AVIR

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.
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.
We expect to incur operating losses in 2026 and for the foreseeable future.
For the years ended December 31, 2025 and December 31, 2024, our operating expenses were $180.9 million and $193.0 million, respectively.
As of December 31, 2025, we had an accumulated deficit of $522.6 million.
This demonstration requires significant research and extensive data from in vitro and in 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.
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 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.
Further, we expect we will continue to incur substantial operating expenses if or as we: • continue to discover and develop additional product candidates; • 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 HEV or other product candidates, if any; • 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; • manufacture product in quantities sufficient to support product launch and commercialization, if approved; • establish a sales, marketing, internal systems and distribution infrastructure to commercialize any products for which we may obtain regulatory approval, if any, in geographies in which we plan to commercialize our products ourselves or with collaborators; • maintain, expand, protect and enforce our intellectual property portfolio; • hire additional staff, including clinical, scientific, technical, regulatory, operational, financial, commercial and support personnel, to execute our business plan and support our product candidate discovery, development and potential future commercialization efforts; • more extensively utilize external vendors for support with respect to research, development, manufacturing, commercialization, regulatory, pharmacovigilance and other functions; • acquire or in-license commercial products or additional product candidates and technologies; • make milestone, royalty or other payments under the Merck License Agreement with respect to the development and commercialization of ruzasvir in combination with bemnifosbuvir for the treatment of HCV; • make upfront, milestone, royalty or other payments in connection with any future in-license agreements relating to other product candidates; and • incur continuing and increasing legal, accounting and other expenses in operating our business as a public company.
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.
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 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 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 December 31, 2025, we have completed the Share Repurchase Program expending the total authorized amount of $25.0 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.
The timing and amount of our future capital requirements will depend on many factors, including but not limited to: • the scope, progress, results and costs of our preclinical studies and clinical trials, in particular the Phase 3 development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV; • 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; • the timing of, and the costs involved in, obtaining marketing approvals for our current and future product candidates in regions where we choose to commercialize any products; • the number of future product candidates and potential additional indications that we may pursue and their development requirements; • the stability, scale, yield and cost of manufacturing our product candidates for clinical trials, in preparation for regulatory approval and in preparation for commercialization; • the costs of manufacturing and commercialization activities for any approved product candidate to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of manufacturing commercial supply at a scale to meet demand and the costs and timing of establishing commercialization capabilities for and conducting product sales, marketing, distribution activities; • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; • the costs, timing and changes in pharmaceutical pricing and reimbursement infrastructure resulting from, among other things, the enactment of the Inflation Reduction Act (“IRA”) and other legislation, regulations, executive orders and other initiatives and policies that may be subsequently enacted; • our ability to compete with other therapies in the indications we target; • the extent to which we in-license or acquire rights to products, product candidates or technologies in addition to ruzasvir; • growth of our headcount and associated costs if and as we establish a commercial infrastructure; • the costs of preparing, filing and prosecuting patent applications and maintaining and protecting our intellectual property rights, including enforcing and defending intellectual property-related claims; and • the continued costs of operating as a public company.
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.
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 incurred a net loss of $158.3 million for the year ended December 31, 2025.
Our HCV and HEV product candidates 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.
Our ability to generate revenue depends on a number of factors, including, but not limited to: • timely completion of our clinical trials, including the Phase 3 clinical trials evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, as well as our preclinical studies and other clinical trials, each of which may be significantly slower or more costly than we currently anticipate and will depend substantially upon the performance of third-party contractors; • 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; • 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; • 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; • 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; • the timely receipt of necessary marketing approvals from the FDA, European Medicines Agency ("EMA") and other foreign regulatory authorities; • 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; • 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; • 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; • 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 • 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.
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.
For the years ended December 31, 2025 and 2024, we have completed a Section 382 study, the results of which indicated that no ownership shift occurred during such respective period.
Risks Related to the Discovery, Development, Preclinical and Clinical Testing, Manufacturing and Regulatory Approval of Our Product Candidates 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 will require significant additional clinical testing, including successful completion of Phase 3 clinical testing, before we can seek regulatory approval and potentially launch commercial sales.
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.
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.
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.
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.
We must complete additional clinical and preclinical studies to demonstrate the safety and efficacy of our product candidates in humans to the satisfaction of the regulatory authorities before we will be able to obtain these approvals, and it is possible that none of our product candidates will ever obtain regulatory approval.
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.
Events that may prevent successful or timely initiation or completion of clinical trials include but are not limited to: • inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials; • delays in reaching a consensus with regulatory authorities on study design or implementation of the clinical trials; • delays or failure in obtaining regulatory allowance to commence or amend a clinical trial; • 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; • delays in identifying, recruiting and training suitable clinical investigators; • delays in obtaining required institutional review board or ethics committee approval or positive opinion at each clinical trial site; • delays in recruiting, screening and enrolling a suitable number and diversity of patients to participate in our clinical trials; • subjects enrolled in our clinical trials or clinical sites deviating from the clinical trial protocol or dropping out of a trial; • delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing; • insufficient or inadequate supply or quality of product candidates or other materials necessary for use in clinical trials, or delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for clinical trials; • imposition of a temporary or permanent clinical hold by regulatory authorities for a number of reasons, including after review of an IND or amendment or equivalent foreign application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; or a negative finding from an inspection of our clinical trial operations or study sites; • developments on trials conducted by competitors for related technology that raises FDA or foreign regulatory authority concerns about risk to patients of the technology broadly; • developments during the course of a clinical trial that cause the FDA, a foreign regulatory authority or the clinical trial data safety monitoring board (“DSMB”) to find that the investigational protocol or plan is clearly deficient to meet its stated objectives; • difficulty collaborating with patient groups and investigators; • failure by our CROs, other third parties or us to adhere to clinical trial protocols; failure to perform in accordance with the FDA’s or any other regulatory authority’s good clinical practices (“GCPs”), or applicable regulatory guidelines in other countries; • occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits, or occurrence of adverse events in trial of the same class of agents conducted by other companies; • changes to the clinical trial protocols; • delays caused by patients withdrawing from clinical trials or failing to return for post-treatment follow-up; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols or otherwise impact the conduct of the clinical trial; • changes in the standard of care or rate of event occurrence upon which a clinical development plan was based, which may require discontinuation of current trials or new or additional trials; • selection of clinical endpoints that require prolonged periods of observation or analyses of resulting data; • the cost of clinical trials of our product candidates being greater than we anticipate; • clinical trials of our product candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us to conduct additional clinical trials or abandon development of such product candidates; • transfer of manufacturing processes to larger-scale facilities operated by a contract manufacturing organization (“CMO”) and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process; and • third parties being unwilling or unable to satisfy their contractual obligations to us.

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Gone since FY2024

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.
As we continue to build our business, including beginning and completing late stage clinical trials, 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.
We expect to incur operating losses in 2025 and for the foreseeable future.
For the years ended December 31, 2024 and 2023, our operating expenses were $192.9 million and $164.2 million, respectively.
As of December 31, 2024, we had an accumulated deficit of $364.2 million.
This demonstration requires significant research and extensive data from animal tests, which are referred to as nonclinical or preclinical studies, as well as human tests, which are referred to as clinical trials.
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.
Further, we expect we will continue to incur substantial operating expenses if or as we: • continue to discover and develop additional product candidates; • successfully complete clinical trials and seek regulatory approval for our regimen of bemnifosbuvir and ruzasvir or other product candidates, if any; • establish manufacturing and supply chain capacity sufficient to provide commercial quantities of any product candidates for which we may obtain marketing approval, if any; • establish a sales, marketing, internal systems and distribution infrastructure to commercialize any products for which we may obtain regulatory approval, if any, in geographies in which we plan to commercialize our products ourselves or with collaborators; • maintain, expand, protect and enforce our intellectual property portfolio; • hire additional staff, including clinical, scientific, technical, regulatory, operational, financial, commercial and support personnel, to execute our business plan and support our product development and potential future commercialization efforts; • more extensively utilize external vendors for support with respect to research, development, manufacturing, commercialization, regulatory, pharmacovigilance and other functions; • acquire or in-license commercial products or additional product candidates and technologies; • make milestone, royalty or other payments under the Merck License Agreement with respect to the development and commercialization of ruzasvir in combination with bemnifosbuvir for the treatment of HCV; • make upfront, milestone, royalty or other payments in connection with any future in-license agreements relating to other product candidates; and • incur continuing and increasing legal, accounting and other expenses in operating our business as a public company.
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.
Our ability to generate product revenue and maintain profitability will depend on, among other things, successful completion of the clinical 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; 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 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.
The timing and amount of our future capital requirements will depend on many factors, including but not limited to: • the scope, progress, results and costs of our preclinical studies and clinical trials, in particular the Phase 3 development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV; • the timing of and costs associated with discovery, license or acquisition of a product candidate for the treatment of respiratory or other diseases resulting from infection with single stranded RNA viruses; • the timing of, and the costs involved in, obtaining marketing approvals for our current and future product candidates in regions where we choose to commercialize any products; • the number of future product candidates and potential additional indications that we may pursue and their development requirements; • the stability, scale, yield and cost of manufacturing our product candidates for clinical trials, in preparation for regulatory approval and in preparation for commercialization; • the costs of manufacturing and commercialization activities for any approved product candidate to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of manufacturing commercial supply at a scale to meet demand and the costs and timing of establishing commercialization capabilities for and conducting product sales, marketing, distribution activities; • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; • the costs, timing and changes in pharmaceutical pricing and reimbursement infrastructure resulting from, among other things, the enactment of the Inflation Reduction Act (“IRA”) and other legislation and regulations that may be subsequently enacted; • our ability to compete with other therapies in the indications we target; • the extent to which we in-license or acquire rights to products, product candidates or technologies in addition to ruzasvir; • growth of our headcount and associated costs if and as we establish a commercial infrastructure; • the costs of preparing, filing and prosecuting patent applications and maintaining and protecting our intellectual property rights, including enforcing and defending intellectual property-related claims; and • the continued costs of operating as a public company.
In the fourth quarter of 2024, we announced that we had engaged Evercore LLC, a global independent investment bank, to assist us in identifying and exploring potential strategic partnerships related to our regimen of the bemnifosbuvir and ruzasvir.
While this process is ongoing, there is no assurance that it will result in the completion of 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 on favorable terms, or at all.
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 incurred a net loss of $168.4 million for the year ended December 31, 2024.
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.
Our ability to generate revenue depends on a number of factors, including, but not limited to: • timely completion of our clinical trials, including the Phase 3 clinical trials evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, as well as our preclinical studies and other clinical trials, each of which may be significantly slower or more costly than we currently anticipate and will depend substantially upon the performance of third-party contractors; • 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; • 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; • 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; • 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; • the timely receipt of necessary marketing approvals from the FDA or similar foreign regulatory authorities; • 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; • 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; • 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; • 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 • our ability to establish, maintain, protect and enforce intellectual property rights in and to our HCV product candidate or any future product candidates.
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.
For the years ended December 31, 2024 and 2023, we have completed a Section 382 study, the results of which indicated that no ownership shift occurred during such respective period.
Risks Related to the Discovery, Development, Preclinical and Clinical Testing, Manufacturing and Regulatory Approval of Our Product Candidates 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.
During the near term we expect that a substantial portion 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.
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.
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.
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.
We must complete additional clinical and preclinical studies to demonstrate the safety and efficacy of our product candidates in humans to the satisfaction of the regulatory authorities before we will be able to obtain these approvals, and it is possible that neither our HCV product candidate nor any product candidates we may seek to develop in the future will ever obtain regulatory approval.
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 if these trials begin, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials.
Events that may prevent successful or timely initiation or completion of clinical trials include but are not limited to: • inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials; • delays in reaching a consensus with regulatory authorities on study design or implementation of the clinical trials; • delays or failure in obtaining regulatory allowance to commence or amend a clinical trial; • 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; • delays in identifying, recruiting and training suitable clinical investigators; • delays in obtaining required institutional review board (“IRB”) or ethics committee approval or positive opinion at each clinical trial site; • delays in recruiting, screening and enrolling a suitable number and diversity of patients to participate in our clinical trials; • subjects enrolled in our clinical trials or clinical sites deviating from the clinical trial protocol or dropping out of a trial; • delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing; • insufficient or inadequate supply or quality of product candidates or other materials necessary for use in clinical trials, or delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for clinical trials; • imposition of a temporary or permanent clinical hold by regulatory authorities for a number of reasons, including after review of an IND or amendment or equivalent foreign application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; or a negative finding from an inspection of our clinical trial operations or study sites; • developments on trials conducted by competitors for related technology that raises FDA or foreign regulatory authority concerns about risk to patients of the technology broadly; • developments during the course of a clinical trial that cause the FDA, a foreign regulatory authority or the clinical trial DSMB to find that the investigational protocol or plan is clearly deficient to meet its stated objectives; • difficulty collaborating with patient groups and investigators; • failure by our CROs, other third parties or us to adhere to clinical trial protocols; failure to perform in accordance with the FDA’s or any other regulatory authority’s good clinical practices (“GCPs”), or applicable regulatory guidelines in other countries; • occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits, or occurrence of adverse events in trial of the same class of agents conducted by other companies; • changes to the clinical trial protocols; • delays caused by patients withdrawing from clinical trials or failing to return for post-treatment follow-up; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols or otherwise impact the conduct of the clinical trial; • changes in the standard of care or rate of event occurrence upon which a clinical development plan was based, which may require discontinuation of current trials or new or additional trials; • selection of clinical endpoints that require prolonged periods of observation or analyses of resulting data; • the cost of clinical trials of our product candidates being greater than we anticipate; • clinical trials of our product candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials or abandon development of such product candidates; • transfer of manufacturing processes to larger-scale facilities operated by a CMO and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process; and • third parties being unwilling or unable to satisfy their contractual obligations to us.
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.
We could also encounter delays if a clinical trial is suspended or terminated by us, by the DSMB for such trial, or by the FDA or any other regulatory authority, or if the IRBs of the institutions at which such trials are being conducted suspend or terminate the participation of the clinical investigators and sites subject to their review.
Further, conducting clinical trials in foreign countries, as we are currently doing for our HCV product candidate and otherwise expect to do for other product candidates, if any, presents additional risks that may delay completion of our clinical trials.
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, the regulatory landscape related to clinical trials in the EU recently evolved.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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