Amani Therapeutics Closes $25 Million Series A to Advance AM-01, a Potential Best-in-Class Therapy for Serious Neuropsychiatric Disorders

阿玛尼治疗公司完成2500万美元A轮融资，以推进AM-01，一种潜在的治疗严重神经精神障碍的最佳疗法。

NEW YORK, March 23, 2026-- 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..

纽约，2026年3月23日——由RTW Investments支持的新成立的生物技术公司Amani Therapeutics今天宣布完成了2500万美元的A轮融资。该公司还宣布了其执行领导团队的任命，并从阿斯利康获得了其主要项目AM-01中的一个准备进入第三阶段的新型化学实体（NCE）的全球授权。

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

阿马尼的使命是为患有严重神经精神疾病的人们开发高效且更安全的药物。

About AM-01

关于 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..

AM-01 是一种固定剂量的复方产品，包含氯氮平和一种从阿斯利康获得全球授权的、处于第三阶段的新型化学实体 (NCE)。Amani 认为 AM-01 有潜力在提供氯氮平对精神分裂症患者的无与伦比疗效的同时，解决氯氮平最严重的安全问题——严重中性粒细胞减少症，以及限制其使用的繁琐的血液监测。

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..

氯氮平仍然是唯一一种被证实可有效改善难治性精神分裂症症状，并降低精神分裂症和分裂情感障碍患者自杀风险的药物。尽管它具有临床益处，但由于安全问题和监测要求，其使用率极低。

“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.

“我们对氯氮平诱发中性粒细胞减少症的机制的理解，在我们的临床前模型结果的支持下，使我们相信我们已经找到了解决几十年来开发更安全的氯氮平这一挑战的方案，”Amani Therapeutics首席医疗官卡拉·卡努索医学博士说道。

“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.”.

“通过将氯氮平与阿斯利康授权的NCE结合使用，我们旨在降低中性粒细胞减少症的风险以及相关的血液监测要求，同时保留氯氮平的疗效。”

Executive Appointments

高级管理层任命

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..

Rob Swoboda 加入 Amani 担任首席运营官，他在 Karuna Therapeutics、bluebird bio 和 Vertex Pharmaceuticals 的领导岗位上积累了深厚的运营、开发和商业化经验。最近，他担任 Karuna Therapeutics 的高级副总裁，负责公司及产品组合运营，并作为跨职能的 Cobenfy 项目负责人，帮助公司完成了被百时美施贵宝收购的过程。

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.

卡拉·卡努索医学博士加入阿玛尼担任首席医疗官，她在强生公司拥有二十多年的神经精神临床开发经验。最近，她担任副总裁兼神经精神科主管，并主导了Intracellular收购案的临床工作。她之前领导了鼻腔给药esketamine的跨职能化合物开发团队。

Currently, she serves as a non-voting industry representative on the FDA Psychopharmacologic Drugs Advisory Committee..

目前，她担任FDA精神药理药物咨询委员会的无投票权行业代表。

About RTW Investments, LP

关于RTW投资有限公司伙伴关系

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.

RTW Investments, LP 是一家总部位于纽约的全球全生命周期投资公司，专注于发现生物制药和医疗技术领域的变革性和颠覆性创新。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含前瞻性声明。除历史事实陈述外，本新闻稿中的所有声明均为前瞻性声明，包括有关潜在里程碑付款、开发和监管时间表、商业化计划以及财务回报的声明。这些声明受风险和不确定性影响，包括临床结果、监管决策（包括适用于含氯氮平产品的任何监管要求）、意外成本或延误以及市场接受度。

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..

实际结果可能与这些表达或暗示的结果有重大差异。阿斯利康和阿玛尼不承担更新任何前瞻性声明的义务，除非法律要求。

Contact:

联系人：

Rob Swoboda

罗布·斯沃博达

info@amanitx.com

info@amanitx.com