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 and other rare disorders, today announced its financial
results for the first quarter 2019 and provided a corporate update.
“We continue with the clinical development of
CAP-1002, our lead cell therapy product, to treat Duchenne muscular
dystrophy,” said Linda Marbán, Ph.D., Capricor president and chief
executive officer. Our HOPE-2 clinical trial, which is testing the
safety and efficacy of CAP-1002 in boys and young men in the
advanced stages of Duchenne, has enrolled 20 patients to
date. Previous pre-clinical and clinical studies have shown
that CAP-1002 is generally safe, well-tolerated and demonstrated
significant and sustained signals of improvement in cardiac and
skeletal muscle function in patients with Duchenne muscular
dystrophy. We will be conducting an interim analysis in early Q3
and look forward to sharing that data with the patient and investor
community.”
Capricor has been granted RMAT and Orphan Drug
Designation by the U.S. Food and Drug Administration (FDA) for
CAP-1002 for the treatment of Duchenne muscular dystrophy.
CAP-2003 is comprised of proprietary
extracellular vesicles, including exosomes, which are derived from
cardiosphere-derived cells. Exosomes are nano-sized,
membrane-enclosed vesicles, that are secreted by cells and contain
bioactive molecules, including proteins, RNAs and microRNAs.
Exosomes act as messengers to regulate the functions of neighboring
cells. Because of these unique capacities, researchers are
increasingly viewing exosomes as both a potential therapeutic and a
vehicle to deliver gene and other therapies to targeted tissues in
the human body.
“We continue to be encouraged by exciting
developments in the exosomes field and we continue to explore their
use as a potential therapeutic and as a delivery vehicle for genes
and other drugs to targeted tissues,” said Dr. Marbán.
First Quarter Highlights and Recent
Clinical and Operational Developments
- The Company resumed dosing of patients already enrolled in the
HOPE-2 clinical trial of CAP-1002 in accordance with the study
protocol. It is the Company’s intention to conduct an interim
analysis on available data in early Q3 2019. The HOPE-2 study is a
Phase II, randomized, double-blind, placebo-controlled study in
patients in the later stages of Duchenne muscular dystrophy, a
fatal genetic disease with few treatment options. HOPE-2 will
evaluate the safety and efficacy of repeat doses of CAP-1002, which
consists of allogeneic cardiosphere-derived cells, or CDCs.
CAP-1002 has been shown to exert potent immunomodulatory activity
and stimulate cellular regrowth. Enrollment of new patients will
depend on various factors but will not commence until additional
funding is secured.
- The Journal of Neurology published the results of the
HOPE-Duchenne clinical trial reporting significant improvements in
Duchenne muscular dystrophy patients treated with Capricor’s
CAP-1002. The Phase I/II, randomized, controlled, open-label trial
found that CAP-1002 demonstrated improvement in cardiac muscle
function and reduction in cardiac scarring that were
statistically-significant and sustained improvement of skeletal
muscle functions in patients with Duchenne muscular dystrophy. The
HOPE-Duchenne trial also found no serious safety issues, according
to the study published in the January 23, 2019, online issue of
Neurology, the medical journal of the American Academy of
Neurology.
Anticipated
Events and Milestones in 2019
- Plan to report interim data from
the HOPE-2 clinical trial in early Q3 2019.
- Continue to conduct pre-clinical
research for CAP-2003 to treat various diseases of inflammation and
fibrosis.
- Continue to explore financing and
other strategic alternatives with respect to the Company as well as
one or more of our product candidates.
First Quarter Financial
Results
The Company reported a net loss of approximately
$2.5 million, or $0.08 per share, for the first quarter of 2019,
compared to a net loss of approximately $3.7 million, or $0.14 per
share, for the first quarter of 2018.
As of March 31, 2019, the Company’s cash, cash
equivalents and marketable securities totaled approximately $7.2
million compared to approximately $7.3 million on December 31,
2018. Additionally, in the first quarter of 2019, Capricor raised
approximately $1.4 million in net proceeds at an average price of
approximately $0.66 per share under its at-the-market offering
program. The Company’s at-the-market offering program expired on
April 23, 2019.
Capricor believes that its current financial
resources should be sufficient to fund its operations and meet its
financial obligations into the fourth quarter of 2019 based on the
Company's current projections.
Conference Call and Webcast
To participate in the conference call, please
dial 866-717-4562 (domestic) or 210-874-7812 (international) and
reference the access code: 4575759
To participate via a webcast, please visit:
https://edge.media-server.com/m6/p/zxabvq2r. 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 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 leading companies investigating the field of extracellular
vesicles and is exploring the potential of CAP-2003, a cell-free,
exosome-based candidate, to treat a variety of disorders. The
HOPE-Duchenne trial was funded in part by the California Institute
for Regenerative Medicine. For more information, visit
www.capricor.com. Keep up with Capricor on social media:
www.facebook.com/capricortherapeutics,
www.instagram.com/capricortherapeutics/ and
https://twitter.com/capricor
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, 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. 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. CAP-2003 has not yet been
approved for clinical investigation.
CAPRICOR THERAPEUTICS,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(UNAUDITED)
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
REVENUE |
|
|
|
|
Revenue |
$ |
230,504 |
|
$ |
400,066 |
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
Research and development |
|
1,811,182 |
|
|
2,696,517 |
|
General and administrative |
|
976,490 |
|
|
1,389,732 |
|
|
|
|
|
|
TOTAL OPERATING EXPENSES |
|
2,787,672 |
|
|
4,086,249 |
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
(2,557,168) |
|
|
(3,686,183) |
|
|
|
|
|
|
OTHER INCOME (EXPENSE) |
|
|
|
|
Investment income |
|
37,823 |
|
|
14,653 |
|
|
|
|
|
|
NET LOSS |
|
(2,519,345) |
|
|
(3,671,530) |
|
|
|
|
|
|
OTHER COMPREHENSIVE INCOME (LOSS) |
|
|
|
|
Net unrealized gain (loss) on marketable securities |
|
(12,393) |
|
|
8,709 |
|
|
|
|
|
|
COMPREHENSIVE LOSS |
$ |
(2,531,738) |
|
$ |
(3,662,821) |
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.08) |
|
$ |
(0.14) |
|
Weighted average number of shares, basic and diluted |
|
32,903,837 |
|
|
26,905,331 |
|
|
|
|
|
|
CAPRICOR THERAPEUTICS,
INC.SUMMARY BALANCE SHEETS
|
|
|
|
March 31, 2019 (unaudited) |
|
December 31, 2018 |
|
Cash, cash equivalents and marketable securities |
|
$ |
7,170,220 |
|
$ |
7,256,416 |
|
Total assets |
|
$ |
8,617,505 |
|
$ |
9,247,065 |
|
|
|
|
|
|
|
Total liabilities |
|
$ |
4,877,203 |
|
$ |
4,631,478 |
|
|
|
|
|
|
|
Total stockholders' equity - 33,661,346 and 31,387,729 common
shares issued and |
|
|
|
|
|
outstanding at March 31, 2019 and December 31, 2018,
respectively |
|
|
3,740,302 |
|
|
4,615,587 |
|
Total liabilities and stockholders' equity |
|
$ |
8,617,505 |
|
$ |
9,247,065 |
|
|
|
|
|
|
|
For more information, please contact:
AJ Bergmann, Chief Financial Officer
+1-310-358-3200abergmann@capricor.com
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