical care center is performing the analysis. For statutory and/or privately insured patients in Germany and in other countries, we may need to apply for a specific reimbursement code, which may call for a new clinical study and additional CE-IVD approvals.
We believe that it may take several years to achieve reimbursement with a majority of third-party payors for our tests. If we fail to establish and maintain broad adoption of and reimbursement for all of our current tests and any future tests that we may develop, our reputation could be harmed and our future prospects, revenue and our business could suffer. Additionally, we have in the past experienced, and anticipate further experiencing, delays and temporary interruptions in the receipt of payments from third-party payors due to modifications in existing contracts or arrangements, contract implementation matters, documentation requirements and other issues, which could cause our revenues to fluctuate from period to period.
We will need to make significant inroads with general practitioners in Europe. In most European countries, health care is considered a public responsibility, and the main payer is public health insurance. This implies that the private pay market is limited, and that general practitioners are the main gate keepers to market penetration. If we cannot convince general practitioners in Europe that our products are the superior choice, we cannot grow there as quickly as we need, if at all.
We may depend on possible future collaborations to develop and commercialize many of our diagnostic test candidates and to provide the manufacturing, regulatory compliance, sales, marketing and distribution capabilities required for the success of our business.
We may enter into various collaborative research and development, manufacturing, and diagnostic test marketing agreements to develop and commercialize our diagnostic tests. Any future milestone payments and cost reimbursements from collaboration agreements could provide an important source of financing for our research and development programs, thereby facilitating the application of our technology to the development and commercialization of our diagnostic tests, but there are risks associated with entering into collaboration arrangements.
There is a risk that we could become dependent upon one or more collaborative arrangements for diagnostic test development or manufacturing or as a source of revenues from the sale of any diagnostic tests that may be developed by us alone or through one of the collaborative arrangements. A collaborative arrangement upon which we might depend might be terminated by our collaboration partner or they might determine not to actively pursue the development or commercialization of our diagnostic tests. A collaboration partner also may not be precluded from independently pursuing competing diagnostic tests or technologies.
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There is a risk that a collaboration partner might fail to perform its obligations under the collaborative arrangements or may be slow in performing its obligations. In addition, a collaboration partner may experience financial difficulties at any time that could prevent it from having available funds to contribute to the collaboration. If a collaboration partner fails to conduct its diagnostic test development, manufacturing, commercialization, regulatory compliance, sales and marketing or distribution activities successfully and in a timely manner, or if it terminates or materially modifies its agreements with us, the development and commercialization of one or more diagnostic test candidates could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue diagnostic test development, manufacturing, and commercialization on our own.
If we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could create undue competition and pricing pressures. There is no certainty that any future patent applications will result in the issuance of patents or that issued patents, if we receive any, will be deemed enforceable.
The success of our business depends significantly on our ability to operate without infringing patents and other proprietary rights of others. If the technology that we use infringes a patent held by others, we could be sued for monetary damages by the patent holder or its licensee, or we could be prevented from continuing research, development, and commercialization of diagnostic tests that rely on that technology, unless we are able to obtain a license to use the patent. The cost and availability of a license to a patent cannot be predicted, and the likelihood of obtaining a license at an acceptable cost would be lower if the patent holder or any of its licensees is using the patent to develop or market a diagnostic test with which our diagnostic test would compete. If we cannot obtain a necessary license, we would need to develop or obtain rights to alternative technologies, which could prove costly and could cause delays in diagnostic test development, or we could be forced to discontinue the development or marketing of any diagnostic tests that were developed using the technology covered by the patent.
Our success will depend in part on our ability to obtain and enforce intellectual property protection. We currently rely on trade secrets, know how and technology to protect our intellectual property and do not have any patents or any pending patent applications. In January 2022, we entered into a Technology Rights Agreement pursuant to which we may license certain biomarkers developed at the Université de Sherbrooke. If we exercise our option to acquire to such license, we will be responsible for prosecuting and maintaining any patents on such biomarkers, including the patent application filed with the U.S. PTO (application no. 68/108,510) and the International Patent System. If we are unsuccessful in obtaining or maintaining such protection and our trade secrets and know are revealed to our competitors, they could use our intellectual property and create diagnostic tests that compete with our diagnostic tests, without paying license fees or royalties to us.
Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.
We rely on trade secrets, know-how and technology, which are not protected by patents and do not have any patent applications pending, to protect the intellectual property behind our diagnostic tests. We do not yet use confidentiality agreements with our collaborators, employees, consultants, outside scientific collaborators and sponsored researchers and other advisors to protect our proprietary technology and processes. We intend to use such agreements in the future, but these agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover trade secrets and proprietary information, and in such cases, we cannot assert any trade secret rights against such party. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.
Results of FDA required studies may not create desired clinical performance resulting in follow-on studies delaying the launch of the product in the US.
We will be required to undertake a clinical study to achieve FDA market authorization that will be significantly larger than the study used to receive CE-IVD certification under the IVD-D. The clinical performance of the ColoAlert test for the FDA study might not meet the current product performance. As a result, we may need to undertake additional studies or abandon the study altogether. Additional studies would be costly and delay or prevent our rollout of ColoAlert in the United States.
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Risks Related to Regulations
Our global operations expose us to numerous and sometimes conflicting legal and regulatory requirements, and violations of these requirements could harm our business.
We are subject to numerous, and sometimes conflicting, legal regimes in the countries in which we operate, including on matters as diverse as health and safety standards, marketing and promotional activities, anticorruption, import/export controls, content requirements, trade restrictions, tariffs, taxation, sanctions, immigration, internal and disclosure control obligations, securities regulation, anti-competition, data privacy and labor relations. This includes in emerging markets where legal systems may be less developed or familiar to us. We strive to abide by and maintain compliance with these laws and regulations. Compliance with diverse legal requirements is costly and time-consuming. Violations of one or more of these regulations in the conduct of our business could result in significant fines, criminal sanctions against us or our board of directors or officers, prohibitions on doing business and damage to our reputation. Violations of these regulations in connection with the performance of our obligations to our clients or partners also could result in liability for significant monetary damages, fines and/or criminal prosecution, unfavorable publicity and other reputational damage, restrictions on our ability to process information and allegations by our clients or partners that we have not performed our contractual obligations. Due to the varying degrees of development of the legal systems of the countries in which we operate, local laws might be insufficient to protect our rights.
Our international operations could be affected by changes in laws, trade regulations, labor and employment regulations, and procedures and actions affecting approval, products and solutions, pricing, reimbursement and marketing of our products and solutions, as well as by inter-governmental disputes. Any of these changes could adversely affect our business. The imposition of new laws or regulations, including potential trade barriers, may increase our operating costs, impose restrictions on our operations or require us to spend additional funds to gain compliance with the new rules, if possible, which could have an adverse impact on our financial condition.
Our business is subject to various complex laws and regulations. We could be subject to significant fines and penalties if we or our partners fail to comply with these laws and regulations.
As a manufacturer of clinical diagnostic products and clinical diagnostic services, we and our partners are subject to extensive and frequently changing federal, state and local laws and regulations governing various aspects of our business. In particular, the clinical laboratory industry is subject to significant governmental certification and licensing regulations, as well as federal and state laws regarding:
• test ordering and billing practices;
• marketing, sales and pricing practices;
• health information privacy and security, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and comparable state and local laws;
• anti-markup legislation; and
• consumer protection.
We expect to be required to comply with U.S. Food and Drug Administration, or FDA, regulations, including with respect to our labeling and promotion activities. In addition, advertising of our tests is subject to regulation by the Federal Trade Commission, or FTC. Violation of any FDA requirement could result in enforcement actions, such as seizures, injunctions, civil penalties and criminal prosecutions, and violation of any FTC requirement could result in injunctions and other associated remedies, all of which could have a material adverse effect on our business. Most states also have similar regulatory and enforcement authority for devices. Additionally, most foreign countries have authorities comparable to the FDA and processes for obtaining marketing approvals. Obtaining and maintaining these approvals, and complying with all laws and regulations, may subject us to similar risks and delays as those we could experience under FDA and FTC regulation. We incur various costs in complying and overseeing compliance with these laws and regulations.
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Healthcare policy has been a subject of extensive discussion in many national, regional and local governments, and healthcare laws and regulations are subject to change. Development of the existing commercialization strategy for our tests have been based on existing healthcare policies. We cannot predict what additional changes, if any, will be proposed or adopted or the effect that such proposals or adoption may have on our business, financial condition, and results of operations. If we or our partners, including independent sales representatives, fail to comply with these laws and regulations, we could incur significant fines and penalties and our reputation and prospects could suffer. Additionally, our partners could be forced to cease offering our products and services in certain jurisdictions, which could materially disrupt our business.
We will have to maintain facilities, or maintain relationships with third party laboratories, for the manufacture and use of diagnostic tests. Our ability to provide services and pursue our research and development and commercialization efforts may be jeopardized if these facilities were to be harmed or rendered inoperable.
Our facilities and equipment could be harmed or rendered inoperable by natural or man-made disasters, including fire, flooding and power outages, which may render it difficult or impossible for us to perform our tests or provide laboratory services for some period of time. The inability to perform our tests or the backlog of tests that could develop if any of our facilities is inoperable for even a short period of time may result in the loss of customers or harm to our reputation or relationships with key researchers, collaborators, and customers, and we may be unable to regain those customers or repair our reputation in the future. Furthermore, our facilities and the equipment we use to perform our research and development work could be costly and time-consuming to repair or replace.
Additionally, a key component of our research and development process involves using biological samples and the resulting data sets and medical histories, as the basis for our diagnostic test development. In some cases, these samples are difficult to obtain. If the parts of our laboratory facilities where we store these biological samples are damaged or compromised, our ability to pursue our research and development projects, commercialization of our diagnostic tests, as well as our reputation, could be jeopardized. We carry insurance for damage to our property and the disruption of our business, but this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, if at all.
We anticipate being required to obtain regulatory approval of our diagnostic test products to enter new markets.
If our products enter new markets, they will need to satisfy the regulatory rules in that market. Given the nature of our products and product candidates, we believe that our entry into the U.S. market will require FDA market authorization through pre-market review. This may also be the case for corresponding foreign regulatory authorities. Our products and product candidates may not be cleared or approved on a timely basis, if at all. The regulatory approval process may involve, among other things, successfully completing additional clinical trials and filing a pre-market approval application (PMA) with the FDA. Similar review and approval processes may be applicable for corresponding foreign regulatory authorities.
We are required to comply with national, regional and local laws governing the privacy of health information, and any failure to comply with these laws could result in material criminal and civil penalties.
National, regional and local laws set forth security regulations that establish administrative, physical and technical standards for maintaining the confidentiality, integrity and availability of protected health information in electronic form. If protected health information is breached, additional laws, require us to provide certain health information security breach notifications to those individuals whose protected health information is breached.
We may incur significant compliance costs related to varying national and state privacy regulations and varying national and state privacy and security laws. Given the complexity of such laws and their overlap with national and state privacy and security laws, and the fact that these laws are rapidly evolving and are subject to changing and potentially conflicting interpretation, our ability to comply with such laws and requirements is uncertain and the costs of compliance are significant. The costs of complying with any changes to the national and state privacy restrictions may have a negative impact on our operations. Noncompliance could subject us to criminal penalties, civil sanctions and significant monetary penalties as well as reputational damage.
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We are subject to national and regional healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws.
We are subject to healthcare fraud and abuse regulation and enforcement by both national governments and the regions in which we conduct our business. In the United States, where we intend to seek approval to rollout our ColoAlert product, these health care laws and regulations include the following:
• The federal Anti-Kickback Statute;
• The federal physician self-referral prohibition, commonly known as the Stark Law;
• The federal false claims and civil monetary penalties laws;
• The federal Physician Payment Sunshine Act requirements under the Affordable Care Act; and
• State law equivalents of each of the federal laws enumerated above.
Any action brought against us for violation of these laws or regulations, even if we are in compliance and successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of these laws and regulations, we may be subject to applicable penalties associated with the violation, including, among others, administrative, civil and criminal penalties, damages and fines, and/or exclusion from participation in Medicare, Medicaid programs, including the California Medical Assistance Program (Medi-Cal — the California version of the Medicaid program) or other state or federal health care programs. Additionally, we could be required to refund payments received by us, and we could be required to curtail or cease our operations.
Risks Related to Our Ordinary Shares and this Offering
The market price of our ordinary shares may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
The public market for our ordinary shares has a limited history. Our ordinary shares began trading on the Nasdaq Capital Market on November 5, 2021, and from then until January 20, 2022, the volume of shares traded per trading day has been approximately 563,000 shares. The daily trading volume and our per ordinary share market price may decrease significantly, and our per ordinary share market price might never be in excess of the per ordinary share price in this offering. The value of your investment could decline due to the impact of any of the following factors upon the market price of our ordinary shares:
• sales or potential sales of substantial amounts of our ordinary shares;
• announcements about us or about our competitors;
• litigation and other developments relating to our intellectual property or other proprietary rights or those of our competitors;
• conditions in the diagnostic test industry;
• governmental regulation and legislation;
• variations in our anticipated or actual operating results;
• change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations;
• change in general economic trends; and
• investor perception of our industry or our prospects.
Many of these factors are beyond our control. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. As a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. A broad or active public trading market for our ordinary shares may not develop or be sustained.
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You may experience dilution of your ownership interests if we issue additional ordinary shares or preferred shares.
In the future, we may issue our authorized but previously unissued equity securities, resulting in the dilution of the ownership interests of our present shareholders. We are authorized to issue an aggregate of 48,550,000 ordinary shares. Assuming an offering price of $23.75 as set out on the cover page of this prospectus, upon the closing of this offering, we will have approximately 13,510,000 ordinary share outstanding (or 13,735,000 ordinary shares outstanding if the over-allotment option is exercised in full).
We may issue additional ordinary shares or other securities that are convertible into or exercisable for ordinary shares in order to raise additional capital, or in connection with hiring or retaining employees, directors, or consultants, or in connection with future acquisitions of licenses to technology or diagnostic tests in connection with future business acquisitions, or for other business purposes. The future issuance of any such additional ordinary shares or other securities would dilute the voting power of our stockholders who purchase shares in this offering, could dilute the net tangible book value per share at the time of such future issuance and may create downward pressure on the trading price of our ordinary shares.
We may also issue preferred shares having rights, preferences, and privileges senior to the rights of our ordinary shares with respect to dividends, rights to share in distributions of our assets if we liquidate our company, or voting rights. Any preferred shares may also be convertible into ordinary shares on terms that would be dilutive to holders of ordinary shares.
We do not intend to pay dividends, and there will thus be fewer ways in which you are able to make a gain on your investment.
We have never paid any cash or stock dividends, and we do not intend to pay any dividends for the foreseeable future. To the extent that we require additional funding currently not provided for in our financing plan, our funding sources may prohibit the payment of any dividends. Because we do not intend to declare dividends, any gain on your investment will need to result from an appreciation in the price of our ordinary shares. There will therefore be fewer ways in which you are able to make a gain on your investment. Our articles of association prescribe that any profits in any financial year will be distributed first to holders of preferred shares, if outstanding.
FINRA sales practice requirements may limit your ability to buy and sell our ordinary shares, which could depress the price of our shares.
FINRA rules require broker-dealers to have reasonable grounds for believing that an investment is suitable for a customer before recommending that investment to the customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status and investment objectives, among other things. Under interpretations of these rules, FINRA believes that there is a high probability such speculative low-priced securities will not be suitable for at least some customers. Thus, FINRA requirements may make it more difficult for broker-dealers to recommend that their customers buy our ordinary shares, which may limit your ability to buy and sell our shares, have an adverse effect on the market for our shares and, thereby, depress their market prices.
Volatility in our ordinary shares price may subject us to securities litigation.
The market for our ordinary shares may have, when compared to seasoned issuers, significant price volatility, and we expect that our share price may continue to be more volatile than that of a seasoned issuer for the indefinite future. In the past, plaintiffs have often initiated securities class action litigation against a company following periods of volatility in the market price of its securities. We may, in the future, be the target of similar litigation. Securities litigation could result in substantial costs and liabilities and could divert management’s attention and resources.
We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.
Our management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described in the section entitled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and
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variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. The failure by our management to apply these funds effectively could harm our business.
We are a foreign private issuer within the meaning of the rules under the Exchange Act, and as such we are exempt from certain provisions applicable to U.S. domestic public companies.
We are a foreign private issuer within the meaning of the rules under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As such, we are exempt from certain provisions applicable to U.S. domestic public companies. For example:
• we are not required to provide as many Exchange Act reports, or as frequently, as a domestic public company;
• for interim reporting, we are permitted to comply solely with our home country requirements, which are less rigorous than the rules that apply to domestic public companies;
• we are not required to provide the same level of disclosure on certain issues, such as executive compensation;
• we are exempt from provisions of Regulation FD aimed at preventing issuers from making selective disclosures of material information;
• we are not required to comply with the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; and
• we are not required to comply with Section 16 of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and establishing insider liability for profits realized from any “short-swing” trading transaction.
Our shareholders may not have access to certain information they may deem important and are accustomed to receiving from U.S. reporting companies.
As an “emerging growth company” under applicable law, we will be subject to lessened disclosure requirements. Such reduced disclosure may make our ordinary shares less attractive to investors.
For as long as we remain an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), we will elect to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies”, including, but not limited to, not being required to comply with the auditor attestation requirements of 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 non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. Because of these lessened regulatory requirements, our shareholders would be left without information or rights available to shareholders of more mature companies. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for such securities and their market prices may be more volatile.
We incur significant costs as a result of being a public company, which costs will grow after we cease to qualify as an “emerging growth company.”
We incur significant legal, accounting and other expenses as a public company that we did not incur as a private company. The Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC and the Nasdaq Capital Market, impose various requirements on the corporate governance practices of public companies. We are an “emerging growth company,” as defined in the JOBS Act and will remain an emerging growth company until the earlier of (1) (a) December 31, 2026, (b) the last day of the fiscal year in which we have total annual gross revenue of at least $1.07 billion, or (c) the last day of the fiscal year in which we are deemed to be a large accelerated filer, which means the market value of our ordinary shares that is held by non-affiliates exceeds $700 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period. 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 exemption from the auditor attestation
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requirement under Section 404 in the assessment of the emerging growth company’s internal control over financial reporting and permission to delay adopting new or revised accounting standards until such time as those standards apply to private companies.
Compliance with these rules and regulations increases our legal and financial compliance costs and makes some corporate activities more time-consuming and costly. After we are no longer an emerging growth company, we expect to incur significant expenses and devote substantial management effort toward ensuring compliance with the requirements of Section 404 and the other rules and regulations of the SEC. For example, as a public company, we have been required to increase the number of independent directors and adopt policies regarding internal controls and disclosure controls and procedures. We have incurred additional costs in obtaining director and officer liability insurance. In addition, we incur additional costs associated with our public company reporting requirements. It may also be more difficult for us to find qualified persons to serve on our board of directors or as executive officers. We are currently evaluating and monitoring developments with respect to these rules and regulations, and we cannot predict or estimate with any degree of certainty the amount of additional costs we may incur or the timing of such costs.
If we are, or were to become, a passive foreign investment company (a “PFIC”) for U.S. federal income tax purposes, U.S. investors in our ordinary shares would be subject to certain adverse U.S. federal income tax consequences.
In general, a non-U.S. corporation will be a PFIC for any taxable year if (i) 75% or more of its gross income consists of passive income or (ii) 50% or more of the average quarterly value of its assets consists of assets that produce, or are held for the production of, passive income. We do not expect to be a PFIC for our current taxable year or in the foreseeable future. However, there can be no assurance that we will not be considered a PFIC for any taxable year. If we were a PFIC for any taxable year during which a U.S. investor held ordinary shares, such investor would be subject to certain adverse U.S. federal income tax consequences, such as ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, an additional interest charge on certain taxes treated as deferred, and additional reporting requirements under U.S. federal income tax laws and regulations. If we are characterized as a PFIC, a U.S. investor may be able to make a “mark-to-market” election with respect to our ordinary shares that would alleviate some of the adverse consequences of PFIC status. Although U.S. tax rules also permit a U.S. investor to make a “qualified electing fund” election with respect to the shares of a non-U.S. corporation that is a PFIC if the non-U.S. corporation provides certain information to its investors, we do not currently intend to provide the information that would be necessary for a U.S. investor to make a valid “qualified electing fund” election with respect to our ordinary shares.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains statements that constitute “forward-looking statements”. Any statements that are not statements of historical facts may be deemed to be forward-looking statements. These statements appear in a number of different places in this prospectus and, in some cases, can be identified by words such as “anticipates”, “estimates”, “projects”, “expects”, “contemplates”, “intends”, “believes”, “plans”, “may”, “will”, or their negatives or other comparable words, although not all forward-looking statements contain these identifying words. Forward-looking statements in this prospectus may include, but are not limited to, statements and/or information related to: strategy, future operations, projected production capacity, projected sales or rentals, projected costs, expectations regarding demand and acceptance of our products, availability of material components, trends in the market in which we operate, plans and objectives of management.
We believe that we have based our forward-looking statements on reasonable assumptions, estimates, analysis and opinions made in light of our experience and our perception of trends, current conditions and expected developments, as well as other factors that we believe to be relevant and reasonable in the circumstances at the date that such statements are made, but which may prove to be incorrect. Although management believes that the assumption and expectations reflected in such forward-looking statements are reasonable, we may have made misjudgments in preparing such forward-looking statements. Assumptions have been made regarding, among other things: our expected production capacity; labor costs and material costs, no material variations in the current regulatory environment and our ability to obtain financing as and when required and on reasonable terms. Readers are cautioned that the foregoing list is not exhaustive of all factors and assumptions which may have been used.
The forward-looking statements, including the statements contained in the sections entitled Risk Factors, Description of Business and Management’s Discussion and Analysis of Financial Conditions and Results of Operations and elsewhere in this prospectus, are subject to known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed or implied by such forward-looking statements.
Although management has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. Forward-looking statements might not prove to be accurate, as actual results and future events could differ materially from those anticipated in such forward-looking statements or we may have mad misjudgments in the course of preparing the forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. We wish to advise you that these cautionary remarks expressly qualify, in their entirety, all forward-looking statements attributable to our company or persons acting on our company’s behalf. We do not undertake to update any forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting such statements, except as, and to the extent required by, applicable securities laws. You should carefully review the cautionary statements and risk factors contained in this prospectus and other documents that we may file from time to time with the securities regulators.
27
IMPLICATIONS OF BEING A FOREIGN PRIVATE ISSUER
We are considered a foreign private issuer. In our capacity as a foreign private issuer, we are exempt from certain rules under the Exchange Act that impose certain disclosure obligations and procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and the rules under the Exchange Act with respect to their purchases and sales of our securities. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. In addition, we are not required to comply with Regulation FD, which restricts the selective disclosure of material information.
We may take advantage of these exemptions until such time as we are no longer a foreign private issuer. We would cease to be a foreign private issuer at such time as more than 50% of our outstanding voting securities are held by U.S. residents and any of the following three circumstances applies: (1) the majority of our executive officers or directors are U.S. citizens or residents, (2) more than 50% of our assets are located in the United States or (3) our business is administered principally in the United States.
We have taken advantage of certain reduced reporting and other requirements in this prospectus. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold equity securities.
28
IMPLICATIONS OF BEING AN EMERGING GROWTH COMPANY
The U.S. Congress passed the JOBS Act, which provides for certain exemptions from various reporting requirements applicable to reporting companies under the Exchange Act, that qualify as “emerging growth companies.” We are an “emerging growth company” and we will continue to qualify as an “emerging growth company” until the earliest to occur of: (a) the last day of the fiscal year during which we have total annual gross revenues of $1.07 billion (as such amount is indexed for inflation every five years by the SEC) or more; (b) the last day of our fiscal year following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act; (c) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or (d) the date on which we are deemed to be a “large accelerated filer”, as defined in Exchange Act Rule 12b–2. Therefore, we expect to continue to be an emerging growth company for the foreseeable future.
An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:
• the ability to include only two years of audited financial statements and only two years of related management’s discussion and analysis of financial condition and results of operations disclosure in this prospectus;
• an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; and
• Exemption from mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional information about the audit and the financial statements of the registrant (auditor discussion and analysis).
We may take advantage of these provisions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, have more than $700 million in market value of our ordinary shares held by non-affiliates or issue more than $1 billion of non-convertible debt over a three-year period.
29
Assuming the sale of 1,500,000 ordinary shares in this offering at a price of $23.75 per share, the closing price of our ordinary shares on the Nasdaq Capital Market on January 20, 2022, after deducting the estimated underwriting discounts and commissions and offering expenses payable by us, we expect to receive net proceeds of approximately $32,524,000 from this offering. If the underwriter exercises its over-allotment option in full, our aggregate net proceeds will be approximately $37,454,000.
We currently expect to use the net proceeds from this offering (assuming no exercise of the underwriter’s over-allotment option) as follows:
Description of Use |
Estimated
|
||
Research & Development (further development of ColoAlert and PancAlert) |
$ |
3,500,000 |
|
Clinical study related to the UdeS Biomarkers |
|
1,250,000 |
|
Clinical studies for FDA approval of ColoAlert |
$ |
20,000,000 |
|
Marketing and Sales |
$ |
4,750,000 |
|
General Corporate Purposes |
$ |
3,024,000 |
|
Total: |
$ |
32,524,000 |
A $1.00 increase or decrease in the assumed public offering price of $23.75 per share would increase or decrease the net proceeds from this offering by approximately $1,384,000 assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and offering expenses payable by us. Similarly, each increase or decrease of 100,000 shares offered would increase or decrease our net proceeds by approximately $2,191,000, assuming the assumed public offering price remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
Pending our use of the net proceeds from this offering, we may invest the net proceeds in a variety of capital preservation investments, including short-term, investment grade, interest bearing instruments and U.S. government securities. We do not intend to use the proceeds from this offering to make principal payments, scheduled or early, on any of our outstanding debt.
30
Under Dutch law, we may only pay dividends following the closing of the offering to the extent our shareholders’ equity (eigen vermogen) exceeds the sum of the paid-up and called-up share capital plus the reserves required to be maintained by Dutch law or by our articles of association. Subject to such restrictions, the amount of any distributions will depend on many factors, such as our results of operations, financial condition, cash requirements, prospects and other factors deemed relevant by our board of directors.
Our articles of association prescribe that profits in any financial year will be distributed first to holders of our preferred shares, if any are outstanding. Any remaining profits may be reserved by our Board of Directors.
We have not adopted a formal dividend policy with respect to future dividends. We may adopt such a policy in the future.
CORPORATE REORGANIZATION
On November 9, 2021, we converted our company from a private company with limited liability under Dutch law into a public company under Dutch law.
31
CAPITALIZATION AND INDEBTEDNESS
The following table sets forth the capitalization of PharmGenomics GmbH, which is considered for accounting purposes to be our predecessor entity. Mainz Biomed N.V. was not formed as of December 31, 2020 and to date has had no operations. Such information is set forth on the following basis:
• on an actual basis for PharmGenomics GmbH;
• on a pro forma basis, giving effect to
(a) the Contribution Agreement reflecting (i) our merger with PharmGenomics GmbH, (ii) our sale of 1,000,000 units (consisting of an ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00) in August 2021 at a per unit price of $0.60 and the related issuance of 70,000 broker warrants, (iii) our issuance of 200,000 shares to our Chief Executive Officer and (iv) our sale of 500,000 units (consisting of an ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00) in September 2021 at a per unit price of $2.00 and the related issuance of 25,000 broker warrants; and
(b) the closing of our initial public offering on November 9, 2021 pursuant to which we sold 2,300,000 Shares for net proceeds of $10,358,750; and
• on a pro forma, as adjusted basis, giving effect to the sale by us of 1,500,000 Shares (excluding any sale of Shares pursuant to the underwriter’s over-allotment option), at an assumed public offering price of $23.75 per Share, after deducting underwriting discounts and commissions and estimated offering expenses.
The pro forma and pro forma as adjusted information below is illustrative only and our capitalization following the completion of this offering will be adjusted based on the actual public offering price and other terms of this offering determined at pricing. You should read this table together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our audited financial statements and the related notes appearing elsewhere in this prospectus and our and unaudited consolidated pro forma information appearing elsewhere in this prospectus.
As of June 30, 2021 |
||||||||||||
Actual |
Pro Forma |
Pro Forma
|
||||||||||
Cash |
$ |
195,165 |
|
$ |
10,469,397 |
|
$ |
42,993,460 |
|
|||
|
|
|
|
|
|
|||||||
Debt: |
|
|
|
|
|
|
||||||
Convertible Debt |
$ |
— |
|
$ |
— |
|
$ |
— |
|
|||
Convertible Debt – Related Parties |
|
79,856 |
|
|
79,856 |
|
|
79,856 |
|
|||
Loans Payable |
|
23,702 |
|
|
23,702 |
|
|
23,702 |
|
|||
Loans Payable – Related Parties |
|
105,414 |
|
|
105,414 |
|
|
105,414 |
|
|||
Silent Partnerships |
|
1,537,826 |
|
|
1,537,826 |
|
|
1,537,826 |
|
|||
Silent Partnerships – Related Parties |
|
488,726 |
|
|
488,726 |
|
|
488,726 |
|
|||
Total Debt |
$ |
2,235,524 |
|
$ |
2,235,524 |
|
$ |
2,235,524 |
|
|||
|
|
|
|
|
|
|||||||
Stockholders’ Equity (Deficit): |
|
|
|
|
|
|
||||||
Common Shares, €1.00 par value, 99,069 shares issued and outstanding of PharmGenomics GmbH; on a Pro Forma basis 9,710,001 common shares of Mainz Biomed N.V., €0.01 par value |
|
114,010 |
|
|
139,568 |
|
|
156,818 |
|
|||
Reserves |
|
2,810,022 |
|
|
13,034,720 |
|
|
45,541,470 |
|
|||
Accumulated Deficit |
|
(5,216,581 |
) |
|
(5,244,581 |
) |
|
(5,244,581 |
) |
|||
Accumulated Other Comprehensive Loss |
|
(119,527 |
) |
|
(119,527 |
) |
|
(119,527 |
) |
|||
Total Stockholders’ Equity (Deficit) |
$ |
(2,412,076 |
) |
$ |
7,810,180 |
|
$ |
40,334,180 |
|
|||
Total Capitalization |
$ |
(176,552 |
) |
$ |
10,045,704 |
|
$ |
42,569,704 |
|
A $1.00 increase or decrease in the assumed public offering price per share would increase or decrease our pro forma as adjusted cash, additional paid-in capital, total stockholders’ equity (deficit) and total capitalization by approximately $1,384,000 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 discount and estimated offering expenses payable by us.
32
If you invest in our ordinary shares, your interest in our ordinary shares will be diluted to the extent of the difference between the offering price per ordinary share and the as adjusted net tangible book value per ordinary share after the offering. Dilution results from the fact that the per ordinary share offering price is substantially in excess of the book value per ordinary share attributable to the existing shareholders for our presently outstanding ordinary shares. Our net tangible book value attributable to shareholders at June 30, 2021 was $222,256, or approximately $0.11 per ordinary share. Net tangible book value per ordinary share as of June 30, 2021 represents the amount of total assets less intangible assets and total liabilities, divided by the number of ordinary shares outstanding.
After giving effect to the issuance of 10,00,000 ordinary shares since July 1, 2021, the receipt of $11,958,750 in connection with such issuances (the “Post-June 30, 2021 Issuances”) and our September 2021 merger with PharmGenomics, our pro forma net tangible book value as of June 30, 2021 would have been approximately $9,546,674, or approximately $0.79 per ordinary share, based on 12,010,000 ordinary shares outstanding on a pro forma basis.
Our pro forma as adjusted net tangible book value of our ordinary shares as of June 30, 2021 gives further effect to the sale of ordinary shares at the assumed public offering price of $23.75 per ordinary share, after deducting the underwriting discounts and commissions and estimated offering expenses and assuming the underwriter does not exercise its over-allotment option. We will issue 1,500,000 ordinary shares upon completion of the offering. Our pro forma as adjusted net tangible book value as of June 30, 2021, which gives effect to the net proceeds from the offering and the issuance of additional shares in the offering but does not take into consideration any other changes in our net tangible book value after June 30, 2021, will be approximately $42,070,000, or $3.11 per ordinary share. This would result in dilution to investors in this offering of approximately $20.64, or approximately 86.9% from the assumed offering price of $23.75 per ordinary share. Pro forma as adjusted net tangible book value per ordinary share would increase to the benefit of present shareholders by $2.32 per share attributable to the purchase of the ordinary shares by investors in this offering.
If the underwriter exercises its option to purchase additional shares to cover over-allotments in full, the pro forma as adjusted net tangible book value per share after giving effect to our public offering would be approximately $3.65 per share, and the dilution in pro forma net tangible book value per share to investors in our public offering would be approximately $20.10 per share.
The following table sets forth the estimated net tangible book value per ordinary share after the offering (assuming no exercise of the over-allotment option) and the dilution to persons purchasing ordinary shares.
Assumed offering price per ordinary share |
$ |
$ |
23.75 |
|||
Pro forma net tangible book value per ordinary share before the offering |
$ |
0.79 |
$ |
|||
Increase per ordinary share attributable to this offering |
|
2.32 |
|
|
||
Pro forma as adjusted net tangible book value after the offering |
$ |
$ |
3.11 |
|||
Pro forma as adjusted dilution per ordinary share to new investors in this offering |
$ |
$ |
20.64 |
If any ordinary shares are issued upon exercise of outstanding warrants or options, you may experience further dilution.
The following table summarizes, as of January 20, 2022, the differences between the number of ordinary shares purchased from us, the total cash consideration paid, and the average price per share paid by our existing stockholders and by our new investors purchasing shares in our public offering at the assumed public offering price of $23.75 per ordinary share, as disclosed on the cover page of this prospectus, before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us:
Shares Purchased |
|
Average
|
||||||||||
Number |
Percent |
Amount |
Percent |
|||||||||
Existing stockholders |
12,010,000 |
88.9% |
|
16,624,332 |
31.8% |
$ |
1.38 |
|||||
New investors |
1,500,000 |
11.1% |
|
35,625,000 |
68.2% |
$ |
23.75 |
|||||
Total |
13,510,000 |
100% |
$ |
52,249,332 |
100% |
|
33
A $1.00 increase (decrease) in the assumed public offering price of $23.75 per share would increase (decrease) total consideration paid by new investors by $1,500,000 (and net proceeds by approximately $1,384,000), assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions payable by us.
If the underwriter exercises its option to purchase additional shares to cover over-allotments in full, our existing stockholders would own 87.4% and our new investors would own 12.6% of the total number of shares of our common stock outstanding after our public offering.
34
The following table sets forth, for each period indicated, the high and low exchange rate for Euros expressed in U.S. dollars, and the average exchange rate for the periods indicated as rounded to the nearest whole cent. These rates are based on the noon-buying rate certified for custom purposes by the U.S. Federal Reserve Bank of New York set forth in the H.10 statistical release of the Federal Reserve Board. These rates are provided solely for your convenience and are not necessarily the exchange rates that we used in preparation of our financial statements or elsewhere in this prospectus or will use in the preparation of our periodic reports or any other information to be provided to you. We make no representation that any Euro or U.S. dollar amounts referred to in this prospectus could have been or could be converted into U.S. dollars or Euros, as the case may be, at any particular rate or at all.
Period End |
High Rate |
Low Rate |
|||||||
Year Ended |
|
|
|
||||||
December 31, 2021 |
$ |
1.13 |
$ |
1.23 |
$ |
1.12 |
|||
December 31, 2020 |
$ |
1.22 |
$ |
1.23 |
$ |
1.07 |
|||
Month Ended |
|
|
|
||||||
December 31, 2021 |
$ |
1.13 |
$ |
1.13 |
$ |
1.13 |
|||
November 30, 2021 |
$ |
1.13 |
$ |
1.16 |
$ |
1.12 |
|||
October 31, 2021 |
$ |
1.16 |
$ |
1.17 |
$ |
1.15 |
|||
September 30, 2021 |
$ |
1.16 |
$ |
1.19 |
$ |
1.16 |
|||
August 30, 2021 |
$ |
1.18 |
$ |
1.19 |
$ |
1.17 |
|||
July 31, 2021 |
$ |
1.19 |
$ |
1.19 |
$ |
1.18 |
Except in our financial statements or where otherwise noted in this prospectus, we have translated Euro amounts into dollars using the noon-buying rate certified for custom purposes by the U.S. Federal Reserve Bank of New York set forth in the H.10 statistical release of the Federal Reserve Board on December 30, 2021 of €1.00:$1.13.
35
History and Development of the Company
We are a public company under Dutch law. We were incorporated in the Netherlands on March 8, 2021. We were formed to acquire PharmGenomics GmbH (“PharmGenomics“), a German company with limited liability.
We have registered our ordinary shares under the Exchange Act, and we intend to make our periodic reports and other information filed with or furnished to the SEC, pursuant to Section 13(a) or 15(d) of the Exchange Act, available free of charge through our website as soon as reasonably practicable after those reports and other information are electronically filed with or furnished to the SEC. The SEC maintains a website at http://www.sec.gov that contains reports and other information regarding issuers that file electronically with the SEC.
Information on our website or any other website is not incorporated by reference into this prospectus and does not constitute a part of this prospectus. We have included our website address as an inactive textual reference only.
36
General
We are a molecular genetics cancer diagnostic company formed in 2021 to acquire PharmGenomics GmbH (“PharmGenomics“) for the purpose of commercializing their product portfolio in Europe and the United States. PharmGenomics, a German DIN EN ISO 13485-certified manufacturer of in-vitro diagnostic (“IVD”) tests with its own molecular genetic laboratory, has developed several IVD tests for the European market since it was founded in 2008.
Our portfolio consists of the following products and product candidates:
• ColoAlert, a colorectal cancer (“CRC”) screening stool-based DNA (deoxyribonucleic acid) test licensed from ColoAlert AS and sold in Europe,
• PancAlert, a product candidate in an early stage of research for a pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction (“PCR”)-based multiplex detection of molecular-genetic biomarkers in stool samples,
• GenoStrip, a proposed platform technology in an early stage of research to detect pathogens or genetic aberrations in environments on a molecular genetic basis where a qualitative evaluation must be made in a short-time period and
• Legacy Research-Use-Only (“RUO”) and IVD tests, such as the GenoChips and the HumaSense product line, that we intend to license to third parties or sell the products to third parties or discontinue within the coming 18 months as well as third-party laboratory testing that we plan to discontinue.
About the Industry
The cancer industry can be divided into a diagnostics segment focused on detecting cancers, and a therapeutic segment focused on treating them. We are focused on the diagnostic aspect of the cancer industry.
For most cancer, early detection is lifesaving and for CRC, in particular, the symptoms are unclear and removal of cancer by surgery in the early stage is easy compared to treatment at a late stage. Screening of CRC is both lifesaving and cost saving. We compete with other entities developing and offering diagnostic tests to detect the presence of cancers. Our core product is a CRC screening stool DNA test, and we are in the early stages of researching a similar test for pancreatic cancer.
CRC are malignant tumors in the colon or rectum. These tumors usually develop from benign polyps, which over time degenerate and become cancerous. Between 5 and 15 years may elapse between the development of CRC and the formation of metastases. One method for the categorization of cancer stages of CRC is referred to as Dukes’ Stages which range from A, the least threatening, to D, the most severe. In Dukes’ Stage A, the tumor is limited to the superficial cell layers of the intestinal mucosa. According to a 2018 report from the American Cancer Society, if patients are diagnosed at this stage, the 5-year survival rate is usually over 90%. In the course of the further stages, the tumor continuously grows into other tissue layers and spreads to the nearest lymph nodes. In the final Dukes’ Stage D, the tumor metastasizes and affects other organs and thus minimize the 5-year survival rate to 8%. Because of the high survival rates in case of early detection, regular and accurate screening is essential. According to the Robert Koch Institute, relative 5-years survival rates in Germany are 63% for women and 62% for men.16
According to the American Cancer Society, CRC is the third most-commonly diagnosed cancer and the second leading cause of cancer death in the world.17 According to the International Agency for Research on Cancer, the distribution of CRC cases varies widely, with more than two-thirds of all cases and about 60% of all deaths occurring in countries with a high or very-high human development index.18 According to an article in BMJ Journals, global
____________
16 https://www.krebsdaten.de/Krebs/EN/Content/Cancer_sites/Colorectal_cancer/colorectal_cancer_node.html
17 American Cancer Society, CA - A cancer journal for clinicians, Volume 71, issue3
18 Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 11. Lyon, France: International Agency for Research on Cancer, 2013
37
cases of CRC are expected to increase by 60% to more than 2.2 million new cases and 1.1 million deaths by 2030.19 Across Europe, 378,445 new CRC cases were diagnosed in 2018, with more than 170,000 deaths.20 Therefore, in 2020 CRC was the second most common gender-unspecific cancer in Europe according to the European Commission.21 In the United States 141,074 new cases of CRC were reported in 2018, and 52,163 people died of this cancer according to the U.S. Cancer Statistics Working Group. For every 100,000 people, 37 new CRC cases were reported, with 13 deaths,22 and CRC is expected to cause about 52,980 deaths during 2021 in the United States.23
A recent report by Fact.MR projects the global CRC diagnostics market to register an expansion at a CAGR of 8.5% from 2017 to 2022. Revenues from the global CRC diagnostics market are expected to surpass $2 billion by the end of 2022.24
In Europe, there are more than 194 million people over the age of 50 years. A Global Market Insights Inc. report from 2018 forecasts a European market volume of 50 million screening tests annually by 2023.
Approximately 19 million colonoscopies were performed in 2017 in the United States, according to iData Research.25 With nearly 40% of the US population aged between 50 and 75 years having undergone no CRC screening at all, there is still plenty of potential for highly sensitive, non-invasive tests. With the core target group aged over 50 years growing from 112 million to 157 million26 individuals within the next 10 years, we believe that our addressable market in the United States alone will increase from $3.7 billion to over $5.2 billion annually.
Products and Product Candidates
We strive to make the diagnosis of various diseases more effective by using the latest genetic diagnostic technologies. Enabling earlier detection of these diseases allows for earlier and better therapy for affected individuals. In addition to offering the CRC screening test, ColoAlert, we are currently developing two product candidates, PancAlert and GenoStrip. We aim to use known and existing biomarkers (concepts) in applicable and reliable diagnostic tools.
ColoAlert
We offer a CE-IVD certified CRC diagnostic test, ColoAlert. We believe that molecular genetic stool tests like ColoAlert increase the participation rate in CRC screening and shift the detection of CRC to an earlier point of time which increases the likelihood of successful treatment of the cancer.
In the human intestines, epithelial skin cells are continuously shed into the stool. In addition to healthy cells, cells from polyps and colon cancer are also released. Using state-of-the-art genetic diagnostic methods, such as PCR analysis (a proceed used to rapidly make millions to billions of copies of a specific DNA sample, allowing for the amplification of a small sample of DNA to a large enough amount to study in detail), these shed cells can be isolated and examined for genetic changes.
ColoAlert is a multitarget test in which the stool sample is analyzed for genetic anomalies as well as for the presence of hidden blood, often called occult blood. The genetic analysis consists of the quantification of human DNA, the analysis of somatic point mutations in the KRAS (codon 12/13) and BRAF (codon 600) genes. An independent clinical test lead by Professor Matthias Dollinger and conducted with 566 patients by the University Hospitals in Leipzig and Halle-Wittenberg, Germany showed ColoAlert to have a sensitivity of 85% and a specificity of 92%27 while being as non-invasive as other stool tests and showing a very high patient satisfaction of 98%.28 Compared to the FITs
____________
19 BMJ Journals, Global patterns and trends in colorectal cancer incidents and mortality, Volume 66, Issue 4. Arnold M, Sierra MS, Laversanne M, et alGlobal patterns and trends in colorectal cancer incidence and mortality. Gut 2017;66:683-691.
20 UEG Research, Healthcare in Europe: Scenarios and implications for digestive and liver diseases, 2019
21 European Commission. Colorectal cancer burden in EU-27, 2021
22 U.S. Cancer Statistics Working Group. U.S. Cancer Statistics Data Visualizations Tool, based on 2020 submission data (1999-2018): U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; www.cdc.gov/cancer/dataviz, released in June 2021.
23 American Cancer Society, “Key Statistics for ColoRectal Cancer”,
https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
24 https://www.factmr.com/report/70/colorectal-cancer-diagnostics-market
25 https://idataresearch.com/an-astounding-19-million-colonoscopies-are-performed-annually-in-the-united-states/
26 https://www.prb.org/resources/u-s-population-is-growing-older/
27 Dollinger MM et al. (2018) ClinLab 64(10)
28 Internal customer survey with n = 131 (2019)
38
reimbursed in Germany, this meant up to 60% less overseen CRCs.29 The genetic markers were chosen to complement the diagnostic accuracy of the occult blood test and lead to an increased clinical added value. Since the independent clinical study, we have updated the occult blood test component of ColoAlert to what we believe is a more accurate occult blood test in terms of sensitivity and specificity.
We target individuals covered by national CRC screening programs. Most screening programs recommend CRC screening starting at age 50. However, a trend exists to further lower the screening age. For example, the FDA recently recommended CRC screening starting at age 45. Due to the increasing prevalence of the disease in the younger population, we anticipate a further decrease in the screening age, especially for test methods such as ColoAlert that are, in principle, capable of detecting cancer at early stages. In addition to age, other personal characteristics in favor of CRC screening include a family predisposition to CRC, risk factors such as obesity, irritable bowel syndrome (“IBS”), inflammatory bowel disease (“IBD”), excessive meat, alcohol and nicotine consumption, and pre-existing conditions such as breast cancer or type 2 diabetes mellitus.
We license the ColoAlert test from a Norwegian research and development company, ColoAlert AS, pursuant to an exclusive licensing agreement dated January 1, 2019. Pursuant to the terms of our license, we pay ColoAlert AS 50% of the net profit that we generate from the ColoAlert test, in addition to a protection fee of €5 per test sold. The license has no fixed term but will be terminated if the quarterly fee paid to ColoAlert AS is less than €25,000 for each of the quarters ending on or prior to December 31, 2022 and €250,000 per quarter thereafter. On February 11, 2021, we obtained an option exercisable for three years to acquire the intellectual property for the ColoAlert test for (i) either a one-time cash payment of €2,000,000 or a €4,000,000 payment in ordinary shares at the valuation of our most recent financing plus (ii) a lifetime royalty payment of €3 per ColoAlert test sold. If we opt to make the one-time payment in cash, ColoAlert AS has the right to require us to pay the €2,000,000 in ordinary shares at the valuation of our most recent financing.
In the European Union, ColoAlert is a CE-IVD registered product under the current In-Vitro Diagnostics Directive 98/79 /EC (“IVD-D”). Starting on May 26, 2022, IVD products in the European Union will be regulated by the In-Vitro Diagnostics Regulation, EU 2017/746 (“IVD-R”), which replaces the IVD-D. We are currently evaluating the necessary steps to meet the upcoming regulations for our ColoAlert product. ColoAlert is currently validated on the Roche LightCycler 480 II and Lightcycler v2.0. Mainz BioMed is planning to validate the test on additional real time PCR instruments used in many laboratories worldwide to allow a potential faster market penetration. We manufacture the ColoAlert IVD test kits at our facility in Mainz, Germany.
In January 2022, we entered into a Technology Rights Agreement related a portfolio of novel mRNA biomarkers developed at the Université de Sherbrooke (the “UdeS Biomarkers”. Pursuant to the agreement, we acquired an exclusive unilateral option to acquire an exclusive license to the UdeS Biomarkers in exchange for a payment of €10,000 and an agreement to pay for the prosecution and maintenance of certain intellectual property relating to the UdeS Biomarkers. The option to license the technology is for one year, which period can be extended at our sole discretion for six additional months (the “Option Period”).
The UdeS Biomarkers are five gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting CRC lesions including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to this deadly disease. In a UdeS sponsored study evaluating these biomarkers,30 study results achieved overall sensitivities of 75% for AA and 95% for CRC, respectively, for a 96% specificity outcome.
We have a license during the Option Period to use the UdeS Biomarkers to further analyze their sensitivity and specificity. Depending on positive results from these further studies, we intend to exercise the option to license the UdeS Biomarkers for future integration into ColoAlert. If we exercise the option, we will pay the licensor a royalty on all products incorporating the UdeS Biomarkers and we will pay for the prosecution and maintenance of patents relating to the UdeS Biomarkers.
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29 Giess et al. Gastroenterology 154/2018
30 Herring, E.; Tremblay, É.; McFadden, N.; Kanaoka, S.; Beaulieu, J.-F. Multitarget Stool mRNA Test for Detecting Colorectal Cancer Lesions Including Advanced Adenomas. Cancers 2021, 13, 1228. https://doi.org/10.3390/cancers13061228
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Below is a typical process flow for the use of ColoAlert for Germany.
Typical process flow:
1. The patient is informed about the risk of CRC.
2. The physician discusses with the patient the need for a CRC test.
3. The physician provides the kit to the patient or the patient receives the kit shipped from the laboratory partner.
4. The patient collects the sample and ships the collected sample to the testing clinical laboratory.
5. The clinical laboratory tests the sample and provides the result to the ordering physician.
6. The ordering physician informs patient about the results and decides on next steps.
PancAlert
We are in the early stages of developing PancAlert, a stool-based screening test for the detection of pancreatic cancer. According to the Global Cancer Observatory, pancreatic cancer was diagnosed in over 460,000 patients worldwide in 2018.31 Due to the asymptomatic early stages, in most cases this disease is detected too late, making pancreatic cancer one of the most lethal malignant neoplasms with over 430,000 annual deaths according to the Global Cancer Observatory.32 The overall 5-year survival rate is approximately 8%, which is the lowest survival rate of all cancer types. On the other hand, the 5-year survival rate is around 56% if the pancreatic cancer is still in the early stages at the time of diagnosis.33 Studies have shown that the prognosis in asymptomatic patients, when who were diagnosed by chance during other examinations, is significantly better than in patients with characteristic symptoms such as rapid weight loss or back pain.34
The mean age of onset is 71 years for men and 75 years for women .35 Similar to other cancers, age is an essential risk factor. Most patients are over 50, with most diagnoses occurring between the ages of 60 and 80. The fact that pancreatic cancer is the European Union’s third biggest cancer killer, despite being the seventh most common cancer, highlights the extremely poor outlook for patients. Although, the survival rate of pancreatic cancer patients has improved in the last few decades, there is still the urgent need for early diagnostic optimization.
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31 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.
32 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.
33 Egawa S, Takeda K, Fukuyama S et al. Clinicopathological aspects of small pancreatic cancer. Pancrdeas 2004;28:235-40. And http://www.aboutcancer.com/pancreas3.htm
34 Egawa S, Takeda K, Fukuyama S et al. Clinicopathological aspects of small pancreatic cancer. Pancrdeas 2004;28:235-40.
35 Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016, CA Cancer J Clin 2016;66:7-30
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A definitive diagnosis is currently made through a series of investigations, including imaging scans, blood tests and biopsy, which are usually only performed in symptomatic patients. However, recent research suggests that the disease can persist for a longer period of time without patients becoming symptomatic; providing an important opportunity for early detection. Because the initiation of pancreatic cancer occurs on a molecular level, genetic diagnostic methods can be a promising approach for early detection. The biomarkers associated with pancreatic cancer reach the stool, amongst other ways by the pancreatic juice, which enables a user-friendly sample collection. The development approach includes the selection and verification of a specific biomarker panel with the establishment of a suitable method for sample preparation, the establishment and validation of the detection and measurement technology with purchased or clinically defined samples (biopsies, pancreatic juice, stool and others), the transfer to routine diagnostics (stool) and the optimization and clinical evaluation as a potential screening tool for the early detection of pancreatic cancer.
Our goal is to make PancAlert the world’s first pancreatic cancer screening test based on Real-Time PCR-based multiplex detection of molecular-genetic biomarkers in stool samples. The most promising candidates for disease-specific biomarkers to date are KRAS, mBMP3, NDRG4, and GNAS codon 201. In addition, the platform technology used will enable simple integration of further biomarkers if indicated. The analysis of the results will be additionally facilitated by a specialized IT solution. Based on the research progress in this project, we plan to initiate an initial pilot study with one or more selected clinical sites. We do not expect to conclude such studies prior to 2024 at the earliest. If the clinical pilot studies show promising results, we intend to start developing an IVD-R and FDA approvable product for the European market.
GenoStrip
We are in the early stages of developing a rapid and easy to use molecular lateral-flow test that we call GenoStrip. We intend to develop the GenoStrip technology as a platform technology which combines the advantages of highly precise molecular genetics and the easy-to-handle usage of a customized lateral-flow-dipstick to provide molecular results in as little as 20 minutes, depending on the sample preparation method amplification system used. The target sequences (DNA or RNA) are amplified either way in single or multiplex amplification reactions.
If successful, the GenoStrip technology could be modified for various applications where qualitative evaluations have to be made within a short time frame, as for instance in the case of COVID-19 diagnosis, and other respiratory viruses, as well as pathogens causing sexually transmitted diseases or the detection of mutated or deleted genes.
One prototypic example is our Abacavir Hypersensitivity reaction test (HLA*57:01).
Abacavir is used as an antiretroviral drug to treat HIV-1 infection. A hypersensitive reaction (“HSR”) occurs in 5% to 8% of patients when administered, which manifests itself in symptoms such as fever, rash, malaise, gastrointestinal complaints or shortness of breath and in some cases can even be fatal. These side effects have been shown to be related to the HLA-B * 57:01 allele. For this reason, appropriate screening has been prescribed by the BfArM and FDA since 2008 before the start of therapy.
For this application, the DNA extracted from a simple cheek swab is replicated using allele-specific, labeled primers for the HLA-B * 57: 01 allele in an isothermal approach in a conventional heating block. The detection is then carried out on the lateral flow test strip. If the allele is not present, an internal control confirms that the test has been carried out successfully.
In this particular example, the steps and time requirements are:
• Extract the DNA from a cheek swab
• RPA isothermal allele-specific amplification in a heating block
• Incubation of the lateral flow stripe readout
As we are in the early stages of development, we cannot be sure that at this time that GenoStrip will ever become a commercially viable product.
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Legacy Diagnostic Products and Services
We currently sell several genetic diagnostic products that we manufacture to clinical laboratories, mostly in Germany. Some of these products are CE-IVD registered while others are RUO products. Due to the high cost of meeting the new IVD-R regulatory requirements starting in May 2022, we have decided to license out, sell off or discontinue those products. Additionally, we have provided third-party laboratory testing services that we also intend to discontinue.
Competitive Advantages & Operational Strengths
We face competition from providers of more traditional CRC screening diagnostics, such as colonoscopies, as well as other manufacturers of non-invasive stool- or blood-based tests. We believe the primary competitive factors for ColoAlert include but are not limited to:
• Accuracy: End-users want as accurate a result as possible without worrying about costs, hassle and time associated with false-negative and false-positive results. A report by Professor Dollinger found ColoAlert to have a specificity of 92%, above the 90% specificity requirement set by the European CRC screening guidelines, and has a sensitivity of 85%. Sensitivity defines how often a test correctly generates a positive result for the condition being tested. Specificity is the ability of the test to correctly identify those without the disease (true negative rate). Since that report, we have updated the occult blood test component of ColoAlert in a way that we believe will increase sensitivity and specificity. In January 2022, we entered into a Technology Rights Agreement by which we have a unilateral option to exclusively license certain biomarkers developed ay the Université de Sherbrooke with the goal of further increasing the sensitivity and specificity of ColoAlert.
• Time-to-result: The faster the results of a diagnostic test are known; the sooner treatment may begin or the end user can gain ease of mind. Due to ColoAlert’s simplicity of the testing procedure, the resultant turn-around time between the patient’s decision and delivery of the test report can be as low as three days in Germany, which we believe is significantly shorter than most other tests.
• Ease of use: As many people will delay or avoid getting an invasive diagnostic test, such as a colonoscopy, the easier it is to take such a test, the higher the participation rates will be, which could mean more detection of cancer at earlier stages and higher rates of survival. ColoAlert is less invasive than traditional colonoscopies, requiring neither the drinking of barium (oral or suppository) the night prior to the test, nor prior fasting, and does not require a trip to a clinic or the administration of anesthesia. Compared to blood-based tests, stool tests can be performed at home and do not require the patient to visit their physician.
• Executive team: Our leadership team and advisors have extensive experience developing and commercializing innovative diagnostic products globally. We have strong relationships with government organizations and universities in Europe.
• Research and Development: We are confident that we have organized a strong team to front our research and development. Our research and development efforts have been supported by a grant of up to approximately €440,000 from the German Federal Ministry of Research and Education for the development of PancAlert, a non invasive product candidate to detect pancreatic cancers, and a grant of up to approximately €205,000 from the European Fund for Economic and Regional Development for the development of GenoStrip, a product candidate for a rapid and easy to use molecular lateral-flow test.
Strategy
We intend to make ColoAlert the global CRC screening market leader by providing the best performance at an affordable cost. To fulfil this goal efficiently, our sales strategy is primarily based on collaborations with large laboratory chains. This distribution strategy is chosen because laboratories typically have a large customer base of physicians as well as a strong sales team. This can increase awareness of ColoAlert within the physician community in a cost-effective manner. At the same time, it offers the opportunity for accelerated product rollouts in foreign markets,
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as large laboratory chains operate across Europe or worldwide and successful products are often distributed within the laboratory chain. Laboratory partners benefit from the introduction and distribution of ColoAlert especially from the increased medical added value, the positioning as innovation leaders and from, we believe, significantly higher margins compared to conventional stool tests such as FIT. In December 2021, one of the laboratory chains in our distribution network, GANZIMMUN Diagnostics AG, found the association with ColoAlert so beneficial that they have agreed to offer ColoAlert as a co-branded product. We believe that this distribution approach also provides a strong business differentiation in the United States from the Cologuard, a test offered by Exact Sciences Corporation. Cologuard is performed exclusively in Exact Sciences’ in-house laboratories and therefore other laboratories currently do not have access to a multitarget stool test. By providing the ColoAlert test kits, other laboratories can also offer highly sensitive, non-invasive CRC screening to their affiliated physicians and their patients.
To introduce ColoAlert into the United States and potentially other markets like China, extensive regulatory studies are required. We are actively exploring the required regulatory path for the United States.
Therefore, we intend to use the proceeds from this offering to:
• Expand the commercial opportunity of our ColoAlert product in Europe by expanding our commercial team and partnerships.;
• Prepare and execute a comprehensive clinical and regulatory strategy to achieve market authorization from the FDA to use ColoAlert as a screening test for CRC in the United States; and
• Continue research and development of PancAlert and GenoStrip.
Expansion of ColoAlert in Europe
There are currently nearly 400 medical care centers with a laboratory focus in Germany, of which over 60 have a molecular genetic laboratory in house. Approximately 50% of the market share is held by five laboratory chains (Sonic, Limbach, Synlab, Amedes and LADR), rendering activities towards those and their large networks of physicians especially attractive. Two of these five laboratory chains are currently our customers. We plan on securing additional partner laboratories to market, as we did by adding GANZIMMUN Diagnostics AG to our distribution network in December 2021, and to sell our ColoAlert product through sales representatives. Partner laboratories will, once part of our distribution network, receive support from us for the proper administration of the product in the client’s clinical laboratory. This validation process for new IVD products is being performed every day by all other diagnostic companies in Germany (e.g. Roche, Abbott, Siemens). If needed, we will also provide co-branded marketing materials.
We primarily sell the ColoAlert IVD test kits to German clinical reference laboratories. The reference laboratories provide the patient kit and accompanying marketing materials, to their affiliated physicians and educate them about the clinical advantages of ColoAlert. The laboratories perform the diagnostic analysis and report the results to the physicians.
We also initiated a pilot program to allow patients to use the ColoAlert website for ordering a patient kit online. The collected samples are sent by the patient directly to our own clinical laboratory. We plan to conduct joint marketing activities with the reference labs to connect patients and physicians supported by the newly established online portal www.gemeinsam-gegen-darmkrebs.de (currently in beta status).
Our primary market is currently Germany, and we intend to expand to other German-speaking countries. After the rollout in the German-speaking region, we intend to launch ColoAlert in other western European markets, particularly in the United Kingdom, with its innovation-friendly National Health Service, followed by countries such as Spain or in Scandinavia.
In the coming year, we seek to expand the current European sales team with strong diagnostic sales experience. The sales team will focus on sales of our ColoAlert test to clinical laboratories that perform diagnostics tests ordered by physicians. To ensure that the clinical laboratory sales teams approach the primary care physician with the highest possible efficiency and effectiveness inside their respective laboratory network, we are planning to conduct training for sales representatives, seminars for physicians and joint marketing campaigns to expand our product awareness. We will also look into partnering with third parties or outsourcing parts of the sales organization that directly visit with physicians.
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Entry into the U.S. Market
We plan to employ a product and marketing strategy in the United States that is substantially similar to what we use in Europe. Prior to employing these strategies, we will seek to sell the ColoAlert test as a test kit to clinical laboratories that are certified by the Secretary of the Department of Health and Human Services under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA labs”) requiring FDA market authorization. This might be a comparably fast entry option, as the top five laboratory chains in the United States had revenues of nearly USD 38 billion in 2020.36 Alternatively or in addition , we could offer ColoAlert, or as a laboratory developed test offered by the Mainz BioMed clinical laboratory governed under US Centers for Medicare and Medicaid Services (“CMS”). We plan to explore the required clinical and regulatory path to submit ColoAlert to the FDA to achieve a CRC screening claim for asymptomatic patients who are at average risk for CRC, aged 45 to 80.
We expect to conduct extensive clinical trials considering the desired CRC screening claims. The duration of the study will be defined by the required number of patients to be enrolled. Cologuard, the main competitor in the United States, has performed multiple large studies which took several years to execute followed by a PMA submission. In addition, we will evaluate achieving claims for early identification of cancerous polyps and advanced adenomas. In preparation for our clinical trials, we appointed a Vice President of Regulatory Affairs to oversee the process and as well as our application to the FDA to achieve a CRC screening claim.
During this market preparation period market conditions may change, existing competitors may improve their products or new competitors may become commercially active which may force us to adjust our future commercial strategy if the FDA eventually authorizes the product. We may consider manufacturing our ColoAlert test kits as private label products to be sold to labs. In this case, we likely would not undertake any marketing efforts in the United States to promote it to physicians and patients but expect our business partner to take on this obligation.
Research and Development
Our research and development strategy has been centered on developing our product candidates PancAlert, a proposed stool-based screening test for pancreatic cancer, and GenoStrip, a proposed platform technology to detect pathogens. Both of these product candidates are in the early stages of development and might never become products. As of January 2022, our research and development efforts will also include conducting and overseeing clinical trials on the UdeS biomarkers that we have an option to license.
Our research and development team is located at our facilities in Mainz, Germany, and consists of 6 employees and independent contractors as of June 30, 2021. We currently do not have any patents or any pending patent applications protecting our intellectual property, but if our research and development efforts are successful for ColoAlert, PancAlert or GenoStrip, we intend to file patent applications to protect the intellectual property derived from such research and development.
We have received government grants as part of our research and development programs, including approximately $200,000 in our fiscal year ended December 31, 2020 and $170,000 in our fiscal year ended December 31, 2019. Since January 1, 2021, we have received additional funding in the aggregate amount of approximately $100,000.
Government Regulation
In-vitro diagnostic devices are regulated by the governments in the areas where such products are sold. Consequently, there is no uniform set of regulations governing our products and product candidates. We summarize below, the material governmental regulations in Europe, our principal market, and the United States, the next market that we seek to enter.
Europe
Currently in Europe, medical devices such as ColoAlert are regulated by the IVD-D requiring CE-Mark through self-certification. Under this system, developers and manufacturers must operate a Quality System and validate medical devices in a limited clinical trial to demonstrate the manufacturer has met analytical and clinical performance
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36 marketwatch.com report: Clinical Laboratory Services Market 2020 Global Analysis, Opportunities And Forecast To 2025. LabCorp ($11.5B), Sanofi Genzyme ($8.1B), Quest Diagnostics ($7.75B), Abbott Laboratories ($7.7B) and Charles River ($2.6B)
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criteria. We have implemented an International Organization for Standardization standard — ISO 13485 — quality management system for the design and manufacture of medical devices. ISO 13485 addresses managerial awareness of regulatory requirements, control systems, inspection and traceability, device design, risk and performance criteria as well as verification for corrective and preventative measures for device failure. Medical device companies such as ours are subject to pre-market compliance assessments from Notified Bodies, a certification organization which the national authority (the competent authority) of a European Union member state designates to carry out one or more of the conformity assessment procedures. ISO 13485 certification establishes conformity to specific European Union directives related to medical devices and allows CE Marking and sale of the device.
The new European In Vitro Diagnostic Regulation (EU 2017/746), or the IVD-R, became effective as of May 25, 2017, marking the start of a transition period for manufacturers selling IVD devices into Europe. The IVD-R, which replaces IVD Directive (98/79/EC), or the IVD-D, has a transition period of five years, after which the IVD-R will apply in full, and no new applications pursuant to the IVD-D will be accepted. Manufacturers have the duration of the five-year transition period to update their technical documentation and processes to meet the new, more stringent EU regulatory requirements. We believe that the most challenging areas under the IVD-R will be regarding the classification of products, which will bring almost all IVDs under the direct control of Notified Bodies, and the performance evaluation of IVDs, which will not only include the classic clinical performance and analytical performance but also scientific validity, the role and responsibilities of the economic actors of the supply chain, the traceability and the transparency of the devices with, in particular, the introduction of the UDI-system and an expanded EUDAMED database.
Notified Bodies can begin auditing to the IVD-R once they have been designated as a Notified Body under the IVD-R by their Competent Authority. For now, we expect the first Notified Bodies to be notified according the IVD-R by the end of 2019, and as of this filing TÜV SÜD has been designated as a Notified Body under the IVDR. In practice, it will not be possible to CE mark a product according to the IVDR beforehand. For Class C devices (such as ColoAlert), the conformity assessment procedure will be a combination of the Quality Management System audits and Technical Documentation assessments. The assumed assessment time needed for a Technical Documentation assessment of a Class C device currently is expected to last from about nine months. We have already begun discussions with the TÜV SÜD in order to ensure compliance with the IVD-R as soon as possible.
We believe that we have structured our business operations to comply with applicable legal requirements. However, it is possible that governmental entities or other third parties could interpret these laws differently and assert otherwise, which could have a material adverse impact on our business.
United States
U.S. Food and Drug Administration
Obtaining FDA market authorization for our ColoAlert test is critical to our strategy. We intend to shortly start the process of seeking a premarket approval (PMA) for our ColoAlert test.
Under the FDA’s regulatory framework, in vitro diagnostic devices (IVDs), including tests that can be used in the diagnosis or detection of cancer such as ColoAlert, are a type of medical device. The FDA categorizes medical devices into one of three classes — class I, II, or III — based on the risks presented by the device and the regulatory controls necessary to provide a reasonable assurance of the device’s safety and effectiveness. Devices deemed by FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA. We believe that ColoAlert would be a Class III IVD, as this is consistent with the prior FDA approval of similar devices, such as Cologuard. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance process in order to be commercially distributed.
Class III devices generally require PMA approval before they can be marketed. Obtaining PMA approval requires the submission of “valid scientific evidence” to FDA to support a finding of a reasonable assurance of the safety and effectiveness of the device. A PMA must provide complete analytical and clinical performance data and also information about the device and its components regarding, among other things, device design, manufacturing, and labeling. Following receipt of a PMA, FDA determines whether the application is sufficiently complete to permit a substantive review. If FDA accepts the application for review, it has 180 days under the FDC Act to complete its review of a PMA, although in practice, FDA’s review often takes significantly longer, and can take up to several years.
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An advisory panel of experts from outside FDA may be convened to review and evaluate the application and provide recommendations to FDA as to the approvability of the device. FDA may or may not accept the panel’s recommendation. As part of FDA’s review of a PMA, FDA will typically inspect the manufacturer’s facilities for compliance with Quality System Regulation (QSR) requirements, which impose requirements related to design controls, manufacturing controls, documentation, and other quality assurance procedures.
FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s). FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements to conduct additional clinical studies post-approval. FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to FDA on the clinical status of those patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the approval.
Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission of a PMA supplement. PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel. Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.
The studies required in connection with our seeking FDA approval of our technologies will be costly and time-intensive. FDA might not ultimately approve any PMA submitted by us in a timely manner or at all.
Clinical Trials
Clinical trials are usually required to support a premarket approval application. If the device presents a “significant risk,” as defined by the FDA, to human health, the FDA requires the device sponsor to file an IDE application with the FDA and obtain IDE approval prior to commencing the human clinical trials. The investigational device exemption application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The investigational device exemption application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a “non-significant risk” device and eligible for more abbreviated investigational device exemption requirements. Clinical trials for a significant risk device may begin once the investigational device exemption application is approved by the FDA and the appropriate institutional review boards at the clinical trial sites. Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, including informed consent and healthcare privacy. A clinical trial may be suspended by the FDA or the investigational review board at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation in the study. Even if a study is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device, or may be equivocal or otherwise not be sufficient to obtain approval of our product.
Laboratory Certification, Accreditation and Licensing
If we operate clinical laboratories in the United States, we will also be subject to U.S. and state laws and regulations regarding the operation of clinical laboratories. Federal Clinical Laboratory Improvement Amendments (CLIA) requirements and laws of certain other states impose certification requirements for clinical laboratories, and establish standards for quality assurance and quality control, among other things. Clinical laboratories are subject to inspection by regulators, and to sanctions for failing to comply with applicable requirements. Sanctions available under CLIA include prohibiting a laboratory from running tests, requiring a laboratory to implement a corrective plan, and imposing
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civil monetary penalties. If we fail to meet any applicable requirements of CLIA or state law, that failure could adversely affect any future CMS consideration of our technologies, prevent their approval entirely, and/or interrupt the commercial sale of any products and otherwise cause us to incur significant expense.
HIPAA and Other Privacy Laws
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, established for the first time comprehensive protection for the privacy and security of health information. The HIPAA standards apply to three types of organizations, or “Covered Entities”: health plans, healthcare clearinghouses, and healthcare providers that conduct certain healthcare transactions electronically. Covered Entities and their business associates must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. If we are able to commercialize our ColoAlert test, we might perform activities that may implicate HIPAA, such as providing clinical laboratory testing services or entering into specific kinds of relationships with a Covered Entity or a business associate of a Covered Entity.
Federal and State Billing and Fraud and Abuse Laws
Antifraud Laws/Overpayments. If our ColoAlert test is successfully accepted by federal and state healthcare programs, we will be subject to numerous federal and state antifraud and abuse laws. Many of these antifraud laws are broad in scope, and neither the courts nor government agencies have extensively interpreted these laws. Prohibitions under some of these laws include:
• the submission of false claims or false information to government programs;
• deceptive or fraudulent conduct;
• excessive or unnecessary services or services at excessive prices; and
• prohibitions in defrauding private sector health insurers.
We could be subject to substantial penalties for violations of these laws, including denial of payment and refunds, suspension of payments from Medicare, Medicaid or other federal healthcare programs and exclusion from participation in the federal healthcare programs, as well as civil monetary and criminal penalties and imprisonment. Numerous federal and state agencies enforce the antifraud and abuse laws. In addition, private insurers may also bring private actions. In some circumstances, private whistleblowers are authorized to bring fraud suits on behalf of the government against providers and are entitled to receive a portion of any final recovery.
Federal and State “Self-Referral” and “Anti-kickback” Restrictions
If we or our operations are found to be in violation of applicable laws and regulations prohibiting improper referrals for healthcare services or products, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal or state health care programs, and the curtailment or restructuring of our operations.
Anti-Kickback Statute. The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” is not defined in the federal Anti-Kickback Statute and has been broadly interpreted to include anything of value, including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payment, ownership interests and providing anything at less than its fair market value. Sanctions for violations of the federal Anti-Kickback Statute may include imprisonment and other criminal penalties, civil monetary penalties and exclusion from participation in federal healthcare programs. Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs, and do not contain identical safe harbors.
Self-Referral law. The federal “self-referral” law, commonly referred to as the “Stark” law, provides that physicians who, personally or through a family member, have ownership interests in or compensation arrangements with a laboratory are prohibited from making a referral to that laboratory for laboratory tests reimbursable by Medicare, and
47
also prohibits laboratories from submitting a claim for Medicare payments for laboratory tests referred by physicians who, personally or through a family member, have ownership interests in or compensation arrangements with the testing laboratory. The Stark law contains a number of specific exceptions which, if met, permit physicians who have ownership or compensation arrangements with a testing laboratory to make referrals to that laboratory and permit the laboratory to submit claims for Medicare payments for laboratory tests performed pursuant to such referrals. We are subject to comparable state laws, some of which apply to all payors regardless of source of payment, and do not contain identical exceptions to the Stark law.
Any action against us for violation of these or similar foreign laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.
Sunshine Act
In 2010, Congress enacted a statute commonly known as the Sunshine Act, which aims to promote transparency. The Sunshine Act requires manufacturers of drugs, devices, biologicals and medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program, or CHIP, to report annually to CMS any payments or other transfers of value made to physicians and teaching hospitals, with limited exceptions. Manufacturers must also disclose to CMS any physician ownership or investment interests.
Competition
Our principal product, ColoAlert, competes with other methods of CRC screening, such as the colonoscopy or the FIT test. The current standard for CRC screening test is the colonoscopy, although we also compete with non-invasive CRC screening tests. In addition to these widespread, traditional screening tests, we also compete with companies that provide or are developing novel CRC screening tests.
Colonoscopy
The colonoscopy was established over 50 years ago and is used by countless physicians worldwide. The colonoscopy is an invasive procedure in which the inner wall of the intestine is examined by a physician using an endoscope. Preparation requires patients to undergo bowel cleansing at least the day prior to the procedure. Colonoscopy is a painful process and associated with risk of punctuating the colon. An experienced scopeist will perform the process with less pain and higher detection rate. The average detection rate of colonoscopy is approximately 95%.
The compliance rate for colonoscopy in Germany even after a consultation with a physician is a mere 16%.37 The occurrence of false-positive results is not possible due to the nature of the method. Usually, national screening programs suggest a screening interval of 10 years for this method. Because of the invasive procedure and the prior bowel cleansing, this method has a patient acceptance rate of less than 20%. The cost of colonoscopy can vary depending on the region. In Germany, average total costs amount to approximately €220, which corresponds to €22 annually.
Any developments that result in the reduction of the cost of colonoscopies, the accuracy of their results or the ease of use may not be transferable to IVD tests.
Occult blood tests
With Fecal Immunochemical Tests (“FITs”), a patient’s stool sample can be examined for hidden, or occult, blood in a laboratory which can be a symptom of CRC. Unfortunately, occult blood is often only present in the later stages of the disease. There is no need for patients to prepare prior to sample collection, which leads to a high patient acceptance. According to IKK Südwest, when coordinated by a centralized invitation to screening, participation rates can get as high as 73%.38 Since this method can only provide an indirect indication of CRC via fecal blood, the sensitivity normally hovers around 65% with a false-positive rate around 5% per an article published by the American Gastroenterological Association.39 Since this method depends on the presence of a blood signal and many tumors do
____________
37 Riens B et al (2011) Versorgungsatlas/Krebsfrüherkennung
38 (IKK Südwest. IKK Südwest in Zahlen: https://www.ikk-suedwest.de/ueber-uns/daten-und-fakten/ikk-suedwest-in-zahlen/)
39 (Giess et al. Gastroenterology 154/2018)
48
not bleed in the early stages, many affected individuals are diagnosed in later stages of the disease which leads to lower than 5-year survival rates and higher treatment costs. This current state of international screening programs suggests a need for more sensitive non-invasive screening tools. The recommended screening interval for FITs is normally yearly. The average reimbursement for occult blood tests is €14 in Germany40 and $19.92 based on the Current Procedural Terminology (CPT) code 82274 in the United States.41
Entities Providing Screening Tests
We compete with other entities that offer other non-invasive screening tests. Most of our current and potential competitors in Europe and the United States have significantly greater financial, technical, manufacturing, marketing, and other resources than we have and consequently may have better and more competitive products, services, marketing or distribution. Most of our competitors have more extensive customer bases and broader customer and industry relationships than we do. In addition, many of these companies have longer operating histories and greater name recognition than we do. Our competitors may be in a stronger position to respond quickly to new technologies and may be able to design, develop, market and sell their products more effectively.
Entities producing or developing CRC screening tests with which we compete include:
• Exact Sciences: The most established of the entities that we compete with is Exact Sciences, a publicly traded molecular diagnostic company focusing on the early detection of various cancers, which manufactures Cologuard and conducts the analysis of the tests. Cologuard is also a stool-based CRC screening test, and it achieves a sensitivity of 92% and a specificity of 87% per a study published in the New England Journal of Medicine.42 The average reimbursement is about $500,43 which is equivalent to approximately $166 annually when used in the recommended three-year screening interval. Exact Sciences is currently pursuing the goal of further expanding the market share it has gained in the United States, broadening its relationships with relevant health care provider and building a diversified product portfolio in the oncology screening space through targeted acquisitions. Our ColoAlert product uses three of the four biomarkers used in ColoGuard. We ask for a significantly smaller stool sample for ColoAlert.
• Epigenomics AG, which focuses on the development of blood tests for cancer detection. The CRC test “Epi proColon”, one of its two approved products approved in the United States and the European Union, is a blood-based test that achieves a sensitivity of 68% with a specificity of 80%.44
• Novigenix SA, a Swiss company specializing in the development of immuno-transcriptomics solutions. Novigenix’s LITOseek Platform is designed to provide information for early cancer detection, disease progression and therapy selection. For CRC screening, Novigenix has developed the Colox blood test, which is currently available on the Swiss market. It achieved a sensitivity of 78% and a specificity of 92% in a clinical study.45
• Agena Biosciences Inc., a U.S. company active in the field of genetic diagnostics. The company’s core product is its proprietary MassArray platform. This offers laboratory customers the possibility to provide rapid and broad genetic analysis. From the large number of panels, the UltraSeek Colon Panel initially shows competitive potential. This is used for the investigation of disease progression and resistance of CRC. As this product is not suitable for CRC screening, it is not yet a direct competitor to ColoAlert, but could be relevant through a future product variation.
____________
40 (https://www.kbv.de/html/praevention_darmkrebsfrueherkennung.php)
41 https://www.upmc.com/-/media/upmc/healthcare-professionals/physicians/documents/lab-fee-schedule.pdf
42 (Imperiale et al (2014) N Engl J Med 2014; 370)
43 https://investor.exactsciences.com/investor-relations/press-releases/press-release-details/2015/Exact-Sciences-Additional-Update-on-CMS-Reimbursement-for-Cologuard/default.aspx or https://www.businesswire.com/news/home/20151202005242/en/CMS-Corrects-2016-Reimbursement-Rate-for-Cologuard%C2%AE#:~:text=(Nasdaq%3A%20EXAS)%20announced%20that,NLA)%20for%20Cologuard%20at%20%24493.21.
44 https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130001B.pdf
45 https://novigenix.com/wp-content/uploads/2018/02/Tableau-comparatif-novigenix-colox-ENGLISH.pdf
49
• Schebo AG, a German company, has developed a Tumor M2-PK (Pyruvatekinase M2) based test, a biomarker that is only expressed in tumor tissue in adult humans. M2-PK can be detected in stool as well as in EDTA blood plasma and thus serves as an indicator of cancer. In a clinical study, in the regular combination with an occult blood test, it showed a high sensitivity of over 90%, while its specificity was below 70%.46
• CellMaxLife, a liquid biopsy company focused on blood sample-based cancer screening. The company has no available products on the market yet, but is currently working on the development of the CRC screening test “FirstSight”, which screens patients’ blood sample for circulating gastrointestinal epithelial cells (CECs) and somatic mutations of cell-free tumor DNA (ctDNA).
• GRAIL, Inc., which develops products based on next-generation sequencing (NGS) for the early detection of cancer. The blood-based screening test “Galleri” is the company’s current core product. According to the company, this test can detect over 50 types of cancer. The list price for screening with Galleri is $959. GRAIL recommends using Galleri only in combination with conventional screening methods.
• Guardant Health, Inc., a California-based company that aims to improve early cancer detection based on liquid biopsy. The product “Guardant Reveal” is a blood test used to control residual disease and recurrence after CRC. Guardant Reveal was launched in the U.S. market in the start of 2021. Alongside the other products Guardant360, Guardant360 CDx and GuardantOMNI, Guardant Reveal contributes to the development of the LUNAR screening program, which will be used in the future for cancer screening of asymptomatic patients.
• Thrive, a subsidiary of Exact Sciences Corp., is researching a holistic cancer screening based on a liquid biopsy. The test is currently under development and has not yet received marketing approval.
We might not be able to compete successfully in our market, particularly as we seek to enter the United States and commercialize ColoAlert. We expect that some of the screening tests currently being developed will be commercially available in the United States by the time we obtain FDA approval for ColoAlert, if at all. If our competitors introduce new diagnostic tests that compete with or surpass the accuracy, price or ease of use of our products, we may be unable to satisfy existing customers or attract new customers at the prices and levels that would allow us to generate attractive rates of return on our investment. Increased competition could result in price reductions and revenue shortfalls, loss of customers and loss of market share, which could harm our business, prospects, financial condition and operating results.
Customers
Our current customers are primarily laboratories in Germany, including some of the largest chains in Germany, that offer our ColoAlert test to physicians for use with their patients. No customer accounted for more than 10% of our revenues in our prior fiscal year. We are actively seeking to expand our customer base in Europe, and intend to do so in the United States depending upon the progress of an application with the FDA for approval of ColoAlert.
Suppliers and Raw Material
We purchase most of our supplies “off-the-shelf” and at market rates and have normally second source suppliers available in case we experience supply issues with the primary supplier. We are planning to establish a safety stock from the primary suppliers to allow enough time for the necessary valuation to be performed if a secondary supplier is required.
____________
46 Dollinger MM et al. (2018) ClinLab 64(10)
50
Employees
As of January 20, 2022, the breakdown of employees by main category of activity is as follows:
Activity |
Number of
|
Number of
|
||
Manufacturing and Clinical Laboratory |
3 |
2 |
||
Research & Development |
4 |
1 |
||
Sales & Marketing |
3 |
2 |
||
General & Administration |
5 |
2 |
||
Executives |
4 |
0 |
||
Total: |
19 |
7 |
None of our employees are covered by a collective bargaining agreement.
Property, Plant and Equipment
Our principal premises are located at Robert Koch Strasse 50, Mainz, Germany. In 2013, we entered into a fifteen year lease agreement for these premises with a monthly minimum rent of approximately €5,730 plus ancillary rental costs of approximately €1,250 per month. The leased premises is approximately 7,300 sq. ft. in size. Starting in January 2022, we entered into an additional seven-year lease agreement with a monthly minimum rent of approximately €2,308 plus ancillary costs of approximately €621. The newly leased premises is approximately 2,228 sq. ft. in size.
We use these facilities for administrative purposes, research and development, manufacturing of our products and analysis by our laboratory s. We believe that these facilities will satisfy our manufacturing and research and development needs in the next 12 months.
Some members of our management work outside of these premises in office space that we do not rent.
Legal Proceedings
We are not involved in, or aware of, any legal or administrative proceedings contemplated or threatened by any governmental authority or any other party. As of the date of this prospectus, no director, officer or affiliate is a party adverse to us in any legal proceeding or has an adverse interest to us in any legal proceeding.
51
The following tables summarize our financial data. We derived the summary financial statement data for the years ended December 31, 2020 and 2019 set forth below from the audited financial statements of PharmGenomics GmbH, which is considered for accounting purposes to be our predecessor entity, and from the unaudited financial statements of PharmGenomics GmbH for the three and six months ended June 30, 2021 and 2020 contained in this prospectus. Mainz Biomed N.V. was not formed as of December 31, 2020 and to date has had no operations. Our historical results are not necessarily indicative of the results that may be expected in the future. Our financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. You should read the information presented below together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our financial statements, the notes to those statements and the other financial information contained in this prospectus and the unaudited consolidated pro forma information appearing elsewhere in this prospectus.
Summary of Operations in U.S. Dollars (audited)
Six Months Ended
|
Years Ended
|
|||||||||||||||
2021 |
2020 |
2020 |
2019 |
|||||||||||||
Revenues |
$ |
417,311 |
|
$ |
166,701 |
|
$ |
493,565 |
|
$ |
281,393 |
|
||||
Cost of Revenues |
|
240,954 |
|
|
152,285 |
|
|
370,480 |
|
|
342,664 |
|
||||
GROSS PROFIT (LOSS) |
|
176,357 |
|
|
14,416 |
|
|
123,085 |
|
|
(61,271 |
) |
||||
|
|
|
|
|
|
|
|
|||||||||
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
||||||||
Research and Development |
|
160,531 |
|
|
144,330 |
|
|
311,851 |
|
|
250,316 |
|
||||
Sales and Marketing |
|
70,979 |
|
|
51,575 |
|
|
110,380 |
|
|
181,460 |
|
||||
General and administrative |
|
199,481 |
|
|
179,438 |
|
|
374,569 |
|
|
428,862 |
|
||||
Operating loss |
|
(254,634 |
) |
|
(360,927 |
) |
|
(673,715 |
) |
|
(921,909 |
) |
||||
|
|
|
|
|
|
|
|
|||||||||
OTHER INCOME/(EXPENSE) |
|
(7,087 |
) |
|
20,866 |
|
|
86,820 |
|
|
(35,146 |
) |
||||
|
|
|
|
|
|
|
|
|||||||||
NET LOSS |
|
(261,721 |
) |
|
(340,061 |
) |
|
(586,895 |
) |
|
(957,055 |
) |
||||
|
|
|
|
|
|
|
|
|||||||||
Foreign Currency Translation |
|
82,963 |
|
|
(29,550 |
) |
|
(224,656 |
) |
|
22,166 |
|
||||
|
|
|
|
|
|
|
|
|||||||||
TOTAL COMPREHENSIVE LOSS |
$ |
(178,758 |
) |
$ |
(369,611 |
) |
$ |
(811,551 |
) |
$ |
(934,889 |
) |
Balance Sheet in U.S. Dollars (audited)
As of
|
As of
|
|||||||
Cash |
$ |
195,165 |
|
$ |
122,568 |
|
||
Total Current Assets |
|
281,607 |
|
|
186,398 |
|
||
Total Assets |
|
734,472 |
|
|
673,270 |
|
||
|
|
|
|
|||||
Total Current Liabilities |
|
672,051 |
|
|
701,954 |
|
||
|
|
|
|
|||||
Long Term Debt |
|
2,058,839 |
|
|
2,265,431 |
|
||
|
|
|
|
|||||
Total Liabilities |
|
3,146,548 |
|
|
3,414,825 |
|
||
|
|
|
|
|||||
Working Capital (Deficit) |
|
(390,444 |
) |
|
(515,556 |
) |
||
|
|
|
|
|||||
Total Stockholders’ Equity (Deficit) |
|
(2,412,076 |
) |
|
(2,741,555 |
) |
52
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes to those statements included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives, expectations, forecasts and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the section titled “Risk Factors” and elsewhere in this prospectus. You should carefully read the “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”
Organization and Overview of Operations
We were incorporated for the purpose of acquiring PharmGenomics GmbH, and on August 3, 2021, we entered into a contribution agreement (the “Contribution Agreement”) with PharmGenomics GmbH. Under the Contribution Agreement, 100% of the shares of the PharmGenomics GmbH were acquired in exchange for 6,000,000 shares of Mainz. Upon the closing of the Contribution Agreement on September 20, 2021, PharmGenomics GmbH became a wholly owned subsidiary of Mainz, and the former shareholders of the PharmGenomics GmbH hold approximately 62% of the outstanding shares of Mainz.
Pursuant to the accounting guidance provided by IFRS 10 and IFRS 3.7 and B13, we have determined that for accounting purposes the merger of Mainz BioMed N.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed N.V. as the acquired company. As such, the assets and liabilities of PharmGenomics have been presented at their historical carrying values. The information below includes financial data and discussion derived from the audited financial statements of PharmGenomics GmbH. Mainz Biomed N.V. was not formed as of December 31, 2020 and to date has had no operations.
We develop in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. We additionally operate a clinical diagnostic laboratory. We develop and distribute our IVD Kits to third party laboratories for their own diagnostic purposes. The majority of our revenues comes from the sale of our IVD Kits.
In addition, we conduct research and development in order to increase and diversify our product portfolio. Currently, we are managing two government funded research and development projects, which provide us non-refundable grant income that cover a percentage of the individual project related costs.
On November 9, 2021, we completed our initial public offering whereby we sold 2,300,000 ordinary shares for gross proceeds of $11,500,000.
53
Results of Operations
Comparison of the Six Months Ended June 30, 2021 and 2020
The following table provides certain selected financial information for the periods presented:
Six Months Ended
|
|||||||||||||||
2021 |
2020 |
Change |
% Change |
||||||||||||
Revenue |
$ |
417,311 |
|
$ |
166,701 |
|
$ |
250,610 |
|
150 |
% |
||||
Cost of revenue |
$ |
240,954 |
|
$ |
152,285 |
|
$ |
88,669 |
|
58 |
% |
||||
Gross profit |
$ |
176,357 |
|
$ |
14,416 |
|
$ |
161,941 |
|
1123 |
% |
||||
Gross profit percentage |
|
42 |
% |
|
9 |
% |
|
|
|
||||||
Research and Development |
$ |
160,531 |
|
$ |
144,330 |
|
$ |
16,201 |
|
11 |
% |
||||
Sales and Marketing |
$ |
70,979 |
|
$ |
51,575 |
|
$ |
19,404 |
|
38 |
% |
||||
General and Administrative |
$ |
199,481 |
|
$ |
179,438 |
|
$ |
20,043 |
|
11 |
% |
||||
Total operating expenses |
$ |
430,991 |
|
$ |
375,343 |
|
$ |
55,648 |
|
15 |
% |
||||
Loss from operations |
$ |
254,634 |
|
$ |
360,927 |
|
$ |
(106,293 |
) |
(29 |
)% |
||||
Other income (expense) |
$ |
(7,087 |
) |
$ |
20,866 |
|
$ |
(27,953 |
) |
(134 |
)% |
||||
Net loss |
$ |
261,721 |
|
$ |
340,061 |
|
$ |
(78,340 |
) |
(23 |
)% |
||||
Total Comprehensive Loss |
$ |
178,758 |
|
$ |
369,611 |
|
$ |
(190,853 |
) |
(52 |
)% |
||||
Basic and dilutive loss per common share |
$ |
2.51 |
|
$ |
3.67 |
|
$ |
(1.16 |
) |
(32 |
)% |
||||
Weighted average number of common shares outstanding – basic and diluted |
|
104,869 |
|
|
92,584 |
|
|
|
|
Revenue
Revenue for the six months ended June 30, 2021 was $417,311 as compared to $166,701 for the six months ended June 30, 2020, an increase of $250,610. This increase was the result of a 100% increase in the sale of ColoAlert Lab-kits and an increase of approximately $245,000 from statutory healthcare system reimbursements related to third-party laboratory testing and lab support, mitigated by a decrease of approximated $46,000 from sales of legacy research use only products and other revenue. Our third-party laboratory testing and related statutory healthcare system reimbursements was related to our support of COVID-19 diagnostic testing during the pandemic, which may or may not continue in the future. We expect our research use only and other legacy products will decrease over time as we focus our marketing and sales efforts on our ColoAlert product.
Our revenue by product and service category is as follows:
Six Months Ended
|
||||||
2021 |
2020 |
|||||
ColoAlert |
$ |
104,851 |
$ |
52,427 |
||
Third-party lab testing and support |
|
261,019 |
|
16,365 |
||
Research use only product sales |
|
37,812 |
|
59,297 |
||
Other revenue |
|
13,630 |
|
38,613 |
||
Total Revenue |
$ |
417,311 |
$ |
166,701 |
Cost of Revenue
Cost of Revenue for the six months ended June 30, 2021 was $240,954 as compared to $152,285 for the six months ended June 30, 2020, a 58% increase. This increase was the result increased revenue and was primarily driven by a $27,978 increase in salary and benefits costs and an increase of $39,793 in royalty payments, resulting from increased sales in the 2021 period.
54
Gross profit
Gross profit increased to $176,357 from $14,416, for the six months ended June 30, 2021, as compared to the six months ended June 30, 2020. This gross profit increase was due to increased revenue from our ColoAlert product and statutory healthcare system reimbursements related to third-party laboratory testing and lab support, which have higher gross margins.
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2021 were $160,531 compared to $144,330 for the six months ended June 30, 2020, an increase of $16,201. This increase was driven by an increase of approximately $15,000 in salary related expenses resulting from increased headcount in research and development to support our PancAlert and GenoStrip product candidates.
Sales and Marketing Expenses
Sales and marketing expenses for the six months ended June 30, 2021, were $70,979 compared to $51,575 for the six months ended June 30, 2020, an increase of $19,369. This increase was primarily the result of an approximately $14,000 increase in advertising expenses to support the sale of our ColoAlert product.
General and Administrative Expenses
General and administrative expenses for the six months ended June 30, 2021 were $199,481 compared to $179,438 for the six months ended June 30, 2020, an increase of $20,043. The increased expenses were primarily the result of increased salary related expenses of approximately $18,000, to support our increased volume of business.
Other income (expense)
Other income (expense) for the six months ended June 30, 2021 was $(7,0874) compared to $20,866 for the six months ended June 30, 2020, resulting in increased other expenses (net) of $27,953. The increased expenses were primarily the result of increased accretion expense of $61,315, mitigated by an increase of $47,476 from government R&D grant income.
Liquidity and Capital Resources
Our principal liquidity requirements are for working capital and operating losses. We fund our liquidity requirements primarily through cash on hand, cash flows from operations, and debt financing, including officers, shareholders. As of June 30, 2021, we had $195,165 of cash and cash equivalents, with $122,568 as of December 31, 2020.
The following table summarizes our cash flows from operating, investing and financing activities:
Six Months Ended
|
|||||||||||
2021 |
2020 |
Change |
|||||||||
Cash used in operating activities |
$ |
(132,530 |
) |
$ |
(187,746 |
) |
$ |
55,216 |
|||
Cash used in investing activities |
$ |
(4,580 |
) |
$ |
(5,251 |
) |
$ |
671 |
|||
Cash provided by financing activities |
$ |
217,029 |
|
$ |
48,448 |
|
$ |
168,581 |
Cash Flow from Operating Activities
For the six months ended June 30, 2021, net cash flows used in operating activities was $132,530 compared to $187,746 used during the year ended six months ended June 30, 2020. The improvement in operating cash flows is primarily due improved gross profits in 2021, net of timing differences for the settlement of assets and liabilities.
Cash Flows from Investing Activities
During the six months ended June 30, 2021, we used $4,580 in investing activities compared to $5,251 used during the year ended six months ended June 30, 2020. Cash used for investing activities in both periods was for the purchase of fixed assets.
55
Cash Flows from Financing Activities
During the six months ended June 30, 2021, we had cash flow provided by financing activities of $217,029 compared to cash flow provided by financing activities of $48,448 for the six months ended June 30, 2020, an increase of $168,581. This increase was primarily the result of decreased new borrowings. Our financing activities are primarily debt financing, including silent partnerships and convertible debt from officers and shareholders.
Comparison of the Year Ended December 31, 2020 and 2019
The following table provides certain selected financial information for the periods presented:
Year Ended
|
|||||||||||||||
2020 |
2019 |
Change |
% Change |
||||||||||||
Revenue |
$ |
493,565 |
|
$ |
281,393 |
|
$ |
212,172 |
|
75 |
% |
||||
Cost of revenue |
$ |
370,480 |
|
$ |
342,664 |
|
$ |
27,816 |
|
8 |
% |
||||
Gross profit |
$ |
123,085 |
|
$ |
(61,271 |
) |
$ |
184,356 |
|
NM |
|
||||
Gross profit percentage |
|
25 |
% |
|
(22 |
)% |
|
|
|
||||||
Research and Development |
$ |
311,851 |
|
$ |
250,316 |
|
$ |
61,535 |
|
25 |
% |
||||
Sales and Marketing |
$ |
110,380 |
|
$ |
181,460 |
|
$ |
(71,080 |
) |
(39 |
)% |
||||
General and Administrative |
$ |
374,569 |
|
$ |
428,862 |
|
$ |
(54,293 |
) |
(13 |
)% |
||||
Total operating expenses |
$ |
796,800 |
|
$ |
860,638 |
|
$ |
(63,838 |
) |
(7 |
)% |
||||
Loss from operations |
$ |
673,715 |
|
$ |
921,909 |
|
$ |
(248,194 |
) |
(26 |
)% |
||||
Other income (expense) |
$ |
86,820 |
|
$ |
(35,146 |
) |
$ |
121,966 |
|
NM |
|
||||
Net loss |
$ |
586,985 |
|
$ |
957,055 |
|
$ |
(370,070 |
) |
(39 |
)% |
||||
Total Comprehensive Loss |
$ |
811,551 |
|
$ |
934,889 |
|
$ |
(123,338 |
) |
(13 |
)% |
||||
Basic and dilutive loss per common share |
$ |
6.34 |
|
$ |
10.34 |
|
$ |
(4.00 |
) |
(39 |
)% |
||||
Weighted average number of common shares outstanding – basic and diluted |
|
92,584 |
|
|
92,584 |
|
|
|
|
Revenue
Revenue for the year ended December 31, 2020 was $493,565 as compared to $281,393 for the year ended December 31, 2019, an increase of $212,172. This increase was the result of statutory healthcare system reimbursements related to third party laboratory testing and lab support conducted during 2020, which increased by approximately $111,000, and increased sales volume of ColoAlert Lab-kits, which increased by approximately $30,000, and sales of legacy research use only products which increased by approximately $52,000 in 2020, when compared to 2019.
Our revenue by product and service category is as follows:
Year Ended
|
||||||
2020 |
2019 |
|||||
ColoAlert |
$ |
167,074 |
$ |
136,678 |
||
Third party lab testing and support |
|
176,692 |
|
65,987 |
||
Research use only product sales |
|
93,894 |
|
42,084 |
||
Other revenue |
|
55,905 |
|
36,563 |
||
Total Revenue |
$ |
493,565 |
$ |
281,313 |
Cost of Revenue
Cost of Revenue for the year ended December 31, 2020 was $370,480 as compared to $342,684 for the year ended December 31, 2019, an 8% increase. This increase was the result an increase in raw material costs and in tandem with our increase in revenue, off-set in part from license fee payment of approximately $112,000, which was an increase from 2019 to 2020 of $66,000. This decrease is the result of a license payment made in 2019 to record, and pay, an amount we agreed to with ColoAlert AS for 2019 and periods prior to 2019.
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Gross profit
Gross profit increased to $123,085 from $(61,271), for the year ended December 31, 2020, as compared to the year ended December 31, 2019. This increase was due to increased testing volume during 2020, which has higher margin profile, and the one-time license fee for our ColoAlert product in 2019, which decreased our 2019 gross profit. Absent the one-time license fee payment in 2019, gross profit in 2019 would have been positive.
Research and Development Expenses
Research and development expenses for the year ended December 31, 2020, were $311,851 compared to $250,316 for the year ended December 31, 2019, an increase of $61,535. This increase was driven by an increase of approximately $46,000 in salary related expenses resulting from increased headcount in research and development to support our PancAlert and GenoStrip product candidates.
Sales and Marketing Expenses
Sales and marketing expenses for the year ended December 31, 2020, were $110,380 compared to $181,460 for the year ended December 31, 2019, a decrease of $71,080. This decrease was the result of an approximately $47,000 decrease in salary related expenses due our decreased headcount in our sales group. Additionally, we had decreased advertising and office expenses.
General and Administrative Expenses
General and administrative expenses for the year ended December 31, 2020 were $374,569 compared to $428,862 for the year ended December 31, 2019, a decrease of $54,293. From 2019 to 2020 salary costs increased by approximately $45,000 while consulting expenses decreased by approximately $66,000, for a net decrease of $21,000, resulting from the Company’s focus on the use of internal resources. The remainder of the decrease in operating expenses in 2020 was primarily due to a decrease in professional fees, bad debt expense and travel expenses, driven by continued focus on cost savings efforts.
Other income (expense)
Other income (expense) for the year ended December 31, 2020 was $86,820 compared to $(35,146) for the year ended December 31, 2019. This increase was related to government sponsored research and development grants related to PancAlert and GenoStrip and the benefit recorded due to a below market financing benefit related to a government loan.
Liquidity and Capital Resources
Our principal liquidity requirements are for working capital and capital expenditures. We fund our liquidity requirements primarily through cash on hand, cash flows from operations, and debt financing, including officers, shareholders. As of December 31, 2020 we had $122,568 of cash and cash equivalents, with $203,588 as of December 31, 2019.
The following table summarizes our cash flows from operating, investing and financing activities:
Year Ended
|
||||||||||||
2020 |
2019 |
Change |
||||||||||
Cash used in operating activities |
$ |
(468,737 |
) |
$ |
(416,495 |
) |
$ |
(52,242 |
) |
|||
Cash used in investing activities |
$ |
(9,685 |
) |
$ |
— |
|
$ |
(9,685 |
) |
|||
Cash provided by financing activities |
$ |
396,681 |
|
$ |
423,996 |
|
$ |
27,316 |
|
Cash Flow from Operating Activities
For the year ended December 31, 2020, net cash flows used in operating activities was $468,737 compared to $416,495 used during the year ended December 31, 2019, respectively, primarily due to net loss and timing of settlement of assets and liabilities.
57
Cash Flows from Investing Activities
During the year ended December 31, 2020, we used $9,685 in investing activities for the purchase of fixed assets. During the year ended December 31, 2019, we did not have any investing activities.
Cash Flows from Financing Activities
During the year ended December 31, 2020 we had cash flow provided by financing activities of $396,680 compared to cash flow provided by financing activities of $423,996 in 2019, a decrease of $27,316. This decrease was primarily the result of decreased new borrowings. Our financing activities are primarily debt financing, including silent partnerships and convertible debt from officers and shareholders.
Critical Accounting Policies and Significant Judgments and Estimates
This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. The preparation of these financial statements requires us 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, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in the notes to our financial statements included elsewhere in this prospectus, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
We believe our most critical accounting policies and estimates relate to the following:
• Revenue Recognition
• Foreign Currency Translation
• Stock Option Compensation
• Lease Accounting
• Financial Instruments
Revenue Recognition
Our revenue is primarily derived through providing genetic diagnostic tests to customers. We recognize revenue in accordance with International Financial Reporting Standards (“IFRS”) 15 “Revenue from Contracts with Customers”.
In accordance with IFRS 15, revenue is recognized upon the satisfaction of performance obligations. Performance obligations are satisfied at the point at which control of the promised goods or services are transferred to customers, in an amount that reflects the consideration we expect to be entitled to receive for those goods and services.
We provide a genetic diagnostic testing service and testing kits which are not considered separately identifiable from each other as we use the testing kits to collect samples in order to deliver the diagnostic test results to the customer. Accordingly, we have one performance obligation which is fulfilled upon the delivery of the test results to the customer and revenue is recognized at that point in time.
We also receive income from government sponsored R&D grants. Income is recognized on these programs when funds are received and all performance obligations, as defined in the grant, are completed. This income is included in the Statements of Comprehensive Loss as Other Income.
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Foreign Currency Translation
The functional currency is determined using the currency of the primary economic environment in which that entity operates. The functional, as determined by our management, is the European dollar (EUR).
Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. Foreign currency monetary items are translated at the period-end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction. Non-monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined.
Exchange differences arising on the translation of monetary items or on settlement of monetary items are recognized in the statement of comprehensive loss in the period in which they arise, except where deferred in equity as a qualifying cash flow or net investment hedge.
Exchange differences arising on the translation of non-monetary items are recognized in other comprehensive income to the extent that gains and losses arising on those non-monetary items are also recognized in other comprehensive income. Where the non-monetary gain or loss is recognized in profit or loss, the exchange component is also recognized in profit or loss.
Our presentation currency is the US dollar. For presentation purposes, all amounts are translated from the Euro functional currency to the US dollar presentation currency for each period using the exchange rate at the end of each reporting period for the statement of financial position. Revenues and expenses are translated on the basis of average exchange rates during the year.
Exchange gains and losses arising from translation to our presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss).
Stock Option Compensation
We have adopted our 2021 Omnibus Incentive Plan (the (“Plan”). Under the Plan, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plan, the aggregate number of shares underlying awards that we could issue cannot exceed, 2,300,000 ordinary shares.
On November 4, 2021, we awarded 1,484,650 stock options under the Plan, with a strike price of $5.00, the per share price in our November 2021 initial public offering. Such stock options were granted to all of our current employees, directors, advisors and senior management team. Such stock options for our non-senior management team, independent directors and advisors will begin vesting on November 4, 2022 and stop vesting on November 4, 2025 at the latest. Such stock options for the four members of our senior management team will begin vesting in portions equal to 25% of such options granted if, prior to November 4, 2025, the four-year anniversary of our initial public offering, for ten consecutive trading days (with at least 100,000 shares traded per trading day) the volume-weighted average price of the ordinary shares on the principal market is at least:
• $7.50;
• $10.00;
• $12.50, provided that such options cannot vest until the twelve-month anniversary of this offering at the earliest; and
• $15.00, provided that such options cannot vest until the twelve-month anniversary of this offering at the earliest.
We will value these stock options as follows: (a) for those options that have time-based vesting, we will use the Black Scholes method to value the stock options at the time of award and record the compensation expense in our Statement of Operations over the vesting period, and (b) for options issued with milestone based vesting criteria, we will use a Monte Carlo simulation to value the options at the time of issuance and each subsequent reporting date until fully vested or expired, with any change in compensation expense measured by such method to be recorded in our Statement of Operations.
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The Black Scholes option pricing model considers, among other factors, the expected term of the award and the expected volatility of our stock price. Due to the lack of an adequate history of a public market for the trading of our ordinary shares, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded with historical share price information sufficient to meet the expected life of the stock-based awards. The Monte Carlo simulation approach is a class of computational algorithms that rely on repeated random sampling to compute their results. This approach allows the calculation of the value of such stock options based on a large number of possible stock price path scenarios. Expense for the market-condition stock options will be recognized over the derived service period as determined through the Monte Carlo simulation model.
Of the 1,484,650 stock options granted prior to this offering, 393,000 were granted with simple time-based vesting. Using the Black Scholes method, we have estimated the compensation costs related to these options to be approximately $1.3 million, which will be recognized over the vesting period in our Statement of Operations. The remaining options for our senior management team vest, as described above, based on milestones tied to increased shareholder value as measured by increases in our stock price. The accounting for the 1,091,650 options issued to our senior management team, will be measured at the time of issuance and each subsequent reporting period until fully vested or expiration. The initial valuation and subsequent measurements may result in material compensation costs and cost reversals as a result of the Monte Carlo simulation, producing a wide range of potential values. For example, if the probability of not meeting the first milestone of 50% increase in our stock price is high, the value would render a low valuation (approaching nil). Conversely, if the probability of our value as measured by stock price increasing by 200% from the exercise price is measured at a high likelihood the total compensation charge could be as large as approximately $11 million. For each reporting period after issuance, and prior to full vesting or expiration, we will record the valuation change as measured by the Monte Carlo simulation, which will be impacted by the changed probabilities of meeting certain milestones.
Lease Accounting
We assess at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. We apply a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. We recognize lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying assets.
At the commencement date of the lease, we recognize lease liabilities measured at the present value of lease payments to be made over the lease term. Lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. Lease payments also include the exercise price of a purchase option reasonably certain to be exercised by us and payments of penalties for terminating the lease, if the lease term reflects us exercising the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, we use our incremental borrowing rate at the lease commencement date because the interest rate implicit in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset.
We recognize right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.
60
Financial Instruments
(a) Classification
The Company classifies its financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. The Company determines the classification of financial assets at initial recognition. The classification of debt instruments is driven by the Company’s business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL. For other equity instruments, on the day of acquisition the Company can make an irrevocable election (on an instrument-by-instrument basis) to designate them as at FVTOCI. Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or if the Company has opted to measure them at FVTPL.
(b) Measurement
Financial assets and liabilities at amortized cost
Financial assets and liabilities at amortized cost are initially recognized at fair value plus or minus transaction costs, respectively, and subsequently carried at amortized cost less any impairment.
Financial assets and liabilities at FVTPL
Financial assets and liabilities carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statements of loss and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets and liabilities held at FVTPL are included in the statements of loss and comprehensive loss in the period in which they arise.
Debt investments at FVTOCI
These assets are subsequently measured at fair value. Interest income calculated using the effective interest method, foreign exchange gains and losses and impairment are recognized in profit or loss. Other net gains and losses are recognized in OCI. On derecognition, gains and losses accumulated in OCI are reclassified to profit or loss.
Equity investments at FVTOCI
These assets are subsequently measured at fair value. Dividends are recognized as income in profit or loss unless the dividend clearly represents a recovery of part of the cost of the investment. Other net gains and losses are recognized in OCI and are never reclassified to profit or loss.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditure or capital resources that is material to investors.
Disclosure of Contractual Arrangements
On December 31, 2020, the Company was committed to minimum lease payments as follows:
Contractual Obligation |
Less than
|
1 – 3 Years |
3 – 5 Years |
Over 5 Years |
||||||||
Office Rent |
$ |
84,312 |
$ |
168,625 |
$ |
168,626 |
$ |
238,886 |
||||
Laboratory Equipment |
$ |
3,417 |
$ |
6,833 |
$ |
569 |
$ |
— |
||||
Office Equipment |
$ |
7,064 |
$ |
14,128 |
$ |
11,457 |
$ |
4,378 |
||||
TOTAL |
$ |
94,793 |
$ |
189,586 |
$ |
180,652 |
$ |
243,264 |
The amounts above are undiscounted and include the total amounts due, including the interest component.
61
DIRECTORS AND EXECUTIVE OFFICERS
Board of Directors
We five directors, three of whom satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. Our directors are elected annually at each annual meeting of our company’s shareholders. Currently, our board of directors assesses potential director candidates for required skills, expertise, independence and other factors, but after the offering, we intend for out Nominating Committee to take responsibility for this action.
Our Board of Directors is responsible for appointing our company’s officers.
Board Committees
We established three committees under the board of directors: an Audit Committee, a Compensation Committee and a Nominating Committee. Each committee is governed by a charter approved by our Board of Directors. In addition, we have an informal Strategic Advisory Board that will assist the board in setting strategies, achieving goals and analyzing opportunities.
Audit Committee
We appointed to our Audit Committee three directors that satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. One of our directors on the Audit Committee is an “audit committee financial expert” within the meaning of the SEC rules and possesses financial sophistication within the meaning of the Listing Rules of the Nasdaq Stock Market. The Audit Committee oversees our accounting and financial reporting processes and the audits of the financial statements of our company. The Audit Committee is responsible for, among other things:
• selecting our independent registered public accounting firm and pre-approving all auditing and non-auditing services permitted to be performed by our independent registered public accounting firm;
• reviewing with our independent registered public accounting firm any audit problems or difficulties and management’s response and approving all proposed related-party transactions, as defined in Item 404 of Regulation S-K;
• discussing the annual audited financial statements with management and our independent registered public accounting firm;
• annually reviewing and reassessing the adequacy of our Audit Committee charter;
• meeting separately and periodically with the management and our independent registered public accounting firm;
• reporting regularly to the full board of directors;
• reviewing the adequacy and effectiveness of our accounting and internal control policies and procedures and any steps taken to monitor and control major financial risk exposure; and
• such other matters that are specifically delegated to our Audit Committee by our board of directors from time to time.
Compensation Committee
We appointed to our Compensation Committee three directors that will satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. Our Compensation Committee assists the board in reviewing and approving
62
the compensation structure, including all forms of compensation, relating to our directors and executive officers. No officer may be present at any committee meeting during which such officer’s compensation is deliberated upon. The Compensation Committee is responsible for, among other things:
• reviewing and approving to the board with respect to the total compensation package for our most senior executive officers;
• approving and overseeing the total compensation package for our executives other than the most senior executive officers;
• reviewing and recommending to the board with respect to the compensation of our directors;
• reviewing periodically and approving any long-term incentive compensation or equity plans;
• selecting compensation consultants, legal counsel or other advisors after taking into consideration all factors relevant to that person’s independence from management; and
• programs or similar arrangements, annual bonuses, employee pension and welfare benefit plans.
Nominating Committee
We appointed to our Nominating Committee three directors that satisfy the “independence” requirements of Rule 5605(a)(2) of the Listing Rules of the Nasdaq Stock Market and meet the independence standards under Rule 10A-3 under the Exchange Act. The Nominating Committee is responsible for overseeing the selection of persons to be nominated to serve on our board of directors. The Nominating Committee considers persons identified by its members, management, shareholders, investment bankers and others.
Strategic Advisory Board
We have appointed a Strategic Advisory Board. Although the Strategic Advisory Board has no formal powers, our Board of Directors plans to consult it in setting strategies, achieving goals and analyzing opportunities. Our Strategic Advisory Board currently has three members;
Dr. Heiner Dreismann. Dr. Dreismann joined in November 2021. He is a seasoned executive with more than 35 years of experience in the life sciences and health care industries and widely regarded as a pioneer in the early adoption of polymerase chain reaction (PCR) technique, one of the most ubiquitous technologies in molecular biology and genetics research today. He joined F. Hoffmann La Roche AG in 1985, and held various national and international management positions, including head of manufacturing for microbiological diagnostics, head of R&D microbiological diagnostics and head of the Business Area Microbiology. After Roche’s acquisition of PCR technology in 1991, Dr. Dreismann headed the PCR Business Unit for Europe and strategic planning for PCR diagnostics. From 2000 to 2006 he was President and CEO of Roche Molecular Systems in Pleasanton, California. Other senior positions he held in Roche included Head of Global Business Development, Roche Diagnostics and Member of Roche’s Global Diagnostic Executive Committee. Dr. Dreismann currently serves on the boards of several public and private life sciences and health care companies in the United States, Europe and Israel.
Dr. Soren Thestrup-Nielsen. Dr. Thestrup-Nielsen has spent over 25 years in the medical device industry, first at Boston Scientific and later at Danaher Corporation where he led the inorganic growth of Danaher’s acute care and laboratory diagnostics portfolio. He has previously held a series of notable executive roles including Chairman of Althea Group, as well as board member at numerous companies including lung cancer screening company Oncimmune. During his career, Dr. Thestrup-Nielson has overseen IPOs, trade-sales, acquisitions, and a variety of investment transactions with medical companies in both North America and Europe. He received a M.D. from the University of Copenhagen, School of Medicine, practiced five years as a general & vascular surgeon, and received an MBA from the IMD in Lausanne, Switzerland.
Michele Pedrocchi. Dr. Pedrocchi is a seasoned healthcare executive with over 25 years of international experience at Roche spanning in vitro diagnostics, digital health, and personalized medicine. During his tenure at Roche, Dr. Pedrocchi held senior leadership positions across corporate strategy, commercial and business development including, serving as Global Head of Strategy and Business Development for Diagnostics. Under his leadership, the division pioneered the entry into digital health and executed more than 20 acquisitions and 500 licensing deals. Prior leadership positions held at Roche included multiple international roles where Dr. Pedrocchi served as in-country and regional general manager and consistently built a track record of profitably growing businesses in emerging and mature markets.
63
Moreover, he had an instrumental role in introducing patient selection through Companion Diagnostics (CDx) and establishing polymerase chain reaction (PCR) as a routine diagnostics methodology. Dr. Pedrocchi is currently an Independent Strategic Advisor and Non-Executive Director to private and public healthcare companies.
Directors and Executive Officers
The following table sets forth the names and ages of all of our directors and executive officers.
Name, Region/State and Country of Residence |
Age |
Position |
Director/Officer
|
|||
Guido Baechler
|
56 |
Chief Executive Officer, Director |
July 2021 |
|||
William Caragol
|
54 |
Chief Financial Officer |
July 2021 |
|||
Dr. Moritz Eidens
|
38 |
Chief Science Officer, Director |
June 2008 |
|||
Alberto Libanori
|
32 |
Director |
November 2021 |
|||
Hans Hekland
|
63 |
Director |
November 2021 |
|||
Philipp Freese
|
40 |
Chief Operating Officer |
February 2015 |
|||
Nicole Holden
|
48 |
Director |
November 2021 |
Business Experience
The following summarizes the occupation and business experience during the past five years or more for our directors, and executive officers as of the date of this prospectus:
Guido Baechler, our Chief Executive Officer and a director, has global experience in private and public companies specializing in the life science and medical diagnostics fields. Mr. Baechler founded Berkeley Life Science Advisors, a diagnostic and life science start-up consulting business, in 2019. He was the Chief Executive Officer of SummerBio, a leading COVID testing CLIA laboratory in California, from July 2020 to February 2021 and Chief Executive Officer and Chief Operating Officer of Singulex, Inc. from November 2008 to June 2019.
Mr. Baechler previously held several leadership positions at Roche Molecular Systems, including serving as a member of its executive team. He held various leadership positions at Roche Diagnostics within Research, Development, and Marketing in Switzerland and California during his almost twenty years with the company.
Since 2020, Mr. Baechler has been a board member of SummerBio and Chip Diagnostics and the chairman of the board of Telo Genomics, a publicly traded Canadian biotech company.
Mr. Baechler holds a Bachelor’s Degree in Electrical Engineering and completed a series of executive finance and management classes at the London School of Business and at the Haas Business School at the University of California, Berkeley.
William Caragol, our Chief Financial Officer, has over thirty years of experience working with growth stage technology companies. In 2018, he founded and is the Managing Director of Quidem LLC, a corporate strategic and financial advisory firm. Since 2015, Mr. Caragol has been Chairman of the Board of Thermomedics, Inc., a privately held medical diagnostic equipment company. Since February 2021, Mr. Caragol is also on the Board of Directors and is Chairman of the Audit Committee of Greenbox POS (NASDAQ: GBOX) a financial technology company leveraging proprietary blockchain security to build customized payment solutions, and since July 2021 is on the Board of Directors of Worksport Ltd. (Nasdaq: WKSP), an emerging electric vehicle company. From 2012 to 2018, Mr. Caragol was Chairman and CEO of PositiveID, a holding company that was publicly traded that had a portfolio of products in the fields of bio detection systems and molecular diagnostics. Also, since April 2020, Mr. Caragol has served as a director and the Executive Vice President, Chief Operating and Chief Financial Officer of Hawaiian Springs LLC, a natural spring artesian bottled water company. Mr. Caragol earned a B.S. in business administration and accounting from Washington & Lee University and is a member of the American Institute of Certified Public Accountants.
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Dr. Moritz Eidens, our Chief Science Officer and a director, received his Masters Degree at the international oriented University of Applied Sciences in Rheinbach near Bonn, Germany in 2006 with a focal point on human genetics and genetic diseases. In 2019, Mr. Eidens graduated from the University-Medicine Hospital of the Johannes Gutenberg University in Mainz, Germany, and was awarded with a Ph.D. from the medical faculty.
In 2008, Mr. Eidens founded PharmGenomics and has served since then as an executive of the organization. Mr. Eidens has been involved in PharmGenomics’ development and distribution of several innovative products, managed and coordinated several national and international grant projects with large industrial or academic partners process development, technology transfer, supply chain management as well as internal and external audits.
Philipp Freese, our Chief Operating Officer, received his Diploma in Business Administration with focus on marketing, business law and production technology at Excellence University RWTH in Aachen/Germany in 2008. Until 2015 he worked in project, product, process, quality and key account management as well as business development for the Cologne Institute for Economic Research. In 2014, he successfully finished his postgraduate studies in the IT-related management of companies.
Mr. Freese served as the Interim Head of Marketing at PharmGenomics from 2013 to 2015, and in 2015 he became its Commercial Managing Director responsible for marketing, sales, operations, legal affairs and Finance/IR. He was the major driver for ColoAlert’s product-market-fit, brand, processes and marketing strategies, established relationships with reference laboratories and assisted in our capital raises.
Hans Hekland, a director, graduated Siviløkonom (MBA) from Norwegian School of Economics and Business Administration in Bergen, Norway in 1983. He has had several executive positions in international Banking and Industry until 2001 when he established Sarsia Innovation as the tech-transfer-office for University of Bergen. He has during his career developed Sarsia into a venture fund management company, established three venture funds and managed two IPOs. He holds board positions in several healthcare and biotech companies.
Hans Hekland is a certified business coach within the EIT Health program.
In 2013 he established ColoAlert AS together with Dr. Dagfinn Øgreid and Dr Roger Løvlie and engaged PharmGenomics to develop the ColoAlert test, which led to the current license agreement. Since 2017, he has been a business advisor to PharmGenomics GmbH.
Alberto Libanori, a director, is a Research Scientist at the University of California, Los Angeles (“UCLA”) and serves as Senior Advisor to Boustead Securities, LLC. Alberto has 10 years’ work experience at the science-business interface in venture capital, BD&L, M&A and IPOs, focusing in life-sciences, med-tech and cosmeceuticals, having worked with L’Oréal Research and Innovation, M-Ventures, and Novartis Venture Funds (NVF). Previously Alberto founded and helped with the strategic exits of a number of technology start-ups including Atelier Mnemist SAS and Cutech (acquired by Symrise). A prolific scientist, Alberto has published more than 20 peer-reviewed articles in journals including Advanced Materials, ACS Nano, Materials Today and Biosensors and Bioelectronics, and is the holder of two patents. Alberto Libanori holds an MS in Bioengineering from UCLA, with focus on wearable and implantable bioelectronics and biomaterials for regenerative medicine, an MPhil in Bioscience Enterprise from Cambridge University, and a Bachelor’s in Bimolecular Sciences (Hons) from St Andrews University. Raised internationally, Alberto is fluent in English, French, Spanish, Mandarin Chinese and Portuguese, alongside his native Italian.
Nicole Holden, CPA, a director, has more than 20 years of advisory experience including mergers and acquisitions, divestitures, initial public offerings and transaction support services for large publicly traded and privately held clients. Ms. Holden advises clients in matters involving SEC reporting, complex financial transactions, initial public offerings, acquisitions and divestiture accounting, restructuring, discontinued operations, and various technical accounting matters. Currently, Ms. Holden is the Audit Committee Chair for Nerds On Site, Inc. (CSE: NERD), a position she has held since 2018, shortly prior to its Initial Public Offering. Prior to joining our Board, Ms. Holden had a broad professional career. She is currently the Vice President, Client Advisory in the Advisory Service practice for Alliance. Ms. Holden was also an Assistant Controller for Enviva LP (NYSE: EVA). She was a Director in the Professional practice for the Center for Audit Quality (The CAQ). She also served as a Senior Manager in the Office of Research and Analysis and Assistant Chief Auditor in the Office of the Chief Auditor for the Public Company Accounting Oversight Board (PCAOB). Ms. Holden was involved in the rule-making process impacting auditor independence, audit firm rotation and identification of higher risk audits for closer consideration by the PCAOB Division of Inspections and the PCAOB Division of Enforcement. She was a Director in the Transaction Services practice at KPMG LLP. She also served as a Senior Manager in the Assurance practice at Stonefield Josephson, Inc. She was a Staff Accountant
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in the Corporate Finance division of the U.S. Securities and Exchange Commission (SEC). Her regulatory experience at the SEC and the PCAOB contributed to her deep understanding of current rules and regulations affecting public companies, audit firms, and Boards of Directors. She also worked on the Internal Audit team for Computer Sciences Corp (NYSE: DXC). She began her career first as an Assurance associate for Arthur Andersen, then as an Assurance associate for Ernst & Young, LLP. Ms. Holden is a licensed Certified Public Accountant in Washington, DC (Active). She received a Master of Accounting from the American University, Kogod School of Business.
Family Relationships
There are no family relationships among any of our directors and executive officers.
Arrangements
We are not aware of any arrangement among shareholders regarding the nomination or approval of directors or senior management.
Term of Office
Each director is to serve until his successor is elected and qualified or until his death, resignation or removal. Our Board of Directors appoints our officers and each officer is to serve until his successor is appointed and qualified or until his or her death, resignation or removal.
Involvement in Certain Legal Proceedings
During the past ten years, none of our directors or executive officers have been the subject of the following events:
1. a petition under the Federal bankruptcy laws or any state insolvency law was filed by or against, or a receiver, fiscal agent or similar officer was appointed by a court for the business or property of such person, or any partnership in which he was a general partner at or within two years before the time of such filing, or any corporation or business association of which he was an executive officer at or within two years before the time of such filing;
2. convicted in a criminal proceeding or is a named subject of a pending criminal proceeding (excluding traffic violations and other minor offenses);
3. the subject of any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining him from, or otherwise limiting, the following activities;
i) acting as a futures commission merchant, introducing broker, commodity trading advisor, commodity pool operator, floor broker, leverage transaction merchant, any other person regulated by the Commodity Futures Trading Commission, or an associated person of any of the foregoing, or as an investment adviser, underwriter, broker or dealer in securities, or as an affiliated person, director or employee of any investment company, bank, savings and loan association or insurance company, or engaging in or continuing any conduct or practice in connection with such activity;
ii) engaging in any type of business practice; or
iii) engaging in any activity in connection with the purchase or sale of any security or commodity or in connection with any violation of Federal or State securities laws or Federal commodities laws;
4. the subject of any order, judgment or decree, not subsequently reversed, suspended or vacated, of any Federal or State authority barring, suspending or otherwise limiting for more than 60 days the right of such person to engage in any activity described in paragraph 3.i in the preceding paragraph or to be associated with persons engaged in any such activity;
5. was found by a court of competent jurisdiction in a civil action or by the SEC to have violated any Federal or State securities law, and the judgment in such civil action or finding by the SEC has not been subsequently reversed, suspended, or vacated;
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6. was found by a court of competent jurisdiction in a civil action or by the Commodity Futures Trading Commission to have violated any Federal commodities law, and the judgment in such civil action or finding by the Commodity Futures Trading Commission has not been subsequently reversed, suspended or vacated;
7. was the subject of, or a party to, any Federal or State judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of:
i) any Federal or State securities or commodities law or regulation; or
ii) any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or
iii) any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
8. was the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
Director Independence
We have three directors who qualify as “independent” according to the rules of the Nasdaq Stock Market, LLC. Our Board has determined that the following director are “independent” as such directors do not have a direct or indirect material relationship with our company: Alberto Libanori, Nicole Holden and Hans Hekland.
A material relationship is a relationship which could, in the view of our Board of Directors, be reasonably expected to interfere with the exercise of a director’s independent judgment.
Code of Ethics and Business Conduct
We have adopted a Code of Ethics and Business Conduct that applies to our directors, officers and other employees.
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Compensation Discussion and Analysis
This section sets out the objectives of our company’s executive compensation arrangements, our company’s executive compensation philosophy and the application of this philosophy to our company’s executive compensation arrangements. It also provides an analysis of the compensation design, and the decisions that the Board intends to make with respect to our executive officers. When determining the compensation arrangements for our executive officers, our Compensation Committee considers the objectives of: (i) retaining an executive critical to our success and the enhancement of shareholder value; (ii) providing fair and competitive compensation; (iii) balancing the interests of management and our shareholders; and (iv) rewarding performance, both on an individual basis and with respect to the business in general.
Benchmarking
Our Compensation Committee handles matters relating to compensation, including benchmarking. The Compensation Committee considers a variety of factors when designing and establishing, reviewing and making recommendations for executive compensation arrangements for all our executive officers. The Compensation Committee does not intend to position executive pay to reflect a single percentile within the industry for each executive. Rather, in determining the compensation level for each executive, the Compensation Committee will look at factors such as the relative complexity of the executive’s role within the organization, the executive’s performance and potential for future advancement and pay equity considerations.
Elements of Compensation
The compensation paid to executive officers in any year consists of two primary components:
(a) base salary; and
(b) long-term incentives in the form of stock options.
The key features of these two primary components of compensation are discussed below:
Base Salary
Base salary recognizes the value of an individual to our company based on his or her role, skill, performance, contributions, leadership and potential. It is critical in attracting and retaining executive talent in the markets in which we compete for talent. Base salaries for the Named Executive Officers are intended to be reviewed annually. Any change in base salary of a Named Executive Officer is generally determined by an assessment of such executive’s performance, a consideration of competitive compensation levels in companies similar to our company and a review of our performance as a whole and the role such executive officer played in such corporate performance.
Stock Option Awards
We provide long-term incentives to executive officers in the form of stock options as part of our overall executive compensation strategy. Our Compensation Committee believes that stock option grants serve our executive compensation philosophy in several ways: firstly, it helps attract, retain, and motivate talent; secondly, it aligns the interests of the executive officers with those of the shareholders by linking a specific portion of the officer’s total pay opportunity to the share price; and finally, it provides long-term accountability for executive officers.
Risks Associated with Compensation Policies and Practices
The oversight and administration of our executive compensation program requires the Compensation Committee to consider risks associated with our compensation policies and practices. Potential risks associated with compensation policies and compensation awards are considered at annual reviews and also whenever it is deemed necessary by the Compensation Committee.
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Our executive compensation policies and practices are intended to align management incentives with the long-term interests of the Corporation and its shareholders. In each case, the Corporation seeks an appropriate balance of risk and reward. Practices that are designed to avoid inappropriate or excessive risks include (i) financial controls that provide limits and authorities in areas such as capital and operating expenditures to mitigate risk taking that could affect compensation, (ii) balancing base salary and variable compensation elements and (iii) spreading compensation across short and long-term programs.
Compensation Governance
The Compensation Committee intends to conduct a yearly review of directors’ compensation having regard to various reports on current trends in directors’ compensation and compensation data for directors of reporting issuers of comparative our size. Director compensation is currently limited to the grant of stock options pursuant to the Stock Option Plan. It is anticipated that the Chief Executive Officer will review the compensation of our executive officers for the prior year and in comparison to industry standards via information disclosed publicly and obtained through copies of surveys. The Board expects that the Chief Executive Officer will make recommendations on compensation to the Compensation Committee. The Compensation Committee will review and make suggestions with respect to compensation proposals, and then make a recommendation to the Board.
The Compensation Committee will be comprised of independent directors.
The Compensation Committee’s responsibility is to formulate and make recommendations to our directors in respect of compensation issues relating to our directors and executive officers. Its responsibilities are more fully described under the section of this prospectus entitled “Directors and Executive Officers — Board Committees — Compensation Committee”.
Summary Compensation Table
We set out below certain disclosure on compensation paid to our executives on an aggregate basis for the year ended December 31, 2021, as disclosure of compensation on an individual basis is not required in our home country and is not otherwise publicly disclosed by us.
(U.S. dollars in thousands) |
All executive officers |
||
Base compensation |
$ |
452,957 |
|
Bonuses |
|
— |
|
Additional benefit payments |
|
47,774 |
|
Total cash compensation |
$ |
500,731 |
Executive Compensation Agreements
Guido Baechler, Chief Executive Officer
On July 1, 2021, we entered into a management services agreement with Guido Baechler (as amended, the “Baechler Agreement”). Pursuant to the Baechler Agreement: (a) Mr. Baechler is appointed as our Chief Executive Officer and will undertake and perform the duties and responsibilities normally and reasonably associated with such office; (b) we paid Mr. Baechler annual base remuneration of $240,000 that increased to $350,000 upon the filing of the Form F-1 for our initial public offering, and to $450,000 in the year after the initial public offering provided we make satisfactory progress in Board-approved goals (the “Base Remuneration”); (c) we shall reimburse Mr. Baechler for one U.S. health plan and one U.S. dental plan (if not included in the health plan) amounting up to $3,500 per month; (d) we shall provide to Mr. Baechler any benefits plan, if and when we have adopted such benefits; (e) our Board of Directors shall, in good faith, consider the payment of an annual bonus equal to 50% of that year’s Base Remuneration based upon our performance and upon the achievement of mutually agreed-upon milestones (the “Annual Bonus”); and (e) Mr. Baechler will be entitled to twenty days paid annual vacation per calendar year as well as the reimbursement of reasonable and necessary business expenses. Furthermore, our Board of Directors will grant Mr. Baechler 467,850 stock options exercisable into ordinary shares subject to a Stock Option Plan that the Board of Directors and the shareholders of the Company will approve. Such options shall vest in quarterly amounts on each of those dates when
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for the ten prior trading days the volume-weighted average price of the ordinary shares on the principal market is at least $7.50, $10.00, $12.50 and $15.00, provided that on each of those ten prior trading days at least 100,000 shares traded per trading day.
We or Mr. Baechler, under the Baechler Agreement, may terminate the engagement at any time for any reason by providing not less than ten calendar days’ notice in writing, provided that (a) Company shall have the option to provide a lump sum payment equal to ten (10) days’ Base Remuneration in lieu of such notice if terminating without cause; and (b) the Company may waive all or any part of the notice period for no consideration by giving written notice to Mr. Baechler if terminating with cause.
In the event of the Company’s termination of the Baechler Agreement for cause or if Mr. Baechler’s terminates the Baechler Agreement without good reason, Mr. Baechler is entitled to (i) any accrued but unpaid Base Remuneration and payment for any accrued but unused vacation; (ii) reimbursement for unreimbursed business expenses properly incurred by Mr. Baechler; and (iii) such benefits (including equity compensation), if any, to which Mr. Baechler may be entitled under the Company’s benefit plans as of termination; provided that, in no event shall Mr. Baechler be entitled to any payments in the nature of severance or termination payments except as specifically provided in the Baechler Agreement (collectively the “Accrued Amounts”).
If we elect to terminate the Baechler Agreement without good cause or Mr. Baechler resigns with good reason in compliance with the relevant terms and conditions of the Baechler Agreement, we shall be obligated to provide a severance package to Mr. Baechler that includes: (i) the Accrued Amounts (ii) equal installment payments payable under the Company’s normal payroll practices, but no less frequently than monthly, which are in the aggregate equal to the Mr. Baechler’s Base Remuneration for the year in which termination occurs; (iii) an amount equal to the Annual Bonus for the year in which the termination takes place; (iv) Vesting of an additional 12 months (removing any cliff) under all time-based vesting schedules for equity-based incentives held by Mr. Baechler; and (v) Reimbursement for up to $3,500 of the monthly U.S. health insurance premium paid by Mr. Baechler for himself and his dependent until the earliest date set forth by the Baechler Agreement.
The Baechler Agreement will terminate upon the death of Mr. Baechler. The Company may terminate Mr. Bachelor upon disability as defined by the Baechler Agreement. If Mr. Baechler is terminated on account of death or disability, we will provide Mr. Baechler, his estate, or, if applicable, Mr. Baechler’s beneficiaries with the Accrued Amounts.
William Caragol, Chief Financial Officer
On July 16, 2021, we entered into a consulting agreement with William Caragol (as amended on the “Caragol Agreement”). Pursuant to the Caragol Agreement: (a) Mr. Caragol will act as our Chief Financial Officer and will undertake and perform the duties and responsibilities normally and reasonably associated with such office; (b) we shall pay to Mr. Caragol a monthly salary of $15,000; and (c) Mr. Caragol will be entitled to receive 155,950 options to purchase our ordinary shares subject to a Stock Option Plan that the Board of Directors and the shareholders of the Company will approve. Such options shall vest in quarterly amounts on each of those dates when for the ten prior trading days the volume-weighted average price of the ordinary shares on the principal market is at least $7.50, $10.00, $12.50 and $15.00, provided that on each of those ten prior trading days at least 100,000 shares traded per trading day.
If we elect to terminate the Caragol Agreement without good cause or Mr. Caragol resigns with good reason in compliance with the relevant terms and conditions of the Caragol Agreement, we shall be obligated to provide a severance package to Mr. Caragol that includes: (i) any amounts due to him under the Caragol Agreement that have not yet been paid, (ii) the amounts due to Mr. Caragol for the year in which termination occurs; and (iii) the vesting of an additional six months under all time-based vesting schedules for equity-based incentives held by Mr. Caragol.
Dr. Moritz Eidens, Chief Science Officer
On September 20, 2021, we entered into a Management Services Agreement with Dr. Moritz Eidens with a term of three years (as amended, the “Eidens Agreement”). The Eidens Agreement is subject to automatic renewal on a three-year term basis unless either party provides written notice not to renew the Eidens Agreement with six months’ notice before the end of the current or renewal term.
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Pursuant to the terms and provisions of the Eidens Agreement: Dr. Eidens shall remain an executive of PharmGenomics GmbH and was appointed as a Director of Mainz Biomed N.V.
As a Director, Dr. Eidens is expected to undertake and perform the duties and responsibilities normally and reasonably associated with such office. For his services, Dr. Eidens will (a) receive a fixed gross annual salary of €164,000, payable monthly; (b) Dr. Eidens will be entitled to receive 233,925 options to purchase our ordinary shares subject to a Stock Option Plan that the Board of Directors and the shareholders of the Company will approve; and (c) be granted, up to the amount of the statutory income threshold applicable at the time, an amount equal to the employer’s share of the contributions to his private health and nursing care insurance (collectively the “Eidens Remuneration”). The options in the Eidens Remuneration shall vest in quarterly amounts on each of those dates when for the ten prior trading days the volume-weighted average price of the ordinary shares on the principal market is at least $7.50, $10.00, $12.50 and $15.00, provided that on each of those ten prior trading days at least 100,000 shares traded per trading day.
Furthermore, we will provide Dr. Eidens with (a) paid annual vacation time of 30 working days; (b) a company car for business and private use upon request; (c) a monthly budget of €400 a month alongside a one-time €2,000 budget for work equipment; (d) an annual budget of €5,000 for health care not covered by insurance; (e) an annual training budget; and (f) a company credit card.
If we terminate the Eidens Agreement, Dr. Eidens is entitled upon request to be released from his duties until the end of the relationship. He will also receive a severance payment equal to three months of Remuneration for each year of service under the Eidens Agreement.
If Dr. Eidens is unable to work due to reasons beyond his control, he is entitled to the Remuneration minus any benefits granted by the statutory health insurance fund institutions or a private health insurance fund for the lesser of six months or the end of the current three-year term. In addition, in the event of Dr. Eidens’ death, his spouse and dependents will be entitled to receive Remuneration for the month of death and the lesser of twelve months or the end of the current three-year term after the month of death.
In the event of a change of control, Dr. Eidens may resign and terminate the Eidens Agreement with written notice until the last day of the sixth month after the change of control has occurred.
Philipp Freese, Chief Operating Officer
On September 20, 2021, we entered into a Management Services Agreement with Mr. Phillip Freese with a three-year term (as amended, the “Freese Agreement”). The Freese Agreement is subject to automatic renewal on a three-year term basis unless either party provides written notice not to renew the Freese Agreement with six months’ notice before the end of the current or renewal term.
Pursuant to the terms and provisions of the Freese Agreement: Mr. Freese shall remain an executive of PharmGenomics GmbH and serve as one of our Directors. Mr. Freese was appointed as our Chief Operations Officer.
As a Director, Mr. Freese is expected to undertake and perform the duties and responsibilities normally and reasonably associated with such office. For his services, Mr. Freese will (a) receive a fixed gross annual salary of €164,000, payable monthly; (b) Mr. Freese will be entitled to receive 233,925 options to purchase our ordinary shares subject to a Stock Option Plan that the Board of Directors and the shareholders of the Company will approve (collectively the “Freese Remuneration”). Such options shall vest in quarterly amounts on each of those dates when for the ten prior trading days the volume-weighted average price of the ordinary shares on the principal market is at least $7.50, $10.00, $12.50 and $15.00, provided that on each of those ten prior trading days at least 100,000 shares traded per trading day.
Furthermore, we will provide Mr. Freese with (a) paid annual vacation time of 30 working days; (b) a company car for business and private use upon request; (c) a monthly budget of €400 a month alongside a one-time €2,000 budget for work equipment; (d) an annual budget of €5,000 for health care not covered by insurance; (e) an annual training budget; and (f) a company credit card.
If we terminate the Freese Agreement, Mr. Freese is entitled upon request to be released from his duties until the end of the relationship. He will also receive a severance payment equal to three months of the Freese Remuneration for each year of service under the Freese Agreement.
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If Mr. Freese is unable to work due to reasons beyond his control, he is entitled to the Freese Remuneration minus any benefits granted by the statutory health insurance fund institutions or a private health insurance fund for the lesser of six months or the end of the current three-year term. In addition, in the event of Mr. Freese’s death his spouse and dependents will be entitled to receive Freese Remuneration for the month of death and the lesser of twelve months or the end of the current three-year term after the month of death.
In the event of a change of control, Mr. Freese may resign and terminate the Freese Agreement with written notice until the last day of the sixth month after the change of control has occurred.
Stock Option Plans and Stock Options
We have adopted our 2021 Omnibus Incentive Plan (the (“Plan”). Under the Plan, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plan, the aggregate number of shares underlying awards that we could issue cannot exceed, 2,300,000 ordinary shares.
At the time of our IPO, we awarded 1,484,650 stock options under the Plan, with a strike price of $5.00, the per share price in our November 2021 initial public offering. Such stock options were granted to all of our current employees, directors, advisors and senior management team. Such stock options for our non-senior management team, independent directors and advisors will begin vesting starting November 4, 2022 and ending on November 4, 2025 at the latest. Such stock options for the four members of our senior management team will begin vesting in portions equal to 25% of such options granted if, prior to November 4, 2025, the four-year anniversary of our initial public offering, for ten consecutive trading days (with at least 100,000 shares traded per trading day) the volume-weighted average price of the ordinary shares on the principal market is at least:
• $7.50;
• $10.00;
• $12.50, provided that such options cannot vest until November 4, 2022, at the earliest; and
• $15.00, provided that such options cannot vest until November 4, 2022, at the earliest.
Of the 1,484,650 stock options granted prior to our initial offering, we granted 1,166,650 to our directors and executive officers as follows (i) 467,850 to Guido Baechler, (ii) 233,925 to Dr. Moritz Eidens, (iii) 233,925 to Philipp Freese, (iv) 155,950 to William Caragol, (v) 25,000 to Hans Hekland, (vi) 25,000 to Alberto Libanori and (vii) 25,000 to Nicole Holden.
Between our initial public offering and this offering, we have issued additional options to purchase up to 65,000 ordinary shares at an exercise price of between $8.75 and $10.56 per ordinary share. These options were issued in connection with new hires since the initial public offering.
Except as noted above, we did not, and will not, issue any other stock options or ordinary share grants prior to this offering.
Director Compensation for Fiscal 2021
We did not pay our directors for their services as directors in our fiscal 2020, although we did compensate some of our directors in that fiscal year for services that they provided as officers. In the fourth quarter of 2021, we paid each of our independent directors a quarterly fee of $10,500.
Pension Benefits
We do not have any defined benefit pension plans or any other plans requiring us to make retirement payments or pay comparable benefits.
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Security Ownership of Certain Beneficial Owners and Management
The following table sets forth certain information regarding the beneficial ownership of our ordinary shares as of January 20, 2022 by (a) each shareholder who is known to us to own beneficially 5% or more of our outstanding ordinary shares; (b) all directors; (c) our executive officers and (d) all executive officers and directors as a group. Except as otherwise indicated, all persons listed below have (i) sole voting power and investment power with respect to their ordinary shares, except to the extent that authority is shared by spouses under applicable law, and (ii) record and beneficial ownership with respect to their ordinary shares.
Name |
Ordinary
|
Percentage of
|
Percentage of
|
||||
Directors and Executive Officers: |
|
||||||
Guido Baechler, Chief Executive Officer, Director(3) |
488,432 |
4.0 |
% |
3.6% |
|||
William Caragol, Chief Financial Officer(4) |
77,975 |
0.6 |
% |
0.6% |
|||
Dr. Moritz Eidens, Chief Science Officer, Director(5) |
1,007,615 |
8.3 |
% |
7.4% |
|||
Alberto Libanori, Director |
— |
— |
|
||||
Hans Hekland, Director(6) |
821,427 |
6.8 |
% |
6.1% |
|||
Philipp Freese, Chief Operating Officer(7) |
243,239 |
2.0 |
% |
1.8% |
|||
Nicole Holden, Director |
— |
— |
|
||||
Directors and Executive Officers as a Group (Seven Persons) |
2,638,637 |
21.0 |
% |
18.8% |
|||
|
|||||||
Other 5% or more Shareholders: |
|
||||||
Kreditanstalt für Wiederaufbau(8) |
1,237,501 |
10.3 |
% |
9.2% |
|||
Coloalert AS(3) |
821,427 |
6.8 |
% |
6.1% |
____________
(1) Based on 12,010,000 ordinary shares outstanding.
(2) Excludes any ordinary shares that may be issued if the underwriter exercises its options to cover over allotments.
(3) Includes 233,925 ordinary shares underlying options that may be exercised within the next 60 days.
(4) Includes 77,975 ordinary shares underlying options that may be exercised within the next 60 days.
(5) Includes 116,963 ordinary shares underlying options that may be exercised within the next 60 days.
(6) Hans Hekland has dispositive and voting control over the shares held by ColoAlert AS.
(7) Includes 116,963 ordinary shares underlying options that may be exercised within the next 60 days.
(8) Kreditanstalt für Wiederaufbau (known as KfW) is a public law institution (Anstalt des öffentlichen Rechts) serving domestic and international public policy objectives of the Federal Government of the Federal Republic of Germany.
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Apart from the employment and consulting agreements described elsewhere in this prospectus and the agreements with ColoAlert AS (one of our directors is a director and controlling shareholder of ColoAlert AS) described below under “Material Agreements”, we have not entered into any material transactions with our directors, officers, promoters and shareholders or who beneficially own more than 10% of our ordinary shares (or their immediate family members). We have the following arrangements with immediate family members of related parties that we consider to be arms’-length and immaterial: (i) we have a services arrangement with the wife of our Chief Operating Officer whereby we pay her approximately €5,400 per year, (ii) we have an employment agreement with the wife of our Chief Science Officer whereby we pay her approximately €42,000 per year and (iii) we have entered into a loan agreement with the father of our Chief Science Officer whereby a €50,000 loan bearing 6% annual interest is due on January 31, 2023.
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We set out below, other than those agreements discussed in the sections of this prospectus entitled “Related-Party Agreements,” “Executive Compensation — Executive Compensation Agreements” and “Business — Property, Plant and Equipment”, those material agreements that we have entered into outside of our ordinary course of business in the past three years.
Contribution Agreement
On September 20, 2021, we acquired PharmGenomics GmbH (“PharmGenomics”) pursuant to the terms of a Contribution Agreement. Under the Contribution Agreement, we acquired all of the outstanding shares of PharmGenomics in exchange for 6,000,000 of our ordinary shares at a deemed valuation of $2.00 per share. The ordinary shares issued to the shareholders of PharmGenomics equaled approximately 62% of our outstanding shares on the date of issuance. Under the Contribution Agreement, we were to establish prior to the closing of our initial public offering an equity incentive plan for a number of shares not to exceed 12% of our issued and outstanding stock. Additionally, under the Contribution Agreement we agreed not to terminate or relocate the business without the consent of each subsidiary of S-Innovations-Beteiligungsfinanzierungsgesellschaft Rheinland-Pfalz mbH, a company with limited liability under German law, that is a currently a shareholder or creditor of PharmGenomics for so long as such subsidiary remains a shareholder or creditor.
ColoAlert License and Development Agreement
On January 1, 2019, we entered into a License and Development Agreement (as amended, the “License Agreement”) with ColoAlert AS whereby we were granted an exclusive, global sub-license to manufacture, market, and sublicense the ColoAlert CRC screening test. In 2017, ColoAlert AS obtained an exclusive license for the ColoAlert CRC screening test from Norda ASA. Under the License Agreement, ColoAlert AS has also engaged us to co-operate and further develop ColoAlert AS’s technology.
In consideration of the exclusive license, we will pay ColoAlert AS (i) a fee of €5 per sample analyzed, payable at the end of each quarter and (ii) a quarterly profit split in which ColoAlert AS receives 50% of the profit from ColoAlert tests (the “Profit Split”).
Either party has the right to terminate the Agreement in the event (i) a material breach is not cured within 30 days of notice; (ii) the other party enters into liquidation (other than for an amalgamation or reconstruction) or if a petition of bankruptcy is filed against either party and not dismissed within 60 days; and (iii) the other party is adjudicated bankrupt or insolvent. Furthermore, ColoAlert shall have the right to terminate the Agreement if the Profit Split is less than for each quarter (i) from January 1, 2020, to December 31, 2022, €25,000 and (ii) thereafter €250,000.
Option to Purchase Intellectual Property Assets
In February 2021, we entered into an Option to Purchase Intellectual Property Assets (the “Option Agreement”) with ColoAlert and Norda ASA (together the “Optionors”), whereby we were granted the option to acquire the intellectual property related to ColoAlert (the “ColoAlert IP”) within a three-year term. The intellectual property that we may acquire pursuant to the Option Agreement are trade secrets and no patents or patents pending currently exist in connection with such intellectual property. The Company believes that its future research and development activities related to ColoAlert, PancAlert and GenoStrip may lead to patent filings in the future.
Pursuant to the Option Agreement, we may purchase the ColoAlert IP in exchange for (i) €2,000,000 in cash or (ii) €4,000,000 to be paid in our ordinary shares. In the event that we exercise the option for cash, ColoAlert AS has the option to have us instead pay this amount in our ordinary shares.
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Silent Partnership Agreements
We have entered into various silent partnership agreements with different investors as described below:
• In 2020, we entered into a Silent Partnership Agreement to borrow €499,400. Prior to December 31, 2020, we borrowed €299,400 and during the six months ended June 30, 2021, we borrowed the remaining €200,000 that we are to repay by December 31, 2025. We are required to a minimum of 3% interest per annum on the loans, and in addition, until maturity the lenders are entitled to 3% of our net income in each fiscal year that we are profitable. Upon the amounts coming due, the lenders have the option to demand an additional payment equal to 15% of the contribution as a final remuneration;
• In 2020, we borrowed €50,000 under silent partnership agreements that we are to repay by June 30, 2025. We are required to pay a minimum of 3.5% interest per annum on the loans, and in addition until maturity the lenders are entitled to 0.5% of our net income in each year that we are profitable;
• Between the years of 2013 to 2016, we entered into silent partnership agreements for loans totaling €798,694 (of which $398,634 matures by June 30, 2023 and $400,000 that matures on December 31, 2025). We must pay a minimum of 8.5% interest per annum on the loans, and in addition until maturity the lenders are entitled to 1.66% of our net income in each year that are profitable. At maturity, the lenders have the option to demand an additional payment equal to 30% of the principal of the loans;
• In 2010, we entered into a silent partnership agreement to borrow €300,000 that we are to repay January 31, 2023. We must pay a minimum of 8% interest per annum on the loan, and in addition until maturity the lender is entitled to 1.95% of our net income in each that we are profitable. At maturity, the lender has the option to demand an additional payment of up to 30% of the principal of the loan.
Technology Rights Agreement for the UdeS Biomarkers
In January 2022, we entered into a Technology Rights Agreement with Socpra Sciences Santé Et Humaines S.E.C. (“TTS”) related to the UdeS Biomarkers. Pursuant to the agreement, we acquired an exclusive unilateral option to acquire an exclusive license to the UdeS Biomarkers in exchange for a payment of €10,000 and an agreement to pay for the prosecution and maintenance of certain intellectual property relating to the UdeS Biomarkers. The option to license the technology is for one year, which period can be extended at our sole discretion for six additional months (the “Option Period”).
We have a license during the Option Period to use the UdeS Biomarkers to further analyze their sensitivity and specificity. Depending on positive results from these further studies, we intend to exercise the option to license the UdeS Biomarkers for future integration into ColoAlert. If we exercise the option, we will pay the licensor a royalty on all products incorporating the UdeS Biomarkers and we will pay for the prosecution and maintenance of patents relating to the UdeS Biomarkers.
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Our ordinary shares began trading on the Nasdaq Capital Market on November 4, 2021 under the symbol “MYNZ”. From then until January 20, 2022, the closing price of our ordinary shares has ranged from a low of $8.05 to a high of $26.69.
SECURITIES ELIGIBLE FOR FUTURE SALE
Ordinary shares
Upon completion of this offering, we will have 13,510,000 ordinary shares outstanding (or 13,735,000 if the underwriter exercises its over-allotment option in full). We granted up to 1,484,650 options under the 2021 Omnibus Incentive Plan, which options will vest between November 9, 2022 and November 9, 2025 and had outstanding warrants exercisable into 3,745,000 ordinary shares.
All of the ordinary shares sold in this offering will be freely transferable by persons other than by our “affiliates” without restriction or further registration under the Securities Act. All of the ordinary shares sold in by the selling shareholders will be freely transferable without restriction or further registration under the Securities Act. Sales of substantial amounts of our ordinary share in the public market could adversely affect prevailing market prices of our ordinary share.
Rule 144
In general, under Rule 144 as currently in effect, once we have been subject to public company reporting requirements for at least 90 days, a person who is not deemed to have been one of our affiliates for purposes of the Securities Act 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 our affiliates, is entitled to sell those shares without complying with the manner of sale, volume limitation or notice provisions of Rule 144, subject to compliance with the public information requirements of Rule 144. If such a person has beneficially owned the shares proposed to be sold for at least one year, including the holding period of any prior owner other than our affiliates, then that person is entitled to sell those shares without complying with any of the requirements of Rule 144.
In general, under Rule 144, as currently in effect, our affiliates or persons selling shares on behalf of our affiliates are entitled to sell within any three-month period beginning 90 days after the date of this prospectus, a number of shares that does not exceed the greater of:
• 1% of the number of ordinary shares then outstanding, which will equal 135,100 shares immediately after this initial public offering (assuming no exercise of the over-allotment option), or
• the average weekly trading volume of the ordinary shares during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such sale.
Sales under Rule 144 by our affiliates or persons selling shares on behalf of our affiliates are also subject to certain manner of sale provisions and notice requirements and to the availability of current public information about us.
Rule 701
In general, under Rule 701 as currently in effect, any of our employees, consultants or advisors who purchase shares from us in connection with a compensatory stock or option plan or other written agreement in a transaction before the effective date of our initial public offering that was completed in reliance on Rule 701 and complied with the requirements of Rule 701 will be eligible to resell such shares 90 days after the date of this prospectus in reliance on Rule 144, but without compliance with certain restrictions, including the holding period, contained in Rule 144.
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ARTICLES OF ASSOCIATION OF OUR COMPANY
The following description of our Articles of Association is intended as a summary only and does not constitute legal advice regarding those matters and should not be regarded as such. The description is qualified in its entirety by reference to the complete text of the articles of association.
Overview
We were incorporated on March 8, 2021 as a private limited liability company (besloten vennootschap met beperkte aansprakelijkheid) under Dutch law, and on November 9, 2021 we converted into a Dutch public company with limited liability (naamloze vennootschap).
We are registered in the Commercial Register of the Chamber of Commerce (Kamer van Koophandel) in the Netherlands under number 82122571. We have our corporate seat is in Amsterdam, the Netherlands and our registered office is at Robert-Koch Strasse 50, 55129 Mainz, Federal Republic of Germany.
The ordinary shares to be sold in this offering will be subject to, and will have been created under, Dutch law. Set forth below is a summary of relevant information concerning the material provisions of our articles of association and applicable Dutch law.
Board of Directors
We have a one-tier board structure. Upon the closing of the offering, the board of directors of the Company (the “Board of Directors”) will consist of two executive directors and three non-executive directors. The Board of Directors shall consist of such number of executive Directors as the Board of Directors may determine.
The Board of Directors will be charged with the management of the company. In fulfilling their duties, our directors will serve the interest of the company and the business connected with it. The executive directors and the executive committee are charged with the day-to-day management of the company. Supervision of the fulfilment of duties by the executive directors and of the general course of the company’s affairs and the business connected with it will primarily be carried out by the non-executive directors. The executive directors must in due time provide the non-executive directors with the information they need to carry out their duties.
Our directors will be elected by the general meeting upon a binding nomination. The Board of Directors will be authorized to nominate one or more director candidates for appointment at the general meeting. Shareholders who individually or jointly represent at least 20% of the issued share capital will have the same right to nominate one or more director candidates for appointment at the general meeting. The general meeting may at all times overrule the binding nature of each nomination by a resolution adopted by a majority of at least two thirds of the votes cast, representing more than half of the issued share capital.
The general meeting may at any time suspend and dismiss a non-executive director or executive director. The general meeting may only adopt a resolution to suspend or dismiss a non-executive director or executive director by a majority of at least two thirds of the votes cast, representing more than half of the issued share capital, unless the resolution is adopted on the basis of a proposal of the Board of Directors.
Authorized Share Capital
Our authorized share capital consists of 45,000,000 ordinary shares with a nominal value of EUR 0.01 per share and 5,000,000 preferred shares with a nominal value of EUR 0.01 per share. The preferred shares are divided into five series, each consisting of 1,000,000 preferred shares. Currently there are no preferred shares outstanding.
The number of ordinary shares included in the authorized share capital may be decreased and the number of preferred shares included in the authorized share capital may be increased pursuant to a resolution of the Board of Directors by a number not exceeding the number of ordinary shares included in the authorized share capital which have not been issued and which are not subject to any rights to subscribe for ordinary shares.
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The preferred shares may, at the request of the holder, be converted into ordinary shares. The conditions for conversion and the further terms and conditions related to the preferred shares will be determined by our Board of Directors, subject to the prior approval of our general meeting and the meeting of holders of the series of preferred shares concerned, if such series of preferred shares has been issued and are held by persons other than us. The preceding sentence applies by analogy to any adjustment to the conditions.
Issuance of shares
Under Dutch law, shares are issued and rights to subscribe for shares are granted pursuant to a resolution of our general meeting. Our articles of association provide that the general meeting may only resolve to issue shares upon the proposal of our Board of Directors. The general meeting may authorize the Board of Directors to issue new ordinary shares or grant rights to subscribe for ordinary shares. The authorization can be granted and extended, in each case for a period not exceeding five years. For as long as, and to the extent, that such authorization is effective, our general meeting will not have the power to issue ordinary shares.
A resolution of the general meeting has irrevocably authorized our Board of Directors until November 9, 2026, to issue ordinary shares and preferred shares up to the amount of the authorized share capital (from time to time).
Preemptive Rights
Subject to restrictions in our articles of association, holders of ordinary shares have preemptive rights in relation to newly issued ordinary shares under Dutch law.
Under our articles of association, the preemptive rights in respect of newly issued ordinary shares may be restricted or excluded by a resolution of our general meeting, which resolution requires a two-thirds majority of the votes cast if less than half of the issued share capital is present or represented at the meeting. The general meeting may authorize our Board of Directors to limit or exclude the preemptive rights in respect of newly issued ordinary shares. Such authorization for our Board of Directors can be granted and extended, in each case for a period not exceeding five years.
A resolution of the general meeting has irrevocably authorize our Board of Directors until November 9, 2026 to limit or exclude preemptive rights on ordinary shares.
Preemptive rights do not exist with respect (a) to the issue of ordinary shares or grant of rights to subscribe for ordinary shares to our employees or a “group” company of ours, (b) the issue of ordinary shares against a contribution other than cash, and (c) preferred shares to be issued. A holder of preferred shares has no preemptive right to acquire newly issued ordinary shares.
Transfer of Ordinary Shares
Under Dutch law, transfers of ordinary shares (other than in book-entry form) require a written deed of transfer and, unless the company is a party to the deed of transfer, and acknowledgement by or proper service upon the company to be effective.
Our articles of association provide that, if one or more ordinary shares or preferred shares are admitted to trading on Nasdaq or any other regulated foreign stock exchange located in the United States the laws of the State of New York will apply to the property law aspects of the ordinary shares and preferred shares included in the part of the register of shareholders kept by the relevant transfer agent.
Form of Ordinary Shares
Pursuant to our articles of association, the ordinary shares and preferred shares are in registered form.
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Purchase and Repurchase of Ordinary Shares
Under Dutch law, we may not subscribe for newly issued ordinary shares. We may acquire ordinary shares, subject to applicable provisions and restrictions of Dutch law and our articles of association, to the extent that:
• such ordinary shares are fully paid-up;
• such repurchase would not cause our shareholders’ equity to fall below an amount equal to the sum of the paid-up and called-up part of the issued share capital and the reserves we are required to maintain pursuant to Dutch law or our articles of association; and
• immediately after the acquisition of such ordinary shares, we and our subsidiaries would not hold, or would not hold as pledgees, shares having an aggregate nominal value that exceeds 50% of our issued share capital.
Other than ordinary shares acquired for no valuable consideration or under universal title of succession (onder algemene titel) (e.g., through a merger or spin off) under statutory Dutch or other law, we may acquire ordinary shares only if our general meeting has authorized our Board of Directors to do so. An authorization by our general meeting for the acquisition of ordinary shares can be granted for a maximum period of 18 months. Such authorization must specify the number of ordinary shares that may be acquired, the manner in which these shares may be acquired and the price range within which the shares may be acquired. No authorization of our general meeting is required if ordinary shares are acquired by us on Nasdaq with the intention of transferring such ordinary shares to our employees or employees of a group company pursuant to an arrangement applicable to them. For each annual general meeting, we expect that our Board of Directors, will place on the agenda a proposal to re-authorize our Board of Directors to repurchase shares for a period of 18 months from the date of the resolution. We cannot derive any right to any distribution from ordinary shares, or voting rights attached to ordinary shares acquired by it.
A resolution of the general meeting has irrevocably authorized our Board of Directors for a period of 18 months to resolve for us to acquire fully paid-up ordinary shares up to the maximum number of ordinary shares permitted pursuant to the law and our articles of association from time to time, through privately negotiated repurchases, in self-tender offers, or through accelerated repurchase arrangements, at prices ranging from the nominal value of the ordinary shares up to one hundred and ten percent (110%) of the market price of ordinary shares, provided that (i) for open market or privately negotiated repurchases, the market price will be the last closing price for ordinary shares on the Nasdaq Stock Market prior to the transaction, (ii) for self-tender offers, the market price will be the volume weighted average price for the ordinary shares on the Nasdaq Capital Market during a period, determined by the Board of Directors, of no less than one and no more than five consecutive trading days immediately prior to the expiration of the tender offer, and (iii) for accelerated repurchase arrangements, the market price will be the volume weighted average price of the ordinary shares on the Nasdaq Capital Market over the term of the arrangement. The volume weighted average price for any number of trading days will be calculated as the arithmetic average of the daily volume weighted average price on those trading days.
Pursuant to a resolution of the general meeting dated November 1, 2021, our Board of Directors is furthermore irrevocably authorized for a period of 18 months, commencing on November 9, 2021, to resolve for us to acquire fully paid up preferred shares up to the maximum number of preferred shares permitted pursuant to the law and our articles of association from time to time and that preferred shares may be acquired through privately negotiated repurchases, in self-tender offers, or through accelerated repurchase arrangements, at prices ranging from the nominal value of the preferred shares up to the higher of (i) the amount that would be paid by us upon cancellation of such preferred shares in accordance with the relevant provisions of our articles of association and (ii) one hundred and ten percent (110%) of the market price of the ordinary shares into which the preferred shares may be converted in accordance with the applicable provisions of our articles of association, whereby the market price shall be determined in the manner as set out in our articles of association.
Capital Reduction
At a general meeting, our shareholders may resolve on the proposal of our Board of Directors to reduce our issued share capital by (i) cancelling ordinary shares and preferred shares or (ii) reducing the nominal value of the ordinary shares and preferred shares by amending our articles of association. In either case, this reduction would be subject to applicable statutory provisions. A resolution to cancel shares may only relate to (i) shares held by us or in respect of which we hold the depository receipts, or (ii) all preferred shares of a particular series. In order to be approved by our
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general meeting, a resolution to reduce the capital requires approval of a majority of the votes cast at a general meeting if at least half of the issued share capital is represented at such meeting or at least two thirds of the votes cast, if less than half of the issued share capital is represented at such meeting.
Reduction of the nominal value of shares without repayment shall be effected proportionally to all ordinary shares and preferred shares. The requirement of proportionality may be waived by agreement of all shareholders concerned.
A resolution that would result in a reduction of capital requires approval by a majority of the votes cast of each group of shareholders of the same class whose rights are prejudiced by the reduction. In addition, a reduction of capital involves a two-month waiting period during which creditors have the right to object to a reduction of capital under specified circumstances.
General Meeting
General meetings are held in Amsterdam, Rotterdam, The Hague, Arnhem, Utrecht, or in the municipality of Haarlemmermeer (Schiphol Airport), the Netherlands. All of our shareholders and others entitled to attend our general meetings are authorized to address the meeting and, in so far as they have such right, to vote, either in person or by proxy.
We will hold at least one general meeting each year, to be held within six months after the end of its financial year. A general meeting will also be held within three months after our Board of Directors has determined it to be likely that our equity has decreased to an amount equal to or lower than half of its paid up and called up capital, in order to discuss the measures to be taken if so required. If our Board of Directors fails to hold such general meeting in a timely manner, each shareholder and other person entitled to attend our general meeting may be authorized by the Dutch court to convene our general meeting.
Our Board of Directors may convene additional extraordinary general meetings at its discretion, subject to the notice requirements described below. Pursuant to Dutch law, one or more shareholders and/or others entitled to attend general meetings of shareholders, alone or jointly representing at least 10% of our issued share capital, may on their application be authorized by the Dutch court to convene a general meeting. The Dutch court will disallow the application if (i) the applicants have not previously requested in writing that our Board of Directors convenes a shareholders’ meeting or (ii) our Board of Directors convenes a shareholders’ meeting or (ii) our Board of Directors has not taken the necessary steps so that the shareholders’ meeting could be held within six weeks after such request.
The general meeting is convened by a notice, which includes an agenda stating the items to be discussed and the location and time of our general meeting. For the annual general meeting the agenda will include, among other things, the adoption of our annual accounts, the appropriation of its profits or losses and proposals relating to the composition of and filling of any vacancies on Board of Directors. In addition, the agenda for a general meeting includes such additional items as determined by our Board of Directors. Pursuant to Dutch law, one or more shareholders and/or others entitled to attend general meetings of shareholders, alone or jointly representing at least 3% of the issued share capital, have the right to request the inclusion of additional items on the agenda of shareholders’ meetings. Such requests must be made in writing, and may include a proposal for a shareholder resolution, and must be received by us no later than on the 60th day before the day the relevant shareholders’ meeting is held. Under our articles of association, certain items can only be put on the agenda as a voting item by our Board of Directors. Shareholders meeting the relevant requirements may still request the inclusion of such items on the agenda as a discussion item.
We will give notice of each general meeting by publication on its website and, to the extent required by applicable law, in a Dutch daily newspaper with national distribution, and in any other manner that we may be required to follow in order to comply with Dutch law and applicable stock exchange and SEC requirements. We will observe the statutory minimum convening notice period for a general meeting. Holders of registered shares may further be provided notice of the meeting in writing at their addresses as stated in its shareholders’ register.
Pursuant to our articles of association and Dutch law, our Board of Directors may determine a record date (registratiedatum) of 28 calendar days prior to a general meeting to establish which shareholders and others with meeting rights are entitled to attend and, if applicable, vote at our general meeting. The record date, if any, and the manner in which shareholders can register and exercise their rights will be set out in the notice of our general meeting. Our articles of association provide that a shareholder must notify us in writing of his or her intention to attend (or be represented at) our general meeting, such notice to be received by us on the date set by our Board of Directors in accordance with our articles of association and as set forth in the convening notice.
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Our general meeting will be presided over by the chairman of our Board of Directors, who, nevertheless, may charge another person to preside over the meeting in his place even if he or she is present at the meeting. If the chairman of our Board of Directors is absent and he or she has not charged another person to preside over the meeting in his or her place, the directors present at the meeting will appoint one of them to be chairman. In the absence of all directors, our general meeting will appoint its chairman.
Voting Rights and Quorum
In accordance with Dutch law and our articles of association, each ordinary share, irrespective of which class it concerns, confers the right on the holder thereof to cast one vote at our general meeting. The voting rights attached to any ordinary shares held by us or our direct or indirect subsidiaries are suspended, unless the ordinary shares were encumbered with a right of usufruct or a pledge in favor of a party other than us or a direct or indirect subsidiary before such ordinary shares were acquired by us or such a subsidiary, in which case, the other party may be entitled to exercise the voting rights on the ordinary shares. We may not exercise voting rights for ordinary shares in respect of which its or a direct or indirect subsidiary has a right of usufruct or a pledge.
Voting rights may be exercised by shareholders or by a duly appointed proxy holder (the written proxy being acceptable to the chairman of our general meeting) of a shareholder, which proxy holder need not be a shareholder. The holder of a usufruct or pledge on shares will have the voting rights attached thereto if so provided for when the usufruct or pledge was created.
Under our articles of association, blank votes (votes where no choice has been made), abstentions and invalid votes will not be counted as votes cast. However, shares in respect of which a blank vote or invalid vote has been cast and shares in respect of which the person with meeting rights who is present or represented at the meeting has abstained from voting are counted when determining the part of the issued share capital that is present or represented at a general meeting. The chairman of our general meeting will determine the manner of voting and whether voting may take place by acclamation.
Resolutions of the shareholders are adopted at a general meeting by an absolute majority of votes cast, except where Dutch law or our articles of association provide for a special majority in relation to specified resolutions. Our articles of association do not provide for a quorum requirement, subject to any provision of mandatory Dutch law.
Subject to certain restrictions in our articles of association, the determination during our general meeting made by the chairman of that general meeting with regard to the results of a vote will be decisive. Our Board of Directors will keep a record of the resolutions passed at each general meeting.
Amendment of Articles of Association
At a general meeting, at the proposal of our Board of Directors, our general meeting may resolve to amend the articles of association. A resolution by the shareholders to amend the articles of association requires an absolute majority of the votes cast.
Dissolution and liquidation
Our shareholders may at a general meeting, based on a proposal by our Board of Directors, by means of a resolution passed by an absolute majority of the votes cast resolve that the Company will be dissolved. In the event of dissolution of the company, the liquidation will be effected by our executive directors, under the supervision of our non-executive directors, unless our general meeting decides otherwise.
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Certain Other Major Transactions
Our articles of association and Dutch law provide that resolutions of our Board of Directors concerning a material change in our identity, character or business are subject to the approval of our general meeting. Such changes include:
• a transfer of all or materially all of its business to a third party;
• the entry into or termination of a long-lasting alliance of the company or of a subsidiary either with another entity or company, or as a fully liable partner of a limited partnership or partnership, if this alliance or termination is of significant importance to the company; and
• the acquisition or disposition of an interest in the capital of a company by the company or by its subsidiary with a value of at least one third of the value of our assets, according to the balance sheet with explanatory notes or, if the company prepares a consolidated balance sheet, according to the consolidated balance sheet with explanatory notes in our most recently adopted annual accounts.
Dividends and Other Distributions
The company may only make distributions to its shareholders if its equity exceeds the aggregate amount of the issued share capital and the reserves which must be maintained pursuant to Dutch law.
Under our articles of association, any profits or distributable reserves must first be applied to pay a dividend on the preferred shares, if outstanding. Any amount remaining out of distributable profits is added to our reserves as our Board of Directors determines. After reservation by our Board of Directors of any distributable profits, our general meeting will be authorized to declare distributions on the proposal of our Board of Directors. Our Board of Directors is permitted, to declare interim dividends without the approval of the shareholders. Interim dividends may be declared as provided in our articles of association and may be distributed to the extent that the shareholders’ equity, based on interim financial statements, exceeds the paid-up and called-up share capital and the reserves that must be maintained under Dutch law or our articles of association. We may reclaim any distributions, whether interim or not interim, made in contravention of certain restrictions of Dutch law from shareholders that knew or should have known that such distribution was not permissible. In addition, on the basis of Dutch case law, if after a distribution we are not able to pay its due and collectable debts, then our shareholders or directors who at the time of the distribution knew or reasonably should have foreseen that result may be liable to its creditors.
The general meeting may determine that distributions will be made in whole or in part in the form of shares or a currency other than the Euro, provided on the proposal of the Board of Directors. The Company shall announce any proposal for a distribution and the date when and the place where the distribution will be payable to all shareholders by electronic means of communication with due observance of the applicable law and stock exchange rules. Claims for payment of dividends and other distributions not made within five years from the date that such dividends or distributions became payable will lapse, and any such amounts will be considered to have been forfeited to the company (verjaring).
Transfer Agent
We have appointed Transhare Corporation as the transfer agent for our ordinary shares. Transhare Corporation’s telephone number and address is (303) 662-1112 and 17755 US Hwy 19 N, Clearwater, FL 33764.
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MATERIAL INCOME TAX INFORMATION
Material Dutch Tax Income Tax Considerations
The following are the material Dutch tax consequences of the acquisition, ownership and disposal of our ordinary shares, and, to the extent it relates to legal conclusions under current Dutch tax law. This does not purport to set forth all possible tax considerations or consequences that may be relevant to all categories of investors, some of which may be subject to special treatment under applicable law (such as trusts or other similar arrangements), and in view of its general nature, it should be treated with corresponding caution. Holders or prospective holders of ordinary shares should consult with their tax advisors with regard to the tax consequences of investing in the ordinary shares in their particular circumstances.
Please note that this section does not set forth the tax considerations for:
• Holders of ordinary shares if such holders, and in the case of individuals, his/her partner or certain relatives by blood or marriage in the direct line (including foster children), have a substantial interest (aanmerkelijk belang) or a deemed substantial interest (fictief aanmerkelijk belang) in us under the Dutch Income Tax Act 2001 (Wet inkomstenbelasting 2001). A holder of ordinary shares in a company is considered to hold a substantial interest in such company if such holder alone or, in the case of individuals, together with his/her partner (as defined in the Dutch Income Tax Act 2001), directly or indirectly holds (i) an interest of 5% or more of the total issued and outstanding capital of that company or of 5% or more of the issued and outstanding capital of a certain class of shares of that company; or (ii) rights to acquire, directly or indirectly, such interest; or (iii) certain profit sharing rights in that company that relate to 5% or more of the company’s annual profits and/or to 5% or more of the company’s liquidation proceeds. A deemed substantial interest may arise if a substantial interest (or part thereof) in a company has been disposed of, or is deemed to have been disposed of, on a non-recognition basis;
• A holder of ordinary shares that is not an individual for which its shareholdings qualify or qualified as a participation (deelneming) for purposes of the Dutch Corporate Income Tax Act 1969 (Wet op de vennootschapsbelasting 1969). A taxpayer’s shareholding of 5% or more in a company’s nominal paid-up share capital (or, in certain cases, in voting rights) qualifies as a participation. A holder may also have a participation if such holder does not have a shareholding of 5% or more but a related entity (verbonden lichaam) has a participation or if the company in which the shares are held is a related entity (verbonden lichaam);
• Holders of ordinary shares who are individuals for whom the ordinary shares or any benefit derived from the ordinary shares are a remuneration or deemed to be a remuneration for (employment) activities performed by such holders or certain individuals related to such holders (as defined in the Dutch Income Tax Act 2001); and
• Pension funds, investment institutions (fiscale beleggingsinstellingen), exempt investment institutions (vrijgestelde beleggingsinstellingen) and other entities that are, in whole or in part, not subject to or exempt from corporate income tax in the Netherlands, as well as entities that are exempt from corporate income tax in their country of residence, such country of residence being another state of the European Union, Norway, Liechtenstein, Iceland or any other state with which the Netherlands have agreed to exchange information in line with international standards.
Except as otherwise indicated, this section only addresses Dutch national tax legislation and published regulations, whereby the Netherlands and Dutch law means the part of the Kingdom of the Netherlands located in Europe and its law, respectively, as in effect on the date hereof and as interpreted in published case law until this date, without prejudice to any amendment introduced (or to become effective) at a later date and/or implemented with or without retroactive effect. The applicable tax laws or interpretations thereof may change, or the relevant facts and circumstances may change, and such changes may affect the contents of this section, which will not be updated to reflect any such changes.
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Dividend Withholding Tax
Holders of ordinary shares are generally subject to Dutch dividend withholding tax at a rate of 15% on dividends distributed by us. We are required to withhold such Dutch dividend withholding tax at source (which dividend withholding tax will not be borne by us but will be withheld by us from the gross dividends paid on the ordinary shares). However, as long as we continue to have our place of effective management in Germany, and not in the Netherlands, we will be considered to be solely tax resident in Germany for purposes of the Convention between the Federal Republic of Germany and the Netherlands for the avoidance of double taxation and prevention of fiscal evasion with respect to taxes on income (the “German-Dutch tax treaty”), and we will in principle not be required to withhold Dutch dividend withholding tax. This exemption from withholding Dutch dividend withholding tax may not apply to dividends distributed by us to a holder who is resident or deemed to be resident in the Netherlands for Dutch income tax purposes or Dutch corporate income tax purposes or to holders of ordinary shares that are neither resident nor deemed to be resident of the Netherlands if the ordinary shares are attributable to a Dutch permanent establishment of such non-resident holder, in which case the following paragraph applies.
Dividends distributed by us to individuals and corporate legal entities who are resident or deemed to be resident in the Netherlands for Dutch (corporate) income tax purposes (“Dutch Resident Individuals” and “Dutch Resident Entities,” as the case may be) or to holders of ordinary shares that are neither resident nor deemed to be resident of the Netherlands if the ordinary shares are attributable to a Dutch permanent establishment of such non-resident holder are generally subject to Dutch dividend withholding tax at a rate of 15%. The expression “dividends distributed” include, but are not limited to:
• Distributions in cash or in kind, deemed and constructive distributions and repayments of paid-in capital not recognized for Dutch dividend withholding tax purposes;
• Liquidation proceeds, proceeds of redemption of shares, or proceeds of the repurchase of shares by us or one of our subsidiaries or other affiliated entities to the extent such proceeds exceed the average paid-in capital of those shares as recognized for purposes of Dutch dividend withholding tax, unless, in case of a repurchase, a particular statutory exemption applies;
• An amount equal to the par value of shares issued or an increase of the par value of shares, to the extent that it does not appear that a contribution, recognized for purposes of Dutch dividend withholding tax, has been made or will be made; and
• Partial repayment of the paid-in capital, recognized for purposes of Dutch dividend withholding tax, if and to the extent that we have net profits (zuivere winst), unless the holders of shares have resolved in advance at a general meeting to make such repayment and the par value of the shares concerned has been reduced by an equal amount by way of an amendment of our articles of association. The term “net profits” includes anticipated profits that have yet to be realized.
Dutch Resident Individuals and Dutch Resident Entities may credit the Dutch dividend withholding tax against their income tax or corporate income tax liability (maximized to the amount of corporate income tax due in that financial year) or may under certain circumstances be entitled to an exemption. The same applies to holders of ordinary shares that are neither resident nor deemed to be resident of the Netherlands if the shares are attributable to a Dutch permanent establishment of such non-resident holder. Depending on their specific circumstances, holders of ordinary shares that are resident in a country other than the Netherlands, may be entitled to exemptions from, reduction of, or full or partial refund of, Dutch dividend withholding tax pursuant to Dutch law, EU law or treaties for avoidance of double taxation.
On November 2, 2021, the Dutch Parliament adopted a proposal of law to which an alternative withholding tax (the “Alternative Dividend Withholding Tax”) will be imposed on dividends paid to related entities in designated low-tax jurisdictions and in certain abusive situations, effective January 1, 2024. The Alternative Dividend Withholding Tax may be imposed at the highest Dutch corporate income tax rate in effect at the time of the distribution (currently 25.8%), if the shareholder entitled to those dividend payments has such an interest in us, possibly as part of a cooperating group, that such party can exert such influence on our decisions as to determine our activities, while that shareholder is established in a jurisdiction that is included in the Regulation of low-taxing countries and non-cooperative jurisdictions for tax purposes (Regeling laagbelastende staten en niet-coöperatieve rechtsgebieden voor belastingdoeleinden), or has a relevant connection therewith.
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However, as long as we continue to have our place of effective management in Germany, and not in the Netherlands, we will be considered to be solely tax resident in Germany for purposes of the German-Dutch tax treaty, and we will in principle not be required to withhold the Alternative Dividend Withholding Tax.
Pursuant to legislation to counteract “dividend stripping,” a reduction, exemption, credit or refund of Dutch dividend withholding tax is not granted if the recipient of the dividend is not the beneficial owner (uiteindelijk gerechtigde) as described in the Dutch Dividend Withholding Tax Act 1965 (Wet op de dividendbelasting 1965) of such dividends. This legislation targets situations in which a shareholder retains its economic interest in shares but reduces the withholding tax costs on dividends by a transaction with another party. It is not required for these rules to apply that the recipient of the dividends is aware that a dividend stripping transaction took place. The Dutch State Secretary of Finance takes the position that the definition of beneficial ownership introduced by this legislation will also apply in the context of a double taxation convention.
Taxes on Income and Capital Gains
Dutch Resident Individuals
If a holder of ordinary shares is a Dutch Resident Individual, any benefit derived or deemed to be derived from the shares is taxable at the progressive income tax rates, if:
(i) the ordinary shares are attributable to an enterprise from which the Dutch Resident Individual derives a share of the profit, whether as an entrepreneur (ondernemer) or as a person who has a co-entitlement to the net worth (medegerechtigd tot het vermogen) of such enterprise, without being an entrepreneur or a shareholder in such enterprise, as defined in the Dutch Income Tax Act 2001; or
(ii) the holder of the shares is considered to derive benefits from the shares that are taxable as benefits from other activities (resultaat uit overige werkzaamheden), such as activities with respect to the shares that go beyond ordinary asset management (normaal actief vermogensbeheer).
If the above-mentioned conditions (i) and (ii) do not apply to the individual holder of ordinary shares, such Dutch Resident Individual holder will be subject to an annual income tax imposed on a deemed return on the net value of the ordinary shares under the regime for savings and investments (inkomen uit sparen en beleggen). Irrespective of the actual income and capital gains realized, the deemed annual return of the Dutch Resident Individual’s net investment assets that are taxed under this regime, including the ordinary shares, is set at a variable percentage of the net value of the investment assets (with a maximum of 5.53% in 2022). Such fictitious annual return deemed to be derived from the ordinary shares will be taxed at a flat rate of 31% in 2022.
The net value of the investment assets for the year are the fair market value of the investment assets less the allowable liabilities on January 1 of the relevant calendar year. The ordinary shares are included as investment assets. A tax-free allowance of €50,650 is available (2022). For the avoidance of doubt, actual income, capital gains or losses in respect of the ordinary shares are as such not subject to Dutch income tax under the regime for savings and investments (inkomen uit sparen en beleggen). The deemed, variable return will be adjusted annually on the basis of historic market yields.
Dutch Resident Entities
Any benefit derived or deemed to be derived from the shares held by Dutch Resident Entities, including any capital gains realized on the disposal thereof, will be subject to Dutch corporate income tax at a rate of 15% with respect to taxable profits up to €395,000 and 25.8% with respect to taxable profits in excess of that amount (rates and brackets for 2022).
Non-residents of the Netherlands
A holder of ordinary shares that is neither a Dutch Resident Individual nor a Dutch Resident Entity will not be subject to Dutch taxes on income or on capital gains in respect of any payment under shares or any gain realized on the disposal or deemed disposal of the shares, provided that:
• such holder does not have an interest in an enterprise which, in whole or in part, is either effectively managed in the Netherlands or is carried out through a permanent establishment, or a permanent representative in the Netherlands and to which enterprise or part of an enterprise the shares are attributable; and
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• in the event such holder is an individual, such holder does not derive benefits from the shares that are taxable as benefits from other activities in the Netherlands, such as activities in the Netherlands with respect to the shares that go beyond ordinary asset management.
Under certain specific circumstances, Dutch taxation rights may be restricted for a holder of ordinary shares that is neither a Dutch Resident Individual nor a Dutch Resident Entity pursuant to treaties for the avoidance of double taxation.
Gift and Inheritance Taxes
Residents of the Netherlands
Gift or inheritance taxes will arise in the Netherlands with respect to a transfer of the ordinary shares by way of a gift by, or on the death of, a holder of ordinary shares who is resident or deemed to be resident in the Netherlands at the time of the gift or the holder’s death.
Non-residents of the Netherlands
No Dutch gift or inheritance taxes will arise on the transfer of the ordinary shares by way of gift by, or on the death of, a holder of ordinary shares who is neither resident nor deemed to be resident in the Netherlands, unless:
• in the case of a gift of ordinary shares by an individual who at the date of the gift was neither resident nor deemed to be resident in the Netherlands, such individual dies within 180 days after the date of the gift, while being resident or deemed to be resident in the Netherlands; or
• the transfer is otherwise construed as a gift, such as a gift that is made under a condition precedent, or inheritance made by, or on behalf of, a person who, at the time of the gift or death, is or is deemed to be resident in the Netherlands.
For purposes of Dutch gift and inheritance taxes, a person that holds the Dutch nationality will be deemed to be resident in the Netherlands if such person has been resident in the Netherlands at any time during the 10 years preceding the date of the gift or his/her death. Additionally, for purposes of Dutch gift tax, any person, irrespective of his nationality will be deemed to be resident in the Netherlands if such person has been resident in the Netherlands at any time during the 12 months preceding the date of the gift.
Other Taxes and Duties
No Dutch value-added tax (omzetbelasting) and no Dutch registration tax, stamp duty or any other similar documentary tax or duty will be payable by a holder of shares on any payment in consideration for the acquisition, ownership or disposal of the shares.
Material U.S. Federal Income Tax Considerations
The following is a general summary of material U.S. federal income tax considerations applicable to a U.S. Holder (as defined below) arising from the acquisition, ownership and disposition of our securities. This summary applies only to U.S. Holders that acquire securities pursuant to this prospectus, hold our ordinary shares as capital assets within the meaning of Section 1221 of the Code (as defined below) and have the U.S. dollar as their functional currency.
This summary is for general information purposes only and does not purport to be a complete analysis or listing of all potential U.S. federal income tax considerations that may apply to a U.S. Holder as a result of the acquisition, ownership and disposition of our ordinary shares. In addition, this summary does not take into account the individual facts and circumstances of any particular U.S. Holder that may affect the U.S. federal income tax consequences to such U.S. Holder, including specific tax consequences to a U.S. Holder under an applicable tax treaty. Accordingly, this summary is not intended to be, and should not be construed as, legal or U.S. federal income tax advice with respect to any particular U.S. Holder. In addition, this summary does not address the U.S. federal alternative minimum, net investment income, U.S. federal estate and gift, U.S. Medicare contribution, U.S. state and local, or non-U.S. tax consequences of the acquisition, ownership or disposition of our ordinary shares. Except as specifically set forth
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below, this summary does not discuss applicable tax reporting requirements. Each U.S. Holder should consult its own tax advisor regarding all U.S. federal, U.S. state and local and non-U.S. tax consequences of the acquisition, ownership and disposition of our ordinary shares.
No opinion from U.S. legal counsel or ruling from the Internal Revenue Service (the “IRS”) has been requested, or will be obtained, regarding the U.S. federal income tax consequences of the acquisition, ownership or disposition of our ordinary shares. This summary is not binding on the IRS, and the IRS is not precluded from taking a position that is different from, or contrary to, any position taken in this summary. In addition, because the authorities upon which this summary is based are subject to various interpretations, the IRS and the U.S. courts could disagree with one or more of the positions taken in this summary.
The following discussion does not describe all the tax consequences that may be relevant to any particular U.S. Holders, including those subject to special tax situations such as:
• banks and certain other financial institutions;
• regulated investment companies;
• real estate investment trusts;
• insurance companies;
• broker-dealers;
• traders that elect to mark-to-market;
• tax-exempt entities or governmental organizations;
• individual retirement accounts or other tax deferred accounts;
• persons deemed to sell our ordinary shares under the constructive sale provisions of the Code;
• persons liable for alternative minimum tax or the Medicare contribution tax on net investment income;
• U.S. expatriates;
• persons holding our ordinary shares as part of a straddle, hedging, constructive sale, conversion or integrated transaction;
• persons that directly, indirectly, or constructively own 10% or more of the total combined voting power or total value of our ordinary shares;
• persons that are resident or ordinarily resident in or have a permanent establishment in a jurisdiction outside the United States;
• persons who acquired our ordinary shares pursuant to the exercise of any employee share option or otherwise as compensation;
• persons subject to special tax accounting rules as a result of any item of gross income with respect to our ordinary shares being taken into account in an applicable financial statement; or
• persons holding our ordinary shares through partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes.
PROSPECTIVE PURCHASERS ARE URGED TO CONSULT THEIR TAX ADVISORS ABOUT THE APPLICATION OF THE U.S. FEDERAL TAX RULES TO THEIR PARTICULAR CIRCUMSTANCES AS WELL AS THE STATE, LOCAL AND NON-U.S. TAX CONSEQUENCES TO THEM OF THE PURCHASE, OWNERSHIP, AND DISPOSITION OF OUR ORDINARY SHARES.
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As used herein, the term “U.S. Holder” means a beneficial owner of our ordinary shares that, for U.S. federal income tax purposes, is or is treated as:
• an individual who is a citizen or resident of the United States;
• a corporation created or organized in or under the laws of the United States, any state thereof or the District of Columbia;
• an estate whose income is subject to U.S. federal income taxation regardless of its source; or
• a trust that (1) is subject to the supervision of a court within the United States and the control of one or more U.S. persons or (2) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.
The tax treatment of a partner (or other owner) in an entity or arrangement treated as a partnership for U.S. federal income tax purposes that holds our ordinary shares, and such entity or arrangement, generally will depend on such partner’s (or other owner’s) status and the activities of such entity or arrangement. A U.S. Holder that is a partner (or other owner) in such an entity or arrangement should consult its tax advisor.
Dividends and Other Distributions on Our Ordinary shares
Subject to the passive foreign investment company rules discussed below, the gross amount of distributions made by us with respect to our ordinary shares (including the amount of non-U.S. taxes withheld therefrom, if any) generally will be includible as dividend income in a U.S. Holder’s gross income in the year received, to the extent such distributions are paid out of our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Because we do not maintain calculations of our earnings and profits under U.S. federal income tax principles, a U.S. Holder should expect all cash distributions will be reported as dividends for U.S. federal income tax purposes. Such dividends will not be eligible for the dividends-received deduction allowed to U.S. corporations with respect to dividends received from other U.S. corporations.
Dividends received by certain non-corporate U.S. Holders (including individuals) may be “qualified dividend income,” which is taxed at the lower applicable capital gains rate, provided that (1) our ordinary shares are readily tradable on an established securities market in the United States, (2) we are neither a passive foreign investment company (as discussed below) nor treated as such with respect to the U.S. Holder for our taxable year in which the dividend is paid or the preceding taxable year, (3) the U.S. Holder satisfies certain holding period requirements, and (4) the U.S. Holder is not under an obligation to make related payments with respect to positions in substantially similar or related property. Under IRS authority, ordinary shares generally are considered for purposes of clause (1) above to be readily tradable on an established securities market in the United States if they are listed on the Nasdaq Capital Market, as our ordinary shares are expected to be. U.S. Holders should consult their own tax advisors regarding the availability of the lower rate for dividends paid with respect to our ordinary shares.
The amount of any distribution paid in foreign currency will be equal to the U.S. dollar value of such currency, translated at the spot rate of exchange on the date such distribution is actually or constructively received by the U.S. Holder, regardless of whether the payment is in fact converted into U.S. dollars at that time. A U.S. Holder generally should not recognize any foreign currency gain or loss in respect of such distribution if such foreign currency is converted into U.S. dollars on the date received by the U.S. Holder. Any further gain or loss on a subsequent conversion or other disposition of the currency for a different U.S. dollar amount will be U.S. source ordinary income or loss.
Dividends on our ordinary shares generally will constitute foreign source income for foreign tax credit limitation purposes. Subject to certain complex conditions and limitations, non-U.S. taxes withheld, if any, on any distributions on our ordinary shares may be eligible for credit against a U.S. Holder’s U.S. federal income tax liability. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific classes of income. For this purpose, dividends distributed by us with respect to our ordinary shares will generally constitute “passive category income.” The U.S. federal income tax rules relating to foreign tax credits are complex, and U.S. Holders should consult their tax advisors regarding the availability of a foreign tax credit in their particular circumstances and the possibility of claiming an itemized deduction (in lieu of the foreign tax credit) for any foreign taxes paid or withheld.
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Sale or Other Taxable Disposition of Our Ordinary shares
Subject to the passive foreign investment company rules discussed below, upon a sale or other taxable disposition of our ordinary shares, a U.S. Holder will recognize capital gain or loss for U.S. federal income tax purposes in an amount equal to the difference between the amount realized and the U.S. Holder’s adjusted tax basis in such ordinary shares. Any such gain or loss generally will be treated as long-term capital gain or loss if the U.S. Holder’s holding period in ordinary shares exceeds one year. Non-corporate U.S. Holders (including individuals) generally will be subject to U.S. federal income tax on long-term capital gain at preferential rates. The deductibility of capital losses is subject to significant limitations. Gain or loss, if any, recognized by a U.S. Holder on the sale or other taxable disposition of our ordinary shares generally will be treated as U.S. source gain or loss for U.S. foreign tax credit limitation purposes.
If the consideration received upon the sale or other disposition of our ordinary shares is paid in foreign currency, the amount realized will be the U.S. dollar value of the payment received, translated at the spot rate of exchange on the date of the sale or other taxable disposition. If our ordinary shares are treated as traded on an established securities market, a cash basis U.S. Holder or an accrual basis U.S. Holder who has made a special election (which must be applied consistently from year to year and cannot be changed without the consent of the IRS) will determine the U.S. dollar value of the amount realized in foreign currency by translating the amount received at the spot rate of exchange on the settlement date of the sale. If our ordinary shares are not treated as traded on an established securities market, or the relevant U.S. Holder is an accrual basis taxpayer that does not make the special election, such U.S. Holder will recognize foreign currency gain or loss to the extent attributable to any difference between the U.S. dollar amount realized on the date of sale or disposition (as determined above) and the U.S. dollar value of the currency received translated at the spot rate on the settlement date.
A U.S. Holder’s initial U.S. federal income tax basis in our ordinary shares generally will equal the cost of such ordinary shares. If a U.S. Holder used foreign currency to purchase the ordinary shares, the cost of the ordinary shares will be the U.S. dollar value of the foreign currency purchase price on the date of purchase, translated at the spot rate of exchange on that date. If our ordinary shares are treated as traded on an established securities market and the relevant U.S. Holder is either a cash basis taxpayer or an accrual basis taxpayer who has made the special election described above, the U.S. Holder will determine the U.S. dollar value of the cost of such ordinary shares by translating the amount paid at the spot rate of exchange on the settlement date of the purchase.
Passive Foreign Investment Company Considerations
We will be classified as a passive foreign investment company (a “PFIC”) for any taxable year if either: (1) at least 75% of our gross income is “passive income” for purposes of the PFIC rules or (2) at least 50% of the value of our assets (determined on the basis of a quarterly average) is attributable to assets that produce or are held for the production of passive income. For this purpose, we will be treated as owning our proportionate share of the assets and earning our proportionate share of the income of any other corporation in which we own, directly or indirectly, 25% or more (by value) of the stock.
Under the PFIC rules, if we were considered a PFIC at any time that a U.S. Holder holds our ordinary shares, we would continue to be treated as a PFIC with respect to such U.S. Holder unless (1) we cease to qualify as a PFIC under the income and asset tests discussed in the prior paragraph and (2) the U.S. Holder has made a “deemed sale” election under the PFIC rules.
Based on the anticipated market price of our ordinary shares in the offering and the current and anticipated composition of our income, assets and operations, we do not expect to be treated as a PFIC for the current taxable year or in the foreseeable future. This is a factual determination, however, that depends on, among other things, the composition of our income and assets and the market value of our shares and assets from time to time, and thus the determination can only be made annually after the close of each taxable year. Therefore, there can be no assurance that we will not be classified as a PFIC for the current taxable year or for any future taxable year.
If we are considered a PFIC at any time that a U.S. Holder holds our ordinary shares, any gain recognized by a U.S. Holder on a sale or other disposition of our ordinary shares, as well as the amount of any “excess distribution” (defined below) received by the U.S. Holder, would be allocated ratably over the U.S. Holder’s holding period for our ordinary shares. The amounts allocated to the taxable year of the sale or other disposition (or the taxable year of receipt, in the case of an excess distribution) and to any year prior to the year in which we became a PFIC would be taxed as ordinary income. The amount allocated to each other taxable year would be subject to tax at the highest rate in effect
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for individuals or corporations, as appropriate, for that taxable year, and an interest charge would be imposed. For the purposes of these rules, an excess distribution is the amount by which any distribution received by a U.S. Holder on its ordinary shares exceeds 125% of the average of the annual distributions on our ordinary shares received during the preceding three years or the U.S. Holder’s holding period, whichever is shorter.
Certain elections may be available that would result in alternative treatments (such as qualified electing fund treatment or mark-to-market treatment) of our ordinary shares if we are considered a PFIC. We do not intend to provide the information necessary for U.S. Holders of our ordinary shares to make qualified electing fund elections, which, if available, would result in tax treatment different from the general tax treatment for an investment in a PFIC described above. If we are treated as a PFIC with respect to a U.S. Holder for any taxable year, the U.S. Holder will be deemed to own shares in any of our subsidiaries that are also PFICs. However, an election for mark-to-market treatment would likely not be available with respect to any such subsidiaries.
If we are considered a PFIC, a U.S. Holder will also be subject to annual information reporting requirements. U.S. Holders should consult their tax advisors about the potential application of the PFIC rules to an investment in our ordinary shares.
U.S. Information Reporting and Backup Withholding
Dividend payments with respect to our ordinary shares and proceeds from the sale, exchange or redemption of our ordinary shares may be subject to information reporting to the IRS and possible U.S. backup withholding. A U.S. Holder may be eligible for an exemption from backup withholding if the U.S. Holder furnishes a correct taxpayer identification number and makes any other required certification or is otherwise exempt from backup withholding. U.S. Holders who are required to establish their exempt status may be required to provide such certification on IRS Form W-9. U.S. Holders should consult their tax advisors regarding the application of the U.S. information reporting and backup withholding rules.
Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a U.S. Holder’s U.S. federal income tax liability, and such U.S. Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by timely filing an appropriate claim for refund with the IRS and furnishing any required information.
Additional Information Reporting Requirements
A U.S. Holder that acquires ordinary shares generally will be required to file Form 926 with the IRS if (1) immediately after the acquisition such U.S. Holder, directly or indirectly, owns at least 10% of the ordinary shares, or (2) the amount of cash transferred in exchange for ordinary shares during the 12-month period ending on the date of the acquisition exceeds $100,000. Significant penalties may apply for failing to satisfy these filing requirements. U.S. Holders are urged to contact their tax advisors regarding these filing requirements.
Certain U.S. Holders who are individuals (and certain entities) that hold an interest in “specified foreign financial assets” (which may include our ordinary shares) are required to report information relating to such assets, subject to certain exceptions (including an exception for ordinary shares held in accounts maintained by certain financial institutions). Penalties can apply if U.S. Holders fail to satisfy such reporting requirements. U.S. Holders should consult their tax advisors regarding the applicability of these requirements to their acquisition and ownership of our ordinary shares.
THE DISCUSSION ABOVE IS A GENERAL SUMMARY. IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE IMPORTANT TO YOU. EACH PROSPECTIVE PURCHASER SHOULD CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES OF AN INVESTMENT IN OUR ORDINARY SHARES UNDER THE INVESTOR’S OWN CIRCUMSTANCES.
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In connection with this offering, we entered into an underwriting agreement with Boustead Securities, LLC, as Underwriter in this offering. The Underwriter may retain other brokers or dealers to act as a sub-agents or selected dealers on their behalf in connection with this offering. The Underwriter has agreed to purchase from us, on a firm commitment basis, the number of ordinary shares set forth opposite its name below, at the offering price less the underwriting discounts set forth on the cover page of this prospectus:
Name of Underwriter |
Number of Ordinary Shares |
|
Boustead Securities, LLC |
The Underwriter is committed to purchase all the ordinary shares offered by this prospectus if it purchases any ordinary shares. The Underwriter is offering the ordinary 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, such as the receipt by the Underwriter of officer’s certificates and legal opinions. The Underwriter reserves the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.
Fees, Commissions and Expense Reimbursement
We will pay the Underwriter a fee/commission equivalent to seven percent (7%) of the gross proceeds of this offering. The Underwriter proposes initially to offer the ordinary shares to the public at the offering price set forth on the cover page of this prospectus and to dealers at those prices less the aforesaid fee (“underwriting discount”) set forth on the cover page of this prospectus. If all of the ordinary shares offered by us are not sold at the offering price, the Underwriter may change the offering price and other selling terms by means of a supplement to this prospectus.
The following table shows the underwriting fees/commission payable to the Underwriting with this offering:
Per
|
Total without
|
Total with full
|
|||||||
Public offering price |
$ |
$ |
$ |
||||||
Underwriting fees and commissions (7%) |
$ |
$ |
$ |
||||||
Proceeds, before expenses, to us |
$ |
$ |
$ |
In addition to the cash commission, we will also reimburse the Underwriter for its accountable out-of-pocket expenses not to exceed more than $100,000 in Underwriter’s legal counsel fees. We have also agreed pay the Underwriter a non-accountable expense allowance equal to three-quarters percent (0.75%) of the gross proceeds of this offering.
We estimate that the total expenses payable by us in connection with the offering, other than the underwriting fees and commissions, will be approximately $607,000, which includes the maximum of $100,000 in accountable expenses payable to the Underwriter.
We have granted a 45-day option to the underwriter to purchase up to 225,000 additional ordinary shares at the public offering price from us solely to cover over-allotments, if any, less underwriting discounts and commissions.
The Underwriter intends to offer our ordinary shares to their retail customers only in states in which we are permitted to offer our ordinary shares. We have relied on an exemption to the blue-sky registration requirements afforded to “covered securities.” Securities listed on a National Securities Exchange are “covered securities.” If we were unable to meet a National Securities Exchange listing standards, then we would be unable to rely on the covered securities exemption to blue sky registration requirements and we would need to register the offering in each state in which we planned to sell shares. Consequently, we will not complete this offering unless we meet a National Securities Exchange’s listing requirements.
The foregoing does not purport to be a complete statement of the terms and conditions of the underwriting agreement and subscription agreement. A form of the underwriting agreement is included as an exhibit to the registration statement of which this prospectus forms a part.
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Right of First Refusal
Until twenty-four (24) months from the closing of our initial public offering, the Underwriter shall have a right of first refusal to act as lead or managing underwriter, exclusive or joint financial advisor or in any other similar capacity, on the representative’s customary terms and conditions, in the event we pursue a registered, underwritten public offering of securities (in addition to this offering), a public or private offering of securities (debt or equity), a merger, acquisition of another company or business, change of control, sale of substantially all assets, business combination, recapitalization or other similar transaction (regardless of whether we would be considered an acquiring party, a selling party or neither in such transaction). In accordance with FINRA Rule 5110(f)(2)(E)(i), such right of first refusal shall not have a duration of more than three years from the date of commencement of sales of the public offering or the termination date of the engagement between the us and the Underwriter. Notwithstanding the above, we have the right to terminate our obligations as they pertain to the Underwriter’s “right of first refusal” for “cause” pursuant to FINRA Rule 5110(g)(5)(B)(i). For the avoidance of doubt, “for cause” termination shall include termination due to any material failure by the Underwriter to provide the underwriting services contemplated herein.
Lock-Up Agreements
In connection with our initial public offering, we agreed with the Underwriter that, subject to certain exceptions set forth in the underwriting agreement, we would not, without the prior written consent of the Underwriter, until November 9, 2022 (i) 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 or extend any option, right or warrant to purchase or otherwise transfer or dispose of, directly or indirectly, or file with the SEC a registration statement under the Securities Act relating to, any ordinary shares or any securities convertible into or exercisable or exchangeable for ordinary shares, or (ii) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the ordinary shares or any such other securities. The Underwriter has consented to this offering.
In connection with our initial public offering, our officers, directors, and all existing shareholders agreed not to offer, issue, sell, contract to sell, encumber, grant any option for the sale of or otherwise dispose of any ordinary shares or other securities convertible into or exercisable or exchangeable for ordinary shares for a period of up to November 5, 2022; provided that those persons who purchased units in our April 2021 private placement and August 2021 private placement would be able to:
• sell one-third of the shares contained in the units that are not registered for resale in the selling shareholder offering and one-third of the shares underlying the warrants contained in such units after May 8, 2022;
• sell one-third of the shares contained in the units that are not registered for resale in the selling shareholder offering and one-third of the shares underlying the warrants contained in such units after August 6, 2022;
• sell one-third of the shares contained in the units that are not registered for resale in the selling shareholder offering and one-third of the shares underlying the warrants contained in such units after November 9, 2022; and
• commencing February 7, 2022, if our ordinary share price is over $7.50 per share for ten consecutive trading days, with at least 100,000 shares traded per day, the such persons may sell one-third of their shares subject to a maximum sale on any trading day of 3% of the daily volume;
• commencing February 7, 2022, if our ordinary share price is over $10.00 per share for ten consecutive trading days, with at least 100,000 shares traded per day, such persons may sell an additional one-third of their shares subject to a maximum sale on any trading day of 3% of the daily volume; and
• commencing February 7, 2022, if our ordinary share price is over $15.00 per share for ten consecutive trading days, with at least 100,000 shares traded per day, such persons may sell an additional one-third constituting a maximum total of all of their shares subject to a maximum sale on any trading day of 3% of the daily volume.
The Underwriter may in its sole discretion and at any time without notice release some or all of the ordinary shares subject to lock-up agreements prior to the expiration of the lock-up period. When determining whether or not to release shares from the lock-up agreements, the Underwriter will consider, among other factors, the security holder’s reasons for requesting the release, the number of shares for which the release is being requested and market conditions at the time.
93
Price Stabilization
The Underwriter will be required to comply with the Securities Act and the Exchange Act, including without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares of capital stock by the Underwriter acting as principal. Under these rules and regulations, the Underwriter:
• may not engage in any stabilization activity in connection with our securities; and
• may not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until it has completed its participation in the distribution.
Determination of Offering Price
The public offering price of the ordinary shares we are offering was determined by us in consultation with the Underwriter based on discussions with potential investors in light of the history and prospects of our Company, the stage of development of our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management, the public stock price for similar companies, general conditions of the securities markets at the time of the offering and such other factors as were deemed relevant.
Electronic Offer, Sale and Distribution of Securities
A prospectus in electronic format may be delivered to potential investors by the Underwriter. The prospectus in electronic format will be identical to the paper version of such prospectus. Other than the prospectus in electronic format, the information on the Underwriter’ website and any information contained in any other website maintained by the Underwriter is not part of the prospectus or the registration statement of which this Prospectus forms a part.
Foreign Regulatory Restrictions on Purchase of our Ordinary Shares
We have not taken any action to permit a public offering of our ordinary shares outside the United States or to permit the possession or distribution of this prospectus outside the United States. People outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating to this offering of our ordinary shares and the distribution of this prospectus outside the United States.
Indemnification
We have agreed to indemnify the Underwriter against liabilities relating to the offering arising under the Securities Act and the Exchange Act and to contribute to payments that the Underwriter may be required to make for these liabilities. We have been advised that, in the opinion of the Securities and Exchange Commission, indemnification of liabilities under the Securities Act is against public policy as expressed in the Securities Act, and is therefore, unenforceable.
94
EXPENSES RELATING TO THIS OFFERING
Set forth below is an itemization of the total expenses, excluding placement discounts and commissions, the underwriter’s non-accountable expenses and the underwriter’s accountable expenses, that we expect to incur in connection with this offering. With the exception of the SEC registration fee and the FINRA filing fee listing fee, all amounts are estimates.
Securities and Exchange Commission Registration Fee |
$ |
3,798 |
|
FINRA |
$ |
6,646 |
|
Legal Fees and Expenses |
$ |
175,000 |
|
Accounting Fees and Expenses |
$ |
40,000 |
|
Printing and Engraving Expenses |
$ |
10,000 |
|
Miscellaneous Expenses |
$ |
4,556 |
|
Total Expenses |
$ |
240,000 |
95
Ortoli Rosenstadt LLP is acting as counsel to our company regarding U.S. securities law matters. The current address of Ortoli Rosenstadt LLP is 501 Madison Avenue, 14th Floor, New York, NY 10022. CMS Derks Star Busmann N.V. is acting as counsel to our company regarding Dutch securities law matters. The current address of CMS Derks Star Busmann N.V. is Atrium, Parnassusweg 737, 1077 DG Amsterdam, Netherlands.
Sichenzia Ross Ference LLP is acting as counsel to the underwriter.
The financial statements of Mainz Biomed, N.V. as of March 31, 2021 and for the period from March 8, 2021 (inception) through to March 31, 2021 included in this prospectus and registration statement have been so included in reliance on the report of BF Borgers CPA P.C., an independent registered public accounting firm, given on the authority of said firm as experts in accounting and auditing. BF Borgers CPA P.C. has offices at 5400 W Cedar Ave, Lakewood, CO 80226. Their telephone number is (303) 953-1454.
The financial statements of PharmGenomics GmbH as of December 31, 2020 and 2019 for the years respectively then ended included in this prospectus and registration statement have been so included in reliance on the report of BF Borgers CPA P.C., an independent registered public accounting firm, given on the authority of said firm as experts in accounting and auditing. BF Borgers CPA P.C. has offices at 5400 W Cedar Ave, Lakewood, CO 80226. Their telephone number is (303) 953-1454.
INTERESTS OF EXPERTS AND COUNSEL
None of the named experts or legal counsel was employed on a contingent basis, owns an amount of shares in our company which is material to that person, or has a material, direct or indirect economic interest in our company or that depends on the success of the offering.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
96
ENFORCEABILITY OF CIVIL LIABILITIES
We are a corporation organized under the laws of the Netherlands, and the majority of our directors and officers reside outside of the United States. Service of process upon such persons may be difficult or impossible to effect within the United States. Furthermore, because a substantial portion of our assets, and substantially all the assets of our directors and officers and the experts named herein, are located outside of the United States, any judgment obtained in the United States, including a judgment based upon the civil liability provisions of United States federal securities laws, against us or any of such persons may not be collectible within the United States.
As there is no treaty on the reciprocal recognition and enforcement of judgments other than arbitration awards in civil and commercial matters between the United States and the Netherlands, courts in the Netherlands will not automatically recognize and enforce a final judgment rendered by a U.S. court. In order to obtain a judgment enforceable in the Netherlands, claimants must litigate the relevant claim again before a Dutch court of competent jurisdiction. Under current practice, however, a Dutch court will generally recognize and consider as conclusive evidence a final and conclusive judgment for the payment of money rendered by a U.S. court and not rendered by default, provided that the Dutch court finds that:
• the jurisdiction of the U.S. court has been based on grounds that are internationally acceptable;
• the final judgment results from proceedings compatible with Dutch concepts of proper administration of justice including sufficient safeguards (behoorlijke rechtspleging);
• the final judgment does not contravene public policy (openbare orde) of the Netherlands;
• the judgment by the U.S. court is not incompatible with a decision rendered between the same parties by a Dutch court, or with a previous decision rendered between the same parties by a foreign court in a dispute that concerns the same subject and is based on the same cause, provided that the previous decision qualifies for acknowledgment in the Netherlands; and
the final judgment has not been rendered in proceedings of a penal, revenue or other public law nature. If a Dutch court upholds and regards as conclusive evidence the final judgment, that court generally will grant the same judgment without litigating again on the merits.
Shareholders may originate actions in the Netherlands based upon applicable Dutch laws.
Under Dutch law, in the event that a third party is liable to us, only we ourselves can bring civil action against that party. The individual shareholders do not have the right to bring an action on our behalf. Only in the event that the cause for the liability of a third party to us also constitutes a tortious act directly against a shareholder does that shareholder have an individual right of action against such third party in its own name. The Dutch Civil Code does provide for the possibility to initiate such actions collectively. A foundation or an association whose objective is to protect the rights of a group of persons having similar interests can institute a collective action. The collective action itself cannot result in an order for payment of monetary damages but may only result in a declaratory judgment (verklaring voor recht). In order to obtain compensation for damages, the foundation or association and the defendant may reach — often on the basis of such declaratory judgment — a settlement. A Dutch court may declare the settlement agreement binding upon all the injured parties with an opt out choice for an individual injured party. An individual injured party may also itself institute a civil claim for damages.
The name and address of our agent for service of process in the United States is Vcorp Services, LLC, 25 Robert Pitt Drive, Suite 204, Monsey, NY 10952.
97
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form F-1 under the Securities Act with respect to the ordinary shares offered hereby. This prospectus does not contain all of the information set forth in the registration statement and the exhibits thereto, to which reference is hereby made. With respect to each contract, agreement or other document filed as an exhibit to the registration statement, reference is made to such exhibit for a more complete description of the matter involved. The registration statement and the exhibits thereto filed by us with the SEC may be inspected at the public reference facility of the SEC listed below.
The registration statement, reports and other information filed or to be filed with the SEC by us can be inspected and copied at the public reference facilities maintained by the SEC at 100 F. Street NW, Washington, D.C. 20549. The SEC maintains a website at www.sec.gov that contains reports, proxy and information statements, and other information regarding registrants that make electronic filings with the SEC using its EDGAR system.
We are subject to the information reporting requirements of the Exchange Act that are applicable to foreign private issuers, and under those requirements are filing reports with the SEC. Those other reports or other information may be inspected without charge at the locations described above. As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file annual, quarterly and current reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we will file with the SEC, within 120 days after the end of each fiscal year, or such applicable time as required by the SEC, an annual report on Form 20-F containing financial statements audited by an independent registered public accounting firm, and will submit to the SEC, on Form 6-K, unaudited quarterly financial information.
98
Page |
||
MAINZ BIOPHARMA B.V. |
||
From March 1, 2021 (inception) to March 31, 2021 |
||
F-2 |
||
Financial Statements: |
||
Statement of operations from March 1, 2021 (inception) to March 31, 2021 |
F-3 |
|
F-4 |
||
F-5 |
||
F-6 |
||
F-7 |
||
From March 1, 2021 (inception) to June 30, 2021 |
||
Statement of operations from March 1, 2021 (inception) to June 30, 2021 |
F-12 |
|
F-13 |
||
F-14 |
||
F-15 |
||
F-16 |
||
PHARMGENOMICS GmbH |
||
Year Ended December 31, 2020 and 2019 |
||
F-22 |
||
Financial Statements: |
||
F-23 |
||
F-24 |
||
F-25 |
||
F-26 |
||
F-27 |
||
Six Months Ended June 30, 2021 |
||
F-47 |
||
F-48 |
||
F-49 |
||
F-50 |
||
F-51 |
||
F-64 |
||
Year Ended December 31, 2020 |
||
Unaudited Pro Forma Consolidated Statement of Operations for the Year Ended March 31, 2021 |
F-65 |
|
Period Ended June 30, 2020 |
||
Unaudited Pro Forma Consolidated Balance Sheet as of June 30, 2021 |
F-69 |
|
Unaudited Pro Forma Consolidated Statement of Operations for the six months Ended June 30, 2021 |
F-70 |
F-1
Report of Independent Registered Public Accounting Firm
To the shareholders and the board of directors of Mainz Biomed B.V.
Opinion on the Financial Statements
We have audited the accompanying statement of financial position of Mainz Biomed B.V. (the “Company”) as of March 31, 2021, the related statement of operations, stockholders’ equity (deficit), and cash flows for the period from March 8, 2021 (inception) thru to March 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 March 31, 2021, and the results of its operations and its cash flows for the period from March 8, 2021 (inception) thru to March 31, 2021, in conformity with the International Financial Reporting Standards as issued by the International Accounting Standards Board.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company’s significant operating losses raise substantial doubt about its ability to continue as a going concern. 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 audit. 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit 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 audit, 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 audit 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 audit 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 audit provides a reasonable basis for our opinion.
/s/ BF Borgers CPA PC
BF Borgers CPA PC
Served as Auditor since 2021
Lakewood, CO
August 3, 2021
F-2
Mainz Biomed B.V.
Statement of Operations
Note |
March 8, 2021
|
|||||
Net sales |
$ |
— |
|
|||
|
|
|||||
Operating expenses: |
|
|
||||
Professional fees |
|
39,992 |
|
|||
Total operating expenses |
|
39,992 |
|
|||
|
|
|||||
Loss from operations |
|
(39,992 |
) |
|||
|
|
|||||
Net loss |
$ |
(39,992 |
) |
|||
|
|
|||||
Comprehensive loss |
$ |
(39,992 |
) |
|||
|
|
|||||
Basic and dilutive loss per ordinary share |
$ |
(39,992.00 |
) |
|||
Weighted average number of ordinary shares outstanding |
|
1 |
|
The accompanying notes are an integral part of these financial statements.
F-3
Mainz Biomed B.V.
Statement of Financial position
The accompanying notes are an integral part of these financial statements.
F-4
Mainz Biomed B.V.
Statement of Changes in Shareholders’ Deficit
Note |
Share
|
Accumulated
|
Total
|
||||||||||
Inception, March 8, 2021 |
$ |
— |
$ |
— |
|
$ |
— |
|
|||||
Share issuance at inception |
5 |
|
— |
|
— |
|
|
— |
|
||||
Net loss |
|
— |
|
(39,992 |
) |
|
(39,992 |
) |
|||||
Balance, March 31, 2021 |
$ |
— |
$ |
(39,992 |
) |
$ |
(39,992 |
) |
The accompanying notes are an integral part of these financial statements.
F-5
Mainz Biomed B.V.
Statement of Cash Flows
Note |
March 8, 2021
|
|||||
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
||||
Net income |
$ |
(39,992 |
) |
|||
Adjustments to reconcile net income to net cash provided by (used in)
|
|
|
||||
Changes in operating assets and liabilities: |
|
|
||||
Accounts payable |
|
39,992 |
|
|||
Cash generated from operating activities |
|
— |
|
|||
Net cash provided by (used in) operating activities |
|
— |
|
|||
|
|
|||||
Net change in cash |
|
— |
|
|||
Cash at beginning of period |
|
— |
|
|||
Effect of movements in exchange rates |
|
— |
|
|||
Cash at end of period |
$ |
— |
|
The accompanying notes are an integral part of these financial statements.
F-6
Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021
NOTE 1. Reporting Entity
Mainz Biomed B.V. (the “Company”) is domiciled in Netherlands. The Company’s registered office is at Sirius Gutenberg Park, Robert-Koch-Str. 50, 55129 Mainz, Germany. The Company was formed to acquire the business of PharmGenomics GmbH (“PharmGenomics”), is a limited liability company based in Mainz, Germany. PharmGenomics develops in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. The Company plans to complete a Contribution Agreement to affect such acquisition (see Note 7).
NOTE 2. Basis of preparation and going concern
These financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and interpretations of the International Financial Reporting Issues Committee (“IFRIC”). The principal accounting policies applied in the preparation of these financial statements are set out below. They were authorized for issue by the Company’s board of directors on August 3, 2021.
These financial statements are presented in United States dollars. The fiscal year end is December 31.
Going concern
These financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The continuing operations of the Company are dependent upon its ability to evaluate and complete a business combination. At March 31, 2021, the Company has an accumulated deficit of $39,992 including a loss for the year ended March 31, 2021 of $39,992.
These uncertainties may cast significant doubt upon the Company’s ability to continue as a going concern. These financial statements do not include any adjustments relating to the recoverability and classification of assets and liabilities which might be necessary should the Company be unable to continue in existence.
NOTE 3. Use of judgements and estimates
In preparing these financial statements, management has made judgements and estimates that affect the application of the Company’s accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates.
Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to estimates are recognized prospectively. Areas requiring a significant degree of estimation and judgment include fair value measurements for financial instruments, the recoverability and measurement of deferred tax assets and liabilities and assessment of the Company’s ability to continue as a going concern.
NOTE 4. Significant accounting policies
General
The accounting policies described in these financial statements have been applied consistently to all periods presented in these financial statements.
Foreign currency
Transactions in foreign currencies are translated to the respective functional currencies of the Company using the exchange rates at transaction date. Receivables, payables and other monetary assets and liabilities denominated in foreign currencies are re-translated to the functional currency using the exchange rates at the balance sheet date. Resulting foreign currency differences are recognized in the income statement, except for foreign currency differences arising on re-translation of Fair Value through Other Comprehensive Income (FVOCI) investments and financial liabilities designated as a hedge of a net investment, which are recognized in other comprehensive income.
F-7
Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021
NOTE 4. Significant accounting policies (cont.)
Non-monetary assets and liabilities denominated in foreign currencies that are measured at fair value are re-translated to the functional currency at the exchange rate at the date that the fair value was determined. Non-monetary items in a foreign currency that are measured at cost are translated into the functional currency at the exchange rate at transaction date.
Cash and cash equivalents
Cash and cash equivalents include cash on hand and other short-term highly liquid investments with original maturities of three months or less.
Revenue
Revenue is measured based on the consideration specified in a contract with a customer. The Company recognizes revenue when it transfers control over a good or service to a customer.
Earnings (loss) per share
The calculation of earnings per share (EPS) for the period ended March 31, 2021 is based on the loss attributable to the shareholder of the Company (net profit (loss)) and the weighted average number of shares outstanding (basic and diluted) during the period ended March 31, 2021. The Company has no potentially dilutive securities, such as options or warrants, currently issued and outstanding.
Income tax
Income tax expense comprises current and deferred tax. It is recognized in profit or loss except to the extent that it relates to a business combination, or items recognized directly in equity or in OCI.
Current tax comprises the expected tax payable or receivable on the taxable income or loss for the year and any adjustment to the tax payable or receivable in respect of previous years. The amount of current tax payable or receivable is the best estimate of the tax amount expected to be paid or received that reflects uncertainty related to income taxes, if any. It is measured using tax rates enacted or substantively enacted at the reporting date. Current tax also includes any tax arising from dividends. Current tax assets and liabilities are offset only if certain criteria are met.
Deferred tax is recognized in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax is not recognized for:
• temporary differences on the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss;
• temporary differences related to investments in subsidiaries, associates and joint arrangements to the extent that the Company is able to control the timing of the reversal of the temporary differences and it is probable that they will not reverse in the foreseeable future; and
• taxable temporary differences arising on the initial recognition of goodwill.
The amount of deferred tax provided is based on the expected manner of recovery or settlement of the carrying amount of assets and liabilities, using tax rates (substantively) enacted, at year-end. Deferred tax assets are recognized to the extent that it is probable that future taxable profits will be available against which they can be utilized. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax liabilities and assets, and they relate to income taxes levied by the same tax authority on the same taxable entity, or on different taxable entities which intend either to settle current tax liabilities and assets on a net basis or to realize the assets and settle the liabilities simultaneously. Current and deferred tax are recognized in the income statement, except when it relates to a business combination or for items directly recognized in equity or other comprehensive income.
F-8
Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021
NOTE 4. Significant accounting policies (cont.)
Foreign Currency Translation
The functional and reporting currency of the Company is the United States dollar. Transactions denominated in foreign currencies are translated using the exchange rate in effect on the transaction date or at an average rate. Monetary assets and liabilities denominated in foreign currencies are translated at the rate of exchange in effect at the statement of financial position date. Non-monetary items are translated using the historical rate on the date of the transaction. Foreign exchange gains and losses are included in profit and loss
Share capital
Incremental costs directly attributable to the issue of ordinary shares are recognized as a deduction from equity. Income tax relating to transaction costs of an equity transaction is accounted for in accordance with IAS 12.
Fair value measurement
Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date in the principal or, in its absence, the most advantageous market to which the Company has access at that date. The fair value of a liability reflects its non-performance risk.
When one is available, the Company measures the fair value of an instrument using the quoted price in an active market for that instrument. A market is regarded as ‘active’ if transactions for the asset or liability take place with sufficient frequency and volume to provide pricing information on an ongoing basis. If there is no quoted price in an active market, then the Company uses valuation techniques that maximize the use of relevant observable inputs and minimize the use of unobservable inputs. The chosen valuation technique incorporates all of the factors that market participants would take into account in pricing a transaction. If an asset or a liability measured at fair value has a bid price and an ask price, then the Company measures assets and long positions at a bid price and liabilities and short positions at an ask price
Accounting standard issued but not yet effective
Certain accounting standards or amendments to existing accounting standards that have been issued but have future effective dates are either not applicable or are not expected to have a significant impact on the Company’s financial statements
NOTE 5. Capital
Ordinary shares
|
||
Inception at March 8, 2021 |
||
Share issuance at inception |
1 |
|
Issued and outstanding at March 31, 2021 |
1 |
Ordinary shares
Holders of these shares are entitled to dividends as declared from time to time and are entitled to one vote per share at general meetings of the Company. All rights attached to the Company’s shares held by the Company are suspended until those shares are reissued.
On March 8, 2021, the Company issued share capital of EUR0.01 consisting of one share with a nominal value of EUR0.01.
F-9
Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021
NOTE 6. Financial instruments and risk management
Financial instruments
Trade receivables and debt securities issued are initially recognized when they are originated. All other financial assets and financial liabilities are initially recognized when the Company becomes a party to the contractual provisions of the instrument.
A financial asset (unless it is a trade receivable without a significant financing component) or financial liability is initially measured at fair value plus or minus, for an item not at Fair value through profit or loss (FVTPL), transaction costs that are directly attributable to its acquisition or issue. A trade receivable without a significant financing component is initially measured at the transaction price.
The Company derecognizes a financial asset when:
• the contractual rights to the cash flows from the financial asset expire; or
• it transfers the rights to receive the contractual cash flows in a transaction in which either:
• substantially all of the risks and rewards of ownership of the financial asset are transferred; or
• the Company neither transfers nor retains substantially all of the risks and rewards of ownership and it does not retain control of the financial asset
Financial liabilities are classified as measured at amortized cost or fair value through profit or loss (FVTPL). A financial liability is classified as at FVTPL if it is classified as held-for-trading, it is a derivative or it is designated as such on initial recognition. Financial liabilities at FVTPL are measured at fair value and net gains and losses, including any interest expense, are recognized in profit or loss. Other financial liabilities are subsequently measured at amortized cost using the effective interest method. Interest expense and foreign exchange gains and losses are recognized in profit or loss. Any gain or loss on derecognition is also recognized in profit or loss.
The Company derecognizes a financial liability when its contractual obligations are discharged or cancelled, or expire. The Company also derecognizes a financial liability when its terms are modified and the cash flows of the modified liability are substantially different, in which case a new financial liability based on the modified terms is recognized at fair value. On derecognition of a financial liability, the difference between the carrying amount extinguished and the consideration paid (including any non-cash assets transferred or liabilities assumed) is recognized in profit or loss.
At March 31, 2021, the Company’s financial instrument is trade payables.
Financial risk management
The Company’s board of directors has overall responsibility for the establishment and oversight of the Company’s risk management framework. The board of directors has established the risk management committee, which is responsible for developing and monitoring the Company’s risk management policies. The committee reports regularly to the board of directors on its activities.
The Company’s risk management policies are established to identify and analyze the risks faced by the Company, to set appropriate risk limits and controls and to monitor risks and adherence to limits. Risk management policies and systems are reviewed regularly to reflect changes in market conditions and the Company’s activities. The Company, through its training and management standards and procedures, aims to maintain a disciplined and constructive control environment in which all employees understand their roles and obligations.
F-10
Mainz Biomed B.V.
Notes to the Financials Statements
March 8, 2021 (Inception) to March 31, 2021
NOTE 6. Financial instruments and risk management (cont.)
The Company has exposure to the following risks arising from financial instruments:
• Credit risk is the risk of financial loss to the Company if a customer or counterparty to a financial instrument fails to meet its contractual obligations and arises principally from the Company’s receivables from customers and investments in debt securities.
• Liquidity risk is the risk that the Company will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. The Company’s objective when managing liquidity is to ensure, as far as possible, that it will have sufficient liquidity to meet its liabilities when they are due, under both normal and stressed conditions, without incurring unacceptable losses or risking damage to the Company’s reputation.
• Market risk is the risk that changes in market prices — e.g. foreign exchange rates, interest rates and equity prices — will affect the Company’s income or the value of its holdings of financial instruments. The objective of market risk management is to manage and control market risk exposures within acceptable parameters, while optimizing the return.
Currency risk
The Company is exposed to transactional foreign currency risk to the extent that there is a mismatch between the currencies in which sales, purchases, receivables and payables are denominated and the respective functional currency of the Company. The functional currency of the Company is the United States dollar. The currencies in which these transactions are primarily denominated are Euro, United States dollar, British pound sterling and Canadian dollar.
NOTE 7. Subsequent events
Management evaluated all additional events subsequent to the balance sheet date through to August 3, 2021, the date the financial statements were available to be issued, and determined the following items:
On April 22, 2021, the Company entered into securities purchase agreement. The Company shall issue and sell to the buyers in the respective amounts of units set forth against the relevant buyer’s name on the buyers’ signature page(s) (the “Subscription Amounts”) an aggregate of up to 2,010,000 Units (which amount may be increased upon approval of the Company’s Board of Directors). Each unit shall consist of (i) one (1) ordinary share in the capital of the Company (an “Ordinary Share”) and (ii) one (1) warrant to purchase an Ordinary Share at an exercise price of $3.00 and expire five years from issuance (the “Warrant Share”). The purchase price for each Unit shall be $0.30. On April 26, 2021, the Company sold 2,010,000 of these units and an additional 140,000 warrants at an excise price of $3.00, for total proceeds of $603,000.
On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) to acquire PharmGenomics GmbH, a company with limited liability under German law. Under the Contribution Agreement, 100% of the shares of the PharmGenomics will be acquired in exchange for 6,000,000 shares of the Company. Upon the closing of the Contribution Agreement, PharmGenomics will become a wholly owned subsidiary of the Company and the former shareholders of PharmGenomics will hold approximately 62% of the outstanding shares of the Company.
F-11
Mainz Biomed B.V.
Condensed Interim Statements of Operations
(Unaudited)
Note |
March 8,
|
|||||
Net sales |
$ |
— |
|
|||
|
|
|||||
Operating expenses: |
|
|
||||
General and administrative |
|
38,385 |
|
|||
Professional fees |
|
242,359 |
|
|||
Total operating expenses |
|
280,744 |
|
|||
|
|
|||||
Loss from operations |
|
(280,744 |
) |
|||
|
|
|||||
Net loss |
$ |
(280,744 |
) |
|||
|
|
|||||
Comprehensive loss |
$ |
(280,744 |
) |
|||
|
|
|||||
Basic and dilutive loss per ordinary share |
$ |
(0.23 |
) |
|||
Weighted average number of ordinary shares outstanding |
|
1,211,801 |
|
The accompanying notes are an integral part of these unaudited financial statements.
F-12
Mainz Biomed B.V.
Condensed Interim Statements of Financial position
(Unaudited)
The accompanying notes are an integral part of these unaudited financial statements.
F-13
Mainz Biomed B.V.
Condensed Interim Statement of Changes in Shareholders’ Equity
(Unaudited)
Note |
Share
|
Share
|
Reserve |
Accumulated
|
Total
|
||||||||||||||
Inception, March 8, 2021 |
$ |
— |
$ |
— |
$ |
— |
$ |
— |
|
$ |
— |
|
|||||||
Share issuance at inception |
4 |
|
— |
|
— |
|
— |
|
— |
|
|
— |
|
||||||
Issue of ordinary shares and warrants |
4 |
|
24,138 |
|
442,312 |
|
36,550 |
|
— |
|
|
503,000 |
|
||||||
Net loss |
|
— |
|
— |
|
— |
|
(280,744 |
) |
|
(280,744 |
) |
|||||||
Balance, June 30, 2021 |
$ |
24,138 |
$ |
442,312 |
$ |
36,550 |
$ |
(280,744 |
) |
$ |
222,256 |
|
The accompanying notes are an integral part of these unaudited financial statements.
F-14
Mainz Biomed B.V.
Condensed Interim Statements of Cash Flows
(Unaudited)
Note |
March 8,
|
|||||
Cash Flows From Operating Activities |
|
|
||||
Net loss |
$ |
(280,744 |
) |
|||
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
||||
Changes in operating assets and liabilities: |
|
|
||||
VAT receivable |
|
(12,463 |
) |
|||
Accounts payable |
|
64,439 |
|
|||
Net cash used in operating activities |
|
(228,768 |
) |
|||
|
|
|||||
Cash Flows From Financing Activities |
|
|
||||
Proceeds from issuance of ordinary shares and warrants, net of offering fees |
|
503,000 |
|
|||
Net cash provided by financing activities |
|
503,000 |
|
|||
|
|
|||||
Net change in cash |
|
274,232 |
|
|||
Cash at beginning of period |
|
— |
|
|||
Effect of movements in exchange rates |
|
— |
|
|||
Cash at end of period |
$ |
274,232 |
|
The accompanying notes are an integral part of these unaudited financial statements.
F-15
Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)
NOTE 1. Reporting Entity
Mainz Biomed B.V. (the “Company”) is domiciled in Netherlands. The Company’s registered office is at Keizersgracht 391A, EJ Amsterdam. The Company was formed to acquire the business of PharmGenomics GmbH (“PharmGenomics”), and is a limited liability company based in Mainz, Germany. PharmGenomics develops in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. Subsequent to June 30, 2021, the Company completed a Contribution Agreement to effect such acquisition (see Note 7).
NOTE 2. Basis of preparation and going concern
Statement of compliance with International Financial Reporting Standards (“IFRS”)
These condensed interim financial statements, including comparatives, have been prepared in accordance with International Accounting Standards (“IAS”) 34, “Interim Financial Reporting” using accounting policies consistent with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and International Financial Reporting Interpretations Committee (“IFRIC”). This interim financial report does not include all of the information required of a full annual financial report and is intended to provide users with an update in relation to events and transactions that are significant to an understanding of the changes in financial position and performance of the Company since its March 31, 2021 audited financial statements. It is therefore recommended that this financial report be read in conjunction with the audited financial statements of the Company for the period from March 8, 2021 (inception) to March 31, 2021 and notes thereto contained in the Company’s registration statement on Form F-1.
The condensed interim financial statements were authorized for issuance by the Board of Directors on October 1, 2021.
Basis of measurement
These condensed interim financial statements are presented in United States dollars. The Company’s fiscal year end is December 31.
Going concern
These financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The continuing operations of the Company are dependent upon its ability to evaluate and complete a business combination. At June 30, 2021, the Company has an accumulated deficit of $280,744 including a loss for the three months ended June 30, 2021 of $240,752.
These uncertainties may cast significant doubt upon the Company’s ability to continue as a going concern. These financial statements do not include any adjustments relating to the recoverability and classification of assets and liabilities which might be necessary should the Company be unable to continue in existence.
NOTE 3. Use of judgements and estimates
In preparing these financial statements, management has made judgements and estimates that affect the application of the Company’s accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates.
Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to estimates are recognized prospectively. Areas requiring a significant degree of estimation and judgment include fair value measurements for financial instruments, the recoverability and measurement of deferred tax assets and liabilities and assessment of the Company’s ability to continue as a going concern.
F-16
Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)
NOTE 4. Capital
Ordinary
|
||
March 31, 2021 |
1 |
|
Share issuance on April 22, 2021 |
2,010,000 |
|
Shares issued at June 30, 2021 |
2,010,001 |
Ordinary shares
Holders of these shares are entitled to dividends as declared from time to time and are entitled to one vote per share at general meetings of the Company. All rights attached to the Company’s shares held by the Company are suspended until those shares are reissued.
On March 8, 2021, the Company issued share capital of EUR0.01 consisting of one share with a nominal value of EUR0.01.
On April 22, 2021, the Company entered into securities purchase agreement (“SPA”). Pursuant to the SPA, the Company sold 2,010,000 Units. Each unit consisted of (i) one (1) ordinary share of the Company (an “Ordinary Share”) and (ii) one (1) warrant to purchase an Ordinary Share at an exercise price of $3.00, with an expiration date that is two years from the date of the Company’s planned initial public offering. The purchase price for each Unit was $0.30.
On April 26, 2021, the Company closed the SPA, selling 2,010,000 units and issuing an additional 140,000 warrants to a broker, with identical terms to the investor warrants, for gross proceeds of $603,000. Fees and expenses from the financing were $100,000.
Warrants
During the period ended June 30, 2021, the Company granted 2,150,000 warrants valued at $36,550. The warrants were valued using the Black-Scholes pricing model. The Black-Scholes model requires six basic data inputs: the exercise or strike price, time to expiration, the risk free interest rate, the current stock price, the estimated volatility of the stock price in the future, and the dividend rate. Changes to these inputs could produce a significantly higher or lower fair value measurement.
For the period ended June 30, 2021, the estimated fair values of the warrants measured are as follows:
June 30,
|
||||
Stock price |
$ |
0.28 |
|
|
Expected term |
|
2 years |
|
|
Expected average volatility |
|
95 |
% |
|
Expected dividend yield |
|
0 |
|
|
Risk-free interest rate |
|
0.16 |
% |
A summary of activity during the period ended June 30, 2021 follows:
Warrant
|
Weighted-Average
|
||||
Balance as of March 8, 2021 |
— |
$ |
— |
||
Grants |
2,150,000 |
|
3.00 |
||
Exercised |
— |
|
— |
||
Expiry |
— |
|
— |
||
Balance as of June 30, 2021 |
2,150,000 |
$ |
3.00 |
F-17
Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)
NOTE 5. Financial instruments and risk management
Financial instruments
Trade receivables and debt securities issued are initially recognized when they are originated. All other financial assets and financial liabilities are initially recognized when the Company becomes a party to the contractual provisions of the instrument.
A financial asset (unless it is a trade receivable without a significant financing component) or financial liability is initially measured at fair value plus or minus, for an item not at Fair value through profit or loss (FVTPL), transaction costs that are directly attributable to its acquisition or issue. A trade receivable without a significant financing component is initially measured at the transaction price.
The Company derecognizes a financial asset when:
• the contractual rights to the cash flows from the financial asset expire; or
• it transfers the rights to receive the contractual cash flows in a transaction in which either:
• substantially all of the risks and rewards of ownership of the financial asset are transferred; or
• the Company neither transfers nor retains substantially all of the risks and rewards of ownership and it does not retain control of the financial asset
Financial liabilities are classified as measured at amortized cost or fair value through profit or loss (FVTPL). A financial liability is classified as at FVTPL if it is classified as held-for-trading, it is a derivative or it is designated as such on initial recognition. Financial liabilities at FVTPL are measured at fair value and net gains and losses, including any interest expense, are recognized in profit or loss. Other financial liabilities are subsequently measured at amortized cost using the effective interest method. Interest expense and foreign exchange gains and losses are recognized in profit or loss. Any gain or loss on derecognition is also recognized in profit or loss.
The Company derecognizes a financial liability when its contractual obligations are discharged or cancelled, or expire. The Company also derecognizes a financial liability when its terms are modified and the cash flows of the modified liability are substantially different, in which case a new financial liability based on the modified terms is recognized at fair value. On derecognition of a financial liability, the difference between the carrying amount extinguished and the consideration paid (including any non-cash assets transferred or liabilities assumed) is recognized in profit or loss.
At June 30, 2021, the Company’s financial instrument is cash, VAT receivable and trade payables.
Financial risk management
The Company’s board of directors has overall responsibility for the establishment and oversight of the Company’s risk management framework. The board of directors has established the risk management committee, which is responsible for developing and monitoring the Company’s risk management policies. The committee reports regularly to the board of directors on its activities.
The Company’s risk management policies are established to identify and analyze the risks faced by the Company, to set appropriate risk limits and controls and to monitor risks and adherence to limits. Risk management policies and systems are reviewed regularly to reflect changes in market conditions and the Company’s activities. The Company, through its training and management standards and procedures, aims to maintain a disciplined and constructive control environment in which all employees understand their roles and obligations.
F-18
Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)
NOTE 5. Financial instruments and risk management (cont.)
The Company has exposure to the following risks arising from financial instruments:
• Credit risk is the risk of financial loss to the Company if a customer or counterparty to a financial instrument fails to meet its contractual obligations, and arises principally from the Company’s receivables from customers and investments in debt securities.
• Liquidity risk is the risk that the Company will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. The Company’s objective when managing liquidity is to ensure, as far as possible, that it will have sufficient liquidity to meet its liabilities when they are due, under both normal and stressed conditions, without incurring unacceptable losses or risking damage to the Company’s reputation.
• Market risk is the risk that changes in market prices — e.g. foreign exchange rates, interest rates and equity prices — will affect the Company’s income or the value of its holdings of financial instruments. The objective of market risk management is to manage and control market risk exposures within acceptable parameters, while optimizing the return.
Currency risk
The Company is exposed to transactional foreign currency risk to the extent that there is a mismatch between the currencies in which sales, purchases, receivables and payables are denominated and the respective functional currency of the Company. The functional currency of the Company is the United States dollar. The currencies in which these transactions are primarily denominated are Euro, United States dollar, British pound sterling and Canadian dollar.
NOTE 6. Subsequent events
Management evaluated all additional events subsequent to the balance sheet date through to September 30, 2021, the date the condensed interim financial statements were available to be issued, and determined the following items:
On July 1, 2021, the Company recruited a Chief Executive Officer and entered into an employment agreement. Pursuant to the employment agreement the CEO was issued 200,000 shares of restricted stock. These shares vest 50% immediately, 25% vest after one year and 25% vest after two years following a successful initial public offering by the Company. The shares were valued at $56,600, based on the value of shares that were sold to third party investors, in an arm’s length transaction on April 26, 2021. The Company plans to record the compensation expense based on the vesting schedule of the restricted shares.
On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) to acquire PharmGenomics GmbH, a company with limited liability under German law. Under the Contribution Agreement, 100% of the shares of the PharmGenomics will be acquired in exchange for 6,000,000 shares of the Company. On September 20, 2021 the Company and PharmGenomics closed the Contribution Agreement. Upon the closing of the Contribution Agreement, PharmGenomics became a wholly owned subsidiary of the Company with the former shareholders of PharmGenomics holding approximately 62% of the outstanding shares of the Company.
On August 20, 2021, the Company entered into securities purchase agreement (the “August SPA”). Pursuant to the August SPA, the Company sold 1,000,000 Units. Each unit consisted of (i) one (1) ordinary share in the capital of the Company (an “Ordinary Share”) and (ii) one (1) warrant to purchase an Ordinary Share at an exercise price of $3.00 and an expiration date two years from the date of the Company’s initial public offering of ordinary shares. The purchase price for each Unit was $0.60, and the Company issued 70,000 broker warrants in conjunction with the offering, with identical terms to the investor warrants.
F-19
Mainz Biomed B.V.
Notes to the Condensed Interim Financial Statements
For the period from March 8, 2021 to June 30, 2021
(Unaudited)
NOTE 6. Subsequent events (cont.)
On September 20, 2021, the Company entered into securities purchase agreement (the “September SPA”). Pursuant to the September SPA, the Company sold 500,000 units. Each unit consisted of (i) one (1) ordinary share in the capital of the Company (an “Ordinary Share”) and (ii) one (1) warrant to purchase an Ordinary Share at an exercise price of $3.00 and an expiration date two years from the date of the Company’s initial public offering of ordinary shares. The purchase price for each Unit was $2.00, and the Company issued 25,000 broker warrants in conjunction with the offering, with identical terms to the investor warrants.
F-20
PharmGenomics GmbH
Mainz
FINANCIAL STATEMENTS
DECEMBER 31, 2020 and 2019
(Expressed in US Dollars)
Report of Independent Registered Public Accounting Firm
To the shareholders and the board of directors of PharmGenomics GmbH
Opinion on the Financial Statements
We have audited the accompanying statements of financial position of PharmGenomics GmbH (the “Company”), as of December 31, 2020 and 2019, the related statements of comprehensive loss, changes in shareholders’ equity (deficit) and cash flows for the years then ended, and 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, 2020 and 2019, and the results of its operations and its cash flows for the years ended December 31, 2020 and 2019, in conformity with the International Financial Reporting Standards as issued by the International Accounting Standards Board.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company’s significant operating losses raise substantial doubt about its ability to continue as a going concern. 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit 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 audit, 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 audit 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 audit 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 audit provides a reasonable basis for our opinion.
/s/ BF Borgers CPA PC
Served as Auditor since 2021
Lakewood, CO
August 3, 2021
F-22
STATEMENTS OF FINANCIAL POSITION
(Expressed in US Dollars)
As at
Note |
December 31, 2020 |
December 31, 2019 |
||||||||
ASSETS |
|
|
|
|
||||||
Current |
|
|
|
|
||||||
Cash |
$ |
122,568 |
|
$ |
203,588 |
|
||||
Trade and other receivables |
4 |
|
44,241 |
|
|
40,800 |
|
|||
Prepaid and other current assets |
|
19,589 |
|
|
15,618 |
|
||||
|
186,398 |
|
|
260,006 |
|
|||||
Non-current |
|
|
|
|
||||||
Property and equipment |
5 |
$ |
30,337 |
|
$ |
22,815 |
|
|||
Right-of-use assets |
6 |
|
456,535 |
|
|
433,138 |
|
|||
Total assets |
$ |
673,270 |
|
$ |
715,959 |
|
||||
|
|
|
|
|||||||
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY |
|
|
|
|
||||||
Current |
|
|
|
|
||||||
Accounts payable and accrued liabilities |
7 |
$ |
433,813 |
|
$ |
249,953 |
|
|||
Deferred revenue |
|
1,508 |
|
|
2,500 |
|
||||
Convertible debt – related party |
8,14 |
|
86,189 |
|
|
78,815 |
|
|||
Loans payable |
9 |
|
24,527 |
|
|
— |
|
|||
Loans payable – related party |
9,14 |
|
108,306 |
|
|
94,843 |
|
|||
Lease liabilities |
6 |
|
47,611 |
|
|
33,603 |
|
|||
|
701,954 |
|
|
459,714 |
|
|||||
Non-current |
|
|
|
|
||||||
Convertible debt |
8 |
|
409,660 |
|
|
337,714 |
|
|||
Convertible debt – related party |
8,14 |
|
37,521 |
|
|
31,763 |
|
|||
Silent partnerships |
10 |
|
1,319,769 |
|
|
976,257 |
|
|||
Silent partnerships – related party |
10,14 |
|
498,481 |
|
|
442,668 |
|
|||
Lease liabilities |
6 |
|
447,440 |
|
|
418,139 |
|
|||
Total liabilities |
|
3,414,825 |
|
|
2,666,255 |
|
||||
|
|
|
|
|||||||
Deficiency |
|
|
|
|
||||||
Share capital |
$ |
106,111 |
|
$ |
106,111 |
|
||||
Reserves |
|
2,309,684 |
|
|
2,289,392 |
|
||||
Accumulated deficit |
|
(4,954,860 |
) |
|
(4,367,965 |
) |
||||
Accumulated other comprehensive income |
|
(202,490 |
) |
|
22,166 |
|
||||
Total stockholders’ deficiency |
|
(2,741,55 |
) |
|
(1,950,296 |
) |
||||
Total liabilities and stockholders’ deficiency |
$ |
673,270 |
|
$ |
715,959 |
|
Nature of operations and going concern (Note 1)
Subsequent events (Note 18)
The accompanying notes are an integral part of these financial statements.
F-23
STATEMENTS OF COMPREHENSIVE LOSS
(Expressed in US Dollars)
For the years ended December 31,
Note |
2020 |
2019 |
||||||||
Revenue |
16 |
$ |
493,565 |
|
$ |
281,393 |
|
|||
Cost of Revenues |
13 |
|
(370,480 |
) |
|
(342,664 |
) |
|||
Gross Profit |
|
123,085 |
|
|
(61,271 |
) |
||||
|
|
|
|
|||||||
Operating Expenses |
|
|
|
|
||||||
Research and development |
19 |
|
311,851 |
|
|
250,316 |
|
|||
Sales and marketing |
19 |
|
110,380 |
|
|
181,460 |
|
|||
General and administrative |
19 |
|
374,569 |
|
|
428,862 |
|
|||
|
(796,800 |
) |
|
(860,638 |
) |
|||||
|
|
|
|
|||||||
Other Income (Expense) |
|
|
|
|
||||||
Accretion expense |
8,9,10 |
|
(92,375 |
) |
|
(45,069 |
) |
|||
Gain on debt extinguishment |
9 |
|
8,214 |
|
|
— |
|
|||
Government grant – research and development |
15 |
|
224,134 |
|
|
151,015 |
|
|||
Government grant – below market financing |
10,15 |
|
92,774 |
|
|
— |
|
|||
Interest expense |
|
(176,417 |
) |
|
(156,867 |
) |
||||
Other income |
|
30,490 |
|
|
15,775 |
|
||||
|
86,820 |
|
|
(35,146 |
) |
|||||
|
|
|
|
|||||||
Net loss |
$ |
(586,895 |
) |
$ |
(957,055 |
) |
||||
|
|
|
|
|||||||
Foreign currency translation |
$ |
(224,656 |
) |
$ |
22,166 |
|
||||
|
|
|
|
|||||||
Total comprehensive loss |
$ |
(811,551 |
) |
$ |
(934,889 |
) |
||||
|
|
|
|
|||||||
Income (Loss) per share – Basic and diluted |
$ |
(6.34 |
) |
$ |
(10.34 |
) |
||||
|
|
|
|
|||||||
Weighted average number of common shares outstanding – basic and diluted |
|
92,584 |
|
|
92,584 |
|
The accompanying notes are an integral part of these financial statements.
F-24
STATEMENT OF CHANGES IN (DEFICIENCY) EQUITY
(Expressed in US Dollars)
Common Stock |
Reserves |
Accumulated Deficit |
Accumulated Other Comprehensive Income |
Total Equity |
|||||||||||
Number of shares |
Amount |
||||||||||||||
Balance, January 1, 2019 |
92,584 |
106,111 |
2,198,084 |
(3,410,910 |
) |
— |
|
(1,106,715 |
) |
||||||
Debt conversion feature (Note 8) |
— |
— |
91,308 |
— |
|
— |
|
91,308 |
|
||||||
Net loss |
— |
— |
— |
(957,055 |
) |
— |
|
(957,055 |
) |
||||||
Currency translation adjustment |
— |
— |
— |
— |
|
22,166 |
|
22,166 |
|
||||||
Balance, December 31, 2019 |
92,584 |
106,111 |
2,289,392 |
(4,367,965 |
) |
22,166 |
|
(1,950,296 |
) |
||||||
Debt conversion feature (Note 8) |
— |
— |
20,292 |
— |
|
— |
|
20,292 |
|
||||||
Net loss |
— |
— |
— |
(586,895 |
) |
— |
|
(586,895 |
) |
||||||
Currency translation adjustment |
— |
— |
— |
— |
|
(224,656 |
) |
(224,656 |
) |
||||||
Balance, December 31, 2020 |
92,584 |
106,111 |
2,309,684 |
(4,937,881 |
) |
(202,490 |
) |
(2,741,555 |
) |
The accompanying notes are an integral part of these financial statements.
F-25
STATEMENTS OF CASH FLOWS
(Expressed in US Dollars)
For the years ended December 31,
2020 |
2019 |
|||||||
Cash flows from operating activities |
|
|
|
|
||||
Net loss |
$ |
(586,895 |
) |
$ |
(957,055 |
) |
||
Items not affecting cash: |
|
|
|
|
||||
Depreciation and amortization |
|
60,462 |
|
|
53,042 |
|
||
Bad debt expense |
|
506 |
|
|
19,411 |
|
||
Accretion expense |
|
92,375 |
|
|
45,069 |
|
||
Government grant |
|
(92,774 |
) |
|
— |
|
||
|
|
|
|
|||||
Changes in non-cash working capital |
|
|
|
|
||||
Trade and other receivables |
|
(99,152 |
) |
|
339,624 |
|
||
Prepaid expenses and other assets |
|
(2,510 |
) |
|
111 |
|
||
Accounts payable and accrued liabilities |
|
160,476 |
|
|
87,419 |
|
||
Deferred revenue |
|
(1,225 |
) |
|
(4,116 |
) |
||
|
|
|
|
|||||
Net cash flows used in operating activities |
|
(468,737 |
) |
|
(416,495 |
) |
||
|
|
|
|
|||||
Cash flows from investing activities |
|
|
|
|
||||
Purchases of fixed assets |
|
(9,685 |
) |
|
— |
|
||
|
|
|
|
|||||
Net cash flows used in investing activities |
|
(9,685 |
) |
|
— |
|
||
|
|
|
|
|||||
Cash flows from financing activities |
|
|
|
|
||||
Proceeds received from convertible debt |
|
11,414 |
|
|
450,143 |
|
||
Proceeds received from loans payable |
|
25,334 |
|
|
4,265 |
|
||
Proceeds received from silent partnerships |
|
398,811 |
|
|
— |
|
||
Repayment of principal portion of lease obligations |
|
(38,878 |
) |
|
(30,413 |
) |
||
|
|
|
|
|||||
Net cash flows provided by financing activities |
|
396,681 |
|
|
423,995 |
|
||
|
|
|
|
|||||
Change in cash |
$ |
(81,741 |
) |
$ |
7,500 |
|
||
|
|
|
|
|||||
Effects of currency translation on cash |
|
721 |
|
|
(33,442 |
) |
||
|
|
|
|
|||||
Cash |
|
|
|
|
||||
Beginning of year |
$ |
203,588 |
|
$ |
229,530 |
|
||
End of year |
$ |
122,568 |
|
$ |
203,588 |
|
||
|
|
|
|
|||||
Supplemental cash flow disclosure |
|
|
|
|
||||
Interest paid |
$ |
159,438 |
|
$ |
156,867 |
|
||
Right of use asset additions |
$ |
39,850 |
|
$ |
— |
|
The accompanying notes are an integral part of these financial statements.
F-26
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
1. NATURE OF OPERATIONS AND GOING CONCERN
PharmGenomics GmbH, is a limited liability company based in Mainz, Germany and was incorporated in Germany under the laws of Mainz, Germany. The Company develops in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. The Company offers genotyping services. The registered office of the Company is located at Sirius Gutenberg Park, Robert-Koch-Str.50, 55129 Mainz, Germany.
The Company has recurring losses, a working capital deficiency of $515,556, accumulated deficit totaling $4,954,860 and negative cash flows used in operating activities of $468,737 as of and for the year ended December 31, 2020. The Company has the ability to reduce discretionary spending and may also receive additional financial support from the current investor group and certain executives that have the financial ability and interest to fund any financial shortfalls. Other strategic options may be available to the Company under certain circumstances. As a result of the actions noted above, management believes that it will have sufficient working capital to meet its planned operating cash flow requirements.
On March 11, 2020, the outbreak of the novel strain of coronavirus specifically identified as “COVID-19” was declared a pandemic by the World Health Organization. The outbreak has resulted in governments worldwide enacting emergency measures to combat the spread of the virus which in turn have caused material disruption to business globally. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Company in future periods.
These financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. These financial statements do not reflect the adjustments to the carrying values of assets and liabilities, the reported revenues and expenses, and the statement of financial position classifications used, that would be necessary if the Company were unable to realize its assets and settle its liabilities as a going concern in the normal course of operations. Such adjustments could be material.
2. BASIS OF PRESENTATION
Basis of Presentation and Statement of Compliance
These financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and interpretations of the International Financial Reporting Issues Committee (“IFRIC”). The principal accounting policies applied in the preparation of these financial statements are set out below. These policies have been consistently applied to all years presented, unless otherwise stated.
These financial statements have been prepared on a historical cost basis, modified where applicable. In addition, these financial statements have been prepared using the accrual basis of accounting except for cash flow information. They were authorized for issue by the Company’s board of directors on August 3, 2021.
F-27
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS
Property and Equipment
Property and equipment are recorded at cost less accumulated depreciation. Expenditures that extend the life of the asset are capitalized and depreciated. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the assets. Maintenance and repairs are charged to expense as incurred; cost of major additions and betterments are capitalized. Leasehold improvements are depreciated on a straight-line basis over the lesser of the length of the lease and the estimated useful life of the assets. Upon sale or other disposition of a depreciable asset, cost and accumulated depreciation are removed from property and equipment and any gain or loss is reflected as a gain or loss from operations.
The estimated useful lives are:
Laboratory equipment |
5 – 10 years |
|||
Office equipment |
3 – 10 years |
|||
Right-of-use assets |
Lease terms |
Impairment of Assets
The Company performs impairment tests on its long-lived assets, including property and equipment when new events or circumstances occur, or when new information becomes available relating to their recoverability. When the recoverable amount of each separately identifiable asset or cash generating unit (“CGU”) is less than its carrying value, the asset or CGU’s assets are written down to their recoverable amount with the impairment loss charged against profit or loss. A reversal of the impairment loss in a subsequent period will be charged against profit or loss if there is a significant reversal of the circumstances that caused the original impairment. The impairment will be reversed up to the amount of depreciated carrying value that would have otherwise occurred if the impairment loss had not occurred.
The CGU’s recoverable amount is evaluated using fair value less costs to sell calculations. In calculating the recoverable amount, the Company utilizes discounted cash flow techniques to determine fair value when it is not possible to determine fair value from active markets or a written offer to purchase. Management calculates the discounted cash flows based upon its best estimate of a number of economic, operating, engineering, environmental, political and social assumptions. Any changes in the assumptions due to changing circumstances may affect the calculation of the recoverable amount.
Leases
The Company assesses at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Company applies a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. The Company recognizes lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying assets.
At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. Lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. Lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating the lease, if the lease term reflects the Company exercising the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, the Company
F-28
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)
uses its incremental borrowing rate at the lease commencement date because the interest rate implicit in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset.
The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.
Revenue Recognition
The Company’s revenue is primarily derived through providing genetic diagnostic tests to customers. The Company recognizes revenue in accordance with International Financial Reporting Standards (“IFRS”) 15 “Revenue from Contracts with Customers”.
In accordance with IFRS 15, revenue is recognized upon the satisfaction of performance obligations. Performance obligations are satisfied at the point at which control of the promised goods or services are transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to receive for those goods and services.
The Company provides a genetic diagnostic testing service and testing kits which are not considered separately identifiable from each other as the Company uses the testing kits to collect samples in order to deliver the diagnostic test results to the customer. Accordingly, the Company has one performance obligation which is fulfilled upon the delivery of the test results to the customer and revenue is recognized at that point in time.
Research and Development
Expenditure on research activities, undertaken with the prospect of gaining new technical knowledge and understanding, is recognized in profit or loss as incurred.
Development activities involve a plan or design for the production of new or substantially improved products and processes. Development expenditure is capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to and has sufficient resources to complete development and to use or sell the asset. The expenditure capitalized includes the cost of materials, direct labour, overhead costs that are directly attributable to preparing the asset for its intended use, and borrowing costs on qualifying assets. Other development expenditures are recognized in profit or loss as incurred.
Research and development costs incurred subsequent to the acquisition of externally acquired intangible assets and on internally generated intangible assets are accounted for as research and development costs.
F-29
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)
Government Grants
The Company receives government grants related to research and development programs. Government grants are recognized only when there is reasonable assurance that (a) the Company has complied with any conditions attached to the grant and (b) the grant will be received. Government grant income is recognized in the statement of operations as Other Income.
Financial Instruments
(a) Classification
The Company classifies its financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. The Company determines the classification of financial assets at initial recognition. The classification of debt instruments is driven by the Company’s business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL. For other equity instruments, on the day of acquisition the Company can make an irrevocable election (on an instrument-by-instrument basis) to designate them as at FVTOCI. Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or if the Company has opted to measure them at FVTPL.
(b) Measurement
Financial assets and liabilities at amortized cost
Financial assets and liabilities at amortized cost are initially recognized at fair value plus or minus transaction costs, respectively, and subsequently carried at amortized cost less any impairment.
Financial assets and liabilities at FVTPL
Financial assets and liabilities carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statements of loss and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets and liabilities held at FVTPL are included in the statements of loss and comprehensive loss in the period in which they arise.
Debt investments at FVTOCI
These assets are subsequently measured at fair value. Interest income calculated using the effective interest method, foreign exchange gains and losses and impairment are recognized in profit or loss. Other net gains and losses are recognized in OCI. On derecognition, gains and losses accumulated in OCI are reclassified to profit or loss.
Equity investments at FVTOCI
These assets are subsequently measured at fair value. Dividends are recognized as income in profit or loss unless the dividend clearly represents a recovery of part of the cost of the investment. Other net gains and losses are recognized in OCI and are never reclassified to profit or loss.
(c) Impairment of financial assets at amortized cost
The Company recognizes a loss allowance for expected credit losses on financial assets that are measured at amortized cost. At each reporting date, the Company measures the loss allowance for the financial asset at an amount equal to the lifetime expected credit losses if the credit risk on the financial asset has increased
F-30
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)
significantly since initial recognition. If at the reporting date, the financial asset has not increased significantly since initial recognition, the Company measures the loss allowance for the financial asset at an amount equal to the twelve month expected credit losses. The Company shall recognize in the statements of loss and comprehensive loss, as an impairment gain or loss, the amount of expected credit losses (or reversal) that is required to adjust the loss allowance at the reporting date to the amount that is required to be recognized.
(d) Derecognition
Financial assets
The Company derecognizes financial assets only when the contractual rights to cash flows from the financial assets expire, or when it transfers the financial assets and substantially all of the associated risks and rewards of ownership to another entity.
Financial liabilities
The Company derecognizes a financial liability when its contractual obligations are discharged or cancelled, or expire. The Company also derecognizes a financial liability when the terms of the liability are modified such that the terms and/or cash flows of the modified instrument are substantially different, in which case a new financial liability based on the modified terms is recognized at fair value.
Gains and losses on derecognition are generally recognized in profit or loss.
Foreign Currency Translation
The functional currency is determined using the currency of the primary economic environment in which that entity operates. The functional, as determined by management, of the Company is the Euro (EUR).
Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. Foreign currency monetary items are translated at the period-end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction. Non-monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined.
Exchange differences arising on the translation of monetary items or on settlement of monetary items are recognized in the statement of comprehensive loss in the period in which they arise, except where deferred in equity as a qualifying cash flow or net investment hedge.
Exchange differences arising on the translation of non-monetary items are recognized in other comprehensive income to the extent that gains and losses arising on those non-monetary items are also recognized in other comprehensive income. Where the non-monetary gain or loss is recognized in profit or loss, the exchange component is also recognized in profit or loss.
The Company’s presentation currency is the US dollar. For presentation purposes, all amounts are translated from the Euro functional currency to the US dollar presentation currency for each period using the exchange rate at the end of each reporting period for the statement of financial position. Revenues and expenses are translated on the basis of average exchange rates during the year.
Exchange gains and losses arising from translation to the Company’s presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss).
F-31
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)
Income Taxes
Current income tax:
Current income tax assets and liabilities for the current period are measured at the amount expected to be recovered from or paid to taxation authorities. The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted, at the reporting date, in the countries where the Company operates and generates taxable income.
Current income tax relating to items recognized directly in other comprehensive income or equity is recognized in other comprehensive income or equity and not in profit or loss. Management periodically evaluates positions taken in the tax returns with respect to situations in which applicable tax regulations are subject to interpretation and establishes provisions where appropriate.
Deferred tax:
Deferred tax is recognized on temporary differences at the reporting date arising between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes.
The carrying amount of deferred tax assets is reviewed at the end of each reporting period and recognized only to the extent that it is probable that future taxable income will be available to allow all or part of the temporary differences to be utilized.
Deferred tax assets and liabilities are measured at the tax rates that are expected to apply to the year when the asset is realized or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted and are expected to apply by the end of the reporting period. Deferred tax assets and deferred income tax liabilities are offset if a legally enforceable right exists to set off current tax assets against current income tax liabilities and the deferred taxes relate to the same taxable entity and the same taxation authority.
Government Grants
Government grants are recognized when there is reasonable assurance that the grant will be received and that the Company will comply with the conditions attached to them. When the grant relates to an expense item, it is recognized as income on a systematic basis over the periods that the related costs, for which it is intended to compensate, are expensed. When the grant relates to an asset, it is recognized as income in equal amounts over the expected useful life of the related asset.
Loans received from government grants are recognized initially at fair value, with the difference between the fair value of the loan based on prevailing market interest rates and the amount received recorded as a government grant gain in the statements of loss and comprehensive loss.
Loss per Share
Basic loss per share is calculated by dividing the loss attributable to common shareholders by the weighted average number of common shares outstanding in the period. For all periods presented, the loss attributable to common shareholders equals the reported loss attributable to owners of the Company.
F-32
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)
Critical Accounting Estimates and Significant Management Judgments
The preparation of financial statements in accordance with IFRS requires the Company to use judgment in applying its accounting policies and make estimates and assumptions about reported amounts at the date of the financial statements and in the future. The Company’s management reviews these estimates and underlying assumptions on an ongoing basis, based on experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. Revisions to estimates are adjusted for prospectively in the period in which the estimates are revised.
Useful lives of property and equipment
Estimates of the useful lives of property and equipment are based on the period over which the assets are expected to be available for use. The estimated useful lives are reviewed annually and are updated if expectations differ from previous estimates due to physical wear and tear, technical or commercial obsolescence, not electing to exercise renewal options on Leases, and legal or other limits on the use of the relevant assets. In addition, the estimation of the useful lives of the relevant assets may be based on internal technical evaluation and experience with similar assets. It is possible, however, that future results of operations could be materially affected by changes in the estimates brought about by changes in the factors mentioned above. The amounts and timing of recorded expenses for any period would be affected by changes in these factors and circumstances. A reduction in the estimated useful lives of the property and equipment would increase the recorded expenses and decrease the non-current assets.
Provision for expected credit losses on trade receivables
The provision for expected credit losses on trade receivables are estimated based on historical information, customer concentrations, customer solvency, current economic and geographical trends, and changes in customer payment terms and practices. The Company will calibrate its provision matrix to adjust the historical credit loss experience with forward-looking information. The assessment of the correlation between historical observed default rates, forecast economic conditions and expected credit losses is a significant estimate. The amount of expected credit losses is sensitive to changes in circumstances and of forecast economic conditions. The Company’s historical credit loss experience and forecast of economic conditions may also not be representative of customer’s actual default in the future.
Estimating the incremental borrowing rate on leases
The Company cannot readily determine the interest rate implicit in leases where it is the lessee. As such, it uses its incremental borrowing rate (“IBR”) to measure lease liabilities. The IBR is the rate of interest that the Company would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of comparable value to the right-of-use asset in a similar economic environment. IBR therefore reflects what the Company “would have to pay”, which requires estimation when no observable rates are available or where the applicable rates need to be adjusted to reflect the terms and conditions of the lease. The Company estimates the IBR using observable inputs (such as market interest rates) when available and is required to make certain entity-specific estimates.
F-33
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES AND JUDGMENTS (cont.)
Other significant judgments
The preparation of these financial statements in accordance with IFRS requires the Company to make judgments, apart from those involving estimates, in applying accounting policies. The most significant judgments in applying the Company’s financial statements include:
• |
The assessment of the Company’s ability to continue as a going concern and whether there are events or conditions that may give rise to significant uncertainty; |
|||
• |
The determination of the lease term of contracts with renewal and termination options; |
|||
• |
Determination of the extent to which it is probable that future taxable income will be available to allow all or part of the temporary differences to be utilized; and |
|||
• |
Whether there are indicators of impairment of the Company’s long-lived assets. |
4. TRADE AND OTHER RECEIVABLES
December 31, 2020 |
December 31, 2019 |
|||||||||
Accounts receivable |
$ |
47,149 |
|
$ |
81,661 |
|
||||
Less: allowance for doubtful accounts |
|
(3,066 |
) |
|
(41,450 |
) |
||||
Accounts receivable, net |
|
44,083 |
|
|
40,211 |
|
||||
Other |
|
158 |
|
|
589 |
|
||||
$ |
44,241 |
|
$ |
40,800 |
|
5. PROPERTY AND EQUIPMENT
Property and equipment consisted of the following as of December 31, 2020, December 31, 2019 and January 1, 2019:
Laboratory Equipment |
Office Equipment |
Total |
||||||||||||
Cost |
|
|
|
|
|
|
||||||||
Balance at January 1, 2019 |
$ |
55,110 |
|
$ |
10,243 |
|
$ |
65,353 |
|
|||||
Effects of currency translation |
|
(1,184 |
) |
|
(221 |
) |
|
(1,405 |
) |
|||||
Balance at December 31, 2019 |
$ |
53,926 |
|
$ |
10,022 |
|
$ |
63,948 |
|
|||||
Additions |
|
7,949 |
|
|
1,739 |
|
|
9,685 |
|
|||||
Effects of currency translation |
|
5,637 |
|
|
1,067 |
|
|
6,704 |
|
|||||
Balance at December 31, 2020 |
$ |
67,512 |
|
$ |
12,825 |
|
$ |
80,337 |
|
|||||
|
|
|
|
|
|
|||||||||
Accumulated depreciation |
|
|
|
|
|
|
||||||||
Balance at January 1, 2019 |
$ |
33,003 |
|
$ |
4,836 |
|
$ |
37,839 |
|
|||||
Depreciation |
|
3,312 |
|
|
787 |
|
|
4,099 |
|
|||||
Effects of currency translation |
|
(703 |
) |
|
(102 |
) |
|
(805 |
) |
|||||
Balance at December 31, 2019 |
$ |
35,612 |
|
$ |
5,521 |
|
$ |
41,133 |
|
|||||
Depreciation |
|
3,818 |
|
|
852 |
|
|
4,670 |
|
|||||
Effects of currency translation |
|
3,616 |
|
|
581 |
|
|
4,197 |
|
|||||
Balance at December 31, 2020 |
$ |
43,046 |
|
$ |
6,954 |
|
$ |
50,000 |
|
|||||
|
|
|
|
|
|
|||||||||
Net book value |
|
|
|
|
|
|
||||||||
December 31, 2019 |
$ |
18,314 |
|
$ |
4,501 |
|
$ |
22,815 |
|
|||||
December 31, 2020 |
$ |
24,466 |
|
$ |
5,871 |
|
$ |
30,337 |
|
F-34
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
5. PROPERTY AND EQUIPMENT (cont.)
As of December 31, 2020, December 31, 2019 and January 1, 2019, management assessed that there were no events or changes in circumstances that would require impairment testing.
6. LEASES
Right-of-Use Assets
The Company’s leases certain assets under lease agreements.
Office Equipment |
Laboratory Equipment |
Office |
Total |
|||||||||||||
Cost |
|
|
|
|
|
|
||||||||||
Balance at January 1, 2019 |
$ |
— |
$ |
— |
$ |
492,760 |
|
$ |
492,760 |
|
||||||
Additions |
|
— |
|
— |
|
— |
|
|
— |
|
||||||
Effects of currency translation |
|
— |
|
— |
|
(10,589 |
) |
|
(10,589 |
) |
||||||
Balance at December 31, 2019 |
$ |
— |
$ |
— |
$ |
|
$ |
|
||||||||
Additions |
|
29,395 |
|
10,455 |
|
— |
|
|
39,850 |
|
||||||
Effects of currency translation |
|
2,189 |
|
779 |
|
45,114 |
|
|
48,082 |
|
||||||
Balance at December 31, 2020 |
$ |
31,584 |
$ |
11,234 |
$ |
527,285 |
|
$ |
570,103 |
|
||||||
|
|
|
|
|
|
|||||||||||
Accumulated depreciation |
|
|
|
|
|
|
||||||||||
Balance at January 1, 2019 |
$ |
— |
$ |
— |
$ |
— |
|
$ |
— |
|
||||||
Depreciation |
|
— |
|
— |
|
48,943 |
|
|
48,943 |
|
||||||
Effects of currency translation |
|
— |
|
— |
|
90 |
|
|
90 |
|
||||||
Balance at December 31, 2019 |
$ |
— |
$ |
— |
$ |
49,033 |
|
$ |
49,033 |
|
||||||
Depreciation |
|
3,707 |
|
2,178 |
|
49,907 |
|
|
55,792 |
|
||||||
Effects of currency translation |
|
276 |
|
162 |
|
8,305 |
|
|
8,743 |
|
||||||
Balance at December 31, 2020 |
$ |
3,983 |
$ |
2,340 |
$ |
107,245 |
|
$ |
113,568 |
|
||||||
|
|
|
|
|
|
|||||||||||
Net book value |
|
|
|
|
|
|
||||||||||
December 31, 2019 |
$ |
— |
$ |
— |
$ |
433,138 |
|
$ |
433,138 |
|
||||||
December 31, 2020 |
$ |
27,601 |
$ |
8,894 |
$ |
420,040 |
|
$ |
456,535 |
|
As of December 31, 2020, December 31, 2019 and January 1, 2019, management assessed that there were no events or changes in circumstances that would require impairment testing.
The carrying amount of the right-of-use assets is depreciated on a straight-line basis over the life of the leases, which at December 31, 2020, had an average expected life of 8 years.
F-35
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
6. LEASES (cont.)
Lease Liabilities
The Company’s lease liabilities consists of office and laboratory equipment and office space The present value of future lease payments were measured using an incremental borrowing rate of 10% per annum as of January 1, 2019.
Total |
||||||
Balance as at January 1, 2019 |
$ |
492,760 |
|
|||
Additions |
|
— |
|
|||
Interest expenses |
|
46,543 |
|
|||
Lease payments |
|
(76,956 |
) |
|||
Effects of currency translation |
|
(10,605 |
) |
|||
As at December 31, 2019 |
$ |
451,742 |
|
|||
Additions |
|
39,850 |
|
|||
Interest expenses |
|
47,173 |
|
|||
Lease payments |
|
(86,051 |
) |
|||
Effects of currency translation |
|
42,337 |
|
|||
As at December 31, 2020 |
$ |
495,051 |
|
Lease liabilities |
December 31, 2020 |
December 31, 2019 |
||||||
Current portion |
$ |
47,611 |
$ |
33,603 |
||||
Long-term portion |
|
447,440 |
|
418,139 |
||||
Total lease liabilities |
$ |
495,051 |
$ |
451,742 |
At December 31, 2020, the Company is committed to minimum lease payments as follows:
Maturity analysis |
December 31, 2020 |
|||||
Less than one year |
$ |
94,973 |
|
|||
One year to three years |
|
189,586 |
|
|||
Three to five years |
|
180,652 |
|
|||
Greater than five years |
|
243,264 |
|
|||
Total undiscounted lease liabilities |
$ |
708,295 |
|
|||
Amount representing implicit interest |
|
(213,244 |
) |
|||
Lease obligations |
$ |
495,051 |
|
7. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
December 31, 2020 |
December 31, 2019 |
|||||||
Accounts payable |
$ |
248,576 |
$ |
200,061 |
||||
Accrued liabilities |
|
78,345 |
|
36,208 |
||||
Payroll liabilities |
|
87,075 |
|
8,192 |
||||
Value added taxes payable |
|
19,817 |
|
5,492 |
||||
$ |
433,813 |
$ |
249,953 |
F-36
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
8. CONVERTIBLE DEBT
During the years ended December 31, 2019 and 2020, the Company entered into loan agreements totalling EUR$417,133 (approximately $467,154) (the “2019 and 2020 Convertible Loans”). The 2019 and 2020 Convertible Loans bear interest at 3.5% and have a maturity date of September 30, 2022. While the 2019 and 2020 Convertible Loans are outstanding, the lenders are entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the 2019 and 2020 Convertible Loans are convertible common shares of the Company at EUR$1 per share.
The 2019 and 2020 Convertible Loans were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 2019 and 2020 Convertible Loans between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.
In November 2017, the Company entered into loan agreements with two shareholders of the Company for loans totalling EUR$80,278 (approximately $92,007) (the “2017 Convertible Loans”). The loans are convertible at the option of the lender to shares totalling 4.25% of the Company’s common shares outstanding at the time of conversion. The loans are non-interest bearing, are unsecured and are due on demand. During the year ended December 31, 2019, principal in the amount of EUR$5,000 ($5,597) was exchanged for the 2019 and 2020 Convertible Loans and EUR$5,000 ($5,597) was extinguished as the lender elected to offset the debt amount against amounts in trade receivables due to the Company.
A continuity of the Company’s convertible debt is as follows:
2019 and 2020 Convertible Loans |
2017 Convertible Loans |
Total |
||||||||||||
Balance, December 31, 2018 |
$ |
— |
|
$ |
92,007 |
|
$ |
92,007 |
|
|||||
Issued during the year |
|
450,143 |
|
|
— |
|
|
450,143 |
|
|||||
Conversion feature |
|
(91,307 |
) |
|
— |
|
|
(91,307 |
) |
|||||
Accretion |
|
4,358 |
|
|
— |
|
|
4,358 |
|
|||||
Extinguished |
|
— |
|
|
(5,597 |
) |
|
(5,597 |
) |
|||||
Exchanged |
|
5,597 |
|
|
(5,597 |
) |
|
— |
|
|||||
Effects of currency translation |
|
686 |
|
|
(1,998 |
) |
|
(1,312 |
) |
|||||
Balance, December 31, 2019 |
|
369,477 |
|
|
78,815 |
|
|
448,292 |
|
|||||
Issued during the year |
|
11,414 |
|
|
— |
|
|
11,414 |
|
|||||
Conversion feature |
|
(2,055 |
) |
|
— |
|
|
(2,055 |
) |
|||||
Accretion |
|
30,786 |
|
|
— |
|
|
30,786 |
|
|||||
Effects of currency translation |
|
37,559 |
|
|
7,374 |
|
|
44,933 |
|
|||||
Balance, December 31, 2020 |
$ |
447,181 |
|
$ |
86,189 |
|
$ |
533,370 |
|
9. LOANS PAYABLE
During the year ended December 31, 2020, the Company entered into a loan agreement for the principal amount of EUR20,000 (approximately $22,828) (the “0.1% Loan). The 0.1% Loan bears interest at 0.1% per month and is due on demand. And is secured against the Company’s trade receivables.
Between the years of 2011 to 2013, the Company received loans from related parties totalling EUR$35,000 (approximately $40,144) (the “6% Loans”). The Loans have a stated interest rate of at 6.0%. EUR$10,000 (approximately $11,461) of the loans matures on July 31, 2020 and EUR$25,000 (approximately $28,653) of the
F-37
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
9. LOANS PAYABLE (cont.)
loan matures on December 31, 2021. As the 6% Loans were received at below market interest rates, the initial fair value of the 3% Loan was determined to be EUR$21,936 (approximately $25,140), determined using an estimated effective interest rate of 11.5%.
In 2017, the Company was obtained a line of credit of up to EUR$200,000 (approximately $458,440) (the “LOC”). The LOC accrues interest of 4% on amounts drawn, and a 0.5% fee if no amounts are drawn. The LOC is available until September 30, 2020.
A continuity of the Company’s loans payable is as follows:
0.1%
|
6%
|
LOC |
Total |
||||||||||||||
Balance, December 31, 2018 |
$ |
— |
$ |
34,927 |
|
$ |
55,712 |
|
$ |
90,639 |
|
||||||
Issued during the year |
|
— |
|
— |
|
|
4,265 |
|
|
4,265 |
|
||||||
Accretion |
|
— |
|
1,876 |
|
|
— |
|
|
1,876 |
|
||||||
Effects of currency translation |
|
— |
|
(747 |
) |
|
(1,190 |
) |
|
(1,937 |
) |
||||||
Balance, December 31, 2019 |
|
— |
|
36,056 |
|
|
58,787 |
|
|
94,843 |
|
||||||
Issued during the year |
|
22,828 |
|
— |
|
|
2,506 |
|
|
25,334 |
|
||||||
Accretion |
|
— |
|
1,765 |
|
|
— |
|
|
1,765 |
|
||||||
Effects of currency translation |
|
1,700 |
|
3,505 |
|
|
5,686 |
|
|
10,891 |
|
||||||
Balance, December 31, 2020 |
$ |
24,528 |
$ |
41,326 |
|
$ |
66,979 |
|
$ |
132,833 |
|
10. SILENT PARTNERSHIPS
During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR$299,400 (approximately $341,740) (the “3% SPAs”). The Company is to repay the amount by December 31, 2025. The Company must pay a minimum of 3% interest per annum on the loans. The lender is entitled to 3% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt ; the lender does not partake in the Company’s losses. Upon the amounts coming due, the lender of the 3% SPAs have the option to demand an additional payment equal to 15% of the contribution as a final remuneration (the “Final Renumeration”). The Final Remuneration is considered to be the cost of issuing debt. The 3% SPAs were received at below market interest rates as part of a government program for COVID-19 relief. The initial fair value of the 3% SPAs was determined to be EUR$218,120 (approximately $248,966), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3% SPAs of EUR$81,280 ($92,774) has been recognized as government grant income during the period.
During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR$50,000 (approximately $57,071) (the “3.5% SPAs”). The Company is to repay the amount by June 30, 2025. The Company must pay a minimum of 3.5% interest per annum on the loans. The lender is entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the ender does not partake in the Company’s losses. The 3.5% SPAs are convertible to common shares of the Company at EUR$1 per share in the event that the Company is involved in any of the following transactions: capital increases, a share or asset deal or a public offering. Pursuant to the silent partnership agreement, the Company notified the holder, at which point the holder declined the opportunity to convert their loan into common shares. The 3.5% SPAs were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 3.5% SPAs between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.
F-38
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
10. SILENT PARTNERSHIPS (cont.)
Between the years of 2013 to 2016, the Company entered into silent partnership agreements for loans totalling EUR$798,694 (approximately $915,383) (the “8.5% SPAs”). Under the 8.5% SPAs, the Company is to repay EUR$398,634 (approximately $408,496) of the loans by June 30, 2023 and EUR$400,000 (approximately $409,859) of the loans matures on December 31, 2025. The Company must pay a minimum of 8.5% interest per annum on the loans. The lenders are entitled to 1.66% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the lenders of the 8.5% SPAs have the option to demand an additional payment equal to 30% of the principal of the loans as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8.5% SPAs was determined to be EUR$772,568 (approximately $85,440), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lenders also agreed to invest in the Company and contributed EUR676,366 (approximately $775,183) to acquire 27,752 shares of the Company between the years of 2013 and 2016. During the year ended December 31, 2020, EUR80,000 (approximately $99,527) of the 8.5% SPAs was extinguished as the lender, who is a also a customer of the Company, elected to offset the debt amount against amounts in trade receivables due to the Company. The debtor did not demand the Final Remuneration and the Company recognized a gain on the extinguishment of $8,214.
In 2010, the Company entered into a silent partnership agreement whereby the lender agreed to lend the Company EUR$300,000 (approximately $343,830) (the “8% SPA”). The Company must repay the loan by January 31, 2023. The Company must pay a minimum of 8% interest per annum on the loan. The lender is entitled to 1.95% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. At maturity, the lender of the 8% SPA has the option to demand an additional payment of up to 30% of the principal of the loan as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8% SPA was determined to be EUR$289,900 (approximately $332,254), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lender also agreed to invest in the Company and contributed EUR100,000 to acquire 2,800 shares of the Company.
A continuity of the Company’s silent partnerships is as follows:
3%
|
3.5%
|
8.5%
|
8%
|
Total |
||||||||||||||||||
Balance, December 31, 2018 |
$ |
— |
|
$ |
— |
|
$ |
1,002,907 |
|
$ |
407,415 |
|
$ |
1,410,322 |
|
|||||||
Accretion |
|
— |
|
|
— |
|
|
29,710 |
|
|
9,125 |
|
|
38,835 |
|
|||||||
Effects of currency translation |
|
— |
|
|
— |
|
|
(21,494 |
) |
|
(8,738 |
) |
|
(30,232 |
) |
|||||||
Balance, December 31, 2019 |
|
|
|
— |
|
|
1,011,123 |
|
|
407,802 |
|
|
1,418,925 |
|
||||||||
Issued during the year |
|
341,740 |
|
|
57,071 |
|
|
— |
|
|
— |
|
|
398,811 |
|
|||||||
Extinguished |
|
— |
|
|
— |
|
|
(99,527 |
) |
|
— |
|
|
(99,527 |
) |
|||||||
Discount |
|
(92,774 |
) |
|
(18,238 |
) |
|
— |
|
|
— |
|
|
(111,012 |
) |
|||||||
Accretion |
|
19,596 |
|
|
1,478 |
|
|
29,204 |
|
|
9,544 |
|
|
59,822 |
|
|||||||
Effects of currency translation |
|
19,996 |
|
|
3,002 |
|
|
89,367 |
|
|
38,866 |
|
|
151,231 |
|
|||||||
Balance, December 31, 2020 |
$ |
288,558 |
|
$ |
43,313 |
|
$ |
1,030,167 |
|
$ |
456,212 |
|
$ |
1,818,250 |
|
F-39
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
11. EQUITY
Authorized share capital
Unlimited number of common shares with a par value of EUR$1 per share. German corporate law dictates that the registered nominal amount of a GmbH entity must be at least EUR$1 per share.
Shares outstanding
As at December 31, 2020: 92,584 common shares issued and outstanding (2019 – 92,584).
There were no share capital transactions during the years ended December 31, 2020 and 2019.
12. SEGMENTED INFORMATION
The Company has one operating segment, being the provider of genetic diagnostic testing services.
13. COST OF REVENUE
December 31, 2020 |
December 31, 2019 |
|||||||
Test kit materials |
$ |
149,612 |
$ |
79,179 |
||||
Selling expenses |
|
26,696 |
|
54,101 |
||||
Maintenance of laboratory equipment |
|
56,151 |
|
39,761 |
||||
Salaries and benefits |
|
88,665 |
|
55,006 |
||||
Royalties |
|
46,017 |
|
111,940 |
||||
Depreciation of laboratory equipment |
|
3,339 |
|
2,677 |
||||
Total costs of revenue |
$ |
370,480 |
$ |
342,664 |
The royalty expense includes an approximate $66,000 decrease from 2019 to 2020. This decrease is the result of a license payment made in 2019 to record, and pay, an amount agreed to between the Company and ColoAlert A.S. for 2019 and periods prior to 2019.
14. RELATED PARTY TRANSACTIONS
Related Party Transactions
Key management personnel include those persons having authority and responsibility for planning, directing and controlling the activities of the Company as a whole. The Company has determined that key management personnel consist of members of the Company’s Board of Directors and corporate officers. The remuneration of directors and key management personnel during the year ended December 31, 2020 and 2019 was as follows:
December 31, 2020 |
December 31, 2019 |
|||||||
Salaries and benefits |
$ |
202,442 |
$ |
192,423 |
Remuneration paid to related parties other than key personnel during the year ended December 31, 2020 and 2019 was as follows:
December 31, 2020 |
December 31, 2019 |
|||||||
Salaries and benefits |
$ |
33,078 |
$ |
3,500 |
During the year ended December 31, 2020, the Company incurred interest expense of $5,658 (2019 – $4,920) on balances owing to related parties.
F-40
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
14. RELATED PARTY TRANSACTIONS (cont.)
During the year ended December 31, 2020, the Company incurred accretion expense of $2,135 (2019 – $1,916) on balances owing to related parties.
Related Party Balances
As at December 31, 2020, $1,148 (2019 – $Nil) is included in accounts payable and accrued liabilities and loans payable in relation to transactions with related parties, which are non-interest bearing, unsecured and due on demand.
As at December 31, 2020 and 2019, the entire balance of the 6% Loans of $41,326 (2019 – $36,056) were owing to shareholders of the Company (Note 8).
As at December 31, 2020, EUR$30,130 (approximately $36,951) (2019 – EUR$30,130, $33,790) and EUR40,139 (approximately $49,226) (2019 – EUR$40,139, $44,931) of the 2017 Convertible Loans were owing to the Chief Executive Officer (the “CEO”) of the Company and a major shareholder of the Company, respectively. The amounts are due on demand (Note 8).
As at December 31, 2020, EUR$5,000 (approximately $6,132) (2019 – EUR$5,000, $5,607) with a carrying value of $5,360 (2019 – 4,537) and EUR$30,000 (approximately $36,792) (2019 – EUR$30,000, $33,581) with a carrying value of $32,161 (2019 – $27,225) of the 2019 and 2020 Convertible Loans were owing to the CEO of the Company and a major shareholder of the Company, respectively. The amounts are due on September 30, 2022.
As at December 31, 2020, EUR$350,000 (approximately $429,240) (2019 – EUR$350,000, $392,516) with a carrying value of $498,481 (2019 – $442,668) of the 8.5% SPAs were owing to major shareholders of the Company. EUR$150,000 of the loan is due on June 30, 2023 and EUR$200,000 of the loan is due on December 31, 2025.
As at December 31, 2020 and 2019, the entire balance of the LOC of $66,979 (2019 – $58,787) is due to a family member of the CEO of the Company (Note 9).
15. GOVERNMENT GRANTS
The Company receives government grants related to its research and development activities. The amount of government grants received during the years ended December 31, 2020 and 2019 and recognized as research grant revenue were as follows:
Research and Development Projects |
December 31, 2020 |
December 31, 2019 |
||||||
Rapid detection of antibody-based pathogens |
$ |
91,461 |
$ |
— |
||||
Multi-marker test for the early detection of pancreatic cancer |
|
100,591 |
|
— |
||||
Microarray based on nucleic acid detection for respiratory pathogens |
|
5,995 |
|
51,511 |
||||
Genetically based rapid detection of respiratory tract infections |
|
26,087 |
|
99,503 |
||||
$ |
224,134 |
$ |
151,015 |
As of December 31, 2020, the grants for rapid detection of antibody-based pathogens and a multi-marker test for the early detection of pancreatic cancer had remaining grant balances of approximately $148,000 and $456,000, respectively.
During the year ended December 31, 2020, the Company recognized government grant income in the amount of $92,774 related to the 3% SPAs which were received at below market interest rates as part of a government program for COVID-19 relief (Note 10).
F-41
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
16. FINANCIAL INSTRUMENT RISK MANAGEMENT
Basis of Fair Value
Financial instruments measured at fair value are classified into one of three levels in the fair value hierarchy according to the relative reliability of the inputs used to estimate the fair values. The three levels of the fair value hierarchy are:
• Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities;
• Level 2 — Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly; and
• Level 3 — Inputs that are not based on observable market data.
The Company’s financial instruments consist of cash, trade and other receivables, accounts payable and accrued liabilities, lease liabilities, convertible debentures, and loans payable. With the exception of convertible debentures and loans payable, the carrying value of the Company’s financial instruments approximate their fair values due to their short-term maturities. The fair value of convertible debentures and notes payable approximate their carrying value, excluding discounts, due to minimal changes in interest rates and the Company’s credit risk since issuance of the instruments.
The Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors the risk management processes, inclusive of documented investment policies, counterparty limits, and controlling and reporting structures.
Credit Risk
The Company’s principal financial assets are cash and trade receivables. The Company’s credit risk is primarily concentrated in its cash which is held with institutions with a high credit worthiness. Management believes that the Company is not exposed to any significant credit risk with respect to its cash.
The Company mitigates its credit risk on receivables by actively managing and monitoring its receivables. The Company has been determined that no credit loss provision is required, as all amounts outstanding are considered collectible. During the year ended December 31, 2020, the Company incurred $19,411 in bad debt expense (2019 - $506). The Company mitigates credit risk by evaluating the creditworthiness of customers prior to conducting business with them and monitoring its exposure for credit losses with existing customers.
Liquidity Risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due. The Company has a planning and budgeting process in place to help determine the funds required to support the Company’s normal operating requirements on an ongoing basis. As at December 31, 2020, the Company had an unrestricted cash balance of $122,568 to settle current liabilities of $814,491.
Historically, the Company’s primary source of funding has been the issuance of equity securities for cash, primarily through the issuance of preferred shares and credit facility borrowings. The Company’s access to financing is always uncertain. There can be no assurance of continued access to significant equity funding.
F-42
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
16. FINANCIAL INSTRUMENT RISK MANAGEMENT (cont.)
The following is an analysis of the contractual maturities of the Company’s financial liabilities as at December 31, 2020:
Within
|
Between one and
|
More than
|
|||||||||
Accounts payable and accrued liabilities |
$ |
415,570 |
$ |
— |
$ |
— |
|||||
Convertible debt |
|
86,189 |
|
511,571 |
|
— |
|||||
Loans payable |
|
312,732 |
|
— |
|
— |
|||||
Silent partnerships |
|
— |
|
1,775,869 |
|
— |
|||||
Lease liabilities |
|
94,793 |
|
370,238 |
|
243,264 |
|||||
$ |
814,491 |
$ |
2,287,440 |
$ |
243,264 |
Foreign Exchange Risk
Foreign currency risk is the risk that the fair values of future cash flows of a financial instrument will fluctuate because they are denominated in currencies that differ from the respective functional currency. The Company is not exposed to currency risk as it does not hold any financial assets or liabilities in foreign denominated currencies.
Interest Rate Risk
Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company is not exposed to interest rate risk as its financial liabilities carry interest at fixed rates.
Capital Management
In the management of capital, the Company includes components of stockholders’ equity. The Company aims to manage its capital resources to ensure financial strength and to maximize its financial flexibility by maintaining strong liquidity and by utilizing alternative sources of capital including equity, debt and bank loans or lines of credit to fund continued growth. The Company sets the amount of capital in proportion to risk and based on the availability of funding sources. The Company manages the capital structure and makes adjustments to it in light of changes in economic conditions and the risk characteristics of the underlying assets. As a young growth company, issuance of equity has been the primary source of capital to date. Additional debt and/or equity financing may be pursued in future as deemed appropriate to balance debt and equity. To maintain or adjust the capital structure, the Company may issue new shares, take on additional debt or sell assets to reduce debt.
17. CONCENTRATIONS
Major customers are defined as customers that each individually account for greater than 10% of the Company’s annual revenues. For the year ended December 31, 2020, the Company had revenue from three major customers (2019 — four major customers) that accounted for approximately 46% (2019 – $59%) of revenue.
F-43
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
18. INCOME TAXES
The provision for income taxes differs from the amount that would have resulted in applying the combined federal statutory tax rate as follows:
December 31, 2020 |
December 31, 2019 |
|||||||||
Net loss for the period |
$ |
(569,619 |
) |
$ |
(957,055 |
) |
||||
Statutory income tax rate |
|
31.2 |
% |
|
31.2 |
% |
||||
Expected in tax recovery at statutory income tax rates |
$ |
(177,814 |
) |
$ |
(298,889 |
) |
||||
Permanent differences |
|
14,390 |
|
|
3,498 |
|
||||
Difference in tax rates, foreign exchange, and other |
|
(112,435 |
) |
|
16,485 |
|
||||
Change in deferred tax assets not recognized |
|
275,859 |
|
|
278,906 |
|
||||
Income tax recovery |
$ |
— |
|
$ |
— |
|
Temporary differences that give rise to the following deferred tax assets and liabilities at are:
December 31, 2020 |
December 31, 2019 |
|||||||||
Deferred tax assets |
|
|
|
|
||||||
Net operating loss carryforwards |
$ |
1,347,532 |
|
$ |
1,071,673 |
|
||||
Deferred tax assets not recognized |
|
(1,347,532 |
) |
|
(1,071,673 |
) |
||||
Net deferred tax asset |
$ |
— |
|
$ |
— |
|
As at December 31, 2020, the Company has approximately $4,314,863 (2019 – $3,752,610) of non-capital losses in Germany that may be used to offset future taxable income. These losses may be carried forward on an indefinite basis and do not expire. The Company has not recognized the deferred tax assets due to the uncertainty around utilizing all of the losses carry-forwards.
Tax attributes are subject to review, and potential adjustment, by tax authorities.
19. OPERATING EXPENSES
For the years ended December 31, 2020 and 2019, operating expenses consisted of the follows,
General and administrative |
2020 |
2019 |
||||||
Bad Debt |
$ |
506 |
$ |
19,411 |
||||
Consulting |
|
2,179 |
|
68,424 |
||||
Depreciation |
|
26,069 |
|
20,666 |
||||
Office |
|
55,497 |
|
45,363 |
||||
Professional Fees |
|
20,020 |
|
36,997 |
||||
Salaries and Benefits |
|
268,545 |
|
223,495 |
||||
Travel and entertainment |
|
1,753 |
|
14,506 |
||||
$ |
374,569 |
$ |
428,862 |
Research and development |
2020 |
2019 |
||||||
Depreciation |
$ |
23,220 |
$ |
17,867 |
||||
Office |
|
49,432 |
|
39,221 |
||||
Salaries and Benefits |
|
239,199 |
|
193,228 |
||||
$ |
311,851 |
$ |
250,316 |
F-44
PharmGenomics GmbH
NOTES TO THE FINANCIAL STATEMENTS
(Expressed in US dollars)
December 31, 2020 and 2019
19. OPERATING EXPENSES (cont.)
Sales and marketing |
2020 |
2019 |
||||||
Advertising |
$ |
5,187 |
$ |
15,690 |
||||
Depreciation |
|
7,833 |
|
11,833 |
||||
Office |
|
16,674 |
|
25,973 |
||||
Salaries and Benefits |
|
80,686 |
|
127,964 |
||||
$ |
110,380 |
$ |
181,460 |
20. SUBSEQUENT EVENTS
Management evaluated all additional events subsequent to the balance sheet date through to August 3, 2021, the date the consolidated financial statements were available to be issued, and determined the following items:
• Subsequent to the year ended December 31, 2020, EUR$387,133 (approximately $474,780) of the 2019 and 2020 Convertible Loans and EUR$30,139 (approximately $36,962) of the 2017 Convertible Loans were converted to 13,985 shares of the Company. 7,500 of the shares issued for the settlement of the Convertible Loans were held by the Company as at December 31, 2020 and transferred to the debtholders. The Company issued 6,485 new shares to satisfy the remainder of the obligation.
• On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) with Mainz Biomed B.V. (“Mainz”), which is a private company with limited liability under Dutch law incorporated for the purpose of acquiring the Company. Mainz intends to apply to list its shares on the Nasdaq along with a concurrent financing of a minimum $7 million and a maximum of $10 million at a price of $5 per share. Under the Contribution Agreement, 100% of the shares of the Company will be acquired in exchange for 6,000,000 shares of Mainz. Upon the closing of the Contribution Agreement, the Company will become a wholly owned subsidiary of Mainz and the former shareholders of the Company will hold approximately 62% of the outstanding shares of Mainz.
F-45
PharmGenomics GmbH
UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
JUNE 30, 2021
(Expressed in US Dollars)
UNAUDITED CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(Expressed in US Dollars)
Note |
June 30,
|
December 31, 2020 |
||||||||
ASSETS |
|
|
|
|
||||||
Current |
|
|
|
|
||||||
Cash |
$ |
195,165 |
|
$ |
122,568 |
|
||||
Trade and other receivables |
4 |
|
74,536 |
|
|
44,241 |
|
|||
Prepaid expenses |
|
11,906 |
|
|
19,589 |
|
||||
|
281,607 |
|
|
186,398 |
|
|||||
Non-current |
|
|
|
|
||||||
Property and equipment |
5 |
|
30,660 |
|
|
30,337 |
|
|||
Right-of-use asset |
6 |
|
422,205 |
|
|
456,535 |
|
|||
Total assets |
$ |
734,472 |
|
$ |
673,270 |
|
||||
|
|
|
|
|||||||
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY |
|
|
|
|
||||||
Current |
|
|
|
|
||||||
Accounts payable and accrued liabilities |
7 |
$ |
442,657 |
|
$ |
433,813 |
|
|||
Deferred revenue |
|
1,458 |
|
|
1,508 |
|
||||
Convertible debt – related party |
8 |
|
47,569 |
|
|
86,189 |
|
|||
Loans payable |
9 |
|
23,702 |
|
|
24,527 |
|
|||
Loans payable – related party |
9 |
|
105,414 |
|
|
108,306 |
|
|||
Lease liabilities |
|
51,251 |
|
|
47,611 |
|
||||
|
672,051 |
|
|
701,954 |
|
|||||
Non-current |
|
|
|
|
||||||
Convertible debt |
8 |
|
— |
|
|
409,660 |
|
|||
Convertible debt – related party |
8 |
|
32,287 |
|
|
37,521 |
|
|||
Silent partnerships |
10 |
|
1,537,826 |
|
|
1,319,769 |
|
|||
Silent partnerships – related party |
10 |
|
488,726 |
|
|
498,481 |
|
|||
Lease liabilities |
6 |
|
415,658 |
|
|
447,440 |
|
|||
Total liabilities |
|
3,146,548 |
|
|
3,414,825 |
|
||||
|
|
|
|
|||||||
Deficiency |
|
|
|
|
||||||
Share capital |
|
114,010 |
|
|
106,111 |
|
||||
Reserves |
|
2,810,022 |
|
|
2,309,684 |
|
||||
Accumulated deficit |
|
(5,216,581 |
) |
|
(4,954,860 |
) |
||||
Accumulated other comprehensive income |
|
(119,527 |
) |
|
(202,490 |
) |
||||
Total stockholders’ deficiency |
|
(2,412,076 |
) |
|
(2,741,555 |
) |
||||
Total liabilities and stockholders’ deficiency |
$ |
734,472 |
|
$ |
673,270 |
|
Nature of operations and going concern (Note 1)
Subsequent events (Note 18)
The accompanying notes are an integral part of these unaudited condensed financial statements.
F-47
UNAUDITED CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Expressed in US Dollars)
Note |
2021 |
Six months ended
|
||||||||
|
|
|
|
|||||||
Revenue |
16 |
$ |
417,311 |
|
$ |
166,701 |
|
|||
Cost of revenue |
13 |
|
(240,954 |
) |
|
(152,285 |
) |
|||
Gross profit |
|
176,357 |
|
|
14,416 |
|
||||
|
|
|
|
|||||||
Operating expenses |
|
|
|
|
||||||
General and administrative |
20 |
|
199,481 |
|
|
179,438 |
|
|||
Research and development |
20 |
|
160,531 |
|
|
144,330 |
|
|||
Sales and marketing |
17,20 |
|
70,979 |
|
|
51,575 |
|
|||
|
430,991 |
|
|
375,343 |
|
|||||
|
|
|
|
|||||||
Other income (expense) |
|
|
|
|
||||||
Accretion expense |
8,9,10 |
|
(95,687 |
) |
|
(34,372 |
) |
|||
Government grant – research and development |
9 |
|
143,712 |
|
|
96,236 |
|
|||
Government grant – below market financing |
10 |
|
1,897 |
|
|
— |
|
|||
Interest expense |
15 |
|
(73,364 |
) |
|
(64,291 |
) |
|||
Gain on debt extinguishment |
|
— |
|
|
7,932 |
|
||||
Other income |
|
16,355 |
|
|
15,361 |
|
||||
|
(7,087 |
) |
|
20,866 |
|
|||||
|
|
|
|
|||||||
Net loss |
$ |
(261,721 |
) |
$ |
(340,061 |
) |
||||
|
|
|
|
|||||||
Foreign currency translation |
|
82,963 |
|
|
(29,550 |
) |
||||
Total comprehensive loss |
|
(178,758 |
) |
|
(369,611 |
) |
||||
|
|
|
|
|||||||
Loss per share – Basic and diluted |
$ |
(2.51 |
) |
$ |
(3.67 |
) |
||||
Weighted average number of common shares outstanding – basic and diluted |
|
98,281 |
|
|
92,584 |
|
The accompanying notes are an integral part of these unaudited condensed financial statements.
F-48
UNAUDITED CONDENSED INTERIM STATEMENTS OF CHANGES IN (DEFICIENCY) EQUITY
(Expressed in US Dollars)
For the six months ended June 30, 2021
|
Reserves |
Accumulated deficit |
Accumulated
|
Total |
||||||||||||||||
Number of
|
Amount |
|||||||||||||||||||
Balance, December 31, 2020 |
92,584 |
$ |
106,111 |
$ |
2,309,684 |
$ |
(4,954,860 |
) |
$ |
(202,490 |
) |
$ |
(2,741,555 |
) |
||||||
Shares issued for conversion of debt (Note 8, 11) |
6,485 |
|
7,899 |
|
500,338 |
|
— |
|
|
— |
|
|
508,237 |
|
||||||
Net loss |
— |
|
— |
|
— |
|
(261,721 |
) |
|
— |
|
|
(261,721 |
) |
||||||
Currency translation |
— |
|
— |
|
— |
|
— |
|
|
82,963 |
|
|
82,963 |
|
||||||
Balance, June 30, 2021 |
99,069 |
$ |
114,010 |
$ |
2,810,022 |
$ |
(5,216,581 |
) |
$ |
(119,527 |
) |
$ |
(2,412,076 |
) |
For the six months ended June 30, 2020
|
Reserves |
Accumulated
|
Accumulated
|
Total |
||||||||||||||||
Number of
|
Amount |
|||||||||||||||||||
Balance, December 31, 2019 |
92,584 |
$ |
106,111 |
$ |
2,289,392 |
$ |
(4,367,965 |
) |
$ |
22,166 |
|
$ |
(1,950,296 |
) |
||||||
Debt conversion feature (Note 8) |
— |
|
— |
|
20,292 |
|
— |
|
|
— |
|
|
20,292 |
|
||||||
Net loss |
— |
|
— |
|
— |
|
(340,061 |
) |
|
— |
|
|
(340,061 |
) |
||||||
Currency translation |
— |
|
— |
|
— |
|
— |
|
|
(29,550 |
) |
|
(29,550 |
) |
||||||
Balance, June 30, 2020 |
92,584 |
$ |
106,111 |
$ |
2,309,684 |
$ |
(4,708,026 |
) |
$ |
(7,384 |
) |
$ |
(2,299,615 |
) |
The accompanying notes are an integral part of these unaudited condensed financial statements.
F-49
UNAUDITED CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Expressed in US Dollars)
For the six months ended June 30, 2021 and 2020
Six months ended
|
||||||||
2021 |
2020 |
|||||||
Cash flows from operating activities |
|
|
|
|
||||
Net loss |
$ |
(261,721 |
) |
$ |
(340,061 |
) |
||
Items not affecting cash: |
|
|
|
|
||||
Depreciation and amortization |
|
34,835 |
|
|
28,073 |
|
||
Accretion expense |
|
95,687 |
|
|
34,372 |
|
||
|
|
|
|
|||||
Changes in non-cash working capital |
|
|
|
|
||||
Trade and other receivables |
|
(32,325 |
) |
|
(62,138 |
) |
||
Prepaid expenses and other assets |
|
7,143 |
|
|
7,716 |
|
||
Accounts payable and accrued liabilities |
|
23,851 |
|
|
145,393 |
|
||
Deferred revenue |
|
— |
|
|
(1,101 |
) |
||
|
|
|
|
|||||
Net cash flows used in operating activities |
|
(132,530 |
) |
|
(187,746 |
) |
||
|
|
|
|
|||||
Cash flows from investing activities |
|
|
|
|
||||
Purchases of property and equipment |
|
(4,580 |
) |
|
(5,251 |
) |
||
|
|
|
|
|||||
Net cash flows used in investing activities |
|
(4,580 |
) |
|
(5,251 |
) |
||
|
|
|
|
|||||
Cash flows from financing activities |
|
|
|
|
||||
Proceeds received from convertible debt |
|
— |
|
|
11,023 |
|
||
Proceeds received from silent partnerships |
|
241,040 |
|
|
55,115 |
|
||
Repayment of principal portion of lease obligations |
|
(24,011 |
) |
|
(17,690 |
) |
||
|
|
|
|
|||||
Net cash flows provided by financing activities |
|
217,029 |
|
|
48,448 |
|
||
|
|
|
|
|||||
Change in cash |
$ |
79,919 |
|
$ |
(144,549 |
) |
||
|
|
|
|
|||||
Effects of currency translation on cash |
|
(7,322 |
) |
|
9,419 |
|
||
|
|
|
|
|||||
Cash |
|
|
|
|
||||
Beginning of period |
$ |
122,568 |
|
$ |
203,588 |
|
||
End of period |
$ |
195,165 |
|
$ |
68,458 |
|
||
|
|
|
|
|||||
Supplemental cash flow disclosure |
|
|
|
|
||||
Interest paid |
$ |
23,959 |
|
$ |
21,914 |
|
||
Right of use asset additions |
$ |
12,346 |
|
$ |
38,485 |
|
||
Capital shares issued for conversion debt |
$ |
508,237 |
|
$ |
— |
|
The accompanying notes are an integral part of these unaudited condensed financial statements.
F-50
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
1. NATURE OF OPERATIONS AND GOING CONCERN
PharmGenomics GmbH (the “Company”), is a limited liability company based in Mainz, Germany and was incorporated in Germany under the laws of Germany. The Company develops in-vitro diagnostic and research use only tests for clinical diagnostics in the area of human genetics, focusing in the areas of personalized medicine. The Company also offers genotyping services. The registered office of the Company is located at Sirius Gutenberg Park, Robert-Koch-Str.50, 55129 Mainz, Germany.
The Company has recurring losses, a working capital deficiency of $390,444, accumulated deficit totalling $5,219,966 and negative cash flows used in operating activities of $134,427 as of and for the six months ended June 30, 2021. The Company has the ability to reduce discretionary spending and may also receive additional financial support from the current investor group and certain executives that have the financial ability and interest to fund any financial shortfalls. Other strategic options may be available to the Company under certain circumstances. As a result of the actions noted above, management believes that it will have sufficient working capital to meet its planned operating cash flow requirements.
On March 11, 2020, the outbreak of the novel strain of coronavirus specifically identified as “COVID-19” was declared a pandemic by the World Health Organization. The outbreak has resulted in governments worldwide enacting emergency measures to combat the spread of the virus which in turn have caused material disruption to business globally. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Company in future periods.
These condensed interim financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. These condensed interim financial statements do not reflect the adjustments to the carrying values of assets and liabilities, the reported revenues and expenses, and the condensed interim statement of financial position classifications used, that would be necessary if the Company were unable to realize its assets and settle its liabilities as a going concern in the normal course of operations. Such adjustments could be material.
2. BASIS OF PRESENTATION
Basis of Presentation and Statement of Compliance
These condensed interim financial statements, including comparatives, have been prepared in accordance with International Accounting Standards (“IAS”) 34, “Interim Financial Reporting” using accounting policies consistent with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and International Financial Reporting Interpretations Committee (“IFRIC”). These condensed interim financial statements do not include all of the information required of a full set of annual financial statements and is intended to provide users with an update in relation to events and transactions that are significant to an understanding of the changes in financial position and performance of the Company since the end of the last annual reporting period. It is therefore recommended that these condensed interim financial statements be read in conjunction with the annual financial statements of the Company for the year ended December 31, 2020 and notes thereto contained in the Company’s Form F-1.
F-51
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
2. BASIS OF PRESENTATION (cont.)
These condensed interim financial statements have been prepared on a historical cost basis, modified where applicable. In addition, these condensed interim financial statements have been prepared using the accrual basis of accounting except for cash flow information.
The condensed interim financial statements were authorized for issuance by the Managing Directors on September 30, 2021.
3. CRITICAL ACCOUNTING ESTIMATES AND SIGNIFICANT MANAGEMENT JUDGMENTS
The preparation of financial statements in accordance with IFRS requires the Company to use judgment in applying its accounting policies and make estimates and assumptions about reported amounts at the date of the financial statements and in the future. The Company’s management reviews these estimates and underlying assumptions on an ongoing basis, based on experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. Revisions to estimates are adjusted for prospectively in the period in which the estimates are revised.
Useful lives of property and equipment
Estimates of the useful lives of property and equipment are based on the period over which the assets are expected to be available for use. The estimated useful lives are reviewed annually and are updated if expectations differ from previous estimates due to physical wear and tear, technical or commercial obsolescence, not electing to exercise renewal options on Leases, and legal or other limits on the use of the relevant assets. In addition, the estimation of the useful lives of the relevant assets may be based on internal technical evaluation and experience with similar assets. It is possible, however, that future results of operations could be materially affected by changes in the estimates brought about by changes in the factors mentioned above. The amounts and timing of recorded expenses for any period would be affected by changes in these factors and circumstances. A reduction in the estimated useful lives of the property and equipment would increase the recorded expenses and decrease the non-current assets.
Provision for expected credit losses on trade receivables
The provision for expected credit losses on trade receivables are estimated based on historical information, customer concentrations, customer solvency, current economic and geographical trends, and changes in customer payment terms and practices. The Company will calibrate its provision matrix to adjust the historical credit loss experience with forward-looking information. The assessment of the correlation between historical observed default rates, forecast economic conditions and expected credit losses is a significant estimate. The amount of expected credit losses is sensitive to changes in circumstances and of forecast economic conditions. The Company’s historical credit loss experience and forecast of economic conditions may also not be representative of customer’s actual default in the future.
Estimating the incremental borrowing rate on leases
The Company cannot readily determine the interest rate implicit in leases where it is the lessee. As such, it uses its incremental borrowing rate (“IBR”) to measure lease liabilities. The IBR is the rate of interest that the Company would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of comparable value to the right-of-use asset in a similar economic environment. IBR therefore reflects what the Company “would have to pay”, which requires estimation when no observable rates are available or where the applicable rates need to be adjusted to reflect the terms and conditions of the lease. The Company estimates the IBR using observable inputs (such as market interest rates) when available and is required to make certain entity-specific estimates.
F-52
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
3. CRITICAL ACCOUNTING ESTIMATES AND SIGNIFICANT MANAGEMENT JUDGMENTS (cont.)
Other significant judgments
The preparation of these financial statements in accordance with IFRS requires the Company to make judgments, apart from those involving estimates, in applying accounting policies. The most significant judgments in applying the Company’s financial statements include:
• The assessment of the Company’s ability to continue as a going concern and whether there are events or conditions that may give rise to significant uncertainty;
• The determination of the lease term of contracts with renewal and termination options;
• Determination of the extent to which it is probable that future taxable income will be available to allow all or part of the temporary differences to be utilized; and
• Whether there are indicators of impairment of the Company’s long-lived assets.
4. TRADE AND OTHER RECEIVABLES
Trade and other receivables consisted of the following as of June 30, 2021 and December 31, 2020:
June 30,
|
December 31, 2020 |
|||||||||
Accounts receivable |
$ |
77,346 |
|
$ |
47,149 |
|
||||
Less: allowance for doubtful accounts |
|
(2,963 |
) |
|
(3,066 |
) |
||||
Accounts receivable, net |
|
74,383 |
|
|
44,083 |
|
||||
Other |
|
153 |
|
|
158 |
|
||||
$ |
74,536 |
|
$ |
44,241 |
|
5. PROPERTY AND EQUIPMENT
Property and equipment consisted of the following as of June 30, 2021 and December 31, 2020:
Laboratory equipment |
Office equipment |
Total |
||||||||||||
Cost |
|
|
|
|
|
|
||||||||
Balance at December 31, 2020 |
$ |
67,512 |
|
$ |
12,825 |
|
$ |
80,337 |
|
|||||
Additions |
|
4,580 |
|
|
— |
|
|
4,580 |
|
|||||
Disposal |
|
— |
|
|
(213 |
) |
|
(213 |
) |
|||||
Effects of currency translation |
|
(2,351 |
) |
|
(427 |
) |
|
(2,778 |
) |
|||||
Balance at June 30, 2021 |
$ |
69,741 |
|
$ |
12,185 |
|
$ |
81,926 |
|
|||||
|
|
|
|
|
|
|||||||||
Accumulated depreciation |
|
|
|
|
|
|
||||||||
Balance at December 31, 2020 |
$ |
43,046 |
|
$ |
6,954 |
|
$ |
50,000 |
|
|||||
Depreciation |
|
2,308 |
|
|
692 |
|
|
3,000 |
|
|||||
Effects of currency translation |
|
(1,488 |
) |
|
(246 |
) |
|
(1,734 |
) |
|||||
Balance at June 30, 2021 |
$ |
43,866 |
|
$ |
7,400 |
|
$ |
51,266 |
|
|||||
|
— |
|
|
— |
|
|
— |
|
||||||
Net book value |
|
|
|
|
|
|
||||||||
December 31, 2020 |
$ |
24,466 |
|
$ |
5,871 |
|
$ |
30,337 |
|
|||||
June 30, 2021 |
$ |
25,875 |
|
$ |
4,785 |
|
$ |
30,660 |
|
F-53
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
5. PROPERTY AND EQUIPMENT (cont.)
As of June 30, 2021 and December 31, 2020, management assessed that there were no events or changes in circumstances that would require impairment testing.
6. LEASES
Right-of-Use Assets
The Company’s leases certain assets under lease agreements.
Office Equipment |
Laboratory Equipment |
Office |
Total |
|||||||||||||||
Cost |
|
|
|
|
|
|
|
|
||||||||||
Balance at December 31, 2020 |
$ |
31,584 |
|
$ |
11,234 |
|
$ |
527,285 |
|
$ |
570,103 |
|
||||||
Additions |
|
— |
|
|
12,346 |
|
|
— |
|
|
12,346 |
|
||||||
Effects of currency translation |
|
(1,064 |
) |
|
(585 |
) |
|
(17,756 |
) |
|
(19,405 |
) |
||||||
Balance at June 30, 2021 |
$ |
30,520 |
|
$ |
22,995 |
|
$ |
509,529 |
|
$ |
563,044 |
|
||||||
Check: |
|
|
|
|
|
|
|
|
||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Accumulated depreciation |
|
|
|
|
|
|
|
|
||||||||||
Balance at December 31, 2020 |
$ |
3,983 |
|
$ |
2,340 |
|
$ |
107,245 |
|
$ |
113,568 |
|
||||||
Depreciation |
|
2,610 |
|
|
2,666 |
|
|
26,349 |
|
|
31,625 |
|
||||||
Effects of currency translation |
|
(178 |
) |
|
(123 |
) |
|
(4,053 |
) |
|
(4,354 |
) |
||||||
Balance at June 30, 2021 |
$ |
6,415 |
|
$ |
4,883 |
|
$ |
129,541 |
|
$ |
140,839 |
|
||||||
|
|
|
|
|
|
|
|
|||||||||||
Net book value |
|
|
|
|
|
|
|
|
||||||||||
December 31, 2020 |
$ |
27,601 |
|
$ |
8,894 |
|
$ |
420,040 |
|
$ |
456,535 |
|
||||||
June 30, 2021 |
$ |
24,105 |
|
$ |
18,112 |
|
$ |
379,988 |
|
$ |
422,205 |
|
As of June 30, 2021 and December 31, 2020, management assessed that there were no events or changes in circumstances that would require impairment testing.
The carrying amount of the right-of-use assets is depreciated on a straight-line basis over the life of the leases, which at June 30, 2021, had an average expected life of 7.5 years.
Lease Liabilities
The Company’s lease liabilities consist of office and laboratory equipment and office space The present value of future lease payments were measured using an incremental borrowing rate of 10% per annum.
Total |
||||||
Balance as at December 31, 2020 |
$ |
495,051 |
|
|||
Additions |
|
12,346 |
|
|||
Interest expenses |
|
23,959 |
|
|||
Lease payments |
|
(47,970 |
) |
|||
Effects of currency translation |
|
(16,477 |
) |
|||
As at June 30, 2021 |
$ |
466,909 |
|
F-54
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
6. LEASES (cont.)
Lease payments and interest expenses during the six months ended June 30, 2020, were $37,890 and $21,786
Lease liabilities |
June 30,
|
December 31,
|
||||||
Current portion |
$ |
51,251 |
$ |
47,611 |
||||
Long-term portion |
|
415,658 |
|
447,440 |
||||
Total lease liabilities |
$ |
466,909 |
$ |
495,051 |
At June 30, 2021, the Company is committed to minimum lease payments as follows:
Maturity analysis |
June 30,
|
|||||
Less than one year |
$ |
47,718 |
|
|||
One to two years |
|
94,888 |
|
|||
Two to three years |
|
94,888 |
|
|||
Three to four years |
|
92,136 |
|
|||
Four to five years |
|
85,705 |
|
|||
More than five years |
|
235,072 |
|
|||
Total undiscounted lease liabilities |
$ |
650,407 |
|
|||
Amount representing implicit interest |
|
(183,498 |
) |
|||
Lease liabilities |
$ |
466,909 |
|
7. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consisted of the following as of June 30, 2021 and December 31, 2020:
June 30,
|
December 31, 2020 |
|||||||
Accounts payable |
$ |
234,671 |
$ |
248,576 |
||||
Accrued liabilities |
|
98,216 |
|
78,345 |
||||
Payroll liabilities |
|
71,883 |
|
87,075 |
||||
Value added taxes payable |
|
37,887 |
|
19,817 |
||||
$ |
442,657 |
$ |
433,813 |
8. CONVERTIBLE DEBT
During the years ended December 31, 2019 and 2020, the Company entered into loan agreements totalling EUR417,133 (approximately $467,154) (the “2019 and 2020 Convertible Loans”). The 2019 and 2020 Convertible Loans bear interest at 3.5% and have a maturity date of September 30, 2022. While the 2019 and 2020 Convertible Loans are outstanding, the lenders are entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the 2019 and 2020 Convertible Loans are convertible common shares of the Company at EUR1 per share.
The 2019 and 2020 Convertible Loans were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 2019 and 2020 Convertible Loans between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.
F-55
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
8. CONVERTIBLE DEBT (cont.)
In November 2017, the Company entered into loan agreements with two shareholders of the Company for loans totalling EUR80,278 (approximately $92,007) (the “2017 Convertible Loans”). The loans are convertible at the option of the lender to shares totalling 4.25% of the Company’s common shares outstanding at the time of conversion. The loans are non-interest bearing, are unsecured and are due on demand.
During the six months ended June 30, 2021, the loan amount of EUR417,272 ($508,237) were converted into 6,485 shares of share capital. To satisfy these conversions, the Company also issued 7,500 shares that the Company held for a total of 13,985 ordinary shares issued for the conversions. The conversion rights for all loans not converted have been waived.
A continuity of the Company’s convertible debt is as follows:
2019 and 2020
|
2017
|
Total |
||||||||||||
Balance, December 31, 2020 |
$ |
447,181 |
|
$ |
86,189 |
|
$ |
533,370 |
|
|||||
Accretion |
|
59,956 |
|
|
— |
|
|
59,956 |
|
|||||
Conversion |
|
(471,528 |
) |
|
(36,709 |
) |
|
(508,237 |
) |
|||||
Effects of currency translation |
|
(3,322 |
) |
|
(1,911 |
) |
|
(5,233 |
) |
|||||
Balance, June 30, 2021 |
$ |
32,287 |
|
$ |
47,569 |
|
$ |
79,856 |
|
9. LOANS PAYABLE
During the year ended December 31, 2020, the Company entered into a loan agreement for the principal amount of EUR20,000 (approximately $22,828) (the “0.1% Loan). The 0.1% Loan bears interest at 0.1% per month and is due on demand. And is secured against the Company’s trade receivables.
Between the years of 2011 to 2013, the Company received loans from related parties totalling EUR35,000 (approximately $40,144) (the “6% Loans”). The Loans have a stated interest rate of at 6.0%. EUR10,000 (approximately $11,461) of the loans matures on July 31, 2020 and EUR25,000 (approximately $28,653) of the loan matures on December 31, 2021. As the 6% Loans were received at below market interest rates, the initial fair value of the 6% Loan was determined to be EUR21,936 (approximately $25,140), determined using an estimated effective interest rate of 11.5%.
In 2017, the Company was obtained a line of credit of up to EUR200,000 (approximately $458,440) (the “LOC”). The LOC accrues interest of 4% on amounts drawn, and a 0.5% fee if no amounts are drawn. The LOC is available until September 30, 2020.
A continuity of the Company’s loans payable is as follows:
0.1%
|
6%
|
LOC |
Total |
|||||||||||||||
Balance, December 31, 2020 |
$ |
24,528 |
|
$ |
41,326 |
|
$ |
66,979 |
|
$ |
132,833 |
|
||||||
Accretion |
|
— |
|
|
768 |
|
|
— |
|
|
768 |
|
||||||
Interest expense |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||||||
Effects of currency translation |
|
(826 |
) |
|
(1,404 |
) |
|
(2,255 |
) |
|
(4,485 |
) |
||||||
Balance, June 30, 2021 |
$ |
23,702 |
|
$ |
40,690 |
|
$ |
64,724 |
|
$ |
129,116 |
|
F-56
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
10. SILENT PARTNERSHIPS
During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lenders agreed to lend a total of EUR499,400, of which EUR299,400 was received by the Company by December 31, 2020 (approximately $341,740) (the “3% SPAs”). The Company is to repay the amount by December 31, 2025. The Company must pay a minimum of 3% interest per annum on the loans. The lender is entitled to 3% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt ; the lender does not partake in the Company’s losses. Upon the amounts coming due, the lender of the 3% SPAs have the option to demand an additional payment equal to 15% of the contribution as a final remuneration (the “Final Renumeration”). The Final Remuneration is considered to be the cost of issuing debt. The 3% SPAs were received at below market interest rates as part of a government program for COVID-19 relief. The initial fair value of the 3% SPAs received in 2020 was determined to be EUR218,120 (approximately $248,966), which was determined using an estimated effective interest rate of 11.5%. The difference between the face value and the fair value of the 3% SPAs received in 2020 of EUR81,280 ($92,774) has been recognized as government grant income during the period. During the six months ended June 30, 2021 the Company received the remaining EUR200,000 ($241,040). The initial fair value of the 3.0% SPAs received during the six months ended June 30, 2021, was determined to be EUR230,000 (approximately $272,573), determined using an estimated effective interest rate of 6.1%. The initial fair value of the 3.0% SPAs received during June 30, 2021 was determined to be EUR198,426 (approximately $239,143), which was determined using an estimated effective interest rate of 3.1% – 3.3%. The difference between the face value and the fair value of the 3.0% SPAs received in 2021 of EUR1,574 (approximately $1,897) has been recognized as government grant income during the period.
During the year ended December 31, 2020, the Company entered into silent partnership agreements whereby the lender agreed to lend a total of EUR50,000 (approximately $57,071) (the “3.5% SPAs”). The Company is to repay the amount by June 30, 2025. The Company must pay a minimum of 3.5% interest per annum on the loans. The lender is entitled to 0.5% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the ender does not partake in the Company’s losses. The 3.5% SPAs are convertible to common shares of the Company at EUR1 per share in the event that the Company is involved in any of the following transactions: capital increases, a share or asset deal or a public offering. The 3.5% SPAs were determined to be a financial instrument comprising an equity classified conversion feature with a host debt component. On initial recognition, the Company used the residual value method to allocate the principal amount of the 3.5% SPAs between the two components. The host debt component was valued first, based on similar debt securities without an embedded conversion feature and the residual was allocated to the equity-classified conversion feature.
Between the years of 2013 to 2016, the Company entered into silent partnership agreements for loans totalling EUR798,694 (approximately $915,383) (the “8.5% SPAs”). Under the 8.5% SPAs, the Company is to repay EUR398,634 (approximately $408,496) of the loans by June 30, 2023 and EUR400,000 (approximately $409,859) of the loans matures on December 31, 2025. The Company must pay a minimum of 8.5% interest per annum on the loans. The lenders are entitled to 1.66% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lenders do not partake in the Company’s losses. At maturity, the lenders of the 8.5% SPAs have the option to demand an additional payment equal to 30% of the principal of the loans as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8.5% SPAs was determined to be EUR772,568 (approximately $85,440), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lenders also agreed to invest in the Company and contributed EUR676,366
F-57
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
10. SILENT PARTNERSHIPS (cont.)
(approximately $775,183) to acquire 27,752 shares of the Company between the years of 2013 and 2016. During the year ended December 31, 2020, EUR80,000 (approximately $99,527) of the 8.5% SPAs was extinguished as the lender, who is a also a customer of the Company, elected to offset the debt amount against amounts in trade receivables due to the Company. The debtor did not demand the Final Remuneration and the Company recognized a gain on the extinguishment of $8,214.
In 2010, the Company entered into a silent partnership agreement whereby the lender agreed to lend the Company EUR300,000 (approximately $343,830) (the “8% SPA”). The Company must repay the loan by January 31, 2023. The Company must pay a minimum of 8% interest per annum on the loan. The lender is entitled to 1.95% of the Company’s net income each year should the Company be profitable and provided that the amount paid does not exceed the principal amount of the debt; the lender does not partake in the Company’s losses. At maturity, the lender of the 8% SPA has the option to demand an additional payment of up to 30% of the principal of the loan as a Final Remuneration. The Final Remuneration is considered to be cost of issuing the debt and as such, the initial fair value of the 8% SPA was determined to be EUR289,900 (approximately $332,254), determined using an estimated effective interest rate of 11.5%. Under the agreements, the lender also agreed to invest in the Company and contributed EUR100,000 to acquire 2,800 shares of the Company.
A continuity of the Company’s silent partnerships is as follows:
3%
|
3.5%
|
8.5%
|
8%
|
Total |
||||||||||||||||||
Balance, December 31,
|
$ |
288,558 |
|
$ |
43,313 |
|
$ |
1,030,167 |
|
$ |
456,212 |
|
$ |
1,818,250 |
|
|||||||
Issued during the year |
|
241,040 |
|
|
— |
|
|
— |
|
|
— |
|
|
241,040 |
|
|||||||
Discount |
|
— |
|
|
— |
|
|
(1,897 |
) |
|
— |
|
|
(1,897 |
) |
|||||||
Accretion |
|
13,249 |
|
|
1,593 |
|
|
15,049 |
|
|
5,069 |
|
|
34,960 |
|
|||||||
Effects of currency translation |
|
(13,958 |
) |
|
(1,485 |
) |
|
(34,911 |
) |
|
(15,447 |
) |
|
(65,801 |
) |
|||||||
Balance, June 30, 2021 |
$ |
528,889 |
|
$ |
43,421 |
|
$ |
1,008,408 |
|
$ |
445,834 |
|
$ |
2,026,552 |
|
11. EQUITY
Authorized share capital
Unlimited number of common shares with a par value of EUR1 per share. German corporate law dictates that the registered nominal amount of a GmbH entity must be at least EUR1 per share.
Shares outstanding
As at June 30, 2021: 99,069 common shares issued and outstanding (December 31, 2020: 92,584).
During the six months ended June 30, 2021, 6,485 shares were issued for conversion of debt of $508,237.
F-58
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
12. COST OF REVENUE
Cost of revenue consisted of the following for the six months ended June 30, 2021 and 2020:
Six months ended
|
||||||||
2021 |
2020 |
|||||||
Test kit materials |
$ |
64,776 |
$ |
53,919 |
||||
Selling expenses |
|
8,967 |
|
7,159 |
||||
Maintenance of laboratory equipment |
|
54,997 |
|
46,764 |
||||
Salaries and benefits |
|
67,562 |
|
39,584 |
||||
Royalties |
|
44,652 |
|
4,859 |
||||
Total costs of revenue |
$ |
240,954 |
$ |
152,285 |
13. RELATED PARTY TRANSACTIONS
Related Party Transactions
Key management personnel include those persons having authority and responsibility for planning, directing and controlling the activities of the Company as a whole. The Company has determined that key management personnel consist of members of the Company’s Board of Directors and corporate officers. The remuneration of directors and key management personnel during the six months ended June 30, 2021 and 2020 was as follows:
June 30,
|
June 30,
|
|||||||
Salaries and benefits |
$ |
109,733 |
$ |
114,044 |
Remuneration paid to related parties other than key personnel during the six months ended June 30, 2021 and 2020 was as follows:
June 30,
|
June 30,
|
|||||||
Salaries and benefits |
$ |
943 |
$ |
15,972 |
During the six months ended June 30, 2021, the Company incurred interest expense of $24,983 (2020 – $22,831) on balances owing to related parties.
During the six months ended June 30, 2021, the Company incurred accretion expense of $9,908 (2020 – $8,567) on balances owing to related parties.
Related Party Balances
As at June 30, 2021, $1,001 (December 31, 2020, $1,148) is included in accounts payable and accrued liabilities and loans payable in relation to transactions with related parties, which are non-interest bearing, unsecured and due on demand.
As at June 30, 2021, the entire balance of the 6% Loans of $41,326 (December 31, 2020 - $41,326) were owing to shareholders of the Company (Note 8).
As at June 30, 2021, EUR40,139 (approximately $47,569) of the 2017 Convertible Loans was owed to a major shareholder of the Company (December 31, 2020 — EUR70,278, $86,189); the right of conversion has been waived. The amounts are due on demand (Note 8).
F-59
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
13. RELATED PARTY TRANSACTIONS (cont.)
As at June 30, 2021, EUR30,000 (approximately $35,553) (December 31, 2020 — EUR30,000, $36,792) with a carrying value of $32,787 (December 31, 2020 — $32,161) of the 2019 and 2020 Convertible Loans were owing to a major shareholder of the Company, respectively; the rights of conversion have been waived. The amounts are due on September 30, 2022.
As at June 30, 2021, EUR350,000 (approximately $414,785) (December 31, 2020 — EUR350,000, $429,240) with a carrying value of $488,726 (December 31, 2020 — $498,481) of the 8.5% SPAs were owing to major shareholders of the Company. EUR150,000 of the loan is due on June 30, 2023 and EUR200,000 of the loan is due on December 31, 2025.
As at June 30, 2021, the entire balance of the LOC of $64,724 (December 31, 2020 — $66,979) is due to a family member of the CEO of the Company (Note 9).
14. GOVERNMENT GRANTS
The Company receives government grants related to its research and development activities. The amount of government grants received during the six months ended June 30, 2021 and 2020 and recognized in other income were as follows:
Research and Development Projects |
June 30,
|
June 30,
|
||||||
Rapid detection of antibody-based pathogens |
$ |
64,596 |
$ |
40,200 |
||||
Multi-marker test for the early detection of pancreatic cancer |
|
79,116 |
|
25,053 |
||||
Microarray based on nucleic acid detection for respiratory pathogens |
|
— |
|
5,790 |
||||
Genetically based rapid detection of respiratory tract infections |
|
— |
|
25,193 |
||||
$ |
143,712 |
$ |
96,236 |
15. FINANCIAL INSTRUMENT RISK MANAGEMENT
Basis of Fair Value
Financial instruments measured at fair value are classified into one of three levels in the fair value hierarchy according to the relative reliability of the inputs used to estimate the fair values. The three levels of the fair value hierarchy are:
• Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities;
• Level 2 — Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly; and
• Level 3 — Inputs that are not based on observable market data.
The Company’s financial instruments consist of cash, trade and other receivables, accounts payable and accrued liabilities, lease liabilities, convertible debentures, and loans payable. With the exception of convertible debentures and loans payable, the carrying value of the Company’s financial instruments approximate their fair values due to their short-term maturities. The fair value of convertible debentures and notes payable approximate their carrying value, excluding discounts, due to minimal changes in interest rates and the Company’s credit risk since issuance of the instruments.
The Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors the risk management processes, inclusive of documented investment policies, counterparty limits, and controlling and reporting structures.
F-60
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
15. FINANCIAL INSTRUMENT RISK MANAGEMENT (cont.)
Credit Risk
The Company’s principal financial assets are cash and trade receivables. The Company’s credit risk is primarily concentrated in its cash which is held with institutions with a high credit worthiness. Management believes that the Company is not exposed to any significant credit risk with respect to its cash.
The Company mitigates its credit risk on receivables by actively managing and monitoring its receivables. The Company has been determined that no credit loss provision is required, as all amounts outstanding are considered collectible. During the six months ended June 30, 2021, the Company incurred $0 in bad debt expense (2020 — $0). The Company mitigates credit risk by evaluating the creditworthiness of customers prior to conducting business with them and monitoring its exposure for credit losses with existing customers.
Liquidity Risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due. The Company has a planning and budgeting process in place to help determine the funds required to support the Company’s normal operating requirements on an ongoing basis. As at June 30, 2021, the Company had an unrestricted cash balance of $195,165 to settle current liabilities of $672,051.
Historically, the Company’s primary source of funding has been the issuance of equity securities for cash, primarily through the issuance of preferred shares and credit facility borrowings. The Company’s access to financing is always uncertain. There can be no assurance of continued access to significant equity funding.
The following is an analysis of the contractual maturities of the Company’s financial liabilities as at June 30, 2021:
Within
|
Between one and
|
More than
|
|||||||||
Accounts payable and accrued liabilities |
$ |
442,657 |
$ |
— |
$ |
— |
|||||
Convertible debt |
|
47,569 |
|
32,287 |
|
— |
|||||
Loans payable |
|
129,116 |
|
— |
|
— |
|||||
Silent partnerships |
|
— |
|
2,026,552 |
|
— |
|||||
Lease liabilities |
|
47,718 |
|
367,617 |
|
235,072 |
|||||
$ |
667,060 |
$ |
2,426,456 |
$ |
235,072 |
Foreign Exchange Risk
Foreign currency risk is the risk that the fair values of future cash flows of a financial instrument will fluctuate because they are denominated in currencies that differ from the respective functional currency. The Company is not exposed to currency risk as it does not hold any financial assets or liabilities in foreign denominated currencies.
Interest Rate Risk
Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company is not exposed to interest rate risk as its financial liabilities carry interest at fixed rates.
F-61
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
15. FINANCIAL INSTRUMENT RISK MANAGEMENT (cont.)
Capital Management
In the management of capital, the Company includes components of stockholders’ equity. The Company aims to manage its capital resources to ensure financial strength and to maximize its financial flexibility by maintaining strong liquidity and by utilizing alternative sources of capital including equity, debt and bank loans or lines of credit to fund continued growth. The Company sets the amount of capital in proportion to risk and based on the availability of funding sources. The Company manages the capital structure and makes adjustments to it in light of changes in economic conditions and the risk characteristics of the underlying assets. As a young growth company, issuance of equity has been the primary source of capital to date. Additional debt and/or equity financing may be pursued in future as deemed appropriate to balance debt and equity. To maintain or adjust the capital structure, the Company may issue new shares, take on additional debt or sell assets to reduce debt.
16. CONCENTRATIONS
Major customers are defined as customers that each individually account for greater than 10% of the Company’s annual revenues. For the six months ended June 30, 2021, the Company had revenue from two major customers (2020 — four major customers) that accounted for approximately 51.32% (2020 — 58.55%) of revenue.
17. OPERATING EXPENSES
For the periods ended June 30, 2021 and 2020, operating expenses consisted of the following:
General and administrative |
2021 |
2020 |
||||||
Depreciation |
$ |
15,801 |
$ |
12,811 |
||||
Office |
|
26,823 |
|
30,607 |
||||
Professional Fees |
|
14,521 |
|
11,072 |
||||
Salaries and Benefits |
|
141,359 |
|
123,842 |
||||
Travel and entertainment |
|
977 |
|
1,106 |
||||
$ |
199,481 |
$ |
179,438 |
Research and development |
2021 |
2020 |
||||||
Depreciation |
$ |
14,074 |
$ |
11,411 |
||||
Office |
|
20,546 |
|
22,610 |
||||
Salaries and Benefits |
|
125,911 |
|
110,309 |
||||
$ |
160,531 |
$ |
144,330 |
Sales and marketing |
2021 |
2020 |
||||||
Advertising |
$ |
16,829 |
$ |
2,891 |
||||
Depreciation |
|
4,748 |
|
3,849 |
||||
Office |
|
6,930 |
|
7,626 |
||||
Salaries and Benefits |
|
42,472 |
|
37,209 |
||||
$ |
70,979 |
$ |
51,575 |
F-62
PharmGenomics GmbH
NOTES TO THE UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
(Expressed in US dollars)
Six months ended June 30, 2021 and 2020
18. SUBSEQUENT EVENTS
Management evaluated all additional events subsequent to the balance sheet date through to September 30, 2021, the date the consolidated financial statements were available to be issued, and determined the following items:
• On August 3, 2021, the Company entered into a contribution agreement (the “Contribution Agreement”) with Mainz Biomed B.V. (“Mainz”), which is a private company with limited liability under Dutch law incorporated for the purpose of acquiring the Company. Mainz intends to apply to list its shares on the Nasdaq along with a concurrent initial public offering of its ordinary shares. Under the Contribution Agreement, 100% of the shares of the Company will be acquired in exchange for 6,000,000 shares of Mainz. Upon the closing of the Contribution Agreement, the Company will become a wholly owned subsidiary of Mainz and the former shareholders of the Company will hold approximately 62% of the outstanding shares of Mainz. On September 20, 2021 the Company and Mainz closed the Contribution Agreement.
F-63
MAINZ BIOMED B.V.
UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS
The following unaudited pro forma combined financial statements give effect to the acquisition of PharmGenomics GmbH (“PharmGenomics”) by Mainz Biomed B.V. (the “Company”) pursuant to a Contribution Agreement, dated August 3, 2021. Pursuant to the Contribution Agreement the Company will acquire all of the outstanding shares of capital stock of PharmGenomics from its shareholders in exchange for 6,000,000 shares of the Company issued pro rata to the PharmGenomics’ shareholders. These financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.
F-64
MAINZ BIOMED B.V.
Unaudited Pro Forma Condensed Combined Statement of Operations
Year Ended March 31, 2021
Mainz
|
PharmGenomics
|
Proforma
|
Notes |
Proforma
|
|||||||||||||
Revenue |
$ |
— |
|
$ |
493,565 |
|
$ |
— |
$ |
493,565 |
|
||||||
Cost of revenue |
|
— |
|
|
370,480 |
|
|
— |
|
370,480 |
|
||||||
Gross profit |
|
— |
|
|
123,085 |
|
|
— |
|
123,085 |
|
||||||
|
|
|
|
|
|
|
|||||||||||
Operating Expenses |
|
|
|
|
|
|
|
||||||||||
Research and Development |
|
— |
|
|
311,851 |
|
|
— |
|
311,851 |
|
||||||
Sales and Marketing |
|
— |
|
|
110,380 |
|
|
— |
|
110,380 |
|
||||||
General and Administrative |
|
39,992 |
|
|
374,569 |
|
|
— |
|
414,561 |
|
||||||
Total operating expenses |
|
39,992 |
|
|
796,800 |
|
|
— |
|
836,792 |
|
||||||
Operating loss |
|
(39,992 |
) |
|
(673,715 |
) |
|
— |
|
(713,707 |
) |
||||||
Other Income (Expense) |
|
|
|
|
|
|
|
||||||||||
Accretion expense |
|
— |
|
|
(92,375 |
) |
|
28,563 |
4(a) |
|
(63,812 |
) |
|||||
Gain on debt extinguishment |
|
— |
|
|
8,214 |
|
|
— |
|
8,214 |
|
||||||
Government grant – research and development |
|
|
|
224,134 |
|
|
|
224,134 |
|
||||||||
Government grant – below market financing |
|
— |
|
|
92,774 |
|
|
— |
|
92,774 |
|
||||||
Interest expense |
|
— |
|
|
(176,417 |
) |
|
15,339 |
4(a) |
|
(161,078 |
) |
|||||
Other income |
|
— |
|
|
30,490 |
|
|
— |
|
30,490 |
|
||||||
Total other expense |
|
— |
|
|
86,820 |
|
|
43,902 |
|
130,722 |
|
||||||
|
|
|
|
|
|
|
|||||||||||
Net loss before provision for income taxes |
|
(39,992 |
) |
|
(586,895 |
) |
|
43,902 |
|
(582,985 |
) |
||||||
Income taxes |
|
— |
|
|
— |
|
|
— |
|
— |
|
||||||
Net loss |
$ |
(39,992 |
) |
$ |
(586,895 |
) |
$ |
43,902 |
$ |
(582,985 |
) |
||||||
|
|
|
|
|
|
|
|||||||||||
Other comprehensive loss |
|
|
|
|
|
|
|
||||||||||
Foreign currency translation adjustment |
|
— |
|
|
(224,656 |
) |
|
— |
|
(224,656 |
) |
||||||
Total comprehensive loss |
$ |
(39,992 |
) |
$ |
(811,551 |
) |
$ |
43,902 |
$ |
(807,641 |
) |
||||||
|
|
|
|
|
|
|
|||||||||||
Basic and dilutive loss per common share |
$ |
(39,992.00 |
) |
|
|
|
$ |
(0.10 |
) |
||||||||
Weighted average number of common shares outstanding |
|
1 |
|
|
|
|
6,000,000 |
4(b) |
|
6,000,001 |
|
See accompanying notes to the Unaudited Pro Forma Condensed Combined Financial Statements.
F-65
MAINZ BIOMED B.V.
Notes to the Unaudited Pro Forma Condensed Combined Financial Statements
On August 3, 2021, Mainz Biomed B.V. (the “Company”) entered into a Contribution Agreement (the “Agreement”) with PharmGenomics GmbH, a company registered in Mainz, Germany (“PharmGenomics”), pursuant to which the Company will acquire all of the outstanding shares of capital stock of PharmGenomics from its shareholders in exchange for 6,000,000 shares of the Company issued pro rata to the PharmGenomics’ shareholders.
NOTE 1. BASIS OF PRO FORMA PRESENTATION
The unaudited pro forma condensed combined financial statements are based on the Company’s and PharmGenomics’ historical consolidated financial statements as adjusted to give effect to the acquisition of PharmGenomics and the shares issued as part of the acquisition. The unaudited pro forma combined statements of operations for the year ended March 31, 2021 give effect to the PharmGenomics’ acquisition as if it had occurred on April 1, 2020. The unaudited proforma combined balance sheet as of March 31, 2021 gives effect to the PharmGenomics acquisition as if it had occurred on March 31, 2021.
For accounting purposes, the Company has considered the accounting guidance provided by IFRS 10 and IFRS 3.7 and B13 and determined that the merger of Mainz BioMed B.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed B.V. as the acquired company. As such, the assets and liabilities of PharmGenomics have been presented at their historical carrying values.
Historical financial information has been adjusted in the pro forma balance sheet to pro forma events that are: (1) directly attributable to the acquisition; (2) factually supportable; and (3) expected to have a continuing impact on the Company’s results of operations. The pro forma adjustments presented in the pro forma combined balance sheet and statement of operations are described in Note 4 — Pro Forma Adjustments.
The unaudited pro forma condensed combined financial information is for illustrative purposes only. These companies may have performed differently had they actually been combined for the periods presented. You should not rely on the pro forma combined financial information as being indicative of the historical results that would have been achieved had the companies always been combined or the future results that the combined companies will experience after the acquisition.
NOTE 2. ACCOUNTING PERIODS PRESENTED
Certain pro forma adjustments were made to conform PharmGenomics accounting policies to the Company’s accounting policies as noted below.
The unaudited pro forma condensed combined balance sheet as of March 31, 2021 is presented as if the acquisition had occurred on March 31, 2021 and combines the historical balance sheet of the Company at March 31, 2021 and the historical balance sheet of the PharmGenomics at December 31, 2020.
The unaudited pro forma condensed combined statement of operations for the year ended March 31, 2021 has been prepared by combining the Company’s historical consolidated statement of operations for the period ended March 31, 2021, with the historical statement of operations of PharmGenomics for the year ended December 31, 2020.
F-66
MAINZ BIOMED B.V.
Notes to the Unaudited Pro Forma Condensed Combined Financial Statements
NOTE 3. PRO FORMA ADJUSTMENTS
The pro forma adjustments are based on our preliminary estimates and assumptions that are subject to change. The following adjustments have been reflected in the unaudited pro forma condensed combined financial information:
a) In connection with the Agreement, a portion of convertible debt of PharmGenomics is being converted to commons shares of PharmGenomics prior to the share exchange. This represents the adjustment to reduce interest and accretion expenses, to give effect to the cost savings from the reduced debt and to record the conversion of €368,544 ($451,984) in debt to 6,485 common shares of PharmGenomics. Such converted common shares of PharmGenomics were in turn exchanged for common shares of the Company pursuant to the Contribution Agreement.
b) Represents an adjustment to increase common shares of the Mainz by the par value of the 6,000,000 shares issued in connection with the transaction and to eliminate the carrying value of the common shares of PharmGenomics, as well as increase the capital for the net difference.
F-67
MAINZ BIOMED B.V.
UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS
The following unaudited pro forma combined financial statements give effect to the acquisition of PharmGenomics GmbH (“PharmGenomics”) by Mainz Biomed B.V. (the “Company”) pursuant to a Contribution Agreement, dated August 3, 2021, which closed on September 20, 2021. Pursuant to the Contribution Agreement the Company acquired all of the outstanding shares of capital stock of PharmGenomics from its shareholders in exchange for 6,000,000 shares of the Company issued pro rata to the PharmGenomics’ shareholders. These financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.
F-68
MAINZ BIOMED B.V.
Unaudited Pro Forma Condensed Combined Balance Sheet
As of June 30, 2021
Mainz
|
PharmGenomics
|
Proforma
|
Notes |
Proforma
|
||||||||||||||
Assets |
|
|
|
|
|
|
|
|
||||||||||
Current Assets |
|
|
|
|
|
|
|
|
||||||||||
Cash |
$ |
274,232 |
|
$ |
195,165 |
|
$ |
1,600,000 |
|
3 (b) |
$ |
2,069,397 |
|
|||||
Trade and other receivables |
|
12,463 |
|
|
74,536 |
|
|
— |
|
|
86,999 |
|
||||||
Prepaid expenses |
|
— |
|
|
11,906 |
|
|
— |
|
|
11,906 |
|
||||||
Total Current assets |
|
286,695 |
|
|
281,607 |
|
|
1,600,000 |
|
|
2,168,302 |
|
||||||
|
|
|
|
|
|
|
|
|||||||||||
Property and equipment |
|
— |
|
|
30,660 |
|
|
— |
|
|
30,660 |
|
||||||
Right-of-use asset |
|
— |
|
|
422,205 |
|
|
— |
|
|
422,205 |
|
||||||
Total Assets |
$ |
286,695 |
|
$ |
734,472 |
|
$ |
1,600,000 |
|
$ |
2,621,167 |
|
||||||
|
|
|
|
|
|
|
|
|||||||||||
Liabilities and Shareholders’ Deficit |
|
|
|
|
|
|
|
|
||||||||||
Current Liabilities |
|
|
|
|
|
|
|
|
||||||||||
Accounts payable and accrued liabilities |
$ |
64,439 |
|
$ |
442,657 |
|
$ |
— |
|
$ |
507,096 |
|
||||||
Deferred revenue |
|
— |
|
|
1,458 |
|
|
— |
|
|
1,458 |
|
||||||
Convertible debt – related party |
|
— |
|
|
47,569 |
|
|
— |
|
|
47,569 |
|
||||||
Loans payable |
|
— |
|
|
23,702 |
|
|
— |
|
|
23,702 |
|
||||||
Loans payable – related party |
|
— |
|
|
105,414 |
|
|
— |
|
|
105,414 |
|
||||||
Lease liabilities |
|
— |
|
|
51,251 |
|
|
— |
|
|
51,251 |
|
||||||
Total Current Liabilities |
|
64,439 |
|
|
672,051 |
|
|
— |
|
|
736,490 |
|
||||||
|
|
|
|
|
|
|
|
|||||||||||
Convertible debt – related party |
|
— |
|
|
32,287 |
|
|
— |
|
|
32,287 |
|
||||||
Silent partnerships |
|
— |
|
|
1,537,826 |
|
|
— |
|
|
1,537,826 |
|
||||||
Silent partnerships – related party |
|
— |
|
|
488,726 |
|
|
— |
|
|
488,726 |
|
||||||
Lease liabilities |
|
— |
|
|
415,658 |
|
|
— |
|
|
415,658 |
|
||||||
Total Liabilities |
|
64,439 |
|
|
3,146,548 |
|
|
— |
|
|
3,210,987 |
|
||||||
|
|
|
|
|
|
|
|
|||||||||||
Shareholders’ Deficit |
|
|
|
|
|
|
|
|
||||||||||
Capital: 2,010,001 common shares issued and outstanding and 9,710,001 common shares outstanding as adjusted |
|
24,138 |
|
|
114,010 |
|
|
(22,380 |
) |
3(a, b, c) |
|
115,768 |
|
|||||
Share premium |
|
442,312 |
|
|
— |
|
|
1,397,636 |
|
3(a, b, c) |
|
1,839,948 |
|
|||||
Reserves |
|
36,550 |
|
|
2,810,022 |
|
|
(28,000 |
) |
3(c) |
|
2,818,572 |
|
|||||
Accumulated deficit |
|
(280,744 |
) |
|
(5,216,581 |
) |
|
252,744 |
|
|
(5,244,581 |
) |
||||||
Accumulated other comprehensive loss |
|
— |
|
|
(119,527 |
) |
|
— |
|
|
(119,527 |
) |
||||||
Total Shareholder’s Deficit |
|
222,256 |
|
|
(2,412,076 |
) |
|
1,600,000 |
|
|
(589,820 |
) |
||||||
|
|
|
|
|
|
|
|
|||||||||||
Total Liabilities and Shareholders’ Deficit |
$ |
286,695 |
|
$ |
734,472 |
|
$ |
1,600,000 |
|
$ |
2,621,167 |
|
See accompanying notes to the Unaudited Pro Forma Condensed Combined Financial Statements.
F-69
MAINZ BIOMED B.V.
Unaudited Pro Forma Condensed Combined Statement of Operations
Period Ended June 30, 2021
Mainz
|
PharmGenomics
|
Proforma
|
Notes |
Proforma
|
||||||||||||||
Revenue |
$ |
— |
|
$ |
417,311 |
|
$ |
— |
|
$ |
417,311 |
|
||||||
Cost of revenue |
|
— |
|
|
240,954 |
|
|
— |
|
|
240,954 |
|
||||||
Gross profit |
|
— |
|
|
176,357 |
|
|
— |
|
|
176,357 |
|
||||||
|
|
|
|
|
|
|
|
|||||||||||
Operating Expenses |
|
|
|
|
|
|
|
|
||||||||||
General and administrative |
|
280,744 |
|
|
199,481 |
|
|
28,000 |
|
4(c) |
|
508,225 |
|
|||||
Research and development |
|
— |
|
|
160,531 |
|
|
— |
|
|
160,531 |
|
||||||
Sales and marketing |
|
— |
|
|
70,979 |
|
|
— |
|
|
70,979 |
|
||||||
Total operating expenses |
|
280,744 |
|
|
430,991 |
|
|
28,000 |
|
|
739,735 |
|
||||||
Operating loss |
|
(280,744 |
) |
|
(254,634 |
) |
|
(28,000 |
) |
|
(563,378 |
) |
||||||
Other Income (Expense) |
|
|
|
|
|
|
|
|
||||||||||
Accretion expense |
|
— |
|
|
(95,687 |
) |
|
— |
|
|
(95,687 |
) |
||||||
Government grant – research and development |
|
— |
|
|
143,712 |
|
|
— |
|
|
143,712 |
|
||||||
Government grant – below market financing |
|
— |
|
|
1,897 |
|
|
— |
|
|
1,897 |
|
||||||
Interest expense |
|
— |
|
|
(73,364 |
) |
|
— |
|
|
(73,364 |
) |
||||||
Other income |
|
— |
|
|
16,355 |
|
|
— |
|
|
16,355 |
|
||||||
Total other expense |
|
— |
|
|
(7,087 |
) |
|
— |
|
|
(7,087 |
) |
||||||
|
|
|
|
|
|
|
|
|||||||||||
Net loss before provision for income taxes |
|
(280,744 |
) |
|
(261,721 |
) |
|
(28,000 |
) |
|
(570,465 |
) |
||||||
Income taxes |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
||||||
Net loss |
$ |
(280,744 |
) |
$ |
(261,721 |
) |
$ |
(28,000 |
) |
$ |
(570,465 |
) |
||||||
Other comprehensive loss |
|
|
|
|
|
|
|
|
||||||||||
Foreign currency translation adjustment |
|
— |
|
|
82,963 |
|
|
— |
|
|
82,963 |
|
||||||
Total comprehensive loss |
$ |
(280,744 |
) |
$ |
(178,758 |
) |
$ |
(28,000 |
) |
$ |
(487,502 |
) |
||||||
|
|
|
|
|
|
|
|
|||||||||||
Basic and dilutive loss per common share |
$ |
(0.18 |
) |
|
|
|
|
$ |
(0.06 |
) |
||||||||
Weighted average number of common shares outstanding |
|
1,531,316 |
|
|
|
|
7,700,000 |
|
3(a) |
|
9,231,316 |
|
See accompanying notes to the Unaudited Pro Forma Condensed Combined Financial Statements.
F-70
MAINZ BIOMED B.V.
Notes to the Unaudited Pro Forma Condensed Combined Financial Statements
NOTE 1. BASIS OF PRO FORMA PRESENTATION
On August 3, 2021, Mainz Biomed B.V. (the “Company”) entered into a Contribution Agreement (the “Agreement”) with PharmGenomics GmbH, a company registered in Mainz, Germany (“PharmGenomics”), pursuant to which the Company acquired all of the outstanding shares of capital stock of PharmGenomics from its shareholders in exchange for 6,000,000 shares of the Company issued pro rata to the PharmGenomics’ shareholders. On September 20, 2021, the Company and PharmGenomics closed the Contribution Agreement.
The unaudited pro forma condensed combined financial statements are based on the Company’s and PharmGenomics’ historical consolidated financial statements as adjusted to give effect to the acquisition of PharmGenomics and the shares issued as part of the acquisition. The unaudited pro forma combined statements of operations for the period ended June 30, 2021, give effect to the PharmGenomics’ acquisition as if it had occurred on January 1, 2021. The unaudited proforma combined balance sheet as of June 30, 2021 gives effect to the PharmGenomics acquisition as if it had occurred on June 30, 2021.
For accounting purposes, the Company has considered the accounting guidance provided by IFRS 10 and IFRS 3.7 and B13 and determined that the merger of Mainz BioMed B.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed B.V. as the acquired company. As such, the assets and liabilities of PharmGenomics have been presented at their historical carrying values.
Historical financial information has been adjusted in the pro forma balance sheet to pro forma events that are: (1) directly attributable to the acquisition; (2) factually supportable; and (3) expected to have a continuing impact on the Company’s results of operations. The pro forma adjustments presented in the pro forma combined balance sheet and statement of operations are described in Note 4 — Pro Forma Adjustments.
The unaudited pro forma condensed combined financial information is for illustrative purposes only. These companies may have performed differently had they actually been combined for the periods presented. You should not rely on the pro forma combined financial information as being indicative of the historical results that would have been achieved had the companies always been combined or the future results that the combined companies will experience after the acquisition.
NOTE 2. ACCOUNTING PERIODS PRESENTED
Certain pro forma adjustments were made to conform PharmGenomics accounting policies to the Company’s accounting policies as noted below.
The unaudited pro forma condensed combined balance sheet as of June 30, 2021 is presented as if the acquisition had occurred on June 30, 2021 and combines the historical balance sheet of the Company at June 30, 2021 and the historical balance sheet of the PharmGenomics at June 30, 2021.
The unaudited pro forma condensed combined statement of operations for the period ended June 30, 2021 has been prepared by combining the Company’s historical consolidated statement of operations from inception (March 8, 2021) to June 30, 2021, with the historical statement of operations of PharmGenomics for the six months ended June 30, 2021.
NOTE 3. PRELIMINARY PURCHASE PRICE ALLOCATION
On September 20, 2021, the Company acquired PharmGenomics for total consideration of 6,000,000 shares of Company’s common stock. The unaudited pro forma condensed combined financial statements include various assumptions, including those related to the preliminary purchase price allocation of the assets acquired and liabilities assumed of PharmGenomics based on carrying values. For accounting purposes, the Company has determined that the merger of Mainz BioMed B.V. and PharmGenomics GmbH should be treated as a reverse acquisition by PharmGenomics GmbH, with PharmGenomics being the accounting acquirer, and Mainz BioMed B.V. as the acquired company. As such, the assets and liabilities of PharmGenomics have been presented at their historical carrying values. Accordingly, pro forma adjustments are preliminary and have been made solely for illustrative purposes.
F-71
MAINZ BIOMED B.V.
Notes to the Unaudited Pro Forma Condensed Combined Financial Statements
NOTE 4. PRO FORMA ADJUSTMENTS
The pro forma adjustments are based on our preliminary estimates and assumptions that are subject to change. The following adjustments have been reflected in the unaudited pro forma condensed combined financial information:
a) Represents an adjustment to increase common shares of Mainz BioMed B.V. by the par value of the 6,000,000 shares issued in connection with the acquisition of PharmGenomics, including the elimination of the historical balance of the PharmGenomics Capital account. This entry also eliminates the historical balance of the Company’s accumulated deficit to create a combined cumulative deficit that reflects the historical balance of PharmGenomics, the acquiror for accounting purposes.
b) Represents the adjustments to reflect two sales of units by Mainz BioMed B.V. The first offering, which closed in August 2021 was for the sale of 1,000,000 units, each unit including a common share and a warrant to acquire a common share at a strike price of $3.00. The second offering, which closed in September 2021 was for the sale of 500,000 units, each unit including a common share and a warrant to acquire a common share at a strike price of $3.00. The first offering raised $600,000 and the second offering raised $1,000,000 of gross proceeds, respectively. The offerings included broker warrants of 70,000 and 25,000 warrants, with the same terms as investor warrants, respectively.
c) Represents the adjustment to reflect the July 1, 2021 issuance of 200,000 ordinary shares issued to our Chief Executive Officer, pursuant to an employment contract.
F-72
1,500,000 Shares
MAINZ BIOMED, N.V.
____________________________
PROSPECTUS
____________________________
Boustead Securities, LLC
, 2022
Through and including (the 25th day after the date of this offering), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 6: INDEMNIFICATION OF DIRECTORS AND OFFICERS
Under Dutch law, members of the board of directors may be liable to the registrant for damages in the event of improper or negligent performance of their duties. They may be jointly and severally liable for damages to the registrant and third parties for infringement of our Articles of Association or certain provisions of the Dutch Civil Code. In certain circumstances, they may also incur additional specific civil and criminal liabilities.
Pursuant to the registrant’s articles of association, to the fullest extent permitted by Dutch law, the following shall be reimbursed to the indemnified officers:
(a) the costs of conducting a defense against claims, also including claims by the Company and its group companies, as a consequence of any acts or omissions in the fulfilment of their duties or any other duties currently or previously performed by them at the company’s request;
(b) any damages or financial penalties payable by them as a result of any such acts or omissions;
(c) any amounts payable by them under settlement agreements entered into by them in connection with any such acts or omissions;
(d) the costs of appearing in other legal proceedings in which they are involved as directors or former directors, with the exception of proceedings primarily aimed at pursuing a claim on their own behalf;
(e) any taxes payable by them as a result of any reimbursements in accordance with the articles of association.
An indemnitee shall not be entitled to reimbursement if and to the extent that:
(a) it has been adjudicated by a Dutch court or, in the case of arbitration, an arbitrator, in a final and conclusive decision that the act or omission of the Indemnitee may be characterized as intentional, deliberately reckless or grossly negligent conduct, unless Dutch law provides otherwise or this would, in view of the circumstances of the case, be unacceptable according to standards of reasonableness and fairness; or
(b) the costs or financial loss of the Indemnitee are covered by an insurance and the insurer has paid out the costs or financial loss.
The description of indemnity herein is merely a summary of the provisions in the registrant’s articles of association described above, and such description shall not limit or alter the mentioned provisions in the articles of association or other indemnification agreements.
Prior to the public offering of the securities being registered by this registration statement, we intend to enter into a directors’ and officers’ liability insurance policy to cover the liability of members of the board of directors and members.
The underwriting agreement the registrant will enter into in connection with the offering being registered hereby provides that the underwriter will indemnify, under certain conditions, the registrant’s board of directors and its officers against certain liabilities arising in connection with this offering.
ITEM 7. RECENT SALES OF UNREGISTERED SECURITIES
In the past three years, we have issued and sold the securities described below without registering the securities under the Securities Act. None of these transactions involved the underwriter’s underwriting discounts or commissions or any public offering. We believe that each of the following issuances was exempt from registration under the Securities Act in reliance on Regulation S promulgated under the Securities Act regarding sales by an issuer in offshore transactions, Regulation D under the Securities Act, Rule 701 under the Securities Act or pursuant to Section 4(a)(2) of the Securities Act regarding transactions not involving a public offering.
II-1
Since our founding, we have issued:
• 2,010,000 units in April 2021, each consisting of one ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00, for a per unit offering price of $0.30;
• 140,000 broker warrants in connection with such April 2021 unit offering, which warrants were on the same terms as the warrants in the unit offering;
• 200,000 ordinary shares in July 2021 to our Chief Executive Officer in connection with his being appointed as our executive officer, of which 100,000 have been issued immediately, 50,000 will be issued on November 9, 2022, one year after our initial public offering, and 50,000 will be issued on November 9, 2023, two years after our initial public offering. Our management determined the fair value of our ordinary shares in such grant to be $0.283 per share;
• 1,000,000 units in August 2021, each consisting of one ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00, for a per unit offering price of $0.60;
• 70,000 broker warrants in connection with such August 2021 unit offering, which warrants were on the same terms as the warrants in the unit offering;
• 6,000,000 ordinary shares in connection with our Contribution Agreement with PharmGenomics GmbH in September 2021;
• 1,000,000 units in September 2021, each consisting of one ordinary share and a warrant to purchase an ordinary share at an exercise price of $3.00, for a per unit offering price of $2.00;
• 25,000 broker warrants in connection with such September 2021 unit offering, which warrants were on the same terms as the warrants in the unit offering;
• 161,000 warrants to our underwriter in our initial public offering, each which warrants are exercisable into an ordinary share at an exercise price of $5.50; and
• 65,000 stock options, granted to employees and advisors at strike prices of between $8.75 and $10.56 per share.
In addition, in January 2022 we agreed to issue 50,000 ordinary shares to a consulting firm pursuant to an advisory agreement, although we have yet to issue these shares.
ITEM 8. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
The following exhibits are filed with this registration statement:
II-2
____________
** Previously filed
ITEM 9. UNDERTAKINGS
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales of securities are being made, a post-effective amendment to this registration statement to:
(i) Include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) 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; and
(iii) 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.
(4) To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Act need not be furnished, provided that the Registrant includes in the prospectus, by means of a post- effective amendment, financial statements required pursuant to this paragraph (4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements. Notwithstanding the foregoing, with respect to registration statements on Form F-3, a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Act or Rule 3-19 of Regulation S- X if such financial statements and information are contained in periodic reports filed with or furnished to the Commission by the Registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the Form F-3.
II-3
(5) 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 provisions described herein, 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.
(6) Each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe it meets all of the requirements for filing on Form F-1 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized on January 21, 2022.
MAINZ BIOMED N.V. |
||||
(Registrant) |
||||
By: |
/s/ Guido Baechler |
|||
Guido Baechler, Chief Executive Officer
|
We, the undersigned directors and officers of the Registrant, hereby severally constitute and appoint Guido Baechler and William Caragol, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, the registration statement on Form F-1 filed herewith, and any and all pre-effective and post-effective amendments to said registration statement, and any registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, in connection with the registration under the Securities Act of 1933, as amended, of equity securities of the Registrant, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, 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 each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature |
Title |
Date |
||
/s/ Guido Baechler |
Chief Executive Officer (Principal Executive Officer), |
January 21, 2022 |
||
Guido Baechler |
Director |
|||
/s/ William Caragol |
Chief Financial Officer (Principal Financial Officer and |
January 21, 2022 |
||
William Caragol |
Principal Accounting Officer) |
|||
/s/ Dr. Moritz Eidens |
Director |
January 21, 2022 |
||
Dr. Moritz Eidens |
||||
/s/ Nicole Holden |
Director |
January 21, 2022 |
||
Nicole Holden |
||||
/s/ Alberto Libanori |
Director |
January 21, 2022 |
||
Alberto Libanori |
||||
/s/ Hans Hekland |
Director |
January 21, 2022 |
||
Hans Hekland |
II-5
SIGNATURE OF AUTHORIZED REPRESENTATIVE IN THE UNITED STATES
Pursuant to the Securities Act of 1933, the undersigned, the duly authorized representative in the United States of Mainz Biomed N.V., has signed this registration statement or amendment thereto in New York, New York, on January 21, 2022.
Ortoli Rosenstadt LLP |
||||
By: |
/s/ William S. Rosenstadt |
|||
Name: |
William S. Rosenstadt |
|||
Title: |
Managing Partner |
II-6
Exhibit 1.1
Mainz Biomed N.V.
UNDERWRITING AGREEMENT
January __, 2022
Boustead Securities, LLC
6 Venture, Suite 395
Irvine, CA 92618
Attn: Keith Moore, Chief Executive Officer
Attn: Daniel J. McClory, Managing Director
Ladies and Gentlemen:
This underwriting agreement (this “Agreement”) constitutes the agreement between Mainz Biomed N.V., a Dutch public company with limited liability (collectively with its subsidiaries and affiliates, including, without limitation, all entities disclosed or described in the Registration Statement (as hereafter defined) as being subsidiaries or affiliates of the Company, the “Company”) on the one hand, and Boustead Securities, LLC (the “Underwriter”), on the other hand, pursuant to which the Underwriter shall serve as the underwriter for the Company in connection with the proposed offering (the “Offering”) by the Company of their Securities (as defined below) on a “Firm Commitment” basis.
The Company proposes, subject to the terms and conditions stated herein, to issue and sell to the Underwriter an aggregate of 1,500,000 authorized but unissued ordinary shares (the “Firm Shares”), €0.01 par value (the “Ordinary Shares”), of the Company.
The Firm Shares together with the Option Shares (as defined herein) may also be referred to as the “Securities.”
The Company hereby confirms its agreement with the Underwriter as follows:
Section 1. Agreement to Act as Underwriter.
(a) Underwriting Discount; Expenses.
(i) Underwriting Discount. An underwriting discount equal to seven percent (7%) of the aggregate public sales price of the Securities sold on a Closing Date, which will be paid to and allocated by the Underwriter among the selling syndicate and soliciting dealers in their sole discretion, if applicable.
(ii) [Intentionally Omitted]
(iii) Non-Accountable Expenses. The Company agrees that, in addition to the expenses payable pursuant to Section 1(iv) below, on each Closing Date it shall pay to the Underwriter, by deduction from the net proceeds of the Offering contemplated herein, a non-accountable expense allowance equal to three-quarters percent (0.75%) of the gross proceeds received by the Company from the sale of the Securities on such Closing Date.
(iv) Expenses. Whether or not the transactions contemplated by this Agreement and the Registration Statement are consummated or this Agreement is terminated, the Company hereby agrees to pay all costs and expenses incident to the Offering, including the following:
A. | all expenses in connection with the preparation, printing, formatting for EDGAR and filing of the Registration Statement, and any and all amendments and supplements thereto and the mailing and delivering of copies thereof to the Underwriter and dealers; |
1
B. | all fees and expenses in connection with filings with FINRA’s Public Offering System; | |
C. | all fees, disbursements and expenses of the Company’s counsel and accountants in connection with the registration of the Securities under the Securities Act of 1933, as amended (the “Securities Act”) and the Offering; | |
D. | all reasonable expenses in connection with the qualifications of the Securities for offering and sale under state or blue-sky laws, when applicable; | |
E. | all fees and expenses in connection with listing the Securities on the Nasdaq (a “Senior Exchange”), if any; | |
F. | any stock transfer taxes incurred in connection with this Agreement or the Offering; | |
G. | the cost and charges of any transfer agent or registrar for the Securities; | |
H. | all of the Underwriter’s reasonable out-of-pocket expenses in connection with the performance of its services hereunder, limited to Underwriter’s counsel’s fees and expenses up to $100,000. |
In the event that this Agreement is terminated pursuant to Section 9 hereof, or subsequent to a Material Adverse Change, the Company will pay all documented out-of-pocket and unreimbursed expenses of the Underwriter (including but not limited to fees and disbursements of Underwriter’s counsel), which are actually incurred as allowed under FINRA Rule 5110 and in any event, the aggregate amount of such expenses to be paid or reimbursed by the Company directly or indirectly to or on behalf of the Underwriter shall not exceed $100,000.
(b) Exclusivity. The term of the Underwriter’s exclusive engagement (the “Exclusive Term”) will be until the termination of the engagement agreement by and between the Company and the Underwriter dated April 13, 2021 (the “Engagement Letter”). Notwithstanding anything to the contrary contained herein, the provisions concerning confidentiality, indemnification and contribution contained herein will survive any expiration or termination of this Agreement, and the Company’s obligation to pay fees actually earned and payable and to reimburse expenses actually incurred and reimbursable pursuant to Section 1 hereof and which are permitted to be reimbursed under FINRA Rule 5110(g)(4)(A), will survive any expiration or termination of this Agreement. Nothing in this Agreement shall be construed to limit the ability of the Underwriter or its Affiliates to pursue, investigate, analyze, invest in, or engage in investment banking, financial advisory or any other business relationship with Persons (as defined below) other than the Company. As used herein (i) “Persons” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind and (ii) “Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person as such terms are used in and construed under Rule 405 under the Securities Act. If during the Exclusive Term, or within twelve (12) months after the date of termination or expiration of the Engagement Letter, no Closing has occurred, the Company sells securities to investors introduced to the Company by the Underwriter or its Affiliates prior to such termination or expiration, then the Company shall pay to the Underwriter, at the time of each such sale, the compensation, set forth in Section 1(a) above, with respect to any such sale.
2
Section 2. Representations, Warranties and Covenants of the Company. The Company hereby represents, warrants and covenants to the Underwriter, as of the date hereof, and as of each Closing Date, except as set out in the Registration Statement, as follows:
(a) Securities Law Filings. The Company has filed with the Securities and Exchange Commission (the “Commission”) a registration statement on Form F-1 (Registration File No. [ ]) under the Securities Act and the rules and regulations (the “Rules and Regulations”) of the Commission promulgated thereunder. At the time of the effective date of the Registration Statement, the Registration Statement and amendments will materially meet the requirements of Form F-1 under the Securities Act. The Company will file with the Commission pursuant to Rules 430A and 424(b) under the Securities Act, a final prospectus included in such registration statement relating to the Offering and the underwriting thereof (the “Final Prospectus”) and has advised the Underwriter of all further information (financial and other) with respect to the Company required to be set forth therein. Such registration statement, including the exhibits thereto, as amended at the date of this Agreement, is hereinafter called the “Registration Statement”; such prospectus in the form in which it appears in the Registration Statement as amended at the date of this Agreement is hereinafter called the “Prospectus.” All references in this Agreement to financial statements and schedules and other information that is “contained,” “included,” “described,” “referenced,” “set forth” or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information that is or is deemed to be incorporated by reference in the Registration Statement or the Prospectus, as the case may be. The Registration Statement has been declared effective on the date hereof. The Company shall, prior to the Closing Date for the Firm Shares, file with the Commission a Form 8-A providing for the registration under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), of the Ordinary Shares.
(b) Assurances. The Registration Statement (and any further documents to be filed with the Commission) contains all exhibits and schedules as required by the Securities Act. Each of (i) the Registration Statement at the time it became effective, (ii) the Prospectus at the time the Registration Statement became effective, (iii) any post-effective amendment to the Registration Statement at the time it becomes effective and (iv) and the Final Prospectus filed with the Commission pursuant to Rule 424(b) at the time of such filing, and at all other subsequent times at each Closing Date, complied in all material respects with the Securities Act and the applicable Rules and Regulations, as amended or supplemented, if applicable, and did not and will not, contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not materially misleading (provided, however, that the preceding representations and warranties contained in this sentence shall not apply to any statements or omissions made in reliance upon and in conformity with information furnished in writing to the Company by the Underwriter expressly for use therein (the “Underwriter Information”). The Prospectus, as of its date, complies in all material respects with the Securities Act and the applicable Rules and Regulations, and the Final Prospectus, as of its date, will comply in all material respects with the Securities Act and the applicable Rules and Regulations. As of its date, the Prospectus did not and will and the Final Prospectus will not contain as of the date thereof any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading (provided, however, that the preceding representations and warranties contained in this sentence shall not apply to any Underwriter Information). All post-effective amendments to the Registration Statement reflecting facts or events arising after the date thereof which represent, individually or in the aggregate, a fundamental change in the information set forth therein have been so filed with the Commission. There are no documents required to be filed with the Commission in connection with the transaction contemplated hereby that (x) have not been filed as required pursuant to the Securities Act or (y) will not be filed within the requisite time period. There are no material contracts or other documents required to be described in the Prospectus (or the Final Prospectus) or filed as exhibits or schedules to the Registration Statement that have not been (or will not be) described or filed as required. The Company is eligible to use free writing prospectuses in connection with the Offering pursuant to Rules 164 and 433 under the Securities Act. Any free writing prospectus that the Company is required to file pursuant to Rule 433(d) under the Securities Act has been, or will be, filed with the Commission in accordance with the requirements of the Securities Act and the applicable Rules and Regulations. Each free writing prospectus that the Company has filed, or is required to file, pursuant to Rule 433(d) under the Securities Act or that was prepared by or behalf of or used by the Company complies or will comply in all material respects with the requirements of the Securities Act and the applicable Rules and Regulations. The Company will not, without the prior consent of the Underwriter, prepare, use or refer to, any free writing prospectus. Except as set out on Schedule 2(b), there are no free-writing prospectuses in connection with this offering.
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(c) Offering Materials. The Company has delivered, or will as promptly as practicable deliver, to the Underwriter complete conformed copies of the Registration Statement and of each consent and certificate of experts, as applicable, filed as a part thereof, and conformed copies of the Registration Statement (without exhibits) and the Prospectus, as amended or supplemented (including the Final Prospectus), in such quantities and at such places as the Underwriter reasonably requests. Neither the Company nor any of its directors and officers has distributed and none of them will distribute, prior to any Closing Date, any offering material in connection with the offering and sale of the Securities other than the Prospectus, the Final Prospectus, the Registration Statement, and any other materials permitted by the Securities Act (collectively, the “Offering Materials”).
(d) Subsidiaries. All of the direct and indirect subsidiaries of the Company (the “Subsidiaries”) are described in the Registration Statement to the extent necessary. The Company owns, directly or indirectly, all of its capital stock or other equity interests of each Subsidiary free and clear of any liens, charges, security interests, encumbrances, rights of first refusal, preemptive rights or other restrictions (collectively, “Liens”), and all of the issued and outstanding shares of capital stock of each Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar rights to subscribe for or purchase securities.
(e) Organization and Qualification. The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing (where applicable) under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation or default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of this Agreement or any other agreement entered into between the Company and the Underwriter (“Transaction Documents”), (ii) a material adverse effect on the results of operations, assets, business, prospects (as such prospects are described in the Prospectus) or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under this Agreement or the Offering (any of (i), (ii) or (iii), a “Material Adverse Effect”) and to the best knowledge of the Company, no action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding, such as a deposition), whether commenced or threatened (“Proceeding”) has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.
(f) Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate the transactions contemplated by this Agreement and each of the other Transaction Documents and the Offering and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of this Agreement by the Company and each of the other Transaction Documents and the consummation by it of the transactions contemplated hereby have been duly authorized by all necessary action on the part of the Company and no further action is required by the Company, the Company’s Board of Directors (the “Board of Directors”) or the Company’s shareholders in connection therewith other than in connection with the Required Approvals (as defined below). This Agreement and each other Transaction Document to which it is a party has been duly executed by the Company and, when delivered in accordance with the terms hereof, will constitute the valid and binding obligation of the Company enforceable against the Company in accordance with its terms, except (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by applicable law.
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(g) No Conflicts. The execution, delivery and performance by the Company of this Agreement, the other Transaction Documents to which it is a party and the transactions contemplated hereby do not and will not (i) conflict with or violate any provision of the Company’s or any Subsidiary’s certificate or articles of incorporation, bylaws or other organizational or charter documents, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien upon any of the properties or assets of the Company or any Subsidiary, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing a Company or Subsidiary debt or otherwise) or other understanding to which the Company or any Subsidiary is a party or by which any property or asset of the Company or any Subsidiary is bound or affected, or (iii) subject to the Required Approvals, conflict with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company or a Subsidiary is subject (including federal and state securities laws and regulations), or by which any property or asset of the Company or a Subsidiary is bound or affected; except in the case of each of clauses (i), (ii) and (iii), such conflict, default or violation could not reasonably be expected to result in a Material Adverse Effect.
(h) Filings, Consents and Approvals. The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other federal, state, local or other governmental authority or other Person in connection with the execution, delivery and performance by the Company of this Agreement, the other Transaction Documents to which it is a party and the transactions contemplated hereby, other than: (i) the filing with the Commission of the Final Prospectus as required by Rule 424 under the Securities Act, (ii) application to a Senior Exchange (the “Trading Market”), for the listing of the Securities for trading thereon in the time and manner required thereby and (iii) if applicable, such filings as are required to be made under applicable state securities laws (collectively, the “Required Approvals”).
(i) Issuance of the Securities; Registration. The Securities are duly authorized and, when issued and paid for in accordance with this Agreement, the other Transaction Documents to which it is a party, and the terms of the Offering as described in the Prospectus, will be duly and validly issued, fully paid and non-assessable, free and clear of all Liens imposed by the Company. The Company has sufficient Ordinary Shares for the issuance of the maximum number of Securities issuable pursuant to the Offering as described in the Prospectus.
(j) Capitalization. The capitalization of the Company as of the date hereof is as set forth in the Registration Statement, and the Prospectus. The Company has not issued any Ordinary Shares since the date of this Agreement, other than pursuant to the Company’s equity incentive plans, the issuance of Ordinary Shares to employees, directors or consultants pursuant to the Company’s equity incentive plans and pursuant to the conversion and/or exercise of any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire Ordinary Shares at any time, including, without limitation, any debt, preferred shares, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive (“Ordinary Shares Equivalents”). No Person has any right of first refusal, preemptive right, right of participation, or any similar right to participate in the transactions contemplated by the Offering Materials. Except as a result of the purchase and sale of the Securities or as disclosed in the Registration Statement, and the Prospectus, there are no outstanding options, warrants, scrip rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities, rights or obligations convertible into or exercisable or exchangeable for, or giving any Person any right to subscribe for or acquire, any Ordinary Shares or the capital stock of any Subsidiary, or contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become bound to issue additional Ordinary Shares or Ordinary Shares Equivalents or capital stock of any Subsidiary. The issuance and sale of the Securities will not obligate the Company or any Subsidiary to issue Ordinary Shares or other securities to any Person (other than the Underwriter) and will not result in a right of any holder of Company securities to adjust the exercise, conversion, exchange or reset price under any of such securities. There are no securities of the Company or any Subsidiary that have any anti-dilution or similar adjustment rights (other than adjustments for stock splits, recapitalizations, and the like) to the exercise or conversion price, have any exchange rights, or reset rights. Except as set forth in the Registration Statement, and the Prospectus, there are no outstanding securities or instruments of the Company or any Subsidiary that contain any redemption or similar provisions, and there are no contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become bound to redeem a security of the Company or such Subsidiary. The Company does not have any share appreciation rights or “phantom stock” plans or agreements or any similar plan or agreement. All of the outstanding Ordinary Shares of the Company are duly authorized, validly issued, fully paid and non-assessable, have been issued in compliance in all material respects with all federal and state securities laws, and none of such outstanding Ordinary Shares was issued in violation of any preemptive rights or similar rights to subscribe for or purchase securities. No further approval or authorization of any shareholder, the Board of Directors or others is required for the issuance and sale of the Securities. Except for the operating agreement of the Company, there are no shareholders agreements, voting agreements or other similar agreements with respect to the Company’s Ordinary Shares to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s shareholders.
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(k) Material Changes; Undisclosed Events, Liabilities or Developments. Since the date of the latest audited financial statements included within the Registration Statement, except as specifically disclosed in the Registration Statement, the Prospectus and the Final Prospectus, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to United States generally accepted accounting principles (“GAAP”) or disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its shareholders or purchased, redeemed or made any agreements to purchase or redeem any Ordinary Shares of the Company and (v) the Company has not issued any equity securities to any officer, director or Affiliate, except pursuant to existing Company stock option plans, if any. The Company does not have pending before the Commission any request for confidential treatment of information. Except for the issuance of the Securities contemplated by the Prospectus or disclosed in the Registration Statement or the Prospectus, no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or exist with respect to the Company or its Subsidiaries or their respective business, prospects (as such prospects are described in the Prospectus), properties, operations, assets or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made or deemed made that has not been publicly disclosed at least one trading day prior to the date that this representation is made.
(l) Litigation. Except for such matter disclosed in the Offering Materials, there is no action, suit, inquiry, notice of violation, proceeding or investigation pending or, to the knowledge of the Company, threatened against or affecting the Company, any Subsidiary or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign) (an “Action”) which (i) adversely affects or challenges the legality, validity or enforceability of this Agreement, any of the Transaction Documents, the Offering or the Securities or (ii) could, if there were an unfavorable decision, reasonably be expected to result in a Material Adverse Effect. Neither the Company nor any Subsidiary, nor any director or officer thereof, is or has within the last 10 years been the subject of any Action involving a claim of violation of or liability under federal or state securities laws or a claim of breach of fiduciary duty. There has not been, and to the knowledge of the Company, there is not pending or contemplated, any investigation by the Commission involving the Company or any current or former director or officer of the Company.
(m) Labor Relations. No material labor dispute exists or, to the knowledge of the Company, is imminent with respect to any of the employees of the Company, which could reasonably be expected to result in a Material Adverse Effect. None of the Company’s or its Subsidiaries’ employees is a member of a union that relates to such employee’s relationship with the Company or such Subsidiary, and neither the Company nor any of its Subsidiaries is a party to a collective bargaining agreement, and the Company and its Subsidiaries believe that their relationships with their employees are good. No executive officer, to the knowledge of the Company, is, or is now expected to be, in violation of any material term of any employment contract, confidentiality, disclosure or proprietary information agreement or non-competition agreement, or any other contract or agreement or any restrictive covenant in favor of any third party, and the continued employment of each such executive officer does not subject the Company or any of its Subsidiaries to any liability with respect to any of the foregoing matters. To the Company’s actual knowledge, the Company and its Subsidiaries are in compliance with all applicable laws and regulations relating to employment and employment practices, terms and conditions of employment and wages and hours, except where the failure to be in compliance could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
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(n) Compliance. Except as set forth in the Offering Materials, neither the Company nor any Subsidiary: (i) is in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company or any Subsidiary under), nor has the Company or any Subsidiary received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived), (ii) is in violation of any judgment, decree or order of any court, arbitrator or governmental body or (iii) is or has been in violation of any statute, rule, ordinance or regulation of any governmental authority, including without limitation all foreign, federal, state and local laws relating to taxes, environmental protection, occupational health and safety, product quality and safety and employment and labor matters, except in each case as could not reasonably be expected to result in a Material Adverse Effect.
(o) Regulatory Permits. The Company and the Subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as described in the Prospectus, except where the failure to possess such permits could not reasonably be expected to result in a Material Adverse Effect (“Material Permits”), and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any Material Permit.
(p) Title to Assets. The Company and the Subsidiaries have good and marketable title in fee simple to all real property owned by them and good and marketable title in all personal property owned by them that is material to the business of the Company and the Subsidiaries, in each case free and clear of all Liens, except for Liens disclosed in the Prospectus, Liens as do not materially affect the value of such property and do not materially interfere with the use made and proposed to be made of such property by the Company and the Subsidiaries and Liens for the payment of federal, state or other taxes, the payment of which is neither delinquent nor subject to penalties. Except as disclosed in the Offering Materials, any real property and facilities held under lease by the Company and the Subsidiaries are held by them under valid, subsisting and enforceable leases with which the Company and the Subsidiaries are in compliance.
(q) Patents and Trademarks. Except as disclosed in the Offering Materials and to the best of the Company’s actual knowledge, the Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the Offering Materials and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). None of, and neither the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned, or is expected to expire or be abandoned, within two (2) years from the date of this Agreement, except where such action would not reasonably be expected to have a Material Adverse Effect. Except as disclosed in the Offering Materials, neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within the Offering Materials, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any Person, except as would not have or reasonably be expected to not have a Material Adverse Effect. To the knowledge of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. The Company has no knowledge that it lacks or will be unable to obtain any rights or licenses to use all Intellectual Property Rights that are necessary to conduct its business.
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(r) Transactions with Affiliates and Employees. Except as set forth in the Registration Statement and the Prospectus, none of the officers or directors of the Company and, to the knowledge of the Company, none of the employees of the Company is presently a party to any transaction with the Company or any Subsidiary (other than for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company, any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee or partner, in each case in excess of $120,000 other than for (i) payment of salary or consulting fees for services rendered, (ii) reimbursement for expenses incurred on behalf of the Company and (iii) other employee benefits, including stock option agreements under any stock option plan of the Company.
(s) Sarbanes-Oxley; Internal Accounting Controls. Except as disclosed in the Registration Statement and in the Prospectus, the Company is in compliance with any and all applicable requirements of the Sarbanes-Oxley Act of 2002 that are effective and applicable to the Company as of the date hereof, and any and all applicable rules and regulations promulgated by the Commission thereunder that are effective as of the date hereof and as of each Closing Date. Except as set forth in the Offering Materials, the Company and the Subsidiaries maintains a system of internal accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company and the Subsidiaries have established disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Company and the Subsidiaries and designed such disclosure controls and procedures to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms.
(t) Certain Fees, FINRA Affiliation. Except as set forth herein and in the Prospectus, contemplated by this Agreement, or a separate agreement regarding the Offering with a soliciting dealer in the sole discretion of the Underwriter, no brokerage or finder’s fees or commissions are or will be payable by the Company or any Subsidiary to any broker, financial advisor or consultant, finder, placement agent, investment banker, bank or other Person with respect to the transactions contemplated by the Transaction Documents. Except as set forth in the Registration Statement, and the Prospectus, to the Company’s knowledge, there are no other arrangements, agreements or understandings of the Company or, to the Company’s knowledge, any of its stockholders that may affect the Underwriter’s compensation, as determined by FINRA. Except for payments to the Underwriter, the Company has not made any direct or indirect payments (in cash, securities or otherwise) to (i) any person, as a finder’s fee, investing fee or otherwise, in consideration of such person raising capital for the Company or introducing to the Company persons who provided capital to the Company, (ii) any FINRA member, or (iii) any person or entity that has any direct or indirect affiliation or association with any FINRA member within the 12-month period prior to the date on which the Registration Statement was filed with the Commission (the “Filing Date”) or thereafter. To the Company’s knowledge, no (i) officer or director of the Company or its subsidiaries, (ii) except for the Underwriter, owner of 5% or more of the Company’s unregistered securities or that of its subsidiaries or (iii) except for the Underwriter, owner of any amount of the Company’s unregistered securities acquired within the 180-day period prior to the Filing Date, has any direct or indirect affiliation or association with any FINRA member. The Company will advise the Underwriter if it becomes aware that any officer, director or stockholder of the Company or its Subsidiaries is or becomes an Affiliate or associated person of a FINRA member participating in the Offering.
(u) Investment Company. The Company is not, and is not an Affiliate of, and immediately after receipt of payment for the Securities, will not be or be an Affiliate of, an “investment company” within the meaning of the Investment Company Act of 1940, as amended. The Company shall conduct its business in a manner so that it will not become an “investment company” subject to registration under the Investment Company Act of 1940, as amended.
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(v) Registration Rights. Except as set forth in the Registration Statement or the Prospectus, no Person has any right to cause the Company to effect the registration under the Securities Act of any securities of the Company.
(w) Registration. The Company shall use its commercially reasonable efforts to maintain the effectiveness of the Registration Statement and a current Prospectus relating thereto for as long as the Securities remain outstanding.
(x) Solvency. Based on the consolidated financial condition of the Company, as of each Closing Date, after giving effect to the receipt by the Company of the proceeds from the sale of the Securities hereunder, the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses of the cash, are sufficient to pay all amounts on or in respect of its liabilities when such amounts are required to be paid. The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt). Except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any facts or circumstances which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction within one year from each Closing Date. The Registration Statement and the Prospectus sets forth as of the date hereof all outstanding secured and unsecured Indebtedness of the Company or any Subsidiary, or for which the Company or any Subsidiary has commitments. For the purposes of this Agreement, “Indebtedness” means (x) any liabilities for borrowed money or amounts owed in excess of $50,000 (other than trade accounts payable incurred in the ordinary course of business), (y) all guaranties, endorsements and other contingent obligations in respect of indebtedness of others, whether or not the same are or should be reflected in the Company’s consolidated balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and (z) the present value of any lease payments in excess of $50,000 due under leases required to be capitalized in accordance with GAAP. Except as set forth in the Registration Statement and the Prospectus, neither the Company nor any Subsidiary is in default with respect to any Indebtedness.
(y) Tax Status. Except for matters that would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and each Subsidiary (i) has made or filed all income and franchise tax returns, reports and declarations required by any jurisdiction to which it is subject, (ii) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations and (iii) has set aside on its books provision reasonably adequate for the payment of all material taxes for periods subsequent to the periods to which such returns, reports or declarations apply. There are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the Company or of any Subsidiary know of no basis for any such claim.
(z) Accountants. BF Borgers CPA PC (“BFB”) is the Company’s independent registered public accounting firm. To the knowledge and belief of the Company, such accounting firm (i) is a registered public accounting firm as required by the Exchange Act and (ii) has expressed its opinion with respect to the financial statements of the Company for the period from March 8, 2021 (inception) thru to March 31, 2021.
(aa) Office of Foreign Assets Control. Neither the Company nor, to the Company’s knowledge, any director, officer, agent, employee or affiliate of the Company is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”).
(bb) Company Not Ineligible Issuer. (i) At the time of filing the Registration Statement relating to the Securities and (ii) as of the date of the execution and delivery of this Agreement (with such date being used as the determination date for purposes of this clause (ii)), the Company met all the requirements set forth in General Instruction I of Form F-1.
(cc) Emerging Growth Company. From the time of the initial confidential submission of the Registration Statement to the Commission (or, if earlier, the first date on which the Company engaged directly or through any person authorized to act on its behalf in any Testing-the-Waters Communications) through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “Emerging Growth Company”). “Testing-the-Waters Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Securities Act.
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(dd) Certificates. Any certificate signed by an officer of the Company and delivered to the Underwriter or to counsel for the Underwriter shall be deemed to be a representation and warranty by the Company to the Underwriter as to the matters set forth therein.
(ee) Reliance. The Company acknowledges that the Underwriter will rely upon the accuracy and truthfulness of the foregoing representations and warranties and hereby consents to such reliance.
(ff) Forward-Looking Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act) contained in either the Registration Statement or the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith.
(gg) Statistical or Market-Related Data. Any statistical, industry-related and market-related data included or incorporated by reference in the Registration Statement or the Prospectus, are based on or derived from sources that the Company reasonably and in good faith believes to be reliable and accurate, and such data agree with the sources from which they are derived.
(hh) Listing and Maintenance Requirements. The Ordinary Shares are registered pursuant to Section 12(b) or 12(g) of the Exchange Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration of the Securities under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration. Except as disclosed in the Offering Materials, the Company is, and has no reason to believe that it will not in the foreseeable future continue to be, in compliance with all such listing and maintenance requirements. The Ordinary Shares are currently eligible for electronic transfer through the Depository Trust Company or another established clearing corporation and the Company is current in payment of the fees to the Depository Trust Company (or such other established clearing corporation) in connection with such electronic transfer. The issuance and sale of the Securities hereunder does not contravene the rules and regulations of a Senior Exchange.
(ii) Foreign Corrupt Practices. Neither the Company, nor to the knowledge of the Company, any agent or other person acting on behalf of the Company, has (i) directly or indirectly, used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii) made any unlawful payment to foreign or domestic government officials or employees or to any foreign or domestic political parties or campaigns from corporate funds, (iii) failed to disclose fully any contribution made by the Company (or made by any person acting on its behalf of which the Company is aware) which is in violation of law, or (iv) violated in any material respect any provision of the Foreign Corrupt Practices Act of 1977, as amended.
(jj) Regulation M Compliance. The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases of, any of the Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Underwriter in connection with the Offering.
(kk) Testing the Waters Communications. The Company (a) has not alone engaged in any Testing-the-Waters Communication other than Testing-the-Waters Communications with the consent of the Underwriter with entities that are qualified institutional buyers within the meaning of Rule 144A under the Securities Act or institutions that are accredited investors within the meaning of Rule 501 under the Securities Act and (b) has not authorized anyone other than the Underwriter to engage in Testing-the-Waters Communications. The Company reconfirms that the Underwriter has been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed any Written Testing-the-Waters Communications.
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(ll) Money Laundering. The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, applicable money laundering statutes and applicable rules and regulations thereunder (collectively, the “Money Laundering Laws”), and no Action or Proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any Subsidiary with respect to the Money Laundering Laws is pending or, to the knowledge of the Company or any Subsidiary, threatened.
(mm) Insurance. The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as the Company believes are prudent and customary in the businesses in which the Company and the Subsidiaries are engaged. Neither the Company nor any Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost.
(nn) Bank Holding Company Act. Neither the Company nor any of its Subsidiaries is subject to the Bank Holding Company Act of 1956, as amended (the “BHCA”) and to regulation by the Board of Governors of the Federal Reserve System (the “Federal Reserve”). Neither the Company nor any of its Subsidiaries owns or controls, directly or indirectly, five percent or more of the outstanding shares of any class of voting securities or 25 percent or more of the total equity of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve. Neither the Company nor any of its Subsidiaries exercises a controlling influence over the management or policies of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve.
(oo) U.S. Real Property Holding Corporation. The Company is not and has never been a U.S. real property holding corporation within the meaning of Section 897 of the Internal Revenue Code of 1986, as amended, and the Company shall so certify upon the Underwriter’s request.
(pp) Senior Exchange Listing. The Ordinary Shares has been approved for listing on a Senior Exchange, subject to official notice of issuance, and the Company has taken no action designed to, or likely to have the effect of, delisting the Ordinary Shares from the Senor Exchange, nor has the Company received any notification that the Senor Exchange is contemplating terminating such listing.
(qq) D&O Questionnaires. To the Company’s knowledge, all information contained in the questionnaires (the “Questionnaires”) completed by each of the Company’s directors, officers and 5% shareholders immediately prior to the Offering (the “Insiders”) as supplemented by all information concerning the Company’s directors, officers and principal shareholders as described in the Offering Materials, provided to the Underwriter, is true and correct in all material respects and the Company has not become aware of any information which would cause the information disclosed in the Questionnaires to become materially inaccurate and incorrect.
(rr) Electronic Road Show. The Company has made available a “bona fide electronic road show” in compliance with Rule 433(d)(8)(ii) of the Securities Act Regulations such that no filing of any “road show” (as defined in Rule 433(h) of the Securities Act Regulations) is required in connection with the Offering.
(ss) Margin Securities. The Company owns no “margin securities” as that term is defined in Regulation U of the Board of Governors of the Federal Reserve System (the “Federal Reserve Board”), and none of the proceeds of Offering will be used, directly or indirectly, for the purpose of purchasing or carrying any margin security, for the purpose of reducing or retiring any indebtedness which was originally incurred to purchase or carry any margin security or for any other purpose which might cause any of the Securities to be considered a “purpose credit” within the meanings of Regulation T, U or X of the Federal Reserve Board.
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(tt) Export and Import Laws. The Company and, to the Company’s knowledge, each of its Affiliates, and any director, officer, agent or employee of, or other person associated with or acting on behalf of the Company, has acted at all times in compliance with applicable Export and Import Laws (as defined below) and there are no claims, complaints, charges, investigations or Proceedings pending or expected or, to the knowledge of the Company, threatened between the Company or any of its subsidiaries and any governmental authority under any Export or Import Laws. The term “Export and Import Laws” means the Arms Export Control Act, the International Traffic in Arms Regulations, the Export Administration Act of 1979, as amended, the Export Administration Regulations, and all other laws and regulations of the United States government regulating the provision of services to non-U.S. parties or the export and import of articles or information from and to the United States of America, and all similar laws and regulations of any foreign government regulating the provision of services to parties not of the foreign country or the export and import of articles and information from and to the foreign country to parties not of the foreign country.
(uu) Integration. Neither the Company, nor any of its affiliates, nor any person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause the Offering to be integrated with prior offerings by the Company for purposes of the Securities Act that would require the registration of any such securities under the Securities Act.
(vv) No Fiduciary Duties. The Company acknowledges and agrees that the Underwriter’s responsibility to the Company is solely contractual in nature and that none of the Underwriter or its Affiliates or any selling agent shall be deemed to be acting in a fiduciary capacity, or otherwise owes any fiduciary duty to the Company or any of its Affiliates in connection with the Offering and the other transactions contemplated by this Agreement. Notwithstanding anything in this Agreement to the contrary, the Company acknowledges that the Underwriter may have financial interests in the success of the Offering that are not limited to the difference between the Per Share Price to the public and the purchase price paid to the Company by the Underwriter for the Offering Securities and the Underwriter has no obligation to disclose, or account to the Company for, any of such additional financial interests. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriter with respect to any breach or alleged breach of fiduciary duty.
Section 3. Delivery and Payment.
3.1 Firm Shares
(a) On the basis of the representations, warranties and agreements herein contained, but subject to the terms and conditions herein set forth, the Company agrees to issue and sell the Securities to the Underwriter, and the Underwriter agrees to purchase the Securities. The purchase price for each Share shall be $[ ] (the “Per Share Price”).
(b) [Intentionally omitted].
(c) The Firm Shares will be delivered by the Company to the Underwriter against payment of the purchase price therefor by wire transfer of same day funds payable to the order of the Company’s offices, or such other location as may be mutually acceptable, at 6:00 a.m. Pacific Time, on the second (or if the Firm Shares are priced, as contemplated by Rule 15c6-1(c) under the Exchange Act, after 4:30 p.m. Eastern Time, the third) full business day following the date hereof, or at such other time and date as the Underwriter and the Company determine pursuant to Rule 15c6-1(a) under the Exchange Act. The time and date of delivery of the Firm Shares and Option Shares, as applicable, is referred to herein as a “Closing Date”. If the Underwriter so elects, delivery of the Firm Shares may be made by credit through full fast transfer to the account at The Depository Trust Company designated by the Underwriter.
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3.2 Option Shares
(a) For the purposes of covering any over-allotments in connection with the distribution and sale of the Firm Shares, the Company hereby grants to the Underwriters an option (the “Over-allotment Option”) to purchase, in the aggregate, up to two hundred, twenty five thousand (225,000) additional shares of the Common Stock (the “Option Shares”), representing fifteen percent (15%) of the Firm Shares sold in the offering, from the Company. The purchase price to be paid per Option Share shall be equal to the Per Share Price. The Option Shares shall be issued directly by the Company and shall have the rights and privileges described in the Registration Statement, the Pricing Disclosure Package and the Prospectus referred to below.
(b) The Over-allotment Option granted pursuant to Section 3.2(a) hereof may be exercised by the Underwriter as to all (at any time) or any part (from time to time) of the Option Shares within forty-five (45) days after the Closing Date for the Firm Shares. The Underwriter shall not be under any obligation to purchase any of the Option Shares prior to the exercise of the Over-allotment Option. The Over-allotment Option granted hereby may be exercised by the giving of written notice to the Company from the Underwriter, setting forth the number of the Option Shares to be purchased and the date and time for delivery of and payment for the Option Shares (the “Option Closing Date”), which shall not be later than five (5) full Business Days after the date of the notice or such other time as shall be agreed upon by the Company and the Underwriter, at the offices of the Underwriter’s Counsel or at such other place (including remotely by facsimile or other electronic transmission) as shall be agreed upon by the Company and the Underwriter. If such delivery and payment for the Option Shares does not occur on the Closing Date for the Firm Shares, the Option Closing Date will be as set forth in the notice. Upon exercise of the Over-allotment Option with respect to all or any portion of the Option Shares subject to the terms and conditions set forth herein, (i) the Company shall become obligated to sell to the Underwriter the number of the Option Shares specified in such notice and (ii) the Underwriter shall purchase that portion of the total number of the Option Shares then being purchased.
(c) The Firm Shares will be delivered by the Company to the Underwriter against payment of the purchase price therefor by wire transfer of same day funds payable to the order of the Company’s offices, or such other location as may be mutually acceptable, at 6:00 a.m. Pacific Time, on the second (or if the Firm Shares are priced, as contemplated by Rule 15c6-1(c) under the Exchange Act, after 4:30 p.m. Eastern Time, the third) full business day following the date hereof, or at such other time and date as the Underwriter and the Company determine pursuant to Rule 15c6-1(a) under the Exchange Act. If the Underwriter so elects, delivery of the Option Shares may be made by credit through full fast transfer to the account at The Depository Trust Company designated by the Underwriter. For Dutch law purposes, the payment of the purchase price for the Underwritten Shares will be deemed to be a payment on the Underwritten Shares.
Section 4. Covenants and Agreements of the Company. The Company further covenants and agrees with the Underwriter as follows:
(a) Registration Statement Matters. The Registration Statement and any amendments thereto have been declared effective, and if Rule 430A is used or the filing of the Prospectus is otherwise required under Rule 424(b), the Company will file the Prospectus (properly completed if Rule 430A has been used) pursuant to Rule 424(b) within the prescribed time period and will provide evidence satisfactory to the of such timely filing. The Company will advise the Underwriter promptly after they receive notice thereof Underwriter of the time when any amendment to the Registration Statement has been filed or becomes effective or any supplement or amendment to the Prospectus has been filed and will furnish the Underwriter with copies thereof. The Company will file promptly all reports and any definitive proxy or information statements required to be filed by the Company with the Commission pursuant to Section 13(a), 14 or 15(d) of the Exchange Act subsequent to the date of the Prospectus and for so long as the delivery of a prospectus is required in connection with the Offering. The Company will advise the Underwriter, promptly after it receives notice thereof (i) of any request by the Commission to amend the Registration Statement or to amend or supplement the Prospectus or for additional information, and (ii) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto or any order preventing or suspending the use of the Prospectus or any amendment or supplement thereto or any post-effective amendment to the Registration Statement, of the suspension of the qualification of the Securities for offering or sale in any jurisdiction, of the institution or threatened institution of any proceeding for any such purpose, or of any request by the Commission for the amending or supplementing of the Registration Statement or the Prospectus or for additional information. The Company shall use its commercially reasonable efforts to prevent the issuance of any such stop order or prevention or suspension of such use. If the Commission shall enter any such stop order or order or notice of prevention or suspension at any time, the Company will use its commercially reasonable efforts to obtain the lifting of such order at the earliest possible moment, or will file a new registration statement and use its commercially reasonable efforts to have such new registration statement declared effective as soon as practicable. Additionally, the Company agrees that it shall comply with the provisions of Rules 424(b), 430A, 430B and 430C, as applicable, under the Securities Act, including with respect to the timely filing of documents thereunder, and will use its commercially reasonable efforts to confirm that any filings made by the Company under such Rule 424(b) are received in a timely manner by the Commission.
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(b) Blue Sky Compliance. The Company will cooperate with the in endeavoring to qualify the Securities for sale under the securities laws of such jurisdictions (United States Underwriter and foreign) as the Underwriter may reasonably request and will make such applications, file such documents, and furnish such information as may be reasonably required for that purpose, provided the Company shall not be required to qualify as a foreign corporation or to file a general consent to service of process in any jurisdiction where it is not now so qualified or required to file such a consent, and provided further that the Company shall not be required to produce any new disclosure document other than the Prospectus. The Company will, from time to time, prepare and file such statements, reports and other documents as are or may be required to continue such qualifications in effect for so long a period as the Underwriter may reasonably request for distribution of the Securities. The Company will advise the Underwriter promptly of the suspension of the qualification or registration of (or any such exemption relating to) the Securities for offering, sale or trading in any jurisdiction or any initiation or threat of any proceeding for any such purpose, and in the event of the issuance of any order suspending such qualification, registration or exemption, the Company shall use its commercially reasonable efforts to obtain the withdrawal thereof at the earliest possible moment.
(c) Amendments and Supplements to the Prospectus and Other Matters. The Company will comply with the Rules and Regulations so as to permit the completion of the distribution of the Securities as contemplated in this Agreement and the Prospectus. If during the period in which a prospectus is required by law to be delivered in connection with the distribution of Securities contemplated by the Prospectus (the “Prospectus Delivery Period”), any event shall occur as a result of which, in the judgment of the Company or in the opinion of the Underwriter or counsel for the Underwriter, it becomes necessary to amend or supplement the Prospectus in order to make the statements therein, in the light of the circumstances under which they were made, as the case may be, not misleading, or if it is necessary at any time to amend or supplement the Prospectus to comply with any law, the Company will promptly prepare and file with the Commission, and furnish at its own expense to the Underwriter and to dealers, an appropriate amendment to the Registration Statement or supplement to the Registration Statement or the Prospectus that is necessary in order to make the statements in the Prospectus as so amended or supplemented, in the light of the circumstances under which they were made, as the case may be, not misleading, or so that the Registration Statement or the Prospectus, as so amended or supplemented, will comply with law. Before amending the Registration Statement or supplementing the Prospectus in connection with the Offering, the Company will furnish the Underwriter with a copy of such proposed amendment or supplement and will not file any such amendment or supplement to which the Underwriter reasonably objects; the Underwriter, and its counsel shall have at least three (3) business days to review and return any comments to the Company.
(d) Copies of any Amendments and Supplements to the Prospectus. The Company will furnish the Underwriter, without charge, during the period beginning on the date hereof and ending on the final Closing Date of the Offering, as many copies of the Prospectus and any amendments and supplements thereto as the Underwriter may reasonably request.
(e) Free Writing Prospectus. The Company covenants that it will not, unless it obtains the prior consent of the Underwriter, make any offer relating to the Securities that would constitute a Company Free Writing Prospectus (as defined below) or that would otherwise constitute a “free writing prospectus” (as defined in Rule 405 of the Securities Act) required to be filed by the Company with the Commission or retained by the Company under Rule 433 of the Securities Act. In the event that the Underwriter expressly consent in writing to any such free writing prospectus (a “Permitted Free Writing Prospectus”), the Company covenants that it shall (i) treat each Permitted Free Writing Prospectus as a Company Free Writing Prospectus, and (ii) comply with the requirements of Rule 164 and 433 of the Securities Act applicable to such Permitted Free Writing Prospectus, including in respect of timely filing with the Commission, legending and record keeping. “Company Free Writing Prospectus” means any “issuer free writing prospectus,” as defined in Rule 433 of the Securities Act Regulations (“Rule 433”), including without limitation any “free writing prospectus” (as defined in Rule 405 of the Securities Act Regulations) relating to the public securities that is (i) required to be filed with the Commission by the Company, (ii) a “road show that is a written communication” within the meaning of Rule 433(d)(8)(i), whether or not required to be filed with the Commission, or (iii) exempt from filing with the Commission pursuant to Rule 433(d)(5)(i) because it contains a description of the public securities or of the Offering that does not reflect the final terms, in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records pursuant to Rule 433(g).
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(f) Transfer Agent. The Company will maintain, at its expense, a registrar and transfer agent for its Ordinary Shares for so long as the Ordinary Shares are publicly traded.
(g) Earnings Statement. As soon as practicable and in accordance with applicable requirements under the Securities Act, but in any event not later than 18 months after the last Closing Date, the Company will make generally available to its security holders and to the Underwriter an earnings statement, covering a period of at least 12 consecutive months beginning after the last Closing Date, that satisfies the provisions of Section 11(a) and Rule 158 under the Securities Act.
(h) Periodic Reporting Obligations. During the Prospectus Delivery Period, the Company will duly file, on a timely basis, with the Commission all reports and documents required to be filed under the Exchange Act within the time periods and in the manner required by the Exchange Act.
(i) Additional Documents. The Company will enter into any subscription, purchase or other customary agreements as the Underwriter deems necessary or appropriate to consummate the Offering, all of which will be in form and substance reasonably acceptable to the Company and the Underwriter.
(j) No Manipulation of Price. The Company will not take, directly or indirectly, any action designed to cause or result in, or that has constituted or might reasonably be expected to constitute, the stabilization or manipulation of the price of any securities of the Company.
(k) Company Lock-Up. [Intentionally Omitted]
(l) Acknowledgment. The Company acknowledges that any advice given by the Underwriter to the Company is solely for the benefit and use of the Board of Directors of the Company and may not be used, reproduced, disseminated, quoted or referred to, without such Underwriter’s prior written consent.
(m) Listing. The Company shall use its commercially reasonable efforts to maintain the listing of the Securities on a Senior Exchange for five (5) years after the date of this Agreement.
(n) Application of Net Proceeds. The Company shall apply the net proceeds from the Offering of the Securities received by it in a manner consistent with the application thereof described under the caption “Use of Proceeds” in the Registration Statement, the Prospectus and the Final Prospectus.
(o) Rule 158. The Company will timely file such reports pursuant to the Exchange Act as are necessary in order to make generally available to its security holders as soon as practicable an earnings statement for the purposes of, and to provide to the Underwriter the benefits contemplated by Rule 158(a) under Section 11(a) of the Securities Act.
(p) Stabilization. Neither the Company nor, to its knowledge, any of its employees, directors or shareholders (without the consent of the Underwriter) has taken or shall take, directly or indirectly, any action designed to or that has constituted or that might reasonably be expected to cause or result in, under Regulation M of the Exchange Act, or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Securities.
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(q) Internal Controls. The Company shall maintain a system of internal accounting controls sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary in order to permit preparation of financial statements in accordance with GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
(r) Accountants. The Company shall retain an independent registered public accounting firm reasonably acceptable to the Underwriter (it being understood that BF Borgers CPA PC is an independent registered public accounting firm that is reasonably acceptable to the Underwriter), and the Company shall continue to retain a nationally recognized independent registered public accounting firm for a period of at least five (5) years after the date of this Agreement.
(s) FINRA. The Company shall advise the Underwriter (who shall make an appropriate filing with FINRA) if it is or becomes aware that (i) any officer or director of the Company, (ii) any beneficial owner of 5% or more of any class of the Company’s securities or (iii) any beneficial owner of the Company’s unregistered equity securities which were acquired during the 180 days immediately preceding the original filing of the Registration Statement is or becomes an affiliate or associated person of a FINRA member participating in the Offering (as determined in accordance with the rules and regulations of FINRA).
(t) Board Composition and Board Designations. The Company shall ensure that: (i) the qualifications of the persons serving as Board members and the overall composition of the Board comply with the Sarbanes-Oxley Act and the rules promulgated thereunder and with the listing requirements of the Senior Exchange and (ii) if applicable, at least one member of the Board qualifies as a “financial expert” as such term is defined under the Sarbanes-Oxley Act and the rules promulgated thereunder.
Section 5. Conditions of the Obligations of the Underwriter. The obligations of the Underwriter hereunder shall be subject to the accuracy of the representations and warranties on the part of the Company set forth in Section 2 hereof, in each case as of the date hereof and as of each Closing Date as though then made, to the timely performance by each of the Company of its covenants and other obligations hereunder on and as of such dates, and to each of the following additional conditions:
(a) Accountants’ Comfort Letter. On the date hereof, the Underwriter shall have received, and the Company shall have caused to be delivered to the Underwriter, a letter from BF Borgers CPA PC addressed to the Underwriter, dated as of the date hereof, in form and substance satisfactory to the Underwriter. The letter shall not disclose any change in the condition (financial or other), earnings, operations, business or prospects of the Company from that set forth in the Prospectus, which, in the Underwriter’s sole judgment, is material and adverse and that makes it, in the Underwriter’s sole judgment, impracticable or inadvisable to proceed with the Offering of the Securities as contemplated by the Prospectus.
(b) Compliance with Registration Requirements; No Stop Order; No Objection from the FINRA. The Registration Statement shall have become effective and all necessary regulatory and listing approvals shall have been received not later than 5:30 P.M., New York City time, on the date of this Agreement, or at such later time and date as shall have been consented to in writing by the Underwriter. The Prospectus (in accordance with Rule 424(b)) and “free writing prospectus” (as defined in Rule 405 of the Securities Act), if any, shall have been duly filed with the Commission in a timely fashion in accordance with the terms thereof. At or prior to each Closing Date and the actual time of the Closing, no stop order suspending the effectiveness of the Registration Statement or any part thereof shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no order preventing or suspending the use of the Prospectus shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no order having the effect of ceasing or suspending the distribution of the Securities or any other securities of the Company shall have been issued by any securities commission, securities regulatory authority or stock exchange and no proceedings for that purpose shall have been instituted or shall be pending or, to the knowledge of the Company, contemplated by any securities commission, securities regulatory authority or stock exchange; all requests for additional information on the part of the Commission shall have been complied with; and the FINRA shall have raised no objections to the fairness and reasonableness of the placement terms and arrangements. On each Closing Date, the Company’s Ordinary Shares shall have been approved for listing on the Senior Exchange.
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(c) Corporate Proceedings. All corporate proceedings and other legal matters in connection with this Agreement, the Registration Statement and the Prospectus, and the registration, sale and delivery of the Securities, shall have been completed or resolved in a manner reasonably satisfactory to the Underwriter’s counsel.
(d) No Material Adverse Effect. Subsequent to the execution and delivery of this Agreement and prior to each Closing Date, in the Underwriter’s sole judgment after consultation with the Company, there shall not have occurred any Material Adverse Effect.
(e) Opinions of Counsel for the Company. The Underwriter shall have received on each Closing Date
(i) the favorable opinion of Ortoli Rosenstadt LLP, Company securities counsel, dated as of such Closing Date, including, without limitation, a customary negative assurance letter, addressed to the Underwriter in customary form reasonably satisfactory to the Underwriter; and
(ii) the favorable opinion of CMS Derks Star Busmann N.V., Company Dutch counsel, dated as of such Closing Date, including, without limitation, a customary negative assurance letter for applicable sections, addressed to the Underwriter in customary form reasonably satisfactory to the Underwriter
(iii) the favorable opinion of German counsel, dated as of such Closing Date, including, without limitation, a customary negative assurance letter for applicable sections, addressed to the Underwriter in customary form reasonably satisfactory to the Underwriter.
The Underwriter shall rely on the opinions of the Company’s Dutch counsel, CMS Derks Star Busmann N.V. , filed as Exhibit 5.1 to the Registration Statement, as to the due incorporation, validity of the Securities and due authorization, execution and delivery of the Agreement.
(f) Officers’ Certificate. The Underwriter shall have received on each Closing Date a certificate of the Company, dated as of such Closing Date, signed by the Chief Executive Officer and Chief Financial Officer of the Company, to the effect that, and the Underwriter shall be satisfied that, the signers of such certificate have reviewed the Registration Statement and the Prospectus, and this Agreement and to the further effect that:
(i) The representations and warranties of the Company in this Agreement are true and correct, as if made on and as of such Closing Date, and the Company has complied with all the agreements and satisfied all the conditions on its part to be performed or satisfied at or prior to such Closing Date;
(ii) No stop order suspending the effectiveness of the Registration Statement or the use of the Prospectus has been issued and no proceedings for that purpose have been instituted or are pending or, to the Company’s knowledge, threatened under the Securities Act; no order having the effect of ceasing or suspending the distribution of the Securities or any other securities of the Company has been issued by any securities commission, securities regulatory authority or stock exchange in the United States and no proceedings for that purpose have been instituted or are pending or, to the knowledge of the Company, contemplated by any securities commission, securities regulatory authority or stock exchange in the United States;
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(iii) When the Registration Statement became effective, at the time of sale, and at all times subsequent thereto up to the delivery of such certificate, the Registration Statement, when it became effective, contained all material information required to be included therein by the Securities Act and the applicable rules and regulations of the Commission thereunder, as the case may be, and in all material respects conformed to the requirements of the Securities Act and the applicable rules and regulations of the Commission thereunder, as the case may be, and the Registration Statement, did not and does not include any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading (provided, however, that the preceding representations and warranties contained in this paragraph (iii) shall not apply to any statements or omissions made in reliance upon and in conformity with the Underwriter Information) and, since the effective date of the Registration Statement, there has occurred no event required by the Securities Act and the rules and regulations of the Commission thereunder to be set forth in the Registration Statement which has not been so set forth; and
(iv) Subsequent to the respective dates as of which information is given in the Registration Statement and the Prospectus, there has not been: (a) any Material Adverse Effect; (b) any transaction that is material to the Company and the Subsidiaries taken as a whole, except transactions entered into in the ordinary course of business; (c) any obligation, direct or contingent, that is material to the Company and the Subsidiaries taken as a whole, incurred by the Company or any Subsidiary, except obligations incurred in the ordinary course of business; (d) any material change in the capital stock (except changes thereto resulting from the exercise of outstanding options or warrants or conversion of outstanding indebtedness into Ordinary Shares of the Company) or outstanding indebtedness of the Company or any Subsidiary (except for the conversion of such indebtedness into Ordinary Shares of the Company); (e) any dividend or distribution of any kind declared, paid or made on Ordinary Shares of the Company; or (f) any loss or damage (whether or not insured) to the property of the Company or any Subsidiary which has been sustained or will have been sustained which has a Material Adverse Effect.
(g) Secretary’s Certificate. As of each Closing Date the Underwriter shall have received a certificate of the Company signed by the Secretary of the Company (or if no Secretary exists on such date, an executive officer of the Company), dated such Closing Date, certifying: (i) that each of the Company’s Articles of Association and Memorandum of Association attached to such certificate is true and complete, has not been modified and is in full force and effect; (ii) that each of the Subsidiaries’ Articles of Association, Memorandum of Association or charter documents attached to such certificate is true and complete, has not been modified and is in full force and effect; (iii) that the resolutions of the Company’s Board of Directors relating to the Offering attached to such certificate are in full force and effect and have not been modified; and (iv) the good standing of the Company and each of the Subsidiaries. The documents referred to in such certificate shall be attached to such certificate.
(h) Bring-down Comfort Letter. On each Closing Date, the Underwriter shall have received from BF Borgers CPA PC, or such other independent registered public accounting firm engaged by the Company at such time, a letter dated as of such Closing Date, in form and substance satisfactory to the Underwriter, to the effect that they reaffirm the statements made in the letter furnished pursuant to subsection (a) of this Section 5, except that the specified date referred to therein for the carrying out of procedures shall be no more than three business days prior to such Closing Date.
(i) Additional Documents. On or before each Closing Date, the Underwriter and counsel for the Underwriter shall have received such customary information and documents as they may reasonably require for the purposes of enabling them to pass upon the issuance and sale of the Securities as contemplated herein, or in order to evidence the accuracy of any of the representations and warranties, or the satisfaction of any of the conditions or agreements, herein contained. If any condition specified in this Section 5 is not satisfied when and as required to be satisfied, this Agreement may be terminated by the Underwriter by notice to the Company at any time on or prior to such Closing Date, which termination shall be without liability on the part of any party to any other party, except that Section 6 (Payment of Expenses), Section 7 (Indemnification and Contribution) and Section 8 (Representations and Indemnities to Survive Delivery) shall at all times be effective and shall survive such termination.
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(j) Subsequent to the execution and delivery of this Agreement or, if earlier, the dates as of which information is given in the Registration Statement (exclusive of any amendment thereof) and the Prospectus (exclusive of any supplement thereto), there shall not have been any change in the capital stock or long-term debt of the Company (other than as described in the Registration Statement or the Prospectus) or any change or development involving a change, whether or not arising from transactions in the ordinary course of business, in the business, condition (financial or otherwise), results of operations, shareholders’ equity, properties or prospects of the Company, taken as a whole, including but not limited to the occurrence of any fire, flood, storm, explosion, accident, act of war or terrorism or other calamity, the effect of which, in any such case described above, is, in the sole judgment of the Underwriter, so material and adverse as to make it impracticable or inadvisable to proceed with the sale of Securities or Offering as contemplated hereby.
(k) Subsequent to the execution and delivery of this Agreement and up to each Closing Date, there shall not have occurred any of the following: (i) trading in securities generally on a Senior Exchange or any Trading Market shall not have commenced, (ii) a banking moratorium shall have been declared by federal or state authorities or a material disruption has occurred in commercial banking or securities settlement or clearance services in the United States, (iii) the United States shall have become engaged in hostilities in which it is not currently engaged, the subject of an act of terrorism, there shall have been an escalation in hostilities involving the United States, or there shall have been a declaration of a national emergency or war by the United States, or (iv) there shall have occurred any other calamity or crisis or any change in general economic, political or financial conditions in the United States or elsewhere, if the effect of any such event in clause (ii) or (iv) makes it, in the sole judgment of the Underwriter, impracticable or inadvisable to proceed with the sale or delivery of the Securities on the terms and in the manner contemplated by the Prospectus.
(l) [Intentionally Omitted]
(m) No action shall have been taken and no statute, rule, regulation or order shall have been enacted, adopted or issued by any federal, state or foreign governmental or regulatory authority that would, as of any Closing Date, prevent the issuance or sale of the Securities; and no injunction or order of any federal, state or foreign court shall have been issued that would, as of such Closing Date, prevent the issuance or sale of the Securities or materially and adversely affect or potentially materially and adversely affect the business or operations of the Company.
If any of the conditions specified in this Section 5 shall not have been fulfilled when and as required by this Agreement, or if any of the certificates, opinions, written statements or letters furnished to the Underwriter or to Underwriter’s counsel pursuant to this Section 5 shall not be reasonably satisfactory in form and substance to the Underwriter and to Underwriter’s counsel, all obligations of the Underwriter hereunder may be cancelled by the Underwriter at, or at any time prior to, the consummation of the Offering. Notice of such cancellation shall be given to the Company in writing or orally. Any such oral notice shall be confirmed promptly thereafter in writing.
Section 6. Payment of Company Expenses. The Company agrees to pay all costs, fees and expenses incurred by the Company in connection with the performance of its obligations hereunder and in connection with the transactions contemplated hereby, including, without limitation: (i) all expenses incident to the issuance, delivery and qualification of the Securities (including all printing and engraving costs); (ii) all fees and expenses of the registrar and transfer agent of the Securities; (iii) all necessary issue, transfer and other stamp taxes in connection with the issuance and sale of the Securities; (iv) all fees and expenses of the Company’s counsel, independent public or certified public accountants and other advisors; (v) all costs and expenses incurred in connection with the preparation, printing, filing, shipping and distribution of the Registration Statement (including financial statements, exhibits, schedules, consents and certificates of experts), the Prospectus, and all amendments and supplements thereto, and this Agreement; (vi) all filing fees, reasonable attorneys’ fees and expenses incurred by the Company or the Underwriter in connection with qualifying or registering (or obtaining exemptions from the qualification or registration of) all or any part of the Securities for offer and sale under the state securities or blue sky laws or the securities laws of any other country, and, if reasonably requested by the Underwriter, preparing and printing a “Blue Sky Survey,” an “International Blue Sky Survey” or other memorandum, and any supplements thereto, advising any of the Underwriter of such qualifications, registrations and exemptions; (vii) if applicable, the filing fees incident to the review and approval by the FINRA of the Underwriter’s participation in the offering and distribution of the Securities; (viii) the fees and expenses associated with including the Ordinary Shares on the Trading Market; and (ix) all costs and expenses incident to the travel and accommodation of the Company’s employees on the “roadshow,” as described in Section 1(a)(iii) of this Agreement.
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Section 7. Indemnification and Contribution.
(a) The Company agrees to indemnify, defend and hold harmless the Underwriter, its Affiliates, directors and officers and employees, and each person, if any, who controls the Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act (each an “Underwriter Indemnified Party”), from and against any losses, claims, damages or liabilities (including in settlement of any litigation if such settlement is effected with the prior written consent of the Company) arising out of (i) an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, including the information deemed to be a part of the Registration Statement at the time of effectiveness and at any subsequent time pursuant to Rules 430A and 430B of the Securities Act Regulations, or arise out of or are based upon the omission from the Registration Statement, or alleged omission to state therein, a material fact required to be stated therein or necessary to make the statements therein not misleading; or (ii) an untrue statement or alleged untrue statement of a material fact contained in the Prospectus, or any amendment or supplement thereto, or in any other materials used in connection with the Offering, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, and will reimburse such Underwriter Indemnified Party for any legal or other expenses reasonably incurred by it in connection with evaluating, investigating or defending against such loss, claim, damage, liability or action; provided, however, that the Company shall not be liable in any such case to the extent that any such loss, claim, damage, liability or action arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, the Prospectus, or any amendment or supplement thereto, or, in reliance upon and in conformity with the Underwriter Information. The indemnification obligations under this Section 7(a) are not exclusive and will be in addition to any liability which the Company might otherwise have and shall not limit any rights or remedies which may otherwise be available at law or in equity to each Underwriter Indemnified Party.
(b) The Underwriter will indemnify, defend and hold harmless the Company, its Affiliates, directors, officers and employees, and each person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act (each a “Company Indemnified Party”), from and against any losses, claims, damages or liabilities to which such Company Indemnified Party may become subject, under the Securities Act or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of the Representative), insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, the Prospectus, or any amendment or supplement thereto, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in the Registration Statement, the Prospectus, or any amendment or supplement thereto, in reliance upon and in conformity with the Underwriter Information, and will reimburse such Company Indemnified Party for any legal or other expenses reasonably incurred by it in connection with defending against any such loss, claim, damage, liability or action; provided, however, that the Underwriter shall not be liable in any such case to the extent that any such loss, claim, damage, liability or action arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, the Prospectus, or any amendment or supplement thereto, or, in reliance upon and in conformity with information furnished in writing to the Underwriter by the Company. The indemnification obligations under this Section 7(b) are not exclusive and will be in addition to any liability which the Underwriter might otherwise have and shall not limit any rights or remedies which may otherwise be available at law or in equity to each Company Indemnified Party.
(c) Promptly after receipt by an indemnified party under subsection (a) or (b) above of notice of the commencement of any action, such indemnified party shall, if a claim in respect thereof is to be made against the indemnifying party under such subsection, notify the indemnifying party in writing of the commencement thereof, but the failure to notify the indemnifying party shall not relieve the indemnifying party from any liability that it may have to any indemnified party except to the extent such indemnifying party has been materially prejudiced by such failure. In case any such action shall be brought against any indemnified party, and it shall notify the indemnifying party of the commencement thereof, the indemnifying party shall be entitled to participate in, and, to the extent that it shall wish, jointly with any other indemnifying party similarly notified, to assume the defense thereof, with counsel reasonably satisfactory to such indemnified party, and after notice from the indemnifying party to such indemnified party of the indemnifying party’s election so to assume the defense thereof, the indemnifying party shall not be liable to such indemnified party under such subsection for any legal or other expenses subsequently incurred by such indemnified party in connection with the defense thereof; provided, however, that if (i) the indemnified party has reasonably concluded (based on advice of counsel) that there may be legal defenses available to it or other indemnified parties that are different from or in addition to those available to the indemnifying party, (ii) a conflict or potential conflict exists (based on advice of counsel to the indemnified party) between the indemnified party and the indemnifying party (in which case the indemnifying party will not have the right to direct the defense of such action on behalf of the indemnified party), or (iii) the indemnifying party has not in fact employed counsel reasonably satisfactory to the indemnified party to assume the defense of such action within a reasonable time after receiving notice of the commencement of the action, the indemnified party shall have the right to employ a single counsel to represent it in any claim in respect of which indemnity may be sought under subsection (a) or (b) of this Section 7, in which event the reasonable fees and expenses of such separate counsel shall be borne by the indemnifying party or parties and reimbursed to the indemnified party as incurred.
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(d) The indemnifying party under this Section 7 shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to indemnify the indemnified party against any loss, claim, damage, liability or expense by reason of such settlement or judgment. No indemnifying party shall, without the prior written consent of the indemnified party, effect any settlement, compromise or consent to the entry of judgment in any pending or threatened action, suit or proceeding in respect of which any indemnified party is a party or could be named and indemnity was or would be sought hereunder by such indemnified party, unless such settlement, compromise or consent (i) includes an unconditional release of such indemnified party from all liability for claims that are the subject matter of such action, suit or proceeding and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of any indemnified party. Notwithstanding the foregoing, if at any time an indemnified party shall have requested an indemnifying party to reimburse the indemnified party for fees and expenses of counsel pursuant to Section 7(c), such indemnifying party agrees that it shall be liable for any settlement effected without its written consent if (i) such settlement is entered into more than 45 days after receipt by such indemnifying party of the aforesaid request and (ii) such indemnifying party shall not have reimbursed such indemnified party in accordance with such request prior to the date of such settlement.
(e) If the indemnification provided for in this Section 7 is unavailable or insufficient to hold harmless an indemnified party under subsection (a) or (b) above, then the indemnifying party shall contribute to the amount paid or payable by such indemnified party as a result of the losses, claims, damages or liabilities referred to in subsection (a) or (b) above, (i) in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and the Underwriter on the other hand from the offering and sale of the Securities or (ii) if the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company on the one hand and the Underwriter on the other hand in connection with the statements or omissions that resulted in such losses, claims, damages or liabilities, as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the Underwriter on the other hand shall be deemed to be in the same proportion as the total net proceeds from the Offering (before deducting expenses) received by the Company bear to the total cash compensation received by the Underwriter. The relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company or the Underwriter and the parties’ relevant intent, knowledge, access to information and opportunity to correct or prevent such untrue statement or omission. The Company and the Underwriter agrees that it would not be just and equitable if contributions pursuant to this subsection (e) were to be determined by pro rata allocation (even if the Underwriter were treated as one entity for such purpose) or by any other method of allocation that does not take account of the equitable considerations referred to in the first sentence of this subsection (e). The amount paid by an indemnified party as a result of the losses, claims, damages or liabilities referred to in the first sentence of this subsection (e) shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending against any action or claim that is the subject of this subsection (e). No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.
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(f) For purposes of this Agreement, the Underwriter confirms, and the Company acknowledges, that there is no information concerning the Underwriter furnished in writing to the Company by the Underwriter specifically for preparation of or inclusion in the Registration Statement or the Prospectus other than the Underwriter Information.
Section 8. Representations and Indemnities to Survive Delivery. The respective indemnities, agreements, representations, warranties and other statements of the Company or any person controlling the Company, of its officers, and of the Underwriter set forth in or made pursuant to this Agreement will remain in full force and effect, regardless of any investigation made by or on behalf of the Underwriter, the Company, or any of its or their partners, officers or directors or any controlling person, as the case may be, and will survive delivery of and payment for the Securities sold hereunder and any termination of this Agreement. A successor to the Underwriter, or to the Company, its directors or officers or any person controlling the Company, shall be entitled to the benefits of the indemnity, contribution and reimbursement agreements contained in this Agreement.
Section 9. Termination.
(a) This Agreement shall become effective upon the later of: (i) receipt by the Underwriter and the Company of notification of the effectiveness of the Registration Statement or (ii) the execution of this Agreement. The Underwriter shall have the right to terminate this Agreement at any time upon 15 days written notice to the Company, or as practical as possible prior to any Closing Date if: (i) any domestic or international event or act or occurrence has materially disrupted, or in the reasonable opinion of the Underwriter will in the immediate future materially disrupt, the market for the Company’s securities or securities in general; or (ii) trading on a Senior Exchange has been rejected by such Senior Exchange or made subject to material limitations, or minimum or maximum prices for trading have been fixed, or maximum ranges for prices for securities have been required, on the Senior Exchange or by order of the Commission, FINRA or any other governmental authority having jurisdiction; or (iii) a banking moratorium has been declared by any state or federal authority or any material disruption in commercial banking or securities settlement or clearance services has occurred; or (iv) (A) there has occurred any outbreak or escalation of hostilities or acts of terrorism involving the United States or China or there is a declaration of a national emergency or war by the United States or China or (B) there has been any other calamity or crisis or any change in political, financial or economic conditions, if the effect of any such event in (A) or (B), in the reasonable judgment of the Underwriter, is so material and adverse that such event makes it impracticable or inadvisable to proceed with the Offering, sale and delivery of the Securities on the terms and in the manner contemplated by the Prospectus.
(b) Any notice of termination pursuant to this Section 9 shall be in writing.
(c) If this Agreement shall be terminated pursuant to any of the provisions hereof, or if the sale of the Securities provided for herein is not consummated because any condition to the obligations of the Underwriter set forth herein is not satisfied or because of any refusal, inability or failure on the part of the Company to perform any agreement herein or comply with any provision hereof, the Company will, subject to demand by the Underwriter, reimburse the Underwriter for only those out-of-pocket expenses (including the reasonable fees and expenses of their counsel, and expenses associated with a due diligence report), actually incurred by the Underwriter in connection herewith as allowed under FINRA Rule 5110, less any amounts previously paid by the Company, subject to the cap on expenses set forth in Section 1(a)(iii) hereof. To the extent that the Underwriter’s out-of-pocket expenses are less than the sums already advanced by the Company to the Underwriter (“Advances”), the Underwriter will return to the Company that portion of the Advances not offset by actual expenses.
Section 10. [Intentionally Omitted]
Section 11. Notices. All communications hereunder shall be in writing and shall be mailed, hand delivered, delivered by reputable overnight courier (i.e., Federal Express) or delivered by facsimile or e-mail transmission to the parties hereto as follows:
If to the Underwriter, then to:
Boustead Securities, LLC
6 Venture, Suite 395
Irvine, CA 92618
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Attn: | Keith Moore | |
Attn: | Daniel J. McClory | |
Email: | Keith@boustead1828.com | |
Dan@boustead1828.com |
With a copy (which shall not constitute notice) to:
Sichenzia Ross Ference LLP
1185 Avenue of the Americas, 31st Floor
New York, NY 10036
Attn: | Benjamin Tan, Esq. |
Email: | btan@SRF.LAW |
If to the Company:
Mainz Biomed N.V.
Robert Koch Strasse 50
55129 Mainz
Germany
Attn:
Email:
With a copy (which shall not constitute notice) to:
Ortoli Rosenstadt LLP
366 Madison Avenue
New York, NY 10017
Attn: | William Rosenstadt, Esq. |
Tim Dockery, Esq.
Email: | wsr@orllp.legal |
tld@orllp.legal
Any party hereto may change the address for receipt of communications by giving written notice to the others.
Section 12. Successors. This Agreement will inure to the benefit of and be binding upon the parties hereto, and to the benefit of the employees, officers and directors and controlling persons referred to in Section 7 hereof, and to their respective successors, and no other person will have any right or obligation hereunder.
Section 13. Partial Unenforceability. The invalidity or unenforceability of any section, paragraph or provision of this Agreement shall not affect the validity or enforceability of any other section, paragraph or provision hereof. If any Section, paragraph or provision of this Agreement is for any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor changes (and only such minor changes) as are necessary to make it valid and enforceable.
Section 14. Governing Law Provisions. This Agreement shall be deemed to have been made and delivered in New York and both this Agreement and the transactions contemplated hereby shall be governed as to validity, interpretation, construction, effect and in all other respects by the internal laws of the State of New York, without regard to the conflict of laws principles thereof. Each of the Underwriter and the Company: (i) agrees that any legal suit, action or proceeding arising out of or relating to this Agreement and/or the transactions contemplated hereby shall be instituted exclusively in New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, (ii) waives any objection which it may now or hereafter have to the venue of any such suit, action or proceeding, and (iii) irrevocably consents to the jurisdiction of the New York Supreme Court, County of New York, and the United States District Court for the Southern District of New York in any such suit, action or proceeding. Each of the Underwriter and the Company further agrees to accept and acknowledge service of any and all process which may be served in any such suit, action or proceeding in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York and agrees that service of process upon the Company mailed by certified mail to the Company’s address shall be deemed in every respect effective service of process upon the Company, in any such suit, action or proceeding, and service of process upon the Underwriter mailed by certified mail to the Underwriter’s address(es) shall be deemed in every respect effective service process upon the Underwriter, in any such suit, action or proceeding.
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Section 15. General Provisions.
(a) This Agreement constitutes the entire agreement of the parties to this Agreement and supersedes all prior written or oral and all contemporaneous oral agreements, understandings and negotiations solely with respect to the subject matters hereof. Notwithstanding anything to the contrary set forth herein, it is understood and agreed by the parties hereto that all other terms and conditions of the Engagement Letter shall remain in full force and effect. This Agreement may be executed in two or more counterparts, each one of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement may not be amended or modified unless in writing and signed by all of the parties hereto, and no condition herein (express or implied) may be waived unless waived in writing by each party whom the condition is meant to benefit. Section headings herein are for the convenience of the parties only and shall not affect the construction or interpretation of this Agreement.
(b) The Company acknowledges that in connection with the Offering of the Securities: (i) the Underwriter has acted at arm’s length, is not an agent of, and owes no fiduciary duties to the Company or any other person, (ii) the Underwriter owes the Company only those duties and obligations set forth in this Agreement and (iii) the Underwriter may have interests that differ from those of the Company. The Company waives to the full extent permitted by applicable law any claims it may have against the Underwriter arising from an alleged breach of fiduciary duty in connection with the offering of the Securities.
[The remainder of this page has been intentionally left blank.]
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If the foregoing is in accordance with your understanding of our agreement, please sign below whereupon this instrument, along with all counterparts hereof, shall become a binding agreement in accordance with its terms.
Very truly yours, | ||
Mainz Biomed N.V. | ||
By: | ||
Name: | ||
Title: |
The foregoing Underwriting Agreement is hereby confirmed and agreed to of the date first above written.
BOUSTEAD SECURITIES, LLC | ||
By: | ||
Name: | Keith Moore | |
Title: | Chief Executive Officer |
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Exhibit 5.1
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Mainz Biomed N.V. Robert Koch Strasse 50 55129 Mainz GERMANY
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CMS Derks Star Busmann N.V. Atrium | Parnassusweg 737 NL-1077 DG Amsterdam P.O. Box 94700 NL-1090 GS Amsterdam
Bank account (Stichting Derdengelden) Iban: NL31 RABO 0103 3545 49 Swift/bic: RABONL2U
|
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T | +31 20 301 63 01 | |||
F | +31 20 301 63 05 | |||
I | cms.law | |||
Our ref. | /CW/CW |
Subject: Mainz Biomed / Legal opinion | 21 January 2022 |
Dear Madam/Sir,
We have acted as Dutch legal counsel to Mainz Biomed N.V. of Amsterdam, the Netherlands (the “Company”), in respect of certain matters of Dutch law in connection with the filing of a registration statement on Form F-1 (the “Registration Statement”) with the United States Securities and Exchange Commission. The Company has been incorporated as a private limited liability company (besloten vennootschap met beperkte aansprakelijkheid) and has been converted into a public company with limited liability (naamloze vennootschap).
The Registration Statement covers the offering of (i) 1,500,000 ordinary shares in the capital of the Company, and (ii) 225,000 ordinary shares in the capital of the Company subject to the underwriter’s option to purchase additional shares (collectively referred to as the “Registration Shares”).
All services are rendered under an agreement of instruction with CMS Derks Star Busmann N.V., with registered office in Amsterdam, the Netherlands. This agreement is subject to the General Conditions of CMS Derks Star Busmann N.V., which have been filed with the registrar of the District Court Amsterdam, the Netherlands, under no. 84/2020 and which contain a limitation of liability. These terms have been published on the website cms.law and will be provided upon request. CMS Derks Star Busmann N.V. is a company with limited liability under the laws of the Netherlands and is registered in the Netherlands with the trade register under no. 30201194 and in Belgium with the RPR Brussels under no. 0877.478.727. The VAT number of CMS Derks Star Busmann N.V. for the Netherlands is NL8140.16.479.B01 and for Belgium BE 0877.478.727. |
CMS Derks Star Busmann is a member of CMS, the organisation of European law firms. In certain circumstances, CMS is used as a brand or business name of, or to refer to, some or all of the member firms or their offices. Further information can be found at www.cms.law. |
CMS offices and associated offices: Aberdeen, Algiers, Amsterdam, Antwerp, Barcelona, Beijing, Belgrade, Berlin, Bogotá, Bratislava, Bristol, Brussels, Bucharest, Budapest, Casablanca, Cologne, Dubai, Duesseldorf, Edinburgh, Frankfurt, Funchal, Geneva, Glasgow, Hamburg, Hong Kong, Istanbul, Johannesburg, Kyiv, Leipzig, Lima, Lisbon, Ljubljana, London, Luanda, Luxembourg, Lyon, Madrid, Manchester, Mexico City, Milan, Mombasa, Monaco, Moscow, Munich, Muscat, Nairobi, Paris, Podgorica, Poznan, Prague, Reading, Rio de Janeiro, Riyadh, Rome, Santiago de Chile, Sarajevo, Seville, Shanghai, Sheffield, Singapore, Skopje, Sofia, Strasbourg, Stuttgart, Tirana, Utrecht, Vienna, Warsaw, Zagreb and Zurich. |
For the purpose of this legal opinion, we have examined and relied solely upon the following documents:
(a) | an electronically received copy of an extract relative to the Company, dated 21 January 2022 (the “Extract”) from the trade register (handelsregister) of the Dutch Chamber of Commerce (Kamer van Koophandel) (the “Trade Register”); |
(b) | an official copy of the notarial deed of incorporation (akte van oprichting) of the Company, dated 8 March 2021 (the “Deed of Incorporation”), containing the articles of association of the Company before the execution of the Deed of Conversion (the “B.V. Articles of Association”); |
(c) | a draft deed of issue of the Registration Shares, dated 21 January 2022 (the “Deed of Issue”); |
(d) | an official copy of the notarial deed of conversion, dated 9 November 2021 (the “Deed of Conversion”), containing the current articles of association of the Company (the “N.V. Articles of Association”); |
(e) | a written resolution of the management board (het bestuur) of the Company, dated 1 November 2021 (“Board Resolution I”); |
(f) | a written resolution of the general meeting of the Company, dated 1 November 2021 (the “Shareholder Resolution”); and |
(g) | a written resolution of the management board (het bestuur) of the Company, dated 21 January 2022 (“Board Resolution II”). |
We do not express any opinion in respect of the Registration Statement.
In connection with such examination and for the purpose of the legal opinion expressed herein, we have assumed:
(i) | that at the time of the issuance of the Registration Shares, the Company’s authorized capital will be sufficient to allow for the issuance; |
(ii) | that the Registration Shares will be subscribed for, issued and accepted by their subscribers in accordance with all applicable laws (including for the avoidance of doubt, Dutch law); |
(iii) | that the Registration Shares will be validly paid up at the time of the issuances; |
(iv) | that the Registration Shares will be issued pursuant to the Deed of Issue that will be accurate, complete and in full force and effect; |
(v) | that each party validly entered or will validly enter into the Deed of Issue; |
(vi) | each signature on each document is the original or electronic (as relevant) signature of the relevant stated person; |
(vii) | the genuineness of all signatures on all original documents of the persons purported to have signed the same; |
(viii) | the conformity to their originals of all documents submitted or transmitted to us in the form of photocopies, electronically or otherwise, and the authenticity and completeness of such originals; |
(ix) | that the Shareholder Resolution, Board Resolution I and Board Resolution II have been validly signed and that the resolutions reflected therein will be in full force and effect at the time of the issuance of the Registration Shares and that none of these resolutions will be withdrawn or restated and that no resolutions have been or will be adopted to amend the contents of these resolutions; |
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(x) | that the Deed of Incorporation is a valid notarial deed (notariële akte), that the content thereof is correct and complete, it being hereby confirmed that on the face of the Deed of Incorporation it does not appear that the Deed of Incorporation is not a valid notarial deed; |
(xi) | that the B.V. Articles of Association were in full force and effect and that the N.V. Articles of Association are in full force and effect at the date hereof, it being hereby confirmed that on the face of the N.V. Articles of Association and the Extract it does not appear that the N.V. Articles of Association are not in full force and effect as at the date hereof; |
(xii) | any and all authorisations and consents of, or other filings with or notifications to, any public authority or other relevant body or person in or of any jurisdiction which may be required (other than under Dutch law) in respect of the issuance of the Registration Shares have been or will be duly obtained or made, as the case may be; |
(xiii) | that no petition has been presented to nor order made by a court for the bankruptcy (faillissement) of the Company and that no resolution has been adopted concerning a statutory merger (juridische fusie) or division (splitsing) involving the Company as disappearing entity, or a voluntary liquidation (ontbinding) of the Company; |
(xiv) | that, at the date hereof, the information contained in the Extract truly and correctly reflects the position of the Company as mentioned therein; |
(xv) | that, at the time of the issuances of the Registration Shares, the Company is not included on the consolidated list of persons, groups and entities subject to EU financial sanctions (the “Sanctions List”); |
(xvi) | that, at the date hereof, the directors of the Company are not included on the list of natural persons subject to a director’s disqualification (civielrechtelijk bestuursverbod) under the laws of the Netherlands; and |
(xvii) | that the Company has not been dissolved (ontbonden), merged (gefuseerd) involving the Company as disappearing entity, demerged (gesplitst), converted (omgezet), granted a suspension of payments (surséance verleend), subjected to emergency regulations (noodregeling) as provided for in the Financial Supervision Act (Wet op het Financieel Toezicht), declared bankrupt (failliet verklaard), subjected to any other insolvency proceedings listed in Annex A of Regulation (EU) 2015/848 of the European Parliament and of the Council of 20 May 2015 on insolvency proceedings (recast), as amended from time to time, and no trustee (curator), administrator (bewindvoerder) or similar officer has been appointed in respect of the Company or any of its respective assets; |
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In support of the assumptions under (xiii), (xiv) and (xvii), we have carried out the following investigations. The office of the bankruptcy registrar of the District Court of Amsterdam has confirmed to us by telephone today at 16:31 CET that the Company has not been declared bankrupt (in staat van faillissement) and has not been granted a suspension of payment (surséance van betaling). Furthermore, we have obtained a confirmation through http://www.rechtspraak.nl, derived from the segment for EU registrations of the Central Insolvency Register, that the Company is not registered as being subject to insolvency proceedings. The Trade Register has confirmed to us by telephone today at 16:20 CET that the Company has not been dissolved at the initiative of the Dutch Chamber of Commerce and that no resolution to dissolve, merge (juridisch fuseren) or demerge (splitsen) the Company was filed. In the same telephone call, the official of the Trade Register confirmed to us that no amendments in the registration of the Company occurred in the period from the provision of the Extract to us through the date and time hereof. Moreover, in support of the assumption under (xiv), we have carried out an online search today at 16:40 CET on https://webgate.ec.europa.eu/europeaid/fsd/fsf showing that the Company is not included on the Sanctions List. We have not investigated any matter that is the subject of an assumption made in this legal opinion other than as set forth herein.
We express no opinion as to any law other than the laws of the Netherlands in force at the date hereof as applied and interpreted according to present duly published case law of the Dutch courts. No opinion is rendered with respect to any matters of fact, anti-trust law, market abuse, equal treatment of shareholders, financial assistance, tax law or the laws of the European Communities, to the extent not or not fully implemented in the laws of the Netherlands.
In this legal opinion, Dutch legal concepts are expressed in English terms and not in their original Dutch terms. Where indicated in italics, Dutch equivalents of these English terms have been given for the purpose of clarification. The Dutch concepts may not be identical to the concepts described by the same English terms as they exist under the laws of other jurisdictions. Terms and expressions of law and of legal concepts as used in this legal opinion have the meaning attributed to them under the laws of the Netherlands and this legal opinion should be read and understood accordingly.
This legal opinion is strictly limited to the matters stated herein and may not be read as extending by implication to any matter not specifically referred to. Nothing in this legal opinion should be taken as expressing an opinion in respect of the factual accuracy of any representations or warranties, or other information, contained in any document, referred to herein or examined in connection with this legal opinion, except as expressly stated otherwise. For the purpose hereof, we have assumed such accuracy.
Based upon the foregoing (including, without limitation, the documents and the assumptions set out above) and subject to the qualifications set out below and any facts, circumstances, events or documents not disclosed to us in the course of our examination referred to above, we are, at the date hereof, of the opinion that:
When issued, the Registration Shares will have been validly issued, fully paid and will be non-assessable.
The opinion expressed above is subject to the following qualifications:
(A) | The opinion expressed above may be affected or limited by any applicable bankruptcy, insolvency, fraudulent conveyance (actio pauliana), reorganization, suspension of payment and other or similar laws now or hereafter in effect, relating to or affecting the enforcement or protection of creditors’ rights. |
(B) | A power of attorney (volmacht) or mandate (lastgeving) granted or issued by the Company will terminate by force of law and without any notice being required upon bankruptcy of the Company and will become ineffective upon a suspension of payments (surséance van betaling) being granted to the Company. |
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(C) | A court applying the laws of the Netherlands may: (i) at the request of any party to an agreement change the effect of an arrangement or dissolve it in whole or in part in the event of unforeseen circumstances (onvoorziene omstandigheden) of such nature that do not, according the standards of reasonableness and fairness, justify the other party to expect the agreement to be maintained unchanged; (ii) limit any claim for damages or penalties on the basis that such claim is deemed excessive by the court; and (iii) refuse to give effect to any provisions for the payment of expenses in respect of the costs of enforcement (actual or attempted) or unsuccessful litigation brought before such court or tribunal or where such court or tribunal has itself made an order for costs. |
(D) | If a party is controlled by or otherwise connected with a person, organization or country that is currently the subject of sanctions by the United Nations, the European Community or the Netherlands, implemented, effective or sanctioned in the Netherlands under the Sanctions Act 1977 (Sanctiewet 1977), the Economic Offences Act (Wet op de economische delicten) or the Financial Supervision Act (Wet op het Financieel Toezicht) or is otherwise the target of any such sanctions, the obligations of the Company to that party may be unenforceable, void or otherwise affected. |
(E) | The term “non-assessable” has no equivalent legal term under Dutch law and for the purpose of this opinion, “non-assessable” means that a holder of a Registration Share will not by reason of merely being such a holder, be subject to assessment or calls by the Company or its creditors for further payment on such Registration Share. |
This opinion is rendered to you for the sole purpose of the filing of this opinion as an exhibit to the Registration Statement to be submitted by the Company on the date hereof, to which filing we consent under the express condition that:
(i) | we do not admit that we are within the category of persons whose consent is required within Section 7 of the Securities Act of 1933; |
(ii) | any issues of interpretation of liability arising under this legal opinion will be governed exclusively by the laws of the Netherlands and be brought exclusively before a Dutch court; |
(iii) | this legal opinion is subject to acceptance of the limitation of liability as mentioned on the first page of this letter; |
(iv) | we do not assume any obligation to notify or to inform you of any developments subsequent to the date hereof that might render its contents untrue or inaccurate in whole or in part at such time; and |
this legal opinion is strictly limited to the matters set forth herein and no opinion may be inferred or implied beyond our opinion expressly stated herein.
Yours faithfully,
|
||
/s/ CMS Derks Star Busmann N.V. | ||
CMS Derks Star Busmann N.V. |
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Exhibit 10.15
TECHNOLOGY RIGHTS AGREEMENT
This Agreement (the “Option Agreement”) is made effective as of _________ (the “Effective Date”).
BETWEEN: |
Socpra sciences santé et humaines s.e.c., operating under the name TransferTech Sherbrooke, a Limited Partnership duly incorporated pursuant to the Civil Code of Québec, having its head office at 35 Radisson Street, Office 200, Sherbrooke, (Quebec), Canada, J1L 1E2, acting and represented by its General Partner, Gestion Socpra sciences santé et humaines inc., a legal person duly constituted under the Business Corporations Act (Quebec), said General Partner being represented by its agent and mandatory Gestion socpra Inc, herein acting and represented by Michel Lambert, its President and CEO, duly authorized for the purposes hereof as he so declares by signing;
hereinafter referred to as “TTS”
|
|
AND: |
Mainz
Biomed N.V., a corporate body incorporated in Amsterdam, with its principal place of business located at Sirius
GutenbergPark
hereinafter referred to as “MAINZ BIOMED”
|
MAINZ BIOMED and TTS shall each individually be referred to as “Party” and collectively as “Parties”. |
WHEREAS | Jean-François Beaulieu, Élizabeth Herring and Éric Tremblay (hereinafter the “Inventors”), while working at the Université de Sherbrooke (the “University”) have developed an invention entitled “Algorithme et méthode de profilage multi-cibles d’ARNm pour le dépistage des lésions colorectales”, which along with other aspects of the work of the Inventors constitute (the “Technology” as further defined herein; |
WHEREAS | TTS is a limited partnership with a mission to elaborate, plan, organize, carry out and manage the commercial and valorization activities regarding the University’s intellectual property; |
WHEREAS | according to a technology transfer agreement agreed upon between the University and TTS, the University has assigned to TTS all its rights, titles and interests in the Technology and TTS has received the exclusive right to commercialize said Technology and to enter into agreements with commercial entities, including the right to enter into this Option Agreement; |
WHEREAS | TTS has filed patent applications on the Technology, as further described in Schedule 1; |
WHEREAS | MAINZ BIOMED is interested in performing various tests on the Technology, for which TTS holds all the rights, in order to assess efficacy, compatibility and quality before exercising the Option, as further described below, on the Intellectual Property, including the Technology, as further defined herein. |
WHEREAS | TTS wishes to grant to MAINZ BIOMED, and MAINZ BIOMED agrees to acquire, a globally exclusive option to excercise an assignment of the Intellectual Property, on certain terms and conditions which include the terms detailed in Schedule 3. |
NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
1.0 | DEFINITIONS |
1.1. | Confidential Information means the terms and conditions of this Option Agreement, any confidential or proprietary information shared between or among Parties for the purposes of this Option Agreement, and any and all discoveries, inventions, processes, methods, techniques, know-how, and intellectual property and proprietary rights relating to the Technology, expressed in whatever form and may include technical information, procedures, formulae, protocols, software, specifications, flowcharts, instructions, research, financial or marketing data, business plans, patent applications, and other documents and materials, and all modifications, variations, updates, enhancements and improvements thereof, that are disclosed by one Party to another Party during the term of this Option Agreement. Confidential Information may include unique combinations of separate items, which individually may or may not be confidential. |
1.2. | TTS-owned Improvements means any addition, modification, extension or perfecting to or of the Technology, which promotes its development, production or marketing and that aredeveloped exclusively by the University, which may or may not be the subject of intellectual property protection. |
1.3. | Intellectual Property means all rights related to the inventions, the Patents, the Technology and TTS-owned Improvements. |
1.4. | Patents means patents and/or patent applications listed in Schedule 1, including but not limited to any issuance, amendments, divisions, continuations, continuations-in-part, reissues, renewals, extensions and supplementary protection certificates of any such patents and patent applications. |
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1.5. | Products and Services means any article, parts, device, system, method, unit, product or component of a product, service or service contract which results from use of the Technology, incorporates the Technology in whole or in part or is covered by one or more patent applications or patents covering the Invention. This includes any Product or Service intended to improve or change a Product or Service. |
1.6. | Technology meansthe drawings, software, technical information, know-how, documents, copyright, patterns, prototypes, models, processes, formulas, products, samples, files, diagrams, plans, specifications, algorithms, methods, research or data owned or controlled by TTS, as described in Schedule 2. |
2.0 | PROPERTY RIGHTS IN AND TO THE TECHNOLOGY |
2.1. | MAINZ BIOMED acknowledges and agrees that TTS owns all rights, titles and interests in and to the Intellectual Property. |
2.2 | TTS acknowledges and agrees that it has the authority to assign all rights, titles and interests in and to the Intellectual Property to MAINZ BIOMED upon of the exercise of the Option and execution of a subsequent assignment agreement. |
3.0 | OPTION |
3.1. | By signing this Option Agreement, TTS grants MAINZ BIOMED, which accepts the same, a globally exclusive option to excercise an assignment of the Intellectual Property, on commercially reasonable terms (the “Option”), including those set out in Schedule 3, hereto. |
3.2. | The Option begins on the Effective Date and is valid for a period of one (1) year. If no assignment agreement is signed during the aforementioned one-year period, MAINZ BIOMED may renew, but it not obligated to renew, this Option for an additional period of six (6) months (collectively, the “Option Period)”. |
3.3. | In accordance with the terms and conditions contained herein, TTS hereby grants MAINZ BIOMED a globally exclusive and non-sublicensable, royalty free, paid-up license to exercise, use, and practice the Intellectual Property, for internal non-commercial research purposes only; provided, that the University and TTS also retain the right to exercise, use and practice the Technology for academic and non-commercial research purposes only. |
3.4. | During the Option Period, TTS will not (a) grant a license to commercially exploit the Intellectual Property to any other party or (b) otherwise diminish TTS’ sole ownership of the Intellectual Property. Following the expiration of the Option Period, or unless previously terminated according to Section 9, TTS shall be free to license the Intelletual Property to any third party upon such terms as they deem appropriate. |
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4.0 | CONSIDERATION |
4.1. | All amounts are expressed in Euros and all applicable taxes will be charged in addition to all amounts payable. |
4.2. | In consideration of the Option granted to MAINZ BIOMED, MAINZ BIOMED agrees to pay TTS the following: |
4.2.1. | Five thousand euros (5,000 €) on the Effective Date, for the first year of the Option Period; and |
4.2.2. | Five thousand euros (5,000 €) on the date of the renewal of the Option, for an additional six-month period. |
4.3. | MAINZ BIOMED shall pay interest on any unpaid and uncontested amounts, calculated at the prime business rate of the Bank of Canada applicable at the time the payment is due, plus three percent (3%), payable and compounded monthly. Interest shall run as of the date on which the payment becomes due until the date on which payment is received. |
5.0 | PATENT MATTERS |
5.1. | In consideration of the Option granted to MAINZ BIOMED, MAINZ BIOMED agrees to cover all reasonable legal and administrative fees related to the prosecution and maintenance of the Patents during the Option Period. |
5.2. | In view of the national-stage applications that will be due prior to the expiration of the renewal of this Option, to the extent that MAINZ BIOMED has not exercised the Option by the national-stage deadline, the Parties will reasonably cooperate in determining the patent strategy, including without limitation, for example, deciding in which countries to file applications. The Parties mutually pledge that the patent applications for the Technology will be filed in a timely manner, avoiding unnecessary delays. |
5.3. | If MAINZ BIOMED exercises the Option, it is understood that all Patent costs borne by TTS, including but not limited to drafting and filing, will be borne by MAINZ BIOMED and repaid to TTS. Once the Option has been exercised, MAINZ BIOMED will be solely responsible for prosecution and maintenance of the Patent at its expense. |
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6.0 | EXERCISE OF OPTION |
6.1. | In order to exercise the Option, MAINZ BIOMED will send TTS a written notice of such exercise prior to the expiry of the Option Period. |
6.2. | If MAINZ BIOMED exercises the Option pursuant to Article 6.1, the Parties will negotiate in good faith to determine the specific terms and conditions on which the assignment will be granted by TTS to MAINZ BIOMED, which will include the terms set out in Schedule 3. |
7.0 | DISCLAIMER OF WARRANTY |
7.1. | TTS and the University do not bind themselves and make no representation or warranty of any kind whatsoever with respect to the Intelletual Property and the Products and Services and, without limiting the generality of the foregoing, TTS and the University make no representation or warranty of any kind whatsoever with respect to the usefulness, quality or marketability of the Intellectul Property and the Products and Services or the effects which may result from their use, or that the development of applications relating to the Technology and the TTS-owned Improvements are complete. Without limiting the generality of the foregoing, TTS does not guarantee the validity of the patent applications or patents protecting the Technology and makes no representation with respect to their scope and validity. TTS and the University shall not be liable for the warranties, representations, undertakings or any other obligations given or assumed by MAINZ BIOMED toward any party whomsoever relating to the Technology and the Improvements. |
7.2. | Nothing in this Option Agreement: |
(a) | constitutes a warranty or representation by TTS that anything made, used, sold or otherwise disposed of under this Option Agreement is or will be free from claims or allegations of infringement of patents, copyrights, trademarks, industrial design or other intellectual property rights; or |
(b) | imposes an obligation on TTS to bring or prosecute or defend actions or suits against third parties for infringement of patents, copyrights, trademarks, industrial designs or other intellectual property or contractual rights. |
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8.0 | INDEMNITY AND LIMITATION OF LIABILITY |
8.1. | MAINZ BIOMED agrees to indemnify, hold harmless and defend TTS and the University, their respective Boards of Governors and Directors, officers, employees, faculty, students, invitees, and agents (the “Indemnified Parties”) against any and all third party demands, claims, suits, proceedings, actions of any nature or kind whatsoever (“Claims”), liabilities, damages, judgments, costs, expenses and fees (including reasonable legal expenses) (“Losses”) arising out of this Option Agreement, to the extent such Claims or Losses are not the result of gross negligence or intentional acts of the Indemnified Parties. |
8.2. | During the term of this Option Agreement, MAINZ BIOMED shall indemnify, hold harmless and defend the Indemnified Parties for any damage, loss, cost or expense incurred by the Indemnified Parties relating to Claims that the Technology, the Improvements and the Products and Services infringe the patent or other proprietary rights of a third party as a result of any activity undertaken by MAINZ BIOMED. |
8.3. | TTS and the University will not be liable for any damage or loss which MAINZ BIOMED or its agents suffer, whether direct, indirect, incidental, consequential or special to the extent arising from any defect, error, fault or failure of the Technology even if TTS or the University have been advised of the possibility of such defect, error, fault, or failure. MAINZ BIOMED acknowledges that it has been advised by TTS to undertake its own due diligence regarding the Technology. |
9.0 | CONFIDENTIALITY |
9.1. | The Parties acknowledge that, during the term of this Option Agreement, they may disclose to each other Confidential Information during the term hereof. |
9.2. | Each Party agrees: |
a) | to use the disclosed Confidential Information solely for the purposes mentioned in the preamble, unless prior written consent has been obtained from the disclosing Party. The foregoing obligation includes, but is not limited to, not reproducing or using the Confidential Information to produce, sell, have produced or have sold marketable products or technologies unless a definitive agreement to that effect is entered between and among the Parties; |
b) | not to disclose the Confidential Information of the disclosing Party or allow it to be disclosed to a third party. In addition, each Party agrees to restrict disclosure of the Confidential Information within its own organization to those employees, administrators, managers or agents who specifically need to know this Confidential Information for the purposes set out by this Option Agreement and associated Schedules and who agree to respect all the obligations hereof; |
c) | to give back the Confidential Information to the disclosing Party, following a written request to this effect, after it has finished its evaluation and to destroy any copy or transcript, in whole or in part, that it may have made of the Confidential Information (other than automatically generated computer backup copies, which shall remain subject to the other confidentiality clauses as set forth herein). Notwithstanding the foregoing, the receiving Party may securely retain a single archival copy of any Confidential Information provided by the disclosing Party under this Option Agreement, which copy shall remain subject to the other confidentiality clauses as set forth herein, and which may only be used by the receiving Party in connection with the review of its obligations under this Option Agreement; |
d) | to handle the Confidential Information in the same manner and with the same diligence that it applies to its own confidential information, but not with less than a reasonable degree of care. |
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9.3. | The Parties acknowledge that the following information is not considered Confidential Information: |
a) | information which is or becomes publicly known without a breach hereof by either Party; |
b) | information which is legally in the possession of a Party before being received from the other Party, as witnessed by its contemporaneous written files; |
c) | information which has been provided to them legally by a third party in good faith who is at arm’s length; |
d) | information which is developed by the receiving Party independently of any disclosures made hereunder, as evidenced by its contemporaneous written records; or |
e) | information which must be disclosed under a law, regulation or court order; provided, that the receiving Party shall to the extent practicable and permissible under law, notify the disclosing Party promptly and afford disclosing Party the opportunity to seek to limit or mitigate such required disclosure, as by filing for a protective order by the disclosing Party; furthermore, receiving Party will only disclose the amount and type of Confidential Information actually required. |
The onus of proving that information is not Confidential Information is on the receiving Party.
9.4. | The period for disclosing Confidential Information starts on the Effective Date and remains in force for two (2) years after the Effective Date. The confidentiality obligations of the receiving Party under this Agreement will remain in force (i) for trade secret, as long as they are protected under applicable laws, and (ii) for any other type of Confidential Information, for a period of two (2) years after the termination or expiration of this Agreement. |
10.0 | TERMINATION |
10.1. | Notwithstanding the terms of the Option Agreement set out above, TTS may unilaterally terminate this Option Agreement by sending a written notice to such effect to MAINZ BIOMED, and TTS shall no longer have any obligation with respect to MAINZ BIOMED, and in particular to assign the Technology to MAINZ BIOMED, if MAINZ BIOMED: |
10.1.1. | definitely ceases or threatens to cease operating its business, takes or threatens to take steps to wind up, becomes insolvent, goes bankrupt, makes an assignment of its property for the benefit of its creditors, if a receiver is appointed to dispose of its property or if it takes any other proceeding under any legislation governing liquidation (other than for a reorganization), insolvency or bankruptcy. |
10.1.2. | materially breaches any other term or provision of this Option Agreement and fails to correct such default within thirty (30) business days of receipt of a written notice from TTS to such effect. |
10.2. | MAINZ BIOMED may terminate this Agreement at any time by sending notice to TTS. |
10.3. | Forthwith upon the termination of this Option Agreement, each Party shall cease to use the Confidential Information, the materials, or the Technology in any manner whatsoever received from the other Party and, upon written request from a Party, the other Party(eis) shall return to to the requesting Party all of the Confidential Information in its possession or control, together with a certificate certifying that no copies or derivatives, as the case may be, have been made or retained. |
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11.0 | OTHER PROVISIONS |
11.1. | Any notice or other communication required or permitted to be made or given under this Option Agreement to any Party will be (a) in writing and will be sufficiently given if hand delivered or sent by certified or registered mail, or broadly recognized national or international delivery service, such as Federal Express or UPS, to the addresses set forth at the beginning of this Option Agreement, or to such other address as such Party may designate to the other Party or Parties, or (b) by email with confirmation from the recipient. Any such notice or other communication will be deemed to be given as of the date it is received by the addressee. |
11.2. | The Parties undertake to execute and deliver such documents and do such things as may be necessary or advisable to give full effect to this Option Agreement. |
11.3. | This Option Agreement may not be modified or amended except by instrument in writing signed by the Parties. |
11.4. | If any covenant, obligation or agreement hereunder or the application of any part of this Option Agreement to any person, party or circumstance shall, to any extent, be invalid or unenforceable, the remainder of this Option Agreement or the application of such covenants, agreements or obligations, other than those as to which it is held invalid or unenforceable, shall not be affected thereby and each covenant, obligation and agreement contained herein shall be separately valid and enforceable to the fullest extent permitted by law. |
11.5. | This Option Agreement shall be binding upon and inure to the benefit and advantage of the Parties hereto and their respective executors, successors and authorized assigns. |
11.6. | No Party will assign, transfer, mortgage, pledge, financially encumber, grant a security interest, charge or otherwise dispose of any or all of the rights granted to it under this Option Agreement, without the prior written consent of the other Parties, which shall not be unreasonably withheld. |
11.7. | No waiver by either of the Parties of any condition or the breach of any term, covenant, representation or warranty contained in this Option Agreement, whether by conduct or otherwise, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such condition or breach or as a waiver of any other condition or breach of any other term, covenant, representation or warranty contained in this Option Agreement. |
11.8. | This Option Agreement constitutes the entire agreement between the Parties hereto with respect to the option and assignment terms set forth herein, and supersedes and replaces the provisions of any agreement heretofore entered into by them with respect thereto. |
11.9. | This Option Agreement shall be interpreted and enforced in accordance with the laws of the province of Quebec and the Canadian Federal laws applicable therein. For the purposes hereof, the Parties elect domicile in the judicial district of St-François (Quebec). |
11.10. | English Language. It is the express wish of the parties that this Option Agreement and all related documents, including notices and other communications, be drawn up in the English language only. Il est la volonté expresse des Parties que cette convention et tous les documents s’y rattachant, y compris les avis et les autres communications, soient rédigés et signés en anglais seulement. |
[Signatures on the next page]
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IN WITNESS WHEREOF, the Parties have signed this Option Agreement:
Socpra sciences santé et humaines s.e.c.
/s/ Michael Lambert | ||
Michel Lambert | ||
President and CEO | ||
Mainz Biomed N.V. | ||
/s/ Guido Baechler | ||
Name: | Guido Baechler | |
Title: | CEO |
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Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors of
Mainz Biomed B.V.
Pharmgenomics GmbH
We consent to the inclusion in the Form F-1 Registration Statement of Mainz Biomed B.V. (the “Company”) our report dated August 3, 2021 relating to our audit of the balance sheet as of March 31, 2021, and statements of operations, stockholders’ equity and cash flows for the period from March 8, 2021 (inception) through to March 31, 2021.
We consent to the inclusion in the Form F-1 Registration Statement of the Company our report of Pharmgenomics GmbH dated August 3, 2021 relating to our audit of the balance sheets as of December 31, 2020 and 2019, and statements of operations, stockholders’ equity and cash flows for the years ended December 31, 2020 and 2019.
We also consent to the reference to us under the caption “Experts” in the Registration Statement.
/s/ BF Borgers CPA PC
Certified Public Accountants
Lakewood, Colorado
January 21, 2022