Full Press Release Details
Capricor Therapeutics Reports Second
Quarter 2020 Financial Results and Provides Corporate Update
Exosome Platform for COVID-19
-Novel Multivalent Exosome mRNA and VLP
Vaccine Candidates Underway in Animal Studies-
-Preclinical Data Shows Positive Antibody
CAP-1002 for COVID-19
-Expanded Access Emergency Use Series
Published in Peer Reviewed Journal-
-Randomized, Double-Blind, Placebo-Controlled,
Phase II IND Submitted to FDA-
-Plan to Initiate Study in Third Quarter,
Subject to FDA Approval-
Duchenne Muscular Dystrophy Program
Top-Line 12-month Results from HOPE-2 Study-
with FDA on Next Steps in Pathway Forward-
-To Host Conference Call and Webcast Today at 4:30 p.m. ET-
ANGELES, Calif. August 6, 2020 -- 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 its financial
results for the second quarter ending June 30, 2020 and provided a corporate update.
"We had a very successful first half
of 2020, marked by continued achievements in our expanding cell and exosome programs. We are now well underway in animal studies
and have seen promising results showing the mRNA vaccine is capable of generating an antibody response to multiple antigens expressed
by COVID-19. Two distinct vaccines are now in development, one using the exosomes as virus-like particles and the other using exosomes
loaded with viral protein mRNAs. We are moving forward as quickly as possible with the goal of bringing a vaccine into the clinic."
"Additionally, we have submitted
a new investigational new drug application (IND) to the FDA for a randomized, placebo-controlled, double-blind, Phase II clinical
trial to treat up to 60 patients in severe or critical condition with COVID-19 with CAP-1002. Furthermore, we continue to discuss
next steps in our DMD program with the FDA" said Linda Marb n, Ph.D., Capricor's president and chief executive
Dr. Marb n continued, "We
are enthusiastic and encouraged to be engaged in the development of the next generation of potential vaccines using our proprietary
exosome platform. Exosomes are intercellular communicators and are uniquely suited and have the potential to change how we treat,
immunomodulate, and mediate serious life-threatening illnesses, correct genetic disorders, engineer vaccines to prevent diseases,
and modify enzymes. A key advantage of exosomes beyond the ability to modify cells is the ability to deliver therapeutic payloads,
without degradation into specific locations."
Capricor remains diligently focused on
the treatment of DMD using CAP-1002. The FDA has continued to encourage us to conduct a Phase III study, however at this time,
we are still discussing the pathway forward for this program with the FDA. Once the regulatory pathway is finalized we expect to
expand our efforts to seek partnerships for this program. We also recently participated in the Parent Project Muscular Dystrophy
(PPMD) Virtual Annual Conference to help better inform families and caregivers around the treatment of DMD.
"We are proud to deliver an update
of those accomplishments today focused on our exosome platform, COVID-19 and DMD programs and our anticipated milestones in 2020,"
Second Quarter Highlights and Recent
Exosome Platform for COVID-19
CAP-1002 for COVID-19
Duchenne Muscular Dystrophy Program
Featured Panelist Spotlight
and Targeted Milestones for Second Half of 2020
Second Quarter Financial Results
The Company reported a net loss of approximately
$3.5 million, or $0.23 per share, for the second quarter of 2020, compared to a net loss of approximately $2.0 million, or $0.59
per share, for the second quarter of 2019.
As of June 30, 2020, the Company's
cash, cash equivalents and marketable securities totaled approximately $36.3 million, compared to approximately $13.2 million on
During the first half of 2020, Capricor
has raised approximately $29.4 million in net proceeds from the sale of common stock and exercise of common warrants comprised
of approximately $19.5 million in net proceeds at an average price of approximately $6.59 per share under its at-the-market offering
program and approximately $9.9 million from the exercise of common warrants.
Conference Call and Webcast Details
To participate in the conference call,
please dial 800-909-4164 (Domestic/Toll-Free) or
303-223-0117 (International) and reference the conference ID: 21967167
To participate via a webcast and view the slides,
please visit: http://public.viavid.com/index.php?id=141092.
The webcast will be archived for approximately
30 days and will be available at:
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. For more information, visit www.capricor.com and
follow the Company on Facebook, Instagram and Twitter.
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 March 31, 2020 as filed with the Securities and Exchange Commission
on May 15, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the