MaaT Pharma Provides Third Quarter 2023 Business Update and Reports Financial Results - Seite 2

• In hemato-oncology:
  • In September 2023, the Company announced that the European Medicines Agency (EMA) had granted MaaT033 an orphan drug designation. MaaT033 aims to improve overall survival in patients undergoing hematopoietic stem cell transplantation (HSCT) and the EMA had recognized the significant benefit that MaaT033 could therefore bring to this patient population. The status offers key benefits including market exclusivity, clinical protocol assistance, waivers or reductions in regulatory fees.
  • As a post period event, in November 2023, the Company announced that the first patient has been treated as part of its Phase 2b trial (PHOEBUS) investigating the efficacy of MaaT033 in improving overall survival at 12 months for patients with blood cancer receiving allo-HSCT. The international, multi-center, randomized, double-blind, placebo-control study (NCT05762211), will be conducted in up to 56 clinical investigation sites and is expected to enroll 387 patients. It is, to date, the largest randomized controlled trial assessing a microbiome therapy in oncology.
  • As a post period event, in November 2023, the Company announced that the design of its Phase 2b study evaluating MaaT033 has been selected for a poster presentation at the 65^th American Society of Hematology (ASH) Annual Meeting.

• In neurodegenerative diseases:
  • In September 2023, the Company announced that the first patient was dosed in the IASO Phase 1b pilot study (NCT05889572) in ALS (also known as Lou Gehrig's disease in the U.S. and Charcot's disease in French-speaking countries).

MET-C

MaaT034

• In immuno-oncology:
  • As a post period event, in November 2023, the Company had two presentations at the 38^th Society for Immunotherapy of Cancer (SITC) Annual Meeting including in vitro results for its new Artificial Intelligence (AI)-generated lead product, MaaT034, designed to improve responses to immunotherapy for patients with solid tumors. MaaT034 is the first member of the MET-C platform. Data presented at SITC 2023 shows that MaaT034 replicates, at large industrial scale, the richness and diversity of healthy native-based microbiome ecosystems, restores the integrity of a damaged gut barrier, activates AhR pathway involved in gut homeostasis, and stimulates both myeloid and lymphoid immune cells and improves immune cell response to immune checkpoint inhibitor (ICI) therapy. The first clinical batches are expected to be produced in 2024 and the first-in-human testing is planned for 2025.

Corporate update