• Detailed results from completed Phase 1b CIMON trial in 21 acute myeloid leukemia (AML) patients treated with the company’s Microbiome Ecosystem Therapy^TM (MET) oral capsule, MaaT033, demonstrating its safety and ability to increase gut microbiota richness.
• Results of the study evaluating the tolerated dose of MaaT033 in patients with AML showed initial engraftment of beneficial bacterial species.
• Company presented topline results in June 2022 and confirms its intention to conduct a Phase IIb pivotal trial shortly in order to evaluate MaaT033 to prevent complication of allo-HSCT. Readiness activities have continued in Q4.22 destined to optimize the protocol in light of deeper data analysis.

Company to host investor webcast on Monday, December 12 at 6:00 pm CET/12:00pm EST. To register and access the webcast, please click here. A replay will be made available shortly after the conclusion of the webcast and archived on MaaT Pharma’s website for at least 90 days.

Regulatory News:

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, today presented detailed results from the completed Phase 1b CIMON trial with MaaT033 at the Annual Society of Hematology (ASH) Annual Meeting in New Orleans, U.S. To access the abstract, please click here.

“MaaT Pharma’s mission is to improve cancer patients’ lives by driving innovation in the microbiome therapeutics field,” said Hervé Affagard, CEO and co-founder of MaaT Pharma. “These positive Phase 1b results reinforces the strong potential for our MET oral formulation, MaaT033, and we plan to investigate it as an adjunctive and maintenance treatment in patients with hematological malignancies.”

Prof. Mohamad Mohty added, “Allo-HSCT is often the only curative approach for patients with hematological malignancies such as acute leukemia. Evidence of a significant reduction in the risk of infection and GvHD-related mortality following stem cell transplantation has been associated with a higher gut microbiome diversity. Our ability to maintain or induce a high richness, and a high diversity gut microbiome would be key to prevent or minimize these adverse effects and contribute to a better overall prognosis for these patients.”

Key clinical findings with MaaT033 in Phase 1b study CIMON

In the dose-finding Phase 1b CIMON trial, 21 patients with acute myeloid leukemia (AML) were treated with MaaT033 and evaluated for safety, tolerability, and initial signs of microbial species engraftment.

• MaaT033 was shown to be safe and tolerable in 21 patients. 4 severe adverse events (SAEs) were reported in 4 patients, only one considered as possibly related by the investigator.
• Treatment with MaaT033 induced increased microbiota richness as well as strong and persistent engraftment in cohorts 3 and 4 of the dose escalation study, which consisted in the intake of 3 capsules of the drug candidate per day.
• Engraftment following MaaT033 treatment correlated with increased anti-inflammatory marker levels and reduced inflammatory marker levels.

Detailed results from the Phase 1b CIMON trial were presented in a poster on December 11 at the ASH Annual Meeting by Prof. Mohamad Mohty, Head of the Clinical Hematology and Cellular Department at the Saint-Antoine Hospital and Sorbonne University.

As previously announced, MaaT Pharma is currently preparing a pivotal Phase IIb randomized, double-blind, placebo-controlled to evaluate MaaT033’s safety, engraftment, and efficacy in improving overall survival at 12 months and preventing complications in patients with blood cancers receiving hematopoietic stem cell transplantation. Initiation should take place shortly and the Company will provide a detailed status update in January 2023.

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 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, 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.

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MaaT Pharma’s mission is to improve cancer patients’ lives by driving innovation in the microbiome therapeutics field.