Full Press Release Details
Capricor Therapeutics
Reports First Quarter 2017 Financial Results and Provides Corporate Update
To Propose Registrational Strategy for
Duchenne Muscular Dystrophy Indication to FDA
LOS ANGELES, May 15, 2017 - Capricor
Therapeutics, Inc. (NASDAQ: CAPR) today announced its financial results for the first quarter ended March 31, 2017 and provided
an update on its business.
"Following our report in late April
of positive results from our ongoing HOPE-Duchenne clinical trial of CAP-1002, we look forward to meeting with the FDA to propose
a potential registrational strategy and clinical development plan for the Duchenne muscular dystrophy indication," said Linda
Marb n, Ph.D., president and CEO of Capricor. "We are delighted to announce that Dr. Francesco Muntoni, Professor
of Paediatric Neurology at University College London, and Head of the Dubowitz Neuromuscular Centre at Great Ormond Street Hospital,
has agreed to serve as a key advisor for our upcoming clinical trial of intravenous CAP-1002 in DMD."
"Although we remain disappointed
with last week's interim results from the ALLSTAR clinical trial of CAP-1002 in the heart attack setting, in which a signal
on the parameter of change in cardiac scar size was not observed, the inconsistency of the placebo response with the well-established
natural history of this disease process as well as the divergence from the extensive record observed with our cell technology together
warrant the conduct of further analyses to understand the factors that led to these unexpected observations," added Dr. Marb n.
"The observed reductions in left ventricular volume measures in the CAP-1002 treated patients, an important indicator of
reverse remodeling of the heart, support the biological activity of CAP-1002."
CAP-1002 Program in Duchenne Muscular
Other Recent Highlights
Anticipated Events and Milestones
First Quarter Financial Results
The Company reported a net loss of approximately $3.7 million, or $0.17 per share, for the first quarter of 2017, compared to a
net loss of approximately $4.3 million, or $0.26 per share, for the first quarter of 2016.
As of March 31, 2017, the Company's cash,
cash equivalents and marketable securities totaled approximately $11.7 million compared to approximately $16.2 million on December
31, 2016. Capricor believes that its current financial resources, including the proceeds from the recently-completed private placement,
should be sufficient to fund its operations and meet its financial obligations through the first quarter of 2018 based on the Company's
current projections.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company developing first-in-class biological therapies
for cardiac and other medical conditions. Capricor's lead candidate, CAP-1002, is a cell-based candidate currently in clinical
development for the treatment of Duchenne muscular dystrophy, myocardial infarction (heart attack), and heart failure. Capricor
is exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information,
visit www.capricor.com.
The ALLSTAR and HOPE-Duchenne clinical
trials are funded in part by 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 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 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, 2016, as filed with the Securities and Exchange Commission on March 16, 2017, and in its Registration Statement on Form S-3,
as filed with the Securities and Exchange Commission on September 28, 2015, together with prospectus supplements thereto. 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. Capricor's exosomes technology, including CAP-2003, has not yet been approved for clinical
CAPRICOR THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| Three months ended March 31, | ||||||||
| 2017 | 2016 | |||||||
| INCOME | ||||||||
| Collaboration income | $ | 683,594 | $ | 911,458 | ||||
| Grant income | 197,214 | 303,631 | ||||||
| TOTAL INCOME | 880,808 | 1,215,089 | ||||||
| OPERATING EXPENSES | ||||||||
| Research and development | 3,257,149 | 4,341,119 | ||||||
| General and administrative | 1,189,238 | 1,084,696 | ||||||
| TOTAL OPERATING EXPENSES | 4,446,387 | 5,425,815 | ||||||
| LOSS FROM OPERATIONS | (3,565,579 | ) | (4,210,726 | ) | ||||
| OTHER INCOME (EXPENSE) | ||||||||
| Investment income | 4,282 | 10,510 | ||||||
| Interest expense | (105,320 | ) | (66,125 | ) | ||||
| TOTAL OTHER INCOME (EXPENSE) | (101,038 | ) | (55,615 | ) | ||||
| NET LOSS | (3,666,617 | ) | (4,266,341 | ) | ||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||
| Net unrealized gain (loss) on marketable securities | 6,187 | (6,157 | ) | |||||
| COMPREHENSIVE LOSS | $ | (3,660,430 | ) | $ | (4,272,498 | ) | ||
| Net loss per share, basic and diluted | $ | (0.17 | ) | $ | (0.26 | ) | ||
| Weighted average number of shares, | ||||||||
| basic and diluted | 21,399,019 | 16,537,502 |
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
| March 31, 2017 (unaudited) | December 31, 2016 | |||||||
| Cash, cash equivalents and marketable securities | $ | 11,743,453 | $ | 16,194,888 | ||||
| Total assets | $ | 14,068,041 | $ | 18,747,355 | ||||
| Total deferred revenue | 683,592 | 1,367,186 | ||||||
| Total liabilities | $ | 21,259,835 | $ | 22,750,509 | ||||
| Total stockholders' equity (deficit) - 21,399,019 common shares issued and outstanding at March 31, 2017 and December 31, 2016 | (7,191,794 | ) | (4,003,154 | ) | ||||
| Total liabilities and stockholders' equity | $ | 14,068,041 | $ | 18,747,355 |
For more information, please contact:
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance