Summit Therapeutics Inc. · NASDAQ:SMMT
Summit Therapeutics — 43rd Annual J.P. Morgan Healthcare Conference (January 2025)
30 slides from Summit Therapeutics's conference presentation, Jan 13, 2025
Slide 1: 43rd Annual J.P. Morgan Healthcare Conference
Mission Vision 43rd Annual J.P. Morgan Healthcare Conference January 13, 2025 BOB DUGGAN, Chairman & CEO DR. MAKY ZANGANEH, CEO & President
Slide 2: Forward Looking Statement
Forward Looking Statement Any statements in this presentation about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s par
Slide 3: 2024 Achievements
Mission Cornerstone To improve quality of life, High-speed Execution increase potential duration of 2024life, by resolving serious unmet medical needs Leadership in Global Oncology with a Proven Track Record Achievements Patients first Helping patients return to the MAGIC of NORMAL SummitConfidentia
Slide 4: Achievements
2024 Achievements Summit Confidential & Proprietary Information 4 Do Not Copy or Distribute Presentation Summit Therapeutics JPM 2025 Presentation January 2025
Slide 5: 2024 Major Achievements
2024 Major Achievements FINANCIAL SUMMARY SMMT 2024 Stock Performance: + 584% Ivonescimab Completed Ivonescimab: statistically significant $435 million in Financing in 2024 enrollment in global 9 Total and decisive PFS z Phase III trial Phase III Trials improvement vs. Pembrolizumab 1 YE 2024, unaud
Slide 6: 2024 Stock Performance
2024 Stock Performance 50-Day Moving Avg FINANCIAL SUMMARY 20.00 SMMT 2024 Stock Performance: + 584%1 15.00 $435 Million in Financing in 2024 10.00 YE 2024, unaudited cash balance in excess of $410 Million Ivonescimab 5.00 Current Debt: $0 ($31.8 Million in principal and interest 0.00 was paid in Q4
Slide 7: Financial Summary
FINANCIAL SUMMARY SMMT 2024 Stock Performance: + 584% $435 million in Financing in 2024 YE 2024, unaudited cash balance in excess of $410 million Ivonescimab Current Debt: $0 ($31.8 million in principal and interest was paid in Q4 2024) Summit Confidential & Proprietary Information 7 Do Not Copy or
Slide 8: Ivonescimab Mechanism of Action
Ivonescimab Mechanism of Action VEGF Dimer PD-1 Receptor in T Cell Announced Phase III Phase III Phase I-II T Cell Cooperative Aspirational VEGF Binding Simultaneous Tumor Cell blocking of Tumor Cell PD-1 & VEGF1-3 PD-1 Anti-Angiogenesis Enhanced Avidity in Ivonescimab is an investigational therapy
Slide 9: 31 Ivonescimab Clinical Trials
Ivonescimab Pipeline Ivonescimab 31 Ivonescimab Clinical Trials Announced Phase III Phase III Cumulative Conducted in China Planned and Ongoing Studies Number Phase I-II 2,300+ Fully Sponsored and Managed by Akeso Phase III Aspirational Phase III of Trials Sponsored by Summit Therapeutics 35 Patient
Slide 10: Ivonescimab Pipeline
Ivonescimab Pipeline Conducted in China Planned and Ongoing Studies Fully Sponsored and Managed by Akeso Sponsored by Summit Therapeutics* Phase III Phase III 2L+ NSCLC: 2L+ NSCLC: 1L NSCLC: 1L NSCLC: 1L NSCLC: 1L NSCLC: 1L R/M HNSCC: Expanding CDP 1L Biliary Tract: Further Announcements in 2025 Not
Slide 11: Ivonescimab Pipeline: NSCLC
Ivonescimab Pipeline: NSCLC Conducted in China Planned and Ongoing Studies Fully Sponsored and Managed by Akeso Sponsored by Summit Therapeutics NSCLC Phase III NSCLC Phase III 2L+ EGFRm Approved in China Enrollment complete; Top-line data expected mid-2025 1L Ivo + chemo Enrolling in China Enrollin
Slide 12: 1L NSCLC
1L NSCLC Ivonescimab vs. Anti-PD-1 Global +/- chemo China PD-L1 High, Monotherapy PD-L1 Positive, Monotherapy Ivonescimab vs Ivonescimab vs pembrolizumab2 pembrolizumab3 Enrollment starting in early 2025 WCLC 2024 Presidential Symposium PD-L1 All-Comers Squamous, PD-L1 All-Comers Ivonescimab + chemo
Slide 13: Monotherapy Ivonescimab vs. Pembrolizumab: Study Design
Monotherapy Ivonescimab vs. Pembrolizumab Akeso Sponsored Study Randomized, Double-blind, Phase III Study NCT05499390a Patient Ivonescimab Population Randomization 20 mg/kg Q3W Treatment Until • Stage IIIB-IV • no clinical benefit NSCLC 1:1 • unacceptable toxicity • 24 months of • 1L therapy for Pem
Slide 14: ITT: PD-L1 Positive NSCLC
Monotherapy Ivonescimab vs. Pembrolizumab Akeso Sponsored Study ITT: PD-L1 Positive NSCLC Ivonescimab Pembro (n=198) (n=200) mPFS, mos 11.14 5.82 (95% CI) (7.33, NE) (5.03, 8.21) Ivonescimab Hazard Ratio 0.51 showed a (95% CI) (0.38, 0.69) p-value <0.0001 decisive, statistically PFS (%) significant
Slide 15: PD-L1 High Expressing Tumors
Monotherapy Ivonescimab vs. Pembrolizumab Akeso Sponsored Study PD-L1 High Expressing Tumors Ivo Pembro (n=83) (n=85) Strat. HR 0.46 Ivonescimab (95% CI) (0.28, 0.75) showed a clinically meaningful PFS (%) improvement Ivonescimab in PFS vs. pembrolizumab across major Pembrolizumab clinical subgroups
Slide 16: NSCLC by Histology
Monotherapy Ivonescimab vs. Pembrolizumab Akeso Sponsored Study NSCLC by Histology Squamous Non-Squamous Ivonescimab Ivo Pembro Ivo Pembro showed a (n=90) (n=91) (n=108) (n=109) Strat. HR 0.48 Strat. HR 0.54 clinically (95% CI) (0.31, 0.74) (95% CI) (0.36, 0.82) meaningful improvement in PFS vs. pem
Slide 17: Treatment-related Adverse Events
Monotherapy Ivonescimab vs. Pembrolizumab Akeso Sponsored Study Ivonescimab Showed Manageable Safety Profile Ivonescimab 20 mg/kg Ivonescimab Treatment-related Adverse Events Ivonescimab + + Pemetrexed 500 mg/m2 safety profile Carboplatin AUC5 Pemetrexed Q3W for04 cycles 5 10 15 20 25 was consistent
Slide 18: Summit Sponsored Study: Ivonescimab vs. Pembrolizumab
Monotherapy Ivonescimab vs. Pembrolizumab Summit Sponsored Study Randomized, Double-blind, Phase III Study 1L NSCLC with PD-L1 High Expression NCT067675141 Key Inclusion • 1L squamous or Safety and Survival Follow-up Ivonescimab non-squamous 20 mg/kg Q3W Treatment until Randomization metastatic NSCL
Slide 19: Ivonescimab + Chemo vs. Pembrolizumab + Chemo
Ivonescimab + Chemo vs. Pembrolizumab + Chemo Summit Sponsored Study Randomized, Double-blind, Phase III Study 1L NSCLC: PD-L1 All-Comers* NCT05899608 Key Inclusion Non-Squamous OR Squamous Maintenance Non-Squamous: • 1L squamous or Ivonescimab + Safety and Survival Follow-up Ivonescimab + Ivonescim
Slide 20: 2L+ EGFRm NSCLC
2L+ EGFRm NSCLC Ivonescimab + Chemo vs. Placebo + Chemo Global China EGFRm after a 3rd-gen TKI EGFRm after a TKI Ivonescimab + chemo vs. Ivonescimab + chemo vs. placebo + chemo1 placebo + chemo2 Completed enrollment Positive Phase III Study: Topline data expected mid-2025 • ASCO 2024 Presentation •
Slide 21: Ivonescimab + Chemo vs. Placebo + Chemo: Study Design
Ivonescimab + Chemo vs. Placebo + Chemo Randomized, Double-blind, Phase III Study Akeso Sponsored Study 2L+ EGFRm NSCLC NCT05184712a Key Eligibility Ivonescimab Ivonescimab Criteria Pemetrexed + + + Maintenance Pemetrexed Randomization • Stage IIIB-IV Carboplatin Treatment Until: Q3W Q3W for 4 cycle
Slide 22: Ivonescimab + Chemo vs. Placebo + Chemo: ORR, DCR
Ivonescimab + Chemo vs. Placebo + Chemo 2L+ EGFRm NSCLC Akeso Sponsored Study Ivonescimab Ivo + Placebo + 100 + Chemo Chemo (n=161) Chemo (n=161) 90 DCR mPFS, mos 7.1 4.8 significantly (95% CI) Hazard Ratio (5.9, 8.7) 0.46 (4.2, 5.6) 80 93.1 95% CI (88.0, 96.5) DCR 83.2 improved PFS (95% CI) (0.34,
Slide 23: Treatment-related Adverse Events (TRAEs)
Ivonescimab + Chemo vs. Placebo + Chemo 2L+ EGFRm NSCLC Akeso Sponsored Study Treatment-related Adverse Events (TRAEs) HARMONi-A 0 5 10 15 20 25 30 safety profile 0 generally Led to death 0 well tolerated, 5.6 without Led to discontinuation 2.5 unexpected AEs and low rate of 6.2 treatment Grade ≥3 i
Slide 24: Summit Sponsored 2L+ EGFRm NSCLC Study
Ivonescimab + Chemo vs. Placebo + Chemo Summit Sponsored Study Randomized, Double-blind, Phase III Study 2L+ EGFRm NSCLC NCT063960651 Locally advanced or metastatic Ivonescimab Ivonescimab Maintenance Randomization Pemetrexed + Carboplatin Pemetrexed Treatment non-squamous Q3W for 4 cycles Q3W Until
Slide 25: Ivonescimab in Phase II Studies in Various Settings
Ivonescimab in Phase II Studies in Various Settings Phase II Studies Conducted in Perioperative Resectable NSCLC1 No TRAEs led to cancelled / China % pCR 43.6 delayed surgery or wound healing complications. Akeso Sponsored (n=39) Overall rate of MPR 71.8 Serious TRAEs (n=39) was 2% 12-month EFS 80.3
Slide 26: Ivonescimab in Phase II Studies in Various Settings
Ivonescimab in Phase II Studies in Various Settings Phase II Studies Conducted in 1L PD-L1 Positive R/M Head and Neck (HNSCC)1 China % ORR 60 No TRAEs led to Akeso Sponsored % DCR 90 discontinuation. Overall rate of Serious TRAEs 0 20 40 60 80 was 5% Promising Median PFS 7.1 Ivo + CD47 (AK117) mos P
Slide 27: Ivonescimab Catalysts in 2025-2026
Ivonescimab Catalysts Global in 2025-2026 China First Global Clinical Trial Enrollment Completion1 Results in Mid-2025 Expanding our Global Clinical Trial Clinical Development Plan2 Data Readouts Way Beyond NSCLC NSCLC and Way Beyond Investigator Sponsored Initiation of Additional Trials Activating3
Slide 28: Ivonescimab Opportunity Goes Beyond Checkpoint Inhibitors
Ivonescimab Clinical Trials Ivonescimab Opportunity Goes Beyond Checkpoint Inhibitors (CPI) 2028 Estimated $90B+ CPI TAM 2 $20B+ NSCLC CPI TAM2,3 50+ Approved Indications for 1 PD-(L)1 & VEGF Therapies Approved Anti-VEGF Therapies Approved Anti PD-(L)1 Therapies Approved Anti PD-(L)1 & Anti-VEGF The
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Slide 30: Summit Therapeutics
Summit .& \\ a therapeutics@e | ANGING THE! FL 20 FOR THE BET rey 7% TOGETHER?
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