Arcus Biosciences Q2 Earnings Call Highlights

Casdatifan is Arcus’ top priority: The company is expanding the HIF-2 alpha inhibitor’s development across first-, second- and later-line clear cell renal cell carcinoma, with data from more than 200 patients expected at an October investor event. The Phase III PEAK-1 trial remains on track to complete enrollment by the end of 2026. Arcus is advancing additional pipeline programs, including the Phase III PRISM-1 pancreatic cancer study, which is expected to produce initial data in the first half of 2027, and AB102, an oral immunology candidate slated to begin human dosing this month. Second-quarter cash totaled $775 million, while revenue reached $41 million, primarily from collaborations. Management expects to end 2026 with about $600 million in cash and investments, providing runway into at least the second half of 2028.

Arcus Biosciences outlined plans to expand development of its casdatifan cancer program across multiple lines of clear cell renal cell carcinoma, or ccRCC, while reporting second-quarter financial results and updates on its pancreatic cancer and immunology pipelines. Chief Executive Officer Terry Rosen said casdatifan, an investigational HIF-2 alpha inhibitor, remains the company’s top priority. Arcus is pursuing combinations designed to position the drug as a treatment option in first-line, second-line and later-line ccRCC. The company expects to present data from more than 200 patients across its casdatifan program at an investor event in October, ahead of the European Society for Medical Oncology meeting. The planned disclosures are expected to include results from first-line, second-line and late-line cohorts in Arcus’ ARC-20 platform study.

Arcus’ first registrational casdatifan study, the Phase III PEAK-1 trial, is evaluating casdatifan plus cabozantinib against cabozantinib in patients with previously treated ccRCC. Rosen said enrollment remains on track to finish by the end of 2026. Chief Medical Officer Richard Markus said Arcus expects to disclose more mature objective response rate and progression-free survival data from approximately 45 second-line patients receiving casdatifan plus cabozantinib, with at least 18 months of follow-up. The company may also have an early look at overall survival, he said.

In the first-line setting, Arcus plans to initiate PEAK-20, a registrational Phase III trial of casdatifan combined with ipilimumab and nivolumab, by the end of 2026. Rosen said the company has discussed the study with the FDA. ARC-20 also includes a cohort evaluating casdatifan with zimberelimab, Arcus’ anti-PD-1 antibody. Markus said enrollment in that cohort was completed early this year and that the company previously reported a 7% primary-progression rate, representing two of 30 patients. Arcus expects to report objective response rate data, waterfall plots and spider plots with approximately 11 months of follow-up. Another ARC-20 cohort is evaluating casdatifan, zimberelimab and ipilimumab. Arcus expects enrollment to complete soon and plans to share initial safety data and preliminary primary-progression data later this year. The company also plans a first-line cohort evaluating casdatifan plus axitinib, with initiation expected in the fourth quarter. In addition, Arcus has established collaborations with Bristol Myers Squibb and Summit Therapeutics to study casdatifan with anti-PD-1/VEGF bispecific antibodies in first-line ccRCC. BMS will study casdatifan-containing regimens in its ROSETTA RCC-208...