Full Press Release Details
Capricor Therapeutics Reports Fourth
Quarter and Full Year 2020 Financial Results and Provides Corporate Update
Exosomes Platform Technology
-Pre-IND Meeting with FDA this Quarter to
Discuss Multivalent Exosome-mRNA Vaccine-
-Pipeline Expansion Underway Using Engineered
Cell Therapy Program
-In Discussions with FDA on Pathway
to Approval for Duchenne Muscular Dystrophy-
-Phase II INSPIRE Top-Line Data
Expected in Third Quarter-
-To Host Conference Call and Webcast
Today at 4:30 p.m. ET-
LOS ANGELES, March 11, 2021 - Capricor
Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell- and exosome-based
therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today its financial results for the fourth
quarter and full year 2020 and provided a corporate update.
"2020 was a tremendously important
and meaningful year for Capricor marked by advances in our engineered exosome platform technology and continued progress in our
clinical-stage cell therapy programs for Duchenne muscular dystrophy and COVID-19," said Linda Marb n, Ph.D., Capricor's
president and chief executive officer. "Pivotal to the plan to initiate our engineered exosome platform technology was the
appointment of Dr. Stephen Gould as executive consultant to guide the development of this platform. In order to validate the technology,
we developed a multi-antigen vaccine for SARS-CoV-2 which led to several publications describing that our vaccine candidate can
induce long-lasting immune responses to multiple SARS-CoV-2 proteins, and potentially elicit a broad-based, cellular and humoral
immunity. We are now planning on moving this vaccine into the clinic in 2021, subject to regulatory approval."
"One of the reasons the exosomes
are potentially so useful and transformative is their ability to speak the language of a cell. We believe that exosomes loaded
with biologic payloads will be important in the development of new therapeutics and vaccines, added Dr. Marb n. "Capricor,
in 2021, is focused on becoming a leading exosome-RNA company and all of our work in the development of a vaccine for SARS-CoV-2
is simply a prelude to the future development of exosome-based vaccines and therapeutics, with the ultimate goal of generating
formulations of engineered exosomes and synthetic mRNAs to potentially prevent and treat human diseases. The opportunities for
pipeline expansion are very exciting."
Dr. Marb n continued, "we
have now conducted two positive clinical trials in Duchenne muscular dystrophy. Our HOPE-2 trial demonstrated statistically significant
results in upper limb skeletal muscle and cardiac function. We are currently discussing this program with FDA to determine the
appropriate path forward and are actively discussing partnership opportunities for this asset. We believe these initiatives position
us well as we look forward to a productive year in our therapeutics development programs."
Fourth Quarter & Full Year 2020
Highlights and Recent Operational Developments
Pipeline Development
Publications & Key Opinion Leader
Anticipated Events and Targeted Milestones
Fourth Quarter and Full Year Financial
The Company reported a net loss of approximately
$4.2 million, or $0.21 per share, for the fourth quarter of 2020, compared to a net loss of approximately $1.5 million, or $0.34
per share, for the fourth quarter of 2019.
For the year ended December 31, 2020, the
Company reported a net loss of approximately $13.7 million, or $0.88 per share, compared to a net loss of approximately $7.6 million,
or $2.06 per share, for the year ended December 31, 2019.
As of December 31, 2020, the Company's
cash, cash equivalents and marketable securities totaled approximately $32.7 million, compared to approximately $9.9 million on
December 31, 2019. Additionally, in 2020, Capricor raised approximately $22.9 million in net proceeds at an average price of approximately
$6.34 per share under its at-the-market offering program.
Capricor believes that based on the current
operating plan and financial resources, the Company expects that the cash, cash equivalents and marketable securities will be sufficient
to cover expenses and capital requirements through at least the second quarter of 2023.
Conference Call and Webcast
To participate in the conference call,
please dial 877-451-6152 (Domestic/Toll-Free) or 201-389-0879 (International) and reference the conference ID: 13717080
To participate via a webcast and view
the slides, please visit: http://public.viavid.com/index.php?id=143779
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 biotechnology company focused on the development of transformative cell- and exosome-based therapeutics and vaccines for
the treatment and prevention of a broad spectrum of diseases. Capricor's lead candidate, CAP-1002, is an allogeneic cardiac-derived
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 developing our exosomes platform technology as a next-generation therapeutic platform.
Our current focus is on the development of exosomes loaded with nucleic acids, including mRNA, to treat or prevent a variety of
diseases. For more information, visit www.capricor.com and follow the Company on Facebook, Instagram and Twitter.
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy is a devastating
genetic disorder that causes muscle degeneration and leads to death, generally before the age of 30, most commonly from heart failure.
It occurs in one in every 3,600 live male births across all races, cultures and countries. Duchenne muscular dystrophy afflicts
approximately 200,000 boys and young men around the world. Treatment options are limited, and there is no cure.
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 September 30, 2020 as filed with the Securities and Exchange Commission
on November 13, 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