Amani Therapeutics, a newly formed biotechnology company based in New York, has closed a USD 25 million Series A financing round to advance AM-01, a fixed-dose combination product targeting serious neuropsychiatric disorders. The company simultaneously announced the in-licensing of worldwide rights from AstraZeneca to a Phase III-ready novel chemical entity that forms a core component of AM-01.

RTW Investments, a New York-based investment firm focused on biopharmaceutical and medical technology sectors, backed the round. No other participating investors were disclosed. The company said it plans to use the proceeds to advance AM-01 toward late-stage clinical development.

AM-01 combines clozapine, the only medication with demonstrated efficacy in treatment-resistant schizophrenia and suicide risk reduction in schizophrenia and schizoaffective disorder, with the AstraZeneca-derived compound. The combination is designed to preserve clozapine’s efficacy while mitigating its primary safety liability, severe neutropenia, and the mandatory blood-monitoring requirements that have limited its clinical uptake. Clozapine was developed in the late 1950s and secured first approval in the US in 1989 under Novartis ownership. The molecule remains underutilized despite its established clinical profile.

The company appointed Rob Swoboda as Chief Operating Officer and Carla Canuso, MD, as Chief Medical Officer. Swoboda previously served as Senior Vice President of Corporate and Portfolio Operations at Karuna Therapeutics, where he led cross-functional work on schizophrenia drug Cobenfy (xanomeline/trospium chloride) and contributed to the company’s acquisition by Bristol Myers Squibb. He also held roles at bluebird bio and Vertex Pharmaceuticals. Canuso spent more than two decades in neuropsychiatric clinical development at Johnson & Johnson, where she served as Vice President and Head of Neuropsychiatry and led the compound development team for intranasal esketamine. She currently serves as a non-voting industry representative on the US FDA Psychopharmacologic Drugs Advisory Committee.