Atea Pharmaceuticals(AVIR)

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Atea Pharmaceuticals to Host Virtual HCV KOL Panel on May 14, 2025
Globenewswire· 2025-05-01 11:00
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]
Atea Pharmaceuticals(AVIR) - 2025 Q1 - Quarterly Results
2025-05-12 20:23
Board Appointments and Changes - Atea Pharmaceuticals appointed Howard H. Berman as a new Class III Director, effective after the 2025 Annual Meeting[2]. - Franklin Berger will retire from the Board effective immediately after the 2027 Annual Meeting, and will not stand for re-election[5]. - The New Director will be appointed to at least one standing committee of the Board following the 2025 Annual Meeting[6]. - The Company will ensure that the New Director receives the same consideration for committee membership as other independent directors[6]. Radoff/JEC Signatories Restrictions and Commitments - The Radoff/JEC Signatories must maintain a Net Long Position of at least 3.0% of the Company's outstanding common stock to recommend a Replacement Director if the New Director is unable to serve[4]. - The Radoff/JEC Signatories are restricted from acquiring more than 6.0% of the Company's outstanding Voting Securities during the Restricted Period[9]. - The Radoff/JEC Signatories are committed to vote in favor of the Board's nominated directors and against any stockholder nominations not approved by the Board[8]. - The Radoff/JEC Signatories must vote in accordance with the Board's recommendations on all proposals, except in cases where ISS or Glass Lewis recommend otherwise[8]. - The Radoff/JEC Signatories are restricted from making any public announcements regarding business combinations or acquisitions involving the Company during the Restricted Period[10]. - The Radoff/JEC Group is prohibited from engaging in proxy solicitations or making public proposals regarding the Company during the Restricted Period[10]. - The Radoff/JEC Group has agreed to withdraw their nomination of candidates for the 2025 Annual Meeting and will not pursue any further actions related to it[21]. - The Radoff/JEC Signatories will conduct themselves as any other stockholder, with similar rights and access to management and the Board[15]. - The Radoff/JEC Signatories must notify the Company of their beneficial ownership of common stock within five business days of a written request[16]. - During the Restricted Period, neither party shall make public statements that disparage the other party[17][18]. Financial and Legal Agreements - The Company plans to initiate a share repurchase program in accordance with the terms set forth in the Press Release[43]. - The Agreement does not require the approval of the stockholders of the Company[43]. - The Company has not taken any actions related to this Agreement that require disclosure on a Current Report on Form 8-K prior to the date of this Agreement[43]. - The Agreement is governed by the laws of the State of Delaware, with exclusive jurisdiction in the Court of Chancery of Delaware[49]. - Each Party waives the right to a jury trial in any litigation arising out of this Agreement[51]. - The Agreement constitutes the only agreement between the Parties regarding its subject matter, superseding all prior agreements[47]. - The Parties acknowledge that they have been represented by counsel throughout the negotiations leading to the execution of this Agreement[55]. - The Agreement may be executed in one or more counterparts, which shall be treated as one and the same agreement[56]. - All representations and obligations under this Agreement are several, not joint, except among the members of Radoff and JEC collectively[58]. - The agreement will terminate upon the expiration of the Restricted Period unless mutually agreed otherwise in writing[60]. - Certain paragraphs of the agreement will survive termination, including liability for breaches prior to termination[60]. - The Company's obligations will terminate immediately upon breach by any member of the Radoff/JEC Group if not cured within ten business days[60]. - The Radoff/JEC Group's obligations will terminate immediately upon breach by the Company if not cured within ten business days[60]. Communication and Reporting - The Company must provide the Radoff/JEC Signatories with a reasonable opportunity to review and comment on the Form 8-K prior to filing[26]. - The Radoff/JEC Signatories will file an amendment to their Schedule 13D reporting the entry into this Agreement promptly after the press release[27]. - The Company is required to issue a press release regarding this Agreement by April 17, 2025, at 9:00 a.m. Eastern time[24]. - The Radoff/JEC Group is allowed to communicate privately with the Company's Board or officers regarding any matter[13]. - The Radoff/JEC Signatories collectively own 4,880,100 shares of the Company's common stock and have voting authority over these shares[41].
Atea Pharmaceuticals Appoints Howard H. Berman to Board of Directors and Announces Share Repurchase Program
Newsfilter· 2025-04-17 11:00
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]
Atea Pharmaceuticals Announces Dosing of First Patient in C-BEYOND, Phase 3 Study Evaluating Regimen of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus
Newsfilter· 2025-04-09 11:00
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]
Driver Notifies Atea Pharmaceuticals of Withdrawal of Notice of Nomination
GlobeNewswire News Room· 2025-03-31 23:04
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].
Atea Pharmaceuticals Highlights Actions Underway to Enhance Shareholder Value
Globenewswire· 2025-03-26 17:58
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].
Atea Pharmaceuticals Issues Statement Regarding Director Nominations
Globenewswire· 2025-03-21 21:54
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]
Atea Pharmaceuticals Announces Presentation of Bemnifosbuvir Preclinical Data at the 38th International Conference on Antiviral Research (ICAR) 2025
Globenewswire· 2025-03-19 11:00
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].
Atea Pharmaceuticals(AVIR) - 2024 Q4 - Earnings Call Transcript
2025-03-07 04:15
Atea Pharmaceuticals (AVIR) Q4 2024 Earnings Call March 07, 2025 12:15 AM ET Company Participants Jonae Barnes - Senior Vice President of Investor Relations & Corporate CommunicationsJean-Pierre Sommadossi - Founder, Chairman, CEO & PresidentJanet Hammond - Chief Development OfficerArantxa Horga - Chief Medical OfficerAndrea Corcoran - CFO, Executive VP of Legal & Secretary Conference Call Participants Isabella Camaj - Equity Research AnalystAndy Hsieh - Research Analyst Operator Good afternoon, everybody, ...
Atea Pharmaceuticals(AVIR) - 2024 Q4 - Earnings Call Transcript
2025-03-06 23:14
Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) Q4 2024 Earnings Conference Call March 6, 2025 4:30 PM ET Company Participants Jonae Barnes - Senior Vice President, Investor Relations & Corporate Communications Jean-Pierre Sommadossi - Chief Executive Officer & Founder Janet Hammond - Chief Development Officer Arantxa Horga - Chief Medical Officer Andrea Corcoran - Chief Financial Officer & Executive Vice President, Legal Conference Call Participants Bella Camaj - JPMorgan Andy Hsieh - William Blair Operator Good ...