• MaaT Pharma and Clinigen signed exclusive long-term licensing and distribution agreement and commercial supply agreement for Xervyteg^® (MaaT013), its first in class treatment proposed for patients with acute Graft-versus-Host Disease
• In June 2025, the European Medicines Agency accepted for review the marketing authorization submission for this medicine
• MaaT Pharma will receive a €10.5 million upfront payment, further potential regulatory and sales milestones of up to €18 million, and royalties of a mid-thirties’ percentage on net sales. MaaT Pharma also entered into a supply agreement to provide Clinigen with finished medicine, at a pre-agreed price per unit
• If this medicine is approved with potential marketing authorization granted by mid-2026, it has the potential to be the first microbiota therapeutic approved in Europe, the first one in hemato-oncology globally and the first and only one in third-line aGvHD

Conference call and webcast to be held on July 3^rd, 2025, at 3:00PM CET/ 9:00AM EDT/9:00PM CST - To register, please click here.

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, today announces the signature of a license and commercial agreement with Clinigen, a global specialty pharmaceutical services group and a leading European player in hospital distribution and market access, to streamline the pathway for ensuring access to this medicine across Europe¹. With this partnership, MaaT Pharma demonstrates its capability to supply products to pharmaceutical companies, including those specializing in rare diseases while ensuring scale-ups for commercial and extending its cash runway into January 2026.

Hervé Affagard, CEO and co-founder of MaaT Pharma says: “This deal is a pivotal step in bridging MaaT Pharma’s innovation with healthcare professionals who care for patients with aGvHD. Clinigen’s hemato-oncology expertise and leading European position in hospital distribution and market access make this team the ideal fit to bring this therapy to patients and we’re confident that this new relationship will maximize the full revenue generation potential of full revenue generation potential of Xervyteg^® (MaaT013). I look forward to working closely with the Clinigen team as we prepare for a successful launch.”

Jerome Charton, CEO of Clinigen, says: “Following the EMA’s acceptance of MaaT Pharma’s submission of an application for assessment for MaaT013 in June, we are very excited about this new relationship. This collaboration brings a novel technology to the forefront of rare disease and oncology care. We’re proud to play a leading role in ensuring access across Europe to this innovative therapy, and we look forward to working closely with MaaT Pharma as we prepare for potential launch.”

Transaction Terms

Under the terms of the agreement, MaaT Pharma will grant Clinigen exclusive European rights to distribute this medicine for the treatment of patients with aGvHD, if approved by the EMA. MaaT Pharma will receive an upfront payment of €10.5 million and additional eligible payments of up to €18 million depending on the achievement of pre-specified regulatory and sales milestones. MaaT Pharma will also be eligible to receive royalty payments on net sales of a percentage in the mid-thirties and regular cash flow as per the supply agreement.

The hematology community has expressed interest in this medicine and this class of medicines to treat patients with aGvHD, as evidenced by the growing requests of Early Access Program between 2023 and 2024 (+75%). This program has been active in Europe since 2019. Under the terms of the agreement, Clinigen will take over this activity to meet the growing expectations of physicians while allowing MaaT Pharma to optimize its internal resources. This transition enhances MaaT Pharma’s capacity to focus on clinical development, regulatory milestones, and industrial scale-up.

MaaT Pharma management will host a conference call and webcast tomorrow Thursday, July 3^nd, 2025, at 3:00pm CET/ 9:00am EDT/ 6:00am PT/ 9:00pm CST. To register, please click here. Participants can also attend the conference by phone by dialing the following number: +33 1 78 42 94 76 + and using the PIN code 43 92 58

¹ Includes the following countries: European Union, Iceland, Norway, Liechtenstein and the United Kingdom

About Clinigen

Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa, and the Asia Pacific. Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year.

For more information on Clinigen, please visit www.clinigen.com.

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.

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.

About acute Graft-versus-Host Disease

Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient’s organs, causing inflammation of the skin, liver and/or gastro-intestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered Steroid Resistant (SR) and other agents can be administered. Currently the only agent approved for treating SR aGvHD after failure of steroid treatment is ruxolitinib, which is currently approved for this indication in USA and has received approval from the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) on March 25, 2022.

About MaaT013 (Xervteg®)

MaaT Pharma’s Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013 (Xervyteg^®) is a full-ecosystem, off-the-shelf, standardized, pooled-donors, 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 (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 (Xervyteg^®) 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)-aGvHD. MaaT013 (Xervyteg^®) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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Clinigen’s hemato-oncology expertise and leading European position in hospital distribution and market access make this team the ideal fit to bring this therapy to patients.