Ambros Therapeutics Launches with $125 Million Series A Financing to Advance Neridronate Through Phase 3 Registrational Program for Complex Regional Pain Syndrome Type 1

Ambros Therapeutics启动1.25亿美元A轮融资，推进Neridronate进入复杂区域疼痛综合征1型的3期注册计划。

• Neridronate granted FDA Breakthrough Therapy, Fast-Track, and Orphan Drug designations; pivotal Phase 3 trial planned to start in the first quarter of 2026

• Neridronate获FDA突破性疗法、快速通道和孤儿药资格认定；关键的III期试验计划于2026年第一季度启动。

• Jay Hagan joins as Chief Executive Officer leading a seasoned late-stage development team and will serve on the Board alongside Co-Founder and Chairman Keith Katkin

杰伊·哈根加入公司，担任首席执行官，领导一支经验丰富的后期开发团队，并将与联合创始人兼董事长基思·卡特金一同加入董事会。

• Oversubscribed Series A financing co-led by RA Capital Management and Patient Square Capital's platform Enavate Sciences with participation from a strong syndicate of dedicated life sciences investors

• 由RA Capital Management和Patient Square Capital的Enavate Sciences平台共同领投，多家专注于生命科学的投资者组成的强大财团参与的超额认购A轮融资

IRVINE, Calif., December 16, 2025-- Ambros Therapeutics, Inc. today announced its launch as a clinical-stage biotechnology company advancing late-stage therapies for severe, underserved diseases beginning with neridronate for Complex Regional Pain Syndrome Type 1 (CRPS-1). Ambros launches with an oversubscribed $125 million Series A financing co-led by RA Capital Management and Patient Square Capital's platform Enavate Sciences, joined by Abiogen Pharma, Janus Henderson Investors, Arkin Bio, Balyasny Asset Management, Transhuman Capital, Adage Capital Partners LP, and other dedicated life sciences investors..

加利福尼亚州尔湾市，2025年12月16日 —— Ambros Therapeutics, Inc. 今日宣布作为一家临床阶段的生物技术公司正式启动，致力于推进针对严重且未被充分满足需求的疾病的晚期疗法，首个项目为用于治疗复杂区域疼痛综合征1型（CRPS-1）的尼立膦酸。Ambros 在由 RA Capital Management 和 Patient Square Capital 的 Enavate Sciences 平台共同领投的超额认购的 A 轮融资中筹集了1.25亿美元，参与投资的还有 Abiogen Pharma、Janus Henderson Investors、Arkin Bio、Balyasny Asset Management、Transhuman Capital、Adage Capital Partners LP 以及其他专注于生命科学的投资者。

The financing is expected to support the neridronate pivotal Phase 3 clinical trial in CRPS-1 (CRPS-RISE) and related regulatory preparations and pre-commercial activities. Ambros licensed the rights to neridronate from the Italian pharmaceutical company, Abiogen Pharma S.p.A., under a strategic collaboration, providing Ambros with exclusive rights to neridronate in North America, with an option for broader market expansion..

这笔资金预计将用于支持那利膦酸钠在CRPS-1（CRPS-RISE）中的关键3期临床试验及相关监管准备和上市前活动。安布罗斯根据一项战略合作从意大利制药公司Abiogen Pharma S.p.A.获得了那利膦酸钠的授权，该合作为安布罗斯提供了在北美对该药物的独家权利，并可选择扩展至更广泛的市场。

Abiogen Pharma is a recognized leader in the discovery and development of bisphosphonates including the advancement of neridronate. Neridronate was approved in Italy based on the safety and efficacy demonstrated in two CRPS Phase 3 studies and has been used for CRPS and other disorders in more than 600,000 patients to date.

Abiogen Pharma 是双膦酸盐类药物发现与开发的公认领导者，包括奈立膦酸的发展。奈立膦酸在意大利获得批准，是基于两项复杂性局部疼痛综合征（CRPS）第三阶段研究中所展示的安全性和有效性，并且迄今为止已被用于治疗 CRPS 和其他疾病患者超过 600,000 人。

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The U.S. Food and Drug Administration (FDA) has granted neridronate Breakthrough Therapy, Fast Track, and Orphan Drug designations for the treatment of CRPS. CRPS-1, the subtype Ambros is targeting, is a severe, debilitating rare disease with an estimated 65,000 new cases annually in the United States..

美国食品药品监督管理局（FDA）已授予奈立膦酸突破性疗法、快速通道和孤儿药资格，用于治疗复杂性区域疼痛综合症（CRPS）。Ambros 公司针对的 CRPS-1 亚型是一种严重且使人衰弱的罕见疾病，据估计美国每年新增约 65,000 例。

'We are launching Ambros with a seasoned leadership team and a therapy that has been used to treat CRPS in Italy for over ten years,' said Jay Hagan, Chief Executive Officer of Ambros Therapeutics. 'With no approved medicines for CRPS-1 outside of Italy, we look forward to working with Abiogen Pharma to advance neridronate through Phase 3 and bring this therapy to patients who urgently need it.'.

“我们正在推出Ambros，拥有一支经验丰富的领导团队和一种在意大利用于治疗CRPS超过十年的疗法，”Ambros Therapeutics首席执行官Jay Hagan表示。“在意大利以外，目前尚无批准用于治疗CRPS-1的药物，我们期待与Abiogen Pharma合作，推动奈立膦酸进入第三阶段，并将这种疗法带给迫切需要的患者。”

'We are excited to partner with Ambros to bring neridronate to patients outside of Italy, where there are currently no approved medicines,' said Massimo Di Martino, President of Abiogen Pharma. 'With decades of leadership in bisphosphonate innovation at our dedicated research and development center, we believe in the potential for neridronate to address CRPS outside of Abiogen's core commercial markets.'.

“我们很高兴与Ambros合作，将奈立膦酸带给意大利以外的患者，目前这些地区尚无获批的药物，”Abiogen制药公司总裁马西莫·迪马蒂诺表示。“凭借我们在专用研发中心几十年的双膦酸盐创新领导地位，我们相信奈立膦酸有潜力在Abiogen核心商业市场之外解决复杂性区域疼痛综合症（CRPS）问题。”

In addition to Mr. Hagan, Ambros' leadership team includes Gail Cawkwell, M.D., Ph.D., Chief Medical Officer; Michael Cruse, Chief Operating Officer; Kunal Kishnani, Senior Vice President Corporate Development; and Jennifer Lam, Senior Vice President Finance and Administration.

除了哈根先生之外，安布罗斯的领导团队还包括首席医学官盖尔·考克威尔医学博士、哲学博士；首席运营官迈克尔·克鲁斯；企业发展高级副总裁库纳尔·基什南尼；以及财务和行政高级副总裁詹妮弗·拉姆。

The Board of Directors is chaired by industry veteran Keith Katkin, and includes Co-Founder Vivek Ramaswamy; Matthew Hammond, Ph.D., of RA Capital Management; Trit Garg, M.D., of Patient Square Capital; Prisca Di Martino of Abiogen Pharma; and Jay Hagan, Chief Executive Officer.

董事会由行业资深人士Keith Katkin担任主席，成员包括联合创始人Vivek Ramaswamy；RA Capital Management的Matthew Hammond博士；Patient Square Capital的Trit Garg博士；Abiogen Pharma的Prisca Di Martino；以及首席执行官Jay Hagan。

'Neridronate is one of the few late-stage programs with a well-established mechanism, extensive real-world experience, and the potential to meaningfully change the trajectory of CRPS-1,' said Matthew Hammond, Partner at RA Capital Management. 'We are pleased to support Ambros as it advances this important therapy through this pivotal program to potentially be available for patients with very few options to address this painful disease.'.

“Neridronate 是为数不多的具有成熟机制、广泛真实世界经验，并有可能显著改变 CRPS-1 病程的晚期项目之一，”RA Capital Management 合伙人 Matthew Hammond 表示。“我们很高兴支持 Ambros 推进这一重要疗法，通过这个关键项目，有望为几乎没有选择来应对这种痛苦疾病的患者提供帮助。”

About Neridronate

关于奈立膦酸

Neridronate is a novel bisphosphonate that was discovered, developed, and commercialized by Abiogen Pharma S.p.A. for the Italian market. Neridronate is approved and marketed in Italy for the treatment of Complex Regional Pain Syndrome (CRPS); clinical studies have demonstrated lasting pain reduction along with improvements in other CRPS related symptoms.

Neridronate是一种新型的双膦酸盐，由Abiogen Pharma S.p.A.公司发现、开发并商业化，面向意大利市场。Neridronate在意大利被批准并用于治疗复杂区域疼痛综合征（CRPS）；临床研究已证明其能够持久减轻疼痛，并改善其他与CRPS相关的症状。

Beyond CRPS, neridronate is approved in Italy for additional indications including osteogenesis imperfecta and Paget's disease. Its well-established safety-profile and therapeutic benefits make it a potential promising treatment for patients with CRPS-1 worldwide. Recognizing its potential, the U.S.

除了CRPS，尼立膦酸在意大利还被批准用于其他适应症，包括成骨不全和佩吉特病。其成熟的安全性和治疗效益使其成为全球CRPS-1患者的潜在有效治疗方案。认识到其潜力，美国...

Food and Drug Administration (FDA) has granted neridronate Breakthrough Therapy, Fast Track, and Orphan Drug designations for the treatment of CRPS..

美国食品药品监督管理局（FDA）已授予奈立膦酸突破性疗法、快速通道和孤儿药资格，用于治疗复杂性区域疼痛综合征（CRPS）。

About Complex Regional Pain Syndrome Type 1 (CRPS-1)

关于复杂性区域疼痛综合征1型（CRPS-1）

Complex Regional Pain Syndrome Type 1 (CRPS-1; formerly known as RSD or Reflex Sympathetic Dystrophy) is a rare and debilitating condition following an injury or trauma to the bone. There are currently no FDA-approved medicines available to treat this high unmet need patient population. The condition is characterized by intense pain that can be continuous in the affected limb – typically in extremities such as the arm, leg, hand or foot.

1型复杂区域疼痛综合征（CRPS-1；以前称为反射性交感神经营养不良或RSD）是一种罕见且使人衰弱的疾病，通常在骨骼受到损伤或创伤后发生。目前尚无FDA批准的药物可用于治疗这一具有高度未满足需求的患者群体。该病的特点是受影响肢体（通常是手臂、腿、手或脚等末端部位）会出现剧烈且持续的疼痛。

Patients with CRPS-1 experience an evolving condition commencing with a 'warm' phase lasting approximately six to twelve months after an initial injury where inflammation causes the affected limb to become red, swollen, warm, and painful to a chronic 'cold' phase, where the affected limb changes its presentation but still faces ongoing, debilitating pain..

复杂性局部疼痛综合征1型（CRPS-1）患者的病情会经历一个演变过程，初始阶段为“热相”，通常在初次受伤后持续大约六至十二个月，此时炎症导致患肢发红、肿胀、发热并伴有疼痛；随后进入慢性“冷相”，患肢的表现虽有所改变，但仍面临持续且令人虚弱的疼痛。

About Ambros Therapeutics

关于Ambros Therapeutics

Ambros Therapeutics, headquartered in Irvine, California, is a clinical-stage biotechnology company focused on the development of innovative and transformative medicines for diseases with high unmet medical need. Ambros' lead investigational program targets Complex Regional Pain Syndrome Type 1 (CRPS-1).

总部位于加利福尼亚州欧文市的Ambros Therapeutics是一家临床阶段的生物技术公司，专注于为存在高度未满足医疗需求的疾病开发创新性和变革性药物。Ambros的主要研究项目针对复杂区域疼痛综合征1型（CRPS-1）。

The Phase 3 pivotal trial (CRPS-RISE) is on track to initiate enrollment in the first quarter of 2026 and represents a potential first-in-class approach to addressing a disease with no FDA-approved medicines..

第三阶段关键试验（CRPS-RISE）有望在2026年第一季度开始招募患者，代表了一种潜在的首创方法来应对一种尚无FDA批准药物的疾病。

About Abiogen Pharma S.p.A.

关于阿比奥根制药股份公司

Abiogen Pharma is headquartered in Pisa, Italy. Since 1997, its business has spanned across several integrated areas: research and development, manufacturing of pharmaceuticals with its own brand or under third-party contracts, and marketing of own and licensed drugs. Its target therapeutic areas include bone metabolism, pain treatment, as well as respiratory, metabolic (diabetes) and dermatological disorders.

Abiogen Pharma总部位于意大利比萨。自1997年以来，其业务跨越多个综合领域：自主研发和生产自有品牌或第三方合同的药品，并营销自有和授权药物。其目标治疗领域包括骨骼代谢、疼痛治疗以及呼吸系统、代谢（糖尿病）和皮肤病相关疾病。

In 2022, Abiogen Pharma started the internationalization process covering Germany and Switzerland to date. With approximately 168 million euros in revenue (2023) and approximately 460 employees, it ranks among the 15 largest Italian pharmaceutical companies..

2022年，Abiogen Pharma启动了国际化进程，至今已覆盖德国和瑞士。公司2023年营收约为1.68亿欧元，员工约460人，位列意大利前15大制药公司之列。

Contact:

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Company Contact

公司联系人

Danielle Spangler

丹妮尔·斯潘格勒

917-924-6752

917-924-6752

investors@ambrostx.com

投资者@安布罗斯TX. com

Media Contact:

媒体联系人：

David Schull

大卫·舒尔

Russo Partners

鲁索合伙人

646-942-5588

646-942-5588

david.schull@russopartnersllc.com

大卫·舒尔@鲁索合伙公司.com