Annovis Bio (ANVS) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern, if we are unable to obtain additional financings
2. 02The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025, contains an explanatory paragraph relating to our ability to continue as a going concern
3. 03We have incurred significant net losses since inception and anticipate that we will continue to incur net losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability
4. 04We will require substantial additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of buntanetap88% rewritten
5. 05buntanetap or any other product candidates. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization effortsNew
6. 06Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates
7. 07We have limited operating history and no history of commercializing pharmaceutical products
8. 08Our ability to use our tax net operating losses is uncertain
9. 09Inflation could adversely affect our business and results of operations28% rewritten
10. 10Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price

Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval

1. 11We are heavily dependent on the success of buntanetap, our most advanced product candidate, which is still under clinical development, and if this drug does not receive regulatory approval or is not successfully commercialized, our business will be materially harmed
2. 12If we are not successful in discovering, developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired
3. 13Business disruptions could harm our ability to complete or could materially delay our clinical trials, as well as cause disruptions to the FDA and other governmental authorities
4. 14Clinical trials are expensive, time-consuming and difficult to design and implement, and involve an uncertain outcome
5. 15The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for buntanetap or any other product candidates, our business will be substantially harmed
6. 16Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay
7. 17We may develop buntanetap and future product candidates for use in combination with other therapies, which could expose us to additional regulatory risks
8. 18Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control
9. 19Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials40% rewritten
10. 20the conclusions reached, our ability to obtain approval for, and commercialize, product candidates may be harmed, which could significantly harm our business prospectsNew
11. 21Our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales
12. 22The market opportunities for buntanetap or any other product candidates, if approved, may be smaller than we anticipate, which could adversely affect our business, financial condition and results of operations
13. 23We have never obtained marketing approval for a product candidate, and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates. Further, even if marketing approval is obtained, we have no experience as a company in commercializing products
14. 24Even if we obtain FDA approval for buntanetap or any other product candidates in the United States, we may never obtain approval for or commercialize buntanetap or any other product candidates in any other jurisdiction, which would limit our ability to realize their full market potential
15. 25Even if we obtain regulatory approval for buntanetap or any product candidates, we will still face extensive and ongoing regulatory requirements and obligations and any product candidates, if approved, may face future development and regulatory difficulties
16. 26The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
17. 27We may seek a Breakthrough Therapy designation for buntanetap from the FDA in PD and AD. However, we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process
18. 28Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit, delay or cease commercialization of any products that we may develop
19. 29Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities

Risks Related to Commercialization

1. 30We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively
2. 31Even if buntanetap or any product candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success, which would adversely affect our business
3. 32If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in commercializing buntanetap, if approved
4. 33A variety of risks associated with operating internationally could materially adversely affect our business

Risks Related to Our Dependence on Third Parties

1. 34terminate or refuse to renew their agreement at a time that is costly or otherwise inconvenient for us. If we were unable to find an adequate CMO or another acceptable solution in time, our clinical trials could be delayed, or our commercial activities could be harmedNew
2. 35We currently rely and in the future intend to rely on third parties to conduct, supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business61% rewritten
3. 36commercialize any product candidate that we develop. As a result, our financial results and the commercial prospects for any product candidate that we develop would be harmed, our costs could increase, and our ability to generate revenue could be delayedNew

Risks Related to Healthcare Laws and Other Legal Compliance Matters

1. 37Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set
2. 38Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect there may be additional challenges and amendments to the ACA in the future. It is uncertain the extent to which any such changes may impact our business or financial condition
3. 39Our 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
4. 40Any clinical trial programs we conduct or research collaborations we enter into in the EEA may subject us to the General Data Protection Regulation
5. 41We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities
6. 42Recent U.S. tax legislation may materially adversely affect our financial condition, results of operations and cash flows

Risks Related to Our Intellectual Property

1. 43If we are unable to obtain additional patent protection to prolong the patent life of our product candidates, we may not be able to continue development of our product candidates95% rewritten
2. 44product candidates, and threaten our ability to commercialize future product candidates. Any such outcome could have a materially adverse effect on our business, and our company could cease to existNew
3. 45International (PCT) application and a U.S. nonprovisional patent application directed to treatment of neurodegenerative diseases and other diseases via administration of this combinationNew
4. 46We may be subject to claims challenging the inventorship of our patents and other intellectual property
5. 47We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope, or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture and market our product candidates
6. 48Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
7. 49Obtaining 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 non-compliance with these requirements
8. 50We enjoy only limited geographical protection with respect to certain patents, and we may not be able to protect our intellectual property rights throughout the world
9. 51If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and under similar legislation in foreign countries, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed
10. 52obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced, possibly materially
11. 53Intellectual property rights do not address all potential threats to our competitive advantage
12. 54We have not yet registered our trademarks in the United States or other jurisdictions. Failure to secure such registrations could adversely affect our business
13. 55If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest, and our business may be adversely affected
14. 56We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties or claims asserting ownership of what we regard as our own intellectual property
15. 57Our proprietary information may be lost, or we may suffer security breaches

Risks Related to Our Employees, Managing Our Growth and Our Operations

1. 58Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel
2. 59We expect to expand our development, regulatory, and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
3. 60We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources
4. 61We may seek to enter into collaborations, license agreements and other similar arrangements in the future, and may not be successful in doing so
5. 62Our business and operations would suffer in the event of failures involving our information technology systems, or those of any of our service providers
6. 63Disruption, failure or cybersecurity breaches affecting or targeting computers and infrastructure used by us or our business partners may adversely impact our business and operations

Risks Related to Our Common Stock

1. 64The market price of our common stock has been volatile and fluctuated substantially in the past and may continue to experience volatility and substantial fluctuations in the future, which could result in substantial losses for purchasers of our common stock
2. 65Our failure to regain the NYSE’s continued listing requirements could result in a delisting of our common stock60% rewritten
3. 66We have been subject to securities class action litigation in the past and could be subject to such litigation in the future
4. 67Our directors, executive officers and certain stockholders own a significant percentage of our common stock and, if they choose to act together, will be able to exert significant control over matters subject to stockholder approval
5. 68If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our common stock, our stock price and trading volume could decline
6. 69Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders
7. 70We incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives and corporate governance practices
8. 71We are an “smaller reporting company,” and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors88% rewritten
9. 72Provisions in our restated certificate of incorporation and amended and restated bylaws and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management