Recent Updates
Recently added Catalysts
CAPR

New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002 -U.S. FDA Approves Company's Expanded Access Protocol to Treat Additional Patients

Key Takeaway: New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002 -U.S. FDA Approves Company's Expanded Access Protocol to Treat Additional Patients- ANGELES, Calif. April 29, 2020 -- Capricor Therapeutics ("Capricor") (NASDAQ: CAPR) a clini

Full Press Release Details

New Capricor Data Reports 100 Percent
Survival in Critical COVID-19
Patients Treated with CAP-1002
-U.S. FDA Approves Company's Expanded
Access Protocol to Treat Additional Patients-
ANGELES, Calif. April 29, 2020 -- Capricor Therapeutics ("Capricor") (NASDAQ: CAPR)
a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment and
prevention of diseases, announced today new data reporting 100 percent survival in critical COVID-19 patients who were treated
with Capricor's lead asset, off-the-shelf ("allogeneic") cardiac cell therapy CAP-1002, at Cedars-Sinai Medical
Center as part of six compassionate care cases.
Over the course of one month, six critically
ill COVID-19 patients, all suffering from acute respiratory distress syndrome (ARDS) and five of whom were on mechanical ventilatory
support, were safely treated with CAP-1002. Of the six patients treated, four of them have been discharged. Following a review
of the available data, the U.S. Food and Drug Administration (FDA) approved the Company's expanded access protocol to treat
up to 20 additional COVID-19 patients. There is also a randomized, placebo-controlled trial planned to treat patients with moderate
and severe disease which is intended to be funded by non-equity capital.
In the compassionate care cases, five male
patients and one female patient (between ages 19 and 75) suffering from COVID-19 received IV infusions of 150 million allogeneic
cardiosphere-derived cells (CAP-1002). Of the five patients on ventilator support, four patients no longer required ventilator
support within just one to four days following the infusion. The fifth patient remains on mechanical ventilation and the sixth
patient is receiving supplemental oxygen and is currently clinically stable. Additionally, laboratory biomarkers correlated
with poor outcomes were measured in all patients. Following infusion, several patients showed improvements in biomarkers, such
as ferritin, absolute lymphocyte counts and CRP. No adverse events related to the administration of CAP-1002 were observed. This
data has been submitted for publication.
CAP-1002 demonstrates immunomodulatory
properties. 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 pneumonia, organ failure and death. Therefore, it can be the body's overreaction
to COVID-19, rather than the virus itself, that delivers the fatal blow.
"As the global medical community continues
to come together in its battle against COVID-19, the results of our initial compassionate care cases are extremely promising and
what we had anticipated. We look forward to continuing to treat additional patients under our recently approved expanded access
program Investigational New Drug application," said Dr. Linda Marb n, Ph.D., CEO, Capricor. "CAP-1002 is an
easy-to-deliver intravenous therapy that has been administered successfully to over 150 patients to date. Given its novel mechanism
of action, it could be a potential game-changer in helping countless COVID-19 patients."
Capricor is also in late-stage clinical
development of CAP-1002 for Duchenne muscular dystrophy (DMD). In DMD, the lack of dystrophin produces abnormal inflammatory responses,
which are responsible for much of the damage to skeletal and cardiac muscle. The Company has previously announced that top-line
results of HOPE-2, a randomized, placebo-controlled study, will be released by mid-May 2020.
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 biological
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. 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.
For more information, visit www.capricor.com and follow the Company on Facebook, Instagram and Twitter.
CAP-1002 consists of allogeneic "off-the-shelf"
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
150 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.
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:
KCSA Strategic Communications
LifeSci Advisors, LLC
AJ Bergmann, Chief Financial Officer
Last updated: Apr 29, 2020