Atea Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Global Phase III HCV program is on track; CBEYOND enrollment to complete next month with top-line results mid-2026; Sea Forward enrollment mid-2026, top-line late 2026.
• New modeling data at Liver Meeting 2025 demonstrated antiviral potency with short treatment duration for HCV regimen.
• New research findings showed bemifovir has a unique dual mechanism of action against HCV.
• Expanded antiviral hepatitis pipeline for immunocompromised hepatitis E patients, with two new potent candidates from nucleotide platform, IND enabling studies ongoing, Phase I initiation anticipated mid-2026.
• Strong balance sheet with ~$329.3 million in cash, cash equivalents, and marketable securities, providing runway through 2027.
• Presentations at Liver Meeting highlighted combination regimen's clinical and pharmacologic profile, resistance analysis, and pharmacokinetic data.
• Virtual panel event on HCV topics on November 13 to discuss various HCV-related topics.
• Phase III program comparing regimen to sofosbuvir/velpatasvir, no drug-drug interaction risk with proton pump inhibitors, 98% SVR12 in Phase II.
• HEV program details: no approved therapies, potential orphan drug designation, preclinical data on candidates showing potent activity against HEV genotypes.

No detailed product segment financial performance with revenue contribution percentages provided in the transcript.

• CBEYOND enrollment to complete next month, with top-line results in mid-2026; Sea Forward enrollment mid-2026, top-line results late 2026.
• Anticipate Phase I initiation mid-2026 for HEV candidates from nucleotide platform.
• Strong cash position provides runway through 2027 to fund Phase III program, launch new regimen, and advance HEV development program.

• Today's discussion contains forward-looking statements involving risks and uncertainties outlined in press release and company's recent SEC filings.
• Actual results may differ materially from forward-looking statements discussed.

Q: How does your recent dataset 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?

A: Dr. Janet Hammond explains that Epclusa has a contraindication for concomitant use with H2 reducing therapy and recommends a four-hour window between dosing, while proton pump inhibitor use is widespread in HCV patients (estimated 35% of HCV patients), and their regimen avoids this issue as it doesn't compromise efficacy due to no such interaction.

Q: From the modeling poster that you presented at AASLD, there is a chart showing time to undetectable with separation between genotype one and genotype three, and curiosity about significance and relation to the dual mechanism announced earlier.

A: Jean-Pierre Sommadossi states that the modeling suggests more rapid decline with genotype three, noting bemifovir is more potent in vitro against genotype three than genotype 1a or 1b, and this aligns with Phase II results where there was 100% cure in genotype three non-cirrhotic patients.

Q: The compound outlined for hepatitis E doesn't employ the protide technology; curious about deliberate decision or optimization context.

A: Jean-Pierre Sommadossi explains the compound does use phosphoramidate prodrug technology, with only a fluorine atom differentiating the active triphosphate metabolite, and these candidates are more potent in vitro against HEV compared to ribavirin, with specific binding rationale related to the fluorine atom in the sugar ring.