Arcus Biosciences, Inc. Q1 FY2025 earnings call

Key Points

• Terry Rosen emphasized casdatifan as the top priority, with positive data from ARC-20 and plans to bring it to market quickly. Highlighted collaboration with AstraZeneca for cas plus volrustomig in first-line RCC.
• Richard Markus discussed ARC-20 study details, including eight cohorts evaluating cas monotherapy and combinations in clear cell RCC, and upcoming data presentations at ASCO.
• Jennifer Jarrett spoke about the RCC market opportunity and casdatifan's potential to displace TKIs in earlier lines.
• Bob Goeltz reviewed financials, noting expected 2025 GAAP revenue of $75M to $90M and R&D expenses related to ongoing programs.

No detailed product segment financial performance with revenue contribution % provided. GAAP revenue for first quarter was $28 million, compared to $36 million in the fourth quarter of last year. R&D expenses for the first quarter were $122 million net of Gilead reimbursements, compared to $111 million in the fourth quarter. G&A expenses were flat at $28 million. Total non-cash stock based compensation was $16 million.

Forward-Looking Statements

• Expected GAAP revenue for 2025 is $75 million to $90 million.
• PRISM-1, the Phase 3 trial of quemli in first-line pancreatic cancer, is expected to be fully enrolled by the end of 2025.
• PEAK-1, the Phase 3 trial of cas plus cabo in clear cell RCC, is expected to enroll quickly due to high clinician interest and use of cabo in both arms.

Risks

• Macro environment risks that could impact resource deployment.
• Differences between actual results and forward-looking statements due to uncertainties.
• Competitive landscape risks, such as other companies' similar trials affecting market position.

Q: Could you talk through pipeline reprioritization and the adenosine inhibitor program?

A: Terry Rosen mentioned the adenosine modulator etruma program is not moving forward at present, with focus on late-stage programs casdatifan, dom, and quemli. Early-stage inflammation and immunology programs will be disclosed later.

Q: What should we expect from the ASCO oral presentation versus the abstract?

A: Terry Rosen stated the abstract is a placeholder, and the oral presentation will include more recent data, including safety and efficacy data for ~25 patients in the cas plus cabo cohort.

Q: Timing for PEAK-1 PFS primary and comparison to Lightspark XI?

A: Jennifer Jarrett said PEAK-1 enrollment is expected to be quick, and while Lightspark XI has a dual endpoint, PEAK-1 has a single PFS endpoint, narrowing the gap in readout timing.

Q: Post Gilead decision, plan to fund cas to completion or seek partnership?

A: Terry Rosen stated Arcus feels confident in executing PEAK-1 independently, with potential for collaborations on an opportunistic basis.

Q: Choice of 100 mg dose for cas in Phase 3 and post-IO cohort makeup?

A: Richard Markus and Jennifer Jarrett discussed the 100 mg dose showing good efficacy and safety, and the post-IO cohort in ARC-20 has a mix of patients, with ORRs similar to those with prior TKI exposure.