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Arcus Biosciences, Inc.: Q3 FY2025 earnings call

What management said about Q3 FY2025, from the documents filed with the SEC on 28 October 2025: press release. Guidance figures: 1 new, 1 kept. The quarter’s numbers.

Key takeaways

  • Revenue fell on prior-year license: Third-quarter revenue was $26 million against $48 million a year earlier. The company attributed the decline to a $15 million prior-year license payment and lower Gilead collaboration revenue. Source
  • Net loss widened to $135 million: Net loss was $135 million against $92 million a year earlier, or $1.27 per share against $1.00. Nine-month net loss was $247 million against $189 million. Source
  • R&D rise tied to late-stage trials: R&D rose by $18 million. The company linked the increase to enrollment and start-up for PRISM-1 and PEAK-1, partly offset by lower STAR-221 costs. Source
  • Better efficacy than marketed inhibitor: Across four late-line monotherapy cohorts, casdatifan performed better than published data for the only marketed HIF-2a inhibitor on each efficacy measure evaluated. Source
  • EDGE-Gastric regimen matches STAR-221: The EDGE-Gastric Arm A1 regimen and population match those of the ongoing Phase 3 STAR-221 study, according to the company. Source
  • Cash fell on R&D spending: Cash, equivalents and marketable securities were $841 million at September 30, 2025, against $992 million at December 31, 2024. The February 2025 offering and a $50 million term-loan draw in June partly offset the decline. Source

“Data from the ARC-20 study demonstrate that casdatifan has a best-in-class profile, based on a meaningfully higher response rate and longer PFS relative to data for the only marketed HIF-2a inhibitor,”

Terry Rosen, Ph.D., chief executive officer of Arcus

Guidance

AreaPeriodFigureAgainst last quarter
Full-year 2025 GAAP revenue SourceFull year 2025$225 million to $235 millionKept
ARC-20 enrollment SourceBy end of 2025complete enrollment by the end of 2025New

What changed from last quarter

  • New: Taiho exercised its option for an exclusive casdatifan license in Japan and certain Asian territories. Arcus receives option and milestone payments and royalties. Source
  • Ended: Gilead's option rights to casdatifan expired, and Arcus retains full rights to the drug, subject to the Taiho license. Source
  • New: Arcus disclosed five research and preclinical programs targeting inflammatory and autoimmune diseases in October. Source
  • New: Recruitment in the Phase 1b portion of the eVOLVE-RCC02 study was temporarily paused after observed immune-mediated adverse events. Participants already enrolled continue treatment. Source

Quarterly results and revenue

  • Revenue fell on prior-year license: Third-quarter revenue was $26 million against $48 million a year earlier. The company attributed the decline to a $15 million prior-year license payment and lower Gilead collaboration revenue. Source
  • Net loss widened to $135 million: Net loss was $135 million against $92 million a year earlier, or $1.27 per share against $1.00. Nine-month net loss was $247 million against $189 million. Source
  • Nine-month revenue lower than prior year: Nine-month total revenue was $214 million against $232 million. License and development services revenue was $192 million against $204 million. Source

Operating costs and reimbursements

  • R&D rise tied to late-stage trials: R&D rose by $18 million. The company linked the increase to enrollment and start-up for PRISM-1 and PEAK-1, partly offset by lower STAR-221 costs. Source
  • Collaboration reimbursements lower: Gross reimbursements for shared collaboration expenses were $28 million, against $37 million a year earlier. Source
  • G&A eased on lower compensation: G&A was $27 million against $30 million. Lower compensation and stock-based costs were partly offset by higher expenses shared under the Gilead collaboration. Source

“We remain well capitalized and funded through readout of multiple Phase 3 trials, and we are looking forward to a steady cadence of key data events in 2026 and beyond.”

Terry Rosen, Ph.D., chief executive officer of Arcus

Casdatifan development

  • Better efficacy than marketed inhibitor: Across four late-line monotherapy cohorts, casdatifan performed better than published data for the only marketed HIF-2a inhibitor on each efficacy measure evaluated. Source
  • Most confirmed responders stay on drug: Of 38 confirmed responders across the four cohorts, 28 remained on treatment in the disclosed data. Source
  • No unexpected safety signals reported: At data cutoff no unexpected safety signals were seen. Management described the profile as acceptable and manageable across all doses. Source
  • ARC-20 cohort mirrors PEAK-1 setting: The ARC-20 casdatifan plus cabozantinib cohort evaluates the same setting and combination as the PEAK-1 Phase 3 study. Source

Domvanalimab and quemliclustat

  • EDGE-Gastric regimen matches STAR-221: The EDGE-Gastric Arm A1 regimen and population match those of the ongoing Phase 3 STAR-221 study, according to the company. Source
  • Regimen generally well tolerated: Management said the regimen was generally well tolerated, with a safety profile consistent with anti-PD-1 and chemotherapy. Source
  • Quemliclustat Phase 3 enrollment complete: PRISM-1, a Phase 3 trial of quemliclustat with gemcitabine/nab-paclitaxel in first-line pancreatic cancer, has completed enrollment. Source

Inflammation and immunology programs

  • New programs target immune pathways: The programs span MRGPRX2, TNF-alpha, CCR6, CD89 and CD40L, with potential indications including atopic dermatitis, rheumatoid arthritis, psoriasis, multiple sclerosis and lupus. Source
  • Gilead early option payment terms: If Gilead exercises its option at the earlier time point, Arcus would be eligible for up to $420 million per optioned inflammation program, in option and milestone payments plus royalties. Source
  • Later Gilead option co-development rights: A later Gilead option exercise on the two inflammation programs would give the parties co-development rights, shared global development costs and US co-promotion with shared profits. Source

Partnerships and collaborations

  • AstraZeneca runs eVOLVE-RCC02: AstraZeneca sponsors and operates the eVOLVE-RCC02 study with Arcus. Both companies will keep monitoring paused-cohort participants to characterize the safety profile with longer follow-up. Source
  • Gilead co-develops three products: Arcus and Gilead co-develop zimberelimab, domvanalimab and quemliclustat. Source
  • Gilead collaboration dates from 2020: The Gilead collaboration is a 10-year agreement established in May 2020, under which Gilead held time-limited option rights to clinical programs. Source

Cash, funding and balance sheet

  • Cash fell on R&D spending: Cash, equivalents and marketable securities were $841 million at September 30, 2025, against $992 million at December 31, 2024. The February 2025 offering and a $50 million term-loan draw in June partly offset the decline. Source
  • Balance sheet totals at quarter end: Total assets were $974 million, total liabilities $538 million and stockholders' equity $436 million at September 30, 2025. Source
  • Interest income declined: Interest and other income, net was $10 million for the quarter, against $14 million a year earlier. Source

Coming up, as management said on 28 October 2025

  • Late-line ARC-20 analyses in first half: Additional analyses of the casdatifan monotherapy late-line cohorts are planned for the first half of 2026. Source
  • Cabozantinib cohort data mid-2026: More mature data from the casdatifan plus cabozantinib cohort are planned for mid-2026. Source
  • Early-line ARC-20 data second half: Initial data from one or more early-line ARC-20 cohorts are planned for the second half of 2026. Source
  • Early-line Phase 3 start targeted: The company aims to start a Phase 3 study in early-line ccRCC in the second half of 2026, informed by eVOLVE-RCC02 and ARC-20 data. Source
  • EVOLVE-RCC02 go-no-go decision: Phase 1b data and a go-no-go decision on the Phase 3 portion of eVOLVE-RCC02 are planned for the second half of 2026. Source
  • STAR-221 Phase 3 data in 2026: Phase 3 STAR-221 data for domvanalimab plus zimberelimab and chemotherapy are expected in 2026. Source
  • Inflammation candidates within 12 months: Development candidates are expected to be selected for at least three of the inflammation programs within the next 12 months. Source
  • MRGPRX2 candidate enters clinic 2026: The first of the inflammation programs, a small molecule against MRGPRX2, is expected to enter the clinic in 2026. Source

Figures management reported

FigureReported
R&D expense, third quarter 2025 Source$141 million
R&D expense, nine months 2025 Source$402 million
ARC-20 late-line monotherapy pooled mPFS and 18-month PFS Source12.2 months; 43%
ARC-20 100mg once-daily cohort confirmed ORR Source35%
EDGE-Gastric Arm A1 median overall survival Source26.7 months
PEAK-1 Phase 3 status Sourceenrolling

Risks management discussed

  • Regulatory: Next steps for the paused eVOLVE-RCC02 study depend on longer follow-up and any discussions with health authorities. Source
  • Operational: Quarterly R&D expense may fluctuate with the timing of clinical manufacturing and standard-of-care purchases, with a matching effect on reimbursements. Source

Earlier plans management reported on

  • Met: Late-line monotherapy data, including PFS, were presented at an October investor event, following the fall timing given in the prior quarter. Source
  • Met: EDGE-Gastric overall survival data were presented at the ESMO Congress in October, as the prior quarter said they would be. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.