Full Press Release Details
Capricor Therapeutics
Provides Corporate Update and Reports First Quarter 2016 Financial Results
and ALLSTAR Clinical Trials on Track to Complete Enrollment in the Third Quarter
to Host Conference Call and Webcast at 4:30 p.m. EDT, Today, May 12, 2016
May 12, 2016 - Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company focused on the discovery, development
and commercialization of first-in-class therapeutics, today provided financial results for the first quarter ended March 31, 2016
as well as a business update.
quarter was a productive start to this year on both the clinical and financial fronts for Capricor. We had two positive developments
in our lead CAP-1002 development programs-first, reducing the enrollment goal of the Phase II ALLSTAR trial in people who
have experienced a large heart attack with persistent cardiac dysfunction and second, successfully completing a pre-specified safety
review in our HOPE-Duchenne trial, a randomized Phase I/II trial in boys with Duchenne muscular dystrophy-associated cardiomyopathy,"
said Linda Marb n, Ph.D., president and chief executive officer of Capricor. "Later this year, we expect to announce
the first clinical indication for our exosomes program. We believe that our activities in 2016 will position Capricor for a transformational
2017, as we look forward to clinical results from both the HOPE-Duchenne and ALLSTAR trials, expected in the first quarter of next
continued, "On the financing front, we raised approximately $4.1 million in a registered direct offering and received approval
for an approximate $3.4 million grant award from the California Institute for Regenerative Medicine (CIRM) in the first quarter.
We believe our current balance sheet will fund our clinical programs beyond key data readouts in the first quarter of 2017."
and Recent Operational Highlights
The Company reported a net loss of approximately
$4.3 million, or $0.26 per share, for the first quarter of 2016, compared to a net loss of approximately $3.5 million, or $0.23
per share, for the first quarter of 2015. At March 31, 2016, the Company's cash, cash equivalents and marketable securities
totaled approximately $14.3 million compared to $13.6 million at December 31, 2015.
Based on current operating plans, the Company
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.
Conference Call and Webcast
Capricor management will hold a conference
call at 4:30 p.m. EDT today. The live call may be accessed by dialing (877) 830-2629 for domestic callers and (785) 424-1231 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.
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 therapeutics.
Capricor has two product candidates under clinical investigation: CAP-1002, a cardiac cell therapy, and Cenderitide, a dual natriuretic
peptide receptor agonist. CAP-1002 is in development for the treatment of post myocardial infarction, advanced heart failure and
Duchenne muscular dystrophy-associated cardiomyopathy. Cenderitide is in development for the outpatient treatment of heart failure
as well as other potential indications. In addition, Capricor is evaluating its exosomes platform technology for cardiac diseases
and other therapeutic areas. For additional information, visit www.capricor.com.
ALLSTAR is being funded in part with the
support of the California Institute for Regenerative Medicine.
Cautionary Note Regarding Forward-Looking
Statements in this press release regarding
the efficacy, safety, and intended utilization of Capricor's product candidates; the conduct, size, timing and results of discovery
efforts and 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, and in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September
28, 2015. 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 THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND
| Three months ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| INCOME | ||||||||
| Collaboration income | $ | 911,458 | $ | 1,041,667 | ||||
| Grant income | 303,631 | 746,235 | ||||||
| TOTAL INCOME | 1,215,089 | 1,787,902 | ||||||
| OPERATING EXPENSES | ||||||||
| Research and development | 4,341,119 | 3,807,087 | ||||||
| General and administrative | 1,084,696 | 1,395,540 | ||||||
| TOTAL OPERATING EXPENSES | 5,425,815 | 5,202,627 | ||||||
| LOSS FROM OPERATIONS | (4,210,726 | ) | (3,414,725 | ) | ||||
| OTHER INCOME (EXPENSE) | ||||||||
| Investment income | 10,510 | 275 | ||||||
| Interest expense | (66,125 | ) | (61,681 | ) | ||||
| TOTAL OTHER INCOME (EXPENSE) | (55,615 | ) | (61,406 | ) | ||||
| NET LOSS | (4,266,341 | ) | (3,476,131 | ) | ||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||
| Net unrealized loss on marketable securities | (6,157 | ) | (3,940 | ) | ||||
| COMPREHENSIVE LOSS | $ | (4,272,498 | ) | $ | (3,480,071 | ) | ||
| Net loss per share, basic and diluted | $ | (0.26 | ) | $ | (0.23 | ) | ||
| Weighted average number of shares, | ||||||||
| basic and diluted | 16,537,502 | 14,869,746 |
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
| March 31, 2016 (unaudited) | December 31, 2015 | |||||||
| Cash, cash equivalents and marketable securities | $ | 14,264,879 | $ | 13,567,316 | ||||
| Total assets | $ | 16,984,850 | $ | 16,069,572 | ||||
| Total deferred revenue | 3,645,833 | 4,557,292 | ||||||
| Total liabilities | $ | 18,067,755 | $ | 17,101,346 | ||||
| Total stockholders' equity (deficit) - 17,952,323 and 16,254,985 common shares issued and | ||||||||
| outstanding at March 31, 2016 and December 31, 2015, respectively | (1,082,905 | ) | (1,031,774 | ) | ||||
| Total liabilities and stockholders' equity | $ | 16,984,850 | $ | 16,069,572 |
For more information, please contact:
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance