On November 4, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and immune diseases, reported financial results for the third quarter ended September 30, 2026, and provided a pipeline update on its clinical-stage investigational molecules and discovery programs.
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"In October, we showed for the first time that robust and durable HIF-2α inhibition from casdatifan can address the needs of patients at every line of kidney cancer therapy: rapid and sustained disease control in the first line, durable benefit and potential survival advantage in the second line, even after a prior TKI-inclusive therapy, and nearly three years of median overall survival in late-line patients who had exhausted multiple therapies," said Terry Rosen, Ph.D., chief executive officer of Arcus. "With PEAK-1 enrollment nearing completion and PEAK-20 set to begin by year-end, we are building the registrational evidence to make casdatifan the backbone of treatment across the continuum of care for clear cell renal cell carcinoma."
Casdatifan (HIF-2α inhibitor)
Development Strategy and Upcoming Milestones:
Arcus’s development strategy is to enable utilization of casdatifan as a backbone therapy in clear cell renal cell carcinoma (ccRCC) across each line of therapy. The strategy builds on existing standards of care in each setting. In the first line, Arcus plans to develop the first and only HIF-2α inhibitor-based tyrosine kinase inhibitor (TKI)-sparing therapy. Arcus also plans to develop consecutive casdatifan-containing regimens for the second- and late-line settings that are enabled by the uniquely robust HIF-2α inhibitory profile of casdatifan.
•First-line ccRCC:
▪Initiation of PEAK-20, a Phase 3 study evaluating casdatifan plus ipilimumab and nivolumab, is expected in the fourth quarter of 2026.
▪Cohorts for casdatifan in combination with anti-PD-x/VEGF bispecifics ivonescimab (sponsored by Arcus in ARC-20), pumitamig (in the BMS-sponsored Phase 1/2 ROSETTA RCC-208 study) and tivunatamig (in the Pfizer-sponsored Phase 1b/2 Symbiotic-GU-08 study) are expected to begin prior to the end of the year.
▪Arcus expects to initiate a new cohort evaluating casdatifan in combination with anti-PD-1 and axitinib in the first half of 2027. This cohort is designed to support the initiation of the PEAK-21 Phase 3 study evaluating casdatifan plus anti-PD-1 and axitinib in first-line ccRCC.
•Second-line ccRCC:
▪Enrollment of PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib, is expected to be complete in the next two to three months.
•Late-line ccRCC:
▪Arcus will initiate a randomized ARC-20 cohort evaluating casdatifan plus tivozanib versus tivozanib alone in patients who received two or more lines of prior therapy, including a belzutifan-containing regimen in the fourth quarter of 2026.
Upcoming Data Expected in 2027:
•First-line ccRCC:
◦More mature PFS and OS data for the ARC-20 cohorts evaluating casdatifan plus zimberelimab and casdatifan plus zimberelimab and ipilimumab.
◦Early efficacy and safety data for the ARC-20 cohort evaluating casdatifan plus ivonescimab.
•Second-line ccRCC:
◦More mature OS data for the ARC-20 cohort evaluating casdatifan plus cabozantinib in second-line ccRCC.
•Late-line ccRCC:
◦Early efficacy and safety data for the randomized ARC-20 cohort evaluating casdatifan plus tivozanib versus tivozanib.
Recent Data Update:
In October, Arcus presented new data from multiple cohorts of the ARC-20 platform study, which showed that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. All cohorts had a data cut-off (DCO) of Sept. 4, 2026, and the key data are summarized below.
•First-line ccRCC:
◦Casdatifan plus zimberelimab (anti-PD-1) (n=30; 11.5 months median follow-up): The combination demonstrated landmark PFS of 86% at 6 months and 69% at 12 months, a 50% confirmed objective response rate (cORR) and a 6.7% rate of primary progression. These results exceeded third-party benchmarks* for pembrolizumab monotherapy and for ipilimumab plus nivolumab in this setting.
◦Casdatifan plus ipilimumab plus zimberelimab (n=31; 3 months median follow-up): One patient (4%) experienced primary progression among 24 patients with at least one scan. Safety data for the regimen were consistent with those observed in other cohorts or prior studies for the individual agents. These safety data will support initiation of the registrational trial PEAK-20 in first-line ccRCC.
•Second-line ccRCC, casdatifan plus cabozantinib (n=43; 21.3 months median follow-up): PFS (median of 14.5 months) and OS (median not reached) substantially exceeded benchmarks for cabozantinib monotherapy, including in patients on casdatifan plus cabozantinib who had progressed on a prior TKI therapy (median PFS of 16.5 months). TKI-pretreated patients represent approximately 60% of second-line patients in current practice and derive substantially diminished benefit from subsequent TKI therapies relative to patients who have not received a prior TKI therapy. Subgroup data, recently presented at ESMO (Free ESMO Whitepaper), from both the belzutifan plus lenvatinib (median PFS of 10.9 months) and cabozantinib (median PFS of 7.5 months) arms of LITESPARK-011 that analyzed PFS for patients previously treated with an immunotherapy plus TKI combination reinforced this unmet need and the opportunity that the casdatifan plus cabozantinib regimen presents for this patient population.
•Late-line ccRCC, casdatifan monotherapy (n=121, four pooled cohorts; 28 months median follow-up): Casdatifan demonstrated unprecedented median OS of 35 months, a median PFS of 13 months and cORR of 36% in heavily pretreated patients, 52% of whom had received at least three prior lines of therapy. Casdatifan showed improvements across each of the key efficacy measures relative to data from benchmark studies with a first-generation HIF-2α inhibitor. In addition, new translational data demonstrated a correlation between pharmacodynamic markers of HIF-2α inhibition and OS.
•Across cohorts, no unexpected safety signals were observed at the time of DCO. Safety data for all the regimens were consistent with those observed in other cohorts or prior studies of each individual molecule.
Quemliclustat (small-molecule CD73 inhibitor)
•An interim analysis for PRISM-1, the fully enrolled Phase 3 trial of quemliclustat plus gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma, will be conducted in the fourth quarter of 2026.
Immunology Portfolio
•AB102 (oral, MRGPRX2 antagonist): Arcus initiated a first-in-human healthy volunteer study in August 2026.
•TNF inhibitor (oral, TNFR1-selective), CCR6 antagonist (oral) and CD89 monoclonal antibody: Development candidates are progressing through preclinical development, with potential to enter the clinic in 2027.
•Additional programs: STAT6 inhibitor (oral) and CD40L inhibitor (oral) programs are each expected to deliver IND-ready candidates in 2027.
Financial Results for Third-Quarter 2026:
•Cash, Cash Equivalents and Marketable Securities were $694 million as of September 30, 2026, compared to $1.0 billion as of December 31, 2025. The decrease during the period is primarily due to the use of cash in our research and development activities. Based on the existing business plan, Arcus believes that its cash, cash equivalents and marketable securities as of September 30, 2026, together with $288 million gross proceeds from its October equity financing will be sufficient to fund its planned level of operations into 2029.
•Revenues were $9 million for the third-quarter 2026, compared to $26 million for the same period in 2025. The decrease in revenues was primarily driven by lower revenues related to activities under the Gilead Collaboration as they wind down or reach completion, partially offset by increased revenues related to programs under the Taiho Collaboration Agreement. Arcus expects to recognize GAAP revenue of between $70 million and $75 million for the full year 2026.
•Research and Development (R&D) Expenses were $117 million for the third-quarter 2026, compared to $141 million for the same period in 2025. The decrease was due to (i) late-stage development activities decreasing primarily due to the wind-down of Phase 3 studies related to domvanalimab and the completion of enrollment of PRISM-1, partially offset by increasing activities in our Phase 3 studies for casdatifan; (ii) early-stage development activities decreasing primarily due to the wind-down of Phase 2 studies related to domvanalimab and lower Phase 2 study costs for casdatifan; partially offset by (iii) partnership reimbursements decreasing primarily due to a shift towards programs fully funded by us. Non-cash stock-based compensation expense was $9 million for the third-quarter 2026, compared to $7 million for the same period in 2025. For the third-quarters 2026 and 2025, Arcus recognized gross reimbursements of $12 million and $28 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
R&D expenses have declined as we have wound down studies related to domvanalimab, implemented streamlining initiatives across our R&D operations in connection with this wind-down and realized efficiencies across our programs outside the Gilead collaboration. We expect R&D expenses to remain relatively consistent in the near term, as increased investment in the development of casdatifan and the advancement of our small-molecule immunology programs continues to offset the decreases in our other programs.
•General and Administrative (G&A) Expenses were $23 million for the third-quarter 2026, compared to $27 million for the same period in 2025. The decrease was primarily due to streamlining initiatives Arcus has undertaken across its operations. Non-cash stock-based compensation expense was $7 million for the third-quarter 2026, compared to $7 million for the same period in 2025.
•Net Loss was $128 million for the third-quarter 2026, compared to $135 million for the same period in 2025.
(Press release, Arcus Biosciences, NOV 4, 2026, View Source [SID1234674192])