Neumora Therapeutics, Inc. (NASDAQ:NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today reported favorable pre-clinical toxicology results from NMRA-215, a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor in development for the treatment of obesity and cardiometabolic disease.

Neumora conducted a repeat 13-week toxicology study in rats following results from a prior study in which unexpected in-life adverse findings were observed in 5 of 142 animals. The Company opened a for-cause audit of that study which revealed various discrepancies resulting in a number of critical audit observations. In a repeat 13-week rat toxicology study in 162 animals, no instances of unexpected in-life adverse findings were observed. Based on the audit observations, the repeat study data and the results from the previously completed 28-day rat, 28-day dog and 13-week dog toxicology studies, Neumora continues to believe the prior adverse findings were not related to NMRA-215 and plans to submit an IND application for NMRA-215 in the fourth quarter of 2026.

"The differentiated properties of NMRA-215 enable it to achieve sustained IC90 coverage in the brain which has resulted in compelling pre-clinical efficacy in the diet induced obesity mouse model. NMRA-215 demonstrated class-leading weight loss as a monotherapy, including incretin-like induction, additive weight loss in the combination setting with semaglutide and potential for use as a switch or maintenance treatment. NMRA-215 also improved peripheral biomarkers related to cardiometabolic risk, which has translated to robust decreases in CV risk factors in clinical studies with other NLRP3 inhibitors," said Nick Brandon, Ph.D., chief scientific officer, Neumora. "These data and the toxicology package to date, support advancing NMRA-215 towards the clinic. We eagerly anticipate initiating a clinical study in 2026."