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 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 ...

Core Viewpoint - Akeso Inc. has received Orphan Drug Designation from the U.S. FDA for its monoclonal antibody ligufalimab (AK117) aimed at treating acute myeloid leukemia (AML) [1][2]. Company Overview - Akeso is a biopharmaceutical company focused on developing innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas, including cancer and autoimmune diseases [15]. - The company utilizes an integrated R&D innovation system and has developed a comprehensive drug development platform [15]. Drug Development and Clinical Trials - Ligufalimab is currently in international clinical development for both hematologic malignancies and solid tumors, with completed patient enrollment in a Phase II study for higher-risk myelodysplastic syndromes [3][4]. - It is the first CD47 monoclonal antibody to enter Phase III trials for solid tumors, with ongoing studies for head and neck squamous cell carcinoma and pancreatic cancer [4]. Clinical Need and Market Opportunity - AML is the most common type of acute leukemia in adults, with limited treatment options for patients ineligible for intensive chemotherapy [5]. - Current treatments, such as venetoclax combined with azacitidine, show a high relapse rate, indicating a significant unmet clinical need [6]. Mechanism of Action - Ligufalimab targets CD47 on tumor cells, enhancing macrophage-mediated phagocytosis and inhibiting tumor growth, with improved safety and efficacy compared to other CD47-targeting agents [7]. Efficacy and Safety Profile - Clinical trials indicate that ligufalimab combined with azacitidine has a favorable safety profile, achieving a complete remission rate of 50% and a composite complete remission rate of 55% [9]. - A Phase II study is underway to further assess the safety and efficacy of ligufalimab in combination with venetoclax and azacitidine for AML patients [10].

Business Highlights - Akeso's commercial sales revenue in 2025H1 reached RMB 1.402 billion, a 49% year-on-year increase[16, 24] - The company has 13 Phase III/registrational trials of ivonescimab covering lung cancer and expanding to cold tumors[13] - The company has 10 phase III clinical studies of cadonilimab across lung cancer, gastric cancer, liver cancer and cervical cancer[13] - Penpulimab receives FDA approval in the United States[14] Pipeline Development - Three blockbuster new drug candidates entered clinical stage[19] - Six Phase III clinical trials reached the primary endpoint[20] - Ivonescimab's first global Phase III trial received positive results[84] - Manfidokimab (IL-4Rα) Reached Endpoints in the Registrational Phase III Trial for Atopic Dermatitis[116] Financial Performance - 1H 2025 Revenue reached RMB 1.412 billion, a 33.7% growth from 1H in 2024[16] - The company has cash and short-term financial assets of approximately RMB 7.14 billion[16] - Sales and Marketing expense as a percentage of sales decreased from 55% in 2024H1 to 48% in 2025 H1[136, 140]