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 has initiated the global Phase 3 C-FORWARD trial for the combination regimen of bemnifosbuvir and ruzasvir to treat hepatitis C virus (HCV) [1][2] - The regimen is designed to be a potential best-in-class treatment with a short duration of 8 to 12 weeks and low risk for drug-drug interactions [1][3] - HCV remains a significant global health issue, with approximately 50 million people infected worldwide, including 2.4 to 4 million in the US [2][9] Group 1: Trial Details - The C-FORWARD trial is the second Phase 3 trial, complementing the C-BEYOND trial currently enrolling patients in the US and Canada [1][5] - Each Phase 3 trial aims to enroll around 880 treatment-naïve patients, comparing the fixed-dose combination of bemnifosbuvir and ruzasvir to sofosbuvir and velpatasvir [5] - The primary endpoint for both trials is achieving HCV RNA below the lower limit of quantitation (LLOQ) at 24 weeks, indicating sustained virologic response (SVR12) [6] Group 2: Efficacy and Safety - Results from a Phase 2 study showed a robust 98% SVR12 rate in the treatment-adherent population and 95% in the efficacy evaluable population [7] - Additional Phase 1 studies indicated a low risk of drug-drug interactions and safety in patients co-infected with HIV [8] - Bemnifosbuvir has demonstrated significantly higher potency compared to sofosbuvir, with a 10-fold increase in activity against various HCV genotypes [11] Group 3: Market Context - The evolving patient population for HCV treatment includes many individuals with co-morbidities and complex medical histories, necessitating more accessible treatment options [3] - The current landscape shows a rising burden of untreated HCV, particularly in Europe, mirroring trends in North America [3] - Atea's regimen is positioned to address these challenges by combining high efficacy, short treatment duration, and minimal drug interaction risks [3]

Atea Pharmaceuticals (AVIR) Conference Call Summary Company Overview - **Company**: Atea Pharmaceuticals - **Event Date**: May 14, 2025 - **Focus**: Hepatitis C Virus (HCV) treatment and clinical trial updates Key Points Industry and Market Context - **HCV as a Global Health Issue**: Despite the availability of direct-acting antivirals (DAAs) for over a decade, HCV infections remain high, with an estimated 2.4 to 4 million untreated patients in the US [31][32] - **Market Opportunity**: The US sees approximately 160,000 new infections annually, with only about 100,000 patients treated, resulting in $1.5 billion in net sales from treated patients last year [32][33] - **Healthcare Impact**: 70% of liver cancer cases are due to HCV disease progression, highlighting the need for effective treatment [31] Clinical Trial Updates - **Regimen Overview**: Atea's regimen consists of benifosbuvir and ruzesvir, designed for chronic HCV treatment with a short duration of 8 weeks for non-cirrhotic patients and 12 weeks for those with compensated cirrhosis [5][6] - **Phase Two Results**: The regimen showed a 98% sustained virologic response (SVR12) in the primary endpoint population and 99% in non-cirrhotic patients [17][29] - **Safety Profile**: The regimen was well tolerated, with 43% experiencing mild to moderate adverse events, and no serious adverse events related to the study drug [26][28] Phase Three Clinical Trials - **Trial Design**: Two open-label phase three trials (C Beyond in the US and Canada, C Forward globally) will enroll approximately 880 treatment-naive patients [9][10] - **Comparison**: The trials will compare Atea's regimen to the fixed-dose regimen of sofosbuvir and velpatasvir (Epclusa) [9] Healthcare Provider Insights - **Provider Satisfaction**: Healthcare providers (HCPs) expressed high satisfaction with current treatments but showed a strong preference for Atea's regimen due to its improved profile, including shorter treatment duration and fewer drug-drug interactions [34][39] - **Market Research Findings**: HCPs rated the likelihood of prescribing Atea's regimen highly, indicating a favorable reception among prescribers [39][40] Challenges in HCV Treatment - **Persistent HCV Issues**: The primary route of transmission is through injection drug use, which presents stigma and barriers to treatment [83][84] - **Need for More Options**: Experts emphasized the importance of having more treatment options to personalize care and address the needs of diverse patient populations [76][78] Conclusion - **Regimen Potential**: Atea's regimen is positioned to address significant unmet needs in the HCV market, with a strong clinical profile and positive feedback from healthcare providers, suggesting a substantial market opportunity if the phase three trials are successful [30][41]

[Special Note Regarding Forward-Looking Statements](index=2&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines forward-looking statements regarding the company's business and financial performance, emphasizing their inherent risks and uncertainties - This report contains forward-looking statements concerning the company's business, clinical development timelines, future financial performance, and strategic plans. These statements are based on current beliefs and are not guarantees of future performance[6](index=6&type=chunk) - Forward-looking statements cover clinical trials, product development, financial estimates, and the share repurchase program - Forward-looking statements involve significant risks and uncertainties, with actual results potentially differing materially[7](index=7&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) [Summary Risk Factors](index=4&type=section&id=SUMMARY%20RISK%20FACTORS) This section summarizes key risks: product dependency, limited operating history, regulatory hurdles, and the need for additional financing - The company's business is **highly dependent** on the success of its lead product candidate, the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV[14](index=14&type=chunk) - The company has a **limited operating history**, has incurred significant operating expenses, has **no products generating commercial revenue**, and may **not achieve or maintain profitability**[14](index=14&type=chunk) - Key operational risks include the **lengthy and unpredictable regulatory approval process**, potential for **substantial delays and costs** in clinical trials, and **dependence on third parties** for manufacturing[14](index=14&type=chunk) - Other significant risks include the need for **substantial additional financing**, potential for **intellectual property disputes**, **dependence on key personnel**, and the impact of **unstable market and economic conditions**[14](index=14&type=chunk)[15](index=15&type=chunk) [PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements show a **$34.3 million net loss** for Q1 2025, primarily due to lower R&D, and a strong **$425.4 million liquidity position** [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$439.96 million** as of March 31, 2025, mainly due to marketable securities, with accumulated deficit growing to **$398.49 million** Condensed Consolidated Balance Sheet Data (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $119,394 | $64,696 | | Marketable securities | $306,042 | $390,025 | | **Total Assets** | **$439,964** | **$464,668** | | Total Liabilities | $28,880 | $25,801 | | Accumulated Deficit | ($398,492) | ($364,220) | | **Total Stockholders' Equity** | **$411,084** | **$438,867** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss improved to **$34.27 million** (or **$0.40 per share**) for Q1 2025, driven by a substantial decrease in research and development expenses Statement of Operations Highlights (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $29,584 | $57,575 | | General and administrative | $9,457 | $12,231 | | **Total operating expenses** | **$39,041** | **$69,806** | | **Net loss** | **($34,272)** | **($63,169)** | | Net loss per share | ($0.40) | ($0.75) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to **$30.56 million** in Q1 2025, with cash and cash equivalents increasing to **$119.39 million** by period-end Cash Flow Summary (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($30,563) | ($39,865) | | Net cash provided by investing activities | $85,608 | $56,802 | | Net increase in cash and cash equivalents | $54,698 | $17,087 | | **Cash and cash equivalents at end of period** | **$119,394** | **$160,910** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's focus on its HCV regimen, strong **$425.4 million liquidity**, a **$5.0 million** Merck milestone, and a **$25.0 million** share repurchase program - The company's **lead product candidate** is the regimen of bemnifosbuvir and ruzasvir for the treatment of **HCV**; enrollment in the **Phase 3 program began in April 2025**[28](index=28&type=chunk) - A **$5.0 million milestone payment** to Merck became due in April 2025 upon initiation of the **HCV Phase 3 clinical trial**[71](index=71&type=chunk) - In April 2025, the Board of Directors authorized a **share repurchase program for up to $25.0 million** of its Common Stock[83](index=83&type=chunk) Stock-based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $3,440 | $5,981 | | General and administrative | $3,511 | $6,605 | | **Total** | **$6,951** | **$12,586** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift to its HCV program, highlighting a reduced net loss and a strong **$425.4 million capital position** sufficient through 2027 [Overview](index=21&type=section&id=Overview) The company focuses on its lead **HCV program** (Phase 3 initiated), discontinued its COVID-19 program, and authorized a **$25 million share repurchase** - The company's primary objective is to develop its **HCV regimen** of bemnifosbuvir and ruzasvir as a **differentiated, pan-genotypic, protease inhibitor-free therapeutic**[91](index=91&type=chunk) - The **COVID-19 program was discontinued** after the Phase 3 SUNRISE-3 trial **failed to meet its primary endpoint** in September 2024[100](index=100&type=chunk) - A **workforce reduction of ~25%** in Q1 2025 is expected to generate aggregate **cost savings of approximately $15.0 million** through 2027[102](index=102&type=chunk) - The company engaged Evercore LLC to **explore a broad range of strategic alternatives** to enhance stockholder value, a process which is ongoing[105](index=105&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Q1 2025 R&D expenses decreased by **$28.0 million** and G&A by **$2.8 million**, narrowing net loss to **$34.3 million** from **$63.2 million** Comparison of Results of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $29,584 | $57,575 | ($27,991) | | General and administrative | $9,457 | $12,231 | ($2,774) | | **Net loss** | **($34,272)** | **($63,169)** | **$28,897** | - The decrease in R&D expenses was primarily driven by **lower external spending related to the COVID-19 Phase 3 SUNRISE-3 clinical trial**, which was completed in 2024[126](index=126&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$425.4 million** in liquidity, deemed sufficient to fund operations and the **$25 million** share repurchase through 2027 - The company had cash, cash equivalents, and marketable securities of **$425.4 million** as of March 31, 2025[131](index=131&type=chunk) - Management believes available capital will be **sufficient to fund** the Share Repurchase Program and planned operations **through 2027**[131](index=131&type=chunk) Cash Flow Summary (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($30,563) | ($39,865) | | Net cash provided by investing activities | $85,608 | $56,802 | [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$425.4 million** liquidity, with a 10% rate change not expected to materially impact fair value - The company's main market risk is **interest rate sensitivity** on its **$425.4 million** portfolio of cash, cash equivalents, and marketable securities[150](index=150&type=chunk) - Due to the short-term maturities and low-risk profile of its investments, a **10% change in interest rates is not expected to have a material effect** on the company's financial position[150](index=150&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were **effective** as of March 31, 2025, with no material changes to internal control over financial reporting - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[153](index=153&type=chunk) - There were **no material changes** in the company's internal control over financial reporting during the first quarter of 2025[154](index=154&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the report date, the company is **not subject to any material legal proceedings**[157](index=157&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks: financial, clinical, regulatory, commercialization, third-party reliance, and intellectual property disputes [Risks Related to Financial Condition and Capital Requirements](index=32&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) This section outlines financial vulnerabilities: limited operating history, no commercial revenue, a **$398.5 million** accumulated deficit, and the need for additional financing - The company has a **limited operating history**, no approved products, and an **accumulated deficit of $398.5 million** as of March 31, 2025[159](index=159&type=chunk)[163](index=163&type=chunk) - A **failure to obtain necessary additional capital** could force the company to **delay, limit, reduce, or terminate product development** or commercialization efforts[171](index=171&type=chunk) [Risks Related to Discovery, Development, and Regulatory Approval](index=37&type=section&id=Risks%20Related%20to%20the%20Discovery,%20Development,%20Preclinical%20and%20Clinical%20Testing,%20Manufacturing%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) Success depends on the lead HCV product candidate navigating a lengthy, uncertain clinical and regulatory pathway, with risks including Phase 3 failure and FDA non-approval - The business is **highly dependent** on the **successful development and regulatory approval** of the bemnifosbuvir and ruzasvir regimen for HCV[186](index=186&type=chunk) - The regulatory approval process is **inherently unpredictable**, and the FDA **may not approve the product** or **may grant a limited approval**[193](index=193&type=chunk)[195](index=195&type=chunk) - **Difficulties in enrolling and retaining patients** in clinical trials could **delay development activities** and adversely affect outcomes[220](index=220&type=chunk) [Risks Related to Commercialization](index=59&type=section&id=Risks%20Related%20to%20Commercialization) Commercialization risks include intense competition, challenges in market acceptance, securing favorable pricing and reimbursement, and building sales capabilities - The company faces **intense competition** from established pharmaceutical companies with approved, widely-accepted oral treatments for HCV, such as **Gilead Sciences and AbbVie Inc.**[307](index=307&type=chunk)[310](index=310&type=chunk)[312](index=312&type=chunk) - Commercial success is **heavily dependent on obtaining adequate coverage and reimbursement** from government and private payors, which is uncertain and **subject to pricing pressures**[315](index=315&type=chunk) - The company has **no experience in commercializing a product** and may **not be successful in establishing sales, marketing, and distribution capabilities**, either on its own or through collaborations[321](index=321&type=chunk) [Risks Related to Manufacturing and Dependence on Third Parties](index=65&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20our%20Dependence%20on%20Third%20Parties) The company relies entirely on third-party CMOs and CROs, posing risks to supply continuity and quality, with critical dependence on a sole Chinese supplier - The company **relies on third-party manufacturers (CMOs)** for all clinical trial materials and has **no long-term supply contracts**, increasing supply chain risk[342](index=342&type=chunk)[343](index=343&type=chunk) - There is a **sole supplier in China** for the active pharmaceutical ingredient of ruzasvir, and **all suppliers of regulatory starting materials for both bemnifosbuvir and ruzasvir are located in China**, creating **significant concentration and geopolitical risk**[347](index=347&type=chunk)[350](index=350&type=chunk) - The company is **dependent on third-party CROs** to conduct its clinical trials, and any failure by these parties to perform adequately could **delay or prevent regulatory approval**[355](index=355&type=chunk) [Risks Related to Intellectual Property](index=71&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Intellectual property risks include potential infringement litigation from Gilead Sciences regarding bemnifosbuvir, and challenges to patents abroad - The company's commercial success depends on its ability to **obtain, maintain, and enforce its intellectual property rights**, which is **uncertain**[369](index=369&type=chunk) - **Gilead Sciences** has been issued U.S. patents ('361 and '529) with claims that purport to cover bemnifosbuvir, which could **block commercialization or force the company to seek a license**[380](index=380&type=chunk)[381](index=381&type=chunk)[389](index=389&type=chunk) - The company is facing **Pre-Grant Oppositions in India** challenging its patent applications for AT-511 and bemnifosbuvir, which could **prevent patent issuance** in that market[412](index=412&type=chunk)[415](index=415&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=90&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company conducted no unregistered sales of equity securities and no share repurchases during Q1 2025 - The company **did not repurchase any of its equity securities** during the three months ended March 31, 2025[465](index=465&type=chunk) - There were **no unregistered sales of equity securities** in the period[466](index=466&type=chunk) [Other Information](index=90&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during Q1 2025 - During the three months ended March 31, 2025, **no director or officer adopted or terminated a Rule 10b5-1 trading arrangement**[467](index=467&type=chunk) [Exhibits](index=91&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, material contracts, and officer certifications - A **list of exhibits** filed with the report is provided, including **corporate governance documents, material contracts, and officer certifications**[469](index=469&type=chunk) [Signatures](index=92&type=section&id=SIGNATURES) The quarterly report was duly signed and authorized on May 12, 2025, by the President and CEO, and the CFO - The quarterly report was **duly signed and authorized on May 12, 2025**, by **Jean-Pierre Sommadossi, Ph.D., President and Chief Executive Officer**, and **Andrea Corcoran, Chief Financial Officer**[472](index=472&type=chunk)[474](index=474&type=chunk)

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].

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]