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member at the 2025 Annual Meeting [1] - The appointment is part of an agreement with the Radoff-JEC Group, which has withdrawn its director nominations and agreed to support Atea's Board nominees [2][3] - The Radoff-JEC Group expressed confidence in Atea's potential to create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].

Financial Data and Key Metrics Changes - In 2024, R&D expenses declined quarter over quarter but increased year over year, primarily due to higher external spending related to the COVID-19 phase three Sunrise-3 trial and the phase two HCV trial [34] - Interest income decreased quarter over quarter and year over year due to lower investment balances [35] - As of December 31, 2024, the company had $454.7 million in cash, cash equivalents, and marketable securities, projecting a cash runway into 2028 [11][36] Business Line Data and Key Metrics Changes - The global phase two trial for the HCV program demonstrated a 98% cure rate in the primary efficacy analysis with an eight-week treatment [7] - The regimen of bemnifosbuvir and ruzasvir is expected to disrupt the global HCV market, which approximates $3 billion in annual net sales [8][15] Market Data and Key Metrics Changes - In the United States, there are between 2.4 to 4 million untreated HCV patients, with only approximately 100,000 patients treated out of 160,000 new infections annually [13][14] - Treated patients in the U.S. resulted in approximately $1.5 billion in net sales last year [15] Company Strategy and Development Direction - The company is initiating a global phase three program for the HCV regimen, with enrollment expected to begin next month [10] - The company has retained Evercore to assist in exploring strategic partnerships related to the phase three HCV program [9] - A workforce reduction of approximately 20-25% was announced to enhance efficiency, expected to result in cost savings of approximately $15 million through 2027 [37] Management's Comments on Operating Environment and Future Outlook - Management believes the global phase three HCV program is de-risked with a compelling value proposition based on substantial preclinical and clinical data [39] - The company aims to become the most prescribed treatment for hepatitis C, potentially disrupting a multibillion-dollar market [40] Other Important Information - The company appointed Arthur Kirsch as a new independent director, bringing extensive financial and strategic advisory experience to the board [9][37] Q&A Session Summary Question: Any specific callouts from the FDA meeting regarding phase three trial design? - Management indicated that the FDA is fully aligned with the approach of conducting two open-label phase three trials and did not have substantive comments on the trial conduct [46][47] Question: What can be expected in terms of the scope of the phase two readout later this half? - Additional data regarding efficacy and safety is expected to be presented at EASL in May [49] Question: Estimated number of cirrhotic patients across the two trials? - Management anticipates enrolling just over 10% cirrhotic patients in the trials, with flexibility in adjusting that number based on enrollment [55][58] Question: How does the modeling compare to Epclusa in the non-cirrhotic population? - The model has been developed by Dr. Alan Perelson, and comparisons with other direct-acting antivirals for HCV can be referenced in their publications [60]

Financial Data and Key Metrics Changes - In 2024, R&D expenses declined quarter over quarter but increased year over year, primarily due to higher external spending related to the COVID-19 phase three Sunrise-3 trial and the phase two HCV trial [34] - Interest income decreased quarter over quarter and year over year due to lower investment balances [35] - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities of $454.7 million, projecting a cash runway into 2028 [11][36] Business Line Data and Key Metrics Changes - The company made significant progress in its HCV program, reporting a 98% cure rate in the primary efficacy analysis from a global phase two trial with an eight-week treatment regimen [7][28] - The phase two trial included 275 treatment-naive patients, achieving a 98% SVR12 rate in adherent patients and a 95% rate regardless of adherence [27] Market Data and Key Metrics Changes - The global HCV market is approximately $3 billion in annual net sales, with a significant number of untreated HCV patients in the U.S. estimated between 2.4 to 4 million [8][13] - In the U.S., approximately 100,000 out of 160,000 new infections are treated annually, resulting in about $1.5 billion in net sales from treated patients [15] Company Strategy and Development Direction - The company is initiating a global phase three program for its HCV regimen, expecting enrollment to begin next month, with a focus on becoming a best-in-class hepatitis C treatment [10][39] - The company has retained Evercore to assist in exploring strategic partnerships related to its phase three HCV program and has taken cost-cutting actions to enhance efficiency [9] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing high rate of HCV infections and the need for new differentiated therapies, highlighting the potential for their regimen to address this healthcare issue [12][14] - The company believes its regimen, if approved, could disrupt the global HCV market and become the most prescribed treatment [40] Other Important Information - The company announced a workforce reduction of approximately 20-25% to enhance efficiency, expected to result in cost savings of about $15 million through 2027 [37] - Arthur Kirsch was appointed as a new independent director, bringing extensive financial and strategic advisory experience to the board [9][37] Q&A Session Summary Question: Any specific callouts from the FDA meeting regarding phase three trial design? - Management indicated that the FDA is fully aligned with their approach of conducting two open-label phase three trials and did not have substantive comments on the trial conduct [46][47] Question: What can be expected in terms of the scope of the phase two readout later this half? - Management expects to present additional data regarding efficacy and safety at the EASL conference in May [49] Question: Estimated number of cirrhotic patients across the two trials? - Management anticipates enrolling just over 10% cirrhotic patients in the trials, with flexibility in adjusting this number based on enrollment [55][58] Question: How does the modeling compare to Epclusa in the non-cirrhotic population? - Management referred to the model developed by Dr. Alan Perelson and suggested checking their publications for comparisons with other direct-acting antivirals [60]

Financial Performance - For the years ended December 31, 2024 and 2023, the company's operating expenses were $192.9 million and $164.2 million, respectively, with an accumulated deficit of $364.2 million as of December 31, 2024[253]. - The company incurred a net loss of $168.4 million for the year ended December 31, 2024, and does not expect to generate product revenue for at least the next few years[265]. - The company has not generated any revenue from product sales and relies heavily on future financing to support ongoing operations[265]. - The company anticipates continued operating losses for the foreseeable future as it seeks to develop and commercialize its product candidates[259]. - As of December 31, 2024, the company had US federal net operating loss carryforwards (NOLs) of $63.3 million and state NOLs of $98.7 million[269]. Clinical Development Challenges - The SUNRISE-3 Phase 3 clinical trial for bemnifosbuvir did not meet its primary endpoint, leading to the discontinuation of its development for COVID-19[249]. - The company has not successfully completed the development of any product candidates and currently has no products approved for commercial sale[275]. - The company discontinued the development of bemnifosbuvir for COVID-19 treatment after the SUNRISE-3 Phase 3 clinical trial failed to reach its primary endpoint in September 2024[273]. - The regulatory approval processes for the company's product candidates are lengthy and unpredictable, which may hinder the ability to generate product revenue[281]. - The company has not submitted a New Drug Application (NDA) for any product candidate, and must complete additional studies to demonstrate safety and efficacy before obtaining regulatory approvals[284]. - The company faces risks related to the manufacturing processes and regulatory approvals, which could delay or prevent the initiation of clinical trials[289]. - The company has not successfully concluded any late-stage clinical trials for its product candidates, raising uncertainty about future clinical trial timelines[288]. - The company may encounter substantial delays and costs in clinical trials, which could adversely affect its ability to commercialize product candidates[287]. - The company is currently conducting Phase 3 clinical trials for bemnifosbuvir and ruzasvir for HCV treatment, with potential delays impacting costs and revenue generation[292]. - Changes in manufacturing or formulation may necessitate additional studies, risking delays in clinical trials and potential loss of market exclusivity[293]. - Conducting clinical trials in foreign countries introduces risks such as patient adherence issues and regulatory complexities, which may delay trial completion[295]. - Delays in clinical trials could lead to increased costs and jeopardize the ability to commence product sales, significantly affecting the company's financial condition[296]. - The EU's new Clinical Trials Regulation (CTR) requires compliance for clinical trial applications, with potential impacts on development plans if not adhered to[297]. - The UK is proposing new regulations for clinical trials that may differ from the EU's approach, potentially affecting trial costs and timelines[299]. - The company is developing combination therapies, which pose additional clinical risks and may affect the approval and marketability of product candidates[301]. - Serious adverse events during trials could halt development and regulatory approval, significantly harming the company's business prospects[305]. - Patient enrollment challenges may delay clinical trials, impacting the timeline for seeking regulatory approval and commercialization[310]. - The FDA's acceptance of foreign clinical trial data is uncertain, which could necessitate additional trials and delay product approvals[319]. - The company may face significant risks if interim or preliminary data from clinical trials differ from final results, potentially harming business prospects[321]. Regulatory and Compliance Risks - The company has not received marketing approval for any product candidates from regulatory authorities in any jurisdiction, which may hinder commercialization efforts[337]. - The marketing approval process is expensive, time-consuming, and uncertain, with potential delays due to regulatory changes or additional required studies[338]. - The company may seek FDA approval through the accelerated approval pathway, but there is no assurance that such applications will be accepted or granted in a timely manner[336]. - Regulatory requirements vary significantly across countries, which could delay or prevent the introduction of products in international markets[342]. - The company may have to conduct additional preclinical studies or clinical trials if it fails to obtain accelerated approval, increasing development costs[330]. - The company may not successfully develop additional product candidates, adversely impacting its business strategy and financial position[326]. - The company’s ability to commercialize product candidates may be harmed if regulatory authorities disagree with its data interpretations or conclusions[322]. - The company focuses on developing product candidates for serious viral diseases, but market acceptance is uncertain and may affect revenue generation[344]. - The potential market for product candidates may be smaller than estimated, impacting business and financial conditions[345]. - Disruptions at the FDA and foreign regulatory authorities due to funding shortages or global health concerns could delay product approvals[346]. - Regulatory compliance is costly and complex, with potential delays in approval processes if requirements are not met[362]. - Legislative changes, such as the Affordable Care Act, may increase costs and complicate the commercialization of product candidates[365]. - The FDA and other regulatory agencies enforce laws prohibiting off-label promotion, with significant liability risks for violations[379]. - Compliance with healthcare laws and regulations may involve substantial costs, and violations could lead to severe penalties, including exclusion from government-funded healthcare programs[382]. - Compliance with the California Consumer Privacy Act (CCPA) requires businesses to provide disclosures, respond to access requests, and enter into specific contracts with service providers, potentially increasing compliance costs[383]. - The EU General Data Protection Regulation (GDPR) imposes fines of up to €20 million or 4% of annual global revenue for noncompliance, creating significant financial risks[385]. - The UK GDPR allows for fines of up to £17.5 million or 4% of global annual revenue for noncompliance, adding to the regulatory burden[387]. - The company faces potential liability related to the privacy of health information obtained from clinical trials, which could result in substantial criminal penalties under HIPAA if not properly managed[390]. - Increased scrutiny from data protection authorities may lead to additional compliance costs and operational challenges, particularly in international markets[385]. - The company may incur significant expenses to ensure ongoing compliance with privacy and data security laws, impacting financial resources[393]. Market and Competitive Landscape - Competition in the pharmaceutical industry is intense, with established products posing a threat to the market acceptance of new product candidates[403]. - The company anticipates facing competition from well-established antiviral HCV products, which may hinder market acceptance of its own HCV product candidate[403]. - Regulatory actions due to noncompliance could adversely affect the company's ability to develop and commercialize product candidates, impacting sales and increasing costs[394]. - The use of social media by employees poses risks of regulatory violations and reputational damage, which could materially affect the company's financial condition[398]. - Competitors have greater capital resources and established market presence, which may hinder the company's ability to maintain market share and achieve product commercialization[404]. - The successful commercialization of product candidates depends on obtaining adequate insurance coverage and reimbursement levels from governmental authorities and health insurers[407]. - There is significant uncertainty regarding insurance coverage and reimbursement for newly approved products, which is essential for patient affordability[408]. - Third-party payors may challenge prices and refuse coverage for drugs when cheaper alternatives are available, impacting the company's ability to generate revenue[409]. Strategic Partnerships and Commercialization - The company is exploring potential strategic partnerships related to its product candidates, but there is no assurance of favorable outcomes[264]. - The company anticipates establishing its own commercial organization in the US for its HCV product candidate, relying on collaborators for international markets[416]. - The company faces risks in building sales and marketing capabilities, including recruiting qualified personnel and managing a geographically dispersed team[417]. - Future growth may depend on the company's ability to penetrate foreign markets, which involves additional regulatory burdens and uncertainties[423]. - The company plans to selectively partner with third parties for marketing product candidates outside the US, facing challenges in compliance with foreign regulations[428]. - The company must navigate complex foreign regulatory requirements and potential political risks in international operations[429]. - The need to identify strong partners for commercialization outside the US poses a risk to the company's financial performance[430]. Supply Chain and Manufacturing Risks - The company relies on a sole supplier in China for the active pharmaceutical ingredient of ruzasvir, which poses a risk of production disruption due to various factors such as natural disasters or trade disruptions[438]. - The company does not have long-term supply agreements with critical suppliers for its product candidates, which could adversely affect development and commercialization efforts if a supplier is lost[442]. - The company currently has clinical trial insurance but lacks product liability insurance for commercialized products, exposing it to potential substantial liabilities[433]. - The company faces risks related to third-party manufacturers, including the inability to meet production schedules or comply with regulatory requirements, which could delay clinical trials and commercialization[440]. - Changes in U.S. trade policies and tariffs may impact the cost and availability of materials sourced from China, affecting the company's operations and financial performance[437]. - The company has not established multiple sources of supply for all components used in its product candidates, increasing vulnerability to supply chain disruptions[443]. - Regulatory inspections of manufacturing suppliers are required for marketing approval, and failure to pass these inspections could delay product approvals[445]. - The company may incur significant costs and delays if it needs to switch suppliers or redesign manufacturing processes due to supplier issues[444]. - The reliance on third-party manufacturers without long-term contracts increases the risk of supply shortages or quality issues, which could materially affect development efforts[434]. - The company may face challenges in scaling up manufacturing to meet clinical and commercial needs, which could hinder the advancement of its product candidates[440].