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
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-- Financing will support investments in commercial readiness activities for adrabetadex ahead of its
-- 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
The financing includes a
“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
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
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
Financial transactions
The
Concurrent with the equity financing, Beren entered a
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Up to
$110 million in term loans based on regulatory and revenue milestones, of which$30 million is currently drawn -
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$55 million royalty financing to be funded upon FDA approval of adrabetadex. The royalty financing carries a 7.5% royalty onU.S . net sales and a 5% royalty on net sales outside theU.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
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
About
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
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.
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Media Contact
Beren Therapeutics Media Relations
media@berentx.com
Source: Beren Therapeutics P.B.C.