Capricor Therapeutics Announces Manufacturing Scale-Up of CAP-1002 Production at New San Diego Facility as it Continues Plans Toward Commercialization

-Cohort B of HOPE-3, Phase 3 Clinical Trial Expected to Complete Enrollment in Second Quarter 2024-

SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today the scale-up to expand manufacturing capacity of CAP-1002 to its new state-of-the-art manufacturing facility, intended for commercial use, subject to regulatory approval, located in San Diego. Furthermore, the Company announced that Cohort B of its HOPE-3, Phase 3 clinical study is enrolling rapidly and is expected to complete full enrollment (n=44) in the second quarter of 2024.

“We are extremely pleased with the progress of our manufacturing scale-up efforts in connection with our new San Diego facility which brings us one step closer towards a successful launch of CAP-1002, should we obtain approval, to meet the significant unmet need in this broad and underserved patient population. This facility was designed to be a versatile and cost-effective way to bring CAP-1002 to market efficiently and it is expected that our enhanced manufacturing capacity to increase our supply capabilities and improve our margins,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Furthermore, with Cohort A of the HOPE-3 trial being fully enrolled and topline data readout expected in the fourth quarter of 2024, we plan to meet with the U.S. Food & Drug Administration (FDA) with the aim to discuss possible expedited pathways to approval.”

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, CAP-1002 — an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown CAP-1002 to demonstrate immunomodulatory, antifibrotic, and regenerative actions specifically tailored for dystrophinopathies and heart disease. CAP-1002 is currently advancing through Phase 3 clinical development for the treatment of Duchenne muscular dystrophy (DMD). Capricor is also harnessing the power of our exosome technology, using our proprietary StealthX platform which is focused on the areas of vaccinology, targeted delivery of oligonucleotides, proteins and small molecule therapeutics to potentially treat and prevent a diverse array of diseases. At Capricor, we stand committed to pushing the boundaries of possibility and forging a path toward transformative treatments for those in need. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and Twitter.