Sagimet Biosciences reports Q1 EPS (56c), consensus (69c)

Cash, cash equivalents and marketable securities as of March 31 were $144.6M.. “Sagimet is committed to bringing innovative therapies to MASH patients, following the successful results of our Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly in more advanced F3 stage patients. In a Phase 1 clinical trial in patients with and without hepatic impairment, denifanstat exhibited similar pharmacokinetic characteristics and was well tolerated among all groups. Considering these strong Phase 1 and Phase 2 data, further development of denifanstat in MASH, including as part of a combination program, could potentially offer an opportunity to serve patient groups with the strongest need of treatment including those with stage 4 fibrosis,” said CEO David Happel. “Building on our presentation of compelling preclinical data at 2024 EASL demonstrating the synergistic effect of a FASN inhibitor combined with resmetirom on important liver disease markers, we anticipate initiating a Phase 1 clinical trial to evaluate the PK and tolerability of a combination of denifanstat and resmetirom in 2H25. If the outcome of this Phase 1 trial is positive, we will explore moving into the development of a combination product — which we envision as a single tablet — for patients living with MASH. We remain strongly convinced of the significant therapeutic potential associated with FASN inhibition across multiple disease states.”