Summit Therapeutics Q1 2024 Earnings Call May 1, 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 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. Summit Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q1 2024 Earnings Call, May 2024
Company Details Focus ONCOLOGY Partnership Akeso Inc. Summit License Territories United States, Canada, Europe, Japan Chief Executive Officers Bob Duggan Chairman & CEO Dr. Maky Zanganeh CEO & President NASDAQ SMMT Market Cap $2.8B† Cash $157M** Employees 110+† 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* 2024 Focus Execute on Phase III clinical trials Expand clinical development plan Summit Therapeutics 3 Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies. *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”). **As of March 31, 2024; †As of April 30, 2024 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 2024
Partnership with An Aligned Mission Bringing ivonescimab to patients around the world Summit is actively recruiting two Phase III NSCLC clinical trials LEADING BIOPHARMA COMPANY IN CHINA Michelle Xia, Ph.D. Co-Founder, Chairwoman, President and CEO Over 2,800 Employees End-to-end In-house Capabilities INNOVATOR1,2 World’s first marketed PD-1 bispecific (cadonilimab)3 3 commercial drugs in China 120+ worldwide clinical trials* 30+ drug candidates 19 clinical-stage candidates 6+ bispecific antibodies 1.Akeso Press Release (2022-12-06), 2. Akeso website accessed on 12.1.23, 3. https://scrip.citeline.com/SC146649/China- Approves-Worlds-First-Bispecific-IO-Drug-Amid-PD-1L1-Glut. Accessed 1.4.24. *Including ISTs with Akeso products. NSCLC: Non-small Cell Lung Cancer Globally, 1,600+ patients treated with ivonescimab across all trials to date4 Summit Proprietary Information - Do Not Copy or Distribute Presentation Summit Therapeutics Q1 2024 Earnings Call, May 2024 Anti-VEGF Anti-PD-1 Linkers Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
VEGF Dimer PD-1 Receptor in T Cell Increased Avidity in TME VEGF increases affinity to PD-1 by >18X4 PD-1 increases affinity to VEGF by >4X4 (in vitro) Enhanced Activity of T Cells VEGF dimer leads to potential interconnection of ivonescimab molecules, which may increase activity of T cells4,5 Simultaneous blocking of PD-1 & VEGF1,2,3 Ivonescimab 5 Cooperative Binding Greater Than the Sum of Its Parts 1. Zhao Y. et al., eClinicalMedicine. 2023; 3(62): 102106.,; 2. Manegold C, et al. J Thorac Oncol 2017;12(2):194-207 ; 3. Data on File. [14, 15] Summit Therapeutics Inc.; 4. Zhong T, et al. AACR-NCI-EORTC International Conference 2023.Poster #B123,Abstract #35333, Boston, MA, USA,; 5. Zhong T, et al. JITC 2022;10(2):521. Summit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 2024 Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
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+ Randomized: Combo (chemo) vs. chemo NSCLC: 1L PD-L1 TPS>1% Randomized: Monotherapy vs. pembro (PD-1) NSCLC: 1L Squamous Randomized: Combo (chemo) vs. tislelizumab (PD-1) + chemo NSCLC: 1L Squamous Randomized: Combo (chemo) vs. pembro (PD-1) + chemo Advanced Solid Tumors Monotherapy NSCLC Combo (chemo) NSCLC Monotherapy GYN Tumors Monotherapy Ovarian Cancer Combination (PARPi) NSCLC Monotherapy & Combo (chemo) CRC Combo (CD47 + chemo) HCC Monotherapy NSCLC Combo (PD-1 / CTLA-4 bsAb + chemo) HNSCC Combo (CD47) Advanced Solid Tumors** Combo (CD47, CD47 + chemo, chemo) TNBC Comb (chemo, CD47 + chemo) NSCLC Combo (CD73 + chemo) Advanced Solid Tumors Monotherapy ES-SCLC Combo (chemo) Ivonescimab Global Oncology Clinical Trials These ivonescimab cl inical trials are being conducted in China and/or Australia and are ful ly sponsored and managed by Akeso. NSCLC: Non-Small-cell Lung Cancer, EGFRm+: Epidermal Growth Factor Receptor mutant positives, Combo: Combination, Chemo: Chemotherapy, pembro: pembrolizumab, CRC: Colorectal Cancer, HCC: Hepatocellular Carcinoma, HNSCC: Head & Neck Squamous Cell Carcinoma, BTC: Biliary Tract Cancer, TNBC: Triple Negative Breast Cancer, ES-SCLC: Extensive Stage Small Cell Lung Cancer, PD-1: Programmed Cell Death Protein 1, PARPi: poly(ADP-ribose) polymerase inhibitors Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies. **Includes Gastric, BTC, Pancreatic, NSCLC Same Subset Patient Population 1,600+ Patients Treated with Ivonescimab 19 Clinical Trials 4 Phase III 13 Phase II 2 Phase I 7 Dedicated Trials Outside NSCLC 6 Same Subset Patient PopulationSummit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 2024
• IC response rate 39% with chemo (25% CRs) by RANO • IC response rate 14% for ivonescimab monotherapy (14% CRs) • Median IC PFS 19.3 months across both cohorts Zhang L, et al., ELCC 2024, poster #174P Range of Intracranial Responses (RANO criteria) and Intracranial Progression-Free Survival in Phase II 7 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 2024 Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
Zhang L, et al., ELCC 2024 poster #FPN 174P Ivonescimab Alone or in Combination with Chemo: CNS activity Intracranial Response Rates (RANO Criteria) Safety of ivonescimab in patients with untreated brain metastasis in Phase II • No cases of intracranial hemorrhage identified among these patients with brain metastases identified at baseline • Grade >3 TRAE rate 31.4% (11/35 patients) • Grade >3 TRSAE rate 20% (7/35 patients) 8 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 2024 Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
Ivonescimab + Chemo (Partial Response) Ivonescimab Monotherapy (Complete Response) Zhang L, et al., ELCC 2024, poster #174P Intracranial (IC) Activity of Ivonescimab in Phase II 9 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 2024 Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
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+ Randomized: Combo (chemo) vs. chemo NSCLC: 1L PD-L1 TPS>1% Randomized: Monotherapy vs. pembro (PD-1) NSCLC: 1L Squamous Randomized: Combo (chemo) vs. tislelizumab (PD-1) + chemo NSCLC: 1L Squamous Randomized: Combo (chemo) vs. pembro (PD-1) + chemo Advanced Solid Tumors Monotherapy NSCLC Combo (chemo) NSCLC Monotherapy GYN Tumors Monotherapy Ovarian Cancer Combination (PARPi) NSCLC Monotherapy & Combo (chemo) CRC Combo (CD47 + chemo) HCC Monotherapy NSCLC Combo (PD-1 / CTLA-4 bsAb + chemo) HNSCC Combo (CD47) Advanced Solid Tumors** Combo (CD47, CD47 + chemo, chemo) TNBC Comb (chemo, CD47 + chemo) NSCLC Combo (CD73 + chemo) Advanced Solid Tumors Monotherapy ES-SCLC Combo (chemo) Ivonescimab Global Oncology Clinical Trials These ivonescimab cl inical trials are being conducted in China and/or Australia and are ful ly sponsored and managed by Akeso. NSCLC: Non-Small-cell Lung Cancer, EGFRm+: Epidermal Growth Factor Receptor mutant positives, Combo: Combination, Chemo: Chemotherapy, pembro: pembrolizumab, CRC: Colorectal Cancer, HCC: Hepatocellular Carcinoma, HNSCC: Head & Neck Squamous Cell Carcinoma, BTC: Biliary Tract Cancer, TNBC: Triple Negative Breast Cancer, ES-SCLC: Extensive Stage Small Cell Lung Cancer, PD-1: Programmed Cell Death Protein 1, PARPi: poly(ADP-ribose) polymerase inhibitors Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies. **Includes Gastric, BTC, Pancreatic, NSCLC Same Subset Patient Population 1,600+ Patients Treated with Ivonescimab 19 Clinical Trials 4 Phase III 13 Phase II 2 Phase I 7 Dedicated Trials Outside NSCLC 10 Same Subset Patient PopulationSummit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 2024
Financial Summary Q1’24 vs. Q4’23 vs. Q1’23 Key Items as of March 31, 2024: • Cash and cash equivalents, restricted cash and short-term investments $157M • Total shares outstanding 702M Updated Cash Guidance: • Cash runway through Q1’2025 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. 11 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 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: In-process research and development represents a one-time charge associated with the Company's in-licensing of ivonescimab from Akeso.12 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 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: In-process research and development represents a one-time charge associated with the Company's in-licensing of ivonescimab from Akeso. 13 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Summit Therapeutics Q1 2024 Earnings Call, May 2024
Summit Therapeutics Q1 2024 Earnings Call May 1, 2024 9:00am ET
