Capricor Announces Publication Highlighting New Advances for its Engineered Exosome Platform

-StealthX™ Exosome Platform Shows Multivalent Vaccine Induces Long-Lasting Immunity to Multiple SARS-CoV-2 Proteins-

SAN DIEGO, Jan. 12, 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 highlighting new advances for its engineered exosome program. The data was published online in bioRxiv and explored the therapeutic potential of Capricor’s proprietary StealthX™ exosome platform, which generated two vaccine candidates (STX-S and STX-N), that independently, and in combination (STX-S+N) induced a strong immune response against two SARS-CoV-2 proteins, spike and nucleocapsid. Results showed that this multivalent, protein-based vaccine candidate has the potential to achieve potent, longer lasting immunization, broaden reactivity and improve T-cell response with only nanograms of protein without any adjuvant. The data from this study suggests that StealthX™ could deliver a more potent vaccine with broader immunity than is currently available, by combining the advantages of both mRNA and recombinant protein vaccines into a potentially superior, rapidly generated, low-dose vaccine.

“We are encouraged with the results of this study as it underscores the therapeutic utility of Capricor’s engineered exosome program and demonstrates StealthX™ has the potential to be used for vaccinology or protein replacement,” said Linda Marban, Ph.D., Capricor’s chief executive officer. “This data shows that exosomes may be used effectively to deliver viral proteins for immunization and induce persistent immune responses to multiple SARS-CoV-2 proteins at extremely low doses, allowing for development of exosome-based vaccines as well as therapeutics. More broadly, this data establishes StealthX™ as a vaccine platform with broad applications across infectious disease, as well as the prospect of combining multiple targets in one vaccine. Additionally, it supports exosomes as a suitable delivery vehicle for a variety of therapeutic cargo. We are looking forward to expanding our pipeline and our partnership opportunities with this platform.”

The current study used engineered exosomes to express either SARS-CoV-2 spike (StealthX-Spike, STX-S) or nucleocapsid (StealthX-Nucleocapsid, STX-N) protein on the exosome surface rapidly, a timeframe similar to mRNA vaccines. When administered as a single product, both STX-S and STX-N induced strong immunization with the production of a potent humoral and cellular immune response simultaneously. These effects were obtained with administration of only nanograms of protein without the use of any adjuvant or lipid nanoparticles which further supports the potential safety profile of this product candidate. The study also investigated the combination of STX-S and STX-N, namely STX-S+N, in two independent animal models. Administration of this multivalent, low dose protein-based vaccine resulted in increased, persistent antibody production, potent neutralizing antibodies with cross-reactivity to other variants of concern, and strong T-cell response. The results show efficacy of this multivalent protein-based vaccine for SARS-CoV-2 and suggests that other vaccines or therapeutics could be rapidly developed using the same StealthX™ platform.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) 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. The Company’s current 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 the Company 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; 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, 2021, as filed with the Securities and Exchange Commission on March 11, 2022 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 as filed with the Securities and Exchange Commission on November 10, 2022. 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