• Positive pre-Investigational New Drug (pre-IND) interaction with the Food Drug Administration (FDA) on Chemistry, Manufacturing and Controls (CMC) and nonclinical topics supports MaaT034’s continued advancement
• FDA alignment on the IND-enabling strategy indicates that no additional non-clinical studies are anticipated to be required to support the safety of MaaT034 administration

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 for patients with cancer through immune modulation, announced productive and constructive feedback from the U.S. FDA following its pre-IND interaction for MaaT034 in potential solid tumor indications including Non-Small Cell Lung Cancer, Melanoma and Renal Cell Carcinoma, focused on CMC and nonclinical development.

Based on the information provided, and pending the receipt and confirmation of the FDA’s final meeting summary, the FDA indicated that MaaT Pharma’s proposed science- and risk-based development approach appears appropriate, subject to review of the complete IND submission. The FDA also indicated that no additional nonclinical studies are required to support the safety of MaaT034 administration. The FDA requested additional information from completed studies for inclusion in the IND submission.

“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across cancer care,” said Hervé Affagard, CEO and co-founder of MaaT Pharma.

MaaT Pharma plans to continue its IND-enabling activities and further engage with the FDA through a Type C meeting focused on the proposed clinical development plan and first-in-human study design.

Subject to obtaining the necessary regulatory clearances and the availability of appropriate funding and taking into account the Company’s estimated cash runway to December 2026, MaaT Pharma could initiate a First-in-Human study evaluating MaaT034 in late 2027. To support the clinical development of MaaT034, the Company is exploring financing opportunities from investors and strategic partnerships.

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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 MaaT034
MaaT034, currently in preclinical development, is a next-generation donor-independent functionally selected, co-cultured microbial ecosystem, designed to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). Developed using MaaT Pharma’s proprietary MET-C co-culturing platform, MaaT034 is optimized for large-scale manufacturing and designed to deliver key microbial functions associated with anti-tumor immune responses.
Preclinical data presented at the AACR and at SITC annual meetings demonstrated that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the potential of MaaT034 to promote gut barrier restoration, enhance T-cell activation, and increase anti-tumor activity when combined with anti-PD-1 or anti-PD-L1 therapies.
By restoring microbiome-mediated functions and modulating immune responses, MaaT034 is designed to complement the mechanism of action of immune checkpoint inhibitors and has the potential to improve treatment outcomes in patients with advanced solid tumors.

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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