Arcus Biosciences, Inc. · NYSE:RCUS
Arcus Biosciences — Q2 2024 Earnings Presentation
65 slides from Arcus Biosciences's earnings presentation, Aug 8, 2024
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 August 8, 2024
Slide 2: 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 regarding events or results
Slide 3: Late-stage Portfolio of Differentiated Assets, Highly Productive R&D Engine
Arcus Has Created a Late-stage Portfolio of Differentiated Assets, Fueled by a Highly Productive R&D Engine FUNDING INTO POTENTIAL PHASE 3 STUDIES FOR DOM 2027 BEST-IN-CLASS HIF-2a IN LUNG & UPPER GI INHIBITOR, CASDATIFAN PROGRESSING TO DATA ~$1.0B in cash, Commercially validated cash equivalents me
Slide 4: Multiple Late-Stage Programs and Opportunities to Win
Multiple Late-Stage Programs and Opportunities to "Win" Dom (+ Zim) • Potential to be first-in-class in upper GI cancer ($3B market opportunity) and (anti-TIGIT + anti-PD-1) best-in-class in NSCLC ($10B+ market opportunity) • 12.9 - 13.8 months PFS in EDGE-Gastric1 is meaningfully higher than THREE*
Slide 5: New Disclosure for the Second Quarter 2024
New Disclosure for the Second Quarter 2024 • OS and PFS data for ARC-10 (dom + zim vs. zim vs. chemo) in PD-L1 high Dom (+ Zim) NSCLC will be presented by YE 2024 (anti-TIGIT + anti-PD-1) • EDGE Gastric OS Data is expected to be presented in 2025 • First Phase 3 study, PEAK-1, will evaluate cas + ca
Slide 6: Targeting Huge Market Opportunities and Unmet Need
Targeting Huge Market Opportunities and Unmet Need ADDRESSABLE MARKET PHASE 1/2 STUDIES PHASE 3 STUDY INDICATION PH 3 STUDY DETAILS PATIENTS1 POTENTIAL2 dom + zim + 1L Gastric/GEJ/EAC chemo vs nivo + 103K ~$3B - all comers mPFS presented at ASCO ‘24 chemo dom + zim + DOM + ZIM 1L NSCLC – all chemo v
Slide 7: Our Partnerships Greatly Expand & Accelerate Our Opportunities
Our Partnerships Greatly Expand & Accelerate Our Opportunities 10-YEAR COLLABORATION • Gilead has opted into 5 molecules to date -- shares costs for studies within the joint development plan • Arcus retains U.S. co-commercialization rights COLLABORATION FOR JAPAN AND OTHER TERRITORIES IN ASIA (EX-CH
Slide 8: Domvanalimab in Non-Small Cell Lung Cancer and Upper GI Cancers
Domvanalimab in Non-Small Cell Lung Cancer and Upper GI Cancers 8 © Arcus Biosciences 2024
Slide 9: Dom is the Most Clinically Advanced Fc-Silent Anti-TIGIT Antibody
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 10: Approaching Pivotal Data & Launch Windows for Dom + Zim
Approaching Pivotal Data & Launch Windows for Dom + Zim 2024 2025+ 2026+ POTENTIAL LAUNCH ENROLLMENT COMPLETED June 2024 DATA UPDATE 1L Gastric/GEJ/EAC - all comers POTENTIAL LAUNCH ENROLLMENT COMPLETION 1L NSCLC DATA UPDATE 2H 2024 – all comers 1L: first line; 2H: second half; dom: domvanalimab; EA
Slide 11: Two De-Risking Phase 2 Datasets for Dom + Zim Regimens
Two De-Risking Phase 2 Datasets Have Been Presented for Domvanalimab Plus Zimberelimab Regimens 1L Gastric/EAC/GEJ 1L PD-L1 high NSCLC dom + zim + FOLFOX (n=40) dom + zim vs. zim vs. etruma + dom + zim (n=150) mPFS well beyond historical benchmarks • PFS HRs: of 7 to 8 months1-3 − 0.67 for DZ vs. Z
Slide 12: Summary of EDGE-Gastric Arm-A1 Results
Summary of EDGE-Gastric Arm-A1 Results and Domvanalimab Plus Zimberelimab Clinical Program in Upper GI Cancers Data presented at 2024 ASCO Annual Meeting, based on data cut off of March 12, 2024. 12 © Arcus Biosciences 2024
Slide 13: Arm A1: 1L Metastatic Gastric/GEJ/EAC Cohort
Arm A1: 1L Metastatic Gastric/GEJ/EAC Cohort EDGE-Gastric (NCT05329766) is a Phase 2 study evaluating the safety and efficacy of treatment combinations with and without chemotherapy in adults with advanced upper gastrointestinal tract malignancies KEY ELIGIBILITY CRITERIA • First-line locally advanc
Slide 14: Baseline Characteristics
Baseline Characteristics Arm A1 Arm A1 N=41, n (%) N=41, n (%) Mean age, years (range) 61 (30 to 82) Current disease status Locally advanced unresectable disease 3 (7) Female 17 (41) Metastatic disease 38 (93) Country Liver metastases 13 (32) United States/France 22 (54) Peritoneal metastases 15 (37
Slide 15: Almost All Patients Experienced Meaningful Tumor Reduction
Almost All Patients Experienced Meaningful Tumor Reduction, Regardless of PD-L1 Status 100 * Treatment status: Ongoing TAP Score Microsatellite instability status: High TAP ≥ 5% Best Percent Change from Baseline, % 60 TAP < 5% Missing 20 -20 * * * -60 * * * * * * * -100 * * One patient had no tissue
Slide 16: Unprecedented Median PFS of 12.9 Months in Overall Population
Unprecedented Median PFS of 12.9 months in the Overall Population Efficacy-Evaluable (N=41) TAP ≥ 5% (n=16); TAP < 5% (n=24) Median, months Month 12 rate, % Median PFS follow-up Median, months Month 12 rate, % Median PFS follow-up Events, n (%) Events, n (%) (95% CI) (95% CI) time, months (95% CI) (
Slide 17: Dom + Zim + Chemo Potential New SOC in 1L Gastric/GEJ/EAC
Dom + Zim + Chemo Has the Potential to Become the New SOC in 1L Gastric/GEJ/EAC Data below are not from head-to-head studies. Cross-trial data interpretation should be considered with caution as it is limited by differences in study population, sample size, inclusion and exclusion criteria and many
Slide 18: Phase 3 Dom + Zim + Chemo vs Nivo + Chemo in 1L Gastric
Phase 3 Evaluating Dom + Zim + Chemo vs Nivo + Chemo in 1L Gastric/GEJ/EAC STAR-221 is evaluating the same regimen in the same setting as EDGE-Gastric – and dom + zim has the potential to be the first anti-TIGIT combination approved for 1L Gastric/GEJ/EAC KEY ELIGIBILITY CRITERIA: N=970 • 1L locally
Slide 19: Summary of ARC-7 Results in Non-Small Cell Lung Cancer
Summary of ARC-7 Results and Domvanalimab Plus Zimberelimab Clinical Program in Non-Small Cell Lung Cancer Data presented at the 2023 ASCO Annual Meeting, based on data cut-off of Feb. 7, 2023. 19 © Arcus Biosciences 2024
Slide 20: Randomized Open-label Ph2 Study in PD-L1-High NSCLC
Randomized, Open-label, Ph2 Study in First-Line, Metastatic, PD-L1-High NSCLC ARM 1 STAGE IV NSCLC zim (Z) 360 mg IV Q3W KEY ELIGIBILITY: CO-PRIMARY ENDPOINTS • Treatment-naïve for • Investigator-assessed ORR & metastatic disease ARM 2 PFS per RECIST v1.1 R dom + zim (DZ) • PD-L1 ≥50%, locally 1:1:1
Slide 21: Addition of Dom to Zim Resulted in 33% Reduction in Risk
Addition of Dom to Zim Resulted in a 33% Reduction in Risk of Progression or Death, Compared to Zim Monotherapy CI: confidence interval; D/dom: domvanalimab; HR: hazard ratio; NE: not evaluable; PFS: progression- free survival; Z/zim: zimberelimab 21 Johnson et al. Abstract 397600, ASCO 2023; data c
Slide 22: Phase 3 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 23: Phase 3 Dom + Durva vs Placebo + Durva in Stage III NSCLC
Phase 3 Evaluating Dom + Durva vs Placebo + Durva in Unresectable, Stage III NSCLC • Combines domvanalimab (dom) with durvalumab (durva) 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) • Patients wit
Slide 24: Casdatifan (HIF-2a) in ccRCC
Casdatifan (HIF-2a) in ccRCC 24 © Arcus Biosciences 2024
Slide 25: Casdatifan (AB521): Potential Best-in-Class HIF-2a Inhibitor
Casdatifan (AB521): A Potential Best-in-Class HIF-2a Inhibitor Novel Combinations in 1L and Efficacy Post-IO Settings Opportunity to reach greater intra- Opportunity to create potentially best- tumoral HIF-2a inhibition compared in-class and first-in-class combinations to the 120mg dose of belzutifa
Slide 26: Study Design and Inclusion Criteria
Study Design and Inclusion Criteria PH 1 DOSE ESCALATION EXPANSION COHORTS (2L+ ccRCC) 3+3 design with 21-day DLT window Solid-tumor patients w/o SOC KEY INCLUSION CRITERIA • At least 1 measurable lesion per 50 mg (n~30) RECIST 1.1 COMPLETED ENROLLMENT • Adequate organ and marrow AB521 150mg QD func
Slide 27: Multiple Casdatifan Datasets from ARC-20 Expected Over Next 12 Months
Multiple Casdatifan Datasets from ARC-20 are Expected Over the Next 12 Months 2H 2023 1H 2024 2H 2024 1H 2025 100mg dose expansion Nov 2023 ENROLLMENT ORR and COMPLETION safety data 50mg dose expansion Efficacy and Apr 2024 safety data ENROLLMENT for 50mg and COMPLETION 100mg 150mg dose 6-month mini
Slide 28: Trial Inclusion Criteria and ORR From Other 2L+ RCC Studies
Trial Inclusion Criteria and ORR From Other 2L+ RCC Studies STUDY # OF LINES OF PHASE INCLUSION CRITERIA PRIOR TKI PRIOR CPI ORR DESCRIPTION THERAPY • 20.5% • Locally advanced/metastatic ccRCC who • Median 3 prior • 91% had prior • 80% had prior LITESPARK-0011 Ph 1 (prior CPI and previously received
Slide 29: Proposed Phase 3 Study of Cas + Cabo in ccRCC
Proposed Phase 3 Study Evaluating Cas + Cabo in Advanced or Metastatic ccRCC, following prior PD-1 Tx PATIENT POPULATION: • Unresectable, locally N~700 advanced or metastatic CASDATIFAN + CABOZANTINIB PRIMARY ENDPOINT: ccRCC • PFS • Measurable disease per KEY SECONDARY RECIST 1.1 R ENDPOINTS: 2:1 •
Slide 30: RCC Treatment Landscape Favors Tailored Combination Therapies
RCC Treatment Landscape Favors Tailored Combination Therapies with Multiple TKIs 2024 ccRCC DRUG TREATABLE INCIDENCE AND US MARKET SHARE US: 12.6k / G7: 30.4k US: 8.8k / G7: 20.3k 100% 3% 4% 10% 90% chemo 5% 3% 80% 6% belz (+/- other) 12% non-cabo TKI mono 70% 32% 4% % Patient Share NCCN Preferred a
Slide 31: RCC Patients Have Typically Cycled Through Multiple TKIs
RCC Patients Have Typically Cycled Through Multiple TKIs Due to Lack of Other Treatment Options GLOBAL 2023 TKI REGIMEN PATIENT POPULATION APPROVAL SALES ($M)1 U.S. (Dec. 2017) monotherapy 1L intermediate-/poor-risk E.U. (May 2018) Jp (Mar. 2020) cabozantinib $2,254 U.S. (Jan. 2021) nivolumab + 1L E
Slide 32: Doubling of Belzutifan Scripts Since ccRCC Data Release
Doubling of Belzutifan Scripts Since ccRCC Data Release in August 2023 MONTHLY BELZUTIFAN SCRIPTS 1,600 • December 2023: Belzutifan received FDA approval for monotherapy in late- 1,400 107% growth from line ccRCC Dec ’23 to June ’24 1,200 • Annualized Run-Rate Sales of >$500M in the U.S. 1,000 − Inc
Slide 33: CD73-Adenosine Axis Programs
CD73-Adenosine Axis Programs 33 © Arcus Biosciences 2024
Slide 34: Three Datasets in Six Months Combining Adenosine Blockade with Chemotherapy
Three Datasets in Six Months Demonstrate the Potential Benefits of Combining Adenosine Blockade with Chemotherapy 3L Colorectal Cancer 1L Metastatic PDAC 1L Metastatic PDAC etruma + zim + FOLFOX/bev vs. rego (n=112) quemli ± zim + G/nP (n=122) etruma + atezo + G/nP (n=35) 100 100 100 EZFB etruma + a
Slide 35: Etrumadenant in Pancreatic and Colorectal Cancers
Etrumadenant in Pancreatic and Colorectal Cancers 35 © Arcus Biosciences 2024
Slide 36: Etrumadenant: Potentially Best-in-Class Adenosine Receptor Antagonist
Etrumadenant Represents a Potentially Best-in-Class Adenosine Receptor Antagonist ETRUMADENANT Etrumadenant has an ideal profile • Highly potent small molecule that inhibits both the A2a and A2b receptors Retains potency in physiologically • Excellent penetration of tumor tissue relevant condition
Slide 37: Summary of ARC-9 Results
Summary of ARC-9 Results Data presented at 2024 ASCO Annual Meeting, based on data cut off of November 13, 2023. 37 © Arcus Biosciences 2024
Slide 38: ARC-9 Cohort B: EZFB vs Regorafenib in 3L mCRC
ARC-9 Cohort B: Etruma + Zim + mFOLFOX6 + Beva (EZFB) vs Regorafenib (Rego) in 3L mCRC PRIMARY ENDPOINTS: Etruma* + zim + mFOLFOX6 + beva • PFS (investigator 2 (n=75) assessed) R E COHORT Post-oxaliplatin and G KEY SECONDARY 3L R I ENDPOINTS: B irinotecan O N • OS Regorafenib** 1 (n=35) • ORR (inves
Slide 39: Prior Performance on FOLFOX Consistent With Historical 1L Data
Prior Performance on FOLFOX Is Consistent With Historical 1L Data • Patients previously performed in-line with expectations for FOLFOX + bev in prior lines • Prior performance in FOLFOX was well-balanced between arms EZFB REGO (N=75) (N=37) Time from first oxaliplatin dose date to progression/discon
Slide 40: EZFB Demonstrated Significant Improvement in PFS vs Rego
EZFB Demonstrated Statistically Significant Improvement in PFS vs Rego EZFB Rego Patients with event, n (%) 58 (77) 34 (92) Median PFS (95% CI), months 6.24 (5.49, 7.52) 2.07 (1.84, 2.96) Hazard ratioa (95% CI) 0.27 (0.17, 0.43) P-value <0.001 2.07 months 6.24 months mPFS 6-month PFS rate, % 54 6 mP
Slide 41: EZFB Demonstrated Significant Improvement in OS vs Rego
EZFB Demonstrated Significant Improvement in OS vs Rego EZFB Rego Patients with event, n (%) 34 (45) 26 (70) 19.68 9.49 Median OS (95% CI), months 19.68 months mOS (14.69, 20.60) (7.95, 12.52) EZFB Hazard ratioa (95% CI) 0.37 (0.22, 0.63) P-value <0.001 6-month OS rate, % 90 71 12-month OS rate, % 6
Slide 42: Median PFS and OS for EZFB in Patients With Liver Metastasis
5.7 Month Median PFS and 20 Month Median OS for EZFB in Patients With Liver Metastasis EZFB Rego EZFB Rego Patients with events , n (%) 45 (85) 28 (97) Patients with events , n (%) 27 (51) 22 (76) Median PFS, months 5.65 1.97 Median OS, months 19.68 9.13 Hazard ratio (95% CI) 0.19 (0.10, 0.35) Hazar
Slide 43: Two-Thirds of Patients on EZFB Experienced Tumor Reduction
Two-Thirds (66%) of Patients on EZFB Experienced Tumor Reduction EZFB REGO Sum of Target Lesion Best Percent Change from Baseline (%) Sum of Target Lesion Best Percent Change from Baseline (%) • Confirmed ORR for EZFB: 17.3% • Confirmed ORR for rego: 2.7% • Median DOR for EZFB: 11.5 months • Median
Slide 44: EZFB Had an Acceptable Safety Profile
EZFB Had an Acceptable Safety Profile, Consistent With Known Toxicity Profile of FOLFOX/bev in Combination With Anti-PD-1 n (%) EZFB (N=74) Rego (N=35) Median treatment duration, weeks 26 7 Any TEAEs 73 (99) 31 (89) Serious TEAEs 37 (50) 9 (26) Grade ≥3 TEAEs 61 (82) 17 (49) Any TEAEs leading to dis
Slide 45: Conclusions
Conclusions This is the first randomized, Phase 2, proof-of-concept study showing EZFB significantly improves PFS and OS compared with standard of care in microsatellite-stable 3L mCRC • Longest OS reported for a randomized clinical trial in 3L mCRC • Meaningful improvement shown across all subgroup
Slide 46: Quemliclustat in Pancreatic Cancer
Quemliclustat in Pancreatic Cancer 46 © Arcus Biosciences 2024
Slide 47: Quemliclustat: Unique, Highly Potent, Selective CD73 Inhibitor
Quemliclustat (quemli): A Unique, Highly Potent and Selective Small Molecule CD73 Inhibitor with Several Key Advantages QUEMLICLUSTAT • Highly potent small molecule Potential advantages over • Target coverage achieved at doses CD73 antibodies1 as low as 25 mg every two weeks • Extremely long (4+ day
Slide 48: Final OS Analysis for Quemliclustat and Zimberelimab in Pancreatic Cancer (ARC-8)
Final Overall Survival Analysis for Quemliclustat and Zimberelimab in Pancreatic Cancer (ARC-8) Data presented at ASCO GI, January 19, 2024, based on a data cutoff of June 19, 2023. 48 © Arcus Biosciences 2024
Slide 49: Highlights from ARC-8, a Phase 1b Study in 1L PDAC
Highlights from the ARC-8, a Phase 1b 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 im
Slide 50: ARC-8 Study Design
ARC-8 Study Design Included Dose Escalation, Expansion and Randomized Portions RANDOMIZATION DOSE ESCALATION DOSE EXPANSION (WITH AND WITHOUT ZIM) 125mg quemli IV Q2W + G/nP + zim (n=3-6) COHORT A1 100mg QZ + G/nP (n=61) COHORT A 100mg quemli IV Q2W + 1L mPDAC R G/nP + zim (n=6) RDE 100mg QZ + G/nP
Slide 51: Dataset Includes Four Groups of Patients Treated with 100 mg Quemli
Dataset Includes Four Groups of Patients Treated with 100 mg of Quemli Quemli Cohort Combination Participants Dosed >18m OS f/u? Population Dose Dose escalation 25mg Q + Z + G/nP (quad) 4 Yes 1L mPDAC Dose escalation 50mg Q + Z + G/nP (quad) 6 Yes 1L mPDAC Dose escalation 75mg Q + Z + G/nP (quad) 3
Slide 52: Demographics And Baseline Characteristics Well Balanced Across Arms
Demographics And Baseline Characteristics Are Well Balanced Across Arms & Efficacy-evaluated Populations % ECOG 1 (65%-69%) Was Higher than Historical G/nP Studies (42-57%); % Liver Mets (59%-69%) Was Slightly Lower than Historical G/nP Studies (78-85%) A2: Q + G/nP A1: QZ + G/nP Pooled Q100 QZ + G/
Slide 53: OS Results Exceed Ph3 Benchmarks for G/nP
With 21-month Median Follow-up, OS Results Exceed Ph3 Benchmarks for G/nP Phase 3 G/nP median OS G/nP Benchmarks1,2 Benchmark Median OS 8.5 – 11.1 months CI: confidence interval; G/nP: gemcitabine/nab-paclitaxel; Ph3: Phase 3 1. Abraxane USPI, 2020 and Wainberg ZA, Melisi D, Macarulla T, et al. NALI
Slide 54: Favorable OS for Patients With & Without Liver Metastasis
Favorable OS for Patients With & Without Liver Metastasis • Because ARC-8 had a lower incidence of liver mets than historical studies, we analyzed the OS for ARC-8 patients with and without liver mets as shown below • When adjusting for the lower incidence of liver mets in the triplet arm, mOS for t
Slide 55: Safety Profile Similar to G/nP with Regards to Overall TEAEs
Safety Profile Similar to G/nP with Regards to Overall TEAEs NAPOLI-3 G/nP A2: Q + G/nP Pooled Q100 QZ + G/nP All Pooled Q100 Q % Benchmark4 (n=29) (n=93) (±Z)+G/nP (n=122) (n=379) Any TEAE 100 100 100 99 Any TRAE 100 98.9 99.2 93 Grade 3-5 TEAE 89.7 83.9 85.2 86 Grade 3-5 TRAE 75.9 72.0 73.0 68 Ser
Slide 56: Arcus & Medidata AI Synthetic Control Arm Project
Arcus & Medidata AI Synthetic Control Arm (SCA) Project • Developed in collaboration with Medidata, the industry’s leading provider of electronic data capture for clinical trials • Constructed SCA using historical data from patients treated with G/nP alone and balanced to the patient baseline charac
Slide 57: Quemli-based Regimen Reduced Risk of Death by 37%
Quemli-based Regimen Reduced Risk of Death by 37% and increased mOS by 5.9 months Compared to SCA CI: confidence interval; mOS: median overall survival; quemli: quemliclustat; SCA: Synthetic Control Arm 57 Wainberg ZA, et al. ASCO GI, Jan. 19, 2024, data cut off of June 19, 2023 © Arcus Biosciences
Slide 58: Proposed Phase 3 Study of Quemli + Chemo in 1L Metastatic PDAC
Proposed Phase 3 Study of Quemli + Chemo in 1L Metastatic PDAC 1L mPDAC Stratification • ECOG 0/1 Arm A: Quemli 100mg Q2W + • Liver metastases GnP PRIMARY ENDPOINT: • Confirmed PDAC untreated • *Region • OS in metastatic setting • Metastatic disease diagnosed 2:1 within 6 weeks prior to KEY SECONDAR
Slide 59: AXL Program
AXL Program 59 © Arcus Biosciences 2024
Slide 60: AB801 is a Potent, Selective AXL Inhibitor
AB801 is a Potent, Selective AXL Inhibitor AXL signals via Ligand-dependent and AB801 is a highly potent Ligand-independent mechanisms and selective AXL inhibitor Assay AB801 AXL Ki 0.024 nM MERTK EGFR TYRO3 VEGFR HER2 Fold selectivity over hMERTK/ hTYRO3 860x / 1400x BIOCHEMICAL (enzyme Ki over AXL
Slide 61: AB801 Potentially Most Potent & Selective AXL Inhibitor in Clinic
AB801 is Potentially the Most Potent & Selective AXL Inhibitor in Clinical Development THERAPEUTIC HYPOTHESIS: Inhibiting AXL will overcome resistance against chemotherapy and immunotherapy in human tumors • AB801 was designed to potently and selectively inhibit AXL signaling in tumors, resulting in
Slide 62: Phase 1 Dose-Finding Study in Advanced Solid Tumors
Phase 1 Dose-Finding Study in Patients with Advanced Solid Tumors PRE-SCREENING / SCREENING DOSE ESCALATION STAGE EXPANSION STAGE DOSE ESCALATION PRIMARY ENDPOINT • Safety / DLT AB801 SECONDARY ENDPOINT • PK • ORR AB801 EXPLORATORY ENDPOINTS Advanced Solid Cohort 1: NSCLC • Biomarkers / PD Tumors AB
Slide 63: Appendix
APPENDIX 63 © Arcus Biosciences 2024
Slide 64: Expansive Development Plan with Multiple Phase Studies
Expansive Development Plan with Multiple Phase 3 Studies Ongoing or Planned Program Disease Study Line & Regimen Ph 1/1b Ph 2 Ph 3 Upcoming Milestones 1L, PD-L1 all-comers, metastatic • 2024: Enrollment completion dom + zim + chemo vs pembro + chemo Perioperative lung cancer IN PLANNING NSCLC Stage
Slide 65: Combining to Cure
RCUS BIOSCIENCES COMBINING TO CURE”