Summit Therapeutics (NasdaqGM:SMMT) Q4 2025 Earnings call February 23, 2026 04:30 PM ET Company ParticipantsAllen Yang - Chief R&D Strategy OfficerDave Gancarz - Chief Business and Strategy OfficerJosh Schimmer - Senior Managing Director and Leader in Biotechnology Equity ResearchMaky Zanganeh - Co-CEO and PresidentManmeet S. Soni - COO and CFOMark Schwartz - Vice ChairmanRobert Duggan - Co-Chief Executive Officer and Chairman of the BoardConference Call ParticipantsAsthika Goonewardene - Managing Director ...

Summit Therapeutics (NasdaqGM:SMMT) Q4 2025 Earnings call February 23, 2026 04:30 PM ET Speaker10Good afternoon, welcome to Summit, Summit Therapeutics Q4 and year-end 2025 earnings call. All participants will be in listen-only mode until the question and answer session portion of this call. We do not expect any technical difficulties today. However, in the event that we lose the webcast connection and are unable to provide any updates, please wait up to 10 minutes for resolution. Please refer to the compan ...

Summary of Summit Therapeutics Conference Call Company Overview - **Company**: Summit Therapeutics (NasdaqGM:SMMT) - **Lead Molecule**: Ivonesimab, a PD-1 and VEGF bispecific antibody designed to enhance safety and efficacy in cancer treatment [8][9][10] Key Points and Arguments Mechanism of Action - Ivonesimab is engineered to combine PD-1 and anti-VEGF mechanisms, targeting both pathways to improve patient outcomes [8] - The molecule has a shorter half-life, which is intended to reduce risks associated with traditional anti-VEGF therapies, such as bleeding and hypertension [9][10] - Cooperative binding in the presence of VEGF ligands enhances the binding affinity to PD-1, potentially increasing effectiveness in the tumor microenvironment [11] Clinical Trials and Results - **Harmony Trials**: Four phase three trials have been conducted, all yielding positive results. Notably, Harmony A showed a statistically significant overall survival (OS) benefit with a hazard ratio of 0.74 [12][13][14] - The Harmony A trial demonstrated that ivonesimab can provide a significant OS benefit where PD-1 plus VEGF therapies have historically failed [14] - Consistency in data across Harmony A and Harmony global studies indicates a reliable benefit-risk profile for ivonesimab [15][20][21] Regulatory and Market Strategy - The company plans to submit a Biologics License Application (BLA) in Q4 2025, based on the favorable benefit-risk profile observed in trials [29][30] - The FDA has been engaged throughout the trial process, and the company is confident in the submission leading to approval [29][31] Future Trials and Expansion - Harmony 6 is a trial comparing ivonesimab plus chemotherapy against atezolizumab plus chemotherapy in squamous non-small cell lung cancer, with promising early results [36][40] - The company is expanding its clinical trials into colorectal cancer and other solid tumors, with 14 phase three trials currently in progress [67][69] - Enrollment for Harmony 3 is progressing rapidly, with expected readouts for squamous in the second half of 2026 and non-squamous in early 2027 [53][54] Competitive Landscape - The competitive landscape is intensifying with major players like Pfizer and BioNTech entering the PD-1 and VEGF space [72] - Summit Therapeutics aims to differentiate itself through novel combinations and collaborations, such as with RevMedica for RAS inhibitors [74][75] - The checkpoint inhibitor market is projected to exceed $90 billion by 2030, indicating significant growth potential despite competition [77] Upcoming Catalysts - Key upcoming events include the readout of Harmony 3, BLA filing for EGFR, and further updates on colorectal cancer trials [81][83] Additional Insights - The company emphasizes the importance of maintaining a manageable safety profile while achieving efficacy, which is critical for gaining physician trust and patient enrollment [22][54] - The consistency of ivonesimab's performance across trials suggests a robust mechanism of action that could lead to broader applications in oncology [68][69]