Arcus Biosciences Q3 2024 Financial Results and Pipeline Update

Arcus Biosciences, Inc., a clinical-stage biopharmaceutical organization, has disclosed its financial outcomes for the third quarter ending September 30, 2024, alongside updates on its clinical-stage investigational treatments targeting TIGIT, HIF-2a, CD73, A2a/A2b receptors, CD-39, AXL, and PD-1 in various cancer types.

CEO Terry Rosen, Ph.D., highlighted the year’s progress, noting significant data presented at medical conferences that have mitigated risks in several programs. Key developments include the advancement of Arcus’s HIF-2a inhibitor, casdatifan, for clear cell renal cell carcinoma (ccRCC), and their Fc-silent anti-TIGIT antibody, domvanalimab, for lung and upper gastrointestinal cancers. Rosen emphasized the upcoming Phase 3 readout for domvanalimab in gastric cancer and the aggressive progression of casdatifan’s development plan, especially in collaboration with AstraZeneca for IO-naive ccRCC and the Phase 3 PEAK-1 study planned for 2025.

In October 2024, Arcus announced a clinical collaboration with AstraZeneca to evaluate casdatifan with AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody, volrustomig, in IO-naive ccRCC patients. AstraZeneca will manage the study, marking their second collaboration with Arcus. Gilead retains the right to opt into casdatifan’s development and commercialization after a qualifying data package is submitted.

Pipeline highlights include:
- Casdatifan, a HIF-2a inhibitor, showed promising Phase 1/1b data in metastatic ccRCC with an objective response rate (ORR) of 34%, a low primary progression rate of 19%, and an 81% disease control rate. Median progression-free survival (PFS) was not reached at the data cutoff. Arcus aims to start the Phase 3 PEAK-1 study for casdatifan in the first half of 2025.
- Domvanalimab, combined with zimberelimab, an anti-PD-1 antibody, showed superior PFS, overall survival, and ORR compared with zimberelimab or chemotherapy in the ARC-10 study for PD-L1 high NSCLC. A significant reduction in the risk of death (hazard ratio [HR]=0.64) was observed for the combination compared to zimberelimab alone. Treatment-related adverse events leading to discontinuation were low (10.5%).
- Updates on the EDGE-Gastric study for upper GI adenocarcinomas, evaluating domvanalimab plus zimberelimab and chemotherapy, are expected in 2025.

Additionally, Arcus has initiated the Phase 3 PRISM-1 trial of quemliclustat, a CD73 inhibitor, combined with gemcitabine/nab-paclitaxel versus the same chemotherapy regimen alone in pancreatic cancer. Early clinical programs include AB801, an AXL inhibitor, which is in the dose-escalation phase of a Phase 1/1b study.

Financially, Arcus reported $1.1 billion in cash, cash equivalents, and marketable securities as of September 30, 2024, up from $866 million at the end of 2023. This increase is primarily attributed to Gilead’s $320 million equity investment in January 2024, a $100 million option continuation payment from Gilead in July 2024, and proceeds from a $50 million term loan, offset by research and development expenditures. The company projects its cash reserves will fund operations into mid-2027.

Revenues for the third quarter of 2024 totaled $48 million, up from $32 million in 2023, driven by license and development services revenue, including Taiho's $15 million exercise for quemliclustat’s license in its territory and ongoing collaboration revenue from Gilead. Research and development expenses rose to $123 million from $82 million in the prior year, with a net loss of $92 million for the third quarter of 2024, compared to $71 million in 2023.

Arcus continues to advance its clinical-stage investigational treatments with several studies across multiple cancer types, aiming to bring innovative therapies to improve patient outcomes.