Summit Therapeutics Q3 2024 Earnings Call October 30, 2024 9:00am ET
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 partnership with Akeso Inc., the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, the audience should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this presentation represent the Company’s views only as of the date of this presentation and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this presentation. . Ivonescimab is an investigational therapy not approved by any regulatory authority other than China’s National Medical Products Administration (NMPA) Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024
3 Q3 2024 Highlights 3 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Raised $235M from Leading Biotech Investors Led by well-known biotech institutional and individual investors, including insiders 49% reduction in risk of disease progression over pembrolizumab Benefit demonstrated across PD-L1 low, PD-L1 high, squamous, and non- squamous subgroups Ivonescimab Improves PFS vs. Pembrolizumab in Akeso Ph III Trial in China Expansion of Global HARMONi-3 Phase III Trial: SQ + NSQ Completion of Enrollment in Global HARMONi Phase III Trial Topline data from multi-regional trial expected mid-2025 Fast Track Designation granted by FDA Phase II Data Featured at WCLC & ESMO Encouraging Phase II data presented in CRC, TNBC, HNSCC, and perioperative NSCLC Supports exploration of clinical development outside mNSCLC Upcoming Initiation of HARMONi-7 global Phase III Trial HARMONi-7 expected to initiate early 2025 Study to compare ivonescimab mono vs. pembrolizumab mono in NSCLC PD-L1 high (TPS ≥ 50%) Enrollment expanded to include patients with tumors of non-squamous histology in addition to the currently enrolling patients with squamous tumors
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 $16.1B‡ Cash $487M** Employees 150+‡ Offices Miami, FL Menlo Park, CA Oxford, UK …Improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs… MISSION Unmatched high-speed execution, proven track record FOCUSED ON PATIENTS FIRST LEADERSHIP Lead Compound: Ivonescimab Only Phase III PD-1/VEGF Bispecific Antibody in Summit’s License Territories* Summit Therapeutics **As of September 30, 2024; ‡As of October 29, 2024 *There are no known PD-1-based bispecific antibodies approved by the U.S. Food and Drug Administration (“FDA”) or the European Medicines Agency (“EMA”). Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA) Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 4 • Displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF1 • Potential to accumulate higher levels of ivonescimab in the TME vs. healthy tissue (higher levels of PD-1 & VEGF expression in the TME)1-3 • The intent of the design, together with shorter half-life of 6 - 7 days1 is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets4-7 1. Zhong T, et al. AACR-NCI-EORTC International Conference 2023. Poster #B123; 2. Zhao Y. et al., eClinicalMedicine. 2023; 3(62): 102106; 3. Wang L, et al. J Thorac Oncol. 2024;19(3):465-475. 4. Avastin® (bevacizumab). Package insert. Genentech; 2022.; 5. Keytruda® (pembrolizumab). Package insert. Merck; 2024.; 6. Opdivo® (nivolumab). Package insert. Bristol Myers Squibb; 2024.; 7. Libtayo® (cemiplimab-rwlc). Package insert. Regeneron; 2024.
Indication Study Treatment Population Regimen Phase Status NSCLC 2L+ EGFRm + Chemo vs. Chemo Approved 1L PD-L1 Positive Monotherapy vs. pembrolizumab (PD-1) III Primary Analysis 1L Squamous + Chemo vs. tislelizumab (PD-1) + chemo III Ongoing AK112-205 Neoadjuvant/Adjuvant +/- Chemo II Ongoing AK112-208 1L advanced or metastatic + PD-1/CTLA-4 bsAb + chemo II Ongoing Biliary Tract CA TBD 1L + Chemo vs. durvalumab (PD-L1) + chemo III Planned Head & Neck CA TBD 1L PD-L1 Positive + CD47 vs. pembrolizumab (PD-1) III Ongoing Pancreatic CA TBD 1L PDAC + Chemo vs. chemo III Planned Ovarian CA AK112-211 PSOC + Chemo +/- PARP inhibitor II Ongoing Colorectal CA AK112-206 Metastatic MSS CRC +/- CD47, +/- chemo II Ongoing Hepatocellular CA AK112-207 BCLC Stage B or C Monotherapy II Ongoing Ovarian CA AK104-221 Recurrent +/- Chemo, PD-1/CTLA-4 bsAb II Ongoing G/GEJ CA AK117-202 HER2 negative +/- CD47 + chemo II Ongoing Breast CA AK117-203 TNBC + Chemo, CD47 + chemo II Ongoing SCLC AK112-103 Extensive Stage + Chemo I Completed Ivonescimab Global Clinical Trials Ivonescimab More Than 25 Clinical Trials Across 17 Tumor Settings1 1,800+ Patients Treated in Clinical Trials 9 Phase III Trials Completed, Ongoing, or Announced1 1 Approved Oncology Indication in China1 6 Head-to-Head Studies vs. PD-(L)1 9 Dedicated Trials Outside NSCLC1 These ivonescimab clinical trials are being conducted in China and/or Australia and are fully sponsored and managed by Akeso. Indication Study Treatment Population Regimen Phase Status NSCLC 2L+ EGFRm + Chemo vs. chemo III Enrollment Complete 1L + Chemo vs. pembrolizumab (PD-1) + chemo III Ongoing 1L PD-L1 High Monotherapy vs. pembrolizumab (PD-1) III Planned 1. Akeso's 2024 First Half Interim Results (prnewswire.com) Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA) Abbreviations: Abbreviations: 1L=first-line; 2L=second-line; Adeno CA=adenocarcinoma; BCLC=Barcelona clinic liver cancer; BRAC=breast cancer gene; bsAb=bispecific antibody; Chemo=chemotherapy; CD47=cluster of differentiation 47; CTLA-4=cytotoxic T lymphocyte antigen-4; CPS=combined positive score; CRC=colorectal cancer; EGFRm+=epidermal growth factor receptor mutant positives; G/GEJ=gastroesophageal junction; HER2=human epidermal growth factor receptor 2; NSCLC=non-small-cell lung cancer; PARPi=poly(ADP-ribose) polymerase inhibitors; PD-L1=programmed cell death ligand 1; PD- 1=Programmed Cell Death Protein 1; TNBC=triple negative breast cancer; TPS=tumor proportion score; SCLC=Extensive Stage Small Cell Lung Cancer; PDAC=pancreatic ductal adenocarinoma5 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Approved in China only
Multiple Meetings > Summit & Akeso Partnership Consummated January 2023 NSCLC Phase II Data (poster) Publications, Approval, New Clinical Trials New Akeso Phase III Trials Announced Biliary Tract CA Head & Neck CA Pancreatic CA 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 of Cancer; NCI: National Cancer Institute; AACR: American Association for Cancer Research; IST: Investigator Sponsored Trials CDE: Centre for Drug Evaluation (China) 6 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA) Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 H1 2023 H2 2023 H1 2024 H2 2024 First Patient In First Patient In Last Patient In Announced ISTs Approved Ivonescimab Studies Lung & non-lung Indications Strategic Collaboration MD Anderson Relationships Approval in China Ivonescimab: NSCLC Ivonescimab MOA (Poster) EORTC-NCI-AACR Ivonescimab MOA (Poster) NSCLC Phase II Data (Article) THE LANCET SITC ASCO ASCO JAMA Phase II Data in Non-lung Indications ELCC NSCLC Data Update (poster) NSCLC Phase III Data Non-lung Phase II Data WCLC ESMO NSCLC Clinical Trials Raised $500M Raised $200M Raised $235M FDA ISTs Approved Ivonescimab Studies Lung & non-lung indications Phase III Data also, Biliary Tract Cancer Phase II Poster
Double-blind, randomized Phase III study comparing ivonescimab with pembrolizumab for patients with advanced or metastatic PD-L1-positive NSCLCa Stratification • Clinical stage (IIIB/C vs. IV) • Histology (SQ vs. non-SQ) • PD-L1 Score (high vs. low expressing) HARMONi-2: Study Design Patient Population • Stage IIIB-IV aNSCLC • No prior systemic therapy • No EGFR mutations or ALK rearrangements • ECOG PS 0 or 1 • PD-L1-positive expressing tumors Ivonescimab 20 mg/kg Q3W (N=198) Pembrolizumab 200 mg Q3W (N=200) Treatment until no clinical benefit, unacceptable toxicity or up to 24 months Endpoints Primary: PFS by blind IRRC per RECIST v1.1 Secondary: OS, PFS assessed by INVs, ORR, DoR, TTR and safety Exploratory: QoL a Patients were randomized from November 2022 to August 2023. Data cut off: January 29, 2024. Abbreviations: aNSCLC, advanced non-small cell lung cancer; EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; ECOG PS, Eastern Cooperative Oncology Group performance score; PD-L1, programmed death ligand 1; TPS, tumor proportion score; R, randomization; SQ, squamous cell carcinoma; Q3W, every three weeks; PFS, progression-free survival; IRRC, independent radiology review committee; OS, overall survival; INV, investigator; ORR, overall response rate; DoR, duration of response; TTR, time to response; QoL, quality of life. 2024 World Conference on Lung Cancer Presidential Symposium, 9/8/24, San Diego, CA Caicun Zhou | HARMONi-2 Akeso Sponsored Study 7 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso. 1:1 Ra nd om iza tio n N=398
HARMONi-2: Primary Endpoint: PFS per IRRC Abbreviations: mPFS, median progression-free survival; IRRC, independent radiology review committee; mo, month; NE, not estimable; HR: hazard ratio; CI, confidence interval. Ivonescimab (n = 198) Pembrolizumab (n = 200) mPFS, mos (95% CI) 11.14 (7.33, NE) 5.82 (5.03, 8.21) Stratified HR (95% CI) 0.51 (0.38, 0.69) p-value <0.0001 Ivonescimab is the first compound to demonstrate a statistically significant improvement in PFS vs. pembrolizumab with HR = 0.51, and 5.3 months improvement in mPFS. 2024 World Conference on Lung Cancer Presidential Symposium, 9/8/24, San Diego, CA Caicun Zhou | HARMONi-28 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso. 9-mo: 40% (32, 48) 9-mo: 56% (47, 64) Median Follow-up: 8.67 months PF S (% ) Time (months) Number at risk (Events) Ivonescimab Pembrolizumab Censor Ivonescimab Pembrolizumab
HARMONi-2: Key PFS Subgroup Analyses PD-L1 High (TPS ≥50%)PD-L1 Low (TPS 1-49%) Ivonescimab showed meaningful improvement in PFS vs. pembrolizumab in patients with both low and high PD-L1, with squamous or non-squamous advanced NSCLC. Stratified HR (95% CI) 0.54 (0.37, 0.79) Stratified HR (95% CI) 0.46 (0.28, 0.75) Stratified HR (95% CI) 0.48 (0.31, 0.74) Stratified HR (95% CI) 0.54 (0.36, 0.82) Non-SquamousSquamous NSCLC Histology PD-L1 Expression 2024 World Conference on Lung Cancer Presidential Symposium, 9/8/24, San Diego, CA Caicun Zhou | HARMONi-29 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso.
a Patients who received ≥1 dose of study treatment. Abbreviations: AEs, adverse events; TRAEs, treatment-related adverse events; SQ, squamous cell carcinoma. TRAEs HARMONi-2: Safety Summary Safety Summary, n (%) Ivonescimab (n = 90a) Pembrolizumab (n = 91a) TRAEs (all grades) 77 (85.6) 73 (80.2) Grade≥3 20 (22.2) 17 (18.7) Serious TRAEs 17 (18.9) 17 (18.7) Leading to discontinuation 2 (2.2) 3 (3.3) Leading to death 0 1 (1.1) TRAEs in SQ Subgroup Safety Summary, n (%) Ivonescimab (n = 197a) Pembrolizumab (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 1 (0.5) 2 (1.0) Most Common TRAEs (incidence ≥10%) 2024 World Conference on Lung Cancer Presidential Symposium, 9/8/24, San Diego, CA Caicun Zhou | HARMONi-210 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso. The differences in AEs were predominantly proteinuria, hypertension, and laboratory abnormalities. Ivonescimab showed a manageable safety profile, which was consistent with previous studies. Ivonescimab also demonstrated a tolerable safety profile in SQ patients.
HARMONi-2: irAEs and Possible VEGF-Related AEs • All VEGF-related AEs were grades 1-3 in both arms. • Grade 3 haemorrhage was observed in two patients with non-SQ and was not reported in SQ patients in the ivonescimab arm. irAEs Safety Summary, n (%) Ivonescimab (n = 197a) Pembrolizumab (n = 199a) Possible VEGF-Related AEs (all grades) 94 (47.7) 42 (21.1) Grade≥3 20 (10.2) 2 (1.0) Possible VEGF-Related AEs Safety Summary, n (%) Ivonescimab (n = 197a) Pembrolizumab (n = 199a) irAEs (all grades) 59 (29.9) 56 (28.1) Grade≥3 14 (7.1) 16 (8.0) Serious irAEs 11 (5.6) 22 (11.1) Leading to discontinuation 0 5 (2.5) Leading to death 0 0 Safety Summary by Classification, n (%) Ivonescimab (n = 197a) Pembrolizumab (n = 199a) All Grade Grade≥3 All Grade Grade≥3 Proteinuria 62 (31.5) 6 (3.1) 20 (10.1) 0 Hypertension 31 (15.7) 10 (5.1) 5 (2.5) 1 (0.5) Haemorrhage 29 (14.7) 2 (1.0) 22 (11.1) 1 (0.5) Arterial thromboembolism 2 (1.0) 2 (1.0) 1 (0.5) 0 Venous thromboembolism 0 0 1 (0.5) 0 a Patients who received ≥1 dose of study treatment. Abbreviations: VEGF, vascular endothelial growth factor; irAEs, immune- related AEs; AEs, adverse events; SQ, squamous cell carcinoma. 2024 World Conference on Lung Cancer Presidential Symposium, 9/8/24, San Diego, CA Caicun Zhou | HARMONi-211 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso. Ivonescimab exhibited similar irAEs to that of pembrolizumab.
HARMONi-7: Phase III Study in 1L Metastatic NSCLC with PD-L1 High (NCT not yet assigned) • Untreated squamous or non- squamous metastatic NSCLC with PD-L1 high expression • ECOG 0 or 1 Stratification factors to include histology (squamous vs non- squamous) Treatment until: • Intolerable toxicity, or • Disease progression, or • 24 months of treatment Safety and Survival Follow up Group B Pembrolizumab 200 mg Q3W R 1:1 (N=780) Group A Ivonescimab 20 mg/kg Q3W Study Endpoints Primary endpoints: PFS, OS Secondary endpoints: ORR, safety and tolerability Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). 12 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024
HARMONi-3: Intended Amended Study Design Ivonescimab + Carboplatin + Paclitaxel (or nab-paclitaxel) + Q3W x 4 cycles Pembrolizumab + Carboplatin + Paclitaxel (or nab-paclitaxel) Q3W x 4 cycles Key Inclusion § First line Stage IV squamous and non- squamous NSCLC Key Exclusion § Known actionable mutations for which first line approved agents are available § Symptomatic CNS metastases § Major blood vessel or organ invasion § Active autoimmune disease Treatment Until: § Disease progression § Unacceptable toxicity § Withdrawal of consent/death § Initiation of a new anti-tumor therapy § Complete 24 months of treatment Primary • OS, PFS by Investigator Secondary • ORR, DCR, DOR , safety, PK, immunogenicity Ivonescimab + Carboplatin + Pemetrexed Q3W x 4 cycles Pembrolizumab + Carboplatin + Pemetrexed, Q3W x 4 cycles 1:1 Ra nd om iza tio n Squamous Non-Squamous OR Squamous: Pembrolizumab Squamous: Ivonescimab Non-Squamous: Pembrolizumab + Pemetrexed Non-Squamous: Ivonescimab + Pemetrexed Maintenance n = ~1080 Safety and Survival Follow -up 13 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Endpoints Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Stratification Factors Include Histology (Squamous vs. Non-Squamous)
AK112-201: Study Design • ORR according to RECIST v1.1 assessed by the investigator • Safety Primary Endpoints Cohort 1 1L without EGFR/ALK alteration Cohort 2 EGFR+ adv Progressed after EGFR-TKI Cohort 3 Progressed after platinum-doublet with PD-1 Ivonescimab + pemetrexed + carboplatin (non-squamous) or Ivonescimab + paclitaxel + carboplatin (squamous) Ivonescimab + pemetrexed + carboplatin Ivonescimab + docetaxel A Trial of AK112 (PD-1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC. ClinicalTrials.gov identifier: NCT04736823. https://classic.clinicaltrials.gov/ct2/show/NCT04736823. (Accessed 2024, May 17); Zhao Y, et al. EClinicalMedicine. 2023;62:102106; 3. Zhang L, et al., ELCC 2024 poster #FPN68P Abbreviations: ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor reception; NSCLC=non-small Cell Lung Cancer; ORR=objective response rate; PD-1=programmed Cell Death Protein 1; TKI=tyrosine kinase inhibitor Phase 2, multi-center, open-label study in patients with advanced NSCLC in China (NCT04736823) Akeso-Sponsored Study Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso. 14 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024
Med OS, mo (95% CI) Squamous NSCLC (n=63) Not Reached (22.5-NE) Non-Squamous NSCLC (n=72) Not Reached (17.5-NE) AK112-201: Efficacy Data Cohort 1 - Ivonescimab plus Chemo in NSCLC Without EGFR/ALK Alteration Abbreviations: CI=confidence interval; KM=Kaplan-Meier; mo=months; NE=non-estimable; NR=not reached; OS=overall survival 1. Zhang L, et al., ELCC 2024 poster #FPN68P Med PFS, mo (95% CI) Squamous NSCLC (n=63) 11.1 (9.5-16.3) Non-Squamous NSCLC (n=72) 13.3 (8.3-16.4) (N=135)1 Median duration of follow up: 22.1 months Data cutoff: October 10, 2023 Median duration of follow up: 21.3 months Data cutoff: October 10, 2023 Pr ob ab ili ty o f O ve ra ll Su rv iv al Pr ob ab ili ty o f P ro gr es si on F re e Su rv iv al Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso.15 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024
Summary of Safety, n (%) Squamous (n=63) Non-Squamous (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 3 (4.2) Data cutoff: October 10, 2023 AK112-201: Safety Data Cohort 1 - Ivonescimab plus Chemo in NSCLC Without EGFR/ALK Alteration Abbreviations: TRAE: Treatment related adverse event; TRSAE: Treatment related serious adverse event Zhang L, et al., ELCC 2024 poster #FPN68P 16 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso.
Phase II Study Designs: CRC, TNBC, HNSCC, Early-Stage NSCLC Akeso-Sponsored Phase II Studies Conducted in China 17 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso. Perioperative Resectable NSCLC • Open-label, multi-center phase II study, • Patients diagnosed with resectable stage II, IIIA or IIIB NSCLC were enrolled into two cohorts • Patients received neoadjuvant ivonescimab (20 mg/kg) monotherapy (cohort 1), or ivonescimab (20 mg/kg or 30 mg/kg) plus chemotherapy (cohort 2), followed by surgery and adjuvant ivonescimab • Primary endpoints: safety and MPR 1L Triple Negative Advanced Breast Cancer (TNBC) • Open-label, multi-center phase II study in patients with locally advanced unresectable or metastatic TNBC • Patients received ivonescimab and chemotherapy or chemotherapy • Primary endpoints: ORR by RECIST v1.1 and safety • Secondary endpoints: DoR, DCR, PFS, and OS 1L MSS Metastatic Colorectal Cancer (mCRC) • Open-label, multi-center, phase II randomized study • Untreated mCRC patients randomized 1:1 to receive FOLFOXIRI + ivonescimab (group A) or FOLFOXIRI + ivonescimab + ligufalimab (CD47) (group B), followed by maintenance with 5-fluoruracil + ivonescimab with (group B) or without ligufalimab (group A) • Primary endpoints: ORR by RECIST v1.1 and safety 1L PD-L1-Positive Head-and-Neck SCC (R/M HNSCC) • Open-label, multi-center phase II study • R/M HNSCC patients with PD-L1 positive (CPS≥1), including oropharynx, hypopharynx, larynx or oral cavity cancer • Patients received ivonescimab monotherapy or in combination with ligufalimab (CD47) • Primary endpoint: ORR per RECIST v1.1 assessed by investigator
Promising Phase II Data: CRC, TNBC, HNSCC, NSCLC Perioperative Resectable NSCLC Ivonescimab (n=11) Ivo + Chemo (n=49) pCR (n = 10; n = 39, respectively) 30.0% 43.6% MPR (n = 10; n = 39, respectively) 60.0% 71.8% 12-month EFS 81.8% 80.3% No TRAEs led to cancelled / delayed surgery or wound healing complications. 1L MSS mCRC Ivo + Chemo (n = 22) Ivo + CD47 + Chemo (n = 18) ORR (n = 22; n = 17, respectively) 81.8% 88.2% DCR (n = 22; n = 17, respectively) 100% 100% 9-month PFS Rate 81.4% 86.2% TRAE-Led Discontinuations 0 1 1L PD-L1-positive R/M HNSCC Ivonescimab (n =10) Ivo + CD47 (n=20) ORR 30.0% 60.0% DCR 80.0% 90.0% Median PFS 5.0 mos 7.1 mos TRAE-Led Discontinuations 0 1L TNBC Ivo + Chemo CPS <10% (n=24) Ivo + Chemo CPS >10% (n=6) ORR (n = 23; n = 6, respectively) 69.6% 83.3% DCR (n = 23; n = 6, respectively) 100% 100% 6-month PFS Rate 71.2% 80.0% TRAE-Led Discontinuations 0 18 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 2024 IASLC World Conference on Lung Cancer European Society of Medical Oncology Annual Meeting 2024 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso. Akeso-Sponsored Phase II Studies Conducted in China
19 Q3 2024 Highlights 19 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Raised $235M from Leading Biotech Investors Led by well-known biotech institutional and individual investors, including insiders 49% reduction in risk of disease progression over pembrolizumab Benefit demonstrated across PD-L1 low, PD-L1 high, squamous, and non- squamous subgroups Ivonescimab Improves PFS vs. Pembrolizumab in Akeso Ph III Trial in China Expansion of Global HARMONi-3 Phase III Trial: SQ + NSQ Completion of Enrollment in Global HARMONi Phase III Trial Topline data from multi-regional trial expected mid-2025 Fast Track Designation granted by FDA Phase II Data Featured at WCLC & ESMO Encouraging Phase II data presented in CRC, TNBC, HNSCC, and perioperative NSCLC Supports exploration of clinical development outside mNSCLC Upcoming Initiation of HARMONi-7 global Phase III Trial HARMONi-7 expected to initiate early 2025 Study to compare ivonescimab mono vs. pembrolizumab mono in NSCLC PD-L1 high (TPS ≥ 50%) Enrollment expanded to include patients with tumors of non-squamous histology in addition to the currently enrolling patients with squamous tumors
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 (1) Excludes stock-based compensation (2) Excludes a one-time charge associated with the Company's in-licensing of ivonescimab from Akeso. Refer to the next slides for reconciliations between Generally Accepted Accounting Principles (GAAP) and Non-GAAP financial measures. 20 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024
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: Acquired in-process research and development represents a one-time charge associated with the Company's in-licensing of ivonescimab from Akeso.21 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024
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: Acquired in-process research and development represents a one-time charge associated with the Company's in-licensing of ivonescimab from Akeso. 22 Summit Confidential & Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q3 2024 Earnings Call – October 2024
Summit Therapeutics Q3 2024 Earnings Call October 30, 2024 9:00am ET