Core Viewpoint - Atea Pharmaceuticals, Inc. will host a live conference call on November 12, 2025, to report its third-quarter financial results and provide a business update [1]. Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing oral antiviral therapies for serious viral infections [3]. - The company utilizes a proprietary nucleos(t)ide prodrug platform to develop novel product candidates targeting single-stranded RNA viruses, which are significant causes of serious viral diseases [3]. - Atea's lead program includes 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 November 12, 2025, and will be accessible via registration or through the company's website [2]. - Participants can join the call by dialing specific telephone numbers and using a designated conference ID [2]. - An archive of the audio webcast will be available on the company's website approximately two hours after the call and will remain accessible for at least 90 days [2].

Core Insights - Atea Pharmaceuticals is hosting a virtual key opinion leader (KOL) event on November 13, 2025, to discuss hepatitis C virus (HCV) topics, including patient demographics, early diagnosis, treatment importance, public policy, and potential new therapies [1][2] Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing oral antiviral therapeutics for serious viral diseases, particularly HCV [16] - The company is advancing a global Phase 3 clinical development program for its lead regimen, bemnifosbuvir and ruzasvir, which targets HCV [2][9] Clinical Development - The Phase 3 program includes two trials: C-BEYOND in the US and Canada, and C-FORWARD outside North America, each enrolling approximately 880 treatment-naïve patients [9] - The trials compare the fixed-dose combination of bemnifosbuvir and ruzasvir to the existing regimen of sofosbuvir and velpatasvir, with treatment durations of 8 to 12 weeks depending on cirrhosis status [9][10] Efficacy and Safety - Phase 2 study results indicated a 98% sustained virologic response (SVR12) rate for the bemnifosbuvir and ruzasvir regimen in treatment-adherent patients [12] - The combination has shown a low risk of drug-drug interactions and can be taken with or without food, making it suitable for co-infected patients [13] Market Opportunity - The KOL event will also cover the commercial market opportunity for HCV treatments and the potential impact of Atea's therapies on prescribers and patients [2] - HCV remains a significant global health issue, with an estimated 50 million people chronically infected worldwide and 240,000 deaths annually [11] Key Opinion Leaders - The event will feature prominent HCV experts, including Dr. Jordan Feld, Dr. Eric Lawitz, Dr. Anthony Martinez, and Dr. Nancy Reau, who will provide insights into HCV management and research [3][4][5][8]

Core Insights - Atea Pharmaceuticals announced new data supporting the combination regimen of bemnifosbuvir and ruzasvir as a potential best-in-class treatment for hepatitis C (HCV) at The Liver Meeting 2025 [1][2] - The company is advancing its global Phase 3 program, with patient enrollment ongoing, and is optimistic about reshaping the standard of care for HCV [2][8] Clinical Data and Presentations - Three abstracts will be presented at The Liver Meeting 2025, including results from a Phase 2 study and a Phase 1 study on the fixed-dose combination [1][2] - The Phase 2 study showed a 98% sustained virologic response (SVR12) in the treatment-adherent population and a 95% SVR12 in the efficacy evaluable population [4][5] - The combination regimen demonstrated high relative bioavailability and can be dosed without regard to food [4][5] Ongoing Trials - Atea's Phase 3 development program includes two trials: C-BEYOND in the US and Canada, and C-FORWARD outside North America, each enrolling approximately 880 treatment-naïve patients [9][10] - The primary endpoint for these trials is HCV RNA below the lower limit of quantitation at 24 weeks, ensuring consistent measurement across all patients [10] Market Context and Challenges - HCV remains a significant global healthcare issue, with approximately 50 million people chronically infected worldwide and an estimated 240,000 deaths annually [11] - In the US, between 2.4 and 4 million people are estimated to have HCV, with new infections outpacing treatment rates [11] Drug Profile - Bemnifosbuvir has shown to be approximately 10-fold more active than sofosbuvir against various HCV genotypes and has a favorable safety profile [12] - Ruzasvir has demonstrated potent antiviral activity and a favorable safety profile in clinical studies [12] Upcoming Events - Atea will host a virtual key opinion leader (KOL) investor event on November 13, 2025, to discuss the HCV commercial market opportunity and ongoing clinical development [6][8]

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]

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].