Company: RCUS
Filing Date: 2025-10-28
Form Type: 10-Q
Source: 0001724521-25-000116
Chunk: 339

Company: Arcus Biosciences, Inc.
Filing Date: 2025-10-28
Form: 10-Q
Item: Part I, Item 2
Chunk 339
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.S. for domvanalimab, zimberelimab and quemliclustat. Gilead holds commercialization rights outside of the U.S. subject to any third-party rights.

**+/- biologic, e.g. bevacizumab or biosimilar, will be included for all patients in whom it is not contraindicated.

21

Significant Developments

The following is a summary of the recent significant developments affecting our business:

Corporate Developments

•In October 2025, Taiho exercised its option for an exclusive license to casdatifan, an investigational small molecule HIF-2α inhibitor, in Japan and certain other territories in Asia (excluding mainland China). In exchange, Taiho will make an option exercise payment to us along with milestone payments upon the achievement of clinical, regulatory and commercialization milestones, and, additionally pay royalties on net sales.

HIF-2α Program (casdatifan)

•In October 2025, we presented new data for our HIF-2α inhibitor, casdatifan, across all four monotherapy cohorts (n=121) of the Phase 1/1b ARC-20 study in late-line metastatic kidney cancer, most of whom had progressed on at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor ("TKI"). At the time of data cut-off (August 15, 2025):

◦For the pooled analysis of all four monotherapy cohorts, with 15.2 months of median follow-up: median progression-free survival ("mPFS") was 12.2 months, the 18-month landmark PFS was 43%, the 12-month landmark PFS was 50% and the confirmed overall response rate ("cORR") was 31%.

◦For the 100mg QD cohort (the Phase 3 PEAK-1 dose and formulation), with 12.4 months of median follow-up: mPFS was not reached, the 18-month landmark PFS was not reached; the 12-month landmark PFS was 60% and the cORR was 35%.

◦No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses. Across all four cohorts, one patient discontinued treatment due to anemia, and four patients (3%) discontinued due to hypoxia.

•