MaaT Pharma: Favorable FDA feedback on MaaT034, but limited cash position through end of 2026
Following a pre-Investigational New Drug (pre-IND) meeting, MaaT Pharma indicated on October 19, 2026 that the U.S. health authority does not anticipate additional non-clinical safety studies on its solid tumor candidate.
The Lyon-based biotech sets a target for the first human study by end of 2027, subject to securing financing, while its cash runway is estimated to extend through December 2026.
The FDA deems the approach appropriate at this stage, subject to review of the complete dossier
Discussions with the Food and Drug Administration covered two areas: chemistry, manufacturing and controls on one hand, and non-clinical development on the other. These concern MaaT034 in potential solid tumor indications, including non-small cell lung cancer, melanoma, and renal cell carcinoma. The candidate, currently at the preclinical stage, is designed to be administered in combination with immune checkpoint inhibitors.
According to the company, the FDA determined that the proposed development approach, based on science and risk assessment, "appears appropriate." This assessment remains, however, conditional on review of the complete IND dossier and receipt and confirmation of the final meeting summary by the agency.
The authority also requested that supplementary information from previously conducted studies be integrated into the application dossier. For Hervé Affagard, Chief Executive Officer and co-founder, this outcome "reinforces the development pathway for MaaT034" and marks a milestone in the group's expansion into immuno-oncology.
First human study considered for end of 2027 subject to conditions
MaaT Pharma plans to continue its preparatory work for IND submission and to request a Type C meeting with the FDA regarding the proposed clinical development plan and design of the first human study.
This study could begin by end of 2027, subject to obtaining necessary regulatory approvals and the availability of appropriate financing. The company notes that it is taking into account its cash runway, estimated to extend through December 2026, and indicates it is exploring financing possibilities with investors as well as strategic partnerships.
When publishing its first-half 2026 results on September 29, 2026, the group reported cash of €17.1 million as of June 30. The holding of this pre-IND meeting in October had been announced on September 22, 2026, as part of the reorientation of its developments following the negative opinion from the European Medicines Agency on Xervyteg.
