Atea Pharmaceuticals, Inc.
For the period ended Mar 31, 2026. Filed May 12, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 12, 2026
AVIR$4.41+2.3%Stored close · as of Nov 9, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001193125-25-277815
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsOther InformationCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-219678
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsOther InformationThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 530 previous paragraphs and 536 current paragraphs.
432 unchanged; 89 reworded; 11 added; 5 removed; 4 previous and 4 current paragraphs rearranged.
Tables are not compared: 1 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
the US federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;
Current report
Our business may be affected by the evolving regulatory framework relating to the use of AI.
Current report
We are increasing our use of AI tools and technology throughout our business. The regulatory framework for AI is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations. Additionally, existing laws and regulations may be interpreted in ways that would affect our use of AI.
Current report
It is possible that new laws and regulations will be adopted in the US and in other non-US jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI for our business. The cost of compliance with such laws, regulations, or decisions and/or guidance interpreting existing laws could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI. Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition and results of operations.
Current report
In the biopharmaceutical industry, AI is being increasingly used by companies and entities with which we compete. We are increasing our use of AI but other entities may be more advanced in their deployment and use of AI which may enhance such other entities’ business operations particularly their discovery efforts and the integration of operational efficiencies in the preclinical and clinical development of product candidates. If we are unable to use AI as effectively as our competitors, we could experience competitive disadvantages.
Current report
We 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 law.
Current report
The Company did not repurchase any equity securities in the three months ended March 31, 2026.
Current report
On March 10, 2026, Janet Hammond, MD, PhD, our Chief Development Officer, adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the “Hammond 10b5-1 Plan”). Between September 1, 2026 and September 1, 2027, the Hammond 10b5-1 Plan provides for the potential exercise of vested stock options and associated sale of up to 305,000 shares of Atea common stock acquired upon the exercise of such stock options. The Hammond 10b5-1 Plan expires on September 1, 2027 or upon the earlier completion of all transactions authorized under the Hammond 10b5-1 Plan.
Current report
On March 11, 2026, John Vavricka, our Chief Commercial Officer, adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the “Vavricka 10b5-1 Plan”). Between September 1, 2026 and September 1, 2027, the Vavricka 10b5-1 Plan provides for the potential exercise of vested stock options and associated sale of up to 200,000 shares of Atea common stock acquired upon the exercise of such stock options. The Vavricka 10b5-1 Plan expires on September 1, 2027 or upon the earlier completion of all transactions authorized under the Vavricka 10b5-1 Plan.
Current report
On March 12, 2026, Arantxa Horga, MD, our Chief Medical Officer, adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the “Horga 10b5-1 Plan”). Between September 1, 2026 and September 1, 2027, the Horga 10b5-1 Plan provides for the potential exercise of vested stock options and associated sale of up to 52,216 shares of Atea common stock acquired upon the exercise of such stock options and the sale of up to 82,697 shares of Atea common stock. The Horga 10b5-1 Plan expires on September 1, 2027 or upon the earlier completion of all transactions authorized under the Horga 10b5-1 Plan.
Removed paragraphs (5)
Previous report
collaborators may decide not to pursue development and commercialization of any product candidates we develop or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding or external factors, such as an acquisition that diverts resources or creates competing priorities;
Previous report
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, which prohibits a person who owns in excess of 15% of our
Previous report
The following table summarizes repurchases of our common stock during the three months ended September 30, 2025:
Previous report
On April 17, 2025, we publicly announced that our Board of Directors approved a stock repurchase program (the “Share Repurchase Program”), authorizing the repurchase of up to $25.0 million of the Company’s common stock (“Common Stock”). As of September 30, 2025, we have completed the Share Repurchase Program.
Previous report
Under the Share Repurchase Program, we repurchased a total of 7,673,792 shares of Common Stock, including 3,054,195 shares of Common Stock repurchased during the three months ended September 30, 2025. All repurchases were made in the open market through a trading plan that was adopted by the Company in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended or through privately negotiated transactions. All repurchases were made in accordance with Rule 10b-18 under the Exchange Act and were funded using cash on hand. For information regarding our Share Repurchase Program, see Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations. – Financial Resources.
Reworded paragraphs (89)
Previous wording
We are a clinical-stage biopharmaceutical company. Our operations to date have been limited to financing and staffing our company, developing our technology, and identifying and developing our product candidates. Our prospects must be considered in light of the uncertainties, risks, expenses and difficulties frequently encountered by biopharmaceutical companies in their early stages of operations. We have not yet demonstrated an ability to successfully develop, obtain marketing approval, manufacture a product at commercial-scale, or conduct sales and marketing activities necessary for successful product commercialization, or have third parties to do these activities on our behalf. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing, obtaining marketing approval for and commercializing antiviral therapies.
Current wording
We are a late-stage clinical biopharmaceutical company. Our operations to date have been limited to financing and staffing our company, developing our technology, and identifying and developing our product candidates. Our prospects must be considered in light of the uncertainties, risks, expenses and difficulties frequently encountered by biopharmaceutical companies in their early stages of operations. We have not yet demonstrated an ability to successfully develop, obtain marketing approval, manufacture a product on a commercial-scale, or conduct sales and marketing activities necessary for successful product commercialization, or have third parties to do these activities on our behalf. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing, obtaining marketing approval for and commercializing antiviral therapies.
Previous wording
As we continue to build our business, including completing Phase 3 clinical trials and preparing and potentially submitting applications seeking marketing approval for our HCV product candidate, we expect our financial condition and operating results may fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results included in this report or reports for any other particular prior quarterly or annual period as indications of future operating performance.
Current wording
As we continue to build our business, including completing Phase 3 clinical trials and preparing and potentially submitting applications seeking marketing approval for our hepatitis C virus (“HCV”) product candidate, we expect our financial condition and operating results may fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results included in this report or reports for any other particular prior quarterly or annual period as indications of future operating performance.
Previous wording
We have incurred significant operating expenses since our inception. For the nine months ended September 30, 2025 and for the year ended December 31, 2024, our operating expenses were $126.0 million and $193.0 million, respectively. As of September 30, 2025, we had an accumulated deficit of $477.7 million.
Current wording
We have incurred significant operating expenses since our inception. For the three months ended March 31, 2026 and the year ended December 31, 2025, our operating expenses were $48.0 million and $180.9 million, respectively. As of March 31, 2026, we had an accumulated deficit of $568.0 million.
Previous wording
In order to obtain the FDA’s or a foreign regulatory authority’s approval to market any product candidate in the US or abroad, respectively, we must submit to the FDA a New Drug Application (“NDA”) or similar application to the foreign regulatory authority demonstrating to the FDA’s or foreign regulatory authority’s satisfaction that the product candidate is safe and effective for its intended use(s). This demonstration requires significant research and extensive data fromin vitro andin vivo laboratory experiments and animal tests, which are referred to as nonclinical or preclinical studies, as well as human tests, which are referred to as clinical trials.
Current wording
In order to obtain the FDA’s or a foreign regulatory authority’s approval to market any product candidate in the US or abroad, respectively, we must submit to the FDA a New Drug Application (“NDA”) or similar application to the foreign regulatory authority demonstrating to the FDA’s or foreign regulatory authority’s satisfaction that the product candidate is safe and effective for its intended use(s). This demonstration requires significant research and extensive data fromin vitro andin vivo laboratory experiments and animal tests, which are referred to as nonclinical or preclinical studies, as well as human tests, which are referred to as clinical trials. Additionally, extensive data related to the chemistry and physical characteristics of the product candidate, the intended packaging of the commercial product, the processes to be used for consistently manufacturing the product candidate in commercial quantities in accordance with certified Good Manufacturing Practices (“GMP”) and the results of stability studies to establish shelf life of the product must also be included in the NDA and similar foreign regulatory applications.
Previous wording
Furthermore, the costs of advancing product candidates into each succeeding clinical phase tend to increase substantially over time. For example, as we advanced and completed the enrollment of our COVID-19 Phase 3 SUNRISE-3 clinical trial, our operating expenses increased. We anticipate that operating expenses will also increase in the future as we advance and complete Phase 3 clinical trials evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV as well as any additional late stage clinical trials we might undertake. Because of the numerous risks and uncertainties associated with the development of our product candidates, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to begin generating revenue from the commercialization of products or again achieve profitability.
Current wording
Furthermore, the costs of advancing product candidates into each succeeding clinical development phase tend to increase substantially over time. For example, the costs of our HCV Phase 3 development program are substantially greater than the costs we incurred in our HCV Phase 2 development program. These increased Phase 3 costs are attributable to a number of factors including a significantly increased number of patients enrolled in the Phase 3 program and costs associated with the use of an active comparator in the Phase 3 program which was not a part of the Phase 2 program. Because of the numerous risks and uncertainties associated with the development of our product candidates, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to begin generating revenue from the commercialization of products or again achieve profitability.
Previous wording
successfully complete clinical trials and seek regulatory approval for our regimen of bemnifosbuvir and ruzasvir or other product candidates, if any;
Current wording
successfully complete clinical trials and seek regulatory approval for the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, AT-587 for the treatment of hepatitis E virus (“HEV”) or other product candidates, if any;
Previous wording
establish manufacturing and supply chain capacity, including US domestic manufacturing capacity, sufficient to provide commercial quantities of any product candidates for which we may obtain marketing approval, if any;
Current wording
establish long-term manufacturing and supply chain capacity, including US domestic manufacturing capacity, sufficient to provide long term commercial quantities of any product candidates for which we may obtain marketing approval, if any;
Previous wording
Furthermore, our ability to successfully develop, commercialize and license any products and generate product revenue is subject to substantial additional risks and uncertainties. Our HCV product candidate and any future product candidates we may discover, license or otherwise acquire, will require regulatory approval in not less than one jurisdiction, the securing of manufacturing supply, capacity, distribution channels and expertise, the use of external vendors, the building of or other access to a commercial organization, substantial investment and significant marketing efforts before we generate any revenue from product sales. Additionally, our HCV product candidate and any future product candidates will require additional preclinical and clinical development. As a result, we expect to continue to use cash for operating activities and incur operating expenses and operating losses for the foreseeable future. The use of cash and incurrence of operating expenses and operating losses has had, and we expect will continue to have, an adverse effect on our working capital.
Current wording
Furthermore, our ability to successfully develop, commercialize and license any products and generate product revenue is subject to substantial additional risks and uncertainties. Our HCV and HEV product candidates and any future product candidates we may discover, license or otherwise acquire, will require regulatory approval in not less than one jurisdiction, the securing of manufacturing supply, capacity, distribution channels and expertise, the use of external vendors, the building of or other access to a commercial organization, substantial investment and significant marketing efforts before we generate any revenue from product sales. Additionally, our HCV and HEV product candidates and any future product candidates require additional preclinical and clinical development. As a result, we expect to continue to use cash for operating activities and incur operating expenses and operating losses for the foreseeable future. The use of cash and incurrence of operating expenses and operating losses has had, and we expect will continue to have, an adverse effect on our working capital.
Previous wording
The amount of future expenses or losses and our ability to achieve or maintain profitability in future years, if ever, are uncertain. We have no products that have generated any commercial revenue, do not expect to generate revenues from the commercial sale of products in the near term, and might never generate revenues from the sale of products. Our ability to generate product revenue and maintain profitability will depend on, among other things, successful completion of the development of our HCV product candidate and other product candidates, if any; obtaining necessary regulatory approvals from the FDA and foreign regulatory authorities; establishing manufacturing and sales capabilities; successfully manufacturing commercial scale quantities of products, market acceptance of our products, if approved, and establishing marketing infrastructure or otherwise arranging to commercialize our product candidates for which we obtain approval; and raising sufficient funds to finance our activities. We might not succeed at any of these undertakings. If we are unsuccessful at some or all of these undertakings in the future, our business, prospects, and results of operations may be materially adversely affected.
Current wording
The amount of future expenses or losses and our ability to achieve or maintain profitability in future years, if ever, are uncertain. We have no products that have generated any commercial revenue, do not expect to generate revenues from the commercial sale of products in the near term, and might never generate revenues from the sale of products. Our ability to generate product revenue and maintain profitability will depend on, among other things, successful completion of the development of our HCV and HEV product candidates and other product candidates, if any; obtaining necessary regulatory approvals from the FDA and foreign regulatory authorities; establishing manufacturing and sales capabilities; successfully manufacturing commercial scale quantities of products, market acceptance of our products, if approved, and establishing marketing infrastructure or otherwise arranging to commercialize our product candidates for which we obtain approval; and raising sufficient funds to finance our activities. We might not succeed at any of these undertakings. If we are unsuccessful at some or all of these undertakings in the future, our business, prospects, and results of operations may be materially adversely affected.
Previous wording
Since inception, we have incurred substantial operating expenses. We expect to incur substantial expenses in connection with our current and planned business activities, particularly the late stage development of the regimen of bemnifosbuvir and ruzasvir. Also, we anticipate that we may incur substantial expenses in connection with the discovery, license or other acquisition and potential development of other product candidates, if any, and, if we successfully develop one or more product candidates, in connection with the establishment of sales, marketing, internal systems and distribution infrastructure to commercialize any products for which we may obtain regulatory approval. Additionally, in April 2025, our Board authorized the utilization of up to $25.0 million of cash to repurchase our common stock (“Share Repurchase Program”). As of September 30, 2025, we have completed the Share Repurchase Program expending the total authorized amount of $25 million, net of transaction costs and excise taxes. Under the Share Repurchase Program, we repurchased, retired and returned to authorized but unissued status 7,673,792 shares of common stock.
Current wording
Since inception, we have incurred substantial operating expenses. We expect to incur substantial expenses in connection with our current and planned business activities, particularly completing the late stage development of the regimen of bemnifosbuvir and ruzasvir, the manufacture of commercial launch supply, the preparation and submission of an NDA and other similar applications seeking marketing approval for our HCV product candidate. Also, we anticipate that we may incur substantial expenses in connection with the development of AT-587 for the treatment of HEV, and in connection with the discovery, license or other acquisition and potential development of other product candidates, if any. If we successfully develop and receive regulatory approval to market the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV or any other product candidates, we expect we will also incur substantial expenses in connection with the establishment of sales, marketing, internal systems and distribution infrastructure to commercialize such products. Additionally, in 2025, our Board authorized and we completed a share repurchase program expending the total authorized amount of $25.0 million, net of transaction costs and excise taxes, in connection with the repurchase of 7,673,792 shares of our common stock.
Previous wording
the timing of and costs associated with discovery, license or acquisition of a product candidate for the treatment of other diseases resulting from infection with single stranded RNA viruses;
Current wording
the timing of and costs associated with the development of AT-587 for the treatment of HEV and the discovery, license or acquisition of a product candidate for the treatment of other diseases resulting from infection with single stranded RNA viruses;
Previous wording
In the future, we may enter into strategic collaborations or other transactions. While we remain open to consideration of a broad range of strategic alternatives, including strategic partnerships, acquisition, merger, or other business combination, sale of assets or other strategic transactions, we believe that it is most likely that actionable alternatives may be available after we receive the results from the currently ongoing HCV Phase 3 clinical program. There is no assurance we will conclude any specific transaction or outcome. If we do identify suitable collaboration candidates or strategic partners, we may not be able to complete such collaborations or other strategic transactions timely or on favorable terms, or at all. Any collaborations or other strategic transactions may not strengthen our competitive position, and these transactions may be viewed negatively by stock research analysts or investors, and we may never realize the anticipated benefits of such transactions. We may decide to issue our common stock or other equity securities to a strategic partner or collaborator which would reduce the percentage ownership of our existing stockholders. In addition, we may not be able to successfully integrate with any collaborator or strategic partner in an effective, timely and non-disruptive manner. Collaborations or other strategic transactions may also divert management attention from day-to-day responsibilities, lead to a loss of key personnel, increase our expenses and reduce our cash and cash equivalents available for operations and other uses. We cannot predict the number, timing or size of future collaborations or strategic partnerships or the effect that any such transactions might have on our operating results.
Current wording
In the future, we may enter into strategic collaborations or other transactions. While we remain open to consideration of a broad range of strategic alternatives, including strategic partnerships, acquisition, merger, or other business combination, sale of assets or other strategic transactions, we believe that it is most likely that actionable alternatives may be available after we receive the results from the currently ongoing HCV Phase 3 clinical program. There is no assurance we will conclude any specific transaction or outcome. If we do identify suitable collaboration candidates or strategic partners, we may not be able to complete such collaborations or other strategic transactions timely or on favorable terms, or at all. Any collaborations or other strategic transactions may not strengthen our competitive position, and these transactions may be viewed negatively by stock research analysts or investors, and we may never realize the anticipated benefits of such transactions. We may decide to issue our common stock or other equity securities to a strategic partner or collaborator which would reduce the percentage ownership of our existing stockholders. In addition, we may not be able to successfully integrate with any collaborator or strategic partner in an effective, timely and non-disruptive manner. Collaborations or other strategic transactions may also divert management attention from day-to-day responsibilities, lead to a loss of key personnel, increase our expenses and reduce our cash and investments available for operations and other uses. We cannot predict the number, timing or size of future collaborations or strategic partnerships or the effect that any such transactions might have on our operating results.
Previous wording
We incurred a net loss of $113.5 million for the nine months ended September 30, 2025. Our ability to achieve and sustain future profitability depends upon our ability to generate revenue from product sales. We have not generated product revenue and we do not expect to generate product revenue unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize, at least one of our product candidates. Our HCV product candidate and future product candidates, if any, will require additional preclinical and clinical development, regulatory review and approval, substantial investment in and access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. Currently, we do not anticipate generating revenue from product sales for at least the next few years. Our ability to generate revenue depends on a number of factors, including, but not limited to:
Current wording
We incurred a net loss of $45.4 million for the three months ended March 31, 2026. Our ability to achieve and sustain future profitability depends upon our ability to generate revenue from product sales. We have not generated product revenue and we do not expect to generate product revenue unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize, at least one of our product candidates. Our HCV and HEV product candidates and future product candidates, if any, require additional preclinical and clinical development, regulatory review and approval, substantial investment in and access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. Currently, we do not anticipate generating revenue from product sales for at least the next few years. Our ability to generate revenue depends on a number of factors, including, but not limited to:
Previous wording
our ability to complete additional investigational drug application (“IND”) enabling studies and successfully submit INDs, clinical trial application (“CTAs”) or comparable applications to allow us to initiate clinical trials for any other product candidates;
Current wording
our ability to complete additional investigational drug application (“IND”) enabling studies and successfully submit INDs, clinical trial application (“CTAs”) or comparable applications to allow us to initiate clinical trials for AT-587, our HEV product candidate, and any other product candidates;
Previous wording
whether we are required by the FDA or similar foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our HCV product candidate or any future product candidates;
Current wording
whether we are required by the FDA or similar foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our HCV and HEV product candidates or any future product candidates;
Previous wording
our ability to demonstrate to the satisfaction of the FDA or similar foreign regulatory authorities the safety and efficacy of our HCV product candidate or any future product candidates;
Current wording
our ability to demonstrate to the satisfaction of the FDA or similar foreign regulatory authorities the safety and efficacy of our HCV and HEV product candidates or any future product candidates;
Previous wording
the prevalence, duration and severity of potential side effects or other safety issues experienced with our HCV product candidate or future product candidates, if any;
Current wording
the prevalence, duration and severity of potential side effects or other safety issues experienced with our HCV and HEV product candidates or future product candidates, if any;
Previous wording
the timely receipt of necessary marketing approvals from the FDA or similar foreign regulatory authorities;
Current wording
the timely receipt of necessary marketing approvals from the FDA, European Medicines Agency ("EMA") and other foreign regulatory authorities;
Previous wording
the availability, actual and perceived advantages and relative cost, convenience, safety and efficacy of our HCV product candidate or other product candidates we may be able to commercialize, compared to other commercially available therapies for the targeted indications, as well as the accuracy and sufficiency of clinical evidence supporting any such advantages of our product candidates;
Current wording
the availability, actual and perceived advantages and relative cost, convenience, safety and efficacy of our HCV and HEV product candidates or other product candidates we may be able to commercialize, compared to other commercially available therapies for the targeted indications, or, in the case of HEV other interventions, as well as the accuracy and sufficiency of clinical evidence supporting any such advantages of our product candidates;
Previous wording
the willingness of physicians, operators of clinics and patients to conduct or participate in clinical trials evaluating our product candidates and, if successfully developed, to utilize or adopt our HCV product candidate or any future product candidates, if approved as antiviral therapies;
Current wording
the willingness of physicians, operators of clinics and patients to conduct or participate in clinical trials evaluating our product candidates and, if successfully developed, to utilize or adopt our HCV and HEV product candidates or any future product candidates, if approved as antiviral therapies;
Previous wording
our ability and the ability of third parties with whom we contract to manufacture adequate clinical and commercial supplies of our HCV or future product candidates, remain in good standing with regulatory authorities and develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices (“cGMP”) or similar requirements outside the US;
Current wording
our ability and the ability of third parties with whom we contract to manufacture adequate clinical and commercial supplies of our HCV and HEV product candidates or future product candidates, remain in good standing with regulatory authorities and develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices (“cGMP”) or similar requirements outside the US;
Previous wording
our ability to successfully establish a commercial strategy and thereafter commercialize our HCV product candidate or any future product candidates, in the US and internationally, if approved for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others; and
Current wording
our ability to successfully establish a commercial strategy and thereafter commercialize our HCV and HEV product candidates or any future product candidates, in the US and internationally, if approved for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others; and
Previous wording
our ability to establish, maintain, protect and enforce intellectual property rights in and to our HCV product candidate or any future product candidates.
Current wording
our ability to establish, maintain, protect and enforce intellectual property rights in and to our HCV and HEV product candidates or any future product candidates.
Previous wording
As of December 31, 2024, we had US federal and state net operating loss carryforwards (“NOLs”), of $63.3 million and $98.7 million, respectively.
Current wording
As of December 31, 2025, we had US federal and state net operating loss carryforwards (“NOLs”), of $202.8 million and $219.3 million, respectively.
Previous wording
Our business is highly dependent on the success of our product candidate, the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, which will require significant additional clinical testing, including successful Phase 3 clinical testing, before we can seek regulatory approval and potentially launch commercial sales. If this product candidate fails in clinical development, does not receive regulatory approval or is not successfully commercialized, or is significantly delayed in doing so, our business will be harmed.
Current wording
Our business is highly dependent on the success of our lead product candidate, the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, which requires significant additional clinical testing, including successful completion of Phase 3 clinical testing, before we can seek regulatory approval and potentially launch commercial sales. If this product candidate fails in clinical development, does not receive regulatory approval or is not successfully commercialized, or is significantly delayed in doing so, our business will be harmed.
Previous wording
During the near term we expect that substantially all of our efforts and expenditures will be devoted to developing the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV which will require additional clinical development, management of clinical, medical affairs and manufacturing activities, obtaining regulatory approvals in multiple jurisdictions, securing of manufacturing supply, building of or otherwise accessing a commercial organization, substantial investment and significant marketing efforts.
Current wording
During the near term, we expect to devote substantial efforts and financial resources to complete the Phase 3 clinical development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, manage clinical, medical affairs and manufacturing activities, including the manufacture of commercial launch supply, seek and obtain regulatory approvals in multiple jurisdictions, secure additional sources of manufacturing supply and capacity, build or otherwise access a commercial organization, and engage in significant pre-launch efforts.
Previous wording
We cannot be certain that our HCV product candidate or any future product candidates will be successful in clinical trials, receive regulatory approval or be successfully commercialized even if we receive regulatory approval. Further, our development of any product candidate may be delayed or suspended, which may affect our ability to successfully commercialize such product candidate. Additionally, our ability to successfully commercialize a product will also be dependent upon our ability to timely manufacture at commercial scale the quantities of product that will satisfy market demand.
Current wording
We cannot be certain that our HCV product candidate, our HEV product candidate or any future product candidates will be successful in clinical trials, receive regulatory approval or be successfully commercialized even if we receive regulatory approval. Further, our development of any product candidate may be delayed or suspended, which may affect our ability to successfully commercialize such product candidate. Additionally, our ability to successfully commercialize a product will also be dependent upon our ability to timely manufacture at commercial scale the quantities of product that will satisfy market demand.
Previous wording
Even if we receive approval to market our HCV product candidate or any other product candidate, we cannot be certain that such product candidate will be as or more effective than commercially available alternatives successfully commercialized or widely accepted in the marketplace. There are currently approved and well established oral antiviral HCV products against which we would be required to compete if the regimen of bemnifosbuvir and ruzasvir is approved for the treatment of HCV.
Current wording
Even if we receive approval to market our HCV product candidate, our HEV product candidate or any other product candidate, we cannot be certain that such product candidate will be as or more effective than commercially available alternatives, successfully commercialized or widely accepted in the marketplace. There are currently approved and well established oral antiviral HCV products against which we would be required to compete if the regimen of bemnifosbuvir and ruzasvir is approved for the treatment of HCV.
Previous wording
We cannot be certain that, if approved, the safety and efficacy profile of the regimen of bemnifosbuvir and ruzasvir will be consistent with the results observed in clinical trials. If we are not successful in the clinical development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, if the required regulatory approvals for this product candidate are not obtained, if there are significant delays in the development or approval of this product candidate or in supplying commercial quantities of any approved products on an uninterrupted basis, or if we are otherwise not commercially successful, our business, financial condition and results of operations may be materially harmed.
Current wording
We cannot be certain that, if approved, the safety and efficacy profile of the regimen of bemnifosbuvir and ruzasvir will be consistent with the results observed in clinical trials. If we are not successful in the clinical development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, if the required regulatory approvals for this product candidate are not obtained, if there are significant delays in the development or approval of this product candidate or in supplying commercial quantities of the regimen of bemnifosbuvir and ruzasvir or any other product, if approved, on an uninterrupted basis, or if we are otherwise not commercially successful, our business, financial condition and results of operations may be materially harmed.
Previous wording
Clinical 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.
Current wording
Clinical development, including enrollment and retention 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.
Previous wording
To date, we have not successfully concluded any late-stage or pivotal clinical trials for any of our product candidates. We cannot guarantee that any of our planned or ongoing clinical trials will be initiated or conducted as planned or completed on schedule, if at all. We also cannot be sure that submission of any future IND or similar application will result in the FDA or other regulatory authority, as applicable, allowing future clinical trials to begin in a timely manner, if at all. Moreover, even for trials that begin or have begun, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials.
Current wording
To date, we have not successfully concluded any late-stage or pivotal clinical trials for any of our product candidates. We cannot guarantee that any of our planned or ongoing clinical trials will be initiated or conducted as planned or completed on schedule, if at all. We also cannot be sure that submission of any future IND or similar application for AT-587 or any future product candidate will result in the FDA or other regulatory authority, as applicable, allowing future clinical trials to begin in a timely manner, if at all. Moreover, even for trials that begin or have begun, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials.
Previous wording
delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among CROs and clinical trial sites;
Current wording
delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among CROs and clinical trial sites;
Previous wording
Any inability to successfully complete our Phase 3 clinical trials evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV or the completion of any other planned clinical trials we may initiate could result in additional costs to us or impair our ability to seek approval for our HCV product candidate or any future product candidates and ultimately generate revenue from product sales.
Current wording
Any inability to successfully complete our Phase 3 clinical trials evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV or the completion of any planned clinical trials we may initiate for our HEV product candidate or otherwise could result in additional costs to us or impair our ability to seek approval for our HCV and HEV product candidate or any future product candidates and ultimately generate revenue from product sales.
Previous wording
Further, conducting clinical trials in foreign countries for our HCV product candidate or other product candidates, if any, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.
Current wording
Further, conducting clinical trials in foreign countries for our HCV and HEV product candidates or other product candidates, if any, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries. For example, as part of our C-FORWARD HCV Phase 3 clinical trial, clinical trial sites in Ukraine are enrolling patients in the study. To the extent that these patients are not able to complete the study or there is a loss of data related to those patients as a result of the ongoing conflict in that area or otherwise, there may be a delay in completing the study or an adverse impact on the results from the study.
Previous wording
In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted. For instance, with very limited exception for certain EU countries and certain clinical trials, the regulatory landscape related to clinical trials in the EU recently evolved. The EU CTR which was adopted in April 2014 and repeals the EU Clinical Trials Directive (“EU Clinical Trials Directive”), became applicable on January 31, 2022. While the EU Clinical Trials Directive required a separate CTA to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. As of January 31, 2025, with very limited exception for certain EU countries and certain clinical trials, all CTAs and clinical trials conducted in the EU (including those which are ongoing) are subject to the provisions of the CTR. As a result, the CTAs we have submitted in connection with the conduct of our HCV Phase 3 clinical trial in the EU were prepared in compliance with the CTR requirements. We have limited experience submitting applications under the CTR. If we or our third-party service providers, such as CROs, encounter difficulties or are unable to comply with the CTR requirements our developments plans would be adversely impacted.
Current wording
In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials being conducted outside North America may change and additional government regulations may be enacted. For instance, with very limited exception for certain EU countries and certain clinical trials, the regulatory landscape related to clinical trials in the EU recently evolved. The EU CTR which was adopted in April 2014 and repeals the EU Clinical Trials Directive (“EU Clinical Trials Directive”), became applicable on January 31, 2022. While the EU Clinical Trials Directive required a separate CTA to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduced a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. With very limited exception for certain EU countries and certain clinical trials, all CTAs and clinical trials conducted in the EU (including those which are ongoing) are subject to the provisions of the CTR. As a result, the CTAs we have submitted in connection with the conduct of our HCV Phase 3 clinical trial in the EU were prepared in compliance with the CTR requirements. We have limited experience submitting applications under the CTR. If we or our third-party service providers, such as CROs, encounter difficulties or are unable to comply with the CTR requirements our developments plans would be adversely impacted.
Previous wording
It is currently unclear to what extent the UK will seek to align its regulations with the EU. The extent to which the regulation of clinical trials in the UK will mirror the (EU) CTR in the long term is not yet certain, however, on December 12, 2024, the UK government introduced a legislative proposal - the Medicines for Human Use (Clinical Trials) Amendment Regulations 2024 - that, if implemented, will replace the current regulatory framework for clinical trials in the UK. The legislative proposal aims to provide a more flexible regime to make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK and make clinical trials more patient centered. The UK government has provided the legislative proposal to the UK Parliament for its review and approval. Once the legislative proposal is approved (with or without amendment), it will be adopted into UK law which is expected in early 2026. A decision by the UK not to closely align its regulations with the new approach that has been adopted in the EU may have an effect on the cost of conducting clinical trials in the UK as opposed to other countries.
Current wording
In April 2025, the UK government adopted the Medicines for Human Use (Clinical Trials) Amendment Regulations. The amendment, which will take full effect from April 2026, aims to provide a more flexible regime to make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK and make clinical trials more patient centered.
Previous wording
Our product candidates may be associated with serious adverse events, 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 consequences.
Current wording
Our 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 consequences.
Previous wording
Adverse events or other undesirable side effects caused by our product candidates could cause us, our collaborators, any DSMB for a trial, or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities.
Current wording
Adverse events (“AEs”) or other undesirable side effects caused by our product candidates could cause us, our collaborators, any DSMB for a trial, or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities.
Previous wording
If any serious adverse events occur, clinical trials or commercial distribution of any product we successfully develop could be suspended or terminated, and our business could be seriously harmed. Treatment-related side effects could also affect patient recruitment and the ability of enrolled patients to complete the trial or result in potential liability claims. Regulatory authorities could order us to cease further development of, deny approval of, or require us to cease selling any product candidate or product for any or all targeted indications. If we are required to delay, suspend or terminate any clinical trial or commercialization efforts, the commercial prospects of such product candidate or product may be harmed, and our ability to generate revenues from such product may be delayed or eliminated. Additionally, if one or more of our product candidates receives marketing approval and we or others later identify undesirable side effects or adverse events caused by such products, a number of potentially significant negative consequences could result, including but not limited to:
Current wording
If any SAEs occur, clinical trials or commercial distribution of any product we successfully develop could be suspended or terminated, and our business could be seriously harmed. Treatment-related side effects could also affect patient recruitment and the ability of enrolled patients to complete the trial or result in potential liability claims. Regulatory authorities could order us to cease further development of, deny approval of, or require us to cease selling any product candidate or product for any or all targeted indications. If we are required to delay, suspend or terminate any clinical trial or commercialization efforts, the commercial prospects of such product candidate or product may be harmed, and our ability to generate revenues from such product may be delayed or eliminated. Additionally, if one or more of our product candidates receives marketing approval and we or others later identify undesirable side effects or adverse events caused by such products, a number of potentially significant negative consequences could result, including but not limited to:
Previous wording
If a product candidate is intended for the treatment of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical needs for such condition, the product candidate sponsor may apply for Fast Track designation. The sponsor of a product candidate that has received Fast Track designation may have opportunities for more frequent interactions with the FDA review team during product development and, once a NDA is submitted, the NDA may be eligible for priority review. An NDA for a Fast Track designated product candidate may also be eligible for rolling review, where the FDA may consider review of sections of the NDA on a rolling basis before the complete NDA is submitted.
Current wording
If a product candidate is intended for the treatment of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical needs for such condition, the product candidate sponsor may apply for Fast Track designation. The sponsor of a product candidate that has received Fast Track designation may have opportunities for more frequent interactions with the FDA review team during product development and, once an NDA is submitted, the NDA may be eligible for priority review. An NDA for a Fast Track designated product candidate may also be eligible for rolling review, where the FDA may consider review of sections of the NDA on a rolling basis before the complete NDA is submitted.
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Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
Additionally, integration of AI in our or any third party’s operations, products or services is expected to pose new or unknown cybersecurity risks and challenges. We cannot assure you that our data protection efforts and our investment in information technology will prevent significant breakdowns, data leakages or breaches in our systems or those of our CROs and other contractors and consultants or that any such significant breakdowns, data leakages or breaches will be timely discovered, disclosed (if applicable) and remediated.
Current report — wording carried from elsewhere
If these competitors access the marketplace before we do with effective vaccines or safer, more effective, or less expensive therapeutics, our product candidates, if approved for commercialization, may not be profitable to sell or worthwhile to continue to develop. Technology in the pharmaceutical industry has undergone rapid and significant change, and we expect that it will continue to do so.
Current report — wording carried from elsewhere
Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in Medicare, Medicaid, other US federal healthcare programs or healthcare programs in other jurisdictions, integrity oversight and reporting obligations to resolve allegations of non-compliance, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations.
Current report — wording carried from elsewhere
Bemnifosbuvir, the product candidate we are developing in combination with ruzasvir for the treatment of HCV, and AT-587, the product candidate we are developing for the treatment of HEV, are each nucleotide prodrugs and other product candidates we may develop, may also be or include nucleotide prodrugs, or nucleotide phosphoramidates. A number of companies and universities have patent applications and issued patents in this general area, including for viral indications, such as, for example, Gilead Pharmasset, LLC; Gilead Sciences; Merck & Co.; Bristol Myers Squibb; F. Hoffmann-La-Roche Ltd.; University of Cardiff; University College Cardiff
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, prospects, financial condition or results of operations.
Previous report — wording carried elsewhere
On April 12, 2022, we received notification of a Pre-Grant Opposition from the Controller General of Patents, Designs, and Trademarks at the Indian Patent Office. The Opposition was filed by Sankalp Rehabilitation Trust and challenged our pending patent claims to AT-511 or a pharmaceutically acceptable salt thereof. In February
Previous report — wording carried elsewhere
If we are unable to continue to attract and retain high quality personnel, our ability to develop and commercialize product candidates will be limited.
Previous report — wording carried elsewhere
our cash, cash equivalents and marketable securities position;