Arcus Biosciences (RCUS) Q4 2025 earnings summary

Executive summary

• Casdatifan demonstrated best-in-class efficacy in late-line RCC, with a confirmed ORR of 45% and median PFS of 15.1 months in the 100mg cohort, outperforming belzutifan and standard TKIs, and is advancing through multiple Phase 3 programs.

• The company maintains a robust oncology and immunology portfolio, including five emerging I&I programs and late-stage assets like quemliclustat, with plans for 1–2 new molecules entering the clinic annually.

• Multiple data presentations for casdatifan are planned in 2026, including mature combination data and early-line results, with new biomarker data linking erythropoietin suppression to clinical benefit.

• The PEAK-1 Phase III study for casdatifan plus cabozantinib in IO-experienced ccRCC is actively enrolling globally, with completion targeted by year-end.

• Quemliclustat is the only small molecule CD73 inhibitor in clinical development, with a completed Phase 3 trial in 1L pancreatic cancer and results expected in 2027.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $1.0 billion at year-end 2025, up from $841 million in Q3, providing funding runway until at least the second half of 2028.

• Q4 2025 GAAP revenue was $33 million, primarily from collaborations, with full-year 2026 GAAP revenue projected at $45–$55 million.

• R&D expenses for Q4 2025 were $121 million, with G&A expenses at $26 million and non-cash stock-based compensation at $15 million.

• Net loss for Q4 2025 was $106 million, compared to $94 million in Q4 2024.

• $288 million was raised in November 2025, with additional capital from stock issuances, loans, and milestone payments.

Outlook and guidance

• Cash and investments are expected to fund operations until at least the second half of 2028.

• Operating and R&D expenses are expected to decrease meaningfully in 2026, with further guidance dependent on the STAR-121 futility analysis.

• Multiple clinical milestones are expected in the next 12–24 months, including Phase 3 data readouts for PRISM-1 (pancreatic cancer) and PEAK-1 (RCC), and first-in-human studies for MRGPRX2 and TNF inhibitors.

• At least two casdatifan data readouts are planned for 2026, including mature ORR and initial PFS data in IO-experienced and early-line settings.