AVIR — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-12

• We are a late-stage clinical biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biochemistry and virology to discover, develop and commercialize novel, orally administered antivirals to treat serious viral diseases. Our current product can…

• The objective of our HCV development program is to improve upon the current SOC by offering bemnifosbuvir and ruzasvir as a differentiated pan-genotypic protease inhibitor-free, short-duration regimen for patients infected with HCV, if successfully developed and approved. We believe that a novel tre…

• Presently, there are no short-course (i.e., eight week) nucleotide inhibitor-based, pan-genotypic HCV treatment regimens. Clinical and nonclinical results from studies conducted to date, including a global Phase 2 clinical trial which enrolled 275 HCV infected patients, have shown that the regimen o…

• The global HCV Phase 3 program we are conducting consists of two randomized, open label studies: C-BEYOND which has clinical trial sites in the United States (“US”) and Canada, and C-FORWARD which has clinical trial sites in countries outside of North America. In these Phase 3 trials we are comparin…

• C-BEYOND is fully enrolled with over 880 patients, and we expect to report topline results mid-2026. We anticipate completing enrollment of an additional 880 patients in C-FORWARD in mid-2026 and reporting topline C-FORWARD results at year-end 2026. Pending successful results from these Phase 3 clin…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• We are a clinical-stage biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biology, biochemistry and virology to discover and develop novel orally administered product candidates to treat serious viral diseases. Our lead product candidate …

• HCV is a blood-borne, positive-sense, single-stranded ribonucleic acid ("RNA") virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease, liver transplants and liver cancer in the US, Europe and Japan.

• Despite the availability of direct-acting antiviral (“DAA”) oral combination treatment regimens and eradication efforts by the World Health Organization and others, HCV continues to be a serious viral disease. An estimated 50 million people globally live with chronic HCV infection, with approximatel…

• In the US, it is estimated that there are between 2.4 and 4.0 million persons infected with untreated HCV. Further it is reported that on an annual basis in the US, there are greater than 160,000 newly reported HCV infections. This incidence of newly reported infections outpaces substantially stagna…

• In the US and elsewhere, HCV is increasingly affecting younger people, with high case rates among those between 20 to 49 years of age. Since recently infected and younger patient populations are less likely to have developed cirrhosis given the relatively shorter cumulative exposure to the virus, th…

Text added vs the prior filing · source: 10-Q · 2026-05-12

• 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. …

• 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 ne…

• 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 esta…

• 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 mar…

• 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…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• 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 operati…

• 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 …

• 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 ne…

• 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;

Text added vs the prior filing · source: 10-Q · 2026-05-12

• 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 potenti…

• 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 exerc…

• 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 o…