Velpatasvir

Enrollment Completed in C-BEYOND Phase 3 Trial with More Than 880 HCV Treatment-Naïve Patients in US and Canada C-BEYOND Topline Results Expected Mid-2026 C-FORWARD Phase 3 Trial, Conducted Outside North America, Enrollment Completion Expected Mid-2026 with Topline Results Anticipated Year-End 2026 C-BEYOND AND C-FORWARD are the First Global Phase 3 Head-to-Head Trials of Direct-Acting Antivirals for Treatment of HCV BOSTON, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced completion of enrollment of more than 880 treatment-naïve patients in the C-BEYOND Phase 3 trial evaluating the fixed-dose combination (FDC) regimen of bemnifosbuvir and ruzasvir compared to the FDC regimen of sofosbuvir and velpatasvir for the treatment of hepatitis C virus (HCV). C-BEYOND is being conducted at approximately 120 clinical trial sites in the US and Canada. Phase 3 topline results are expected mid-year 2026. In addition to C-BEYOND, Atea continues to advance enrollment of treatment-naïve patients in C-FORWARD, a Phase 3 trial evaluating this same FDC regimen in 880 patients at approximately 120 clinical trial sites in up to 17 countries outside of North America. Completion of enrollment in C-FORWARD is expected mid-year 2026, with Phase 3 topline results anticipated year-end 2026. In both studies, the FDC regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the comparator FDC regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks. “Completing enrollment in C-BEYOND marks a critical inflection point in our Phase 3 HCV program and we are on track to deliver topline results from this trial mid-2026,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. “Our goal is and has always been to develop a best-in-class HCV treatment that meaningfully advances the standard of care. We believe that the target profile of our regimen — featuring short treatment duration, low risk of drug-drug interactions and convenience with no food effect — will uniquely position us to address the evolving needs of today’s patients and bring us closer to the ultimate goal of HCV eradication.” HCV continues to be a significant global health burden despite the availability of direct-acting antivirals (DAAs). Up to 4 million people in the US are living with chronic HCV, and an estimated 50 million people are infected worldwide with approximately one million new infections occurring each year. In the US, HCV diagnoses continue to outpace annual cure rates. According to healthcare providers who treat patients with HCV, approximately 80 percent of HCV patients take multiple medications to manage comorbidities and coinfections and concerns related to currently approved HCV therapeutics and drug-drug interactions are a significant factor in HCV treatment delay. As a result, a new treatment option offering high efficacy, short treatment duration, and a low risk of drug-drug interactions could meaningfully help to address patient needs and further the goal of HCV eradication. About the C-BEYOND and C-FORWARD Phase 3 Trials in Adults with Chronic HCV Atea’s HCV development program includes two open-label Phase 3 trials, C-BEYOND conducted in the US and Canada, and C-FORWARD conducted outside of North America. Each trial is enrolling approximately 880 treatment-naïve patients, including those with or without compensated cirrhosis. The trials compare the FDC regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir an NS5A inhibitor, to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks to all patients, with or without compensated cirrhosis. The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients. About HCV HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of DAAs, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, up to 4 million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20-49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan. About Atea Pharmaceuticals Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea’s lead program is the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. For more information, please visit www.ateapharma.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the potential best-in-class profile of the bemnifosbuvir/ruzasvir regimen for the treatment of HCV, the potential opportunity to advance efforts to eradicate HCV, future results of operations and financial position, business strategy, anticipated milestone events and timelines for clinical trials, benefits of cost savings initiatives, repurchases under the Company’s share repurchase program, and the timing and outcome of the Company’s strategic alternatives review. When used herein, words including “expected,” “should,” “anticipated,” “believe,” “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control; our ability to manufacture sufficient commercial product; competition from approved treatments for HCV; the timeline for the completion of the strategic alternatives review process is unknown and there can be no assurance that the process will result in any particular outcome; dependence on the success of Atea’s most advanced product candidates, in particular the bemnifosbuvir/ruzasvir regimen for the treatment of HCV; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985Barnes.jonae@ateapharma.com Joyce AllaireLifeSci Advisorsjallaire@lifesciadvisors.com

GlobalData forecasts that lenacapavir, under all its brand names, will generate $5.3bn in global sales in 2031. Tada Images via Shutterstock.com. Gilead Sciences’ pre-exposure prophylaxis (PrEP) formula of lenacapavir has been approved in the UK as a preventative option for HIV, offering patients a twice-yearly injection to reduce the risk of contracting the virus. As per the authorisation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), lenacapavir will be available to adults and adolescents for the prevention of sexually transmitted HIV-1 infection. The drug, taken as an injection once every six months, will be sold in the UK under the brand name Yeytuo, as it is across Europe. A formulation of lenacapavir was already approved in the UK under the brand name Sunlenca in 2022, which is for the treatment of HIV infection in combination with other antiretrovirals. There were 6,402 new diagnoses of HIV in the UK in 2023, with 107,949 people receiving HIV care that year. The UK Government aims to stop new HIV transmissions and end AIDS-related deaths by 2030. The greenlight as a preventative option in the UK follows similar decisions in the US and Europe earlier this year. In June, the US Food and Drug Administration (FDA) approved the twice-yearly treatment under the brand name Yeztugo, while the European Commission (EC) approved Yeytuo in August . GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Yeytuo works by reducing the risk of the HIV-1 virus multiplying and spreading throughout the body if a person is exposed to the virus. The drug binds to the HIV-1 virus’s outer layer, interfering with multiple steps in the viral lifecycle. The MHRA recommends Yeytuo’s use alongside safer sex practices, such as condoms. Julian Beach, interim executive director of healthcare quality and access at the MHRA, stated: “The approval of Yeytuo marks the introduction of a six-monthly long-acting preventative option for sexually transmitted HIV-1 infection. “Blocking the virus from multiplying if exposure occurs, lenacapavir offers an additional choice alongside existing safer sex practices.” It is unclear whether the National Health Service (NHS) will offer the drug as a preventative option to patients. As per a National Institute for Health and Care Excellence (NICE) entry , a provisional committee meeting is scheduled for March 2026. NICE did not immediately respond to Pharmaceutical Technology when approached for comment on the progress of UK reimbursement for the drug. Dr Paul Martin, chief executive of LGBT Foundation, a UK charity, said: “This approval [in the UK] is a game-changer for HIV prevention. Yeytuo gives people more choice, more control, and more hope. But we know progress cannot happen in isolation – ending new HIV transmissions by 2030 will take national collaboration, shared resources, and sustained investment.” Yeytuo’s approvals this year have been hailed as a momentous step for HIV prevention. Currently, most PrEP therapies require daily oral administration, which often leads to poor adherence. However, the drug’s cost has been a source of concern for accessibility. The US list price for Yeztugo is $28,218 per year for each patient. Gilead has allowed generics of the drug to be manufactured in 120 low- and middle-income countries to ensure that accessibility in areas of high risk is not a challenge, should the drug be approved in these countries. The World Health Organization (WHO) endorsed the use of the PrEP treatment in the fight against HIV earlier this year, citing the drug’s high efficacy, long-acting nature, and improved convenience. WHO director general Dr Tedros Adhanom Ghebreyesus said the shot was the “next best thing” after a vaccine, the latter remaining elusive in pharma so far. The UK approval came alongside Gilead, in addition to eight other pharma companies, reaching a drug pricing deal with the Trump administration . Gilead will reduce the price of its Hepatitis C medication, Epclusa (sofosbuvir/velpatasvir), from $24,920 to $2,425 for patients purchasing directly through TrumpRx. In September, the drugmaker already agreed to deliver Yeztugo for up to two million people in the US as part of a partnership with the US State Department and the US President’s Emergency Plan for AIDS Relief (PEPFAR). GlobalData forecasts that lenacapavir, under all its brand names, will generate $5.3bn in global sales in 2031. GlobalData is the parent company of Pharmaceutical Technology. Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact