Capricor Therapeutics Announces U.S. FDA Acceptance of its IND Application for a Phase 2 Clinical Trial of CAP-1002 in Patients with COVID-19

– The INSPIRE Trial is a Randomized, Placebo-Controlled, Multi-Center Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 –

– The Study Leverages Capricor’s Lead Asset, CAP-1002 Technology –

LOS ANGELES, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics (“Capricor”) (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the development of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for a Phase 2 clinical trial of CAP-1002 in patients with COVID-19. The study will enroll patients who have a confirmed diagnosis of SARS-CoV-2 and require supplemental oxygen. Enrollment is expected to commence shortly.

The INSPIRE trial is a randomized, double-blind, placebo-controlled study that will enroll up to 60 patients from multiple, geographically diverse trial sites across the United States. Patient participation will be a maximum of 13 weeks from screening.

“We greatly appreciate the continued support and encouragement by the FDA as we advance our CAP-1002 program for treatment of COVID-19,” said Linda Marbán, Ph.D., Capricor’s president and chief executive officer. “Based on the data from the initial emergency use individual patient compassionate care cases, we see continued momentum and support for CAP-1002 for the treatment of COVID-19. It is important to remember that many patients are suffering from long term cardiac consequences from COVID-19. As CAP-1002 directly targets cardiac dysfunction, CAP-1002 potentially may also be an important tool in the treatment of the cardiac complications of COVID-19, which represents a patient population with an unmet medical need.”

The promise of CAP-1002 in COVID-19 is its immunomodulatory properties, which have been demonstrated in multiple clinical trials as well as in critically ill COVID-19 patients. Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of COVID-19’s later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing ARDS, multi-system organ failure and death.

“Our ability to leverage the CAP-1002 program to treat the early to mid-stages of the cytokine storm in COVID-19 patients may reduce the need for ventilatory support and may potentially not only save lives but also reduce long-term morbidity that can occur after severe respiratory compromise. We look forward to sharing further updates on this program as they become available,” added Dr. Marbán.

For further information regarding the CAP-1002 INSPIRE safety & efficacy trial, see www.clinicaltrials.gov.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. We are now developing two potential vaccines for COVID-19 as part of our exosome platform. For more information, visit www.capricor.com and follow the Company on Facebook, Instagram and Twitter.

About CAP-1002

CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity. It is being investigated for its potential to modify the immune system’s activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. CDCs have been the subject of over 100 peer-reviewed scientific publications and administered to approximately 200 human subjects across several clinical trials.

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; 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, 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, 2019 as filed with the Securities and Exchange Commission on March 27, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 as filed with the Securities and Exchange Commission on August 10, 2020. 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:

Media Contact:
Caitlin Kasunich
KCSA Strategic Communications
ckasunich@kcsa.com
212.896.1241

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

Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
310.358.3201

Released August 25, 2020