HIF - 2α inhibitor
Search documents
Arcus Biosciences(RCUS) - 2025 Q4 - Earnings Call Presentation
2026-02-25 21:30
Full Year 2025 Investor Presentation Oncology and Immunology Portfolio Summary February 25, 2026 Forward-looking Statements/Safe Harbor Forward-Looking Statements Safe Harbor: This presentation contains forward-looking statements about Arcus Biosciences, Inc. ("we," "Arcus" or the "Company") made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements in this presentation that are not historical facts are forward-looking statements, including, without l ...
Arcus Biosciences (NYSE:RCUS) 2025 Earnings Call Presentation
2025-10-06 14:00
Casdatifan Program Highlights - Arcus Biosciences has $927 million in cash to fund pivotal readouts for domvanalimab, quemliclustat, and casdatifan, including the PEAK-1 study[13] - Casdatifan targets a $2 billion+ peak sales opportunity in IO-experienced ccRCC (PEAK-1) and a $3 billion+ peak sales opportunity in 1L ccRCC (eVOLVE-RCC002)[24] - Casdatifan monotherapy in late-line ccRCC shows a confirmed overall response rate (cORR) of 31% across all pooled cohorts (n=121), exceeding the 22% observed with belzutifan in LITESPARK-005[47] - Median progression-free survival (mPFS) for the pooled casdatifan monotherapy cohorts (n=121) is 122 months, more than double the 56 months seen with belzutifan in LITESPARK-005[67] Clinical Trial Updates - PEAK-1, a Phase 3 trial evaluating casdatifan plus cabozantinib in IO-experienced ccRCC, is currently enrolling with a target of approximately 700 patients[109] - The Phase 1b/3 eVOLVE-RCC002 study, sponsored by AstraZeneca, is evaluating casdatifan plus volrustomig in 1L advanced ccRCC, with Phase 1b currently enrolling[122] Biomarker Analysis - Serum EPO (sEPO) reduction is a strong marker for HIF-2α activity in ccRCC tumors, with a median best EPO reduction of 85% from baseline[154] - Patients with deeper sEPO reduction (>=85%) showed a cORR of 446% compared to 203% in those with less deep reduction[145] - Patients with deeper sEPO reduction (>=85%) had a mPFS of 146 months compared to 96 months in those with less deep reduction, with a hazard ratio of 060[150] Market Opportunity - The RCC market is projected to reach $13 billion by 2030, driven by increasing patient population, HIF-2α MOA introduction, and longer durations of therapy[198] - Arcus Biosciences estimates a potential $5 billion+ opportunity for casdatifan in 1L and IO-experienced ccRCC[204]
Arcus Biosciences(RCUS) - 2025 Q2 - Earnings Call Presentation
2025-08-06 20:05
Pipeline and Programs - Arcus Biosciences has $927 million in cash, cash equivalents, and marketable securities as of June 30, 2025, funding operations through initial pivotal readouts for domvanalimab, quemliclustat, and casdatifan, including PEAK-1[10] - Casdatifan plus cabozantinib showed a confirmed ORR of 46% in patients who reached a minimum of 12 weeks of follow-up in IO-experienced ccRCC[16] - In first-line PDAC, a Phase 1 study showed a median overall survival (mOS) of 157 months (n=122) for patients treated with a quemliclustat-based regimen, exceeding historical benchmarks for chemotherapy alone (85 – 117 months)[108] - The company is targeting substantial market opportunities with three late-stage programs: Post-IO ccRCC (~$2B), IO-naive ccRCC (~$3B), 1L Gastric/GEJ/EAC (~$3B), 1L NSCLC (~$10B), and 1L PDAC (>$4B)[12] Casdatifan (HIF-2α Inhibitor) - Casdatifan plus cabozantinib in IO-experienced ccRCC demonstrated a high confirmed overall response rate (cORR) of 46% with a low rate of primary progression of 4%[29] - Casdatifan monotherapy in 2L+ ccRCC showed a confirmed ORR ranging from 21% to 33% across three cohorts, with median progression-free survival (PFS) of 97 months in the 50mg BID cohort[53] - Casdatifan achieves similar PD effect (EPO suppression) at only 20mg, one-fifth the "going forward" dose of 100mg[21] Domvanalimab (Anti-TIGIT mAb) - In the Phase 2 EDGE-Gastric study, patients with TAP ≥ 5% had a median PFS of 138 months, while those with TAP < 5% had a median PFS of 113 months[82] - In 1L PD-L1 High NSCLC, domvanalimab + zimberelimab showed a median PFS of 93 months compared to 54 months for zimberelimab alone, with a HR of 067[90] - In 1L PD-L1 High NSCLC, domvanalimab + zimberelimab showed a HR of 064 for overall survival (OS) compared to zimberelimab alone[90] Partnerships - Arcus retains co-promotion rights and profit share in the US, with high-teens to low-20's royalties on ex-US sales[19] - Taiho has development/commercial rights in Japan and the rest of Asia (ex-China), with up to $275 million in milestones per program and high single-digit to mid-teens royalties[19]
Arcus Biosciences (RCUS) Earnings Call Presentation
2025-06-02 11:09
Casdatifan (Cas) & Cabozantinib (Cabo) Combination Therapy - The combination of Cas and Cabo shows a confirmed Overall Response Rate (ORR) of 46% in patients eligible for a minimum of 12 weeks follow-up [32] - In the Cas + Cabo cohort, 98% of patients experienced any treatment-related Adverse Events (AEs) [46] - The median duration of follow-up for patients on Cas 100mg QD + Cabo 60mg QD was 37 months [43] Casdatifan Development and Market Opportunity - Arcus Biosciences has $1 billion in cash to fund pivotal readouts for Domvanalimab (dom), Quemliclustat (quemli), and Casdatifan (cas), including the PEAK-1 trial [12] - Belzutifan prescriptions have grown 154% from December 2023 to April 2025 [74] - Belzutifan achieved LTM sales of >$560 million in the US, with run rate sales based on April Rx's at $720 million+ [75] Clinical Trial and Future Development - PEAK-1, a Phase 3 study, is expected to initiate imminently for post-IO ccRCC, randomizing patients to either 100mg Casdatifan + Cabozantinib or Placebo + Cabozantinib in a 2:1 ratio with approximately 700 patients [67, 68] - Arcus is targeting a $3 billion market opportunity in IO-naive metastatic ccRCC with Casdatifan + Volrustomig (volru) [85] - Arcus is also targeting a $2 billion market in post-IO metastatic ccRCC with Casdatifan + Cabozantinib [85]