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 second quarter, which ended June 30, 2018, and
provided a corporate update.
“Capricor continues to move forward 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. “We are actively
enrolling patients in HOPE-2, with multiple sites initiated, and we
anticipate having all sites up and running during the third quarter
of this year. We are thrilled to begin enrolling participants in
HOPE-2 because we have seen the potential for improvements in
muscle function in both pre-clinical studies and in our earlier
HOPE-Duchenne trial.”
Capricor has also been granted RMAT and Orphan
Drug Designation by the U.S. Food and Drug Administration
(FDA).
“These designations will enable us to work
closely with the FDA in finalizing the regulatory approval pathway
for CAP-1002 and to receive expedited FDA reviews,” Dr. Marbán
said. “We are hopeful that HOPE-2 may potentially be a registration
trial.”
Capricor has also recently announced that the
development of CAP-2003, the company’s other investigational
therapy, is moving forward with a collaboration with the U.S. Army
Institute of Surgical Research (USAISR) to explore the potential
for the exosome-based candidate to address traumatic injuries and
conditions.
“This exciting new collaboration with USAISR has
the potential to open up a whole new arena in biotechnology, where
the benefits of cells can be distilled down to the active
pharmaceutical ingredient (API), which we now know is extracellular
vesicles,” said Dr. Marbán. “If this collaboration proves to be
promising, it will result in us working to develop large-scale
manufacturing and clinical development of CAP-2003.”
Second Quarter Highlights and Recent Clinical and
Operational Developments
- Study sites have opened and enrollment has commenced in the
HOPE-2 clinical trial. It is a Phase II, randomized, double-blind,
placebo-controlled study in patients in the later stage of Duchenne
muscular dystrophy, a fatal genetic disease with few treatment
options. Current plans are to open a total of 10 to 15 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, and has been shown
to exert potent immunomodulatory activity and stimulate cellular
regrowth.
- Capricor announced it has entered into an agreement with USAISR
to study the potential for the company’s next-generation
investigational therapeutic platform, CAP-2003. The goal of the
collaboration is to address a wide spectrum of trauma-related
injuries and conditions, which are now the third leading cause of
death in the U.S. Capricor will provide CAP-2003 for the testing of
function, potency and safety for eventual use in therapeutic
indications. CAP-2003 is comprised of nano-scale extracellular
vesicles which have the capacity to reduce inflammation, fibrosis
or scarring and cell death, as well as increase blood vessel
growth.
- Capricor and Parent Project Muscular Dystrophy (PPMD) hosted a
webinar on July 18 to provide information about the HOPE-2 clinical
trial to the Duchenne muscular dystrophy community. Capricor also
provided a corporate overview and a poster presentation at the PPMD
2018 Annual Conference on June 29 in Scottsdale, AZ. The poster
presentation reported on pre-clinical data demonstrating CAP-2003’s
ability to reduce inflammation and improve exercise capabilities in
mdx mice after systemic administration.
- In June, Capricor presented a poster at the Keystone Symposia
on Molecular and Cellular Biology. The poster reported that
CAP-2003’s immunomodulatory capacities increased the survival in a
disease model of Graft vs. Host Disease (GVHD), a medical
complication following the receipt of transplanted tissue from a
genetically different person. The poster reported that CAP-2003 was
effective in immune-modulating T lymphocytes and macrophages in
vitro and increasing the survival in a disease model of GVHD.
Anticipated Events and Milestones in Second Half 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 preparations for manufacturing scale-up and technology
transfer of CAP-1002.
Second Quarter Results
The Company reported a net loss of approximately
$4.1 million, or $0.14 per share, for the second quarter of 2018,
compared to a net loss of approximately $3.5 million, or $0.16 per
share, for the second quarter of 2017.
As of June 30, 2018, the Company's cash, cash
equivalents and marketable securities totaled approximately $12.3
million, compared to approximately $14.1 million on December 31,
2017. Additionally, in the second quarter of 2018, Capricor raised
approximately $2.8 million in net proceeds at an average price of
approximately $1.43 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 8483546.
To participate via a webcast, please visit
https://edge.media-server.com/m6/p/ch8cwhpt. 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 Capricor’s stock
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 March 31, 2018, as filed with the
Securities and Exchange Commission on May 14, 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.
CAPRICOR THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(UNAUDITED)
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
INCOME |
|
|
|
|
|
|
|
Collaboration income |
$ |
- |
|
|
$ |
683,592 |
|
|
$ |
- |
|
|
$ |
1,367,186 |
|
Grant
income |
|
287,302 |
|
|
|
312,870 |
|
|
|
594,051 |
|
|
|
510,083 |
|
Other
income |
|
116,658 |
|
|
|
- |
|
|
|
209,974 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
TOTAL
INCOME |
|
403,960 |
|
|
|
996,462 |
|
|
|
804,025 |
|
|
|
1,877,269 |
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
Research
and development |
|
3,388,908 |
|
|
|
3,128,182 |
|
|
|
6,085,424 |
|
|
|
6,385,331 |
|
General
and administrative |
|
1,178,060 |
|
|
|
1,246,942 |
|
|
|
2,567,792 |
|
|
|
2,436,181 |
|
|
|
|
|
|
|
|
|
TOTAL
OPERATING EXPENSES |
|
4,566,968 |
|
|
|
4,375,124 |
|
|
|
8,653,216 |
|
|
|
8,821,512 |
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
(4,163,008 |
) |
|
|
(3,378,662 |
) |
|
|
(7,849,191 |
) |
|
|
(6,944,243 |
) |
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE) |
|
|
|
|
|
|
|
Investment income |
|
39,460 |
|
|
|
12,052 |
|
|
|
54,113 |
|
|
|
16,334 |
|
Interest
expense |
|
- |
|
|
|
(105,527 |
) |
|
|
- |
|
|
|
(210,847 |
) |
|
|
|
|
|
|
|
|
TOTAL
OTHER INCOME (EXPENSE) |
|
39,460 |
|
|
|
(93,475 |
) |
|
|
54,113 |
|
|
|
(194,513 |
) |
|
|
|
|
|
|
|
|
NET
LOSS |
|
(4,123,548 |
) |
|
|
(3,472,137 |
) |
|
|
(7,795,078 |
) |
|
|
(7,138,756 |
) |
|
|
|
|
|
|
|
|
OTHER COMPREHENSIVE
INCOME (LOSS) |
|
|
|
|
|
|
|
Net
unrealized gain (loss) on marketable securities |
|
(2,044 |
) |
|
|
(2,394 |
) |
|
|
6,665 |
|
|
|
3,793 |
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
$ |
(4,125,592 |
) |
|
$ |
(3,474,531 |
) |
|
$ |
(7,788,413 |
) |
|
$ |
(7,134,963 |
) |
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
$ |
(0.14 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.33 |
) |
Weighted average number
of shares, basic and diluted |
|
29,031,888 |
|
|
|
22,135,198 |
|
|
|
27,974,484 |
|
|
|
21,769,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CAPRICOR THERAPEUTICS,
INC.SUMMARY BALANCE SHEETS
|
|
June 30, 2018 (unaudited) |
|
December 31, 2017 |
Cash, cash equivalents
and marketable securities |
|
$ |
12,334,228 |
|
$ |
14,124,935 |
Total assets |
|
$ |
14,327,071 |
|
$ |
16,273,789 |
|
|
|
|
|
Total liabilities |
|
$ |
4,696,267 |
|
$ |
5,046,934 |
|
|
|
|
|
Total stockholders'
equity - 29,994,316 and 26,270,491 common shares issued and
outstanding at June 30, 2018 and December 31, 2017,
respectively |
|
|
9,630,804 |
|
|
11,226,855 |
Total liabilities and
stockholders' equity |
|
$ |
14,327,071 |
|
$ |
16,273,789 |
|
|
|
|
|
|
|
For more information, please contact:
AJ Bergmann, Chief Financial Officer
+1-310-358-3200
abergmann@capricor.com
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