May 5, 2026 — Leads & Copy — Arcus Biosciences, Inc. (NYSE:RCUS) has released its financial results for the first quarter ended March 31, 2026, along with an update on its clinical-stage investigational molecules and discovery programs.
Terry Rosen, Ph.D., CEO of Arcus, stated that the company is entering a new era, highlighting casdatifan’s potential as a first-line treatment and a portfolio of wholly-owned molecules for inflammation and immunology.
Arcus is prioritizing the establishment of casdatifan as a standard of care in kidney cancer, aiming to provide patients with access to casdatifan-based regimens across various lines of treatment.
The company is focused on completing enrollment for the PEAK-1 trial and initiating a Phase 3 study in the first-line setting by the end of 2026, with casdatifan potentially becoming the first HIF-2a inhibitor-based, TKI-free option.
Arcus is developing casdatifan as a backbone therapy in clear cell renal cell carcinoma (ccRCC), with a strategy to ensure patients can benefit from it throughout their care. The company is executing a strategy to integrate casdatifan into the treatment paradigm, including combinations with anti-PD-1 and anti-CTLA-4 regimens. A cohort in the Phase 1/1b ARC-20 study is currently enrolling to support the initiation of a Phase 3 study by year-end 2026. Arcus also plans to evaluate casdatifan with TKI-containing regimens in first-line and late-line settings.
Enrollment in the global Phase 3 PEAK-1 study, which evaluates casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC, is accelerating, with completion expected by year-end 2026.
Arcus has been evaluating casdatifan-based TKI-free regimens, which have shown a consistently low rate of primary progression. Casdatifan plus zimberelimab (anti-PD-1) showed a primary progression rate of 7% (2 of 30 patients) in the ARC-20 cohort, which is now fully enrolled. A cohort evaluating casdatifan plus zimberelimab and ipilimumab in ARC-20 is currently enrolling to support Arcus’s first Phase 3 study in the first-line setting.
Arcus anticipates multiple data readouts for casdatifan in 2026, including mature overall response rate and initial progression-free survival data for approximately 45 patients in the ARC-20 cohort evaluating casdatifan plus cabozantinib in the IO-experienced setting. Initial data from ARC-20 cohorts evaluating casdatifan in early-line settings, including the cohort evaluating casdatifan plus zimberelimab in 1L ccRCC, and updated data from ARC-20 late-line monotherapy cohorts including overall survival (OS) data are also expected.
Enrollment for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma, was completed in September 2025. Results are expected in the first half of 2027.
In April 2026, Arcus discontinued the Phase 3 STAR-121 study evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC), based on a recommendation from the Independent Data Monitoring Committee. The domvanalimab-based combination did not improve OS relative to pembrolizumab plus chemotherapy. STAR-121 and the Phase 2 EDGE-Lung study will be discontinued.
AB102, an oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, is expected to enter the clinic in the third quarter of 2026. Arcus will present the preclinical profile for AB102 at the Society for Investigative Dermatology Annual Meeting in May.
A development candidate for an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis, and inflammatory bowel disease, is expected to enter the clinic in early 2027. Arcus has also selected an orally active small-molecule antagonist of CCR6 as a development candidate for potential treatment of psoriasis and expects it to enter the clinic in the first half of 2027.
Arcus reported $876 million in cash, cash equivalents, and marketable securities as of March 31, 2026, compared to $1.0 billion as of December 31, 2025. The company believes its cash will be sufficient to fund operations until at least the second half of 2028 and expects to end 2026 with approximately $600 million in cash.
Revenues were $17 million for the first quarter 2026, compared to $28 million for the same period in 2025, primarily due to lower development services revenue from the Gilead collaboration. Arcus expects to recognize GAAP revenue of between $50 million and $65 million for the full year 2026.
Research and Development (R&D) expenses were flat for the first quarter 2026. General and Administrative (G&A) Expenses were $29 million for the first quarter 2026, compared to $28 million for the same period in 2025.
Net loss was $128 million for the first quarter 2026, compared to $112 million for the same period in 2025.
Arcus Biosciences will host a conference call and webcast today, May 5, 2026, at 1:30 PM PT/4:30 PM ET to discuss these results.
Arcus Biosciences is focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases.
Source: Arcus Biosciences
