Major Estimate Revision • May 28
Consensus revenue estimates fall by 26% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from €13.2m to €9.75m. Forecast losses increased from -€1.87 to -€1.91 per share. Biotechs industry in France expected to see average net income growth of 13% next year. Consensus price target down from €16.00 to €10.00. Share price fell 11% to €2.65 over the past week. Price Target Changed • May 28
Price target decreased by 27% to €11.75 Down from €16.00, the current price target is an average from 4 analysts. New target price is 319% above last closing price of €2.81. Stock is down 42% over the past year. The company is forecast to post a net loss per share of €1.91 next year compared to a net loss per share of €1.95 last year. Announcement • May 22
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). 
