Capricor Announces Peer-Reviewed Publication Demonstrating the Therapeutic Potential of Exosome-Based Multivalent Vaccine Developed from its StealthX™ Platform

-Capricor’s StealthX™ Exosome Platform Designed to Support the Advancement of Next Generation Vaccines and Therapeutics-

SAN DIEGO, Calif., April 27, 2023 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today the publication of a preclinical study in Microbiology Spectrum,  a leading peer-reviewed scientific journal of the American Society for Microbiology, highlighting the therapeutic potential of its StealthX™ exosome platform technology to develop a multivalent vaccine against the spike and nucleocapsid SARS-CoV-2 proteins.

“Exosomes offer a new approach to drug delivery with this study showing the potential to rapidly generate multivalent protein-based vaccines,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “We are encouraged by the growing dataset that continues to support the therapeutic potential of our StealthX™ platform. The data from this study suggests that StealthX™ could potentially deliver a more potent vaccine with broader immunity by combining the advantages of both mRNA and recombinant protein vaccines into a potentially superior, rapidly generated, low-dose vaccine. A growing body of literature suggests antibody response against spike surface proteins provide immune protection, while nucleocapsid adds an additional line of defense, which could be clinically meaningful for highly mutating viruses, such as SARS-CoV-2. We look forward to exploring the potential therapeutic utility of these vaccine candidates, and more broadly, expanding our pipeline and partnership opportunities with this platform.”

In this study, exosomes were engineered to express either SARS-CoV-2 spike (StealthX™-spike, STX-S) or nucleocapsid (StealthX™-nucleocapsid, STX-N) proteins on the surface. When administered individually, both STX-S and STX-N induced a potent humoral and cellular immune response. These effects were obtained with administration of only nanogram amounts of protein and without adjuvant or synthetic lipid nanoparticles (LNPs). Importantly, preclinical results from murine and rabbit models suggest the combination, STX-S+N, as a single shot, resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile. These peer-reviewed results which were previously published online on bioRxiv established the prospect of rapidly combining multiple targets in one vaccine and supports exosomes as a suitable delivery vehicle for a variety of therapeutic cargo.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy that is currently in late-stage clinical development for treating Duchenne muscular dystrophy. Capricor is also developing its exosome technology as a next-generation therapeutic platform. Capricor’s focus is on developing exosomes capable of delivering nucleic acids, including mRNA, as well as proteins to treat or prevent a variety of diseases. 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; 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; scope, duration, validity and enforceability of intellectual property rights; future royalty streams and revenue 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, 2022, as filed with the Securities and Exchange Commission on March 17, 2023. 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.

CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.

For more information, please contact:

Capricor Media Contact:
Raquel Cona
KCSA Strategic Communications
rcona@kcsa.com
212.896.1204

Capricor Investor Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
617.435.6602

Capricor Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
310.358.3200