Core Insights - Atea Pharmaceuticals is set to initiate a global Phase 3 program for the bemnifosbuvir and ruzasvir regimen for Hepatitis C virus (HCV) treatment in Q1 2025, aiming to address the significant global healthcare issue posed by HCV, which affects approximately 50 million people worldwide [1][2][3] Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing oral antiviral therapies for serious viral diseases, leveraging a proprietary nucleos(t)ide prodrug platform [12] Market Opportunity - The global HCV market is estimated to be approximately $3 billion in annual net sales, and the bemnifosbuvir and ruzasvir regimen is positioned to disrupt and expand this market if approved [1][3] - US healthcare providers have expressed a high likelihood of prescribing the regimen, indicating strong market potential [3] Clinical Development - The Phase 2 study of the bemnifosbuvir and ruzasvir regimen met its primary endpoints, demonstrating a 98% sustained virologic response (SVR12) rate in treatment-adherent patients after eight weeks [5][6] - Atea plans to conduct two open-label Phase 3 trials, one in the US and Canada and another outside North America, enrolling up to 800 treatment-naïve HCV patients [4] Treatment Profile - The regimen is characterized by its drug potency, short treatment duration, low risk of drug-drug interactions, and no food effect, making it a potentially best-in-class option for HCV treatment [3][9] - Bemnifosbuvir has shown to be approximately 10-fold more active than sofosbuvir against various HCV strains, with a favorable pharmacokinetic profile supporting once-daily dosing [9] Safety and Efficacy - The regimen has been well-tolerated in clinical studies, with no drug-related serious adverse events reported [6][10] - Ruzasvir has demonstrated potent antiviral activity and a favorable safety profile in over 1,500 HCV-infected patients [10]

Core Viewpoint - Atea Pharmaceuticals, Inc. is set to present a business update at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025, highlighting its focus on oral antiviral therapeutics for serious viral diseases [1]. Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing oral antiviral therapies to meet the unmet medical needs of patients with serious viral infections [3]. - The company utilizes a proprietary nucleos(t)ide prodrug platform to develop novel product candidates targeting single-stranded ribonucleic acid (ssRNA) viruses, which are significant contributors to serious viral diseases [3]. - Atea's lead program focuses on the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, aimed at treating Hepatitis C Virus (HCV) [3].

Core Viewpoint - Atea Pharmaceuticals has engaged Evercore to explore strategic partnerships aimed at enhancing shareholder value, particularly for its Phase 3-ready hepatitis C virus treatment program [1]. Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing oral antiviral therapies for serious viral infections, utilizing a proprietary nucleos(t)ide prodrug platform [4]. - The company's lead program targets the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for the treatment of hepatitis C virus [4]. Strategic Review Process - The company has not established a timeline for the conclusion of its strategic review and has not made any decisions regarding potential outcomes [2]. - There is no assurance that the strategic review will lead to any specific transaction or outcome [3].

Core Insights - Atea Pharmaceuticals released Phase 2 study data for bemnifosbuvir and ruzasvir targeting hepatitis C virus, achieving primary endpoints of safety and sustained virologic response at 12 weeks post-treatment (SVR12) [1] Efficacy Results - The study demonstrated a 98% SVR12 rate (208/213) in treatment-adherent patients after eight weeks, while the efficacy evaluable population, including 17% non-adherent patients, achieved a 95% SVR12 rate (242/256) [2] - In a cohort of non-cirrhotic patients infected with genotypes 1-4, 99% (178/179) achieved SVR12, indicating strong pan-genotypic efficacy [4] Safety Profile - The regimen was generally safe and well-tolerated, with no serious drug-related adverse events or treatment discontinuations reported [3] Future Plans - Atea is preparing for a Phase 3 program, which will extend treatment duration to 12 weeks for cirrhotic patients to maximize efficacy, following an End of Phase 2 meeting with the FDA anticipated for early 2025 [5] - The Phase 3 program will utilize a fixed-dose combination tablet, reducing the daily pill count from four to two, enhancing patient convenience [6] Market Reaction - Following the announcement, Atea Pharmaceuticals' stock (AVIR) declined by 9.63%, trading at $3.15 [7]

Core Insights - Atea Pharmaceuticals announced that its Phase 2 study for the treatment of hepatitis C virus (HCV) achieved a primary endpoint with a 98% sustained virologic response at 12 weeks post-treatment after an eight-week regimen [1][2] - The regimen, consisting of bemnifosbuvir and ruzasvir, was found to be generally safe and well-tolerated, with no serious adverse events reported [2][3] - Atea plans to initiate a global Phase 3 program in early 2025, following discussions with regulatory bodies [1][3] Efficacy and Safety - The per-protocol treatment adherent patient population achieved a 98% SVR12 rate (208 out of 213 patients) after eight weeks of treatment [2] - The overall efficacy evaluable population, which included 17% non-adherent patients, achieved a 95% SVR12 rate (242 out of 256 patients) [2] - Among treatment adherent patients who were non-cirrhotic and infected with genotypes 1-4, 99% achieved SVR12 [3] Treatment Population and Duration - The Phase 2 study enrolled 275 treatment-naïve patients, both with and without compensated cirrhosis [5] - Treatment adherent patients with cirrhosis achieved an 88% SVR12 rate [3] - For patients with cirrhosis, the treatment duration in the Phase 3 program will be extended to 12 weeks to maximize efficacy [3] Market Context - The HCV market remains underserved, with annual diagnoses in the U.S. outpacing treatment rates [3] - Less than 10% of the HCV patient population in the U.S. is estimated to have cirrhosis, indicating a significant opportunity for effective treatment options [3][9] Drug Profiles - Bemnifosbuvir has shown to be approximately 10-fold more active than sofosbuvir against various HCV genotypes and has a favorable pharmacokinetic profile supporting once-daily dosing [7] - Ruzasvir has demonstrated potent antiviral activity and a favorable safety profile in clinical studies, also supporting once-daily dosing [8] Future Plans - Atea is preparing for the Phase 3 program, which is expected to utilize a fixed-dose combination tablet to enhance patient convenience [4] - Full data from the Phase 2 study are anticipated to be presented at a scientific meeting in the first half of 2025 [2]

BOSTON, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today presented three poster presentations supporting the combination of bemnifosbuvir and ruzasvir as a potential treatment for hepatitis C virus (HCV). The combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, is in Phase ...

Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) Q3 2024 Results Conference Call November 7, 2024 4:30 PM ET Company Participants Jonae Barnes - SVP of Investor Relations and Corporate Communications Dr. Jean-Pierre Sommadossi - Founder, Chairman and Chief Executive Officer Dr. Janet Hammond - Chief Development Officer John Vavricka - Chief Commercial Officer Dr. Arantxa Horga - Chief Medical Officer Andrea Corcoran - Chief Financial Officer and Executive Vice President of Legal Conference Call Participants Isabell ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-39661 Atea Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) Delaw ...

Exhibit 99.1 Atea Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update Topline SVR12 Results from Global Phase 2 Hepatitis C Virus (HCV) Study (N=275) Expected Q4'24 New Data Supportive of HCV Combination to be Presented at the American Association for the Study of Liver Diseases' (AASLD's) The Liver Meeting 2024 Pharmacokinetic Data for Bemnifosbuvir to be Presented at American College of Pharmacometrics Meeting Conference Call at 4:30 pm ET Today BOSTON, Mass., Novembe ...

Topline SVR12 Results from Global Phase 2 Hepatitis C Virus (HCV) Study (N=275) Expected Q4’24 New Data Supportive of HCV Combination to be Presented at the American Association for the Study of Liver Diseases’ (AASLD’s) The Liver Meeting 2024 Pharmacokinetic Data for Bemnifosbuvir to be Presented at American College of Pharmacometrics Meeting Conference Call at 4:30 pm ET Today BOSTON, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmac ...