domvanalimab

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Arcus Biosciences (NYSE:RCUS) FY Conference Transcript
2025-09-10 13:32
Arcus Biosciences (NYSE:RCUS) FY Conference September 10, 2025 08:30 AM ET Company ParticipantsRichard Markus - CMOJennifer Jarrett - COOConference Call ParticipantsTerrence Flynn - U.S. Biopharma AnalystTerrence FlynnGreat. Good morning. Thanks for joining us, everybody. I'm Terrence Flynn, Morgan Stanley's U.S. Biopharma Analyst. I'm very pleased to be hosting Arcus this morning. Joining us from the company, we have Jennifer Jarrett, the company's Chief Operating Officer, and Richard Markus, the company's ...
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]
Arcus Biosciences(RCUS) - 2025 Q1 - Earnings Call Presentation
2025-05-06 20:18
COMBINING TO CURE ® Arcus is at the forefront of designing combination therapies, with best-in-class potential, in the relentless pursuit of cures for cancer. May 6, 2025 CORPORATE PRESENTATION Notice of Trademark: The Arcus name and logo are the property of Arcus. All other trademarks used herein are the property of their respective owners and are used for reference purposes only. Such use should not be construed as an endorsement of Arcus. Forward-Looking Statements/Safe Harbor Forward Looking Statements ...