91桃色视频

91桃色视频 Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation

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Lyon, France, March 23^rd, 2026 – 6:00pm CET 鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that Florent Malard, MD, PhD, hematology professor at Saint鈥慉ntoine Hospital and Sorbonne University, presented the final results from the Phase 3 ARES single鈥慳rm pivotal trial evaluating MaaT013 in acute Graft鈥憊ersus鈥慔ost Disease (aGvHD). The presentation took place during the Presidential Plenary Session at the 2026 Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Madrid, Spain. MaaT013 is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025, with a decision expected mid-2026, as previously disclosed.

Professor Malard emphasized that 鈥済astrointestinal acute GvHD remains a profoundly devastating condition, associated with dismal outcomes. The response rates observed in the ARES trial鈥�62% GI-ORR at Day 28, sustained at 47% at Day 56 and 44% at Month 3鈥攖ogether with a 54% one-year overall survival, strongly suggest that this therapeutic approach may provide a clinically meaningful benefit for these patients.鈥�

The final efficacy results from the ARES study, previously disclosed in December 2025, are summarized below.

The ARES trial is a single-arm, open-label trial evaluating MaaT013 as third-line treatment in 66 adult patients with severe GI-aGvHD refractory to corticosteroids and ruxolitinib across 50 sites in six European countries:

Patient profile:

• 91% (n=60) presented with Grade III鈥揑V aGvHD with GI involvement
• 86% (n=57) were steroid-resistant and 14% (n=9) steroid-dependent; all were refractory to ruxolitinib
• Male: 53%, Female: 47%

Final Efficacy Outcomes:

• GI-ORR at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients).
• All-organ ORR at Day 28 occurred in 42/66 patients (64%) and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients).
• GI-ORR at Day 56 was maintained at 47% (31/ 66 patients) and prevalently consisted of CR (35%, 23/66 patients).
• All-organ ORR at Day 56 was 45% (30/66 patients) and prevalently consisted of CR (35%, 23/66 patients).
• GI-ORR and all-organ ORR at 3 months were both 44% (29/ 66 patients), with a prevalence of CR (36%, 24/66 patients).
• A durable response was observed, with an estimated cumulative incidence of loss of response at 12 months of 20% (95% CI: 9 to 33) for GI. For all-organs, the estimated cumulative incidence of loss of response at 6 months was 26% (95% CI: 14 to 40).听听
• Overall survival (OS) at 12 months was 54%.
• Median overall survival was not reached, indicating that more than half of the patients were still alive at the end of the study. This suggests a durable survival benefit and reinforces the strong efficacy signal observed in the pivotal ARES study. The median OS of Day 28 responders was not reached, while it was only 54 days for Day 28 non-responders.
• The OS was significantly higher in patients who had a GI response at Day 28 than those who did not respond: 68% vs 28% respectively (p <0.0001) at 1 year, suggesting a strong association between early GI response and improved survival in refractory GI-aGvHD.
• A Data and Safety Monitoring Board (DSMB) provided ongoing safety oversight throughout the study. The final DSMB review conducted in March 2025 reported that 鈥渢he study results show an acceptable safety profile and a favorable benefit /risk ratio鈥�.

The ARES trial results have been submitted to a peer-review leading medical journal for potential publication and will also be presented during an oral presentation by Professor Malard on March 27, 2026, during the annual congress of the French Society of Hematology in Paris. 听

In addition to the oral presentation, 91桃色视频 presents three poster communications, during the EBMT Congress:

PHOEBUS

• Title: MaaT033 for Gut Microbiota Optimization To Improve Survival after Allogeneic HCT: the Phoebus Trial
• Abstract number: A093
• Session: Transplant and Cellular Therapies – Clinical
• Session Date/Time: Monday, March 23, 2026 – 18:00 鈥� 19:00 CET
• Location: VELAZQUEZ
• Presenter: Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and PHOEBUS Trial lead investigator

CHRONOS

• Title: Key results from CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD
• Abstract number: B005
• Session: Graft-versus-Host Disease – Clinical
• Session Date/Time: Tuesday, March 24, 2026 – 18:00 鈥� 19:00
• Location: VELAZQUEZ
• Presenter: Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria

THRASSA

• Title: THRASSA, a Multicenter Open-label Study Evaluating the Safety, Tolerability and Efficacy of MaaT013 in Ruxolitinib-Refractory or Intolerant Paediatric/Adolescent Participants with Gastrointestinal Acute Graft-versus-Host Disease
• Abstract number: P222
• Session: Paediatrics – Clinical
• Session Date/Time: Sunday, March 22, 08:30 鈥� 18:00 CET
• Location: e-Poster area
• Presenter: Marion Bruelle, Clinical Scientist at 91桃色视频

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About 91桃色视频
91桃色视频 is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021.

About MaaT013 (齿别谤惫测迟别驳庐)
91桃色视频鈥檚 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听is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. 听MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem Therapy^TM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of Butycore^TM (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient鈥檚 functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

About MaaT033
MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem Therapy^TM containing anti-inflammatory Butycore^TM species, is currently being developed as an adjunctive therapy seeking to improve overall survival in patients receiving HSCT and other cellular therapies. Its aim is to seek to optimize microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

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