Atea Pharmaceuticals (AVIR) investor relations material

Clinical program updates

• Phase III trials for Bemnifosbuvir and ruzasvir in Hepatitis C are progressing, with North American enrollment completed and global enrollment ahead of schedule; top-line data expected Q3 and Q4 this year, and NDA filing planned for Q1 2027.

• The regimen targets all HCV genotypes, with head-to-head trials against standard of care, aiming for a pan-genotypic label and short treatment duration; Phase 3 trials (C-BEYOND, C-FORWARD) compare BEM/RZR to sofosbuvir/velpatasvir, targeting ~1,760 patients globally.

• Phase II data showed a 98% cure rate (SVR12), and the regimen is designed for minimal drug-drug interactions, supporting a test-and-treat model for broader patient access; no drug-related serious adverse events reported.

• Commercial launch preparations are underway, with manufacturing and packaging in place, and launch readiness targeted for late 2027 or early 2028.

• Financial position is strong, with over $300 million in cash and investments, providing runway through 2027 and supporting both HCV and Hepatitis E programs.

Market and disease landscape

• Despite effective treatments, HCV prevalence in the U.S. has increased to over 4 million, driven by new infections outpacing treatment, especially among younger populations affected by the opioid crisis.

• Experts predict a 50% rise in liver cancer cases over the next five years, with HCV as a major contributor.

• The test-and-treat model, supported by rapid diagnostics and bipartisan legislative efforts, is seen as key to expanding treatment and curbing the epidemic.

• Commercial opportunity for the new regimen is estimated at over $1 billion, with high prescriber and payer interest in the U.S.; market research indicates high willingness to adopt BEM/RZR, with limited competition.

• The global HCV market is valued at $3 billion, with the U.S. representing about half.

Hepatitis E program

• A new clinical candidate, AT-587, has been selected for Hepatitis E, targeting immunocompromised patients in developed countries, with proof-of-concept studies starting by year-end and Phase 1 clinical study planned for mid-2026.

• The program focuses on foodborne transmission, especially in organ transplant recipients, with a significant unmet need and orphan drug potential; HEV causes up to 20M global infections annually, with no approved treatments for chronic cases.

• AT-587 shows high potency in vitro and in animal models, including activity against resistant strains, and demonstrates favorable preclinical safety and pharmacokinetics.

• Phase Ib will test 12-week regimens in small cohorts, with rapid assessment of efficacy and dose selection; Phase 2/3 trials anticipated in 2027.

• Estimated US/EU commercial opportunity for HEV is $750M–$1B, targeting high-risk populations such as transplant recipients.