C-FORWARD is the Second Phase 3 Trial in the Global HCV Development Program; the First Phase 3 Trial, C-BEYOND, is Currently Enrolling Patients in the US and Canada Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People Infected, Including up to 4 Million in US BOSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, ...

Core Insights - Atea Pharmaceuticals is advancing its Phase 3 clinical trials for the combination regimen of bemnifosbuvir and ruzasvir for the treatment of hepatitis C virus (HCV), with ongoing patient enrollment in the C-BEYOND trial in the US and Canada, and plans to initiate the C-FORWARD trial globally [4][11][12] - The company reported promising Phase 2 results, indicating a high sustained virologic response (SVR12) rate of 98% among treatment-adherent patients and 95% overall, showcasing the regimen's potential as a best-in-class treatment for HCV [7][11] - Atea's financial results for Q1 2025 show a decrease in research and development expenses to $29.6 million, down from $57.6 million in Q1 2024, attributed to the completion of a previous COVID-19 trial and a focus on HCV development [16][20] Company Updates - Atea is hosting a virtual key opinion leader (KOL) investor event on May 14, 2025, to discuss HCV treatment challenges and the potential of its drug regimen, replacing the traditional earnings call for Q1 2025 [5][6] - The company has engaged Evercore to explore strategic alternatives to enhance shareholder value, including potential partnerships or acquisitions, while also reducing its workforce by approximately 25% to save around $15 million through 2027 [14][15] Financial Performance - As of March 31, 2025, Atea reported cash, cash equivalents, and marketable securities totaling $425.4 million, a decrease from $454.7 million at the end of 2024 [15][22] - The net loss for Q1 2025 was $34.3 million, compared to a net loss of $63.2 million in Q1 2024, reflecting improved operational efficiency [20][22] Clinical Development - The Phase 3 program includes two trials, C-BEYOND and C-FORWARD, each aiming to enroll approximately 880 treatment-naïve patients, comparing the BEM/RZR regimen to the standard sofosbuvir and velpatasvir regimen [11][12] - The primary endpoint for both trials is achieving HCV RNA levels below the lower limit of quantitation at 24 weeks, ensuring consistent evaluation across patient groups [12][13]

Full Results from Phase 2 Study Confirmed 98% Sustained Virologic Response at 12 Weeks Post-Treatment (SVR12) After Short 8-Week Treatment Duration for Regimen Results from Phase 1 Study Showed Low Risk for Drug-Drug Interactions with Regimen When Co-Administered with Standard HIV Treatment Regimen Bemnifosbuvir Was Generally Safe and Well Tolerated with No Dose Adjustment Needed in Phase 1 Studies in Participants with Hepatic or Renal Impairment Atea Pharmaceuticals to Host Virtual HCV KOL Panel on May 14, ...

Panel to Discuss Current Challenges Encountered by Patients with HCV, Results from Atea’s Phase 2 Study of the Regimen of Bemnifosbuvir and Ruzasvir, and What a New Optimized HCV Therapy Could Provide for Prescribers and Patients Event to Replace Atea’s First Quarter 2025 Earnings Conference Call; Quarterly Calls to Resume with Second Quarter 2025 Financial Results BOSTON, May 01, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea” or “Company”), a clinical-stage biopharmaceutical com ...

Core Viewpoint - Atea Pharmaceuticals has appointed Howard H. Berman, Ph.D. to its Board of Directors, enhancing its leadership as it advances its Phase 3 program for hepatitis C treatment [1][2][3] Group 1: Board Appointment and Strategic Agreement - Dr. Berman will initially serve as a non-voting observer and will become a full voting member at the 2025 Annual Meeting [1] - The appointment is part of an agreement with the Radoff-JEC Group, which has withdrawn its director nominations and agreed to support Atea's Board nominees [2][3] - The Radoff-JEC Group expressed confidence in Atea's potential to create significant shareholder value [3] Group 2: Financial Strategies - Atea's Board has authorized a share repurchase program of up to $25 million, reflecting its commitment to returning capital to shareholders while funding its Phase 3 HCV program [5] - The company is engaged in a strategic alternatives process with Evercore to explore opportunities for enhancing shareholder value, including potential partnerships or acquisitions [6][7] Group 3: Company Overview - Atea Pharmaceuticals focuses on developing oral antiviral therapies for serious viral diseases, leveraging its proprietary nucleos(t)ide prodrug platform [9] - The lead program targets the treatment of hepatitis C virus with a regimen of bemnifosbuvir and ruzasvir, which has the potential to disrupt a multi-billion dollar market [2][9]

Core Insights - Atea Pharmaceuticals has initiated a Phase 3 trial, C-BEYOND, for its HCV treatment regimen combining bemnifosbuvir and ruzasvir, which aims to address the significant global health burden of HCV infections [1][3][6] - The trial compares the new regimen to the existing treatment of sofosbuvir and velpatasvir, with a focus on shorter treatment duration and lower risk of drug-drug interactions [1][4][10] Industry Overview - Approximately 50 million people globally are chronically infected with HCV, with 2.4 to 4 million in the US, highlighting the ongoing need for effective therapies [2][3] - Chronic HCV infection is a leading cause of liver cancer in the US, Europe, and Japan, with new infections outpacing treatment rates [2][3][8] Company Developments - The C-BEYOND trial will enroll around 880 treatment-naïve patients, assessing the efficacy of bemnifosbuvir and ruzasvir over 8 to 12 weeks depending on cirrhosis status [4][5] - Atea's previous Phase 2 study demonstrated that the regimen met its primary endpoints of safety and sustained virologic response [6][10] Treatment Regimen Details - Bemnifosbuvir has shown to be approximately 10-fold more active than sofosbuvir against various HCV strains and has a favorable pharmacokinetic profile supporting once-daily dosing [10] - Ruzasvir has demonstrated potent antiviral activity and a favorable safety profile, also supporting once-daily dosing [11]

Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) Q4 2024 Earnings Conference Call March 6, 2025 4:30 PM ET Company Participants Jonae Barnes - Senior Vice President, Investor Relations & Corporate Communications Jean-Pierre Sommadossi - Chief Executive Officer & Founder Janet Hammond - Chief Development Officer Arantxa Horga - Chief Medical Officer Andrea Corcoran - Chief Financial Officer & Executive Vice President, Legal Conference Call Participants Bella Camaj - JPMorgan Andy Hsieh - William Blair Operator Good ...