Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter Ended June 30, 2025

Ivonescimab Monotherapy Achieved Statistically Significant & Clinically Meaningful Improvement over Pembrolizumab Monotherapy Head-to-Head in HARMONi-2 Phase III Trial in 1L Advanced NSCLC

Positive HARMONi-A Data Featured at ASCO and Published in JAMA Supporting Ivonescimab's First Regulatory Approval in China for 2L+ EGFRm Advanced NSCLC

HARMONi and HARMONi-3 Enrollment Continues with HARMONi Planned to Complete Enrollment in Second Half of This Year

Raised $200 Million in Net Proceeds Supporting Updated Cash Guidance for Operations into Q4 2025

Five-Year Strategic Collaboration with MD Anderson to Accelerate Development of Ivonescimab in Several Solid Tumors across Multiple Clinical Trials

MIAMI--(BUSINESS WIRE)-- Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the second quarter and six months ended June 30, 2024.

Operational & Corporate Updates

• Our operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:
  • In January 2023, we closed our Collaboration and License Agreement with Akeso Inc. (Akeso, HKEX Code: 9926.HK) for ivonescimab (SMT112), with which over 1,800 patients have now been treated in clinical studies globally. At the initial time of the deal, Summit received rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan.
    • In June 2024, the agreement was amended and, as a result, expanded to also include Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa to Summit's license territories for ivonescimab. Akeso retains development and commercialization rights for the rest of the world, including China.
  • Since in-licensing ivonescimab, we have launched a late-stage clinical development program in non-small cell lung cancer (NSCLC) and are actively enrolling two registrational Phase III trials in the following proposed indications:
    • HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI), with enrollment completion expected in the second half of 2024, and
    • HARMONi-3: Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients, with the first patient having been treated in the fourth quarter of 2023.
  • In late May 2024, positive results were announced from the Phase III HARMONi-A trial which were subsequently presented at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO 2024) and published in the Journal of the American Medical Association (JAMA). HARMONi-A, a single-region, randomized, double-blinded Phase III study in patients with NSCLC who have progressed following an EGFR-TKI, achieved its primary endpoint of progression-free survival (PFS) for patients receiving ivonescimab in combination with doublet chemotherapy (pemetrexed and carboplatin). The HARMONi-A trial was conducted in China and sponsored by Akeso with data generated and analyzed by Akeso. This is a clinical setting where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.
    • Patients (n=322) experienced a 54% reduction in disease progression or death as compared to placebo plus doublet chemotherapy (HR: 0.46, 95% CI: 0.34 - 0.62; p