• First-in-human trial of Capricor’s StealthX™ vaccine initiated under HHS’s Project NextGen
  • Trial conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID)

SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the first subjects have been dosed in a Phase 1 clinical trial evaluating its StealthX™ exosome-based vaccine. The study, funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) under the U.S. Department of Health and Human Services’ Project NextGen, follows review and clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). The trial is being conducted by an NIAID-funded network of clinical trial sites.

“The initiation of this study marks an important milestone in vaccine development as StealthX™ potentially offers an alternative to mRNA vaccines as this platform contains no adjuvants, offers a more natural delivery system, and uses native proteins, allowing for rapid adaptability to emerging targets,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “We are proud to collaborate with the NIH on this important trial, enabling us to evaluate the clinical profile of StealthX™ in humans for the first time. While the study is initially focused on SARS-CoV-2, our broader vision is to position StealthX™ as a versatile exosome-based platform with potential across a range of therapeutic areas, including rare diseases and other conditions requiring targeted payload delivery. With first-in-human dosing achieved, this trial advances the platform clinically while also potentially laying the groundwork for strategic partnerships, pipeline expansion and long-term value creation. The NIAID expects initial data from the study in the first quarter of 2026, and we look forward to sharing additional details as they become available. In parallel, we recently held a constructive Type A meeting with FDA on our Deramiocel program for DMD and will provide updates when written feedback is available as we continue working collaboratively to shape the next steps in the program.”

Project NextGen is a federal initiative aimed at accelerating the development of next-generation vaccine platforms that provide broader and more durable protection against respiratory viruses and other infectious threats. Capricor’s vaccine is among several candidates selected for evaluation through this NIAID-sponsored program. The Phase 1 trial includes four dosing arms and is initially focused on the spike (S) protein of SARS-CoV-2. An additional arm of Capricor’s StealthX™ multivalent vaccine incorporating the nucleocapsid (N) protein is planned, pending separate FDA clearance.

For more information, please visit clinicaltrials.gov .

About Capricor’s StealthX™ Vaccine

The StealthX™ vaccine is a proprietary exosome-based platform developed internally by Capricor, using exosomes engineered to display either the spike or nucleocapsid proteins on their surface. Preclinical results published in Microbiology Spectrum demonstrated that StealthX™ elicited robust antibody production, potent neutralizing activity, a strong T-cell response and a favorable safety profile. Exosomes represent a novel antigen delivery system with potential to enable the rapid development of multivalent, protein-based vaccines. Exosomes, originally identified as extracellular vesicles, are nano-sized particles enriched with select proteins, RNAs, and lipids that play a key role in cell-to-cell communication.

About Capricor Therapeutics

Capricor Therapeutics (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, Deramiocel, an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown Deramiocel to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. Deramiocel is currently in late-stage development for the treatment of Duchenne Muscular Dystrophy. Capricor is also harnessing the power of its exosome technology, using its proprietary StealthX™ platform in preclinical development focused on the areas of vaccinology, targeted delivery of oligonucleotides, proteins and small molecule therapeutics with potential to 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 .

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; statements about our financial outlook; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval; the ability to achieve product milestones and to receive milestone payments from commercial partners; plans regarding current and future collaborative activities and the ownership of commercial rights; potential future agreements; scope, duration, validity and enforceability of intellectual property rights; future revenue streams and projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 26, 2025, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the Securities and Exchange Commission on August 11, 2025. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Capricor has entered into an agreement for the exclusive commercialization and distribution of Deramiocel for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:
Raquel Cona
KCSA Strategic Communications
[email protected]
212.896.1204

Capricor Company Contact:
AJ Bergmann, Chief Financial Officer
[email protected]
858.727.1755