MaaT Pharma has reported its half year 2025 financial results, highlighting clinical progress for its lead microbiome therapy candidate Xervyteg (MaaT013) in acute graft-versus-host disease (aGvHD) and continued advancement across its hemato-oncology pipeline.

The company said positive Phase 3 topline data from the ARES trial demonstrated a 62% gastrointestinal overall response rate at Day 28 and an expected 1-year overall survival rate of 54% in patients with aGvHD, indicating improved outcomes compared with available therapies. The trial met its primary endpoint, with final data expected before the end of 2025 to support regulatory submissions and scientific publications.

MaaT Pharma submitted a marketing authorisation application for Xervyteg to the European Medicines Agency in June 2025. If approved, the therapy could become the first microbiota-based medicine authorised in Europe and the first therapy approved for third-line gastrointestinal aGvHD.

In July 2025, the company signed a licensing and commercial agreement with Clinigen to support patient access across Europe. The deal included a €10.5 million upfront payment and up to €18 million in additional regulatory and sales milestone payments, with royalties in the mid-thirties on net sales and ongoing supply-related revenue.

MaaT Pharma also secured a €37.5 million financing facility from the European Investment Bank to support late-stage hemato-oncology programmes, including Xervyteg and MaaT033, which is being evaluated in a Phase 2b trial to improve survival following allogeneic stem cell transplant.

The company reported revenues of €2.4 million in H1 2025, up 41% year-on-year, driven by increasing demand for Xervyteg through early access programmes. As of 30 June 2025, cash and cash equivalents were €15 million, excluding recent Clinigen and EIB funding, extending its runway into early 2026.

MaaT Pharma continues to expand clinical development across immuno-oncology and neurodegenerative disease indications, with multiple investigator-sponsored trials ongoing and data readouts expected in the second half of 2025.

Eric Soyer, chief financial officer at MaaT Pharma, said: “In the first half of the year, MaaT Pharma achieved key clinical and regulatory milestones, bringing us closer to providing a much-needed therapeutic option for patients with aGvHD and to becoming the first company to bring a microbiome medicine to market in Europe.”