Intended for the Investor Community

Clinigen Signs Exclusive Licensing and Distribution Agreement and Commercial Supply Agreement for the European Economic Area and the United Kingdom with MaaT Pharma for Novel Microbiota Therapy

If approved, the therapy could be the first of its kind for patients with acute Graft-versus-Host Disease

  • Exclusive licensing and distribution and commercial supply agreement signed with MaaT Pharma for a first-in-class therapy (MaaT013) in Europe and the United Kingdom.
  • The therapy is being developed for patients with gastrointestinal aGvHD – a serious complication which can arise following stem cell transplants.
  • If approved, it may be the first microbiota-based treatment approved in Europe, the first one in haemato-oncology globally, and the first and only one in third line aGvHD.

London, UK – 02 July 2025 – Clinigen, the global pharmaceutical services Group, today announces an exclusive long-term licensing and distribution agreement and commercial supply agreement with MaaT Pharma, a late clinical-stage biotechnology company, to support future access in Europe and the United Kingdom1 to a microbiota-based therapy (MaaT013).

The therapy is currently under regulatory review by the European Medicines Agency, in the proposed indication of acute Graft-versus-Host Disease (aGvHD) with gastro-intestinal (GI) involvement in patients who have received two prior lines of systemic treatment. It is based on a full-ecosystem microbiota formulation derived from healthy donors, representing a novel approach in microbiome therapeutics for GI aGvHD.  In June 2025, MaaT Pharma submitted an application to the European Medicines Agency for a marketing authorisation in respect of this therapy. If the application is successful, the marketing authorisation might be granted in mid-2026.

Under the terms of the agreement, Clinigen will become responsible for commercialisation of MaaT013 as the exclusive distributor for the therapy across Europe, subject to regulatory approval. If approved, it could be the first microbiota-based product authorised in Europe, the first in haemato-oncology globally, and the first and only approved third-line treatment for this condition – a serious and often life-threatening complication of stem cell transplants. Alongside this, Clinigen will also take over an Early Access Program for MaaT013 currently being managed by MaaT Pharma.

Jerome Charton, CEO of Clinigen, said: “Following the application in June 2025 to the EMA for assessment for MaaT013, 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.”

Hervé Affagard, CEO and co-founder of MaaT Pharma, added: “This deal is a pivotal step in bridging MaaT Pharma’s innovation with healthcare professionals who care for patients with aGvHD. Clinigen’s haemato-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 MaaT013. I look forward to working closely with the Clinigen team as we prepare for a successful launch.”

This press release contains information about medicines that are not approved in the relevant territories. The intent of this press release is to share pertinent information with the investment community about this collaboration between Clinigen and MaaT Pharma.

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

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Email: clinigen@fightorflight.com

Notes to Editors

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.

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 (GI) 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
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 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 ButycoreTM (a 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)-aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).