Financial Status - Atea Pharmaceuticals, Inc. announced preliminary unaudited cash, cash equivalents, and marketable securities balance as of December 31, 2024[4] - The financial closing procedures for Q4 and full year 2024 are not yet complete, indicating that actual results may vary from the preliminary information[6] - The estimated preliminary financial information has not been audited or reviewed by the independent registered public accounting firm[6]

Core Insights - Atea Pharmaceuticals has successfully completed an End-of-Phase 2 meeting with the FDA and is set to begin patient enrollment for its global Phase 3 program for Hepatitis C Virus (HCV) in April 2025 [1][4][3] - The company aims to evaluate the efficacy of its regimen consisting of bemnifosbuvir and ruzasvir, which has shown promising results in previous trials [3][5] - Atea's strategic initiatives include exploring partnerships to enhance shareholder value and implementing cost-cutting measures to improve operational efficiency [3][12] Company Updates - Atea reported a significant reduction in cash reserves, with cash, cash equivalents, and marketable securities totaling $454.7 million as of December 31, 2024, down from $578.1 million a year earlier [14][23] - Research and development expenses for the fourth quarter and full year 2024 were $25.7 million and $144.1 million, respectively, compared to $35.0 million and $114.2 million in 2023, indicating a strategic shift in spending [15] - The company has appointed Arthur S. Kirsch to its Board of Directors, bringing extensive experience in investment banking and strategic advisory [13] Clinical Development - The Phase 2 study of bemnifosbuvir and ruzasvir met its primary endpoints, achieving a 98% sustained virologic response (SVR12) rate in treatment-adherent patients after eight weeks [8][9] - Atea plans to conduct two open-label Phase 3 trials, one in the US and Canada and another outside North America, each enrolling approximately 800 treatment-naïve patients [5][6] - The primary endpoint for the Phase 3 trials will be SVR12, measured 12 weeks post-treatment, ensuring consistency across patient evaluations [6] Market Context - The global HCV market is estimated to be approximately $3 billion in annual net sales, with around 50 million people living with untreated HCV globally, including up to 4 million in the US [3][26] - Chronic HCV infection remains a leading cause of liver disease, with significant healthcare implications despite the availability of direct-acting antivirals [26][25]

Core Viewpoint - Atea Pharmaceuticals, Inc. is set to host a live conference call on March 6, 2025, to report its financial results for Q4 and the full year of 2024, along with a business update [1]. Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery and development of oral antiviral therapies for serious viral diseases [3]. - The company utilizes a proprietary nucleos(t)ide prodrug platform to develop novel product candidates targeting single-stranded RNA viruses, which are significant causes of serious viral infections [3]. - Atea's lead program focuses on the development of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, aimed at treating Hepatitis C Virus (HCV) [3]. Conference Call Details - Participants can register for the live conference call and access the audio webcast through Atea's Investor Relations website [2]. - The audio webcast will be archived on the company's website for at least 90 days following the event [2].

BOSTON, Feb. 24, 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 the appointment of Arthur S. Kirsch to the Company’s Board of Directors, effective immediately. Mr. Kirsch has decades of experience in investment banking and capital markets, as well as extensive knowledge of the healthcare and life sciences industr ...

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].

On Wednesday, Atea Pharmaceuticals, Inc. AVIR released Phase 2 study data from the regimen of bemnifosbuvir and ruzasvir for the hepatitis C virus infection that causes liver swelling and can lead to serious liver damage.The study met its primary endpoints of safety and sustained virologic response at 12 weeks post-treatment (SVR12).Primary endpoint results demonstrated a 98% (208/213) SVR12 rate in the per-protocol treatment adherent patient population after eight weeks of treatment with a regimen of bemni ...

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 ...