Beren Therapeutics Secures $300M Financing to Support the Potential Commercial Launch of Adrabetadex and Long-Term Care Initiatives for Infantile-Onset Niemann-Pick Disease, Type C

-- $135 million equity financing with participation from leading specialist investors, corporate investors, and long-term growth partners, including Wellington Partners, JIC Venture Growth Investments (JIC VGI), Founders Fund, Narya Capital, Eisai Co., Ltd., and other select institutional investors
-- Up to $165 million in flexible, non-dilutive capital, including $110 million senior-secured debt facility and $55 million of royalty financing with Hercules Capital, Inc.
-- Financing will support investments in commercial readiness activities for adrabetadex ahead of its November 17, 2026, Prescription Drug User Fee Act (PDUFA) target action date. This will include the development of a long-term patient access and family support program designed to reduce the burden for those living with infantile-onset Niemann-Pick disease, type C (I-NPC) throughout their treatment journey.
-- This transaction positions Beren to become financially self-sustaining through the potential commercialization of adrabetadex, while providing the flexibility to invest in long-term growth initiatives

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Beren Therapeutics P.B.C., the parent company of Mandos LLC and a leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, today announced it has secured $300 million in combined financing.

The financing includes a $135 million equity financing alongside up to $165 million in a strategic financing facility with Hercules Capital, Inc. (NYSE: HTGC) across a senior secured debt and royalty structure. Capital will support Beren’s growth strategies, including the potential U.S. commercial launch for adrabetadex to treat I-NPC and investments in patient access infrastructure and family support resources.

“I-NPC reshapes family life. Families have consistently told us that their burden extends far beyond the availability of therapies, and that there remains a substantial unmet need for long-term support as families navigate diagnosis, treatment decisions, specialist care, reimbursement, and changing needs over a multi-decade journey with this disease,” said Jason Camm, Founder and Chief Executive Officer at Beren. “Our vision is not only to develop new treatment options, but also to help address the broader challenges families face throughout their journey. We are pleased to be joined by a world-class group of investors who share that vision and our conviction in what may now be possible for this community.”

I-NPC is the most severe, rapidly progressive form of NPC, a rare, always fatal, pediatric neurodegenerative disease characterized by impaired intracellular cholesterol trafficking. If approved, adrabetadex would represent a first-in-class, disease-modifying treatment for I-NPC and be the only therapy approved to directly act on the accumulated intracellular cholesterol that drives the disease. The U.S. Food and Drug Administration (FDA) accepted Beren’s New Drug Application for the investigational therapy, adrabetadex, which is under Priority Review with a PDUFA target action date of November 17, 2026.

Use of proceeds

Financing proceeds will support a comprehensive set of programs in anticipation of a potential approval and launch of adrabetadex that best provides access and meaningful support to the NPC community, including:

• Accelerating diagnosis to support early intervention
• Providing a single point of contact for families
• Ensuring local access to sites of care
• Generating longitudinal real-world evidence and shared learning
• Strengthening peer-to-peer learning and community connectivity

“Infantile-onset NPC is a disease that takes children from their families faster than almost any parent can comprehend. For decades, families in our community have lived with the day-to-day complexity of caring for a child with a progressive neurodegenerative disease – coordinating across specialists, navigating insurance, and managing care that touches every part of family life,” noted Garland Alvey, Executive Director and Founder of ‘AbbyStrong Fights NPC,’ Board Member of the National Niemann-Pick Disease Foundation, and Trustee of the International Niemann-Pick Disease Registry. “Continued commitment from companies and investors to advance new therapies and to build the support systems families actually need is what gives our community reason to believe the path forward keeps getting better.”

Financial transactions

The $135 million equity financing brought together a concentrated group of specialist healthcare investors, long-term growth partners, and strategic investors, including Wellington Partners, JIC Venture Growth Investments (JIC VGI), Founders Fund, Narya Capital, Eisai Co., Ltd., and other select institutional investors. The financing supports Beren’s long-term global strategy, including preparations for the potential commercial launch of adrabetadex and continued investment in patient access, family support, and care infrastructure for the infantile-onset NPC community.

Concurrent with the equity financing, Beren entered a $165 million non-dilutive financing agreement with Hercules Capital, Inc. to provide the company greater financial flexibility at a lower blended cost of capital, comprised of:

• Up to $110 million in term loans based on regulatory and revenue milestones, of which $30 million is currently drawn
• A $55 million royalty financing to be funded upon FDA approval of adrabetadex. The royalty financing carries a 7.5% royalty on U.S. net sales and a 5% royalty on net sales outside the U.S. of adrabetadex, up to a 1.75x cap through 2031 and with the ability to redeem at a lower multiple in the first two years

“Hercules is proud to partner with Beren as they prepare for the potential launch of adrabetadex for children with infantile-onset NPC. Jason and the Beren team have built a company with deep conviction in the science and a clear-eyed plan to ensure this therapy reaches all families who need it. We are pleased to provide the capital to support that work, and Beren’s continued evolution over the coming years,” said Cristy Barnes, Managing Director at Hercules Capital.

Morgan Stanley & Co. LLC acted as sole structuring agent on the transactions. Wilson Sonsini Goodrich & Rosati served as legal advisor to Beren, and Latham & Watkins advised Hercules.

About Infantile-Onset Niemann-Pick Disease, Type C

Niemann-Pick disease, type C (NPC) is a rare, autosomal-recessive, severe, heterogeneous, neurodegenerative disorder caused by pathogenic variants in the NPC1 (~95% of cases) or NPC2 genes, leading to impaired intracellular cholesterol trafficking resulting in progressive neurological decline and premature mortality. Infantile-onset NPC (I-NPC) refers to NPC in infants and children who first experience neurological symptoms <6 years of age. Earlier neurological onset is associated with more rapid progression and poorer prognosis, with mean ages of death of ~5.6 years for early infantile-onset (age of neurological onset <2 years) and ~13.4 years for late-infantile onset (2 to <6 years).

About Adrabetadex

Adrabetadex is a proprietary mixture of 2-hydroxypropyl-β-cyclodextrin isomers under investigation as a treatment for Niemann-Pick disease, type C (NPC). The data suggest that by re-establishing intracellular cholesterol trafficking, adrabetadex is designed to directly address the underlying pathology of NPC. Data from clinical trials and expanded access programs suggest that adrabetadex is generally well tolerated. The main adverse events associated with adrabetadex include hearing impairment that can be managed with hearing aids when necessary, and post-dose fatigue and/or ataxia.

The U.S. Food and Drug Administration (FDA) granted adrabetadex Breakthrough Therapy Designation. In February 2026, the FDA accepted Beren Therapeutics’ New Drug Application (NDA) for adrabetadex in infantile-onset NPC for Priority Review. The agency assigned the NDA a Prescription Drug User Fee Act target action date of November 17, 2026. Adrabetadex has not been approved by the FDA or any other health authority at this time.

About Beren Therapeutics P.B.C.

Beren Therapeutics P.B.C. is a founder-led biotechnology company pioneering the discovery, development, and commercialization of cyclodextrin-based therapeutics for conditions characterized by defective cholesterol trafficking. Beren’s first program, adrabetadex, is under U.S. Food and Drug Administration review with a Prescription Drug User Fee Act target action date of November 17, 2026, for the treatment of infantile-onset Niemann-Pick disease, type C (I-NPC). Beren and its subsidiary Mandos LLC have supported the NPC community since 2021 through an Expanded Access Program and are preparing for the U.S. commercial launch of adrabetadex, if approved, with a comprehensive set of patient access and family support programs.

Beren’s public benefit purpose is to discover, develop, and deliver novel therapies that provide optimal benefit for patients, and to do so by integrating the needs of patients, caregivers, clinicians, and health systems from the beginning of the development process and maintaining a long-term focus on delivering meaningful therapies and access.

Beren is headquartered in Thousand Oaks, Calif. To learn more about Beren, the adrabetadex program, and Beren’s cholesterol-trafficking focused therapeutic strategy, visit the company’s website at: https://www.BerenTx.com/ or follow Beren on LinkedIn.

About Hercules Capital

Hercules Capital, Inc. (NYSE: HTGC) is the leading and largest specialty finance company focused on providing senior secured venture growth loans to high-growth, innovative venture capital-backed companies in a broad variety of technology and life sciences industries. Since inception (December 2003), Hercules has committed more than $27 billion to over 700 companies and is the lender of choice for entrepreneurs and venture capital firms seeking growth capital financing. To learn more, visit htgc.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the U.S. Food and Drug Administration’s review of the New Drug Application for adrabetadex; the timing and outcome of regulatory review; the potential for adrabetadex to provide clinical benefit or to address the underlying pathology of Niemann-Pick disease, type C; the potential for approval or commercialization; the ability to continue providing access through expanded access; and Beren’s plans to expand its pipeline. Actual results may differ materially due to risks and uncertainties including those associated with clinical development, regulatory review, manufacturing, safety and efficacy outcomes, and other factors.