BOSTON, Nov. 19, 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 Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea, together with other members of the Atea management team, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Wednesday, December 3, 202 ...

Financial Data and Key Metrics Changes - At the end of Q3 2025, the company reported approximately $329.3 million in cash, cash equivalents, and marketable securities, providing a runway through 2027 [6][25][28] - R&D expenses increased compared to Q3 2024, primarily due to higher spending in the HCV clinical development program [24] - G&A expenses decreased in Q3 2025 compared to Q3 2024, driven by lower stock-based compensation [24] Business Line Data and Key Metrics Changes - The global phase 3 program for HCV treatment is on track, with patient enrollment for the North American trial expected to complete next month [4][14] - The company is expanding its antiviral hepatitis pipeline to include candidates for hepatitis E, addressing a significant unmet medical need [5][18] Market Data and Key Metrics Changes - The global HCV market is approximately $3 billion in annual net sales, with the company aiming to disrupt and expand this market with its new treatment regimen [28] - The hepatitis E market opportunity could translate into roughly $500 million to $750 million per year or more, given the high incidence of infections [20][21] Company Strategy and Development Direction - The company is focused on completing its phase 3 trials for HCV, which are expected to drive shareholder value and catalyze business development discussions [25][27] - The introduction of a new regimen for HCV treatment is positioned as a potential best-in-class option, with a differentiated profile and a unique dual mechanism of action [12][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong execution of the phase 3 program and the potential for the new treatment to become the most prescribed for hepatitis C [28] - The company highlighted the importance of addressing the unmet needs of immunocompromised patients living with hepatitis E, indicating a strategic expansion of its antiviral pipeline [5][18] Other Important Information - The company completed a share repurchase program, repurchasing $25 million of shares, which were retired and returned to authorized but unissued status [25] - A virtual panel event featuring key opinion leaders in hepatology is scheduled to discuss HCV-related topics, indicating ongoing engagement with the medical community [10][11] Q&A Session Summary Question: How does your recent data set at the liver meeting showing no interaction with famotidine, in addition to your prior data showing no interaction with PPI, increase your differentiation from Epclusa? - Management noted that the contraindication for Epclusa regarding H2-reducing therapy presents a clear problem for patients, making their regimen a significant differentiator [32] Question: There is a chart showing time to undetectable, with genotype three showing a more rapid time to undetectable. Is there any significance in that? - Management confirmed that bemnifosbuvir is more potent against genotype 3, which may relate to the dual mechanism of action [36][37] Question: The compound for hepatitis E does not employ the protide technology. Is that a deliberate decision? - Management clarified that the new candidates utilize a similar prodrug technology as bemnifosbuvir, with a focus on optimizing potency against hepatitis E [39]

Core Insights - Atea Pharmaceuticals is advancing its global Phase 3 clinical program for the treatment of Hepatitis C Virus (HCV) with a combination regimen of bemnifosbuvir and ruzasvir, expecting topline results from the North American trial by mid-2026 [1][3][6] - New data presented at The Liver Meeting 2025 supports the antiviral potency and unique dual mechanism of action of bemnifosbuvir against HCV, positioning it as a potential best-in-class therapy [1][4][8] - The company is also expanding its antiviral pipeline with a new Hepatitis E Virus (HEV) development program, addressing unmet medical needs in immunocompromised patients [1][5][10] Patient Enrollment and Trials - Patient enrollment for the C-BEYOND trial in the US and Canada is on track to be completed by the end of 2025, while the C-FORWARD trial outside North America is expected to finish enrollment by mid-2026 [3][12] - Each Phase 3 trial is enrolling approximately 880 treatment-naïve patients, comparing the bemnifosbuvir and ruzasvir regimen to the existing regimen of sofosbuvir and velpatasvir [12][13] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $329.3 million, a decrease from $454.7 million at the end of 2024 [19][29] - Research and development expenses increased by $12.2 million year-over-year, primarily due to external spending related to the HCV Phase 3 clinical development program [20] Mechanism of Action - Bemnifosbuvir exhibits a unique dual mechanism of action against HCV, inhibiting both HCV RNA replication and the assembly/secretion of new virions, which enhances its antiviral efficacy [7][8] - The combination regimen of bemnifosbuvir and ruzasvir is designed to suppress the virus at multiple critical stages, potentially leading to a shorter treatment duration of approximately 7 to 8 weeks [14] Upcoming Events - Atea will host a virtual event on November 13, 2025, featuring leading HCV clinical experts discussing current challenges in HCV treatment and the potential benefits of next-generation therapies [16][17]

Core Viewpoint - Atea Pharmaceuticals, Inc. will host a live conference call on November 12, 2025, to report its third-quarter financial results and provide a business update [1]. Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing oral antiviral therapies for serious viral infections [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 diseases [3]. - Atea's lead program includes bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, aimed at treating Hepatitis C Virus (HCV) [3]. Conference Call Details - The conference call will take place at 4:30 p.m. ET on November 12, 2025, and will be accessible via registration or through the company's website [2]. - Participants can join the call by dialing specific telephone numbers and using a designated conference ID [2]. - An archive of the audio webcast will be available on the company's website approximately two hours after the call and will remain accessible for at least 90 days [2].

Core Insights - Atea Pharmaceuticals is hosting a virtual key opinion leader (KOL) event on November 13, 2025, to discuss hepatitis C virus (HCV) topics, including patient demographics, early diagnosis, treatment importance, public policy, and potential new therapies [1][2] Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing oral antiviral therapeutics for serious viral diseases, particularly HCV [16] - The company is advancing a global Phase 3 clinical development program for its lead regimen, bemnifosbuvir and ruzasvir, which targets HCV [2][9] Clinical Development - The Phase 3 program includes two trials: C-BEYOND in the US and Canada, and C-FORWARD outside North America, each enrolling approximately 880 treatment-naïve patients [9] - The trials compare the fixed-dose combination of bemnifosbuvir and ruzasvir to the existing regimen of sofosbuvir and velpatasvir, with treatment durations of 8 to 12 weeks depending on cirrhosis status [9][10] Efficacy and Safety - Phase 2 study results indicated a 98% sustained virologic response (SVR12) rate for the bemnifosbuvir and ruzasvir regimen in treatment-adherent patients [12] - The combination has shown a low risk of drug-drug interactions and can be taken with or without food, making it suitable for co-infected patients [13] Market Opportunity - The KOL event will also cover the commercial market opportunity for HCV treatments and the potential impact of Atea's therapies on prescribers and patients [2] - HCV remains a significant global health issue, with an estimated 50 million people chronically infected worldwide and 240,000 deaths annually [11] Key Opinion Leaders - The event will feature prominent HCV experts, including Dr. Jordan Feld, Dr. Eric Lawitz, Dr. Anthony Martinez, and Dr. Nancy Reau, who will provide insights into HCV management and research [3][4][5][8]

Core Insights - Atea Pharmaceuticals announced new data supporting the combination regimen of bemnifosbuvir and ruzasvir as a potential best-in-class treatment for hepatitis C (HCV) at The Liver Meeting 2025 [1][2] - The company is advancing its global Phase 3 program, with patient enrollment ongoing, and is optimistic about reshaping the standard of care for HCV [2][8] Clinical Data and Presentations - Three abstracts will be presented at The Liver Meeting 2025, including results from a Phase 2 study and a Phase 1 study on the fixed-dose combination [1][2] - The Phase 2 study showed a 98% sustained virologic response (SVR12) in the treatment-adherent population and a 95% SVR12 in the efficacy evaluable population [4][5] - The combination regimen demonstrated high relative bioavailability and can be dosed without regard to food [4][5] Ongoing Trials - Atea's Phase 3 development program includes two trials: C-BEYOND in the US and Canada, and C-FORWARD outside North America, each enrolling approximately 880 treatment-naïve patients [9][10] - The primary endpoint for these trials is HCV RNA below the lower limit of quantitation at 24 weeks, ensuring consistent measurement across all patients [10] Market Context and Challenges - HCV remains a significant global healthcare issue, with approximately 50 million people chronically infected worldwide and an estimated 240,000 deaths annually [11] - In the US, between 2.4 and 4 million people are estimated to have HCV, with new infections outpacing treatment rates [11] Drug Profile - Bemnifosbuvir has shown to be approximately 10-fold more active than sofosbuvir against various HCV genotypes and has a favorable safety profile [12] - Ruzasvir has demonstrated potent antiviral activity and a favorable safety profile in clinical studies [12] Upcoming Events - Atea will host a virtual key opinion leader (KOL) investor event on November 13, 2025, to discuss the HCV commercial market opportunity and ongoing clinical development [6][8]

Company Overview - Atea Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing oral antiviral therapies for serious viral diseases [3] - The company has developed a proprietary nucleos(t)ide prodrug platform aimed at treating single-stranded ribonucleic acid (ssRNA) viruses, which are a significant cause of serious viral infections [3] - Atea's lead program is in global Phase 3 development, focusing on a combination regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, specifically targeting Hepatitis C Virus (HCV) [3] Upcoming Events - Members of Atea's management team will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 1:05 p.m. ET in New York [1] - A live webcast of the presentation will be available on the company's website, with an archived version accessible for at least 90 days following the event [2]

Core Viewpoint - Atea Pharmaceuticals, Inc. will host a live conference call on August 7, 2025, to report its financial results for Q2 2025 and provide a business update [1]. Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing 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 [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]. Conference Call Details - The conference call will take place at 4:30 p.m. ET on August 7, 2025, and will be accessible via telephone or through an audio webcast on the company's website [2]. - Participants can register for the call and access an archive of the audio webcast approximately two hours after the event, which will remain available for at least 90 days [2].

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 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]