Full Press Release Details
Capricor Therapeutics
Reports Third Quarter 2016 Financial
Results and Provides Corporate Update
Completed Treatment in Phase I/II HOPE-Duchenne
and Phase II ALLSTAR Clinical Trials
Announced Planned Expansion of Clinical
Program in Duchenne Muscular Dystrophy to Evaluate CAP-1002 for Peripheral and Respiratory Muscle Improvement
Strengthened Balance Sheet with Net Proceeds
of $9.9 Million from Common Stock Offerings
Company to Host Conference Call and Webcast
Today at 5:00 p.m. ET
LOS ANGELES, November 10, 2016 - Capricor
Therapeutics, Inc. (NASDAQ: CAPR), a clinical-stage biotechnology company developing first-in-class biological therapies for cardiac
and other serious medical conditions, today provided a corporate update and announced financial results for the third quarter ended
Linda Marb n, Ph.D., president and
chief executive officer, said, "The third quarter was marked by meaningful progress in the development of our lead candidate,
CAP-1002 (allogeneic cardiosphere-derived cells), as we completed treatment in both our randomized, controlled Phase I/II HOPE-Duchenne
trial in boys and young men with Duchenne muscular dystrophy (DMD)-associated cardiomyopathy as well as in the randomized, double-blind,
placebo-controlled Phase II ALLSTAR trial in patients with large myocardial scar following a heart attack. We believe the rapid
enrollment in HOPE reflects the need to address what is currently recognized as the number one cause of death in the DMD population-the
progressive deterioration of the heart muscle due to the lack of the dystrophin protein. We look forward to reporting top-line
six-month data from HOPE early in the second quarter of next year."
Capricor successfully completed two concurrent
common stock offerings in September, adding approximately $9.9 million in combined net proceeds to the company's cash resources.
Capricor is sufficiently capitalized to advance CAP-1002 through several important clinical milestones and activities, including
the report of top-line six-month results from the HOPE trial as well as the initiation of a second clinical trial in DMD to evaluate
CAP-1002's potential to improve peripheral and respiratory muscle. The company remains on track to submit an Investigational
New Drug application (IND) to develop CAP-2003 (cardiosphere-derived cell exosomes) for the treatment of ocular graft-versus-host
disease, a debilitating eye condition, in the first half of 2017. Capricor is also exploring its exosome technology in other therapeutic
"Today we also announced that we
have expanded our clinical development program in DMD to evaluate CAP-1002's ability to improve skeletal muscle through systemic
intra-vascular delivery. We are committed to developing products that can offer the broadest therapeutic potential to boys and
young men with this progressively debilitating genetic disorder," added Dr. Marb n.
Third Quarter and Recent Operational
Anticipated Events and Milestones
Third Quarter Results
The Company reported a net loss of approximately $5.3 million, or $0.29 per share, for the third quarter of 2016, compared to a
net loss of approximately $2.9 million, or $0.18 per share, for the third quarter of 2015. At September 30, 2016, the Company's
cash, cash equivalents and marketable securities totaled approximately $20.5 million compared to approximately $13.6 million at
During the third quarter, Capricor sold approximately 3.4 million shares of common stock at a price of $3.20 per share in an underwritten
registered public offering and concurrent registered direct offering that resulted in combined net proceeds of approximately $9.9
million. Capricor currently expects that its cash, cash equivalents and marketable securities will fund its research and development
programs and other operations into the fourth quarter of 2017.
Conference Call and Webcast
Capricor management will hold a conference call at 5:00 p.m. ET today. The live call may be accessed by dialing (866)-320-0174
for domestic callers and (785) 424-1631 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 biological therapies for the treatment of cardiac and other serious medical conditions. 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 is 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 of Health.
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 offering 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 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 June 30, 2016, as filed with the Securities and Exchange Commission on August 15, 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, including CAP-2003, has not yet been approved
for clinical investigation.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| INCOME | ||||||||||||||||
| Collaboration income | $ | 683,595 | $ | 911,458 | $ | 2,506,511 | $ | 2,864,583 | ||||||||
| Grant income | 63,186 | 403,426 | 585,177 | 1,529,669 | ||||||||||||
| TOTAL INCOME | 746,781 | 1,314,884 | 3,091,688 | 4,394,252 | ||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 4,727,111 | 3,192,657 | 13,376,178 | 10,426,548 | ||||||||||||
| General and administrative | 1,259,744 | 972,782 | 3,778,699 | 3,294,601 | ||||||||||||
| TOTAL OPERATING EXPENSES | 5,986,855 | 4,165,439 | 17,154,877 | 13,721,149 | ||||||||||||
| LOSS FROM OPERATIONS | (5,240,074 | ) | (2,850,555 | ) | (14,063,189 | ) | (9,326,897 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 5,410 | 292 | 16,347 | 723 | ||||||||||||
| Interest expense | (98,749 | ) | (61,681 | ) | (241,760 | ) | (185,043 | ) | ||||||||
| TOTAL OTHER INCOME (EXPENSE) | (93,339 | ) | (61,389 | ) | (225,413 | ) | (184,320 | ) | ||||||||
| NET LOSS | (5,333,413 | ) | (2,911,944 | ) | (14,288,602 | ) | (9,511,217 | ) | ||||||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | (3,855 | ) | 5,414 | (8,462 | ) | 11,949 | ||||||||||
| COMPREHENSIVE LOSS | $ | (5,337,268 | ) | $ | (2,906,530 | ) | $ | (14,297,064 | ) | $ | (9,499,268 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.29 | ) | $ | (0.18 | ) | $ | (0.81 | ) | $ | (0.60 | ) | ||||
| Weighted average number of shares, | ||||||||||||||||
| basic and diluted | 18,286,816 | 16,242,090 | 17,594,749 | 15,783,224 |
CAPRICOR THERAPEUTICS,
SUMMARY BALANCE SHEETS
| September 30, 2016 (unaudited) | December 31, 2015 | |||||||
| Cash, cash equivalents and marketable securities | $ | 20,520,850 | $ | 13,567,316 | ||||
| Total assets | $ | 24,471,820 | $ | 16,069,572 | ||||
| Total deferred revenue | 2,050,781 | 4,557,292 | ||||||
| Total liabilities | $ | 24,422,689 | $ | 17,101,346 | ||||
| Total stockholders' equity (deficit) - 21,399,019 and 16,254,985 common shares issued and | ||||||||
| outstanding at September 30, 2016 and December 31, 2015, respectively | 49,131 | (1,031,774 | ) | |||||
| Total liabilities and stockholders' equity | $ | 24,471,820 | $ | 16,069,572 |
For more information, please contact:
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance