Slide 1: Summit Therapeutics Q2 2024 Earnings Call
Summit Therapeutics Q2 2024 Earnings Call August 6, 2024 9:00am ET
Slide 2: Forward Looking Statement
Forward Looking Statement 2 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 p
Slide 3: Company Details
Company Details Focus ONCOLOGY Partnership Akeso Inc. Summit License Territories North America (including United States), South America, Japan, Europe, Middle East, & Africa Chief Executive Officers Bob Duggan Chairman & CEO Dr. Maky Zanganeh CEO & President NASDAQ SMMT Market Cap $7.5B‡ Cash $325M*
Slide 4: Ivonescimab Clinical Development Program
Trial Indication Histology/Population Regimen Phase III NSCLC EGFRm+ 2L+ Advanced or Metastatic Combo ivonescimab + chemo vs. placebo + chemo NSCLC Squamous 1L Metastatic Combo ivonescimab + chemo vs. pembro + chemo Indication Regimen Phase I Phase II Phase III NSCLC: 2L EGFRm+ / HARMONi-A Randomize
Slide 5: Shaping the Path to Become a Commercial Entity
Last Patient In H1 2023 H2 2023 H1 2024 H2 2024 Shaping the Path to Become a Commercial Entity SITC: Society for Immunotherapy of Cancer; MOA: Mechanism of Action; ASCO: American Society of Clinical Oncology; NSCLC: Non-small Cell Lung Cancer; EORTC: European Organisation for Research and Treatment
Slide 6: HARMONi-A: Study Design
HARMONi-A: Study Design A single-region (China), multicenter, double-blind, placebo-controlled, randomized Phase III study comparing ivonescimab + chemo with placebo + chemo for patients with advanced or metastatic EGFR-variant NSCLC who showed disease progression after EGFR-TKI treatment1,2 55 stud
Slide 7: HARMONi-A: Met Primary Endpoint of PFS per IRRC
7 Data cutoff: Mar 10, 2023. Median (IQR) follow-up: 7.1 (5.4-9.0) months for ivonescimab and 8.2 (5.5-9.5) months for placebo. HR and P-value were stratified by previous 3rd Gen EGFR-TKI use (yes vs. no) and presence of brain metastases (yes vs. no), and were calculated with stratified Cox model an
Slide 8: HARMONi-A: OS Analyses at 52% Data Maturity
8 8 HARMONi-A: OS Analyses at 52% Data Maturity Per Request of Chinese Regulatory Authority Data cutoff date: December 2023 (median follow-up: 17.6 months) Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q2 2024 Earnings Call – August 2024 P
Slide 9: HARMONi-A: Treatment Related Adverse Events (TRAEs)
9 HARMONi-A: Treatment Related Adverse Events (TRAEs) WBC count decreased Neutrophil count decreased Platelet count decreased 9 TRAE, n (%) Ivonescimab + chemo (N=161) Placebo + chemo (N=161) Led to discontinuation of ivonescimab / placebo 9 (5.6) 4 (2.5) Led to death 0 (0.0) 0 (0.0) Grade ≥3 immune
Slide 10: HARMONi-2: Study Design
HARMONi-2: Study Design (NCT05499390) Akeso Sponsored Study Key eligibility criteria: • NSCLC (Stage IIIB/C ineligible for surgery or local therapy and IV) • No known EGFR mutation or ALK rearrangement • ECOG PS 0 or 1 • PD-L1 expression >1% Stratification factors: • PD-L1 1-49% vs. >50% • Squamous
Slide 11: HARMONi-2: Monotherapy Head-to-Head Superiority in PFS vs. Pembrolizumab
HARMONi-2: Monotherapy Head-to-Head Achieves Statistically Significant Superiority in PFS vs. Pembrolizumab1 Full data set to be presented at an upcoming major medical conference Abbreviations: IL=first-line; NSCLC=non-small cell lung cancer; NSQ=non-squamous; PD-L1=programmed cell death-ligand 1; P
Slide 12: Q2 2024 Highlights
12 Q2 2024 Highlights 12 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q2 2024 Earnings Call – August 2024 Ivonescimab is an investigational therapy not approved by any regulatory authority other than the China’s National Medical Products
Slide 13: Financial Summary Q2'24 vs. Q1'24
Financial Summary Q2’24 vs. Q1’24 Key Items as of June 30, 2024: • Cash and cash equivalents, restricted cash and short-term investments: $325.8M • Total shares outstanding: 724M Updated Cash Guidance: • Cash runway into Q4 2025 1) Excludes stock-based compensation 2) Excludes a one-time charge asso
Slide 14: 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 15: 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 16: Summit Therapeutics Q2 2024 Earnings Call
Summit Therapeutics Q2 2024 Earnings Call August 6, 2024 9:00am ET