First Berlin Equity Research has published a research update on MaaT Pharma SACA (ISIN: FR0012634822). Analyst Christian Orquera maintained his ?under review? rating and price target.

Abstract
MaaT Pharma’s investment case has changed materially following the negative opinion issued by the CHMP (Committee for Medicinal Products for Human Use) following its re-examination of the conditional MAA for MaaT013 (Xervyteg). The regulator maintained that the single-arm ARES phase 3 dataset does not allow sufficient characterisation of the benefit-risk profile. The CHMP’s negative opinion effectively closes the current European approval route. Future development will now focus on PHOENIX, a global randomised controlled phase 3 trial of MaaT013 versus Best Available Therapy in ~138 patients. Constructively, FDA Type C feedback supports advancing PHOENIX as a registrational phase 3 trial, with first patient enrolment potentially in H1/27, subject to funding and regulatory clearance. The key issue is now financing. MaaT Pharma reported cash of €17.1m at end-June and, following additional cash-conservation measures, now expects its runway to extend to December 2026, one month longer than previously indicated. This remains well short of the funding required for PHOENIX, which will require substantial additional capital on top of the funding needed to maintain ongoing operations. The company has initiated a strategic review of its assets and is exploring financing and partnering opportunities, including for MaaT034, which is progressing towards an FDA pre-IND meeting in October. We believe MaaT Pharma is evaluating a broad range of strategic alternatives to secure funding and maximise the value of its pipeline. However, until a funded path forward is established, visibility on the company’s ability to fund operations beyond year-end remains limited. Our rating and price target remain Under Review.