Atea Pharmaceuticals(AVIR) - 2025 Q2 - Quarterly Results

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 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] HCV Phase 3 Development Program 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 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][6] - Global patient enrollment is on track in both C-BEYOND and C-FORWARD trials, which were initiated in April and June 2025, respectively[4][6] - Each Phase 3 trial enrolls approximately 880 treatment-naïve patients and compares bemnifosbuvir/ruzasvir (8 or 12 weeks) to sofosbuvir/velpatasvir (12 weeks)[7] - 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] EASL Congress 2025 Presentations 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] - Phase 1 pharmacokinetic results support the use of bemnifosbuvir without dose adjustment in patients with hepatic impairment[9] - 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] - Phase 1 renal impairment results suggest bemnifosbuvir may be used without dose adjustment in patients with renal dysfunction, including those undergoing dialysis[9] HCV Key Opinion Leader (KOL) Discussion Panel Event 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] 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 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 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 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 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] - In April 2025, Atea authorized the repurchase of up to $25 million of its common stock[14] - 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] Strategic Alternatives Review 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] - The Company has engaged Evercore to assist in the strategic alternatives review process[14] 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 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] - An estimated 50 million people worldwide are chronically infected with HCV, with approximately one million new infections each year[22] - In the US, between 2.4 and 4.0 million people are estimated to have HCV, with annual new infections outpacing treatment rates[22] - Chronic HCV infection is the leading cause of liver cancer in the US, Europe, and Japan[22] About Atea Pharmaceuticals 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] - The company utilizes a proprietary nucleos(t)ide prodrug platform to develop novel product candidates for single-stranded ribonucleic acid (ssRNA) viruses[23] - Atea's lead program and current focus is the development of the combination of bemnifosbuvir and ruzasvir to treat HCV[23] 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 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] - These statements are based on Atea's current expectations and assumptions, but are inherently uncertain, and actual results could differ materially[24] - 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][25] 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]