BOSTON, Nov. 19, 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 Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea, together with other members of the Atea management team, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Wednesday, December 3, 202 ...

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Core Insights - Atea Pharmaceuticals is hosting a virtual Key Opinion Leader (KOL) event focused on hepatitis C, featuring leading experts in hepatology and infectious diseases [2][3]. Company Overview - Atea Pharmaceuticals is led by Dr. Jean-Pierre Sommadossi, who serves as the Founder, Chairman, and CEO [2]. - The company aims to discuss the commercial market opportunity for hepatitis C virus (HCV) treatments during the event [3]. Expert Panel - The event includes a panel of experts from notable institutions, such as Dr. Jordan Feld from the University of Toronto, Dr. Eric Lawitz from the Texas Liver Institute, Dr. Anthony Martinez from the University of Buffalo, and Nancy Reau from Rush University Medical Center [3]. - Atea's Chief Commercial Officer, John Vavricka, along with other key executives, will present insights on the HCV market and treatment profiles [3].

Summary of Atea Pharmaceuticals Conference Call Company Overview - **Company**: Atea Pharmaceuticals (NasdaqGS:AVIR) - **Focus**: Development of treatments for chronic hepatitis C (HCV) Key Industry Insights - **HCV Treatment Landscape**: Atea is conducting a global phase 3 program comparing its regimen (bemnifosbuvir and ruzasvir) against the current standard of care (sofosbuvir and velpatasvir, marketed as Epclusa) [2][3] - **Epidemiology of HCV**: The patient population has shifted towards younger individuals, often with social challenges rather than advanced liver disease, due to the ongoing opioid epidemic [13][14] - **Market Research Findings**: A quantitative study showed that 76% of high US DAA prescribers are extremely likely to prescribe Atea's regimen, indicating strong market interest [8][9] Core Product Insights - **Regimen Profile**: The regimen includes bemnifosbuvir, a potent nucleotide inhibitor, and ruzasvir, an NS5A inhibitor, with a short treatment duration and low risk for drug-drug interactions [2][3][5] - **Clinical Efficacy**: Phase 2 studies showed a 98% sustained virologic response at 12 weeks post-treatment (SVR12), supporting the regimen's potential as a best-in-class treatment [3][4] - **Resistance Analysis**: The regimen demonstrated effectiveness even in the presence of NS5A-resistant variants, indicating a robust resistance profile [6][7] Phase 3 Program Details - **Trial Structure**: The global phase 3 program consists of two pivotal trials (CBEYOND and CFORG) enrolling approximately 1,760 patients across 240 sites [7][8] - **Enrollment Timeline**: Enrollment for the North America CBEYOND trial is on track for completion next month, with top-line results expected by mid-2026 [8] Economic Considerations - **Cost of Treatment**: The average cost of treating a patient with hepatitis C is approximately $20,000 per year, which can escalate to $70,000 if cirrhosis develops [31][32] - **Economic Argument for Early Treatment**: Engaging newly diagnosed patients early is cost-effective, as delaying treatment increases overall healthcare costs and transmission risks [27][28][34] Challenges and Opportunities - **Barriers to Treatment**: The U.S. healthcare system faces challenges such as insurance hurdles and varying state policies that can impede timely treatment [35][36] - **Need for Provider Readiness**: A shift towards a provider readiness model is necessary to improve access to care and treatment for HCV [66][67] Additional Insights - **Drug-Drug Interactions**: The regimen's design minimizes drug-drug interactions, which is crucial for younger patients often on multiple medications [19][46] - **Adherence Challenges**: The importance of a regimen that allows for some flexibility in adherence is emphasized, as many patients may miss doses due to various life circumstances [51][54] Conclusion - Atea Pharmaceuticals is positioned to make a significant impact in the HCV treatment landscape with its innovative regimen, addressing both clinical efficacy and economic considerations while navigating the complexities of the healthcare system.

Financial Data and Key Metrics Changes - At the end of Q3 2025, the company reported approximately $329.3 million in cash, cash equivalents, and marketable securities, providing a runway through 2027 [6][25][28] - R&D expenses increased compared to Q3 2024, primarily due to higher spending in the HCV clinical development program [24] - G&A expenses decreased in Q3 2025 compared to Q3 2024, driven by lower stock-based compensation [24] Business Line Data and Key Metrics Changes - The global phase 3 program for HCV treatment is on track, with patient enrollment for the North American trial expected to complete next month [4][14] - The company is expanding its antiviral hepatitis pipeline to include candidates for hepatitis E, addressing a significant unmet medical need [5][18] Market Data and Key Metrics Changes - The global HCV market is approximately $3 billion in annual net sales, with the company aiming to disrupt and expand this market with its new treatment regimen [28] - The hepatitis E market opportunity could translate into roughly $500 million to $750 million per year or more, given the high incidence of infections [20][21] Company Strategy and Development Direction - The company is focused on completing its phase 3 trials for HCV, which are expected to drive shareholder value and catalyze business development discussions [25][27] - The introduction of a new regimen for HCV treatment is positioned as a potential best-in-class option, with a differentiated profile and a unique dual mechanism of action [12][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong execution of the phase 3 program and the potential for the new treatment to become the most prescribed for hepatitis C [28] - The company highlighted the importance of addressing the unmet needs of immunocompromised patients living with hepatitis E, indicating a strategic expansion of its antiviral pipeline [5][18] Other Important Information - The company completed a share repurchase program, repurchasing $25 million of shares, which were retired and returned to authorized but unissued status [25] - A virtual panel event featuring key opinion leaders in hepatology is scheduled to discuss HCV-related topics, indicating ongoing engagement with the medical community [10][11] Q&A Session Summary Question: How does your recent data set at the liver meeting showing no interaction with famotidine, in addition to your prior data showing no interaction with PPI, increase your differentiation from Epclusa? - Management noted that the contraindication for Epclusa regarding H2-reducing therapy presents a clear problem for patients, making their regimen a significant differentiator [32] Question: There is a chart showing time to undetectable, with genotype three showing a more rapid time to undetectable. Is there any significance in that? - Management confirmed that bemnifosbuvir is more potent against genotype 3, which may relate to the dual mechanism of action [36][37] Question: The compound for hepatitis E does not employ the protide technology. Is that a deliberate decision? - Management clarified that the new candidates utilize a similar prodrug technology as bemnifosbuvir, with a focus on optimizing potency against hepatitis E [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 hepatitis C virus (HCV) infection, with patient enrollment ongoing since April and June 2025[90]. - The global Phase 3 program aims to enroll approximately 880 treatment-naïve patients in each trial, comparing the new regimen to existing treatments[100]. - The Phase 2 study of bemnifosbuvir and ruzasvir showed a 98% sustained virologic response (SVR12) rate in treatment-adherent patients after eight weeks, demonstrating high efficacy[102]. - The company is also exploring antiviral candidates for hepatitis E virus (HEV) infections, with no approved antiviral therapies currently available for HEV[108]. - The unfavorable results from the COVID-19 SUNRISE-3 trial led the company to discontinue efforts to develop bemnifosbuvir for COVID-19 treatment[107]. Financial Position and Cash Flow - The company had $329.3 million in cash, cash equivalents, and marketable securities as of September 30, 2025, positioning it well to advance its current programs[111]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $329.3 million, expected to fund operations through 2027[144]. - Net cash used in operating activities was $103.8 million for the nine months ended September 30, 2025[119]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $142.2 million, primarily from sales and maturities of marketable securities[155]. - Net cash used in financing activities for the nine months ended September 30, 2025, was $25.7 million, mainly due to stock repurchases of $25.5 million[157]. Revenue and Expenditures - The company has no approved products and does not anticipate generating product revenue in the foreseeable future, relying on financing through equity or debt arrangements[112]. - The company has not generated any product revenue to date and anticipates significant expenditures for product development and regulatory approvals in the foreseeable future[147]. - Research and development expenses increased by $12.2 million from $26.2 million for the three months ended September 30, 2024, to $38.3 million for the same period in 2025[135]. - Research and development expenses for the nine months ended September 30, 2025, were $100.2 million, a decrease of $18.2 million from $118.4 million for the same period in 2024[140]. - The company expects to continue investing significant capital in product development and may seek additional funding through various financing methods[148]. Operational Changes and Cost Management - A workforce reduction of approximately 25% was implemented in Q1 2025, expected to result in cost savings of about $15.0 million through 2027[113]. - The company completed a share repurchase program, repurchasing 7,673,793 shares for a total of $11.4 million during the three months ended September 30, 2025[114]. - Total operating expenses for the three months ended September 30, 2025, were $45.6 million, an increase of $8.4 million compared to $37.2 million for the same period in 2024[134]. - General and administrative expenses decreased by $3.8 million from $11.0 million for the three months ended September 30, 2024, to $7.2 million for the same period in 2025[136]. Losses and Financial Outlook - The net loss for the three months ended September 30, 2025, was $42.0 million, compared to a net loss of $31.2 million for the same period in 2024[134]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $103.8 million, with a net loss of $113.5 million[153]. - Interest income and other, net, decreased by $6.7 million for the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to lower investment balances[142]. - Income tax expense for the nine months ended September 30, 2025, was $0.6 million, compared to $0.7 million for the same period in 2024[143]. - The company anticipates its existing financial resources will be sufficient to fund planned operations through 2027[120]. Market Opportunity - In 2024, global net sales of branded HCV therapeutics exceeded $2.9 billion, with the US contributing approximately 50% of these sales, indicating a substantial market opportunity for HCV treatments[95]. - The company has identified several factors that could significantly impact the costs and timing of product development and commercialization[149]. - As of September 30, 2025, the company does not believe that inflation or interest rate changes have significantly impacted its results of operations[166].

November 12, 2025 Third Quarter Financial and Business Update 1 DISCLAIMERS Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future c ...

Financial Performance - Atea Pharmaceuticals reported a net loss of $42.0 million for Q3 2025, compared to a net loss of $31.2 million in Q3 2024, reflecting an increase of 34.7% year-over-year[28]. - Cash, cash equivalents, and marketable securities decreased to $329.3 million as of September 30, 2025, down from $454.7 million at December 31, 2024[21]. - Atea's financial position and operational results will be discussed in detail during the upcoming conference call[31]. Research and Development - Research and development expenses rose to $38.3 million in Q3 2025, up from $26.2 million in Q3 2024, primarily due to increased spending on the HCV Phase 3 clinical development program[22]. - The global Phase 3 program for HCV treatment is on track, with full enrollment expected in the C-BEYOND trial by the end of 2025 and topline results anticipated in mid-2026[3]. - The combination regimen of bemnifosbuvir and ruzasvir is being evaluated in two Phase 3 trials, each enrolling approximately 880 treatment-naïve patients[14]. - The primary endpoint for the Phase 3 trials is achieving HCV RNA below the lower limit of quantitation at 24 weeks, indicating sustained virologic response[15]. - New data presented at The Liver Meeting 2025 highlighted the regimen's high barrier to resistance and its high relative bioavailability[4]. - Atea's lead program focuses on bemnifosbuvir and ruzasvir for HCV treatment, aiming to address significant unmet medical needs[37]. - Atea plans to expand its pipeline by augmenting its nucleos(t)ide platform with other classes of antivirals[37]. - Atea acknowledges the inherent uncertainties in drug discovery and development, which could impact future results[38]. Market Opportunity - Approximately 240,000 deaths occur annually due to HCV, with an estimated 50 million people chronically infected worldwide[34]. - In the US, between 2.4 and 4.0 million people are estimated to have HCV, with annual new infections outpacing treatment rates[34]. - There are currently no approved antiviral therapies for HEV, highlighting a market opportunity for Atea's product candidate targeting immunocompromised patients[36]. - A survey indicated that 80% of HCV patients are on multiple medications, emphasizing the need for new treatment options with high efficacy and short duration[16]. Corporate Actions - Atea announced the expansion of its antiviral pipeline with a new hepatitis E virus (HEV) program, including two proprietary candidates with potent antiviral activity[6]. - Atea's Board of Directors authorized a stock repurchase program, completing the repurchase of 7,673,793 shares at an average price of $3.26 per share[24]. - Atea Pharmaceuticals will host a conference call on November 12, 2025, to report Q3 2025 financial results and provide a business update[31]. - The company is committed to updating its forward-looking statements as required by law, but disclaims any obligation to do so otherwise[38]. - The company emphasizes the potential best-in-class profile of the bemnifosbuvir/ruzasvir regimen for HCV treatment[38].

Core Insights - Atea Pharmaceuticals is advancing its global Phase 3 clinical program for the treatment of Hepatitis C Virus (HCV) with a combination regimen of bemnifosbuvir and ruzasvir, expecting topline results from the North American trial by mid-2026 [1][3][6] - New data presented at The Liver Meeting 2025 supports the antiviral potency and unique dual mechanism of action of bemnifosbuvir against HCV, positioning it as a potential best-in-class therapy [1][4][8] - The company is also expanding its antiviral pipeline with a new Hepatitis E Virus (HEV) development program, addressing unmet medical needs in immunocompromised patients [1][5][10] Patient Enrollment and Trials - Patient enrollment for the C-BEYOND trial in the US and Canada is on track to be completed by the end of 2025, while the C-FORWARD trial outside North America is expected to finish enrollment by mid-2026 [3][12] - Each Phase 3 trial is enrolling approximately 880 treatment-naïve patients, comparing the bemnifosbuvir and ruzasvir regimen to the existing regimen of sofosbuvir and velpatasvir [12][13] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $329.3 million, a decrease from $454.7 million at the end of 2024 [19][29] - Research and development expenses increased by $12.2 million year-over-year, primarily due to external spending related to the HCV Phase 3 clinical development program [20] Mechanism of Action - Bemnifosbuvir exhibits a unique dual mechanism of action against HCV, inhibiting both HCV RNA replication and the assembly/secretion of new virions, which enhances its antiviral efficacy [7][8] - The combination regimen of bemnifosbuvir and ruzasvir is designed to suppress the virus at multiple critical stages, potentially leading to a shorter treatment duration of approximately 7 to 8 weeks [14] Upcoming Events - Atea will host a virtual event on November 13, 2025, featuring leading HCV clinical experts discussing current challenges in HCV treatment and the potential benefits of next-generation therapies [16][17]

Core Insights - Atea Pharmaceuticals presents new modeling data indicating that the combination of bemnifosbuvir (BEM) and ruzasvir (RZR) achieves near-complete inhibition of hepatitis C virus (HCV) replication, with a modeled time to cure of approximately 7 to 8 weeks [1][5] - The Phase 2 study results show sustained virologic response rates (SVR12) of 98% in treatment-adherent patients and 95% overall, reinforcing the regimen's potential as a best-in-class treatment for HCV [1][16] - A virtual KOL panel event is scheduled for November 13, 2025, to discuss the implications of these findings and the ongoing Phase 3 clinical development program [9][10] Phase 2 Study Results - The combination regimen of BEM and RZR demonstrated a high barrier to resistance, with SVR12 rates unaffected by resistance-associated substitutions (RASs) [2][7] - The regimen's efficacy was supported by a resistance analysis indicating that most viral failures were due to treatment non-adherence rather than resistance [7] - The Phase 2 study involved 275 patients, with a notable 98% SVR12 rate in the per-protocol treatment-adherent population [16] Phase 1 Study Findings - A Phase 1 study showed high relative bioavailability of the BEM/RZR fixed-dose combination (FDC) formulation, which can be dosed with or without food [2][8] - The FDC formulation is currently being utilized in the ongoing Phase 3 program, indicating its readiness for broader clinical application [2][11] HCV Market Context - HCV remains a significant public health crisis, with new diagnoses outpacing cure rates despite the availability of direct-acting antiviral therapies [4][15] - An estimated 50 million people are chronically infected with HCV globally, with approximately 240,000 deaths occurring each year [13][15] - The need for optimized treatment options is critical, especially for patients with co-infections or those on concomitant medications [4][3] Upcoming Events - Atea will host a virtual investor event featuring leading HCV clinical experts to discuss current challenges in HCV treatment and the potential benefits of next-generation therapies [9][10] - The event will provide insights into the HCV commercial market opportunity and updates on the ongoing global Phase 3 clinical development program [10][11]