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PresentationGood morning. Welcome to the 44th Annual JPMorgan Healthcare Conference. My name is [indiscernible]. I'm an associate in the JPMorgan Healthcare Investment Banking team. It is my great pleasure to introduce our next presenting company, Atea Pharmaceuticals.Jean-Pierre SommadossiFounder, Chairman, CEO & President Thank you, and good morning. And before I begin, I would like to thank JPMorgan for the invitation and the opportunity to share with you today some updates on our regimen of bemnifosbuvi ...

Atea Pharmaceuticals Conference Call Summary Company Overview - **Company**: Atea Pharmaceuticals (NasdaqGS:AVIR) - **Event**: FY Conference on January 15, 2026 - **Focus**: Updates on bemnifosbuvir and ruzasvir for Hepatitis C treatment and new Hepatitis E program Key Points on Hepatitis C Treatment - **Phase 3 Program**: Atea is executing a global phase 3 program for Hepatitis C, with pivotal data expected in mid-2026 [2][3] - **Enrollment**: Over 900 patients enrolled in the North American trial, with completion expected by the end of Q2 2026 [3][4] - **NDA Filing**: Anticipated filing of a New Drug Application (NDA) with the FDA in Q1 2026 [4] - **Efficacy**: The regimen shows a 98% efficacy cure rate in phase 2 studies, with a focus on a short treatment duration of 8 weeks [9][32] - **Market Dynamics**: Despite the introduction of effective treatments, the number of Hepatitis C infections in the U.S. has increased from 2.5 million to over 4 million in the last decade [6][28] - **Commercial Opportunity**: The global Hepatitis C market is approximately $3 billion, with the U.S. accounting for about 50% [34] Insights on Hepatitis E Program - **Target Population**: Focus on immunocompromised patients, particularly those undergoing solid organ transplants [4][22] - **Market Potential**: Estimated 450,000 patients annually in the U.S. and Europe, with a potential billion-dollar market opportunity [23] - **Treatment Development**: Atea is advancing a new candidate, 80587, for Hepatitis E, with IND-enabling studies underway [21][25] Financial Position - **Cash Reserves**: Atea has over $300 million in cash and investments, providing a runway through 2027-2028 [5] - **Cost of Goods**: Anticipated low single-digit costs related to net pricing, with expectations for profitability within 24 months post-launch [21] Industry Context - **Infection Trends**: The opioid crisis has contributed to a rising number of Hepatitis C infections, with an estimated 160,000 new infections annually in the U.S. [28] - **Test-and-Treat Model**: A proposed model to enhance screening and treatment access, particularly for younger populations at risk [30][31] Regulatory and Clinical Considerations - **Regulatory Strategy**: Atea is preparing for potential differences in regulatory requirements between the FDA and EMA [17][19] - **Clinical Trial Design**: Emphasis on robust trial designs to ensure sufficient power and efficacy comparisons against standard treatments [19][20] Conclusion - **Pivotal Year**: 2026 is positioned as a critical year for Atea, with significant milestones in both Hepatitis C and E programs expected [26][27]

HCV Program (BEM/RZR) - The company is developing BEM/RZR as a potential best-in-class treatment for HCV, with Phase 3 trials underway[7, 12] - Phase 2 results showed a 98% sustained virologic response (SVR12) with the BEM/RZR combination regimen[12] - Two Phase 3 trials, C-BEYOND (US/Canada) and C-FORWARD (outside North America), are enrolling approximately 1,760 patients in total[12, 30] - The US sees over 160 thousand new chronic HCV infections annually, while approximately 90 thousand are treated, highlighting the need for improved treatment strategies[18] - Market research indicates that 48% of non-cirrhotic patients and 49% of compensated cirrhotic patients are likely to be prescribed BEM/RZR[21] HEV Program (AT-587) - A new program is focused on Hepatitis E Virus (HEV) with product candidate AT-587, targeting Phase 1 initiation in mid-2026[7] - The WHO estimates up to 20 million global HEV infections annually[42] - Approximately 3% of at-risk patients develop chronic HEV, leading to a potential treatment population of ~135 thousand patients annually[51] - The commercial opportunity for HEV treatment in the US & EU is estimated at $750 million to $1 billion[50, 51] - AT-587 demonstrates potent antiviral activity against multiple HEV-3 strains and ribavirin-resistant virus[53] Financial Status - The company reported cash and investments of $3018 million as of December 31, 2025, with a cash runway anticipated through 2027[7, 61]

Financial Position - Atea Pharmaceuticals ended 2025 with cash and investments totaling $301.8 million, providing a cash runway expected to extend through 2027[1]. Clinical Trials and Development - The global Phase 3 program for the HCV treatment regimen of bemnifosbuvir (BEM) and ruzasvir (RZR) includes over 880 patients in the C-BEYOND trial, with topline results expected in mid-2026[7]. - The C-FORWARD trial outside North America is expected to complete enrollment by mid-2026, with topline results anticipated by year-end 2026[7]. - In a Phase 2 study, the 8-week regimen of BEM/RZR achieved a 98% sustained virologic response (SVR12) in the per-protocol population[10]. - Atea's new product candidate AT-587 for Hepatitis E virus (HEV) is anticipated to enter Phase 1 clinical trials in mid-2026, addressing a significant unmet need[5][14]. Market Opportunity - The potential market opportunity for the HEV program is estimated to be between $750 million and $1 billion in the US and EU[15]. - The global HCV market is estimated at approximately $3 billion in net sales annually, with about $1.5 billion attributed to the US[13]. Product Profile and Strategy - Atea's regimen of BEM/RZR is designed to have high efficacy, short treatment duration, and low risk of drug-drug interactions, aligning with the needs of HCV patients[4][12]. - Independent market research indicates strong provider interest in a new HCV treatment option with the profile of the BEM/RZR regimen[11]. - Atea aims to build a diversified antiviral portfolio, with HCV as the lead development pillar and HEV as a strategic expansion[16].

Core Insights - Atea Pharmaceuticals is advancing its global Phase 3 program for a potential best-in-class regimen for Hepatitis C virus (HCV) treatment, with topline results expected in mid-2026 from the C-BEYOND trial in North America and by year-end 2026 from the C-FORWARD trial outside North America [1][6][16] - The company is also initiating a Phase 1 clinical program for its Hepatitis E virus (HEV) product candidate AT-587, anticipated to start in mid-2026 [1][3][12] HCV Treatment Program - The regimen under evaluation consists of bemnifosbuvir (BEM), a nucleotide analog HCV NS5B polymerase inhibitor, and ruzasvir (RZR), an HCV NS5A inhibitor, aimed at addressing challenges with current HCV therapeutics [2][5] - C-BEYOND has over 880 patients fully enrolled, while C-FORWARD is expected to complete enrollment by mid-2026 [6] - The primary endpoint for both trials is achieving HCV RNA below the lower limit of quantitation (LLOQ) at 24 weeks, assessing sustained virologic response 12 weeks post-treatment (SVR12) [7] Market Potential and Provider Insights - The global HCV market is estimated at approximately $3 billion in net sales annually, with about $1.5 billion attributed to the US [11] - A survey of healthcare providers indicated a strong demand for a new treatment option that offers high efficacy, short treatment duration, and low risk of drug-drug interactions (DDIs), as many HCV patients are on multiple medications [10][11] HEV Program Development - Atea's new HEV program targets a significant unmet medical need, particularly for immunocompromised patients, with AT-587 selected as the lead candidate showing potent antiviral activity against HEV [12][13] - The potential market opportunity for HEV treatment in the US and EU is estimated between $750 million to $1 billion [13] Strategic Outlook - Atea aims to build a diversified antiviral portfolio, with HCV as the lead development pillar and HEV as a strategic expansion [14] - The company is focused on disciplined execution and resource deployment to maximize clinical and commercial potential [14][16]

Core Viewpoint - Atea Pharmaceuticals, Inc. is set to present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026, highlighting its focus on oral antiviral therapeutics for serious viral diseases [1]. Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing oral antiviral therapies to meet the unmet medical needs of patients with serious viral infections [3]. - The company utilizes a proprietary nucleos(t)ide prodrug platform to develop novel product candidates targeting single-stranded ribonucleic acid (ssRNA) viruses, which are significant contributors to serious viral diseases [3]. - Atea's lead program involves a regimen combining bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, aimed at treating Hepatitis C Virus (HCV) [3].

Atea Pharmaceuticals ( AVIR ) is developing antiviral treatments for hepatitis C (HCV) and hepatitis E (HEV) viruses. Their lead candidate is bemnifosbuvir/ruzasvir ((BEM/RZR)) being developed for HCV cure, currently being evaluated in two parallel phase 3 trials, one in North America andhttps://biotechpharmainvestor.substack.comBackground: Physician involved in clinical research. Investment style: Clinical-stage biotech stocks, long only, both long-term ideas and event-driven trading. My academic/medical b ...

Company Overview - Atea Pharmaceuticals (AVIR) is focused on developing antiviral treatments for hepatitis C (HCV) and hepatitis E (HEV) viruses [1] - The lead candidate for HCV treatment is bemnifosbuvir/ruzasvir (BEM/RZR), which is currently undergoing evaluation in two parallel phase 3 trials, one located in North America [1] Investment Insights - The investment style associated with Atea Pharmaceuticals includes a focus on clinical-stage biotech stocks, emphasizing both long-term ideas and event-driven trading [1] - The analyst's background in academia and medicine aids in evaluating the scientific fundamentals of biotech stocks, which is crucial for informed investment decisions [1]

Core Insights - Atea Pharmaceuticals has completed enrollment of over 880 treatment-naïve patients in the C-BEYOND Phase 3 trial for HCV treatment, with topline results expected by mid-2026 [2][4] - The C-FORWARD Phase 3 trial, which is being conducted outside North America, is also expected to complete enrollment by mid-2026, with results anticipated by the end of 2026 [3][4] Group 1: Trial Details - C-BEYOND and C-FORWARD are the first global Phase 3 head-to-head trials comparing the fixed-dose combination (FDC) of bemnifosbuvir and ruzasvir against sofosbuvir and velpatasvir for HCV treatment [2][3] - Each trial is enrolling approximately 880 treatment-naïve patients, with the C-BEYOND trial conducted in the US and Canada, and C-FORWARD in up to 17 countries outside North America [3][5] - The FDC regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for 8 weeks for patients without cirrhosis and 12 weeks for those with compensated cirrhosis, while the comparator regimen is given for 12 weeks to all patients [3][5] Group 2: HCV Context - HCV remains a significant global health issue, with up to 4 million people in the US and an estimated 50 million worldwide infected, alongside approximately one million new infections each year [4][8] - Despite the availability of direct-acting antivirals (DAAs), HCV diagnoses in the US continue to outpace annual cure rates, highlighting the need for new treatment options [4][8] - Approximately 80% of HCV patients are on multiple medications for comorbidities, which complicates treatment due to concerns about drug-drug interactions [4][8] Group 3: Company Overview - Atea Pharmaceuticals focuses on developing oral antiviral therapies for serious viral infections, leveraging its expertise in antiviral drug development and nucleos(t)ide chemistry [9] - The company's lead program involves the bemnifosbuvir and ruzasvir regimen aimed at treating HCV, with a goal to create a best-in-class treatment that addresses patient needs effectively [4][9]