Full Press Release Details
Capricor Therapeutics Reports Fourth
Quarter and Full Year 2019
Financial Results and Provides Corporate Update
-To Report Final 12-month HOPE-2
Data in the Second Quarter-
-Exosomes Platform Technology
Expanded to Potentially Combat the Novel Coronavirus-
-To Host Conference Call and
Webcast Today at 4:30 p.m. ET-
LOS ANGELES, March 18, 2020 - Capricor
Therapeutics (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the development of first-in-class biological
therapeutics for the treatment of Duchenne muscular dystrophy (DMD) and other rare disorders, today announced its financial results
for the fourth quarter and full year 2019 and provided a corporate update.
"We continue to make progress toward
the goal of bringing CAP-1002 to patients with DMD with our final 12-month data expected in the second quarter. Importantly, we
continue to expand our exosomes technology where we are aiming to develop a platform of exosomal-based vaccines that could potentially
be beneficial in many indications, including infectious diseases such as the novel coronavirus (SARS-CoV-2). Further, we have strengthened
our program with the appointment of Dr. Stephen Gould from Johns Hopkins University as an Executive Consultant to oversee our exosomes
program. With our recent financing completed at the end of last year, we now have extended our runway through the second quarter
of 2021 to deliver on our milestones and we continue to pursue potential strategic partnerships for our technologies. Over the
next few months, we look forward to making more announcements focusing on our late-stage clinical program and our expanding exosomes
program" said Linda Marb n, Ph.D., Capricor's president and chief executive officer.
Dr. Marb n further noted, "The
fourth quarter and 2019 have been encouraging on multiple levels and we will be providing an overview on pipeline and regulatory
developments, Key Opinion Leader support and increased financial discipline."
The 24th International
Congress of the World Muscle Society provided an exciting venue for the Company's "late breaking" presentation
unveiling our 6-month interim results in the Phase II HOPE-2 clinical trial of CAP-1002. This was a significant milestone not only
for 2019 but also for the clinical pathway of CAP-1002 for DMD.
Ongoing and active communications with
the FDA have been productive for Capricor, as we have the unique advantage for more frequent collaborations with the agency due
to our RMAT Designation. The FDA has granted Capricor Orphan
Drug Designation and a Rare Pediatric Disease Designation to CAP-1002 for the treatment of DMD. If Capricor were to
receive market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher.
Capricor expects 2020 to be a transformative
year with clarity on next steps in its DMD program and the planned expansion of our exosome platform technology that potentially
may be used for vaccine development, vesicle-mediated protein therapies and treatment of inherited diseases, among other things.
"Building on the success and clinical
evidence of our core cardiosphere-derived cells technology, we are enthusiastic to expand our knowledge of exosomes by building
out a platform and utilizing our experience to engineer exosomes as drug delivery vehicles" Dr. Marb n said.
Fourth Quarter & FY Highlights and
Recent Operational Developments
Pipeline Development
Regulatory Advancement
and Financial Discipline
and Targeted Milestones for 2020
Fourth Quarter and Full Year Financial
The Company reported a net loss of approximately
$1.5 million, or $0.34 per share, for the fourth quarter of 2019, compared to a net loss of approximately $3.3 million, or $1.05
per share, for the fourth quarter of 2018.
As of December 31, 2019, the Company's
cash, cash equivalents and marketable securities totaled approximately $9.9 million, compared to approximately $7.3 million on
December 31, 2018. Additionally, in 2019, Capricor raised approximately $4.8 million in net proceeds at an average price of approximately
$4.48 per share under its at-the-market offering programs.
Capricor believes that based on the current
operating plan and financial resources, the Company expects that the cash, cash equivalents and marketable securities at December
31 will be sufficient to cover expenses and capital requirements through at least the second quarter of 2021.
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: 13699780
To participate via a webcast, please visit:
The webcast will be archived for approximately
30 days and will be available at http://capricor.com/news/events/.
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.
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, and is being investigated for its potential to modify the immune system's activity to encourage cellular regeneration.
CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to over 150 human subjects
across several clinical trials.
About Capricor Therapeutics
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 of rare disorders. 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 has
also established itself as one of the companies investigating the field of extracellular vesicles and is exploring the potential
of exosome-based candidates to treat a variety of disorders. For more information, visit
Keep up with Capricor on social media: www.facebook.com/capricortherapeutics,
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, 2018 as filed with the Securities and Exchange Commission on March 29, 2019,
and as amended by its Amendment No. 1 to Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on April
1, 2019, in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2019, as filed with the Securities and