Capricor Therapeutics Awarded $2.4 Million from U.S. Department of Defense to Support Manufacturing Process Development for Therapeutic Exosomes

LOS ANGELES, Sept. 26, 2016 /PRNewswire/ -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a clinical-stage biotechnology company developing biological therapies for cardiac and other serious medical conditions, today announced that the U.S. Department of Defense (DoD) has awarded the company a grant¹ in the amount of approximately $2.4 million to be used toward establishing a scalable, commercially-ready process to manufacture CAP-2003 (Cardiosphere-Derived Cell Exosomes). Capricor has identified ocular graft-versus-host disease (oGVHD) as the first clinical development opportunity for CAP-2003, and expects to submit an IND for this indication in the first half of 2017.

CAP-2003 represents exosomes isolated from the company's proprietary cardiosphere-derived cells (CDCs), which are currently in clinical evaluation by Capricor for the treatment of several cardiac conditions, including that associated with Duchenne muscular dystrophy (DMD).

"As we advance and expand our exosomes program, this grant from the DoD will support our objective of achieving a commercial manufacturing process for a candidate which we believe has broad treatment potential," said Linda Marbán, Ph.D., president and chief executive officer of Capricor. "Studies of CAP-2003 in multiple models in which inflammation, scarring, and cell death are intrinsic to the disease process suggest that CAP-2003 possesses potent regenerative capabilities. As a cell-free material, CAP-2003 can be handled and stored in similar fashion to a traditional biopharmaceutical, and may be better suited than cell-based therapeutics for certain applications. The activity CAP-2003 has shown in models of eye injury supports our enthusiasm to enter it into the clinic for ocular graft-versus-host disease next year."

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of biological therapies for the treatment of cardiac and other serious medical conditions. Capricor's lead candidate, CAP-1002, is a cardiac cell therapy that is currently being evaluated for the treatment of heart disease associated with Duchenne muscular dystrophy and myocardial infarction (heart attack). Capricor is advancing its proprietary exosome product candidate, CAP-2003, for the treatment of ophthalmic disorders and is exploring other therapeutic areas. Capricor's portfolio also features Cenderitide, a dual natriuretic peptide receptor agonist, which may have application for the outpatient treatment of advanced heart failure and other potential indications.

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; 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, expectations with respect to the expected use of proceeds from the recently completed offering 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 are set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission on March 30, 2016, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, and in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, as filed with the Securities and Exchange Commission on August 15, 2016. 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 and Cenderitide are Investigational New Drugs and are not approved for any indications. Capricor's exosomes technology has not yet been investigated in any clinical trial.

¹United States Army Medical Research Acquisition Activity (USAMRAA); Contract# W81XWH-16-1-0712; Developing a Manufacturing Process for Therapeutic Exosomes

For more information, please contact:

Corporate
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance
+1-310-358-3200
abergmann@capricor.com

Investor Relations
Argot Partners
Kimberly Minarovich
+1-212-600-1902
kimberly@argotpartners.com

Media
Argot Partners
Eliza Schleifstein
+1-917-763-8106
eliza@argotpartners.com

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SOURCE Capricor Therapeutics, Inc.