Alpha Cognition (ACOG) risk factors, FY2025 10-K

Risks Related to Commercialization and Manufacturing

1. 01ZUNVEYL 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. 02The market opportunities for ZUNVEYL may be smaller than we anticipate
3. 03We 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. 04As 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 Financial Condition

1. 05We are a commercial biopharmaceutical company with one product approved for commercial sale and have incurred significant losses since our inception. We expect to incur significant losses for the foreseeable future and our costs may increase substantially in the foreseeable futureNew
2. 06Our ability to continue 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
3. 07We have a limited operating history and no prior 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 viability20% rewritten
4. 08We expect to incur significant commercialization expenses related to product manufacturing, sales, marketing, distribution, and continued R&D of ZUNVEYLNew
5. 09We expect to be exposed to fluctuations in currency exchange rates, which could adversely affect our results of operations56% rewritten

Risks Related to Our Business Development

1. 10Our business is heavily dependent on the commercial success 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. 11We 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. 12We 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. 13ZUNVEYL remains subject to regulatory oversight
5. 14For 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. 15The 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. 16We 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. 17Interim “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. 18We 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. 19We 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. 20If 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. 21Significant disruptions of our information technology systems, breaches of data security and other incidents could materially adversely affect our business, results of operations and financial condition39% rewritten

Risk related to Our Industry

1. 22Research and development of pharmaceuticals is lengthy and inherently risky. We cannot give any assurance that our future product candidates will receive regulatory approval
2. 23Failure 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. 24Even 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 Our Intellectual Property

1. 25We may not be able to protect our intellectual property rights throughout the world, which may harm our business
2. 26If we do not obtain protection under the Hatch-Waxman Amendments by obtaining data exclusivity, our business may be harmed
3. 27The 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. 28One 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. 29Obtaining 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. 30We 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. 31Third-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. 32We 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. 33We 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. 34Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline
11. 35Derivation 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. 36Intellectual 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. 37Changes 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. 38Our 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. 39We 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. 40We 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. 41We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
18. 42Any trademarks we have obtained or may obtain may be infringed or successfully challenged, resulting in harm to our business
19. 43Our 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. 44Intellectual property rights do not necessarily address all potential threats to our competitive advantage
21. 45We 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. 46The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable
2. 47The FDA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction
3. 48Even following our regulatory approval of ZUNVEYL or for a future product candidate, our products will remain subject to regulatory scrutiny
4. 49Obtaining 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. 50Healthcare 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. 51The 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. 52Our 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. 53If 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. 54We will need to increase the size of our organization, and we may experience difficulties in managing growth
2. 55Our success is dependent on our ability to attract and retain highly qualified management and other clinical and scientific personnel
3. 56If 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. 57We may explore strategic collaborations that may never materialize or may fail
5. 58We 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. 59We 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 Stock

1. 60Our stock price may be volatile and you may not be able to resell common stock at or above the price you paid
2. 61An active, liquid and orderly market for our common stock may not develop, and you may not be able to resell your common stock at or above the initial public offering price37% rewritten
3. 62We 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. 63It may be difficult to enforce judgments or bring actions outside the United States against us and certain of our directors
5. 64If we sell our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline
6. 65Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions30% rewritten
7. 66Stock eligible for future sale may adversely affect the market77% rewritten
8. 67Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall65% rewritten
9. 68Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations
10. 69We 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. 70Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations
12. 71Tariffs and other trade policies could have a substantial impact on our business
13. 72If 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 decline47% rewritten
14. 73We may be subject to securities litigation, which is expensive and could divert our management’s attention
15. 74We 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. 75Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
17. 76Our 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