MaaT Pharma (EPA:MAAT) saw its shares decline 3.9% to €2.60 on Friday following a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) regarding its lead therapy, Xervyteg (MaaT013). The CHMP cited concerns over data attribution, as the primary evidence came from a single-arm study where patients also received other treatments.
Regulatory Setback and Re-examination Plan
The CHMP issued its negative opinion during its June 22-25 meeting, making Xervyteg one of three drugs to receive a negative assessment that month, alongside six that received positive opinions. For 2026 to date, the committee has issued 42 positive and six negative opinions on new medicines.
MaaT plans to request a re-examination of the CHMP decision, with a new rapporteur and co-rapporteur, and will also seek a hearing before the Scientific Advisory Group in hematology. The re-examination is expected to be reviewed during the CHMP meeting scheduled for September 14-17, with a second opinion possible approximately 60 days after the request is validated.
Clinical Data and Market Context
The CHMP's concern centers on the attribution of the ARES trial data to MaaT013 alone. In the ARES study, 41 of 66 patients (62%) showed a gastrointestinal response at Day 28, with an all-organ response in 42 of 66 (64%) and one-year overall survival of 54%. By comparison, the CHRONOS real-world study, which used third-line best available treatments excluding microbiome therapy, showed a 37% gastrointestinal response at Day 28 and 29% 12-month overall survival.
Florent Malard, a hematology professor at Saint-Antoine Hospital and Sorbonne University, previously stated that the ARES response rates and survival numbers 'strongly suggest' a clinical benefit. However, the CHMP opinion indicates the committee required more robust comparative data.
Financial Position and Cash Runway
MaaT reported €18.1 million in cash and cash equivalents as of March 31, not including a €6 million tranche from the European Investment Bank received in April. CFO Eric Soyer noted that the company's 'financial discipline' has extended its cash runway through November 2026. The stock has fallen approximately 46% this year, with a market capitalization of around €50.97 million.
The timeline is tight: if the CHMP reviews the re-examination in September, it falls within the current cash runway. However, a second negative opinion or any delays could push financing needs closer to the clinical decision deadline.
Early Access Program and Revenue
During the re-examination, MaaT's early access program for Xervyteg will continue. The program covers 13 countries and has reached over 300 patients since 2019. First-quarter revenue from the program was €0.8 million, with like-for-like MaaT013 revenue rising 19% year-over-year.
Chief Executive Hervé Affagard reiterated the company's commitment to the re-examination, stating after the CHMP's negative trend indication in May that MaaT still 'strongly believes' in MaaT013's registration chances. The company's shares traded at €2.60 in Euronext Paris, reflecting the market's cautious outlook as the September review approaches.