Full Press Release Details
Capricor Therapeutics
Reports Fourth Quarter and Full Year 2016
Financial Results and Provides Corporate Update
To Report Top-Line Six-Month Results
from the Randomized HOPE-Duchenne Clinical Trial in April 2017
Company to Host Conference Call and Webcast
Today at 4:30 p.m. ET
LOS ANGELES, March 15, 2017 - Capricor
Therapeutics, Inc. (NASDAQ: CAPR), a clinical-stage biotechnology company developing first-in-class biological therapies for cardiac
and other medical conditions, today provided a corporate update and announced financial results for the fourth quarter and full
year ended December 31, 2016.
"2016 was an eventful year for Capricor,
marked by meaningful advances in our clinical development programs as well as notable corporate achievements," said Linda
Marb n, Ph.D., president and chief executive officer. "Patient follow-up in both the Phase I/II HOPE-Duchenne and
Phase II ALLSTAR clinical trials of CAP-1002 continues following the completion of dosing in each of these trials last fall. We
look forward to announcing top-line six-month results from HOPE next month. By the third quarter, we anticipate hearing from Janssen
on its decision with regard to its license option, following our anticipated delivery of the six-month administrative analysis
from ALLSTAR. Our exosomes program continues to generate encouraging preclinical data in models of inflammatory disease, and we
look forward to submitting the first Investigational New Drug application for CAP-2003 in the second half of this year."
"Capricor ended 2016 with approximately
$16.2 million in cash, cash equivalents and marketable securities, which we believe will fund our operations into the fourth quarter
of 2017. Importantly, we expect our existing resources to enable us to achieve important near-term milestones for our CAP-1002
program," added Dr. Marb n.
Fourth Quarter Highlights and Recent
Clinical and Operational Developments
Anticipated Events and Milestones in
Fourth Quarter and Full Year Financial Results
The Company reported a net loss of approximately $4.5 million, or $0.21 per share, for the fourth quarter of 2016, compared to
a net loss of approximately $3.3 million, or $0.21 per share, for the fourth quarter of 2015. For the year ended December 31, 2016,
the Company reported a net loss of approximately $18.8 million, or $1.01 per share, compared to a net loss of approximately $12.9
million, or $0.81 per share, for the year ended December 31, 2015. As of December 31, 2016, the Company's cash, cash equivalents
and marketable securities totaled approximately $16.2 million compared to approximately $13.6 million on December 31, 2015.
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 4:30 p.m. ET today. The live call may be accessed by dialing 1-866-682-6100
for domestic callers and 1-862-255-5401 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 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 exploring CAP-2003, its exosome product
candidate, for use in cardiac and inflammatory conditions. For additional information, visit www.capricor.com.
The ALLSTAR and HOPE-Duchenne clinical
trials are funded in part by the California Institute for Regenerative Medicine. The DYNAMIC clinical trial 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 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 will be set forth in Capricor's Annual Report on Form 10-K for the year ended
December 31, 2016, to be filed with the Securities and Exchange Commission, 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
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. |
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
| Three months ended December 31, | Years ended December 31, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| INCOME | ||||||||||||||||
| Collaboration income | $ | 683,595 | $ | 911,458 | $ | 3,190,106 | $ | 3,776,041 | ||||||||
| Grant income | 223,335 | 211,938 | 808,512 | 1,741,607 | ||||||||||||
| TOTAL INCOME | 906,930 | 1,123,396 | 3,998,618 | 5,517,648 | ||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 2,665,904 | 3,330,731 | 16,042,082 | 13,757,279 | ||||||||||||
| General and administrative | 1,154,355 | 1,077,594 | 4,933,054 | 4,372,195 | ||||||||||||
| TOTAL OPERATING EXPENSES | 3,820,259 | 4,408,325 | 20,975,136 | 18,129,474 | ||||||||||||
| LOSS FROM OPERATIONS | (2,913,329 | ) | (3,284,929 | ) | (16,976,518 | ) | (12,611,826 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income (loss) | (1,940 | ) | 2,390 | 14,407 | 3,113 | |||||||||||
| Interest expense | (102,905 | ) | (63,583 | ) | (344,665 | ) | (248,626 | ) | ||||||||
| Impairment of in-process research and development | (1,500,000 | ) | - | (1,500,000 | ) | - | ||||||||||
| TOTAL OTHER INCOME (EXPENSE) | (1,604,845 | ) | (61,193 | ) | (1,830,258 | ) | (245,513 | ) | ||||||||
| NET LOSS | (4,518,174 | ) | (3,346,122 | ) | (18,806,776 | ) | (12,857,339 | ) | ||||||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | 2,601 | (2,564 | ) | (5,861 | ) | 9,385 | ||||||||||
| COMPREHENSIVE LOSS | $ | (4,515,573 | ) | $ | (3,348,686 | ) | $ | (18,812,637 | ) | $ | (12,847,954 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.21 | ) | $ | (0.21 | ) | $ | (1.01 | ) | $ | (0.81 | ) | ||||
| Weighted average number of shares, | ||||||||||||||||
| basic and diluted | 21,399,019 | 16,254,985 | 18,551,013 | 15,902,133 |
| CAPRICOR THERAPEUTICS, INC. |
| SUMMARY BALANCE SHEETS |
| December 31, 2016 | December 31, 2015 | |||||||
| Cash, cash equivalents and marketable securities | $ | 16,194,888 | $ | 13,567,316 | ||||
| Total assets | $ | 18,747,355 | $ | 16,069,572 | ||||
| Total deferred revenue | 1,367,186 | 4,557,292 | ||||||
| Total liabilities | $ | 22,750,509 | $ | 17,101,346 | ||||
| Total stockholders' equity (deficit) - 21,399,019 and 16,254,985 common shares issued and | ||||||||
| outstanding at December 31, 2016 and December 31, 2015, respectively | (4,003,154 | ) | (1,031,774 | ) | ||||
| Total liabilities and stockholders' equity | $ | 18,747,355 | $ | 16,069,572 |
For more information, please contact:
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance