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]

Clinical Trials and Product Development - The company is currently conducting two Phase 3 clinical trials, C-Beyond and C-Forward, for its lead product candidate, bemnifosbuvir and ruzasvir, targeting HCV infection, with patient enrollment ongoing since April and June 2025 respectively [85][94]. - The Phase 2 clinical trial results showed a 98% sustained virologic response (SVR12) rate in treatment-adherent patients after eight weeks, demonstrating the regimen's high efficacy [97]. - The company expects to incur significant expenses as it advances its Phase 3 clinical development for the treatment of HCV [116]. - The company plans to continue using third-party service providers for clinical development and manufacturing [115]. Financial Position and Cash Flow - The company had $379.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025, positioning it well to advance its current programs [104]. - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $379.7 million [161]. - Net cash used in operating activities was $63.4 million for the six months ended June 30, 2025 [112]. - For the six months ended June 30, 2025, net cash used in operating activities was $63.4 million, primarily due to a net loss of $71.4 million [149]. - Net cash provided by investing activities for the six months ended June 30, 2025 was $100.9 million, consisting of sales and maturities of marketable securities of $324.3 million [151]. - The company incurred net cash used in financing activities of $14.4 million for the six months ended June 30, 2025, primarily due to stock repurchases [153]. Cost Management and Workforce - A workforce reduction of approximately 25% was implemented in Q1 2025, expected to result in cost savings of about $15.0 million through 2027 [104]. - The company reduced its workforce by approximately 25% in Q1 2025, expecting cost savings of about $15 million through 2027 [112]. - Research and development expenses decreased by $30.4 million from $92.3 million for the six months ended June 30, 2024, to $61.9 million for the same period in 2025 [134]. - Total operating expenses for the six months ended June 30, 2025, were $80.4 million, down from $116.7 million in 2024 [133]. Revenue Generation and Future Outlook - The company has not generated any product revenue since inception and does not anticipate doing so in the foreseeable future, relying on financing for operations [107]. - The company does not anticipate generating any revenue from product sales for the foreseeable future [114]. - The company has not generated any product revenue to date and does not expect to until regulatory approval and commercialization of product candidates occur [141]. - The company anticipates needing to raise substantial additional capital to fund operations and development, with requirements depending on various factors [143]. - The company may face challenges in raising adequate funding on acceptable terms, which could negatively impact its financial condition [146]. - Market volatility and macroeconomic trends may significantly impact the availability of funding sources and terms [147]. Strategic Partnerships and Milestones - The first milestone payment of $5.0 million under the Merck License Agreement was recognized as a research and development expense upon enrolling the first patient in the C-Beyond trial [111]. - The next potential milestone payment of $10.0 million is anticipated upon FDA acceptance of a new drug application for the regimen of bemnifosbuvir and ruzasvir [111]. - The company is exploring strategic alternatives, including partnerships and acquisitions, to enhance stockholder value, with no assurance of specific outcomes [108]. Stock Repurchase Activity - The company repurchased 4,619,597 shares for approximately $14.1 million during the three months ended June 30, 2025, with $11.1 million remaining authorized for future repurchases [106]. - The company repurchased 4,619,597 shares of common stock for approximately $14.1 million during the three months ended June 30, 2025, with $11.1 million remaining for future repurchases [142].

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)

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].