Full Press Release Details
Capricor Therapeutics
Reports Second Quarter 2016 Financial Results and Provides Clinical Update
Duchenne Muscular Dystrophy
Trial on Track to Report Top-Line Six-Month Results in the First Quarter of 2017
Six-Month Results of
ALLSTAR to be Delivered to Janssen Biotech in the First Half of 2017
Exosome Program Advances
with Ocular Graft-Versus-Host Disease as First-in-Man Indication; IND Submission in the First Half of 2017
Company to Host Conference
Call and Webcast at 4:30 p.m. EDT, Today, August 15, 2016
August 15, 2016 - Capricor Therapeutics, Inc.
(NASDAQ: CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics,
today provided an update on its clinical development programs directed toward the treatment of heart disease, including that associated
with Duchenne Muscular Dystrophy (DMD), as well as defined the initial development path for its proprietary exosomes technology.
Capricor also announced financial results for the quarter ended June 30, 2016.
Linda Marb n, Ph.D.,
president and chief executive officer of Capricor said, "Later this quarter, we expect to announce the completion of enrollment
in our two ongoing clinical trials of CAP-1002 (allogeneic cardiosphere-derived cells, or CDCs): the HOPE trial in boys with Duchenne
heart disease and the ALLSTAR trial in adults with cardiac dysfunction following a large heart attack. These are important milestones
as we look toward reporting top-line six-month data from HOPE in the first quarter of 2017 as well as delivering six-month ALLSTAR
data to Janssen. These readouts follow our recent report of positive 12-month results from our DYNAMIC study of CAP-1002 data,
which show persistent improvement in patients with advanced heart failure out to one year post-treatment. We believe the DYNAMIC
data support the potential of CAP-1002 to address the heart disease associated with DMD, the number one cause of death in boys
afflicted with DMD."
exosome-based candidate CAP-2003 toward the clinic, we are building on the unique properties of Capricor's proprietary CDC
technology outside of cardiovascular areas. We have identified ocular graft-versus-host disease as the first clinical development
opportunity for CAP-2003. This selection is supported by compelling pre-clinical results in relevant models and the need for effective
treatment options for this debilitating condition of the eye. We look forward to submitting an IND application for CAP-2003 in
the first of 2017," added Dr. Marb n.
Anticipated Milestones
Second Quarter and Recent
Operational Highlights
Second Quarter Results
The Company reported a
net loss of approximately $4.7 million, or $0.26 per share, for the second quarter of 2016, compared to a net loss of approximately
$3.1 million, or $0.19 per share, for the second quarter of 2015. At June 30, 2016, the Company's cash, cash equivalents and marketable
securities totaled approximately $11.4 million compared to $13.6 million at December 31, 2015.
Based on its current operating
plans, Capricor expects that its existing cash, cash equivalents and marketable securities will fund its research and development
programs and other operations through the first quarter of 2017.
management will hold a conference call and slide presentation at 4:30 p.m. EDT today. The live call may be accessed by dialing
(800) 862-7924 for domestic callers and (785) 424-1047 for international callers, and by using "CAPRICOR" as the conference
ID. Access to the live webcast as well as the link to the replay of the call can be found at http://capricor.com/news/events/.
The webcast will be archived for approximately 30 days.
Exosomes are nano-sized,
membrane-enclosed vesicles, or "bubbles" that are secreted by cells and contain bioactive molecules, including proteins,
RNAs and microRNAs. They act as messengers to regulate the functions of neighboring cells, and pre-clinical research has shown
that exogenously-administered exosomes can direct or, in some cases, re-direct cellular activity, supporting their therapeutic
potential. Their size, ease of crossing cell membranes, and ability to communicate in native cellular language makes them an exciting
class of potential therapeutic agents. CAP-2003 consists of exosomes secreted by CDCs, and is believed to mediate many of the effects
that are observed with these cells, including anti-inflammatory, anti-angiogenic, anti-apoptotic, and anti-fibrotic effects. Capricor
is currently conducting pre-clinical studies to explore the possible therapeutic benefits that exosomes may possess, with a focus
on ophthalmologic, dermatologic and oncologic disease. Capricor expects to submit an Investigational New Drug application for CAP-2003
in the first half of 2017 and to initiate clinical development in ocular graft-versus-host disease in 2017.
About Capricor Therapeutics
Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization
of first-in-class therapeutic products. Capricor's lead candidate, CAP-1002, is a cardiac cell therapy that is currently
being evaluated for the treatment of heart disease associated with Duchenne muscular dystrophy and myocardial infarction (heart
attack). Capricor is advancing its proprietary exosome product candidate, CAP-2003, for the treatment of ophthalmic disorders
and exploring other therapeutic areas. Capricor's portfolio also features Cenderitide, a dual natriuretic peptide receptor
agonist, which may have application for the outpatient treatment of advanced heart failure and other potential indications. For
additional information, visit www.capricor.com.
ALLSTAR and HOPE-Duchenne
are funded in part by the California Institute for Regenerative Medicine. DYNAMIC was funded in part by the National Institutes
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; 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 offering and the anticipated effects of the offering,
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 are set forth in Capricor's Annual Report on Form
10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission on March 30, 2016, in its Registration
Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, and in its Quarterly Report
on Form 10-Q for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission on May 13, 2016. 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 and Cenderitide
are Investigational New Drugs and are not approved for any indications. Capricor's exosomes technology has not yet been investigated
in any clinical trial.
| CAPRICOR THERAPEUTICS, INC. |
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
| (unaudited) |
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| INCOME | ||||||||||||||||
| Collaboration income | $ | 911,458 | $ | 911,458 | $ | 1,822,916 | $ | 1,953,125 | ||||||||
| Grant income | 218,361 | 380,008 | 521,992 | 1,126,243 | ||||||||||||
| TOTAL INCOME | 1,129,819 | 1,291,466 | 2,344,908 | 3,079,368 | ||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 4,307,948 | 3,426,803 | 8,649,067 | 7,233,891 | ||||||||||||
| General and administrative | 1,434,259 | 926,279 | 2,518,955 | 2,321,819 | ||||||||||||
| TOTAL OPERATING EXPENSES | 5,742,207 | 4,353,082 | 11,168,022 | 9,555,710 | ||||||||||||
| LOSS FROM OPERATIONS | (4,612,388 | ) | (3,061,616 | ) | (8,823,114 | ) | (6,476,342 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 427 | 156 | 10,937 | 431 | ||||||||||||
| Interest expense | (76,887 | ) | (61,681 | ) | (143,011 | ) | (123,362 | ) | ||||||||
| TOTAL OTHER INCOME (EXPENSE) | (76,460 | ) | (61,525 | ) | (132,074 | ) | (122,931 | ) | ||||||||
| NET LOSS | (4,688,848 | ) | (3,123,141 | ) | (8,955,188 | ) | (6,599,273 | ) | ||||||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | 1,551 | 10,475 | (4,607 | ) | 6,535 | |||||||||||
| COMPREHENSIVE LOSS | $ | (4,687,297 | ) | $ | (3,112,666 | ) | $ | (8,959,795 | ) | $ | (6,592,738 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.26 | ) | $ | (0.19 | ) | $ | (0.52 | ) | $ | (0.42 | ) | ||||
| Weighted average number of shares, | ||||||||||||||||
| basic and diluted | 17,952,323 | 16,222,754 | 17,244,912 | 15,549,988 |
| CAPRICOR THERAPEUTICS, INC. |
| SUMMARY BALANCE SHEETS |
| June 30, 2016 (unaudited) | December 31, 2015 | |||||||
| Cash, cash equivalents and marketable securities | $ | 11,351,104 | $ | 13,567,316 | ||||
| Total assets | $ | 13,892,196 | $ | 16,069,572 | ||||
| Total deferred revenue | 2,734,376 | 4,557,292 | ||||||
| Total liabilities | $ | 19,008,373 | $ | 17,101,346 | ||||
| Total stockholders' equity (deficit) - 17,952,323 and 16,254,985 common shares issued and | ||||||||
| outstanding at June 30, 2016 and December 31, 2015, respectively | (5,116,177 | ) | (1,031,774 | ) | ||||
| Total liabilities and stockholders' equity | $ | 13,892,196 | $ | 16,069,572 |
For more information, please
Capricor Therapeutics,
AJ Bergmann, Vice President