MaaT Pharma Receives U.S. FDA Response Outlining Path Forward for Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease and Reports Cash and Revenues for Fourth Quarter 2022

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 reported that the U.S. Food and Drug Administration (FDA or the “Agency”) has responded to the Company’s Investigational New Drug (IND) Application to initiate in the U.S. an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy of MaaT013 in patients with steroid-resistant acute Graft-versus-Host Disease (aGvHD). The FDA letter indicates that the Agency agrees to a defined list of conditions that could enable clinical evaluation of MaaT013 in the U.S. These measures will be included, by the Company, in the IND filing. The communication therefore provides a path forward regarding MaaT Pharma’s “pooling” technology for this IND. The Company will promptly prepare a complete response letter and in the interim, the clinical hold remains.

“We appreciate the FDA’s continued commitment and are satisfied that the Agency has provided a clear and, we believe, achievable roadmap for the MaaT013 IND,” said Hervé Affagard, CEO and co-founder of MaaT Pharma. “The dialogue with the FDA remains constructive and positive as it lays the groundwork for the clinical evaluation of our pipeline in the U.S. We are confident about implementing the next steps and we will update investors in due course.”

As announced in August 2022, the FDA had requested further clinical and manufacturing-related information including data on the safety and efficacy of the Company’s “pooling” technology approach (i.e., mixing donations from multiple donors to achieve higher richness, diversity, and better standardization of the product). The Company submitted to the FDA detailed responses to these requests as announced in the press release dated January 24, 2023. In parallel, and as a reminder, the Company continues the development of MaaT013 in Europe with its ongoing international multicenter open-label, single arm, pivotal Phase 3 trial “ARES” evaluating MaaT013, which is progressing as planned. A review by an independent data safety and monitoring board (DSMB), is expected in the first half of 2023 after enrollment of half of the patients in the study.