Arcus Biosciences, Inc.: Q2 FY2026 earnings call
What management said about Q2 FY2026, from the documents filed with the SEC on 5 August 2026: press release. Guidance figures: 1 raised, 1 lowered, 1 new, 7 kept. The quarter’s numbers.
Key takeaways
- Backbone therapy across all lines of ccRCC: Management outlined strategy to establish casdatifan as backbone therapy across all lines of clear cell renal cell carcinoma treatment. Company aims to provide consecutive casdatifan-containing regimens in first-, second- and late-line settings. Source
- PEAK-20 Phase 3 initiation by year-end: First registrational Phase 3 study PEAK-20 for casdatifan plus nivolumab plus ipilimumab in first-line ccRCC expected to initiate by year-end 2026, building on ARC-20 platform cohort data. Source
- Enrollment accelerating toward year-end target: Phase 3 PEAK-1 study in IO-experienced metastatic ccRCC comparing casdatifan plus cabozantinib versus cabozantinib alone is accelerating enrollment toward year-end 2026 completion target. Source
- Nature publication connects outcomes to biomarkers: ARC-20 monotherapy results published in Nature July 2026 provided first comprehensive connection between clinical outcomes in HIF-2α inhibitor-treated patients and peripheral biomarker changes. Deep suppression of serum erythropoietin correlated with higher response rates and longer PFS. Source
- Multiple data readouts expected second half 2026: Arcus expects casdatifan readouts across lines in H2 2026: initial efficacy data for casdatifan plus zimberelimab in first-line, mature ORR and initial PFS data with 18+ months follow-up for casdatifan plus cabozantinib in second-line, and updated overall survival data in late-line. Source
- Cash declined to $775M mid-year: Cash, cash equivalents and marketable securities totaled $775 million as of June 30, 2026, down from $1.010 billion at December 31, 2025. Decrease primarily from R&D spending. Expected year-end 2026 cash approximately $600 million. Source
- Cash runway extends to at least H2 2028: Based on existing business plan, company believes cash sufficient to fund planned operations until at least H2 2028. Runway supports multiple casdatifan Phase 3 studies and immunology program advancement. Source
“Our recent publication in Nature demonstrated our commitment to being the scientific leader in HIF-2α biology and translational medicine. We are leveraging these insights and the differentiated profile of casdatifan compared to that of the competition to ensure that casdatifan becomes the backbone of treatment across every line of therapy in kidney cancer. In the front-line setting especially, we see a clear path to be first-to-market and to provide the best options for physicians and patients.”
Terry Rosen, Ph.D., Chief Executive Officer
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Full year 2026 GAAP revenue Source | full year 2026 | $65 million to $75 million | Raised from $50 million to $65 million |
| End of 2026 cash position Source | year-end 2026 | approximately $600 million | Kept |
| Cash runway Source | future periods | at least second half of 2028 | Kept |
| PEAK-1 enrollment completion Source | 2026 | by year-end 2026 | Kept |
| PEAK-20 Phase 3 initiation Source | 2026 | by year-end 2026 | Kept |
| AB102 proof-of-concept study timing Source | 2027 | mid-2027 | Lowered from early 2027 |
| TNF inhibitor clinic entry Source | early 2027 | early 2027 | Kept |
| PRISM-1 Phase 3 results readout Source | first half 2027 | first half of 2027 | Kept |
| Casdatifan data readouts timing Source | second half 2026 | H2 2026 | Kept |
| Immunology programs IND-readiness Source | 2027 | by end of 2027 | New |
What changed from last quarter
- Guidance raised: Full year 2026 GAAP revenue guidance raised from $50-65M midpoint to $65-75M midpoint, reflecting increased access rights revenues from Gilead option expiration and Taiho collaboration revenues. Source
- Guidance lowered: AB102 proof-of-concept study timing moved from early 2027 potential to mid-2027 expected, indicating later readout than initially considered. Source
- New: Three new clinical collaborations announced to expand casdatifan combinations: BMS ROSETTA RCC-208 with pumitamig, Summit Therapeutics ARC-20 with ivonescimab first-line, AVEO ARC-20 with tivozanib late-line belzutifan-experienced patients. Source
- New: $15 million milestone payment from Taiho Pharmaceutical triggered by PEAK-1 enrollment in Japan, expected Q3 2026. Source
- Ended: Phase 3 PACIFIC-8 study with AstraZeneca evaluating domvanalimab plus durvalumab in Stage III unresectable NSCLC to be discontinued in connection with anti-TIGIT program wind-down. Source
- New: Gilead relinquished its three seats on Arcus Board of Directors effective August 5, 2026, in connection with discontinuation of STAR-221 and STAR-121 trials. Source
Casdatifan Development Strategy
- Backbone therapy across all lines of ccRCC: Management outlined strategy to establish casdatifan as backbone therapy across all lines of clear cell renal cell carcinoma treatment. Company aims to provide consecutive casdatifan-containing regimens in first-, second- and late-line settings. Source
- PEAK-20 Phase 3 initiation by year-end: First registrational Phase 3 study PEAK-20 for casdatifan plus nivolumab plus ipilimumab in first-line ccRCC expected to initiate by year-end 2026, building on ARC-20 platform cohort data. Source
- Late-line evaluation in belzutifan-experienced patients: Arcus initiating new randomized ARC-20 cohort in late-line ccRCC to evaluate casdatifan plus tivozanib versus tivozanib alone in patients receiving two or more prior lines including belzutifan, with enrollment expected Q4 2026. Source
PEAK-1 Second-Line Enrollment Progress
- Enrollment accelerating toward year-end target: Phase 3 PEAK-1 study in IO-experienced metastatic ccRCC comparing casdatifan plus cabozantinib versus cabozantinib alone is accelerating enrollment toward year-end 2026 completion target. Source
- Expected to establish new standard of care: Company confident PEAK-1 will establish casdatifan plus cabozantinib as new standard of care in IO-experienced setting. More mature overall response rate and initial PFS data for 45 patients with 18+ months follow-up expected 2026. Source
“The ARC-20 platform study and strategic clinical collaborations are enabling us to efficiently pursue an integrated approach across multiple lines of therapy, and we expect this year's upcoming ARC-20 data readouts in first-, second- and late-line settings to clarify casdatifan's potential to transform the treatment paradigm for kidney cancer.”
Terry Rosen, Ph.D., Chief Executive Officer
Casdatifan Science and Clinical Data
- Nature publication connects outcomes to biomarkers: ARC-20 monotherapy results published in Nature July 2026 provided first comprehensive connection between clinical outcomes in HIF-2α inhibitor-treated patients and peripheral biomarker changes. Deep suppression of serum erythropoietin correlated with higher response rates and longer PFS. Source
- Multiple data readouts expected second half 2026: Arcus expects casdatifan readouts across lines in H2 2026: initial efficacy data for casdatifan plus zimberelimab in first-line, mature ORR and initial PFS data with 18+ months follow-up for casdatifan plus cabozantinib in second-line, and updated overall survival data in late-line. Source
- Primary progression rates favorable vs published data: Casdatifan plus zimberelimab in first-line showed primary progression rate of 7 percent in ARC-20, comparing favorably to published rates for anti-PD-1 monotherapy or dual IO regimens in first-line.
Strategic Clinical Collaborations
- Taiho $15M milestone payment Q3 2026: Arcus will receive $15 million from Taiho Pharmaceutical in Q3 2026 triggered by PEAK-1 enrollment milestone in Japan, under option and license agreement for casdatifan in Japan and Asian territories. Source
- Fourth partnership expected Q4 initiation: Arcus executed additional clinical collaboration for casdatifan combination with another anti-PD-x/VEGF bispecific antibody in first-line ccRCC, expected to initiate Q4 2026. Source
Financial Position and Cash Runway
- Cash declined to $775M mid-year: Cash, cash equivalents and marketable securities totaled $775 million as of June 30, 2026, down from $1.010 billion at December 31, 2025. Decrease primarily from R&D spending. Expected year-end 2026 cash approximately $600 million. Source
- Cash runway extends to at least H2 2028: Based on existing business plan, company believes cash sufficient to fund planned operations until at least H2 2028. Runway supports multiple casdatifan Phase 3 studies and immunology program advancement. Source
Quarterly Financial Results
- Revenues declined 74 percent year-over-year: Q2 2026 revenues fell to $41 million from $160 million in Q2 2025. Decline primarily from $143 million cumulative catch-up revenue in 2025 for pausing etrumadenant and Gilead license return, partially offset by increased access rights and Taiho collaboration revenues. Source
- G&A expenses down 17 percent: General and administrative expenses declined to $24 million in Q2 2026 from $29 million in Q2 2025, primarily from streamlining initiatives across operations. Source
Quemliclustat Pancreatic Cancer Program
- PRISM-1 enrollment complete, 2027 readout: Phase 3 PRISM-1 trial of quemliclustat plus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer completed enrollment in September 2025. Results expected first half 2027. Source
- Orphan drug designations from EMA and FDA: Quemliclustat received orphan drug designation from European Medicines Agency in May 2026, adding to FDA designation received June 2025, supporting pancreatic cancer development. Source
Immunology Portfolio Development
- AB102 first-in-human study launching August: Arcus expects to initiate first-in-human healthy volunteer study for AB102, a highly selective oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, in August 2026. Preclinical data demonstrated ability to fully block MRGPRX2-dependent mast cell degranulation. Source
- TNF inhibitor candidate entering clinic early 2027: Arcus selected development candidate for oral small-molecule TNF inhibitor designed to selectively block TNFR1 signaling for rheumatoid arthritis, psoriasis and inflammatory bowel disease. Expected to enter clinic early 2027. Source
Anti-TIGIT Program Discontinuation
- PACIFIC-8 with AstraZeneca to be discontinued: Phase 3 PACIFIC-8 study evaluating domvanalimab plus durvalumab versus durvalumab alone in PD-L1 positive Stage III unresectable NSCLC will be discontinued following wind-down of STAR-221 and STAR-121. Source
- Gilead board seats relinquished: Gilead relinquished its three seats on Arcus Board of Directors effective August 5, 2026, in connection with wind-down of STAR-221 and STAR-121 trials and streamlined operational relationship. Source
Coming up, as management said on 5 August 2026
- AB102 first-in-human study initiation August 2026: Arcus expects to initiate first-in-human healthy volunteer study for AB102 oral MRGPRX2 antagonist in August 2026, followed by proof-of-concept study expected mid-2027. Source
- PEAK-1 enrollment completion year-end 2026: Phase 3 PEAK-1 study in IO-experienced ccRCC expected to complete enrollment by year-end 2026, with mature data readout to follow. Source
- PEAK-20 Phase 3 initiation by year-end 2026: First registrational Phase 3 study PEAK-20 for casdatifan plus nivolumab plus ipilimumab in first-line ccRCC expected to initiate by year-end 2026. Source
- TNF inhibitor and broader I&I pipeline 2027: Oral small-molecule TNF inhibitor expected to enter clinic early 2027. CCR6 antagonist and additional programs expected to deliver IND-ready candidates by end 2027. Source
- PRISM-1 Phase 3 results first half 2027: Quemliclustat Phase 3 PRISM-1 pancreatic cancer trial results expected in first half 2027 following September 2025 enrollment completion. Source
- Taiho milestone payment Q3 2026: $15 million milestone payment from Taiho Pharmaceutical expected in Q3 2026 triggered by PEAK-1 enrollment in Japan. Source
- Multiple casdatifan data readouts H2 2026: Arcus expects multiple casdatifan data readouts in second half 2026 including initial efficacy data for casdatifan plus zimberelimab in first-line, PFS data for casdatifan plus cabozantinib in second-line, and overall survival data in late-line. Source
- New casdatifan combination studies Q4 2026: ARC-20 cohorts evaluating casdatifan plus axitinib in first-line and with additional anti-PD-x/VEGF bispecific antibodies expected to begin in fourth quarter 2026. Source
Earlier plans management reported on
- On track: Company remains on track to complete PEAK-1 enrollment by year-end 2026 consistent with Q1 guidance. Source
- On track: PEAK-20 Phase 3 first-line study expected to initiate by year-end 2026 as previously guided. Source
- On track: AB102 first-in-human study expected to initiate in August 2026 as previously guided for Q3 2026. Source
- On track: Company maintains guidance that cash will be sufficient to fund operations until at least H2 2028. Source
- On track: Multiple ARC-20 data readouts across lines of therapy expected in H2 2026 as previously committed. 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.