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Atea Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Globenewswire· 2026-03-05 21:05
Core Insights - Atea Pharmaceuticals is advancing its global Phase 3 program for the treatment of Hepatitis C Virus (HCV) with topline results from the North American C-BEYOND trial expected in mid-2026 and from the C-FORWARD trial outside North America anticipated by year-end 2026 [1][4] - The company is also expanding its antiviral pipeline with a new Hepatitis E Virus (HEV) program, with the lead product candidate AT-587 expected to enter clinical development in mid-2026 [1][11] HCV Program - The global Phase 3 program evaluates the fixed-dose combination of bemnifosbuvir (BEM) and ruzasvir (RZR) for chronic HCV treatment, with over 880 patients enrolled in C-BEYOND and completion of C-FORWARD enrollment expected by mid-2026 [4][5] - The primary endpoint for both trials is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks, assessing sustained virologic response 12 weeks post-treatment (SVR12) [5] - Previous Phase 2 clinical study results showed an 8-week regimen of BEM/RZR achieved 98% SVR12 in treatment-adherent patients and 95% in the efficacy-evaluable population, indicating a strong potential profile [6][10] KOL Engagement and Market Need - Key opinion leaders (KOLs) have emphasized the need for a new optimized HCV regimen to address treatment challenges and support the test-and-treat model of care, which facilitates rapid diagnosis and immediate treatment initiation [9][10] - The BEM/RZR regimen is positioned to meet the demand for high efficacy and practical usability, offering a short treatment duration and low risk of drug-drug interactions (DDIs) [10] HEV Program - Atea's HEV program includes two novel candidates, AT-587 and AT-2490, with AT-587 selected as the lead product candidate due to its potent antiviral activity against HEV [11][12] - In vitro results indicated that AT-587 and AT-2490 were 30-150 times more potent against HEV compared to existing treatments like sofosbuvir and ribavirin, with no observed toxicity [13] Financial Overview - As of December 31, 2025, Atea reported cash and investments of $301.8 million, a decrease from $454.7 million in 2024 [16] - Research and development expenses increased to $148.0 million for the full year 2025, driven by external spending on HCV Phase 3 clinical development [17] - General and administrative expenses decreased to $32.9 million for the full year 2025, primarily due to lower stock-based compensation [18] Summary of Financial Results - The company reported a net loss of $158.3 million for the full year 2025, compared to a net loss of $168.4 million in 2024 [21] - The total operating expenses for the fourth quarter of 2025 were $54.9 million, up from $39.0 million in the same period of 2024 [21]