Arcus Biosciences, Inc.

What they do

Arcus discovers and develops small-molecule and antibody therapies internally, currently focused on cancer with an emerging wave of inflammation and autoimmune programs. Its lead asset is casdatifan, an oral HIF-2 inhibitor, which is being studied across multiple lines of ccRCC treatment in the ARC-20 platform study and the Phase 3 PEAK-1 trial. Partnered assets include domvanalimab (anti-TIGIT) and quemliclustat, developed with Gilead, and zimberelimab, its anti-PD-1 antibody used in combination cohorts. Taiho holds rights to casdatifan in Japan and certain Asian territories.

Revenue drivers

• Gilead collaboration — Upfront, milestone, R&D support and clinical materials reimbursement from Gilead under the 2020 agreement covering domvanalimab, quemliclustat and related programs; the main historical source of reported revenue, with option rights on new early-stage programs ending July 14, 2026.
• Taiho license (casdatifan) — Option and license agreement for casdatifan in Japan and certain Asian countries; includes milestone payments, such as the $15 million triggered by PEAK-1 enrollment in Japan expected in the third quarter of 2026.
• Other collaborations and reimbursements — Clinical trial collaboration and supply agreements, including with Bristol Myers Squibb, Summit Therapeutics and AVEO Oncology, plus research support and clinical materials reimbursement; these contributed to the $33 million in revenue reported for the quarter ended June 30, 2026.

Recent performance

Annual revenue was $33 million in 2025, down from $51 million in 2024, while net loss widened to $353 million from $283 million. Operating cash flow was negative $482 million in 2025, compared with negative $170 million in 2024. In the second quarter of 2026, revenue rose to $33 million from $7 million in the first quarter of 2026. Shareholder equity was $464 million and cash and equivalents $150 million at June 30, 2026, though the company reported $775 million in cash, cash equivalents and marketable securities at quarter-end. Two Phase 3 TIGIT studies, STAR-121 and PACIFIC-8, were discontinued in 2026.

Strategy

Arcus is positioning casdatifan as a backbone therapy across every line of ccRCC treatment, combining it with standard-of-care regimens such as cabozantinib in second-line and nivolumab plus ipilimumab in first-line. The first Phase 3 trial, PEAK-1, evaluates casdatifan plus cabozantinib in patients with prior immunotherapy, and a second Phase 3 trial in TKI-free first-line ccRCC is targeted for initiation by the end of 2026. The company is adding parallel casdatifan combinations through collaborations with BMS, Summit Therapeutics and AVEO Oncology. Management states it is well positioned to advance casdatifan aggressively with cash runway until at least the second half of 2028.

Risks

• No product revenue and recurring losses — Arcus has never generated revenue from product sales, reported a net loss of $353 million for 2025 and an accumulated deficit of $1.5 billion as of December 31, 2025.
• Clinical trial failures or delays — The Phase 3 STAR-121 and PACIFIC-8 trials for domvanalimab were discontinued in 2026, illustrating the risk that later-stage programs, including casdatifan's PEAK-1, may not succeed.
• Dependence on collaborations — Revenue has come primarily from Gilead and Taiho upfront, milestone, R&D support and reimbursement payments, and Gilead's option rights to additional early-stage programs ended in July 2026.
• Capital needs — Operating cash flow was negative $482 million in 2025, and advancing multiple Phase 3 casdatifan studies and collaborations will require substantial additional funding beyond the stated runway to at least the second half of 2028.

Outlook

Management expects multiple ARC-20 data readouts for casdatifan in the second half of 2026, including initial efficacy for casdatifan plus zimberelimab in first-line, PFS for casdatifan plus cabozantinib in second-line, and overall survival for casdatifan monotherapy in late-line ccRCC. Arcus targets initiation of the second Phase 3 trial in TKI-free first-line ccRCC by the end of 2026. The company states it is well positioned to advance casdatifan aggressively with cash runway until at least the second half of 2028.