MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013

“We are very pleased with the productive dialogue with the EMA Pediatric Committee and the positive PIP opinion. This approval marks a major regulatory milestone towards the submission of our Marketing Authorization dossier with the EMA,” said Gianfranco Pittari, MD, PhD, Chief Medical Officer at MaaT Pharma. “Through our Early Access Program, we have already successfully and safely treated two pediatric patients with aGvHD. We are committed to bringing MaaT013 to pediatric patients suffering from aGvHD, who currently have limited
options.”

The EMAPDCO approved the clinical program to evaluate the safety and efficacy of MaaT013 in patients from 6 years old to less than 18 years old, with the initiation, in 2026, of a singlearm trial in third-line treatment for 18 patients with aGvHD and in line with the Company’s cash projections.

Based on this positive opinion, MaaT013 would be eligible for up to an additional two years of marketing exclusivity in Europe, on top of the ten-year European market exclusivity as an orphan drug if the Marketing Authorization is granted by the EMA. This also confirms the Company’s ability to reach the full patient population.

“With this approval of our Pediatric Investigation Plan, we are now on track to submit our Marketing Authorization dossier in June this year. If approved,the Company could be positioned to generate revenues as soon as late 2026 with MaaT013 in third-line treatment in aGvHD,” stated Hervé Affagard co-founder and CEO of MaaT Pharma. “Additionally, the Company will continue to provide the product through its Early Access Program for all patients in need.”

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