Phase III HCV program on track with imminent topline readouts
Completed enrollment for the North American trial C-BEYOND (company reported completion in December) and expect topline results for C-BEYOND midyear and for global C-FORWARD by year-end; combined program expected to enroll >1,760 patients across both trials; studies are randomized 1:1 versus standard of care and powered 90% with a 5% non-inferiority margin.
Strong Phase II efficacy supporting potential best-in-class profile
Phase II (n=275) 8-week bemnifosbuvir+ruzasvir regimen achieved 98% SVR12 in the per-protocol treatment-adherent population and 95% SVR12 in the efficacy-evaluable (mITT) population; regimen demonstrated high barrier to resistance and multi-mechanism antiviral activity.
Favorable safety/administration and drug-drug interaction profile
Regimen has low risk for drug-drug interactions (including proton pump inhibitors and standard HIV therapy), no food effect, and no dose adjustment required for hepatic or renal impairment—features that support convenience and potential suitability for the test-and-treat model.
Commercial preparation and prescriber interest
Company is preparing commercial launch (anticipated focused specialty sales force ~75 people), low cost of goods relative to net price, blister pack dosing for adherence, and independent market research (IQVIA, 153 high-prescribers) indicating physicians would likely prescribe the regimen to ~50% of their HCV patients; payers expressed interest in formulary inclusion.
Strong financial position and runway
Cash, cash equivalents and marketable securities of $301.8 million as of December 31, 2025; company expects cash runway to extend through 2027 and to prioritize spending on completing Phase III and prelaunch activities.
Strategic expansion into Hepatitis E (HEV) with lead AT-587
Selected AT-587 as lead HEV candidate after supporting in vitro and in vivo data showing potent nanomolar activity (genotype 3) and conversion to active triphosphate in human hepatocytes; plan to initiate first-in-human study midyear with proof-of-concept expected by year-end and potential Phase II/III in H2 2027; estimated HEV market opportunity $750M–$1B annually (orphan potential).
Scientific validation and visibility
Presented datasets at EASL 2025, AASLD Liver Meeting 2025, CROI 2026 and JPM 2026 reinforcing regimen profile and AT-587 preclinical data, including data demonstrating additional antiviral mechanisms (inhibition of HCV virion assembly/secretion).
Capital return and disciplined spending
Returned $25 million to shareholders via share repurchase in 2025 while increasing R&D spend to advance Phase III programs and reducing G&A through lower stock-based compensation; company emphasizes financial discipline while funding core programs.