Arcus Biosciences

Company focus and stage

Arcus Biosciences is a late clinical-stage biopharmaceutical company developing differentiated small-molecule therapies for cancer and inflammatory/autoimmune diseases. Its most advanced programs are in Phase 3 registrational studies. The company’s vision is to use internal small-molecule discovery to create, develop, and commercialize therapies that deliver meaningful patient benefit.

Core portfolio

Oncology programs

• Casdatifan (HIF-2α inhibitor)

  • Oral small molecule targeting HIF-2α, designed for improved PK/PD compared with belzutifan.
  • ARC-20 program completed eight cohorts, including four monotherapy late-line clear cell renal cell carcinoma (ccRCC) cohorts, combinations with cabozantinib, and early-line ccRCC cohorts.
  • Registrational path: PEAK-1 Phase 3 study of casdatifan + cabozantinib in ccRCC after prior immunotherapy; primary endpoint is progression-free survival (PFS); the study is enrolling. Potential global peak sales are estimated above $2 billion.
  • A second Phase 3 is planned in first-line, TKI-free ccRCC with potential peak sales above $3 billion; initiation is targeted by the end of 2026.
  • Combination work includes casdatifan with zimberelimab (anti-PD-1) and ipilimumab/zimberelimab. The eVOLVE-RCC02 study (casdatifan + volrustomig) is paused pending data review.

• Quemliclustat (CD73 inhibitor)

  • Small-molecule CD73 inhibitor intended to suppress adenosine-mediated immunosuppression.
  • PRISM-1: Phase 3 in metastatic pancreatic cancer with gemcitabine/nab-paclitaxel; enrollment completed September 2025; topline results expected in the first half of 2027.

• Domvanalimab (anti-TIGIT) and zimberelimab (anti-PD-1)

  • Programs developed in collaboration with Gilead; multiple Phase 3 trials are ongoing, including STAR-121 in non-small cell lung cancer (NSCLC) and PACIFIC-8 in NSCLC after chemoradiation.
  • In December 2025, the STAR-221 study (domvanalimab + zimberelimab + chemotherapy in first-line GI cancers) was discontinued for futility. STAR-121 and PACIFIC-8 remain ongoing.
  • The company elected U.S. co-promotion rights options for domvanalimab and zimberelimab; Gilead has potential options for quemliclustat.

• Zimberelimab (anti-PD-1)

  • Zimberelimab is being evaluated broadly, including in ARC-20 in combination with casdatifan and in additional cohorts with ipilimumab in first-line ccRCC.

Inflammation programs

• The inflammation portfolio includes five discovery/preclinical programs targeting MRGPRX2, TNF, CCR6, CD89, and CD40 ligand.
• Lead MRGPRX2 inhibitor is an oral, highly potent and selective candidate aimed at chronic spontaneous urticaria (CSU) with potential in other inflammatory conditions such as atopic dermatitis.
• TNF inhibitor program focuses on an oral, selective blocker of the TNF pathway that targets TNFR1 while sparing TNFR2; a lead candidate was identified in early 2026 with an IND targeted for late 2026/early 2027.
• The first development candidate from the inflammation programs is expected to enter the clinic in 2026.

Commercial and collaboration details

Commercial rights

• Casdatifan is company-owned globally except for Japan and select Asian countries, where Taiho holds a license in the Taiho Territory.
• The collaboration with Gilead covers anti-TIGIT (domvanalimab), anti-PD-1 (zimberelimab), and CD73 (quemliclustat) in specified markets; Gilead has options to expand its rights to additional programs.
• Taiho holds exclusive regional rights in Japan and certain Asian markets (excluding China) and will handle development and commercialization in the Taiho Territory for specified programs. The company retains global development for casdatifan.

Manufacturing and supply

• The company does not own manufacturing facilities and relies on third-party contract manufacturers.
• WuXi Biologics is the exclusive manufacturer for zimberelimab drug substance for clinical supplies and certain post-approval needs under the WuXi PD-1 Agreement.
• The company may utilize Gilead’s manufacturing infrastructure for optioned products and continues to rely on third parties for API and drug product supply.

Intellectual property

• The patent estate includes over 850 pending or issued patents worldwide and 41 issued U.S. patents covering compositions, drugs, and uses.
• Patent terms generally expire between 2036 and 2045, with potential extensions such as Hatch-Waxman term restoration where applicable.

Competition

• The company competes with large pharmaceutical and biotech firms as well as smaller companies across oncology and inflammation. Competitors include Merck, AstraZeneca, BeiGene, GSK, Bristol-Myers Squibb, Genentech/Roche, AbbVie, Amgen, Sanofi, Regeneron, Novartis, and others. Several programs target TIGIT, PD-1/PD-L1, CD73, TNF, HIF-2α, and related pathways.

Regulatory and reimbursement landscape

• Development follows standard regulatory pathways (IND → clinical trials → NDA/BLA) in the U.S. and comparable pathways in other jurisdictions such as the EU and UK.
• The company pursues expedited pathways where appropriate (Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval) and considers orphan drug designations when applicable.
• The reimbursement environment and payor coverage trends are important factors that influence pricing and market access.

Data privacy and global compliance

• The company addresses GDPR and UK GDPR requirements and maintains data privacy and security measures for health-related data.
• Compliance programs cover anti-kickback statutes, the False Claims Act, HIPAA, and other applicable U.S. and international healthcare laws.

People and corporate information

• Employees: 601 full-time employees as of December 31, 2025; approximately 49% hold Ph.D., M.D., RN, or similar degrees; about 81% are in R&D.
• Diversity and inclusion: 55% of employees are female; 38% of leadership are female. Overall, 58% of employees and 48% of leadership identify as from diverse racial or ethnic groups.
• Workplace: The company emphasizes urgency and ethical decision-making, with ongoing talent development, wellness programs, and a focus on retention and development.

Corporate details:

• Incorporated in Delaware in April 2015.
• Principal offices: 3928 Point Eden Way, Hayward, CA 94545.
• Website: www.arcusbio.com