Item 9.01 Financial Statements and Exhibits
When used in the Current Report on Form 8-K the terms “we,” “us,” “our,” and similar words reference the Company.
Special Note about Forward-Looking Statements
Certain statements in this report, including information incorporated by reference, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect current views about future events and financial performance based on certain assumptions. They include opinions, forecasts, intentions, plans, goals, projections, guidance, expectations, beliefs or other statements that are not statements of historical fact. Words such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “believes,” “anticipates,” “intends,” “estimates,” “approximates,” “predicts,” or “projects,” or the negative or other variation of such words, and similar expressions may identify a statement as a forward-looking statement. Any statements that refer to projections of our future financial performance, our anticipated growth and trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results and the development of our products, are forward-looking statements. Forward-looking statements in this report may include statements about:
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future financial and operating results;
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our ability to fund operations and business plans, and the timing of any funding or corporate development transactions we may pursue;
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the timing, conduct and outcome of discussions with regulatory agencies, regulatory submissions and clinical trials;
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our beliefs and opinions about the safety and efficacy of our products and product candidates and the results of our clinical studies and trials;
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our ability to enter into acceptable relationships with one or more contract manufacturers or other service providers on which we may depend and the ability of such contract manufacturers or other service providers to conduct studies, manufacture biologics or key product components, or to provide other services, of an acceptable quality on a timely and cost-effective basis;
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our ability to enter into acceptable relationships with one or more development or commercialization partners to advance the commercialization of new products and product candidates and the timing of any product launches; our growth, expansion and acquisition strategies, the success of such strategies, and the benefits we believe can be derived from such strategies;
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our ability to pursue and effectively develop new product opportunities and acquisitions and to obtain value from such product opportunities and acquisitions;
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our ability to maintain the listing of our common stock on a national exchange;
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our intellectual property rights and those of others, including actual or potential competitors;
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our personnel, consultants and collaborators;
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current and future economic and political conditions;
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overall industry and market performance;
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the impact of accounting pronouncements;
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management’s goals and plans for future operations; and
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other assumptions described in this report underlying or relating to any forward-looking statements
The forward-looking statements in this report speak only as of the date of this report and caution should be taken not to place undue reliance on any such forward-looking statements. Forward-looking statements are subject to certain events, risks, and uncertainties that may be beyond our control. When considering forward-looking statements, you should carefully review the risks, uncertainties and other cautionary statements in this report as they identify certain important factors that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. These factors include, among others, the risks described under Item 1A and elsewhere in this report, as well as in other reports and documents we file with the United States Securities and Exchange Commission (SEC).
Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statement to conform these statement to actual results.
Item 1.01 Entry into a Material Definitive Agreement
Merger Agreement and Plan of Merger
Previously we announced that the Company entered into a Merger Agreement and Plan of Merger (the “Agreement”) with FasTrack Pharmaceutical, Inc., (“FasTrack”) whereby a subsidiary of the Company would merge into FasTrack and through the merger FasTrack would become a wholly owned subsidiary of the Company. This was announced in a Form 8-K filed on July 20, 2011, with the SEC. The Agreement was filed as an Exhibit to the Report on Form 8-K.
On September 27, 2011, we mailed to our shareholders a definitive information statement describing among other things FasTrack and its assets and future plans and the changes that would be accomplished in the transactions between the Company and FasTrack.
Item 2.01
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Completion of Acquisition or Disposition of Assets
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Closing of Agreement
Pursuant to the Agreement the Company acquired FasTrack. FasTrack became a wholly owned subsidiary of the Company. In the Closing the Company acquired the issued and outstanding shares common stock of FasTrack and the interest of a convertible note holder and a warrant holder. To complete the acquisition the Company issued approximately 15,238,938 shares of its post reverse split common stock. The North Horizon shareholders own approximately eight percent (8%) of the issued and outstanding shares of common stock and the FasTrack shareholders and others own ninety-two per cent of the issued and outstanding shares. These numbers reflect the ten into one reverse split of the issued and outstanding shares of common stock.
Following is a summary of the changes and actions that resulted from the Closing of the Agreement.
1. Name Change: The Company changed its name to Innovus Pharmaceuticals, Inc.
2. Capitalization: The Company’s capitalization is 150,000,000 shares of common stock.
3, New Directors and Change in Control: Vivian Liu; Henry Esber, Ph.D.; and Ziad Mirza, M.D., became the directors of the Company.
4. Reverse Split: The Company’s issued and outstanding shares in the amount of 13,251,250 were subject to a reverse split on the basis of ten shares into one share (10:1) The reverse split was effective on December 7, 2011.
The foregoing is a brief summary of the Agreement and the transactions inherent herein. The summary is subject to the detailed provisions of the Agreement which was an Exhibit to the Report on Form 8-K filed on July 20, 2011, and which is incorporated herein by reference.
In the closing of the Agreement the officers and directors of the Company resigned and Vivian Liu; Henry Esber, Ph.D.; and Ziad Mirza, M.D., became the directors of the Company.
All references and descriptions of the Agreement and the transactions contemplated thereby are subject to the more detailed provisions stated in the Agreement. All references to the Agreement are qualified in their entirety by the text of the Agreement.
The actions necessary to approve the various amendments and other transactions that were encompassed in and part of the Agreement were approved by the respective board of directors of the entities and the requisite shareholder votes were accomplished, in part, by written consents. This obviated the holding and convening of shareholder meetings.
CORPORATE HISTORY
Business of the Company
Innovus Pharmaceuticals, Inc. (“Innovus Pharma”) is focused on the development and in-licensing/acquisition of new and innovative pharmaceutical product opportunities that offer definable pathways to regulatory approvals, partnering and commercialization. We have a three-pronged approach in our business strategy:
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To internally develop new, 505(b)(2) topical products based on a proven drug delivery technology; and
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To in-license/acquire late stage revenue generating pharmaceutical products in dermatology and pain management; and
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To leverage near term revenue opportunities afforded by our proprietary pipeline comprised of ethical therapeutic (“Rx”) and over-the-counter (“OTC”) products
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Our business model is designed to create multiple opportunities for success while minimizing the risks associated with reliance on any single technology platform or product type, and to bridge the critical gap between promising new product candidates and product opportunities that are ready for commercialization. Consistent with our long-term strategy, we intend to consider various corporate development transactions designed to place our product candidates into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses.
In parallel, as our business strategy advances and corresponding valuations are established, we plan to pursue new product opportunities and acquisitions with strong value enhancement potential. Our long-term goal is to improve our balance sheet and cash flow with minimal dilution to our shareholders. This strategy may include debt financing and/or acquisitions of small revenue generating companies and products, which we believe would accelerate our shareholders' return on investment and provide us with additional cash flow to fund our own product development.
Our Proprietary Product and Technology Portfolios
In our portfolio of Rx products, we have a partial interest in the potential commercial value of PrevOnco™, a Phase 2/3 second-line Orphan Drug therapy for patients with hepatocellular carcinoma or liver cancer. PrevOnco is based on lansoprazole, a drug widely used to treat gastro-esophageal reflux disease.
Preclinical animal data have shown the drug to also be effective in shrinking the tumors commonly associated with liver cancer. In 2010, FasTrack sold the development rights of the product to NexMed (U.S.A.), Inc., (“NexMed”) a wholly-owned subsidiary of Apricus Biosciences, Inc. (Nasdaq: APRI) (“Apricus Bio”). In exchange, we are entitled to receive up to 50% of the net commercial value of the product in the event Apricus Bio successfully licenses the product to a commercialization partner.
Pursuant to the overall terms of our PrevOnco agreements with Apricus Bio, we have the right to develop two products based on their proprietary NexACT
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multi-route drug delivery technology. NexACT utilizes patented novel excipients or "penetration enhancers" that when incorporated into drug formulations, may improve their absorption and bioavailability. Varying the concentration of the NexACT enhancer allows for local or systemic delivery of drug as desired. NexACT
has been clinically-validated and has a well-established safety and efficacy profile. The technology is incorporated in Vitaros
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, a topical treatment for erectile dysfunction approved for local marketing by Health Canada in October 2010.
We intend to incorporate NexACT with off-patent drugs and follow a 505(b)(2) approval pathway, which typically has a significantly shorter development cycle with less pre-clinical and clinical studies required by the regulatory agencies. We are actively exploring possible topical product candidates in dermatology. In June 2011, we entered into two research agreements with NexMed to conduct feasibility studies using the NexACT technology with active drug ingredients identified by us. One study, completed in September 2011, focused on a new NexACT-based minoxidil formulation for treating hair loss. Minoxidil is the active ingredient in Rogaine
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, a widely marketed topical product for treating male and female hair loss. The study results showed that the inclusion of NexACT significantly enabled the absorption of minoxidil into the human cadaver skin model. Assuming the availability of financing, we plan to conduct additional studies to optimize the NexACT-based minoxidil formulation and take it into human clinical trials.
Within our Rx portfolio is a development platform based on SSAO inhibitors. SSAO is known as vascular adhesion protein-1 or VAP-1, and is a dual function molecule with enzymatic and cell adhesion activities. These inhibitors are designed to reduce inflammation by blocking the white blood cells and reducing the levels of inflammatory mediators. A prior owner had developed a treatment for Lupus based on the SSAO platform, but that product failed in late-stage clinical studies. In 2009, FasTrack acquired the SSAO patent portfolio because of the possibility that the SSAO platform had potential for the right medical indication. Because the SSAO platform has unproven safety and efficacy profiles, to develop a product based on this platform would require significant resources and longer development time. We do not have these resources presently and no assurance can be given that even if proper resources were available, we would seek to develop or if development were pursued a successful SSAO platform would be accomplished. To facilitate the SSAO development we may seek a partnership relationship.
In our portfolio of OTC products, we have two opportunities for development and/or out-licensing. Apeaz™ is a treatment for pain relief. It is an FDA-compliant arthritis cream that delivers different ingredients to various layers of the skin and muscle. The product had previously reached peak sales of $500,000 per annum, and was sold through a U.S. based distributor. However, the distributor went out of business in 2009 and all sales for Apeaz ceased. We believe that with new packaging and a new distribution network, we could re-launch the product and regain some if not all of the previous sales volume. However, there is no assurance that we would be successful in our efforts.
In addition, we have Regia™, which is a plant-derived, anti-microbial agent for reducing the bleeding of gums when used in OTC products such as mouthwash. We have an issued US patent which expires in … for Regia™ and applications pending in selected international markets. Our intention is to out-license the patent portfolio for Regia™ to potential development partners in the OTC space.
Prior Transactions
Innovus Pharma, formerly known as North Horizon, Inc., was organized as a Utah corporation in 1959. In 2007, we changed our domicile to Nevada, and for the past several years, maintained the Company as a corporate entity and filed requisite reports with the U.S. Securities and Exchange Commission. On December 7, 2011, we acquired FasTrack Pharmaceuticals, Inc., a Delaware corporation, which became our wholly-owned subsidiary. FasTrack was a specialty pharmaceutical company with a development pipeline of Rx and OTC products.
FasTrack was organized by shareholders of Bio-Quant, Inc., (Bio-Quant”), which was a Utah corporation founded in 2000 and operated as a contract research organization for the pharmaceutical industry. In late 2008, Bio-Quant decided to focus on its core business of pre-clinical testing services, and sold its pharmaceutical assets to FasTrack and Sorrento Pharmaceuticals, Inc. (“Sorrento”), which focused on the development of Rx and OTC products, respectively. The limited funding of both FasTrack and Sorrento severely limited their activities and operations. In March 2011, the shareholders of FasTrack and Sorrento decided to combine operations in an effort to better position the combined entity for new investors. Pursuant to an asset purchase agreement between the two companies, FasTrack acquired Sorrento’s assets and liabilities.
In December 2009, Bio-Quant was acquired as a wholly-owned subsidiary by NexMed, Inc., the predecessor of Apricus Bio. NexMed (U.S.A.), Inc., (“NexMed”) is another wholly-owned subsidiary of Apricus Bio, and the party which acquired the rights of PrevOnco from FasTrack in March 2010.
FasTrack anticipates that if it enters into production for any of its products the raw materials will be readily available in the market. At the present time FasTrack has no customers and has no backlog.
FasTrack has one patent issued for Regia™ in Morocco and one issued in the U.S., and an application pending in Europe. FasTrack has a series of patents issued and patent applications pending in the U.S.A. and internationally for its SSAO technology platform.
CONSULTING AGREEMENT
In January 2011 FasTrack entered into a Financial Advisory and Consulting Agreement with Dawson James Securities, Inc., for a 12 month term. If FasTrack is sold or engages in a merger, the Consultant will receive $50,000 and warrants to purchase shares of the FasTrack’s common stock equal to 2.5% of the Company’s outstanding common stock, on a fully-diluted basis. The warrant would have a term of seven years and have an exercise price of $0.01 per share.
Manufacturing
We intend to contract with third parties for the manufacture of our compounds for investigational purposes, for preclinical and clinical testing and for any FDA approved products for commercial sale. All of our compounds are small molecules, generally constructed using industry standard processes and use readily accessible raw materials.
Government Regulation
The U.S. Food and Drug Administration (“FDA”) and other federal, state, local and foreign regulatory agencies impose substantial requirements upon the clinical development, approval, labeling, manufacture, marketing and distribution of drug products. These agencies regulate, among other things, research and development activities and the testing, approval, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, advertising and promotion of our product candidates. The regulatory approval process is generally lengthy and expensive, with no guarantee of a positive result. Moreover, failure to comply with applicable FDA or other requirements may result in civil or criminal penalties, recall or seizure of products, injunctive relief including partial or total suspension of production, or withdrawal of a product from the market.
The FDA regulates, among other things, the research, manufacture, promotion and distribution of drugs in the United States under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and other statutes and implementing regulations. The process required by the FDA before prescription drug product candidates may be marketed in the United States generally involves the following:
– completion of extensive nonclinical laboratory tests, animal
studies and formulation studies, all performed in accordance
with the FDA’s Good Laboratory Practice regulations;
– submission to the FDA of an Investigational New Drug
application (“IND”), which must become effective
before human clinical trials may begin;
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for some products, performance of adequate and well-controlled
human clinical trials in accordance with the FDA’s regulations,
including Good Clinical Practices, to establish the safety and
efficacy of the product candidate for each proposed indication;
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submission to the FDA of a New Drug Application (“NDA”);
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satisfactory completion of an FDA preapproval inspection of the manufacturing facilities at which the product is produced to assess compliance with current Good Manufacturing Practice, or cGMP, regulations; and
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FDA review and approval of the NDA prior to any commercial
Marketing, sale or shipment of the drug.
The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely basis, if at all.
Nonclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animals and other animal studies. The results of nonclinical tests, together with manufacturing information and analytical data, are submitted as part of an IND to the FDA. Some nonclinical testing may continue even after an IND is submitted. The IND also includes one or more protocols for the initial clinical trial or trials and an investigator’s brochure. An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions relating to the proposed clinical trials as outlined in the IND and places the clinical trial on a clinical hold. In such cases, the IND sponsor and the FDA must resolve any outstanding concerns or questions before any clinical trials can begin. Clinical trial holds also may be imposed at any time before or during studies due to safety concerns or non-compliance with regulatory requirements. An independent institutional review board, or IRB, at each of the clinical centers proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences. An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the consent form signed by the trial participants and must monitor the study until completed.
Clinical Trials
Clinical trials involve the administration of the product candidate to human subjects under the supervision of qualified medical investigators according to approved protocols that detail the objectives of the study, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor participant safety. Each protocol is submitted to the FDA as part of the IND.
Human clinical trials are typically conducted in three sequential phases, but the phases may overlap, or be combined.
Phase 1 clinical trials typically involve the initial introduction of the product candidate into healthy human volunteers. In Phase 1 clinical trials, the product candidate is typically tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and pharmacodynamics.
Phase 2 clinical trials are conducted in a limited patient population to gather evidence about the efficacy of the product candidate for specific, targeted indications; to determine dosage tolerance and optimal dosage; and to identify possible adverse effects and safety risks.
Phase 3 clinical trials are undertaken to evaluate clinical efficacy and to test for safety in an expanded patient population at geographically dispersed clinical trial sites. The size of Phase 3 clinical trials depends upon clinical and statistical considerations for the product candidate and disease, but sometimes can include several thousand patients. Phase 3 clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide an adequate basis for product labeling.
Clinical testing must satisfy extensive FDA regulations. Reports detailing the results of the clinical trials must be submitted at least annually to the FDA and safety reports must be submitted for serious and unexpected adverse events. Success in early stage clinical trials does not assure success in later stage clinical trials. The FDA, an IRB or we may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.
New Drug Applications
Assuming successful completion of the required clinical trials, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of an NDA. An NDA also must contain extensive manufacturing information, as well as proposed labeling for the finished product. An NDA applicant must develop information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance with cGMP. The manufacturing process must be capable of consistently producing quality product within specifications approved by the FDA. The manufacturer must develop methods for testing the quality, purity and potency of the final product. In addition, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product does not undergo unacceptable deterioration over its shelf life. Prior to approval, the FDA will conduct an inspection of the manufacturing facilities to assess compliance with cGMP.
The FDA reviews all NDAs submitted before it accepts them for filing. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information and is subject to review before the FDA accepts it for filing. After an application is filed, the FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it considers them carefully when making decisions. The FDA may deny approval of an NDA if the applicable regulatory criteria are not satisfied. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data. The FDA may issue a complete response letter, which may require additional clinical or other data or impose other conditions that must be met in order to secure final approval of the NDA. If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition, the FDA may require us to conduct Phase 4 testing which involves clinical trials designed to further assess a drug’s safety and effectiveness after NDA approval, and may require surveillance programs to monitor the safety of approved products which have been commercialized. Once issued, the FDA may withdraw product approval if ongoing regulatory requirements are not met or if safety or efficacy questions are raised after the product reaches the market.
Section 505(b)(2) NDAs
There are two types of NDAs: the full NDA and the Section 505(b)(2) NDA. When possible, we intend to file Section 505(b)(2) NDAs that might, if accepted by the FDA, save time and expense in the development and testing of our product candidates. A full NDA is submitted under Section 505(b)(1) of the FFDCA, and must contain full reports of investigations conducted by the applicant to demonstrate the safety and effectiveness of the drug. A Section 505(b)(2) NDA may be submitted for a drug for which one or more of the investigations relied upon by the applicant was not conducted by or for the applicant and for which the applicant has no right of reference from the person by or for whom the investigations were conducted. A Section 505(b)(2) NDA may be submitted based in whole or in part on published literature or on the FDA’s finding of safety and efficacy of one or more previously approved drugs, which are known as reference drugs. Thus, the filing of a Section 505(b)(2) NDA may result in approval of a drug based on fewer clinical or nonclinical studies than would be required under a full NDA. The number and size of studies that need to be conducted by the sponsor depends on the amount and quality of data pertaining to the reference drug that are publicly available, and on the similarity of and differences between the applicant’s drug and the reference drug. In some cases, extensive, time-consuming, and costly clinical and nonclinical studies may still be required for approval of a Section 505(b)(2) NDA.
Because we may develop new formulations of previously approved chemical entities, our drug approval strategy is to submit Section 505(b)(2) NDAs to the FDA. The FDA may not agree that our product candidates are approvable as Section 505(b)(2) NDAs. If the FDA determines that Section 505(b)(2) NDAs are not appropriate and that full NDAs are required for our product candidates, the time and financial resources required to obtain FDA approval for product candidates could substantially and materially increase, and our products might be less likely to be approved. If the FDA requires full NDAs for product candidates, or requires more extensive testing and development for some other reason, our ability to compete with alternative products that arrive on the market more quickly than the product candidates would be adversely impacted.
Patent Protections
An applicant submitting a Section 505(b)(2) NDA must certify to the FDA the patent status of the reference drug upon which the applicant relies in support of approval of its drug. With respect to every patent listed in the FDA’s Orange Book, which is the FDA’s list of approved drug products, as claiming the reference drug or an approved method of use of the reference drug, the Section 505(b)(2) applicant must certify that: (1) there is no patent information listed by the FDA for the reference drug; (2) the listed patent has expired; (3) the listed patent has not expired, but will expire on a particular date; (4) the listed patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the product in the Section 505(b)(2) NDA; or (5) if the patent is a use patent, that the applicant does not seek approval for a use claimed by the patent. If the applicant files a certification to the effect of clause (1), (2) or (5), FDA approval of the Section 505(b)(2) NDA may be made effective immediately upon successful FDA review of the application, in the absence of marketing exclusivity delays, which are discussed below. If the applicant files a certification to the effect of clause (3), the Section 505(b)(2) NDA approval may not be made effective until the expiration of the relevant patent and the expiration of any marketing exclusivity delays.
If the Section 505(b)(2) NDA applicant provides a certification to the effect of clause (4), referred to as a paragraph IV certification, the applicant also must send notice of the certification to the patent owner and the holder of the NDA for the reference drug. The filing of a patent infringement lawsuit within 45 days of the receipt of the notification may prevent the FDA from approving the Section 505(b)(2) NDA for 30 months from the date of the receipt of the notification unless the court determines that a longer or shorter period is appropriate because either party to the action failed to reasonably cooperate in expediting the action. However, the FDA may approve the Section 505(b)(2) NDA before the 30 months have expired if a court decides that the patent is invalid, unenforceable, or not infringed, or if a court enters a settlement order or consent decree stating the patent is invalid or not infringed.
Notwithstanding the approval of many products by the FDA pursuant to Section 505(b)(2), over the last few years certain brand-name pharmaceutical companies and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section 505(b)(2) is successfully challenged in court, the FDA may be required to change its interpretation of Section 505(b)(2) which could delay or even prevent the FDA from approving any Section 505(b)(2) NDA that we submit. The pharmaceutical industry is highly competitive, and it is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or even prevent, the approval of the new product. Moreover, even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition.
Marketing Exclusivity
Market exclusivity provisions under the FFDCA can delay the submission or the approval of Section 505(b)(2) NDAs, thereby delaying a Section 505(b)(2) product from entering the market. The FFDCA provides five-year marketing exclusivity to the first applicant to gain approval of an NDA for a new chemical entity, or NCE, meaning that the FDA has not previously approved any other drug containing the same active moiety. This exclusivity prohibits the submission of a Section 505(b)(2) NDA for any drug product containing the active ingredient during the five-year exclusivity period. However, submission of a Section 505(b)(2) NDA that certifies that a listed patent is invalid, unenforceable, or will not be infringed, as discussed above, is permitted after four years, but if a patent infringement lawsuit is brought within 45 days after such certification, FDA approval of the Section 505(b)(2) NDA may automatically be stayed until 7 1/2 years after the NCE approval date. The FFDCA also provides three years of marketing exclusivity for the approval of new and supplemental NDAs for product changes, including, among other things, new indications, dosage forms, routes of administration or strengths of an existing drug, or for a new use, if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by FDA to be essential to the approval of the application. Five-year and three-year exclusivity will not delay the submission or approval of another full NDA; however, as discussed above, an applicant submitting a full NDA under Section 505(b)(1) would be required to conduct or obtain a right of reference to all of the preclinical and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.
Other types of exclusivity in the United States include orphan drug exclusivity and pediatric exclusivity. The FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered from sales in the United States for that drug. Seven-year orphan drug exclusivity is available to a product that has orphan drug designation and that receives the first FDA approval for the indication for which the drug has such designation. Orphan drug exclusivity prevents approval of another application for the same drug for the same orphan indication, for a period of seven years, regardless of whether the application is a full NDA or a Section 505(b)(2) NDA, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Pediatric exclusivity, if granted, provides an additional six months to an existing exclusivity or statutory delay in approval resulting from a patent certification. This six-month exclusivity, which runs from the end of other exclusivity protection or patent delay, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study.
Section 505(b)(2) NDAs are similar to full NDAs filed under Section 505(b)(1) in that they are entitled to any of these forms of exclusivity if they meet the qualifying criteria. They also are entitled to the patent protections described above, based on patents that are listed in the FDA’s Orange Book in the same manner as patents claiming drugs and uses approved for NDAs submitted as full NDAs.
Other Regulatory Requirements
Maintaining substantial compliance with appropriate federal, state and local statutes and regulations requires the expenditure of substantial time and financial resources. Drug manufacturers are required to register their establishments with the FDA and certain state agencies, and after approval, the FDA and these state agencies conduct periodic unannounced inspections to ensure continued compliance with ongoing regulatory requirements, including cGMPs. In addition, after approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval. The FDA may require post-approval testing and surveillance programs to monitor safety and the effectiveness of approved products that have been commercialized. Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including:
– meeting record-keeping requirements;
– reporting of adverse experiences with the drug;
– providing the FDA with updated safety and efficacy information;
– reporting on advertisements and promotional labeling;
– drug sampling and distribution requirements; and
– complying with electronic record and signature requirements.
In addition, the FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed on the market. There are numerous regulations and policies that govern various means for disseminating information to health-care professionals as well as consumers, including to industry sponsored scientific and educational activities, information provided to the media and information provided over the Internet. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label.
The FDA has very broad enforcement authority and the failure to comply with applicable regulatory requirements can result in administrative or judicial sanctions being imposed on us or on the manufacturers and distributors of our approved products, including warning letters, refusals of government contracts, clinical holds, civil penalties, injunctions, restitution, and disgorgement of profits, recall or seizure of products, total or partial suspension of production or distribution, withdrawal of approvals, refusal to approve pending applications, and criminal prosecution resulting in fines and incarceration. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. In addition, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.
Food and Drug Administration Amendments Act of 2007
In September 2007, the Food and Drug Administration Amendments Act of 2007, or FDAAA, became law. This legislation grants significant new powers to the FDA, many of which are aimed at improving drug safety and assuring the safety of drug products after approval. In particular, the new law authorizes the FDA to, among other things, require post-approval studies and clinical trials, mandate changes to drug labeling to reflect new safety information, and require risk evaluation and mitigation strategies for certain drugs, including certain currently approved drugs. In addition, the new law significantly expands the federal government’s clinical trial registry and results databank and creates new restrictions on the advertising and promotion of drug products. Under the FDAAA, companies that violate these and other provisions of the new law are subject to substantial civil monetary penalties.
The FDA has not yet implemented many of the provisions of the FDAAA, so we cannot predict the impact of the new legislation on the pharmaceutical industry or our business. However, the requirements and changes imposed by the FDAAA may make it more difficult, and more costly, to obtain and maintain approval for new pharmaceutical products, or to produce, market and distribute existing products. In addition, the FDA’s regulations, policies and guidance are often revised or reinterpreted by the agency or the courts in ways that may significantly affect our business and our products. It is impossible to predict whether additional legislative changes will be enacted, or FDA regulations, guidance or interpretations changed, or what the impact of such changes, if any, may be.
Employees
We currently have one employee who serves as our President and Chief Executive Officer. Our one employee is not represented by a labor union, and has good relations with Company. See “Management” for biographical information on our management team and directors. Subject to the availability of financing our intention is to expand our staff to five employees within 12 months in order to implement our growth strategy.
PROPERTIES
We currently do not have any corporate facility. Our employee operates from her residence. Subject to the availability of financing our intention is to lease a small corporate office.
Our business endeavors and our common stock involves a high degree of risk. You should carefully consider the risks described below with all of the other information included in this Report. If any of the following risks actually occur, they may materially harm our business and our financial condition and results of operations. In that event, the market price of our common stock could decline, and investors could lose part or all of their investment.
FACTORS THAT COULD AFFECT OUR FUTURE RESULTS
RISKS RELATED TO THE COMPANY
We continue to require external financing to fund our operations, which may not be available.
We expect that we need a positive cash flow to fund our ongoing operations, including the development of our products under development and the annual costs to remain a public company, including legal, audit and listing fees. Given our current lack of cash resources, we may not be able to implement our growth strategy unless we raise significant capital, enter into licensing and commercialization agreements, or partnering agreements. If we are unable to accomplish these objectives, we would be unable to advance certain programs and may be forced to curtail our operations.
We will continue to incur operating losses.
We have not marketed or generated sales revenues from our product candidates under development, we have never been profitable and have incurred an accumulated deficit of approximately $(667,024) since our inception through September 30, 2011. Our ability to generate revenues and to achieve profitability and positive cash flow will depend on the successful licensing and commercialization of our product candidates currently approved or in human clinical trials and those earlier stage products and technology under development.
Our ability to become profitable will depend, among other things, on our (1) raising sufficient capital to implement our growth strategy, (2) obtaining of regulatory approvals of our proposed product candidates, (3) success in licensing, manufacturing, distributing and marketing our proposed product candidates, if approved, and (4) increasing profitability through acquisitions and growth and development of our operations. If we are unable to accomplish these objectives, we may be unable to achieve profitability and would need to raise additional capital to sustain our operations.
If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully operate our business.
Our success depends in part on our continued ability to attract, retain and motivate highly qualified management and scientific personnel and on its ability to develop and maintain important relationships with healthcare providers, clinicians and scientists. We are highly dependent upon our management, particularly Vivian Liu, our Chairman, President and Chief Executive Officer. Although we have an employment agreement with Ms. Liu, these types of agreements are generally terminable at will at any time, and, therefore, we may not be able to retain their services as expected. The loss of services of one or more members of our management could delay or prevent us from obtaining new clients and successfully operating our business. Competition for qualified personnel in the biotechnology and pharmaceuticals field is intense. We may need to hire additional personnel as we expand our commercial activities. We may not be able to attract and retain qualified personnel on acceptable terms.
Our ability to maintain, expand or renew our business and to get business from new clients, particularly in the drug development sector, also depends on our ability to subcontract and retain scientific staff with the skills necessary to keep pace with continuing changes in drug development technologies.
We currently have no sales force or marketing organization and will need, but may not be able, to attract marketing partners or afford qualified or experienced marketing and sales personnel for our product candidates under development.
We have no internal sales and marketing capabilities. In order to market any product candidate directly to customers that may be approved, we will need to build a sales and marketing infrastructure and/or attract marketing partners that will need to spend significant funds to inform potential customers, including third-party distributors, of the distinctive characteristics and benefits of our product candidates. Our operating results and long term success will depend, among other things, on our ability to establish (1) successful arrangements with domestic and additional international distributors and marketing partners and (2) if we cannot find such partners or choose to market and sell the product directly to customers, an effective internal marketing and sales organization. Consummation of partnering arrangements is subject to the negotiation of complex contractual relationships, and we may not be able to negotiate such agreements on a timely basis, if at all, or on terms acceptable to us. If we enter into third party arrangements, our revenues would be lower as we would share the revenues with our licensing, commercialization and development partners. If we are unable to launch a drug, we may realize little or no revenue from sales in markets where we have approval.
Pre-clinical and clinical trials are inherently unpredictable. If we or our partners do not successfully conduct these trials or gain regulatory approval, we or our partners may be unable to market our product candidates.
Through pre-clinical studies and clinical trials, our product candidates must be demonstrated to be safe and effective for their indicated uses. Results from pre-clinical studies and early clinical trials may not be indicative of, or allow for prediction of results in later-stage testing. Many of the pre-clinical studies that we have conducted are in animals with “models” of human disease states. Although these tests are widely used as screening mechanisms for drug candidates before being advanced to human clinical studies, results in animal studies are less reliable predictors of safety and efficacy than results of human clinical studies. Future clinical trials may not demonstrate the safety and effectiveness of our product candidates or may not result in regulatory approval to market our product candidates. Commercial sales in the United States of our product candidates cannot begin until final FDA approval is received. The failure of the FDA to approve our product candidates for commercial sales will have a material adverse effect on our prospects and could have a negative effect on the Company’s stock price.
Patents and intellectual property rights are important to us but could be challenged.
Proprietary protection for our pharmaceutical products and products under development is of material importance to our business in the U.S. and most other countries. We have sought and will continue to seek proprietary protection for our product candidates to attempt to prevent others from commercializing equivalent products in substantially less time and at substantially lower expense. Our success may depend on our ability to (1) obtain effective patent protection within the U.S. and internationally for our proprietary technologies and products, (2) defend patents we own, (3) preserve our trade secrets, and (4) operate without infringing upon the proprietary rights of others. In addition, we have agreed to indemnify our partners for certain liabilities with respect to the defense, protection and/or validity of our patents and would also be required to incur costs or forego revenue if it is necessary for our partners to acquire third party patent licenses in order for them to exercise the licenses acquired from us.
While we have obtained patents and have many patent applications pending, the extent of effective patent protection in the U.S. and other countries is highly uncertain and involves complex legal and factual questions. No consistent policy addresses the breadth of claims allowed in or the degree of protection afforded under patents of medical and pharmaceutical companies. Patents we currently own or may obtain might not be sufficiently broad enough to protect us against competitors with similar technology. Any of our patents could be invalidated or circumvented.
While we believe that our patents would prevail in any potential litigation, the holders of competing patents could determine to commence a lawsuit against us and even prevail in any such lawsuit. If we sell patents to others, we may agree to indemnify the purchaser from third party patent claims, which could expose us to potentially significant damages for patents that we no longer own. Any litigation could result in substantial cost to and diversion of effort by us, which may harm our business. In addition, our efforts to protect or defend our proprietary rights may not be successful or, even if successful, may result in substantial cost to us.
We are dependent upon third party contract research organizations (“CROs”).
We are currently dependent on third party CROs to conduct our research and development programs. If the CRO fails to conduct the contracted studies on a timely and satisfactory basis, we would experience encounter costs and delays in identifying new CROs.
We are dependent upon third party manufacturers for chemical manufacturing supplies.
We are dependent on third party chemical manufacturers. Any products must be supplied on a timely basis and at satisfactory quality levels. If our validated third party chemical manufacturers fail to produce quality products on time and in sufficient quantities, our results would suffer, as we would encounter costs and delays in revalidating new third party suppliers.
We face severe competition.
We are engaged in a highly competitive industry. We and our potential licensees can expect competition from numerous companies, including large international enterprises, and others entering the market for products similar to ours. Most of these companies have greater research and development, manufacturing, patent, legal, marketing, financial, technological, personnel and managerial resources. Acquisitions of competing companies by large pharmaceutical or healthcare companies could further enhance such competitors’ financial, marketing and other resources. Competitors may complete clinical trials, obtain regulatory approvals and commence commercial sales of their products before we could enjoy a significant competitive advantage. Products developed by our competitors may be more effective than our product candidates.
We may be subject to potential product liability and other claims, creating risks and expense.
We are also exposed to potential product liability risks inherent in the development, testing, manufacturing, marketing and sale of human therapeutic products. Product liability insurance for the pharmaceutical industry is extremely expensive, difficult to obtain and may not be available on acceptable terms, if at all. We may need to acquire such insurance coverage prior to the commercial introduction of our product candidates. If we obtain coverage, we have no guarantee that the coverage limits of such insurance policies will be adequate. A successful claim against us if we are uninsured, or which is in excess of our insurance coverage, if any, could have a material adverse effect upon us and on our financial condition.
INDUSTRY RISKS
We are vulnerable to volatile stock market conditions.
The market prices for securities of biopharmaceutical and biotechnology companies, including ours, have been highly volatile. The market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. In addition, future announcements, such as the results of testing and clinical trials, the status of our relationships with third-party collaborators, technological innovations or new therapeutic products, governmental regulation, developments in patent or other proprietary rights, litigation or public concern as to the safety of products developed by us or others and general market conditions, concerning us, our competitors or other biopharmaceutical companies, may have a significant effect on the market price of our common stock.
Instability and volatility in the financial markets and the global economic recession are likely to have a negative impact on our ability to raise necessary funds and on our business, financial condition, results of operations and cash flows.
During the past several years, there has been substantial volatility and a decline in financial markets due in part to the lethargic global economic environment. In addition, there has been substantial uncertainty in the capital markets and access to financing is uncertain. These conditions are likely to have an adverse effect on our industry, licensing partners, and business, including our financial condition, results of operations and cash flows.
To the extent that we do not generate sufficient cash from operations, we may need to raise capital through equity sales and/or incur indebtedness, if available, to finance operations. However, recent turmoil in the capital markets and the potential impact on the liquidity of major financial institutions may have an adverse effect on our ability to fund our business strategy through sales of capital stock or through borrowings, under either existing or newly created instruments in the public or private markets on terms that we believe to be reasonable, if at all.
Changes in trends in the pharmaceutical and biotechnology industries, including difficult market conditions, could adversely affect our operating results.
Industry trends and economic and political factors that affect pharmaceutical, biotechnology and medical device companies also affect our business. For example, the practice of many companies in these industries has been to hire companies like us to conduct discovery, research and development activities. If these companies suspend these activities or otherwise reduce their expenditures on outsourced discovery, research and development in light of current difficult conditions in credit markets and the economy in general, or for any other reason, our operations, financial condition and growth rate could be materially and adversely affected. In the past, mergers, product withdrawal and liability lawsuits, and other factors in the pharmaceutical industry have also slowed decision-making by pharmaceutical companies and delayed drug development projects. Continuation or increases in these trends could have an adverse effect on our business. In addition, numerous governments have undertaken efforts to control growing healthcare costs through legislation, regulation and voluntary agreements with medical care providers and pharmaceutical companies. If future cost-containment efforts limit the profits that can be derived on new drugs, our clients might reduce their drug discovery and development spending, which could reduce our revenue and have a material adverse effect on our results of operations.
The biotechnology, pharmaceutical and medical device industries generally and drug discovery and development more specifically are subject to increasingly rapid technological changes. Our competitors, clients and others might develop technologies, services or products that are more effective or commercially attractive than our current or future technologies, services or products, or that render our technologies, services or products less competitive or obsolete. If competitors introduce superior technologies, services or products and we cannot make enhancements to our technologies, services or products to remain competitive, our competitive position, and in turn our business, revenue and financial condition, would be materially and adversely affected.
We and any potential licensees are subject to numerous and complex government regulations which could result in delay and expense.
Governmental authorities in the U.S. and other countries heavily regulate the testing, manufacture, labeling, distribution, advertising and marketing of our proposed product candidates. Before any products we develop are marketed, FDA and comparable foreign agency approval must be obtained through an extensive clinical study and approval process.
The failure to obtain requisite governmental approvals for our product candidates under development in a timely manner or at all would delay or preclude us and our licensees from marketing our product candidates or limit the commercial use of our product candidates, which could adversely affect our business, financial condition and results of operations.
Any failure on our part to comply with applicable regulations could result in the termination of on-going research, discovery and development activities or the disqualification of data for submission to regulatory authorities. As a result of any such failure, we could be contractually required to perform repeat services at no further cost to our clients, but at a substantial cost to us. The issuance of a notice from regulatory authorities based upon a finding of a material violation by us of applicable requirements could result in contractual liability to our clients and/or the termination of ongoing studies which could materially and adversely affect our results of operations. Furthermore, our reputation and prospects for future work could be materially and adversely diminished.
Because we intend that our product candidates will be sold and marketed outside the U.S., we and/or our potential licensees will be subject to foreign regulatory requirements governing the conduct of clinical trials, product licensing, pricing and reimbursements. These requirements vary widely from country to country. The failure to meet each foreign country’s requirements could delay the introduction of our proposed product candidates in the respective foreign country and limit our revenues from sales of our proposed product candidates in foreign markets.
Successful commercialization of our product candidates may depend on the availability of reimbursement to the consumer from third-party healthcare payers, such as government and private insurance plans. Even if one or more products is successfully brought to market, reimbursement to consumers may not be available or sufficient to allow the realization of an appropriate return on our investment in product development or to sell our product candidates on a competitive basis. In addition, in certain foreign markets, pricing or profitability of prescription pharmaceuticals is subject to governmental controls. In the U.S., federal and state agencies have proposed similar governmental control and the U.S. Congress has recently adopted regulatory reforms that affect companies engaged in the healthcare industry. Pricing constraints on our product candidates in foreign markets and possibly in the U.S. could adversely affect our business and limit our revenues.
We face uncertainty related to healthcare reform, pricing and reimbursement which could reduce our revenue.
In 2009 and 2010, the U.S. Congress adopted legislation regarding health insurance, which has been signed into law. As a result of this new legislation, substantial changes could be made to the current system for paying for healthcare in the United States, including changes made in order to extend medical benefits to those who currently lack insurance coverage. Extending coverage to a large population could substantially change the structure of the health insurance system and the methodology for reimbursing medical services, drugs and devices. These structural changes could entail modifications to the existing system of private payors and government programs, such as Medicare, Medicaid and State Children’s Health Insurance Program, creation of a government-sponsored healthcare insurance source, or some combination of both, as well as other changes. Restructuring the coverage of medical care in the United States could impact the reimbursement for prescribed drugs, biopharmaceuticals, medical devices, or our product candidates. If reimbursement for our approved product candidates, if any, is substantially less than we expect in the future, or rebate obligations associated with them are substantially increased, our business could be materially and adversely impacted.
Recently, there have been efforts in the U.S. Congress to defund the health insurance program described above. As a result of the political uncertainty surrounding the implementation of the health care legislation, it is unclear as to what laws, regulations, procedures and funding will be put into place in the near future. Such uncertainty may impact the reimbursement for certain prescribed drugs, biopharmaceuticals, medical devices, or our product candidates. As described above, if reimbursement for our approved product candidates, if any, is substantially less than we expect in the future, or rebate obligations associated with them are substantially increased, our business could be materially and adversely impacted.
Sales of our product candidates, if approved for commercialization, will depend in part on the availability of coverage and reimbursement from third-party payors such as government insurance programs, including Medicare and Medicaid, private health insurers, health maintenance organizations and other health care related organizations. Both the federal and state governments in the United States and foreign governments continue to propose and pass new legislation affecting coverage and reimbursement policies, which are designed to contain or reduce the cost of health care. Further federal and state proposals and healthcare reforms are likely which could limit the prices that can be charged for the product candidates that we develop and may further limit our commercial opportunity. There may be future changes that result in reductions in current coverage and reimbursement levels for our products, if commercialized, and we cannot predict the scope of any future changes or the impact that those changes would have on our operations.
Adoption of our product candidates, if approved, by the medical community may be limited if third-party payors will not offer coverage. Cost control initiatives may decrease coverage and payment levels for drugs, which in turn would negatively affect the price that we will be able to charge. We are unable to predict all changes to the coverage or reimbursement methodologies that will be applied by private or government payors to any drug candidate we have in development. Any denial of private or government payor coverage or inadequate reimbursement for procedures performed using our drug candidates, if commercialized, could harm our business and reduce our revenue.
RISKS RELATED TO OWNING OUR COMMON STOCK
Our stock may not be quoted on the OTCBB.
Currently, our common stock trades on the OTCBB. We received notification from FINRA regarding a "three-strike rule". In the pat we filed two periodic reports late. If we file untimely again any time before May 2012 we most likely will not have our shares quoted on the OTCBB. It is possible that we could fall out of compliance again in the future. If we fail to maintain compliance with any listing requirements, we could be ineligible for the OTCBB. Our stock is considered a penny stock under regulations of the Securities and Exchange Commission and is subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities. The additional burdens imposed upon broker-dealers by these requirements may discourage broker-dealers from effecting transactions in our common stock, which may severely limit the market liquidity of the common stock and the ability of our shareholders to sell our securities in the secondary market.
We do not expect to pay dividends on our common stock in the foreseeable future.
Although our stockholders may receive dividends if, as and when declared by our board of directors, we do not intend to declare dividends on our common stock in the foreseeable future. Therefore, investors may not purchase our common stock if they need immediate or future income by way of dividends from their investment.
We may issue additional shares of our capital stock that could dilute the value of your shares of common stock.
We are authorized to issue 150,000,000 shares of our common stock. In light of our possible future need for additional financing, we may issue additional shares of common stock below current market prices that could dilute the earnings per share and book value of your shares of our common stock. These issuances would dilute existing stockholders and could depress the value of our common stock.
In addition to provisions providing for proportionate adjustments in the event of stock splits, stock dividends, reverse stock splits and similar events, outstanding warrants representing the right to acquire shares of common stock may cause an adjustment of the exercise or conversion price if we issue shares of common stock at prices lower than the then exercise or conversion price or the then prevailing market price. This means that if we need to raise equity financing at a time when the market price for our common stock is lower than the exercise or conversion price, or if we need to provide a new equity investor with a discount from the then prevailing market price, then the exercise price will be reduced and the dilution to stockholders increased.
MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS AND PRO FORMA FINANCIAL STATEMENTS.
Included in this report are financial statements, audited and unaudited, of FasTrack and North Horizon and pro forma financial statements of the combined entities.
FasTrack’s audited financial statements for the year ended December 31, 2010, and 2009 and unaudited financial statements for the interim period ended September 30, 2011, are included among the financial statements in this Report.
Innovus as a small business issuer is not providing information regarding supplementary financial information and selected financial data. Quantitative and qualitative risks are provided. FasTrack has not paid any dividends.
FasTrack has not had changes in or disagreements with its accountants on any accounting or financial matters. The following is FasTrack’s management’s discussion and analysis of FasTrack’s financial condition and results of operations.
As of December 31, 2010, FasTrack had current assets and total assets of $1,650 and current liabilities of $253,155. For the year ended December 31, 2010, FasTrack had no revenues and incurred expenses and a loss from operations of $(53,601) and interest expense of $(16,322) for a net loss of $(69,923). For the year ended December 31, 2009, we had no revenue and had a loss from operations of $(20,124) and interest expense of $(7,246) for a net loss of $(27,370). The FasTrack financial statements are combined with the financial statements of Sorrento Pharmaceuticals, Inc., because FasTrack purchased the net assets from Sorrento in March of 2011. This purchase by definition is a transaction between entities under common control. The purchase and sale of assets from Bio-Quant is also considered transactions with entities under common control and therefor the transactions are recorded at historical cost and as deemed contributions or distributions.
As of September 30, 2011, FasTrack had cash of $76,844 and total assets of $76,844 and liabilities of $489,769 and a negative stockholders’ deficit of $(412,925). For the quarter ended September 30, 2011, FasTrack had limited operations. FasTrack had no revenues and incurred expenses of $87,450 and incurred interest expense of $5,154 and experienced a total loss of $(92,604). For the same period a year earlier FasTrack had no revenues and had a net loss of $(681). For the nine-month period ended September 30 2011, FasTrack had no revenues and incurred expenses of $158,649 and incurred interest expense of $14,204 and experienced a net loss of $(172,853). For the same period a year earlier, FasTrack had no revenues and incurred a net loss of $(48,308). As of September 30, 2011, FasTrack had an accumulated deficit of $(667,024). For the current nine month and three month time periods, FasTrack had increased general and administrative expenses as it was seeking to commence operations and develop its future plans and endeavors. FasTrack will need additional funds in the future.
Because of its current and past financial condition and activities, there is substantial doubt as to FasTrack’s ability to continue as a going concern. FasTrack needs to be able to generate sufficient cash to meet its obligations and to achieve profitable operations.
FasTrack has engaged in several activities with Apricus Bio through promissory notes. As of December 31, 2009, FasTrack owed Bio-Quant $379,858. This amount was comprised of $250,000 received from Bio-Quant in October 2009, $20,000 borrowed for the purchase of the SSAO inhibitors and Sorrento’s borrowing of $109,858. As of December 31, 2010 and March 31, 2011 the balance was $200,952 comprised of a cancellation of $204,896 pursuant to the FasTrack-NexMed Agreement in March 2010 and a demand note for payment of expenses by Apricus Bio in the amount of $25,990. All notes were demand notes and bore interest of 8% per annum. On April 4, 2011, pursuant to the FasTrack-Apricus Bio Agreement demand notes were combined into one secured convertible note of $474,520.
On March 4, 2011, FasTrack issued a promissory note to Baltimore Medical and Surgical Associates, PA, an entity controlled by Dr. Ziad Mirza a director of FasTrack. On April 5, 2011, FasTrack paid the note’s principal and accrued interest.
Other Related Party Transactions
In January 2010 FasTrack’s Board of Directors approved $7,000 in payment to Dr. Bassam Damaj, a shareholder of FasTrack and CEO of Apricus. The payment was for overhead expenses. The agreement included a provision that if FasTrack was unable to pay cash Dr. Damaj would receive 1% of Fastrack’s outstanding equity based on its outstanding shares as of Janaury 15, 2011. On February 7, 2011, FasTrack issued 44 shares of common stock to Dr. Damaj to satisfy the obligation.
In Janaury 2010 the Sorrento Board of Directors approved a payment of $7,000 to Dr. Bassam Damaj for 2010 overhead expenses. The agreement had a similar provision as the FasTrack agreement. Sorrento paid cash of $7,000 to satisfy the obligation.
From October 2009 to 2011 Directors and Officers of the Company have advanced cash or incurred FasTrack’s expenses. The amounts varied from $600 to $5,000. Substantially all such advances have been repaid.
Since October 2009 FasTrack and Sorrento entered into agreements with others that are deemed to be related parties. In October 2009 FasTrack acquired the right to PrevOnco™ from Bio-Quant for $276,020 paid for by 4,379 shares of FasTrack common stock and the issuance of a promissory note in the amount of $250,000. In October 2009 Sorrento purchased from Bio_Quant the rights of Apeaz™ and Regia™ for a purchase price of $120,858 paid for with 4,379 shares of Sorrento’s common stock valued at $11,000 and a promissory note.
In March 2010 FasTrack entered into an Agreement with NexMed in which FasTrack sold the development rights of PrevOnco™ to NexMed for cancellation of $204,896 of the FasTrack Promissory Note and a right to 50% of the net proceeds defined as gross proceeds less 115% of the aggregate development expenses incurred by NexMed.
In March 2011 FasTrack acquired Sorrento’s over-the counter products. FasTrack assumed Sorrento’s liabilities in the amount of $22,600 and $120,208.
Because the three foregoing transactions are considered transaction with entities under common control, they have been recorded at historical carrying value (nil) and as equity transactions - deemed contributions or distribution.
In April 2011 FasTrack entered into an Agreement with Apricus Bio described herein.
The notes to Apricus Bio aggregate $474,520, bear per annum interest of 4.25% and are due on April 4, 2013. These notes are secured by a first priority security interest in the assets of the Company. The notes are convertible upon the happening of either financing of more than $2,000,000 or a merger or acquisition transaction prior to the maturity date. Any outstanding amount will convert on the date of closing of the financing or the merger or acquisition at a price per share equal to ninety per cent (90%) of the price of the shares sold in the financing or exchange in the merger or acquisition.
There are a licensing agreement and a research agreement between FasTrack and related parties discussed elsewhere herein.
Financial Consulting Agreement
In January 2011 FasTrack entered into an Agreement with Dawson James Securities (the “Consultant”) for a term of 12 months. If a merger or sale is accomplished FasTrack wil pay the Consultant $50,000 and warrant to purchase shares of common stock equivalent to 2.5% of the outstanding common stock of FasTrack. The warrant would have an exercise price of $0.01 per share and a term of seven years from issuance.
Item 5.01 Change in Control of Registrant
As of September 30, 2011,
we had 13,251,250 shares of common stock issued and outstanding. A condition of the Agreement was that we would effect a reverse split of our issued and outstanding shares of common stock. Pursuant to the terms of the Agreement the FasTrack shareholders, convertible note holder and warrant holder will receive 92% of the issued and outstanding shares of common stock or approximately 15,238,938 shares. Our current shareholders will own 8% of the total issued and outstanding shares. There will be approximately 16,564,063 shares issued and outstanding.
Management and Board of Directors
We have new directors. Pursuant to the Agreement our new directors were appointed and the former directors resigned. The new directors are Vivian Liu, Dr. Ziad Mirza, and Dr. Henry Esber
.
The following is biographical information about our new directors.
Vivian Liu, 50, is a director, President and Chief Executive Officer. Ms. Liu became President and Chief Executive Officer in January 2011. In 1995 Ms. Liu co-founded NexMed, Inc., which in 2010 was renamed to Apricus BioSciences, Inc. Apricus Bio trades on NASDAQ with the symbol “APRI.” Ms. Liu was NexMed’s President and Chief Executive Officer from 2007 to 2009. Prior to her appointment as President Ms Liu served in several executive capacities, including Executive Vice President, Chief Operating Officer, Chief Financial Officer, and Vice President of Corporate Affairs. She was appointed as a director of NexMed in 2007 and served as Chairman of the Board from 2009 to 2010. Ms. Liu has an M.P.A. from the University of Southern California, and has a B.A. from the University of California, Berkeley.
She will not be paid a salary until the Company raises at least an additional $500,000 in cash. Ms. Liu may receive as much as 6% of FasTrack’s issued and outstanding shares of common stock. She received 273 shares of restricted common stock which were to vest over 36 months. The shares would vest immediately in the event of the acquisition of FasTrack by another company. Her shares vested upon the closing of the Agreement.
Henry Esber, Ph.D, 73, has served as a Director of FasTrack since January 2011. In 2000 Dr. Esber co-founded Bio-Quant, Inc., the largest pre-clinical discovery contract research organization in San Diego, California. From 2000 to 2010 he served as its Senior Vice President and Chief Business Development Officer. Dr. Esber has more than thirty-five years experience in the pharmaceutical service industry. Dr. Esber currently serves on the Board of Directors of Apricus and several private pharmaceutical companies. In the event that a potential conflict of interest arises between FasTrack and Apricus, Mr. Esber will abstain from participating in the decision involving the conflict.
Ziad Mirza, M.D., 49, is a director of FasTrack and has served as Chairman of the Board of Directors since March 2010. He also served as FasTrack's Acting Chief Executive Officer from March 2010 to December 2010. He is the President and co-founder of Baltimore Medical and Surgical Associates. He is a Certified Medical Director of long term care through the American Medical Directors Association. He is as well a Certified Physician Executive from the American College of Physician Executives. He consults for pharmaceutical companies on clinical trial design. He has a medical degree from the American University of Beirut and completed his residency at Good Samaritan Hospital in Baltimore. He received an MBA from the University of Massachusetts.
Legal Proceedings
The Company is not involved in any legal proceedings.
Recent Sales of Unregistered Shares
Pursuant to the Agreement the Company issued approximately 15,238,938 shares of its common stock (post reverse split) to the FasTrack shareholders, note holder, and warrant holder. No shares of common stock were sold for cash.
Indemnification of Directors and Officers
The Company may indemnify any officer or directors who in their capacity as an officer or a directors is made a party to any suit or proceeding, whether criminal, civil, or administrative unless it is determined that such person acted in bad faith and in a manner opposed to the best interests of the company or in a criminal matter the person had no reasonable cause to believe that his conduct was unlawful.
Changes and Disagreements with Accountants
Neither the Company nor FasTrack has had any disagreements with its accountants on accounting and financial disclosures.
Stock ownership of Officers and Directors and Major Shareholders (5% or more)
Name
|
|
Number of
Shares Owned
Beneficially
|
|
|
Percentage
of Company
|
|
|
|
|
|
|
|
|
Vivian Liu
|
|
|
841,367
|
|
|
|
5.07
|
|
Officer and Director
|
|
|
|
|
|
|
|
|
Henry Esber
|
|
|
2,272,924
|
|
|
|
13.72
|
|
Director
|
|
|
|
|
|
|
|
|
Ziad Mirza
|
|
|
407,071
|
|
|
|
2.46
|
|
Director
|
|
|
|
|
|
|
|
|
Wallace Boyack
|
|
|
840,579
|
|
|
|
5.07
|
|
|
|
|
|
|
|
|
|
|
Ramon Jadra
|
|
|
989,198
|
|
|
|
5.97
|
|
|
|
|
|
|
|
|
|
|
Bassam Damaj & Family
|
|
|
4,555,093
|
|
|
|
27.68
|
|
|
|
|
|
|
|
|
|
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The officers and directors own 3,521,362 shares of common stock which is 21% of the issued and outstanding shares.
The number of shares owned include direct and beneficial ownership. The percentages are based on 16,564,063 shares of common stock being issued and outstanding. Because of the Apricus convertible note discussed below the numbers in the chart are provisional.
Apricus Bio holds a convertible note which will be converted into common stock of Innovus Pharma. That conversion will occur at a later date but the shares converted will be included in the 92% or the issued and outstanding shares received by the FasTrack shareholders.
Item 5.02 Departure of Directors or Principal Officers; Election Arrangement
of Certain Officers.
As previously described the new directors will appoint new officers
of the Company.
Item 5.03 Amendments to Articles of Incorporation or Bylaws; change in Fiscal Year.
Under the terms of the Agreement we agreed to implement three changes to our articles of incorporation and common stock. The three changes are a name change to Innovus Pharmaceuticals, Inc., and an increase in the authorized capital to 150,000,000 shares of common stock, par value of $.001 per share. Our issued and outstanding shares of common stock were subject to a reverse split on the basis of ten shares into one share. We filed Articles of Amendment with the Nevada Secretary of State amending our articles of incorporation. There is no change in our reporting period for our financial statements as it will remain on a calendar year basis.
Item 5.06 Change in Shell Company Status.
Previously we were designated as a “shell company” as that term is defined in Rule 12b-2 promulgated under the Securities Exchange Act of 1934.
As a result of the Closing of the Agreement FasTrack became our subsidiary and main operating business. FasTrack has assets which it is seeking to develop and pursue. With an operating business we are no longer a “shell company.” Information regarding our main operating business is in Item 2.01.
More information about the Company is available because we file annual, quarterly, and current reports and other information with the SEC that states additional information about our company. These materials are available at the public reference facilities of the SEC’s Washington, D.C. office, at 100 F Street, NE, Washington, D.C. 20549 and on the SEC Internet site at
http://www.sec.gov.
On September 27, 2011, North Horizon sent an information statement to its shareholders.
Item 9.01
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Financial Statements and Exhibits.
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FasTrack Financial Statements:
The audited financial statements of FasTrack Pharmaceuticals, Inc., as of December 31, 2010, are attached. Unaudited financial statements of FasTrack as of September 30, 2011, are attached.
North Horizon Financial Statements:
The audited financial statements of North Horizon, Inc., as of December 31, 2010, and December 31, 2009, are attached. Unaudited financial statements of North Horizon as of September 30, 2011, are attached.
North Horizon had not engaged in any material operations during the period ended September 30, 2011. Over the past several years North Horizon had not engaged in any material operations other than matters pertaining to its corporate existence and filing the requisite reports with the SEC.
For the quarter ended September 30, 2011, North Horizon had limited operations. We had no revenues and incurred expenses of $7,196 with a net loss of ($7,196) compared to no revenues and expenses of $2,925 and a net loss of $(2,925) for the same period a year earlier. For the nine month period ended September 30, 2011, we had no revenues and incurred expenses of $16,861 with a net loss of $(16,861) compared to no revenues and expenses of $16,375 and a net loss of $(16,375) for the same period a year earlier. North Horizon had no off-balance sheet arrangements.
The notes are an integral part of the financial statements provided and include additional information and detail.
Pro Forma Financial Statements
The pro forma financial statements of the combined entities are as of September 30, 2011, and December 31, 2010 and show that FasTrack has become a subsidiary of North Horizon. The pro forma statements give effect to the ten shares into one share reverse split and the issuance of the shares of common stock to the FasTrack shareholders when the Agreement closed.
Exhibits:
Exhibits
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No.
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Description
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2.1
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Merger Agreement and Plan of Merger, Report on 8-K filed on July 20, 2011.
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3.1
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Articles of Incorporation previously filed
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3.2
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Bylaws previously filed
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3.3
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Amendment to Articles of Incorporation - Nevada
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3.4
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Certificate of Merger - Delaware
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3.5
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Articles of Merger - Utah
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21.1
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List of subsidiaries.
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