Arcus Biosciences, Inc. · NYSE:RCUS
Arcus Biosciences — Technical Presentation (February 2025)
30 slides from Arcus Biosciences's technical presentation, Feb 15, 2025
Slide 1: ARC-20 Data Update
ARC-20 Data Update Phase 1b Study of Casdatifan in ccRCC Data presented at ASCO GU 2025, February 15, 2025, based on data cutoff of January 3, 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: Agenda
Agenda TOPIC PRESENTER(S) Dr. Terry Rosen Introduction & Opportunity for Casdatifan CEO, Arcus Biosciences ARC-20 Dose Expansion: Updated Safety & Dr. Richard Markus Efficacy Data CMO, Arcus Biosciences Dr. Richard Markus Next Steps and Development Plan CMO, Arcus Biosciences Jennifer Jarrett Market
Slide 4: Arcus Has Created a Broad Portfolio of Late-Stage Programs, Fueled by a Highly Productive R&D Engine
Arcus Has Created a Broad Portfolio of Late-Stage Programs, Fueled by a Highly Productive R&D Engine CASDATIFAN: POTENTIAL BEST-IN-CLASS WORLD-CLASS HIF-2α INHIBITOR DRUG DISCOVERY Small molecules focused on Validated mechanism and Phase 3 initiation expected oncology and I&I compelling market oppor
Slide 5: Overview of Casdatifan
Overview of Casdatifan Dr. Terry Rosen CEO, Arcus Biosciences 5 © Arcus Biosciences 2025
Slide 6: ARC-20 Results are Consistent and Support Casdatifan Having a Potential Best-in-Class Profile for ccRCC
ARC-20 Results are Consistent and 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 rate
Slide 7: EPO Suppression Data Support Our Observations that Casdatifan Has a Best-in-Class Clinical Profile
EPO Suppression Data Support Our Observations that Casdatifan Has a Best-in-Class Clinical Profile Belzutifan (Merck Data) Casdatifan 50mg BID (ARC-20) erythropoietin (mIU/mL) from baseline 20 Mean (90% CI) percentage change in 120mg QD 10 Week 1 (Baseline) 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100
Slide 8: Our Vision is for Every ccRCC Patient to Receive a HIF-2α Inhibitor and for Cas to be the Inhibitor of 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 3-4 ccRCC (anti-PD-1) 57k initiate in March
Slide 9: ARC-20 Dose Expansion: Safety & Efficacy Data
ARC-20 Dose Expansion: Safety & Efficacy Data Data as of January 3, 2025. Results were presented at the ASCO-GU Symposium, February 15, 2025, San Francisco, CA Dr. Richard Markus Chief Medical Officer, Arcus Biosciences © Arcus Biosciences 2025
Slide 10: 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 11: Baseline Characteristics, Other than Number of Prior Regimens, Were Similar to Those in LITESPARK-005
Baseline Characteristics, Other than Number of Prior Regimens, Were Similar to Those in LITESPARK-005 Dose Expansion: 2L+ ccRCC Belzutifan3 Safety-Evaluable Population1 50mg BID (n = 33) 50mg QD (n = 31) 100mg QD (n=29) 120mg QD (n = 374) Age, years, median (range) 62 (41–79) 65 (43–82) 60 (45–77) 6
Slide 12: 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 13: 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 14: Updated Waterfall Plots for 50mg BID and 50mg QD: Responses Have Deepened
Updated Waterfall Plots for 50mg BID and 50mg QD: Responses Have Deepened With Potential for ORRs to Further Improve 50mg BID Cohort* 50mg QD Cohort** 100 100 80 80 PD 60 60 from Baseline in SLD (%) from Baseline in SLD (%) 40 40 PD Best Percent change Best Percent change PD PD 20 SD PD 20 SD PD SD
Slide 15: Updated Spider Plots for 50mg BID and 50mg QD: Highly Durable Disease Control Even in SD Patients
Updated 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 tr
Slide 16: Updated Swimmer Lane Plots for 50mg BID and 50mg QD Cohorts
Updated Swimmer Lane Plots for 50mg BID and 50mg QD Cohorts: Large Number of Patients Remain on Treatment 50mg BID Cohort 50mg QD Cohort ** Expansion: AB521 50mg BID Expansion: AB521 50mg QD 0 10 20 30 40 50 60 70 80 0 10 20 30 40 50 60 70 80 Time on Treatment, Weeks Time on Treatment, Weeks Complet
Slide 17: Kaplan-Meier Estimates of PFS 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 18: Casdatifan was Well Tolerated in All Cohorts, With Comparable Safety Profile to that of Belzutifan
Casdatifan was Well Tolerated in All Cohorts, With Comparable Safety Profile to that of Belzutifan 50 mg BID 50 mg QD 100 mg QD Belzutifan Safety-Evaluable Population1 (n = 33) (n = 31) (n = 29) (LITESPARK-005) Median follow-up, months (range) 15 (7–19+) 12 (9–14+) 5 (2–6+) Any TEAEs, n (%) 32 (97)
Slide 19: 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 20: Next Steps and Development Plan
Next Steps and Development Plan Dr. Richard Markus Chief Medical Officer, Arcus Biosciences 20 © Arcus Biosciences 2025
Slide 21: We Are Aggressively Pursuing Differentiated Combinations
We Are Aggressively Pursuing Differentiated Combinations Phase 3 Post-IO ccRCC IO-naive ccRCC cas + cabo vs. cabo cas + volrustomig (anti-CTLA- • Cabo is the SOC in the post-IO 4/anti-PD-1 bispecific) setting • Potential first-in-class, TKI-sparing combination • Same TKI in both the control arm and
Slide 22: 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 23: Clinical Collaboration with AstraZeneca will Extend Casdatifan into the IO-Naïve Setting
Clinical Collaboration with AstraZeneca will Extend Casdatifan into the IO-Naïve Setting Casdatifan + Volrustomig Potential first-in-class AND best-in- • AstraZeneca is operationalizing the class combination study • Volru is AZ's anti-PD-1 / CTLA-4 bi- • Part of AstraZeneca’s eVOLVE specific; Encour
Slide 24: Opportunity for Casdatifan
Opportunity for Casdatifan Jennifer Jarrett COO, Arcus Biosciences 24 © Arcus Biosciences 2025
Slide 25: 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% 3% 4% 10% 90% chemo 5% 3% 80% 6% belz (+/- other) 12% non-cabo TKI mono 70% 32% Nivo-Ipi % Patient Share 4% avelumab + atixinib
Slide 26: 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 PD-1 + CTLA4 eVOLVE study ~$3B New cohorts being metastatic cas + volru OPPORTU
Slide 27: 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 strengths will minimize pill burden while enabling dose reductions • The robust clinical data observed for the 50mg QD dose coho
Slide 28: Closing Remarks
Closing Remarks Dr. Terry Rosen CEO, Arcus Biosciences 28 © Arcus Biosciences 2025
Slide 29: Rapid Advancement and Expansion of the Cas Program Is Our Priority over the Next Year
Rapid Advancement and Expansion of the Cas Program Is Our Priority over the Next Year Cas is Poised to Be the HIF-2α Multiple Data Events Coming Over Inhibitor of Choice for RCC the Next Year TIMING SETTING EVENT • HIF-2α inhibitors will become another • Initial safety and efficacy SOC in ccRCC, in
Slide 30: Three Phase 3 Programs Targeting Substantial Market Opportunities and Unmet Medical Need
Three Phase 3 Programs Targeting Substantial Market Opportunities and Unmet Medical Need Designed to improve upon the current standard of care PATIENTS MARKET PHASE 3 (MAJOR POTENTIAL TRIAL NAME STATUS INDICATION MARKETS1,2) (MAJOR MARKETS2) To Begin 2Q CAS 2025 Post-IO ccRCC 19K ~$2B HIF-2α small e
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