Arcus Biosciences (RCUS) Investor Day 2026 summary

Strategy and market opportunity

• Casdatifan development targets first-, second- and late-line clear cell RCC with ipilimumab/nivolumab, cabozantinib and tivozanib combinations; ambition is a treatment backbone across lines.

• Estimated opportunity: $4B+ in first line, $2B+ in second line and $1B+ in late line, within a stated $5B–$10B overall market.

• Market plan aims to grow first-line use from ~10% to more than 50%, lead in second line with casdatifan + cabozantinib and build late-line share with casdatifan + tivozanib.

• R&D model targets 1–2 new molecules entering the clinic annually; an immunology molecule entered clinical development in Q3 2026, and a quemli registrational-trial interim analysis was expected that quarter.

• Cash, cash equivalents and marketable securities were $775M at June 30, 2026, with estimated funding through at least 2H 2028 based on planned operations.

Clinical evidence across treatment lines

• Pooled late-line monotherapy data (n=121; median follow-up 28 months) showed 36% confirmed ORR, 13.0-month median PFS and 34.7-month median OS; 52% had received at least three prior lines.

• Late-line results compared favorably with belzutifan benchmarks: ORR 36% vs 23%, PFS 13.0 vs 5.6 months, and 24-month OS 67% vs 45%; cross-trial comparisons are not head-to-head.

• Second-line casdatifan + cabozantinib (n=43; median follow-up 21.3 months) showed 14.5-month median PFS, 44% confirmed ORR, 95% disease control, 5% primary progression and 77% 18-month OS; activity was similar with or without prior TKI.

• First-line casdatifan + zimberelimab (n=30; median follow-up 11.5 months) showed 50% confirmed ORR, 6.7% primary progression and 69% 12-month PFS vs 50% historical ipilimumab/nivolumab PFS; comparisons are cross-trial.

• Frontline casdatifan + ipilimumab + zimberelimab had one primary progression among 24 patients with a scan and no unexpected safety signals.

Development plan and milestones

• Phase 3 PEAK-1 evaluates casdatifan + cabozantinib vs placebo + cabozantinib in 720 previously anti-PD-(L)1-treated second-line patients; PFS is primary and OS a key secondary endpoint.

• Phase 3 PEAK-20 compares casdatifan + nivolumab + four induction cycles of ipilimumab with nivolumab + ipilimumab; initiation was expected in Q4 2026, with PFS as the sole primary endpoint and all IMDC risk groups included.

• Planned late-line Phase 3 study compares casdatifan + tivozanib with tivozanib; ARC-20 was enrolling patients with prior HIF-2 inhibitor exposure, while the Phase 3 plan includes all comers.

• Planned programs include PEAK-21, evaluating casdatifan + axitinib + anti-PD-1; further Phase 3 starts and ARC-20 combination data were planned for 2027.

• ARC-20 had treated more than 300 patients across cohorts; additional 2027+ data were planned for late-line casdatifan + tivozanib and first-line combinations.