Slide 1: Summit Therapeutics Q3 2024 Earnings Call
Summit Therapeutics Q3 2024 Earnings Call October 30, 2024 9:00am ET
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: Q3 2024 Highlights
Q3 2024 Highlights Ivonescimab Improves PFS Completion of Expansion of Global Upcoming Initiation Phase II vs. Pembrolizumab in Akeso Enrollment in Global HARMONi-3 Phase III of HARMONi-7 Data Featured at Ph III Trial in China HARMONi Phase III Trial Trial: SQ + NSQ global Phase III Trial WCLC & ESM
Slide 4: Summit Therapeutics Company Details
Summit Therapeutics Company Details Focus ONCOLOGY MISSION LEADERSHIP Partnership Akeso Inc. …Improve quality of life, increase potential Unmatched high-speed execution, proven Summit North America (including track record United States), South duration of life, and resolve serious medical License Am
Slide 5: Ivonescimab Global Clinical Trials
Ivonescimab Global Clinical Trials Indication Study Treatment Population Regimen Phase Status 2L+ EGFRm + Chemo vs. chemo III Enrollment Complete Ivonescimab NSCLC 1L + Chemo vs. pembrolizumab (PD-1) + chemo III Ongoing More Than 25 1L PD-L1 High Monotherapy vs. pembrolizumab (PD-1) III Planned Clin
Slide 6: Shaping the Path to Become a Commercial Entity
Shaping the Path to Become a Commercial Entity Summit & Akeso Partnership Consummated January 2023 H1 2023 H2 2023 H1 2024 H2 2024 NSCLC Clinical Trials First Patient In First Patient In Last Patient In Announced Relationships ISTs Approved MD Anderson ISTs Approved Ivonescimab Studies Strategic Col
Slide 7: HARMONi-2: Study Design
HARMONi-2: Study Design Akeso Sponsored Study Double-blind, randomized Phase III study comparing ivonescimab with pembrolizumab for patients with advanced or metastatic PD-L1-positive NSCLCa Patient Population Ivonescimab • Stage IIIB-IV aNSCLC Randomization 20 mg/kg Q3W (N=198) Treatment until • No
Slide 8: HARMONi-2: Primary Endpoint: PFS per IRRC
HARMONi-2: Primary Endpoint: PFS per IRRC Ivonescimab Pembrolizumab (n = 198) (n = 200) mPFS, mos 11.14 5.82 (95% CI) (7.33, NE) (5.03, 8.21) Stratified HR 0.51 (95% CI) (0.38, 0.69) p-value <0.0001 9-mo: 56% (47, 64) PFS (%) 9-mo: 40% (32, 48) Censor Median Follow-up: Ivonescimab 8.67 months Pembro
Slide 9: HARMONi-2: Key PFS Subgroup Analyses
HARMONi-2: Key PFS Subgroup Analyses PD-L1 Low (TPS 1-49%) PD-L1 High (TPS ≥50%) Stratified HR 0.54 Stratified HR 0.46 (95% CI) (0.37, 0.79) (95% CI) (0.28, 0.75) PD-L1 Expression Squamous Non-Squamous Stratified HR 0.48 Stratified HR 0.54 (95% CI) (0.31, 0.74) (95% CI) (0.36, 0.82) NSCLC Histology
Slide 10: HARMONi-2: Safety Summary
HARMONi-2: Safety Summary TRAEs Most Common TRAEs (incidence ≥10%) Safety Summary, n (%) Ivonescimab Pembrolizumab (n = 197a) (n = 199a) TRAEs (all grades) 177 (89.8) 163 (81.9) Grade≥3 58 (29.4) 31 (15.6) Serious TRAEs 41 (20.8) 32 (16.1) Leading to discontinuation 3 (1.5) 6 (3.0) Leading to death
Slide 11: HARMONi-2: irAEs and Possible VEGF-Related AEs
HARMONi-2: irAEs and Possible VEGF-Related AEs irAEs Possible VEGF-Related AEs Ivonescimab Pembrolizumab Ivonescimab Pembrolizumab Safety Summary, n (%) Safety Summary, n (%) (n = 197a) (n = 199a) (n = 197a) (n = 199a) Possible VEGF-Related 94 (47.7) 42 (21.1) irAEs (all grades) 59 (29.9) 56 (28.1)
Slide 12: HARMONi-7: Phase III Study in 1L Metastatic NSCLC with PD-L1 High
HARMONi-7: Phase III Study in 1L Metastatic NSCLC with PD-L1 High (NCT not yet assigned) • Untreated squamous or non- Group A (N=780) Ivonescimab Safety and Survival Follow up squamous metastatic NSCLC with Treatment until: PD-L1 high expression 20 mg/kg Q3W • Intolerable • ECOG 0 or 1 toxicity, or
Slide 13: HARMONi-3: Intended Amended Study Design
HARMONi-3: Intended Amended Study Design Non-Squamous OR Squamous Maintenance Non-Squamous: Ivonescimab + Ivonescimab + Treatment Until: Safety and Survival Follow-up Key Inclusion Ivonescimab + Carboplatin + Pemetrexed § Disease Carboplatin + Paclitaxel § First line Stage IV Pemetrexed progression
Slide 14: AK112-201: Study Design
AK112-201: Study Design Phase 2, multi-center, open-label study in patients with advanced NSCLC in China (NCT04736823) Akeso-Sponsored Study Ivonescimab + pemetrexed + carboplatin Cohort 1 (non-squamous) 1L without or EGFR/ALK alteration Ivonescimab + paclitaxel + carboplatin (squamous) Primary Endp
Slide 15: AK112-201: Efficacy Data
AK112-201: Efficacy Data Cohort 1 - Ivonescimab plus Chemo in NSCLC Without EGFR/ALK Alteration (N=135)1 Probability of Progression Free Survival Probability of Overall Survival Median duration of follow up: 22.1 months Median duration of follow up: 21.3 months Data cutoff: October 10, 2023 Data cut
Slide 16: AK112-201: Safety Data
AK112-201: Safety Data Cohort 1 - Ivonescimab plus Chemo in NSCLC Without EGFR/ALK Alteration Squamous Non-Squamous Summary of Safety, n (%) (n=63) (n=72) Grade ≥3 TRAE 28 (44.4) 18 (25.0) TRSAE 18 (28.6) 14 (19.4) TRAE leading to ivonescimab discontinuation 7 (11.1) 2 (2.8) TRAE leading to death 0
Slide 17: Phase II Study Designs: CRC, TNBC, HNSCC, Early-Stage NSCLC
Phase II Study Designs: CRC, TNBC, HNSCC, Early-Stage NSCLC Akeso-Sponsored Phase II Studies Conducted in China Perioperative Resectable NSCLC 1L Triple Negative Advanced Breast Cancer (TNBC) • Open-label, multi-center phase II study, • Open-label, multi-center phase II study in patients with locall
Slide 18: Promising Phase II Data: CRC, TNBC, HNSCC, NSCLC
Promising Phase II Data: CRC, TNBC, HNSCC, NSCLC Akeso-Sponsored Phase II Studies Conducted in China Ivo + Chemo Ivo + Chemo Perioperative Resectable Ivonescimab Ivo + Chemo 1L TNBC CPS <10% CPS >10% NSCLC (n=11) (n=49) (n=24) (n=6) pCR (n = 10; n = 39, respectively) 30.0% 43.6% ORR (n = 23; n = 6,
Slide 19: Q3 2024 Highlights
Q3 2024 Highlights Ivonescimab Improves PFS Completion of Expansion of Global Upcoming Initiation Phase II vs. Pembrolizumab in Akeso Enrollment in Global HARMONi-3 Phase III of HARMONi-7 Data Featured at Ph III Trial in China HARMONi Phase III Trial Trial: SQ + NSQ global Phase III Trial WCLC & ESM
Slide 20: Financial Summary Q3'24 vs. Q2'24
Financial Summary Q3’24 vs. Q2’24 Key Items as of September 30, 2024: • Closed private financing of $235M • Cash, cash equivalents, and short-term investments: $487M • Total shares outstanding: 737M 20 (1) Excludes stock-based compensation Summit Confidential & Proprietary Information - Do Not Copy
Slide 21: Schedule Reconciling Selected Non-GAAP Financial Measures
Schedule Reconciling Selected Non-GAAP Financial Measures Note 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangements. 21 Note
Slide 22: Schedule Reconciling Selected Non-GAAP Financial Measures
Schedule Reconciling Selected Non-GAAP Financial Measures Note 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangements. Note 2:
Slide 23: Summit Therapeutics Q3 2024 Earnings Call
Summit Therapeutics Q3 2024 Earnings Call October 30, 2024 9:00am ET