Cocrystal Pharma (COCP) risk factors, FY2024 10-K

RISK RELATED TO OUR FINANCIAL CONDITION

1. 01Because there is substantial doubt as to the Company’s ability to continue as a going concern, we may not be successful and our ability to continue our operations is in doubt unless we can access sufficient working capital within the timeframe needed

RISKS RELATED TO OUR BUSINESS

1. 02We have never generated revenue from product sales and all of our product candidates are currently in the preclinical and early clinical stage, and we may continue to incur significant losses for the foreseeable future and never generate revenue from product sales
2. 03We had an accumulated deficit of $333,418,000 from inception through December 31, 2024 and expect to continue losing money in the future. We may never achieve income from operations or have positive cash flow from operations
3. 04Because we have yet to generate any revenue from product sales on which to evaluate our potential for future success and to determine if we will be able to execute our business plan, it is difficult to evaluate our prospects and the likelihood of success or failure of our business

RISKS RELATED TO THE DISCOVERY, DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT CANDIDATES

1. 05If we form strategic alliances which are unsuccessful or are terminated, we may be unable to develop or commercialize certain product candidates and we may be unable to generate revenues from our development programs
2. 06We expect to rely on third parties to conduct some or all aspects of our compound formulation, research and preclinical testing, if those third parties do not perform satisfactorily our business and future prospects would be materially and adversely affected
3. 07Because we intend to rely on third-party manufacturers to produce our preclinical and clinical supplies, and commercial supplies of any approved product candidates, we will be subject to a variety of risks
4. 08Because we expect to rely on limited sources of supply for the drug substance and drug product of product candidates, any disruption in the chain of supply may cause a delay in developing and commercializing these product candidates
5. 09If third party manufacturing issues arise, it could increase product and regulatory approval costs or delay commercialization
6. 10Since we expect to continue to rely on third parties to conduct, supervise and monitor our clinical trials, if those third parties fail to perform in a satisfactory manner and one that meets applicable regulatory, scientific and safety requirements, it may materially harm our business
7. 11Because the approach we are taking to discover and develop drugs is novel, it may never lead to marketable products
8. 12If we do not succeed in our efforts to identify or discover additional potential product candidates, your investment may be lost
9. 13Because our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvals
10. 14If we are unable to successfully complete preclinical testing and clinical trials of our product candidates or experience significant delays in doing so, our business will be materially harmed
11. 15We may be unable to demonstrate safety and efficacy of our product candidates to the satisfaction of regulatory authorities or we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
12. 16Our product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance
13. 17Following regulatory approval for a product candidate, we will still face extensive regulatory requirements and the approved product may face future development and regulatory difficulties
14. 18We may not succeed in obtaining or maintaining necessary rights to drug compounds and processes for our development pipeline through acquisitions and in-licenses
15. 19Because third parties may be developing competitive products without our knowledge, we may later learn that competitive products are superior to our product candidates which may force us to terminate our research efforts of one or more product candidates
16. 20We have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain approvals for marketing our product candidates, including approval by the FDA

RISKS RELATED TO OUR BUSINESS OPERATIONS AND INDUSTRY

1. 21If we cannot obtain or protect intellectual property rights related to our future products and product candidates, we may not be able to compete effectively in our markets
2. 22If third-party intellectual property infringement claims are asserted against us, it may prevent or delay our development and commercialization efforts and have a material adverse effect on our business and future prospects
3. 23We may in the future be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful
4. 24We may need to obtain additional licenses to intellectual property rights from third parties
5. 25We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
6. 26Because we face significant competition from other biotechnology and pharmaceutical companies, our operating results will suffer if we fail to compete effectively
7. 27Our business could be negatively impacted by cybersecurity threats and other security threats and disruptions
8. 28Failure of our information technology infrastructure to operate effectively could adversely affect our business
9. 29Artificial intelligence presents risks and challenges that can negatively impact our business
10. 30As artificial intelligence expands, our competitors, which may have significantly greater financial and human capital resources, may use artificial intelligence to further their research efforts and advance competitive product candidates through clinical trials
11. 31The commercial success of our product candidates will depend upon the acceptance of these product candidates by the medical community, including physicians, patients and healthcare payors
12. 32If insurance and/or government coverage and adequate reimbursement are not available for our product candidates, it could impair our ability to achieve and maintain profitability
13. 33Due to the recent change in presidential administration in the U.S., we and our industry face uncertainty including the potential for reduced government funding of research programs and staff and resource reductions at the FDA and other government agencies, which may adversely affect our business
14. 34If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenues from product sales
15. 35If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business
16. 36If we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience increases in our compensation costs, our business may materially suffer
17. 37If we expand our organization, we may experience difficulties in managing growth, which could disrupt our operations
18. 38Because we face potential product liability if claims are brought against us, we may incur substantial liability and costs
19. 39Business interruptions resulting from pandemics, natural disasters and adverse weather events could cause delays in research and development of our product candidates
20. 40If our information technology systems are compromised, the information we store and process, including our intellectual property, could be accessed, publicly disclosed, lost or stolen, which could harm our business, relationships with strategic partners and future results of operations
21. 41If we fail to comply with applicable laws and regulations, including environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business

RISKS RELATED TO OUR COMMON STOCK

1. 42Our stock price and trading volume has historically been volatile, and any increases in these metrics may be temporary for a number of reasons, which may cause investors to lose money
2. 43Due to factors beyond our control, our common stock price may be volatile, or may decline regardless of our operating performance, and you may not be able to resell your shares
3. 44Future issuances of our common stock or rights to purchase our common stock could cause additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
4. 45Future sales of large amounts of our common stock in the public market or a perception that such sales might occur could cause a decrease in our stock price
5. 46(iii) filing of Form 144
6. 47Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited
7. 48Because we may not attract the attention of major brokerage firms, it could have a material impact upon the price of our common stock
8. 49We may issue preferred stock which could make it more difficult for a third-party to acquire us and could depress our stock price