MaaT Pharma (EURONEXT: MAAT), a clinical-stage biotech focused on microbiome-based therapies, has reported positive first-half results and provided a business update highlighting key clinical, regulatory and corporate milestones.

The company’s lead candidate, MaaT013, marketed as Xervyteg, showed promising results in the pivotal Phase 3 ARES trial for acute Graft-versus-Host Disease (aGvHD) with gastrointestinal involvement. Topline data revealed a 62% overall gastrointestinal response rate at Day 28 and a projected 1-year overall survival of 54%, demonstrating meaningful clinical improvement over currently available third-line therapies.

Following these results, MaaT Pharma submitted a Marketing Authorization Application to the European Medicines Agency (EMA) in June 2025, a step that could make Xervyteg the first microbiome therapy approved in hemato-oncology in Europe. The submission follows positive opinions from the EMA Pediatric Committee and confirmation of the treatment’s safety and efficacy by an independent data monitoring committee.

To facilitate European patient access, MaaT Pharma signed a licensing and commercial agreement with Clinigen, a specialist pharmaceutical services company. The deal includes a €10.5 million upfront payment and up to €18 million in additional milestone payments, along with royalties on net sales. In parallel, the company secured €37.5 million in four-tranche financing from the European Investment Bank to advance late-stage clinical programmes, including MaaT033, which is being tested in a Phase 2b trial to improve survival for patients receiving allogeneic hematopoietic stem cell transplants.

MaaT Pharma also reported a 41% rise in first-half revenues to €2.4 million, largely driven by continued demand in its Early Access Program for Xervyteg. Operating loss for the period was €14.7 million, reflecting investment in research and development and ongoing clinical programmes. Including the Clinigen payment and the first tranche of EIB financing, the company’s cash runway extends to the end of February 2026.

Beyond aGvHD, MaaT Pharma is advancing multiple programmes. MaaT033 is being tested in immuno-oncology trials for melanoma and non-small cell lung cancer, while MaaT034 has shown strong preclinical anti-tumor activity in germ-free mice. In neurodegenerative diseases, MaaT033 demonstrated a favourable safety profile in ALS patients, with evidence of slowed disease progression and rapid microbial engraftment.

Corporate developments include the appointment of Frédéric Fasano as chief strategy and corporate development officer and Behzad Kharabi Masouleh as acting chief medical officer, strengthening the company’s scientific and strategic leadership. MaaT Pharma has also been included in the CAC Small, CAC Mid & Small, and CAC All-Tradable indices, increasing its market visibility.

Eric Soyer, chief financial officer of MaaT Pharma, said: “In the first half of the year, we achieved key clinical and regulatory milestones, bringing us closer to providing a much-needed therapeutic option for aGvHD patients. Our EMA submission, Clinigen partnership, and EIB financing strengthen our operations and financial position as we prepare for potential market entry.”

With regulatory reviews ongoing and commercialization plans in Europe underway, MaaT Pharma is positioning itself at the forefront of microbiome-based therapies in oncology.