Atea Pharmaceuticals (AVIR) risk factors, FY2025 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01We have a limited operating history and no history of successfully developing or commercializing any approved antiviral products, which may make it difficult to evaluate the success of our business to date and to assess the prospects for our future viability
2. 02If we successfully develop and obtain approval of any product candidate, we will need to transition from a company with a research and development focus to a company capable of executing commercial activities. We may not be successful in this transition43% rewritten
3. 03incur continuing and increasing legal, accounting and other expenses in operating our business as a public company
4. 04We may require substantial additional financing, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts77% rewritten
5. 05the continued costs of operating as a public company
6. 06We may engage in strategic collaborations or other transactions that could disrupt our business, cause dilution to our stockholders, reduce our financial resources, and subject us to other risks46% rewritten
7. 07We have not generated any revenue from product sales and may not be able to achieve profitability21% rewritten
8. 08our ability to establish, maintain, protect and enforce intellectual property rights in and to our HCV and HEV product candidates or any future product candidates
9. 09We maintain our cash at financial institutions, often in balances that exceed federally insured limits
10. 10As of December 31, 2025, we had US federal and state net operating loss carryforwards (“NOLs”), of $202.8 million and $219.3 million, respectively92% rewritten
11. 11In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development, and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application
12. 12the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
13. 13Clinical development, including enrollment of patients in clinical trials, is an expensive, lengthy and uncertain process. We may encounter substantial delays and costs in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all
14. 14third parties being unwilling or unable to satisfy their contractual obligations to us28% rewritten
15. 15service providers, such as CROs, encounter difficulties or are unable to comply with the CTR requirements our developments plans would be adversely impacted60% rewritten
16. 16For the treatment of HCV, we are currently developing bemnifosbuvir in combination with ruzasvir, a product candidate that has not yet been approved for marketing by the FDA or similar foreign regulatory authorities
17. 17Our product candidates may be associated with serious adverse events (“SAEs”), undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences64% rewritten
18. 18If we encounter difficulties enrolling and retaining enrolled patients in our clinical trials and having patients comply with the clinical trial protocol, our clinical development activities could be delayed or otherwise adversely affected
19. 19other factors outside of our control, such as political unrest, war, terrorism and the occurrence of a global health crisis such as COVID-19 which, among other things, created substantial burdens on healthcare providers who were required to prioritize immediate critical patient care over clinical research
20. 20Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our ongoing and planned clinical trials, which could prevent completion or commencement of these trials and adversely affect our ability to advance the development of our product candidates
21. 21A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval
22. 22We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations
23. 23Interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
24. 24Part of our strategy involves identifying novel product candidates. For example, we are currently conducting IND/CTA enabling studies of AT-587 for the treatment of HEV and are engaged in internal efforts to identify product candidates for other diseases resulting from infection with single stranded RNA viruses
25. 25We may focus on potential product candidates that may prove to be unsuccessful and we may have to forego opportunities to develop other product candidates that may prove to be more successful20% rewritten
26. 26the MA “under exceptional circumstances” is granted definitively, the risk-benefit balance of the medicinal product is reviewed annually, and the MA is withdrawn in case the risk-benefit ratio is no longer favorable
27. 27Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us or any future collaboration partners from obtaining approvals for the commercialization of any product candidate we develop47% rewritten
28. 28Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the US, which would limit our ability to realize their full market potential
29. 29Even if a current or future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
30. 30If the market opportunities for our product candidates are smaller than we believe they are or any approval we obtain is based on a narrower definition of the patient population, our business may suffer
31. 31Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities
32. 32Our business and operations may suffer in the event of information technology system failures, cyberattacks, or deficiencies, which could materially affect our results

Risks Related to Healthcare Laws and Other Legal Compliance Matters

1. 33We are subject to extensive and costly government regulation
2. 34Enacted and future legislation and policies may increase the difficulty and cost for us to commercialize our product candidates and could adversely affect our business25% rewritten
3. 35Since its enactment, there have been judicial, Congressional and executive challenges to certain aspects of the ACA. On June 17, 2021, the US Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA74% rewritten
4. 36We expect that additional US federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the US federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressuresNew
5. 37Enacted and future legislation and policies may increase the difficulty and cost for us to obtain marketing approval of our product candidates and could adversely affect our business
6. 38Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny and post-marketing requirements
7. 39seize or detain products, or require a product recall
8. 40The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
9. 41Our business operations and current and future relationships with clinical trial 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
10. 42similar healthcare laws and regulations in the EU and other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers
11. 43We face potential liability related to the privacy of health information we obtain from clinical trials sponsored by us
12. 44Our business may be affected by the evolving regulatory framework relating to the use of AINew
13. 45We 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
14. 46We and our employees are increasingly utilizing social media tools as a means of communication both internally and externally

Risks Related to Commercialization

1. 47Developments by competitors may render our products or technologies obsolete or non-competitive or may reduce the size of our markets
2. 48launching, marketing and selling products93% rewritten
3. 49We have limited personnel and limited infrastructure for the sales, marketing or distribution of products, and no experience as a company in commercializing a product candidate. The cost of building and maintaining such an organization may exceed the cost-effectiveness of doing so
4. 50In those territories where we engage a collaborator to commercialize our products in whole or in part our sales will depend on the collaborator’s strategic interest in the product and such collaborator’s ability to successfully commercialize the product
5. 51Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
6. 52Foreign sales of any product for which we obtain approval could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs
7. 53production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad
8. 54Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop

Risks Related to Manufacturing and our Dependence on Third Parties

1. 55the misappropriation or unauthorized disclosure of our intellectual property or other proprietary information, including our trade secrets and know-how25% rewritten
2. 56Our third-party manufacturers may be unable to successfully scale up manufacturing of our product candidates in sufficient quality and quantity in a timely manner, if at all, which may impair the clinical advancement and commercialization of our product candidates76% rewritten
3. 57We rely on third parties to conduct our preclinical studies and clinical trials. Any failure by a third-party to conduct the clinical trials according to GCPs and in a timely manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialize our product candidates69% rewritten
4. 58US. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory review processNew
5. 59collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all
6. 60Data provided by collaborators and others upon which we rely that have not been independently verified could turn out to be false, misleading or incomplete
7. 61If our CMOs and CROs use hazardous materials in a manner that causes injury or violates applicable law, we may be liable for damages

Risks Related to Intellectual Property

1. 62Third-party claims of intellectual property infringement, misappropriation or other violation may result in substantial costs or prevent or delay our development and commercialization efforts59% rewritten
2. 63Our products are subject to The Drug Price Competition and Patent Term Restoration Act of 1984, as amended (also referred to as the Hatch-Waxman Act), in the US, that can increase the risk of litigation with generic companies trying to sell our products, and may cause us to lose patent protection46% rewritten
3. 64review or that the result of the review would be favorable to us, which could result in a fine or penaltyNew
4. 65Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time
5. 66The Hatch-Waxman Act in the US provides for the opportunity to seek a patent term extension on one selected patent for each of our products, and the length of that patent term extension, if at all, is subject to review and approval by the USPTO and the FDA
6. 67If we are unable to obtain licenses from third parties on commercially reasonable terms or at all, or fail to comply with our obligations under such agreements, our business could be harmed
7. 68Litigation and adversarial proceedings are expensive, time-consuming and if unsuccessful, can adversely affect our ability to sell our products when commercialized45% rewritten
8. 69Our composition of matter patent filing on bemnifosbuvir has now been granted in over 70 countries including the US, Europe, China, Japan, Korea, Australia, Brazil, Eurasia, Canada, Israel, New Zealand, South Africa, Russia and Mexico, and is pending in certain other countries and regionsNew
9. 70We also solely own a patent application covering the FDC of bemnifosbuvir and ruzasvir. The expected year of expiration for patents, if any, issuing from this application, if valid and enforceable, is 2046, without regard to any adjustments of term that may be available under US or other national lawNew
10. 71Changes in patent laws and enforcement by courts and other authorities in the US and other jurisdictions may impact our ability to protect our patents
11. 72Obtaining 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
12. 73We may not be able to enforce our intellectual property rights throughout the world
13. 74We rely on our ability to stop others from competing by enforcing our patents, however some jurisdictions may require us to grant licenses to third parties. Such compulsory licenses could be extended to include some of our product candidates, which may limit our potential revenue opportunities
14. 75If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed50% rewritten
15. 76protection and we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations and financial conditionNew
16. 77Our proprietary rights may not adequately protect our technologies and product candidates, and intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Employee Matters, Managing Operations and Other Risks Related to Our Business

1. 78In the first quarter of 2025, in order to reduce costs and support longer term business sustainability, we implemented a reduction in our workforce57% rewritten
2. 79Our future success depends upon our ability to retain officers, directors and key employees and attract, retain and motivate qualified personnel
3. 80We do not carry key person life insurance on any officers or directors
4. 81We rely on consultants, advisors and third parties for the performance of critical aspects of our business operations
5. 82Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price
6. 83Our business could face adverse consequences as a result of the actions of activist shareholders

Risks Related to Our Common Stock

1. 84If 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, even if our business is doing well20% rewritten
2. 85Provisions 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
3. 86Our restated certificate of incorporation designates specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us
4. 87Raising additional capital may cause additional dilution to our stockholders, restrict our operations, require us to relinquish rights to our technologies or product candidates, and could cause our share price to fall25% rewritten
5. 88We or the third parties upon whom we depend may be adversely affected by natural disasters or pandemics and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
6. 89Evolving and varied expectations for ESG initiatives could increase our costs, harm our reputation, or otherwise adversely impact our business
7. 90Litigation against us could be costly and time-consuming to defend and could result in additional liabilities
8. 91The market price of our common stock has been volatile and may fluctuate substantially
9. 92the other factors described in this “Risk Factors” section
10. 93If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our company
11. 94Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud