November 3, 2022: MaaT Pharma Announces Oral and Poster Presentations at the 64th American Society of Hematology (ASH) Annual Meeting

MaaT Pharma Announces Oral and Poster Presentations at the 64^th American Society of Hematology (ASH) Annual Meeting

• Oral presentation will detail consolidated results from 81 patients with steroid-resistant, gastrointestinal, acute Graft-versus-Host-Disease (GI-aGvHD)  treated with MaaT013 as salvage therapy, as part of an ongoing Early Access Program (EAP).  
• Poster will present detailed results from the Phase 1b clinical trial of MaaT033 in patients with acute myeloid leukemia. MaaT033, the Company’s first Microbiome Ecosystem Therapy^TM (MET) for oral administration, is being developed as adjunctive and maintenance treatment for patients receiving allo-HCT¹. 

Lyon, France, November 3^rd, 2022, 6:00pm CET – MaaT Pharma (EURONEXT: MAAT – the “Company”), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to improving survival outcomes for patients with cancer, announced today that extended results from its Early Access Program (EAP)  of MaaT013 in patients with GI-aGvHD have been selected for oral presentation at the 64^th American Society of Hematology (ASH) Annual Meeting held from December 10-13, 2022, in New-Orleans, Louisiana, U.S.A. Additionally, detailed results of the Phase 1b trial of MaaT033 in patients with acute myeloid leukemia (AML) were selected for presentation in a poster session. This is the sixth year in a row that the Company’s clinical data are selected for presentation at the ASH Conference, the world-leading event in malignant and non-malignant hematology, and the third year in a row for an oral presentation.  

In line with the conference embargo policy, MaaT Pharma will detail the presented results through a press release on Saturday, December 10, 2022. The Company will also host an investor webcast on Monday, December 12^th, 2022, at 6:00pm CET (additional details will be provided at a later date). 

The EAP results include data from 81 patients treated with MaaT013, with steroid-resistant or steroid-dependent aGvHD with GI involvement, who had previously failed 1 to 6 lines (median: 2) of systemic therapy; MaaT Pharma provided the MET product to hospitals under a compassionate access program in France. In parallel, MaaT013 is currently being evaluated in a pivotal open-label, single-arm Phase 3 trial in Europe (n=75) in GI-aGvHD patients refractory to corticosteroids and ruxolitinib; a first data review is expected in the first half of 2023. As of today, MaaT013 has been safely administered to more than 160 patients in Europe in clinical trials and in the Expanded Access Program in France.

Oral Presentation:  

• Title: Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in France 
• Presenter: Professor Mohamad Mohty, hematology professor and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University 
• Publication Number: 112
• Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Clinical Studies Exploring the Immunobiology of HCT  
• Session Date/Time: Saturday, December 10, 2022; 10:15am EST  
• Room: 252-254 (Ernest N. Morial Convention Center)

Poster: 

• Title: Restoration Of Gut Microbiota Diversity With Oral Pooled Fecal Microbiotherapy In Acute Myeloid Leukemia Patients After Intensive Chemotherapy: The Phase 1b CIMON Trial 
• Presenter: Professor Mohamad Mohty, hematology professor and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University
• Poster number: 2765
• Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies 
• Session Date/Time: Sunday, December 11, 2022: 6:00pm -8:00pm EST 
• Room: Hall D (Ernest N. Morial Convention Center)

Upcoming scientific conferences participations 

• November 8-10, 2022 – 9^th International Human Microbiome Consortium (IHMC) Congress: Poster and oral presentation 
• November 9-11, 2022 – 21^st Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #10 – poster and oral presentation 
• December 10-13, 2022 - 64^th American Society of Hematology (ASH) Annual Meeting: Poster and oral presentation

About MaaT013 

MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, 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 (group of bacterial species known to produce anti-inflammatory metabolites). 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-predominant 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 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem Therapy^TM. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration and allows the potential to treat larger patients’ population while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory Butycore^TM species. 

About MaaT Pharma

MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma has launched, in March 2022 in Europe, a Phase 3 clinical trial for patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial. Its powerful discovery and analysis platform, gutPrint®, supports the development and expansion of its pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions. The company’s Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice.

MaaT Pharma is the first company developing microbiome-based therapies listed on Euronext Paris (ticker: MAAT).

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.