Announcement • Jun 26
MaaT Pharma Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the Treatment of Acute Graft-Versus-Host Disease MaaT Pharma announced that the CHMP of the EMA has adopted a negative opinion on the conditional MAA for MaaT013, under the brand name Xervyteg®, for the treatment of acute Graft-versus-Host Disease (aGvHD) in adult patients with gastrointestinal involvement refractory to prior lines of therapy. The company has reviewed grounds cited by the CHMP and confirms its plan to seek re-examination of the opinion as previously announced. Under EMA procedures, the re-examination includes the appointment of a new rapporteur and co-rapporteur who will conduct a new and independent evaluation of the dossier. MaaT Pharma will also request a Scientific Advisory Group (SAG) hearing with hematology experts on aGvHD to provide input and insights to the CHMP into, among other things, the clinical reality of managing aGvHD with complex concomitant therapies and patients in high need of solutions due to the severity of the disease and the lack of any other efficient third-line therapy so far. In its opinion of June 25, 2026, the CHMP maintained the position that, given the use of concomitant therapies to manage aGvHD, the data package, primarily based on the ARES single-arm study, does not allow sufficient attribution of the observed clinical effect and safety to the study treatment alone. Based on current EMA procedural timelines, a new CHMP opinion is expected within 60 days following validation of the re-examination request, with a second decision anticipated in the CHMP September Session (September 14-17, 2026). MaaT Pharma remains confident in the clinical profile of MaaT013 (Xervyteg®), to treat a population with very limited treatment options and poor prognosis. This is supported by data from the ARES study, as well as data from the CHRONOS study (Clausen et al., 2026) and real-world evidence from its Early Access Program, active in 13 countries, with more than 300 patients treated since 2019. The company also confirms that the re-examination process has no impact on the ongoing Early Access Program, as of the date of the article, and that MaaT013 (Xervyteg®) remains available to eligible patients. MaaT Pharma’s strategy also extends beyond MaaT013 (Xervyteg®), supported by the development of MaaT033, an oral microbiome therapy, currently evaluated in a randomized controlled Phase 2 trial for broader prophylactic and outpatient use in hemato-oncology, and by the expansion of its platform into immuno-oncology with the next generation product MaaT034. 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 TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (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 the symptoms of 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). 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. 
