Arcus Biosciences, Inc. · NYSE:RCUS
Arcus Biosciences — Q1 2025 Earnings Presentation
31 slides from Arcus Biosciences's earnings presentation, May 6, 2025
Slide 1: Combining to Cure
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. CORPORATE PRESENTATION May 6, 2025
Slide 2: Forward-Looking Statements/Safe Harbor
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
Slide 3: Arcus is Capitalized to Advance its Broad Portfolio of Late-Stage Programs Through Phase 3 Readouts
Arcus is Capitalized to Advance its Broad Portfolio of Late- Stage Programs Through Phase 3 Readouts CASDATIFAN: POTENTIAL BEST-IN-CLASS HIF-2α INHIBITOR $1 BILLION IN CASH* Funded through initial Validated mechanism pivotal readouts for dom, and compelling market cas + cabo Phase 3 initiation queml
Slide 4: Three Late-Stage Programs Targeting Substantial Market Opportunities and Unmet Medical Need
Three Late-Stage Programs Targeting Substantial Market Opportunities and Unmet Medical Need Designed to improve upon the current standard of care PATIENTS MARKET PHASE 3 (MAJOR POTENTIAL COMMERCIAL TRIAL NAME INDICATION MARKETS1) (MAJOR MARKETS2) RIGHTS CAS Post-IO ccRCC 19K ~$2B HIF-2α small Arcus
Slide 5: Multiple Data Milestones in 2025 Expected to Enhance Clarity on Multi-Billion $ Opportunities
Multiple Data Milestones in 2025 Expected to Enhance Clarity on Multi-Billion $ Opportunities for Casdatifan and Domvanalimab TIMING STUDY PRODUCT EVENT Updated data from 50mg BID, 50mg QD (ORR, PFS) Early 2025 Casdatifan Initial data from 100mg QD tablet (ORR) mono cohort • Safety and initial e
Slide 6: Our Partnerships Enable Cost-Efficiency and Greatly Expand Our Opportunities
Our Partnerships Enable Cost-Efficiency and Greatly Expand Our Opportunities COST-SHARING R&D Phase 1/1b: cas + volru • Arcus retains co-promotion • Taiho has development / • Both parties retain rights and profit share in commercial rights in Japan economics on their the U.S. and rest of Asia (ex-Ch
Slide 7: Casdatifan (HIF-2α) in ccRCC
Casdatifan (HIF-2α) in ccRCC 7 © Arcus Biosciences 2025
Slide 8: ARC-20 Results Presented at ASCO GU Support Casdatifan Having a Potential Best-in-Class Profile for ccRCC
ARC-20 Results Presented at ASCO GU Support Casdatifan Having a Potential Best-in-Class Profile for ccRCC Across all three expansion cohorts 100mg QD tablet1 (approximately 90 patients) (Selected Phase 3 dose and formulation) Lower primary progressive disease (PD) rate – approximately half the rat
Slide 9: ARC-20 is a Phase 1 Dose-Escalation and Dose-Expansion Study of Casdatifan
ARC-20 is a Phase 1 Dose-Escalation and Dose-Expansion Study of Casdatifan DOSE ESCALATION DOSE EXPANSION Patients with advanced solid tumors N = ~30 per cohort Casdatifan monotherapy 2L+ ccRCC Casdatifan mono 150mg QD 2L+ ccRCC 200mg QD Casdatifan mono Post-IO ccRCC 50mg BID capsule Casdatifan 100m
Slide 10: Key Efficacy Measures All Compare Very Favorably to Contemporary Benchmark Studies Despite Shorter Follow-up
Key Efficacy Measures All Compare Very Favorably to Contemporary Benchmark Studies Despite Shorter Follow-up Casdatifan 50mg BID Casdatifan 50mg QD Casdatifan 100mg QD Efficacy-Evaluable Population1,2 (n = 32) (n = 28) (n = 27) 25% (8) 32% (9)** 33% (9) Confirmed ORR (n) [95% CI] [11.5, 43.4] [15.9,
Slide 11: 100mg QD Cohort: Rapid Response to Casdatifan Treatment With Almost All Patients Still on Therapy
100mg QD Cohort: Rapid Response to Casdatifan Treatment With Almost All Patients Still on Therapy 100mg QD Tablet Waterfall Plot 100mg QD Tablet Spider Plot 100 80 80 60 Best Percent Change from 60 Percent Change from 40 Baseline in SLD, % Baseline in SLD, % 40 20 20 0 0 -20 -20 -40 -40 -60 -60 -80
Slide 12: Spider Plots for 50mg BID and 50mg QD: Highly Durable Disease Control Even in SD Patients
Spider Plots for 50mg BID and 50mg QD: Highly Durable Disease Control Even in SD Patients Only two confirmed responders across all cohorts have discontinued due to progression* 50mg BID Daily Cohort 50mg QD Cohort 80 80 ~40% of patients on 60 60 ~70% of patients on treatment ≥1 year 40 40 treatment
Slide 13: 50mg BID and 50mg QD Cohorts Show Substantially Improved PFS Relative to LITESPARK-005
50mg BID and 50mg QD Cohorts Show Substantially Improved PFS Relative to that of LITESPARK-005 50mg BID Cohort (n=32) 50mg QD Cohort (n=28) 1.0 1.0 Belz LS-005 Belz LS-005 mPFS (Ph 3): mPFS (Ph 3): 0.9 0.9 5.6 months 5.6 months 0.8 0.8 Kaplan-Meier Estimates of Kaplan-Meier Estimates of Progression
Slide 14: ARC-20 Data Support Casdatifan's Potential Best-in-Class Profile Across All Cohorts and Outcome Measures
ARC-20 Data Support Casdatifan’s Potential Best-in-Class Profile Across All Cohorts and Outcome Measures Lower Primary PD Higher ORR* Higher DCR Improved mPFS 35% 34% 33% 100% 32%* 9.7 86% 85% 10.0 30% 81% 80% 25% 25% 22% 61% 5.6 19% 60% 20% 5.0 15% 14% 15% 40% 10% 20% 0.0 5% mPFS (months) mPFS not
Slide 15: Our Vision is for Every ccRCC Patient to Receive a HIF-2α Inhibitor and for Cas to be the Choice
Our Vision is for Every ccRCC Patient to Receive a HIF-2α Inhibitor and for Cas to be the HIF-2α Inhibitor of Choice EST. 2024 PATIENT DOT SETTING COMBINATION POPULATION (MONTHS) ARCUS APPROACH Neoadjuvant cas + zimberelimab Investigator-sponsored trial to initiate 3-4 ccRCC (anti-PD-1) 57k in 2H25
Slide 16: First Phase 3 Study for Cas Has a Simple Design that Utilizes the Preferred SOC in Post-IO ccRCC
First Phase 3 Study for Cas Has a Simple Design that Utilizes the Preferred SOC in Post-IO ccRCC PATIENT POPULATION: • Unresectable, locally advanced or metastatic N~700 PRIMARY ccRCC 100MG CASDATIFAN + ENDPOINT: • Measurable disease per CABOZANTINIB • PFS RECIST 1.1 KEY SECONDARY R • Have had prior
Slide 17: Our Initial Focus Is on the IO-naive and Post-IO Settings, Both Multi-Billion Dollar Market Opportunities
Our Initial Focus Is on the IO-naive and Post-IO Settings, Both Multi-Billion Dollar Market Opportunities POTENTIAL FUTURE MARKET SIZE CURRENT SOC TREATMENT (MAJOR MARKETS1,2) CAS FUTURE DEVELOPMENT 21k patients IO-naive Part of eVOLVE New cohorts being PD-1 + CTLA4 ~$3B metastatic portfolio of tria
Slide 18: Initial Cas Development Plan Targets the Largest Market Segments and Could Expand Share Within These Segments
Initial Cas Development Plan Targets the Largest Market Segments and Could Expand Share Within These Segments 2024 ccRCC • US Market Share 12.6k patients 8.8k patients 100% 4% 10% 90% 4% 4% chemo 3% 80% 6% belz (+/- other) 26% 12% non-cabo TKI mono 70% Nivo-Ipi % Patient Share 4% avelumab + axitinib
Slide 19: Cas Will Be Offered as a Single 100mg QD Tablet
Cas Will Be Offered as a Single 100mg QD Tablet LITESPARK-011 (Merck) Cas 100mg Cabo 20-60mg Belz 120mg Lenva 20mg (1 x 100mg) (1 x Xmg) (3 x 40mg) (2 x 10mg) • Cas tablet strength is expected to minimize pill burden while enabling dose reductions AE: adverse event; cas: casdatifan; cabo: cabozantin
Slide 20: Domvanalimab in Upper GI Cancers and Non-Small Cell Lung Cancer
Domvanalimab in Upper GI Cancers and Non-Small Cell Lung Cancer 20 © Arcus Biosciences 2025
Slide 21: Dom is the Most Clinically Advanced Fc-Silent Anti-TIGIT Antibody in Development
Dom is the Most Clinically Advanced Fc-Silent Anti-TIGIT Antibody in Development TIGIT inhibition turns an immuno-suppressive First-to-Market potential in Upper GI & “brake” into an accelerator of adaptive immunity the only Fc-silent anti-TIGIT in Ph3 NSCLC 1 2 Dom blocks TIGIT, an inhibitory TIGIT
Slide 22: Dom/Zim/Chemo: Unprecedented mPFS in 1L Gastric Cancer
Dom/Zim/Chemo: Unprecedented mPFS in 1L Gastric Cancer Phase 2 EDGE-Gastric: TAP ≥ 5% Phase 2 EDGE-Gastric Data Exceeded (n=16); TAP < 5% (n=24) Phase 3 Benchmark Data CHECK KEY 13.8 months EDGE- RATIONALE MATE- NOTE- 100 GASTRIC -3053 KM Estimate of Progression Free median PFS 6491 8592 TAP ≥5% 75
Slide 23: Phase 3 Study was Fully Enrolled in June 2024
Phase 3 Study was Fully Enrolled in June 2024 Dom + zim is positioned to be the first anti-TIGIT combination approved STAR-221 is evaluating the same regimen in the same setting as EDGE-Gastric 1L locally N=1,046 DUAL PRIMARY advanced ENDPOINTS: domvanalimab + zimberelimab + • OS ITT unresectable or
Slide 24: ARC-7 and ARC-10 Demonstrated Consistent Improvement for Dom + Zim in 1L PD-L1 High NSCLC
ARC-7 and ARC-10 Demonstrated Consistent Improvement for Dom + Zim in 1L PD-L1 High NSCLC 1L PD-L1 High NSCLC 1L PD-L1 High NSCLC dom + zim vs. zim vs. etruma + dom + zim (n=150) dom + zim vs. zim or chemo (n=95) Dom + Zim Zim Dom + Zim Zim Median PFS 9.3 months 5.4 months Median OS NR 24.4 months [
Slide 25: Phase 3 Evaluating Dom + Zim + Chemo vs. Pembro + Chemo in 1L NSCLC
Phase 3 Evaluating Dom + Zim + Chemo vs. Pembro + Chemo in 1L NSCLC (All PD-L1 Subgroups) • Uses standard of care, pembrolizumab, in the comparator arm ELIGIBILITY CRITERIA: ARM A ENDPOINTS: • Metastatic NSCLC without dom + zim + platinum doublet PRIMARY actionable mutations (ARM A vs B) • No prior
Slide 26: Phase 3 Evaluating Dom + Durva vs Placebo + Durva in Unresectable, Stage III NSCLC
Phase 3 Evaluating Dom + Durva vs Placebo + Durva in Unresectable, Stage III NSCLC • Combines domvanalimab with durvalumab standard-of-care in Stage III NSCLC • Potential to be first anti-TIGIT combination in this curative intent setting PATIENT POPULATION: ARM A (N=430) PRIMARY ENDPOINT: • Patients
Slide 27: Quemliclustat in Pancreatic Cancer
Quemliclustat in Pancreatic Cancer 27 © Arcus Biosciences 2025
Slide 28: Quemliclustat: A Small Molecule CD73 Inhibitor with Several Key Attributes
Quemliclustat: A Small Molecule CD73 Inhibitor with Several Key Attributes QUEMLICLUSTAT • Highly potent small molecule Potential advantages over • Target coverage achieved at doses CD73 antibodies1 as low as 25mg Q2W • Extremely long (4+ days) half-life, enabling Q2W dosing by IV infusion Highly
Slide 29: Highlights from the Randomized Phase 2 Study in 1L PDAC
Highlights from the Randomized Phase 1 Study in 1L PDAC Median overall survival (mOS) was 15.7 months for patients treated with a quemliclustat- based regimen, which exceeds the historical benchmark data for chemotherapy alone (8.5 – 11.7 months)1,2 A 37% reduction in risk of death and a 5.9-month i
Slide 30: Phase 3 Study of Quemli + Chemo in 1L Metastatic PDAC
Phase 3 Study of Quemli + Chemo in 1L Metastatic PDAC 1L mPDAC Stratification • ECOG 0/1 Arm A: Quemli 100mg Q2W + • Liver metastases G/nP PRIMARY ENDPOINT: • Confirmed PDAC untreated • *Region • OS in metastatic setting • Metastatic disease diagnosed 2:1 within 6 weeks prior to KEY SECONDARY screen
Slide 31: Combining to Cure
RCUS BIOSCIENCES COMBINING TO CURE”