Alpha Cognition (ACOG) risk factors, FY2024 10-K

Risks Related to Our Financial Condition

1. 01Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve commercial success with ZUNVEYL oral tablet formulation, our one FDA approved product, and continued development and commercialization of our other product candidates, if approved
2. 02We have a limited operating history and have no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability
3. 03A change in the outcome of any of these or other factors with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate
4. 04We expect to be exposed to fluctuations in currency exchange rates, which could adversely affect our results of operations

Risks Related to Our Business Development

1. 05Our business is heavily dependent on the successful commercialization of ZUNVEYL oral tablet formulation, our only FDA approved product, and the development and commercialization of any future product candidates that we may develop or acquire
2. 06We may not successfully expand our pipeline of product candidates. If we are not successful in identifying, developing, in-licensing, acquiring or/and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired
3. 07We have initially concentrated our research and development efforts on the treatment of Alzheimer’s Disease, a disease that has seen limited success in drug development
4. 08ZUNVEYL remains subject to regulatory oversight
5. 09For our other product candidates, we may encounter substantial delays in our preclinical studies, clinical trials and obtaining NDA approval or may not be able to conduct or complete our preclinical studies or clinical trials or receive NDA approval on the timelines we expect, if at all
6. 10The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or other comparable foreign regulatory authorities
7. 11We rely on third parties in the conduct of all of our clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approval for our product candidates
8. 12Interim “top-line” and preliminary data from studies or trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data
9. 13We have conducted, and in the future plan to conduct, clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials
10. 14We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may have been more profitable or for which there could have been a greater likelihood of success
11. 15If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates
12. 16Significant disruptions of our information technology systems, breaches of data security and other incidents could materially adversely affect our business, results of operations and financial condition

Risk related to Our Industry

1. 17Research and development of pharmaceuticals is a lengthy and inherently risky. We cannot give any assurance that our future product candidates will receive regulatory approval
2. 18Failure to comply with health and data protection laws and regulations could lead to government enforcement actions and civil or criminal penalties, private litigation or adverse publicity and could negatively affect our operating results and business
3. 19Even if the product candidates that we develop receive regulatory approval in the United States or another jurisdiction, they may never receive approval in other jurisdictions, which would limit market opportunities for our product candidates and adversely affect our business

Risks Related to Commercialization and Manufacturing

1. 20ZUNVEYL oral tablet formulation may fail to achieve the broad degree of adoption and use by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success
2. 21The market opportunities for ZUNVEYL may be smaller than we anticipate
3. 22We are subject to certain supply chain risks inherent in manufacturing our lead product, ZUNVEYL, and future products with respect to Taiwan. Risks including periodic foreign economic downturns and political instability, which may adversely affect our ability to obtain materials and conduct business in Taiwan
4. 23As the Company continues to manufacture in Taiwan, our success will depend in part, on our ability to anticipate and effectively manage these risks. The impact of any one or more of these factors could materially adversely affect our business, financial condition and results of operations

Risks Related to Our Intellectual Property

1. 24We may not be able to protect our intellectual property rights throughout the world, which may harm our business
2. 25If we do not obtain protection under the Hatch-Waxman Amendments by obtaining data exclusivity, our business may be harmed
3. 26The validity, scope and enforceability of any patents listed in the Orange Book that cover our product candidates including our lead product ZUNVEYL can be challenged by third parties
4. 27One of our patent listings in the Orange Book has an inadvertent inaccuracy which may subject us to administrative proceedings before the FDA or litigation claims
5. 28Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements
6. 29We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms
7. 30Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate patents or other proprietary rights, may delay or prevent the development and commercialization of any of our product candidates including our lead product, ZUNVEYL
8. 31We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might harm our ability to develop and market our products
9. 32We may become involved in lawsuits to protect or enforce our patents or our other intellectual property rights, which could be expensive, time consuming and unsuccessful. Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
10. 33Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline
11. 34Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party
12. 35Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities and have a harmful effect on the success of our business
13. 36Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product including our lead product, ZUNVEYL
14. 37Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed, resulting in harm to our business and competitive position
15. 38We may be subject to claims that our employees, consultants, independent contractors or we have wrongfully used or disclosed confidential information of their former employers or other third parties
16. 39We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers
17. 40We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
18. 41Any trademarks we have obtained or may obtain may be infringed or successfully challenged, resulting in harm to our business
19. 42Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology
20. 43Intellectual property rights do not necessarily address all potential threats to our competitive advantage
21. 44We have not yet registered our trademarks in certain jurisdictions. Failure to secure those registrations could adversely affect our business

Risks Related to Government Regulation

1. 45The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable
2. 46The FDA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction
3. 47Even following our regulatory approval of ZUNVEYL or for a future product candidate, our products will remain subject to regulatory scrutiny
4. 48Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
5. 49Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates
6. 50The Budget Control Act of 2011 has resulted in reductions in spending on certain government programs, including aggregate reductions to Medicare payments to healthcare providers of up to 2.0% per fiscal year. These reductions have been extended until 2030 unless additional Congressional action is taken
7. 51Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties
8. 52If we fail to comply with 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 Employee Matters and Growth Management

1. 53We will need to increase the size of our organization, and we may experience difficulties in managing growth
2. 54Our success is dependent on our ability to attract and retain highly qualified management and other clinical and scientific personnel
3. 55If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval
4. 56We may explore strategic collaborations that may never materialize or may fail
5. 57We may seek to grow our business through acquisitions of complementary businesses, and the failure to manage acquisitions, or the failure to integrate them with our existing business, could harm our financial condition and operating results
6. 58We will incur increased costs and demands upon management as a result of being a public company in the United States

Risks Related to Our Common Shares

1. 59Our stock price may be volatile and you may not be able to resell common shares at or above the price you paid
2. 60An active, liquid and orderly market for our common shares may not develop, and you may not be able to resell your common shares at or above the public offering price
3. 61We are an “emerging growth company” and a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to emerging growth companies and smaller reporting companies, our common stock may be less attractive to investors
4. 62It may be difficult to enforce judgments or bring actions outside the United States against us and certain of our directors
5. 63If we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline
6. 64Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions
7. 65Shares eligible for future sale may adversely affect the market
8. 66Sales of a substantial number of shares of our common shares in the public market could cause our stock price to fall
9. 67Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations
10. 68We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock
11. 69Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations
12. 70Tariffs and other trade policies could have a substantial impact on our business
13. 71If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline
14. 72We may be subject to securities litigation, which is expensive and could divert our management’s attention
15. 73We may fail to comply with the rules that apply to public companies, including Section 404 of the Sarbanes-Oxley Act of 2002, which could result in sanctions or other penalties that could materially and adversely affect our business, financial condition, results of operations and prospects
16. 74Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
17. 75Our business will be subject to the risks of climate change, natural catastrophic events, world events, and man-made problems such as power disruptions or terrorism