Amani Therapeutics, a newly formed biotechnology company backed by RTW Investments, today announced the closing of a $25 million Series A financing. The company also announced the appointment of its executive leadership team and the in-licensing of worldwide rights from AstraZeneca to a Phase 3–ready novel chemical entity (NCE), which is a component of Amani’s lead program, AM-01.

Amani’s mission is to develop highly efficacious, safer medicines for people living with serious neuropsychiatric disorders.

About AM-01

AM-01 is a fixed-dose combination product that includes clozapine and a Phase 3–ready NCE with worldwide rights in-licensed from AstraZeneca. Amani believes AM-01 has the potential to deliver clozapine’s unmatched efficacy for patients with schizophrenia while addressing clozapine’s most significant safety liability—severe neutropenia—and the burdensome blood-monitoring that limit its use.

Clozapine remains the only medication proven to meaningfully improve symptoms in treatment-resistant schizophrenia and to reduce suicide risk in patients with schizophrenia and schizoaffective disorder. Despite its clinical benefits, it is profoundly underutilized due to safety concerns and monitoring requirements.

“Our understanding of the mechanism of clozapine-induced neutropenia, supported by results from our preclinical models, leads us to believe we have identified a solution to the decades-long challenge of developing a safer clozapine,” said Carla Canuso, MD, Chief Medical Officer of Amani Therapeutics. “By combining clozapine with the NCE licensed from AstraZeneca, we aim to mitigate the risk of neutropenia and the associated blood-monitoring requirements, while preserving clozapine’s efficacy.”

Executive Appointments

Rob Swoboda joins Amani as Chief Operating Officer, bringing deep operational, development, and commercialization experience from leadership roles at Karuna Therapeutics, bluebird bio, and Vertex Pharmaceuticals. Most recently, he served as Senior Vice President, Corporate & Portfolio Operations at Karuna Therapeutics, where he was the cross-functional Cobenfy program lead and helped lead the company through its acquisition by Bristol Myers Squibb.

Carla Canuso, MD, joins Amani as Chief Medical Officer, bringing more than two decades of neuropsychiatric clinical development experience at Johnson & Johnson. Most recently, she served as Vice President and Head of Neuropsychiatry and was the clinical lead for the Intracellular acquisition. She previously led the cross-functional compound development team for intranasal esketamine. Currently, she serves as a non-voting industry representative on the FDA Psychopharmacologic Drugs Advisory Committee.

About RTW Investments, LP

RTW Investments, LP is a New York–based, global, full life-cycle investment firm focused on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors.

Forward-Looking Statements

This press release contains forward-looking statements. Except for statements of historical fact, all statements in this release are forward-looking, including statements regarding potential milestone payments, development and regulatory timelines, commercialization plans, and financial returns. These statements are subject to risks and uncertainties, including clinical outcomes, regulatory decisions (including any regulatory requirements applicable to clozapine‑containing products), unexpected costs or delays, and market acceptance. Actual results may differ materially from those expressed or implied. AstraZeneca and Amani undertake no obligation to update any forward-looking statements, except as required by law.

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