MaaT Pharma: EMA's Feedback on Novel Treatment Expected Mid-2026

Submission of Market Authorization Application for MaaT013

In June 2025, MaaT Pharma submitted a market authorization application (MAA) to the EMA for MaaT013, marketed under the brand Xervyteg®, for the treatment of acute graft-versus-host disease (aGvH) with gastrointestinal involvement. This application is supported by the results of the pivotal ARES trial, which achieved its primary endpoint with a 62% overall gastrointestinal response rate on day 28, and data from the compassionate access program (EAP). The EMA's feedback is expected by mid-2026 according to the current agency schedule. MaaT013 (Xervyteg®) represents the most advanced drug candidate in the portfolio and could establish new therapeutic standards in oncology as a 'first-in-class' treatment.

Progress and Developments in MaaT033 and MaaT034

MaaT033, an oral form sharing the same active substance as MaaT013, is advancing in the randomized Phase 2b PHOEBUS trial, designed to be pivotal. The five safety assessments conducted in 2025 and January 2026 by the independent monitoring committee have confirmed a favorable safety profile. The last patient inclusion is now scheduled for the fourth quarter of 2027, pushing back the main results to the fourth quarter of 2028. MaaT034, a next-generation immuno-oncology drug candidate, showcased promising preclinical data in 2025. Its clinical development is now scheduled for 2027, as the Company focuses its resources on MaaT013 in Europe. In 2025, MaaT Pharma consolidated its industrial position by transferring the EAP program to Clinigen in January 2026, preparing the supply chain for potential commercialization. Jean-Marie Lefèvre has taken over as Chairman of the Board of Directors and Dr. Sheri Simmons has been appointed as the interim Chief Scientific Officer.