Announcement • 22h
MaaT Pharma Provides Update On Application For Marketing Authorization Of MaaT013 (Xervyteg) In Treatment Of Acute Graft-Versus-Host Disease MaaT Pharma has been informed by the CHMP of the EMA of a “negative trend” opinion on its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg) for the treatment of acute Graft-versus-Host Disease (aGvHD), following its recent CHMP oral explanation. The CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the Company intends to request a re-examination of the application, a standard procedure enabling a new independent scientific assessment by a different set of reviewers. The EMA’s procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the Company’s official request for re-examination. For context, the CHMP feedback shared during the Oral Explanation reflects challenges, in the Company’s view, expected for first-in-class therapies based on a novel therapeutic approach, particularly those based on a single-arm pivotal trial. The application for MaaT013 (Xervyteg) is assessed under the Conditional Marketing Authorization (CMA) pathway, which is designed to facilitate earlier access to medicines addressing unmet medical needs while confirmatory data is generated post-approval. The Company is taking cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline. MaaT013 (Xervyteg) is supported by clinical data from the pivotal ARES study, and real-world data with the ongoing Early Access Program active in 13 countries and with 300+ patients globally treated to date since 2019. Data supporting MaaT013 (Xervyteg) has previously been presented at major international congresses and in peer-reviewed publications. The Company remains committed to advancing MaaT013 (Xervyteg) through the European regulatory process, expanding patient access and progressing its broader pipeline in microbiome-based in oncology. Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient’s organs, causing inflammation of the skin, liver and/or gastrointestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first-line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered steroid resistant (SR) and other agents can be administered. Currently the only agent approved for treating SR aGvHD after failure of steroid treatment is ruxolitinib, which is currently approved for this indication in USA and has received approval from the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) on March 25, 2022. MaaT Pharma’s Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013 (Xervyteg) is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem Therapy for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of Butycore (a group of bacterial species known to produce anti-inflammatory metabolites). Xervyteg (MaaT013) aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. Xervyteg (MaaT013) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). New Risk • May 21
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €56.2m (US$65.2m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (18% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€10m net loss in 2 years). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (€56.2m market cap, or US$65.2m). Announcement • May 19
MaaT Pharma SA, Annual General Meeting, Jun 16, 2026 MaaT Pharma SA, Annual General Meeting, Jun 16, 2026. Location: 70 avenue tony garnier, lyon France 
