Atea Pharmaceuticals, Inc. Q4 FY2024 earnings call

• Advancement of HCV program: Made progress in 2024 with bemnifosbuvir and ruzasvir regimen, achieving a 98% cure rate in phase two trial. Had a successful end-of-phase two meeting with the FDA in January.
• Phase three initiation: Initiating global phase three HCV program, expecting enrollment to begin in April 2025, targeting over 250 sites worldwide.
• Cost-cutting: Reduced workforce by ~20-25% in early January to enhance efficiency, expected to save ~$15 million through 2027.
• Board update: Appointed new independent director Arthur Kirsch with financial and strategic advisory experience.

Atea Pharmaceuticals' focus was on its HCV program. In 2024, R&D expenses saw a year-over-year increase due to external spend related to the COVID-19 phase three Sunrise-3 trial and the phase two HCV trial. SG&A expenses were stable quarter over quarter and year over year. Interest income decreased due to lower investment balances. The HCV program made significant progress, with a phase two trial showing a 98% cure rate, leading to a successful end-of-phase two meeting with the FDA. The HCV market is approximately $3 billion annually, and the company is advancing its phase three program.

• Initiating global phase three HCV program with enrollment expected in April 2025.
• Strong financial position: $454.7 million in cash, cash equivalents, and marketable securities as of December 31, 2024, with cash runway extending into 2028.
• Phase three program de-risked: Believed to have a compelling value proposition based on robust phase two results and multiscale modeling.

• Uncertainties in clinical trial outcomes and regulatory approvals for the HCV program.
• Potential impact of competitive therapies and market dynamics on the commercial success of the bemnifosbuvir and ruzasvir regimen.

Q: Following your meeting with the FDA, are there any specific callouts that they've guided for in the phase three trial design?

A: No, the FDA is aligned with the approach of two open-label phase three trials and did not have substantive comments on the trial conduct.

Q: What can we expect in terms of the scope of your phase two readout later this half?

A: Expect to present data this summer at EASL in May with additional efficacy and safety details.

Q: On the trial design for the phase three program, estimated number of cirrhotic patients across those two trials?

A: Targeting just north of 10% of cirrhotic patients, with flexibility in enrollment numbers