Full Press Release Details
Capricor Therapeutics Reports Second
Quarter 2015 Business & Financial Highlights
Company to Host Conference Call and Webcast
at 4:30 p.m. EDT, Today, August 13, 2015
August 13, 2015 -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company focused on the discovery, development
and commercialization of first-in-class therapeutics, today provided a business and financial update for the second quarter ended
Second Quarter and Recent Operational
"This second quarter was one of significant
progress as we advanced our current ongoing clinical programs, ALLSTAR, DYNAMIC and HOPE-DUCHENNE, and reached important milestones
which included the receipt of orphan drug designation for CAP-1002 in DMD-related cardiomyopathy," said Linda Marb n,
Ph.D., Chief Executive Officer of Capricor. "To maintain our momentum, we have strengthened our leadership team with the
appointments of a CMO, a Vice President of Medical and Clinical Development for New Therapies and a Vice President of Regenerative
Therapies. We anticipate that these highly experienced individuals will contribute immediately to our clinical programs, particularly
the planned initiation of our Phase I/II trial in patients with DMD-related cardiomyopathy and the choice of the first indication
to emerge from our exosome platform. We look forward to the analysis of top-line data for CDCs from our DYNAMIC trial for the treatment
of advanced heart failure and the data from our natriuretic peptide, Cenderitide trial."
Results of Operations for the Quarter
For the quarter ended June 30, 2015, the
Company had cash, cash equivalents and marketable securities of approximately $20.5 million, plus approximately $0.6 million restricted
cash from the Company's loan award, granted by the California Institute for Regenerative Medicine (CIRM), totaling approximately
$21.1 million. The increase in cash equivalents and marketable securities from the approximately $8.0 million reported as of December
31, 2014 is a result of approximately $17.0 million raised in two private placements of Capricor common stock, less cash used to
fund operations. Restricted cash related to the CIRM loan award decreased by approximately $2.4 million compared to that reported
as of December 31, 2014 as a result of expenses related to the ongoing ALLSTAR clinical trial.
For the quarter ended June 30, 2015, the
Company reported a net loss of approximately $3.1 million, or $0.19 per basic and diluted share, compared to a net loss of approximately
$1.5 million, or $0.13 per basic and diluted share, for the same period in the prior year. Research and development expenses increased
to approximately $3.4 million in the quarter ended June 30, 2015, compared to approximately $1.9 million for the same period in
the prior year. The increase was primarily due to increased expenses related to ongoing or planned clinical trials. General and
administrative expenses increased to approximately $0.9 million in the quarter ended June 30, 2015, compared to approximately $0.7
million for the same period in the prior year. The increase was primarily due to increases in compensation costs and non-cash stock-based
Capricor management will hold a conference
call at 4:30 p.m. EDT today. The live call may be accessed by dialing +1-877-407-4018 for domestic callers and +1-201-689-8471
for international callers. Access to the live webcast and link of the replay can be found at http://capricor.com/news/events/.
A link to the replay of the webcast will be archived for approximately 90 days, additionally a telephone replay of the call
will be available by dialing 877-870-5176 for domestic callers or 858-384-5517 for international callers and entering the conference
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.
Our lead programs target post myocardial infarction (heart attack), heart failure and Duchenne Muscular Dystrophy. The Company
has two leading product candidates under investigation: CAP-1002, a cardiac cell therapy, and Cenderitide, a natriuretic peptide
receptor agonist. CAP-1002 is in development for the treatment of post myocardial infarction (heart attack), advanced heart failure
and Duchenne muscular dystrophy associated cardiomyopathy. Cenderitide is in development for the outpatient treatment of heart
failure as well as potential other indications. In addition, the Company is conducting research and development on its exosomes
platform technology for cardiac diseases and other potential indications. For additional information visit www.capricor.com.
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; scope, duration, validity and enforceability of intellectual property rights; plans regarding regulatory
filings, future research and clinical trials; plans regarding current and future collaborative activities and the ownership of
commercial rights; future royalty streams, 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 our business are set forth in
our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on March
16, 2015, in our Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on March 6, 2015 and
in our Quarterly Report on Form 10-Q for the period ended March 31, 2015, as filed with the Securities and Exchange Commission
on May 13, 2015. All forward-looking statements in this press release are based on information available to us as of the date hereof,
and we assume no obligation to update these forward-looking statements.
CAPRICOR THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| INCOME | ||||||||||||||||
| Collaboration income | $ | 911,458 | $ | 1,041,667 | $ | 1,953,125 | $ | 2,083,334 | ||||||||
| Grant income | 380,008 | - | 1,126,243 | - | ||||||||||||
| TOTAL INCOME | 1,291,466 | 1,041,667 | 3,079,368 | 2,083,334 | ||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 3,426,803 | 1,856,360 | 7,233,891 | 3,236,877 | ||||||||||||
| General and administrative | 926,279 | 665,728 | 2,321,819 | 1,512,895 | ||||||||||||
| TOTAL OPERATING EXPENSES | 4,353,082 | 2,522,088 | 9,555,710 | 4,749,772 | ||||||||||||
| LOSS FROM OPERATIONS | (3,061,616 | ) | (1,480,421 | ) | (6,476,342 | ) | (2,666,438 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 156 | 1,196 | 431 | 1,919 | ||||||||||||
| Interest expense | (61,681 | ) | (54,704 | ) | (123,362 | ) | (80,031 | ) | ||||||||
| TOTAL OTHER INCOME (EXPENSE) | (61,525 | ) | (53,508 | ) | (122,931 | ) | (78,112 | ) | ||||||||
| NET LOSS | (3,123,141 | ) | (1,533,929 | ) | (6,599,273 | ) | (2,744,550 | ) | ||||||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | 10,475 | (470 | ) | 6,535 | 106 | |||||||||||
| COMPREHENSIVE LOSS | $ | (3,112,666 | ) | $ | (1,534,399 | ) | $ | (6,592,738 | ) | $ | (2,744,444 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.19 | ) | $ | (0.13 | ) | $ | (0.42 | ) | $ | (0.23 | ) | ||||
| Weighted average number of shares, | ||||||||||||||||
| basic and diluted | 16,222,754 | 11,692,318 | 15,549,988 | 11,690,888 |
| CAPRICOR THERAPEUTICS, INC. | ||||||||
| SUMMARY BALANCE SHEETS | ||||||||
| June 30, 2015 (unaudited) | December 31, 2014 | |||||||
| Cash, cash equivalents and marketable securities | $ | 20,532,625 | $ | 8,034,765 | ||||
| Total Assets | $ | 23,690,830 | $ | 13,632,072 | ||||
| Total deferred revenue | 6,380,208 | 8,333,333 | ||||||
| Total liabilities | $ | 19,135,635 | $ | 19,880,795 | ||||
| Total stockholders' equity (deficit) - 16,223,281 and 11,707,051 common shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively | 4,555,195 | (6,248,723 | ) | |||||
| Total liabilities and stockholders' equity | $ | 23,690,830 | $ | 13,632,072 |
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance
Christopher Hippolyte