BOSTON, Oct. 07, 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 new data will be presented supporting the combination regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor and ruzasvir, an NS5A inhibitor, as a potential best-in-class regimen for the treatment of hepatitis C (HCV) infection at Th ...

Group 1 - The presentation is led by Maxwell Skor, an equity analyst from Morgan Stanley, indicating a focus on financial analysis and investment insights [1] - The introduction of the Atea team suggests a collaborative effort to present the company's story and value proposition to the audience [1] - The mention of a disclosure highlights the importance of transparency and compliance in financial communications [1]

Group 1 - The presentation is led by Maxwell Skor, an equity analyst from Morgan Stanley, who introduces the Atea team to the audience [1] - The purpose of the introduction is to familiarize the audience with the Atea story, particularly for those who may not be well-acquainted with the company [1]

Atea Pharmaceuticals FY Conference Summary Company Overview - Atea Pharmaceuticals is a biotech company based in Boston focusing on a nucleoside platform for treating serious viral diseases, currently in phase 3 trials for its nucleoside analog, bemnifosbuvir, targeting hepatitis C [2][5] Core Scientific Rationale - Direct-acting antivirals for hepatitis C were approved about 10 years ago, with over 50 million people still infected globally, including 2.4 to 4 million in the U.S. [3] - The patient demographic has shifted to younger populations (30s and 40s), who are more medically complex, with approximately 80% on concomitant medications [3][4] - Atea's regimen aims to improve treatment adherence and minimize drug-drug interactions, aligning with WHO's goal to eradicate hepatitis C by 2030 [4] Clinical Trial Insights - Two ongoing phase 3 trials: CBYOND in North America and C4WRD globally, focusing on an eight-week treatment regimen for non-cirrhotic patients [18][19] - Phase 2 trial results showed a 98% cure rate overall, with 100% in non-cirrhotics, and 95% in non-compliant patients [11][12] - The regimen is designed to be potent, with no food effects and minimal drug-drug interactions, making it suitable for a broad patient population [6][12] Market Research Findings - A market study indicated that 76% of high-prescribing doctors are likely to prescribe bemnifosbuvir, with a preference for its potency and short treatment duration [8][10] - Doctors expressed a need for alternatives to current treatments, highlighting the appeal of Atea's regimen [9][10] Regulatory and Competitive Landscape - Atea's intellectual property extends to 2042, while competitors Epclusa and Mavyret have patent protection until 2034 [26][28] - The FDA has provided positive feedback on trial designs, emphasizing the importance of drug-drug interaction profiles and treatment duration [21][24] Financial Position and Capital Allocation - Atea reported a cash balance of $379 million, sufficient to fund the phase 3 program, estimated to cost around $200 million [36][41] - The company is focused on strategic partnerships post-phase 3 results to maximize asset value [42][43] Patient Demographics and Treatment Dynamics - The U.S. treatment landscape shows a static number of patients treated annually, with increasing incidence rates [30] - Government initiatives are underway to address hepatitis C treatment, including a proposed $10 billion bill targeting high-risk populations [31][32] Future Outlook - Upcoming milestones include phase 3 trial results expected in mid-2026, with additional presentations at major conferences [44] - Atea aims to leverage its unique position in the market to address unmet needs in hepatitis C treatment [46] Additional Considerations - Atea is exploring AI for early discovery activities while maintaining traditional methods [48] - The company believes its U.S. manufacturing capabilities provide a competitive advantage in the evolving regulatory landscape [50]

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 reported its Q2 2025 results, highlighting improved cost controls and progress in its Phase 3 clinical program for hepatitis C, while facing risks from competition and lack of near-term revenue [1][4]. Financial Performance - The company reported a GAAP net loss per share of $0.44 for Q2 2025, better than the consensus estimate of a loss of $0.42 and the prior year's loss of $0.48 [1][2]. - No revenue was reported as the company remains in clinical development [1][7]. - Research and development expenses decreased by 6.9% to $32.3 million compared to Q2 2024, while general and administrative expenses fell by 25.4% to $9.1 million [2][5]. - Cash, cash equivalents, and marketable securities totaled $379.7 million at the end of Q2 2025, providing a multi-year runway at current spending rates [6][7]. Business Overview - Atea Pharmaceuticals focuses on developing therapies for hepatitis C, primarily through a combination therapy using bemnifosbuvir and ruzasvir [3][4]. - The company aims to address the unmet need in HCV treatment by offering shorter courses and improved safety compared to existing therapies [4]. Clinical Development - Atea's lead HCV regimen is advancing in clinical trials, with both global Phase 3 trials, C-BEYOND and C-FORWARD, progressing in enrollment [8]. - Phase 2 results showed a 98% sustained virologic response rate at 12 weeks post-treatment, indicating strong efficacy and safety [9][10]. Strategic Initiatives - The Board authorized a stock repurchase program for up to $25 million, with 4.6 million shares repurchased at an average price of $3.01 per share by the end of Q2 2025 [11]. - Atea engaged Evercore to explore strategic options, including potential mergers or partnerships, to enhance its market position [11]. Future Outlook - Management did not provide formal financial guidance for the remainder of fiscal 2025, reflecting uncertainty in clinical trials and commercial launch timelines [13][14]. - Investors will focus on updates regarding Phase 3 progress, pivotal data timelines, and outcomes from the strategic review process [14].

Financial Data and Key Metrics Changes - The company reported a cash, cash equivalents, and marketable securities balance of $379.7 million as of June 30, 2025, indicating a strong financial position to execute its Phase III HCV program [11] - Research and development (R&D) expenses decreased compared to the same period in 2024, primarily due to the conclusion of the Phase III SUNRISE trial [30] - General and administrative (G&A) expenses also decreased, attributed to lower stock-based compensation and payroll expenses [30] Business Line Data and Key Metrics Changes - The company is advancing its global Phase III HCV program, evaluating the regimen of Benifosbuvir and Ruzasvir, with patient enrollment on track [9][18] - The Phase II trial results showed a 98% sustained virologic response (SVR) rate in treatment-adherent patients after eight weeks, demonstrating the regimen's robust efficacy [16] Market Data and Key Metrics Changes - The global HCV market is approximately $3 billion in annual net sales, with a significant burden of untreated HCV disease representing a large untapped commercial opportunity [10][12] - In the U.S., there are between 2.4 and 4 million untreated individuals infected with HCV, highlighting the need for new therapies [12] Company Strategy and Development Direction - The company aims to develop a best-in-class regimen for HCV treatment, focusing on a new model of care called "test and treat" to enhance patient access and treatment outcomes [13][24] - The addition of a new independent director, Dr. Howard Berman, reflects the company's commitment to strengthening its leadership and strategic direction [8][32] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing high incidence of HCV infections, which outpaces the number of patients treated, underscoring the need for differentiated therapies [11][12] - The company anticipates top-line results from the C BEYOND trial in mid-2026 and from the C FORWARD trial in late 2026, indicating a clear timeline for future developments [10][18] Other Important Information - The company announced a stock repurchase program of up to $25 million, demonstrating its commitment to returning capital to shareholders while funding its clinical programs [8][32] - The Phase III trials will compare the new regimen to existing treatments, aiming to establish its superiority in efficacy and safety [19] Q&A Session Summary Question: Update on enrollment in Phase III C Beyond and C Forward trials - Enrollment is progressing on track, with C BEYOND moving faster due to quicker regulatory approvals in North America compared to C FORWARD [38][39] - Investigator enthusiasm is high, reflecting keen interest in the studies and the value proposition for patients [39]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-39661 Atea Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 4 ...

HCV Program & Clinical Trials - Phase 3 trial C-BEYOND (US/Canada) and C-FORWARD (Outside North America) initiated with first patient dosed in April and June 2025 respectively[12] - Phase 2 results showed 98% SVR12 in treatment adherent patients and 95% SVR12 regardless of adherence[28,29] - Phase 2 results also demonstrated 99% SVR12 in non-cirrhotic treatment adherent patients across genotypes and 97% SVR12 regardless of adherence[31,32] Market Opportunity & KOL Insights - Untreated HCV infections in the US range from 24 million to 4 million, with over 170,000 newly reported annual infections exceeding annual cures[16] - The US HCV market is estimated at ~$15 billion in 2024, with a potential market opportunity exceeding $20 billion[19] - KOL panel highlighted the need for simpler, shorter HCV treatments with fewer drug-drug interactions to improve patient adherence and expand the test-and-treat model[49] Financial Status - Cash, cash equivalents, and marketable securities totaled $3797 million as of June 30, 2025, providing a cash runway through 2027[13] - The company authorized and initiated a repurchase of up to $25 million of its common stock in April 2025, with 46 million shares repurchased as of June 30, 2025[9,67] - Net loss for the second quarter of 2025 was $37161 million, compared to $40522 million for the same period in 2024[64]

Executive Summary & Business Update Atea Pharmaceuticals reported Q2 2025 financial results and business updates, emphasizing global Phase 3 HCV program advancements and recent scientific data [Second Quarter 2025 Highlights](index=1&type=section&id=Second%20Quarter%202025%20Highlights) Atea Pharmaceuticals reported Q2 2025 financial results and a business update, highlighting significant progress in its global Phase 3 HCV treatment program - Atea Pharmaceuticals reported financial results for the second quarter ended June 30, 2025, and provided a business update[2](index=2&type=chunk) [HCV Phase 3 Development Program](index=1&type=section&id=HCV%20Phase%203%20Development%20Program) Atea is advancing its global Phase 3 program for bemnifosbuvir/ruzasvir HCV treatment, with enrollment on track, supported by strong Phase 2 efficacy (**98% SVR12**) and favorable PK/DDI profiles [C-BEYOND and C-FORWARD Trials Overview](index=1&type=section&id=C-BEYOND%20and%20C-FORWARD%20Trials%20Overview) Atea's global Phase 3 HCV program (C-BEYOND, C-FORWARD) is on track, evaluating bemnifosbuvir/ruzasvir against standard therapy, with SVR12 as the primary endpoint - Atea's combination regimen of bemnifosbuvir/ruzasvir is being evaluated in a global Phase 3 development program for HCV, comprising two trials: C-BEYOND (US/Canada) and C-FORWARD (outside North America)[3](index=3&type=chunk)[6](index=6&type=chunk) - Global patient enrollment is on track in both C-BEYOND and C-FORWARD trials, which were initiated in April and June 2025, respectively[4](index=4&type=chunk)[6](index=6&type=chunk) - Each Phase 3 trial enrolls approximately 880 treatment-naïve patients and compares bemnifosbuvir/ruzasvir (8 or 12 weeks) to sofosbuvir/velpatasvir (12 weeks)[7](index=7&type=chunk) - The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment, encompassing SVR12[8](index=8&type=chunk) [EASL Congress 2025 Presentations](index=2&type=section&id=EASL%20Congress%202025%20Presentations) EASL 2025 presentations highlighted bemnifosbuvir/ruzasvir's robust Phase 2 efficacy (**98% SVR12**) and favorable pharmacokinetic profiles for hepatic/renal impairment and drug interactions - Phase 2 efficacy results for bemnifosbuvir/ruzasvir showed a robust **98% SVR12** in the 'Per-Protocol Treatment-Adherent Population' (n=215)[9](index=9&type=chunk) - Phase 1 pharmacokinetic results support the use of bemnifosbuvir without dose adjustment in patients with hepatic impairment[9](index=9&type=chunk) - Phase 1 drug-drug interaction results demonstrated no clinically significant pharmacokinetic changes when co-administered with the standard HIV regimen bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF)[9](index=9&type=chunk) - Phase 1 renal impairment results suggest bemnifosbuvir may be used without dose adjustment in patients with renal dysfunction, including those undergoing dialysis[9](index=9&type=chunk) [HCV Key Opinion Leader (KOL) Discussion Panel Event](index=3&type=section&id=HCV%20Key%20Opinion%20Leader%20(KOL)%20Discussion%20Panel%20Event) Atea hosted a virtual KOL event on May 14, 2025, where experts discussed HCV challenges, Phase 2 results, and commercial opportunities for optimized HCV therapy - Atea hosted a virtual KOL investor event on May 14, 2025, featuring six HCV experts to discuss current challenges, Atea's Phase 2 results, and the commercial market opportunity for an optimized HCV therapy[10](index=10&type=chunk) Financial Results Atea's Q2 2025 financial results indicate decreased cash, reduced R&D and G&A expenses, and an improved net loss year-over-year [Key Financial Metrics](index=3&type=section&id=Key%20Financial%20Metrics) Atea's cash, cash equivalents, and marketable securities decreased to **$379.7 million** by June 30, 2025, with R&D and G&A expenses also decreasing year-over-year **Cash, Cash Equivalents and Marketable Securities:** | Date | Amount (Millions) | | :--- | :--- | | June 30, 2025 | $379.7 | | December 31, 2024 | $454.7 | **Research and Development Expenses (Three Months Ended June 30):** | Year | Amount (Millions) | Change (YoY) | | :--- | :--- | :--- | | 2025 | $32.3 | -$2.4 | | 2024 | $34.7 | | *Primarily driven by substantially lower COVID-19 external spend and decreased internal expenses, offset by increased HCV Phase 3 program spend.* **General and Administrative Expenses (Three Months Ended June 30):** | Year | Amount (Millions) | Change (YoY) | | :--- | :--- | :--- | | 2025 | $9.1 | -$3.2 | | 2024 | $12.2 | | *Primarily related to lower stock-based compensation expense, partially offset by increased professional fees.* **Interest Income and Other, Net (Three Months Ended June 30):** | Year | Amount (Millions) | Change (YoY) | | :--- | :--- | :--- | | 2025 | $4.4 | -$2.2 | | 2024 | $6.6 | | *Primarily due to lower investment balances.* [Condensed Consolidated Statement of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, Atea reported a net loss of **$37.161 million**, an improvement from **$40.522 million** in 2024, with total operating expenses decreasing year-over-year **Condensed Consolidated Statement of Operations and Comprehensive Loss (Unaudited, in thousands):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------------- | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $32,275 | $34,696 | $61,859 | $92,271 | | General and administrative | $9,070 | $12,220 | $18,527 | $24,451 | | Total operating expenses | $41,345 | $46,916 | $80,386 | $116,722 | | Loss from operations | $(41,345) | $(46,916) | $(80,386) | $(116,722) | | Interest income and other, net | $4,391 | $6,637 | $9,363 | $13,505 | | Loss before income taxes | $(36,954) | $(40,279) | $(71,023) | $(103,217) | | Income tax expense | $(207) | $(243) | $(410) | $(474) | | Net loss | $(37,161) | $(40,522) | $(71,433) | $(103,691) | | Net loss per share - basic and diluted | $(0.44) | $(0.48) | $(0.85) | $(1.23) | [Selected Condensed Consolidated Balance Sheet Data](index=4&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, Atea's total assets stood at **$391.605 million**, a decrease from **$464.668 million** at December 31, 2024, with total stockholder's equity also declining **Selected Condensed Consolidated Balance Sheet Data (Unaudited, in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :---------------- | :------------------ | | Cash, cash equivalents and marketable securities | $379,713 | $454,721 | | Working capital | $365,485 | $443,752 | | Total assets | $391,605 | $464,668 | | Total liabilities | $27,189 | $25,801 | | Total stockholder's equity | $364,416 | $438,867 | Business and Organizational Updates Atea strengthened its Board and initiated a stock repurchase program, while actively exploring strategic alternatives to enhance shareholder value [Corporate Governance and Capital Allocation](index=3&type=section&id=Corporate%20Governance%20and%20Capital%20Allocation) Atea strengthened its Board with a new appointment and initiated a **$25 million** common stock repurchase program, demonstrating commitment to shareholder returns - Dr. Howard H. Berman was appointed to Atea's Board of Directors in June 2025, bringing over 20 years of life science industry experience[14](index=14&type=chunk) - In April 2025, Atea authorized the repurchase of up to **$25 million** of its common stock[14](index=14&type=chunk) - As of June 30, 2025, the Company had repurchased **4,619,597 shares** of common stock at an average purchase price of **$3.01 per share**[14](index=14&type=chunk) [Strategic Alternatives Review](index=3&type=section&id=Strategic%20Alternatives%20Review) Atea is actively exploring a broad range of strategic alternatives to maximize shareholder value, including potential partnerships, acquisitions, or asset sales, with Evercore assisting - Atea is evaluating all options to maximize shareholder value, including strategic partnerships, acquisition, merger, or other business combination, and sale of assets[14](index=14&type=chunk) - The Company has engaged Evercore to assist in the strategic alternatives review process[14](index=14&type=chunk) Company and Disease Background This section outlines HCV as a global health burden and introduces Atea Pharmaceuticals' focus on developing oral antiviral therapies using its proprietary nucleos(t)ide prodrug platform [About HCV](index=5&type=section&id=About%20HCV) HCV remains a significant global health burden, with an estimated **50 million people** chronically infected worldwide and approximately **one million new infections** annually - HCV is a blood-borne, single-stranded RNA virus, a leading cause of chronic liver disease and liver transplants, causing approximately **240,000 deaths** annually[22](index=22&type=chunk) - An estimated **50 million people** worldwide are chronically infected with HCV, with approximately **one million new infections** each year[22](index=22&type=chunk) - In the US, between **2.4 and 4.0 million people** are estimated to have HCV, with annual new infections outpacing treatment rates[22](index=22&type=chunk) - Chronic HCV infection is the leading cause of liver cancer in the US, Europe, and Japan[22](index=22&type=chunk) [About Atea Pharmaceuticals](index=5&type=section&id=About%20Atea%20Pharmaceuticals) Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing oral antiviral therapies for serious viral infections - Atea is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing oral antiviral therapies for serious viral infections[23](index=23&type=chunk) - The company utilizes a proprietary nucleos(t)ide prodrug platform to develop novel product candidates for single-stranded ribonucleic acid (ssRNA) viruses[23](index=23&type=chunk) - Atea's lead program and current focus is the development of the combination of bemnifosbuvir and ruzasvir to treat HCV[23](index=23&type=chunk) Legal & Contact Information This section outlines standard forward-looking statements, emphasizing inherent uncertainties and risk factors, and provides contact information for investor and corporate communications [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains standard forward-looking statements, based on current expectations but inherently uncertain, with actual results potentially differing due to various factors - The press release includes 'forward-looking statements' as defined by the Private Securities Litigation Reform Act of 1995[24](index=24&type=chunk) - These statements are based on Atea's current expectations and assumptions, but are inherently uncertain, and actual results could differ materially[24](index=24&type=chunk) - Important factors that could cause actual results to differ include uncertainties in drug discovery and development, regulatory processes, unexpected safety/efficacy data, clinical trial delays, reliance on third parties, competition, and the timeline/outcome of the strategic alternatives review[24](index=24&type=chunk)[25](index=25&type=chunk) [Contacts](index=6&type=section&id=Contacts) This section provides contact information for investor relations and corporate communications - Contact information is provided for Jonae Barnes, SVP, Investor Relations and Corporate Communications, and Joyce Allaire of LifeSci Advisors[26](index=26&type=chunk)