Regulatory News:

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to enhancing survival of patients with cancer, announced the first treatment in the United States of a patient with acute Graft-versus-Host Disease (aGvHD) under the US Food and Drug Administration (FDA) Single Patient Expanded Access. Expanded access, sometimes called “compassionate use,” is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. In the U.S., compassionate use may be requested by a treating physician via a Single-Patient Investigational New Drug (IND).

The patient, who was previously treated with multiple lines of therapies, including steroids and ruxolitinib, received this treatment at City of Hope, by Monzr M. Al Malki, M.D., associate professor and director of Unrelated Donor BMT program and Ryotaro Nakamura, M.D., professor and director of City of Hope’s Center for Hematopoietic Cell Transplantation. City of Hope is one of the largest and most advanced cancer research and treatment organizations in the United States, whose Los Angeles comprehensive cancer center is ranked among the nation’s top 5 cancer centers by U.S. News & World Report. Drs. Al Malki and Dr. Nakamura are renowned for their expertise in the fields of Hematopoietic Cell Transplantation and GvHD.

“We are excited to have access to MaaT013 for this patient for the treatment of refractory aGvHD” said Dr. Nakamura¹. Dr. Al Malki added “We believe that microbiome-based immune modulation may play a crucial role in the treatment of aGvHD and look forward to exploring the potential of MaaT013 to enhance GvHD outcomes and improve patient survival.”

“Providing MaaT013 under compassionate use in the U.S. highlights the pressing global need for innovative therapies to address refractory aGvHD,” said Hervé Affagard, CEO and co-founder of MaaT Pharma. “This also reflects the growing international recognition of MaaT013 as a potential new hope for patients battling this life-threatening condition.”

As previously communicated, MaaT Pharma is currently advancing the Phase 3 ARES trial in Europe (NCT - 04769895). Patient recruitment is now complete for the European study, and topline results are expected in January 2025. Additionally, MaaT Pharma plans to initiate a US Phase 3 clinical trial evaluating MaaT013 in aGvHD with gastrointestinal involvement in ruxolitinib-refractory or intolerant subjects. In this context, clinical batches of MaaT013 have been made available, enabling the product to also be distributed to support expanded access under FDA oversight. Finally, additional efficacy, safety, and long-term follow-up data from the Early Access Program in Europe will be presented at the upcoming ASH 2024 Annual Meeting taking place December 7-10, 2024, in San Diego, California, USA.

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About MaaT Pharma

MaaT Pharma 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.

As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.

About MaaT013

MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, 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 (GI)-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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.

¹ Disclosure: Dr. Nakamura has received compensation from MaaT Pharma for service on an advisory board

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