– Financing led by Ally Bridge Group, with participation from SOLVE FSHD, a venture philanthropy organization

– Lead program, EPI-321, is the first clinical application of epigenetic modulation in neuromuscular diseases, with a first-in-human trial in New Zealand to commence in 2025 as part of a broader global clinical strategy

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Epicrispr Biotechnologies, a biotechnology company focused on developing curative therapies, today announced it has secured $68 million in the first close of its Series B financing. The proceeds will support the clinical development of EPI-321, a first-in-class, disease-modifying therapy for facioscapulohumeral muscular dystrophy (FSHD), a genetic neuromuscular disease.

The Series B financing was led by Ally Bridge Group, with participation from SOLVE FSHD, the venture philanthropy organization founded by Chip Wilson, founder of Lululemon Athletica and FSHD patient, along with other new and existing investors. The financing will support Epicrispr’s upcoming clinical trial of EPI-321, as well as continued advancement of the company’s broader pipeline.

Epicrispr also announced clinical trial application (CTA) approval from New Zealand’s Medsafe to initiate a first-in-human trial of EPI-321, the first epigenetic therapy to enter the clinic for a neuromuscular disease. The study is expected to begin in 2025, and will evaluate the safety, tolerability, pharmacodynamics, and biological activity of a single intravenous dose of EPI-321 in adults with FSHD.

“FSHD is one of the most common adult muscular dystrophies, with estimates of up to 1 million patients affected worldwide. But patients have no disease-modifying therapy for this progressive disease,” said Dr. Richard Roxburgh, Associate Professor of Medicine at the University of Auckland and principal investigator for the EPI-321 clinical trial, which is planned to be conducted in partnership with Pacific Clinical Research Network, a leading clinical research center in New Zealand. “We look forward to advancing this clinical trial which could, with a single treatment, permanently address the disease’s underlying cause, and are hopeful that it will pave the way for new standards for therapies in genetic diseases.”

EPI-321 is an investigational one-time gene-modulating therapy designed to silence aberrant expression of DUX4, a gene that is incorrectly activated in FSHD and leads to progressive muscle degeneration. Delivered systemically via a clinically validated AAV vector, EPI-321 has demonstrated robust suppression of DUX4 expression and protection of muscle tissue in preclinical models. EPI-321 has received FDA Fast Track, Rare Pediatric Disease, and Orphan Drug designations.

“We are developing a first-in-class, one-time epigenetic therapy that targets the genetic root cause of FSHD,” said Amber Salzman, Ph.D., CEO, Epicrispr Biotechnologies. “The Series B financing and regulatory clearance to begin our first-in-human trial marks a pivotal milestone as we become a clinical-stage company. With a strong investor syndicate and recent FDA designations recognizing EPI-321’s potential, our team is laser-focused on advancing EPI-321 into the clinic to provide a much-needed therapy to patients and families in desperate need.”

“With a robust body of data validating the potential of EPI-321 and the GEMS platform broadly, Epicrispr has shown itself to be a leading epigenetic editing company,” said Andrew Lam, Pharm.D., Managing Director, Head of Biotech Private Equity, Ally Bridge Group. “We are proud to lead this investment in Epicrispr’s future, and we look forward to partnering with their leadership to support their continued success.”

“As someone living with FSHD, I know the devastating impact of this disease and the urgent need for treatments that target its root cause,” said Chip Wilson, founder and Chairman of SOLVE FSHD. “We commend Epicrispr’s commitment in advancing EPI-321 for FSHD and are glad to be part of this financing to support its transition to the clinic.”

Concurrent with the funding, Epicrispr has expanded its Board of Directors with the addition of Andrew Lam, Pharm.D., of Ally Bridge Group, Eric Crombez, M.D., Chief Medical Officer of Ultragenyx, and Jennifer King, Ph.D., former SVP of Business Development at Intellia Therapeutics and an expert in rare diseases and strategic partnerships.

About EPI-321

EPI-321 is an investigational epigenetic therapy that aims to address the underlying molecular mechanisms of FSHD with a one-time dose. It has been granted FDA Fast Track, Rare Pediatric Disease, and Orphan Drug designations. Following intravenous administration, EPI-321 is directed to muscle tissue within a single AAV vector, which has been clinically validated for muscle delivery. Preclinical studies on EPI-321 have demonstrated its ability to robustly suppress pathological expression of the DUX4 gene and reduce muscle cell death. A first-in-human clinical trial of EPI-321 is planned for 2025.

About Epicrispr Biotechnologies

Epicrispr Biotechnologies is a biotechnology company pioneering gene-modulating therapies, leading with treatments for neuromuscular diseases. The company’s proprietary Gene Expression Modulation System (GEMS) enables precise, durable control of gene expression, unlocking first-in-class treatments for previously untreatable conditions. Epicrispr’s lead program, EPI-321 is in clinical trials for FSHD, and the company is advancing additional gene-modulating therapies. Epicrispr also has a research collaboration with Kite Pharma to develop next-generation CAR T-cell therapies. Learn more at www.epicrispr.com or follow us on LinkedIn.

About Ally Bridge Group

Ally Bridge Group is a global healthcare investment firm focused on private and public high-impact life science innovation. Founded in 2013 by Frank Yu, the firm has led or co-led over $6 billion in healthcare transactions. The firm’s mission is to generate superior risk-adjusted returns for investors guided by the core principle of selective investment in healthcare innovation that addresses unmet medical needs. Ally Bridge Group has offices in New York and Hong Kong. For more information, visit www.ally-bridge.com or follow us on LinkedIn.

Contacts

Investor Contact
Benson Cheng
benson.cheng@epic-bio.com

Media Contact
Kimberly Ha
KKH Advisors
917-291-5744
kimberly.ha@kkhadvisors.com

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