Full Press Release Details
Capricor Therapeutics Reports First
Quarter 2015 Financial & Business Highlights
Company to Host Conference Call and Webcast
at 4:30 p.m. EDT, Today, May 12, 2015
May 12, 2015 -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company focused on developing novel therapeutics
for the treatment of cardiovascular diseases, today provided a business and financial update for the first quarter ended March
First Quarter and Recent Operational
first quarter of 2015 was an important period for the Company on a number of fronts," said Linda Marb n, Ph.D., Chief
Executive Officer of Capricor. "We strengthened our financial position by raising approximately $17.0 million in two private
placements during the quarter. Both our CDC and Cenderitide programs continue to advance as we initiated and completed the first
arm of the DYNAMIC trial of CAP-1002 in advanced heart failure, received Orphan Drug status for CAP-1002 for the treatment of
cardiomyopathy-associated DMD and initiated and completed enrollment of the Phase II trial using Cenderitide in chronic heart
failure patients. We look forward to reporting on these studies in the coming quarters."
Upcoming Clinical Development Milestones
CDCs (Cardiosphere-Derived Cells)
| 1H15: | Submit IND for DMD-associated cardiomyopathy | |
| 2H15: | Report initial DYNAMIC top-line results | |
| 2H15: | Initiate HOPE-DUCHENNE clinical trial to treat DMD-associated cardiomyopathy | |
| 4Q16-1Q17: | ALLSTAR Phase II top-line data |
Cenderitide (Natriuretic Peptide)
| 2H15: | Report initial Cenderitide top-line results | |
| 2H15: | Announce clinical development program for natriuretic peptides |
Upcoming Investor Presentations
Capricor Therapeutics will participate
in the following conferences in the second quarter of 2015:
Results of Operations for the quarter
ended March 31, 2015
For the quarter ended March 31, 2015, the
Company had cash, cash equivalents and marketable securities totaling approximately $22.4 million, plus approximately $2.0 million
restricted cash from the Company's' loan award, granted by the California Institute for Regenerative Medicine (CIRM),
totaling approximately $24.5 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 $0.9 million
compared to that reported as of December 31, 2014 as a result of expenses related to the ALLSTAR clinical trial.
For the quarter ended March 31, 2015, the
Company reported a net loss of approximately $3.5 million, or $0.23 per basic and diluted share, compared to a net loss of approximately
$1.2 million, or $0.10 per basic and diluted share, for the same period in the prior year. Research and development expenses increased
to approximately $3.8 million in the quarter ended March 31, 2015, compared to approximately $1.4 million for the same period in
the prior year. The increase was primarily due to the initiation of clinical trials, including the DYNAMIC trial and the Cenderitide
Phase II trial in heart failure, as well as the ongoing ALLSTAR Phase II clinical trial. General and administrative expenses increased
to approximately $1.4 million in the quarter ended March 31, 2015, compared to approximately $0.9 million for the same period in
the prior year. The increase was primarily due to increases in compensation costs and non-cash stock-based compensation.
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 can be found at www.capricor.com/investors/.
Additionally, conference call details and a link to the replay of the webcast will be archived for approximately 90 days
and will be available at www.capricor.com/investors/.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR)
is a clinical-stage biotechnology company with expertise in the field of cardiovascular disease aiming to develop novel therapies
for diseases with significant unmet medical needs. Our lead programs target post myocardial infarction (heart attack), heart failure
and Duchenne Muscular Dystrophy. The Company has two leading product candidates under investigation: Cenderitide, a natriuretic
peptide receptor agonist, and CAP-1002, a cardiac cell therapy. Cenderitide is in development for the outpatient treatment of heart
failure as well as potential other indications. CAP-1002 is in development for the treatment of post myocardial infarction (heart
attack), advanced heart failure and Duchenne muscular dystrophy associated cardiomyopathy. 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, and in our Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on March 6, 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.
CONTACT: Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance
Christopher Hippolyte
CAPRICOR THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| Three months ended March 31, | ||||||||
| 2015 | 2014 | |||||||
| INCOME | ||||||||
| Collaboration income | $ | 1,041,667 | $ | 1,041,667 | ||||
| Grant income | 746,235 | - | ||||||
| TOTAL INCOME | 1,787,902 | 1,041,667 | ||||||
| OPERATING EXPENSES | ||||||||
| Research and development | 3,807,087 | 1,374,757 | ||||||
| General and administrative | 1,395,540 | 852,347 | ||||||
| TOTAL OPERATING EXPENSES | 5,202,627 | 2,227,104 | ||||||
| LOSS FROM OPERATIONS | (3,414,725 | ) | (1,185,437 | ) | ||||
| OTHER INCOME (EXPENSE) | ||||||||
| Investment income | 275 | 153 | ||||||
| Interest expense | (61,681 | ) | (25,327 | ) | ||||
| TOTAL OTHER INCOME (EXPENSE) | (61,406 | ) | (25,174 | ) | ||||
| NET LOSS | (3,476,131 | ) | (1,210,611 | ) | ||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||
| Net unrealized gain (loss) on marketable securities | (3,940 | ) | 576 | |||||
| COMPREHENSIVE LOSS | $ | (3,480,071 | ) | $ | (1,210,035 | ) | ||
| Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (0.10 | ) | ||
| Weighted average number of shares, | ||||||||
| basic and diluted | 14,869,746 | 11,689,441 |
CAPRICOR THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET
| March 31, 2015 (unaudited) | December 31, 2014 | |||||||
| Cash, cash equivalents and marketable securities | $ | 22,423,110 | $ | 8,034,765 | ||||
| Total Assets | $ | 27,471,047 | $ | 13,632,072 | ||||
| Total deferred revenue | 7,291,666 | 8,333,333 | ||||||
| Total liabilities | $ | 20,146,503 | $ | 19,880,795 | ||||
| Total stockholders' equity (deficit) - 16,221,985 and 11,707,051 common shares issued and | ||||||||
| outstanding at March 31, 2015 and December 31, 2014, respectively | 7,324,544 | (6,248,723 | ) | |||||
| Total liabilities and stockholders' equity | $ | 27,471,047 | $ | 13,632,072 |