Atea Pharmaceuticals (AVIR) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Program and Clinical Development Updates

• Plans to initiate a global phase III program for bemnifosbuvir and ruzasvir in HCV during Q1 2025, following positive phase II data and an upcoming FDA meeting scheduled for January 2025.

• Phase III will enroll 1,600 patients across US/Canada and international sites, stratified by cirrhosis and genotype, with two open-label trials and head-to-head comparisons against current standards.

• The regimen is a fixed-dose combination tablet, with anticipated commercial launch and patent protection until at least 2042.

• Phase III trial costs are estimated at $200 million, with a cash runway of $454.7M as of 12/31/24, sufficient to fund operations through at least 2028.

• Central IRB approval, draft protocols, and commercial-scale manufacturing readiness are in place, pending final FDA guidance.

Clinical Efficacy, Safety, and Product Profile

• Phase II study showed a 98% cure rate (SVR12) in adherent patients and 95% in the overall population, including non-adherent patients.

• Non-cirrhotic, treatment-adherent patients achieved 99% SVR12 across genotypes, including 100% in genotype 3.

• The regimen demonstrated a favorable safety profile, with no severe drug-related adverse events or treatment discontinuations.

• Drug forgiveness is a key feature, maintaining high cure rates despite 20% non-adherence, and the regimen shows minimal drug-drug interactions, with most concomitant medications permitted.

• The regimen offers short treatment duration, pan-genotypic coverage, low DDI risk, and no food effect.

Market Opportunity and Competitive Landscape

• The global HCV market is valued at $3 billion annually, with the US HCV market estimated at over $20B potential and $1.5B US net sales in 2023.

• HCV remains undertreated, with 2.4–4 million untreated in the US, 50 million infected globally, and over 160,000 new annual infections in the US.

• Only two main products currently dominate the market, with no competitors in clinical development.

• Third-party research indicates strong prescriber and payer interest, with 89–90% of US prescribers responding positively to the regimen's profile.

• Third entrants with differentiated profiles have historically captured 30%+ market share, and the regimen is expected to achieve 35–40% based on its profile.