To Host Conference Call and Webcast Today
at 4:30 p.m. ET
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 third quarter of 2018, which ended September 30,
2018, and provided a corporate update.
“Capricor continues its progress in the clinical
development of our novel cell therapy, CAP-1002, to treat Duchenne
muscular dystrophy, and we are moving forward with our
exosome-based therapy, CAP-2003,” said Linda Marbán, Ph.D.,
Capricor CEO. “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, is well underway with 11 sites
recruiting participants and more sites expected to begin enrollment
before the end of the year. 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.”
Capricor has been granted RMAT and Orphan Drug
Designation by the U.S. Food and Drug Administration (FDA) for
CAP-1002. The company’s leaders and key opinion leaders in the
Duchenne community are scheduled to meet with the FDA in December
under Capricor’s RMAT designation to discuss milestones for
development and commercialization of CAP-1002.
Capricor has entered into a collaboration with
the U.S. Army Institute of Surgical Research (USAISR), which is
studying the potential for CAP-2003 to address trauma-related
injuries and conditions.
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 are pleased to see that the power of
exosomes is beginning to be recognized by the academic and the
biotech communities,” said Dr. Marbán. “Pre-clinical studies
indicate CAP-2003 has potential as a treatment for diseases of
inflammation and fibrosis, which may mean it can potentially serve
as both a therapy for those diseases and as a delivery vehicle for
gene and other therapies to treat those diseases.”
Third Quarter Highlights and Recent Clinical and
Operational Developments
- Eleven study sites have opened and enrollment is underway in
the HOPE-2 clinical trial. It 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. Current plans are to open up to 15 study
sites and enroll approximately 84 patients. 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.
- Capricor announced it will be meeting with the FDA in December
as part of the expedited review process CAP-1002 received under the
RMAT designation, which the FDA granted to CAP-1002 in February
2018. The FDA grants the RMAT designation to regenerative medicine
therapies intended to treat a serious condition and for which
preliminary clinical evidence indicates a potential to address
unmet medical needs for that condition.
- At the Gordon Research Conference on Extracellular Vesicles in
Newry, Maine in August, Capricor presented a poster on the
mechanism of action and the immunomodulatory capacities of
CAP-2003. The poster provided additional evidence that exosomes may
be the active pharmaceutical ingredient in CAP-1002. The
pre-clinical studies further elucidated Capricor’s progress in
developing the exosomes which comprise CAP-2003 as an exciting new
potential therapeutic for diseases of inflammation and
fibrosis.
- In October, Capricor presented a poster at the 2018 Cell &
Gene Meeting on the Mesa in La Jolla, CA. The poster reported on a
pre-clinical study that assessed the biological mechanisms of
action of paracrine factors and exosomes secreted by CDCs, the
active component of CAP-1002. The poster showed that growth factors
released by CDCs are able to activate survival signals in treated
cells. Capricor also reported that the exosomes were responsible
for CAP-1002’s immunomodulatory effects.
- In November, Capricor presented a poster at the Action Duchenne
International Conference in Birmingham, UK. The poster reported on
a pre-clinical study that found exosomes secreted by CDCs were
effective in increasing exercise capabilities and muscle activity
in a mouse model of Duchenne muscular dystrophy. The poster also
reported that the exosomes secreted by the CDCs reduced muscle
fibrosis, which causes a loss of muscle function in Duchenne
patients, and the proliferation of activated T cells, which help
govern the body’s immune response, in the Duchenne mouse
model.
- Capricor provided corporate updates at the BTIG Fall
Biotechnology Conference in New York and at the American Society of
Exosomes and Microvesicles Annual Meeting in October. In November,
Capricor provided an update on its research and development of cell
and exosome-based therapies for Duchenne muscular dystrophy and
other rare diseases during the BIO-Europe® 24th Annual
International Partnering Conference in Copenhagen, Denmark.
Anticipated Events and Milestones in Fourth Quarter of
2018
- Meet with the FDA to discuss Capricor’s Duchenne program
through the RMAT process.
- Continue to add additional sites and enroll patients in the
HOPE-2 clinical trial.
- Continue to conduct pre-clinical research for CAP-2003 to treat
various diseases of inflammation and fibrosis.
- Continue to develop processes for manufacturing scale-up and
technology transfer of CAP-1002.
Third Quarter Results
The Company reported a net loss of approximately
$4.1 million, or $0.14 per share, for the third quarter of 2018,
compared to a net loss of approximately $2.7 million, or $0.12 per
share, for the third quarter of 2017.
As of September 30, 2018, the Company's cash,
cash equivalents and marketable securities totaled approximately
$10.4 million, compared to approximately $14.1 million on December
31, 2017. Additionally, in the third quarter of 2018, Capricor
raised approximately $1.1 million in net proceeds at an average
price of approximately $1.44 per share under its at-the-market
offering program. Capricor believes that its current financial
resources should be sufficient to fund its operations and meet its
financial obligations into the second 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: 4974294.
To participate via a webcast, please visit:
https://edge.media-server.com/m6/p/msqxw8py. 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, 2017 as filed with the Securities and Exchange
Commission on March 22, 2018, in its Registration Statement on Form
S-3, as filed with the Securities and Exchange Commission on
September 28, 2015, together with the prospectus included therein
and prospectus supplements thereto and in its Quarterly Report on
Form 10-Q for the quarter ended June 30, 2018, as filed with the
Securities and Exchange Commission on August 13, 2018. 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.
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CAPRICOR THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(UNAUDITED) |
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
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INCOME |
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|
|
|
|
|
|
Collaboration income |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
1,367,186 |
Grant
income |
172,589 |
|
260,771 |
|
766,641 |
|
770,855 |
Other
income |
46,658 |
|
52,500 |
|
256,633 |
|
52,500 |
|
|
|
|
|
|
|
|
TOTAL
INCOME |
219,247 |
|
313,271 |
|
1,023,274 |
|
2,190,541 |
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
Research
and development |
3,131,999 |
|
1,862,369 |
|
9,217,423 |
|
8,247,700 |
General
and administrative |
1,259,180 |
|
1,088,635 |
|
3,826,972 |
|
3,524,815 |
|
|
|
|
|
|
|
|
TOTAL
OPERATING EXPENSES |
4,391,179 |
|
2,951,004 |
|
13,044,395 |
|
11,772,515 |
|
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LOSS FROM
OPERATIONS |
(4,171,932) |
|
(2,637,733) |
|
(12,021,121) |
|
(9,581,974) |
|
|
|
|
|
|
|
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OTHER
INCOME (EXPENSE) |
|
|
|
|
|
|
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Investment income |
35,792 |
|
10,393 |
|
89,905 |
|
26,726 |
Interest
expense |
- |
|
(107,653) |
|
- |
|
(318,500) |
|
|
|
|
|
|
|
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TOTAL
OTHER INCOME (EXPENSE) |
35,792 |
|
(97,260) |
|
89,905 |
|
(291,774) |
|
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|
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NET
LOSS |
(4,136,140) |
|
(2,734,993) |
|
(11,931,216) |
|
(9,873,748) |
|
|
|
|
|
|
|
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OTHER
COMPREHENSIVE INCOME (LOSS) |
|
|
|
|
|
|
|
Net
unrealized gain on marketable securities |
1,922 |
|
1,276 |
|
8,587 |
|
5,069 |
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
$ |
(4,134,218) |
|
$ |
(2,733,717) |
|
$ |
(11,922,629) |
|
$ |
(9,868,679) |
|
|
|
|
|
|
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Net loss
per share, basic and diluted |
$ |
(0.14) |
|
$ |
(0.12) |
|
$ |
(0.41) |
|
$ |
(0.44) |
Weighted
average number of shares, basic and diluted |
30,610,064 |
|
23,378,141 |
|
28,862,665 |
|
22,311,369 |
CAPRICOR THEAPEUTICS,
INC. |
SUMMARY BALANCE SHEETS |
|
|
|
September 30, 2018
(unaudited) |
|
December 31, 2017 |
Cash, cash equivalents and marketable securities |
|
$ |
10,371,917 |
|
$ |
14,124,935 |
Total assets |
|
$ |
12,232,816 |
|
$ |
16,273,789 |
|
|
|
|
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Total liabilities |
|
$ |
5,252,394 |
|
$ |
5,046,934 |
|
|
|
|
|
Total stockholders' equity - 30,748,872 and 26,270,491
common shares issued and outstanding at September 30, 2018 and
December 31, 2017, respectively |
|
6,980,422 |
|
11,226,855 |
|
Total liabilities and stockholders' equity |
|
$ |
12,232,816 |
|
$ |
16,273,789 |
For more information, please contact:
AJ Bergmann, Chief Financial Officer
+1-310-358-3200abergmann@capricor.com
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