Full Press Release Details
Capricor Therapeutics Reports Third Quarter
2020 Financial Results and Provides Corporate Update
Exosome Platform Technology
-Announced Positive Preclinical Data
for Multivalent Exosome-mRNA Vaccine For COVID-19-
-Novel Vaccine Induced Long-Lasting
Immunity to Multiple SARS-CoV-2 Proteins-
-Development of Safe, Non-toxic
Exosome Formulation Capable of Delivering Functional mRNA in vitro and in vivo-
-Platform Expansion Underway
Using Engineered Exosomes-
Duchenne Muscular Dystrophy Program
-In Discussions with FDA on
Next Steps in Pathway Forward-
CAP-1002 for COVID-19
-Patient Screening Underway in Randomized,
Double-Blind, Placebo-Controlled INSPIRE Study-
-To Host Conference Call and Webcast Today at 4:30 p.m. ET-
LOS ANGELES, CALIF., Nov. 12, 2020
- Capricor Therapeutics, Inc. (NASDAQ: CAPR), 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 a
variety of diseases and disorders, announced today its financial results for the third quarter ending September 30, 2020 and provided
"The Company's development
and achievements in the third quarter have been encouraging on multiple levels. We have continued to build momentum with our exosome
platform technology as well as with our CAP-1002 program. The pandemic has provided a unique opportunity for the development of
a vaccine candidate but also for the use of CAP-1002 as a potential therapeutic," said Linda Marb n, Ph.D., Capricor's
president and chief executive officer.
"We are advancing two separate
and novel vaccine programs. Our strategy has evolved from our original plan to use exosomes from our cell as drug delivery
vehicles to creating exosomes from multiple cell types that are readily available to build products that can be designed to
address targets where delivery has proved to be challenging. We are now leveraging thought leaders and our own expertise to
direct the development of exosome-based vaccines and exosome-based therapeutics. We expect significant pipeline expansion and
will be seeking partnering opportunities in the months ahead to further cement our rebranding. I have never been more excited
at the possibilities for Capricor," Dr. Marb n added.
The Company continues the development of
our late-stage clinical asset, CAP-1002, for the treatment of advanced stages of DMD, and is currently in discussions with potential
partners for this program. The FDA has continued to encourage us to conduct a Phase III study, however at this time, Capricor continues
to work with FDA to explore alternative pathways forward.
Capricor is currently screening patients
for its INSPIRE Phase II study, which is designed to assess the ability of CAP-1002 to modulate the cytokine storm and attenuate
the sequelae associated with severe COVID-19. While other therapeutics are in testing for early and much later stage COVID-19,
there are very few options for those with severe disease at risk for ventilation. Based on our preclinical data, as well as the
data from our emergency use authorization program, CAP-1002 is poised to potentially be an important tool in the toolbox to treat
"We are pleased to deliver an update
of those accomplishments today focused on our engineered exosome platform, DMD and COVID-19 programs and our anticipated milestones,"
Third Quarter Highlights and Recent
Engineered Exosomes Platform
Duchenne Muscular Dystrophy Program
CAP-1002 for COVID-19
Anticipated Events and Targeted Milestones
Third Quarter Financial Results
The Company reported a net loss of approximately
$3.9 million, or $0.20 per share, for the third quarter of 2020, compared to a net loss of approximately $1.6 million, or $0.43
per share, for the third quarter of 2019.
As of September 30, 2020, the Company's cash, cash equivalents
and marketable securities totaled approximately $35.3 million, compared to approximately $9.9 million on December 31, 2019. Additionally,
in the third quarter of 2020, Capricor raised approximately $2.0 million in net proceeds at an average price of approximately $5.87
per share under its at-the-market offering program.
Conference Call and Webcast Details
To participate in the conference call, please dial 877-451-6152
(Domestic/Toll-Free) or 201-389-0879 (International) and reference the conference ID: 13712434
To participate via a webcast, please visit: http://public.viavid.com/index.php?id=142179
The webcast will be archived for approximately 30 days and
will be available at: http://capricor.com/news/events/.
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 the cytokine storm
associated with 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.
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:
Caitlin Kasunich / Raquel Cona
KCSA Strategic Communications
212.896.1241 / 212.896.1204
LifeSci Advisors, LLC