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]

Core Insights - Atea Pharmaceuticals presented results from its Phase 2 study of bemnifosbuvir (BEM) and ruzasvir (RZR) for hepatitis C treatment, achieving a 98% sustained virologic response rate at 12 weeks post-treatment with an 8-week regimen [2][5][8] - The study demonstrated the regimen's safety, low risk of drug-drug interactions, and effectiveness in patients with hepatic or renal impairment [3][9][12] Phase 2 Study Results - The Phase 2 study included 275 patients, showing a 98% SVR12 in treatment-adherent patients and 95% in all patients regardless of adherence [2][8] - Among patients with compensated cirrhosis, the SVR12 rate was 88%, with all achieving undetectable viral levels by the end of the 8-week treatment [6][8] Safety and Tolerability - The combination of BEM and RZR was generally safe and well-tolerated, with treatment-emergent adverse events reported in 43% of patients, mostly mild to moderate [8] - No serious adverse events or treatment discontinuations were linked to the study drugs [8] Drug-Drug Interaction Studies - Phase 1 studies indicated a low risk of drug-drug interactions when BEM/RZR was co-administered with standard HIV treatments [3][10] - BEM was found to be safe for patients with hepatic and renal impairments without the need for dose adjustments [9][12] Future Developments - Atea plans to conduct two Phase 3 trials, C-BEYOND and C-FORWARD, to further evaluate the BEM/RZR regimen against existing treatments [16][18] - The primary endpoint for these trials is achieving HCV RNA levels below the lower limit of quantitation at 24 weeks [17] Market Context - An estimated 2.4 to 4.0 million people in the US are living with chronic HCV, with a significant portion also taking concomitant medications [7][15] - The ongoing need for effective HCV treatments is underscored by the fact that annual diagnoses outpace cure rates [7][15]

Core Insights - Atea Pharmaceuticals is hosting a virtual panel discussion on May 14, 2025, focusing on the treatment challenges of hepatitis C virus (HCV) and the results from its Phase 2 study of bemnifosbuvir and ruzasvir [1][2] - The company will not hold a first quarter 2025 earnings conference call, resuming quarterly calls with the second quarter 2025 financial results [1] Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing oral antiviral therapies for serious viral diseases, particularly focusing on HCV [15] - The company is advancing its lead program, which involves a regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for HCV treatment [15] HCV Treatment Insights - The panel will include key opinion leaders (KOLs) from various medical fields who will discuss current patient challenges, the Phase 2 study results, and the potential benefits of optimized HCV therapies [2] - Atea is conducting two open-label Phase 3 trials, C-BEYOND and C-FORWARD, to evaluate the efficacy of the bemnifosbuvir and ruzasvir regimen compared to existing treatments [13][14] HCV Market Context - HCV remains a significant global health issue, with an estimated 50 million people chronically infected worldwide and approximately one million new infections annually [12] - In the US, between 2.4 and 4 million people are estimated to have HCV, with new infections outpacing treatment rates [12]

BOSTON, April 23, 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 that the full results from the Phase 2 clinical study of Atea's regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for the treatment of hepatitis C virus (HCV) infection will be presented at the Europ ...

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]

Core Viewpoint - Change in the composition of Atea Pharmaceuticals' Board is urgently needed to prioritize stockholder interests over management and directors' interests [1][6]. Board Composition and Nomination - Driver Management Company has withdrawn its nomination notice to support the Radoff-JEC Group's nominees for the Board [1][7]. - The Radoff-JEC Group intends to nominate three candidates for election to the Board at the 2025 annual meeting [7]. Financial Context - Atea's stock was offered at $5.75 per share by Tang Capital Partners, while the last trading price before the offer was $3.70 [4]. - The Board unanimously rejected the Tang Proposal, claiming it undervalued the company, despite the current stock price being $2.93 [4][5]. - The average compensation for Atea's directors in 2023 was $333,099, and the CEO's total compensation was $5,925,790 [5]. Concerns Raised - Driver expressed concerns that the Board's rejection of the Tang Proposal was not aligned with stockholder interests but rather favored management and directors [5][6]. - The Board's inability to justify its rejection of the Tang Proposal based on stockholder value is troubling [5]. Support for Radoff-JEC Group - Driver believes that the Radoff-JEC Group's nominees will better evaluate strategic opportunities in the interest of stockholders [8].

Core Viewpoint - Atea Pharmaceuticals is actively taking steps to enhance shareholder value through strategic actions, including cost reductions and engagement with shareholders [1][6]. Group 1: Shareholder Engagement and Governance - The Atea Board of Directors is committed to engaging in constructive dialogue with shareholders, including Mr. Radoff and Mr. Torok, to ensure actions align with shareholder interests [1]. - The Nominating and Corporate Governance Committee will evaluate director candidates nominated by shareholders and will provide formal recommendations in the definitive proxy statement for the 2025 Annual Meeting [2]. Group 2: Strategic Actions and Financial Advisory - Atea has engaged an independent global investment bank to explore strategic opportunities, particularly related to its Phase 3 program for hepatitis C virus (HCV) treatment [6]. - The company has appointed Arthur S. Kirsch as an independent director, bringing valuable experience in healthcare and life sciences [6]. Group 3: Cost Management - Atea has reduced its workforce by approximately 25% in the first quarter of 2025, expecting to achieve cost savings of around $15 million through 2027 [6]. Group 4: Company Overview - Atea Pharmaceuticals is focused on developing oral antiviral therapies for serious viral infections, utilizing a proprietary nucleos(t)ide prodrug platform to address unmet medical needs [4]. - The company's lead program targets the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C virus [4].

Core Viewpoint - Atea Pharmaceuticals has received a notice from Bradley L. Radoff regarding his intention to nominate three director candidates for election to the Board of Directors at the upcoming 2025 Annual Meeting of Stockholders [1][2] Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery and development of oral antiviral therapeutics for serious viral diseases [4] - The company has developed a proprietary nucleos(t)ide prodrug platform aimed at treating single-stranded ribonucleic acid (ssRNA) viruses, which are significant causes of serious viral diseases [4] - Atea's lead program focuses on the development of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, specifically targeting Hepatitis C Virus (HCV) [4] Shareholder Engagement - The Atea Board of Directors and management maintain regular communication with shareholders and continuously evaluate strategies to enhance shareholder value [2] - The Nominating and Corporate Governance Committee will assess the director candidates in line with established practices, with formal recommendations to be included in the definitive proxy statement [2] Proxy Statement and Meeting Information - Atea plans to file a definitive proxy statement with the SEC, which will include a WHITE proxy card for the solicitation of proxies for the 2025 Annual Meeting of Stockholders [6] - The date for the 2025 Annual Meeting has not yet been scheduled, and shareholders are not required to take any action at this time [2]

Core Viewpoint - Atea Pharmaceuticals is advancing its clinical-stage antiviral drug bemnifosbuvir for the treatment of hepatitis C virus (HCV), with a Phase 3 program set to begin patient enrollment in April 2025, following positive Phase 2 results [1][4][5]. Group 1: Drug Development and Presentation - Atea presented preclinical data on bemnifosbuvir at the 38th International Conference on Antiviral Research, emphasizing the importance of cell model selection in evaluating antiviral efficacy [2][3]. - Bemnifosbuvir is being developed in combination with ruzasvir, a potent NS5A inhibitor, targeting chronic HCV infection [2][3]. Group 2: Phase 3 Program Details - The global Phase 3 program will include two open-label trials, one in the US and Canada and another outside North America, each enrolling approximately 800 treatment-naïve patients [5]. - The primary endpoint for both trials is sustained virologic response 12 weeks post-treatment (SVR12), with specific comparisons between the bemnifosbuvir/ruzavir regimen and existing treatments [6]. Group 3: Drug Efficacy and Safety - In vitro studies indicate that bemnifosbuvir is approximately 10-fold more active than sofosbuvir against various HCV strains and maintains potency against resistance-associated substitutions [7]. - Ruzasvir has shown potent antiviral activity and a favorable safety profile in clinical studies, supporting once-daily dosing [8]. Group 4: HCV Overview - HCV is a significant global health issue, with an estimated 50 million people chronically infected worldwide and approximately 242,000 deaths annually [9]. - In the US, between 2.4 and 4 million people are estimated to have HCV, with a predominance in the 20-49 age group and less than 10% having cirrhosis [9]. Group 5: Company Background - Atea Pharmaceuticals focuses on developing oral antiviral therapies for serious viral infections, leveraging its expertise in antiviral drug development and nucleos(t)ide chemistry [10].