Full Press Release Details
Capricor Therapeutics
Reports Third Quarter 2017 Financial Results and Provides Update on Duchenne Muscular Dystrophy Development Program
12-Month Results from HOPE Clinical Trial
to be Presented Next Week at AHA
Potential Registration Trial Planned
to Initiate in the First Quarter of 2018
Company to Host Conference Call and Webcast
Today at 4:30 p.m. ET
LOS ANGELES, Nov. 8, 2017 - Capricor
Therapeutics, Inc. (NASDAQ: CAPR) today announced its financial results for the third quarter ended September 30, 2017 and provided
an update on its development of CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD).
"Our team has been busy with preparations
to launch the HOPE-2 clinical trial of CAP-1002, for which we recently submitted an Investigational New Drug application (IND)
to the FDA. We are actively building our organization in key functional areas as we continue to advance this candidate toward potential
registration," said Linda Marb n, Ph.D., president and chief executive officer. "In the near-term, we look forward
to the 12-month results from our HOPE clinical trial to be presented at the upcoming AHA meeting."
Third Quarter 2017 and Recent Highlights
Anticipated Events and Milestones
Third Quarter Financial Results
The Company reported a net loss of approximately $2.7 million, or $0.12 per share, for the third quarter of 2017, compared to a
net loss of approximately $5.3 million, or $0.29 per share, for the third quarter of 2016.
As of September 30, 2017, the Company's
cash, cash equivalents and marketable securities totaled approximately $13.9 million, compared to approximately $16.2 million on
December 31, 2016. Capricor believes that its current financial resources should be sufficient to fund its operations and meet
its financial obligations through the third quarter of 2018 based on the Company's current projections.
Conference Call and Webcast
The Company will host a conference call
at 4:30 p.m. ET today. To participate, please dial (866) 939-3921 (domestic) or (678) 302-3550 (international) and reference the
access code 45894700.
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
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 therapeutics for the treatment of rare disorders. Capricor's lead candidate,
CAP-1002, is an "off-the-shelf" cell therapy that is currently in clinical development for the treatment of Duchenne
muscular dystrophy. Capricor has also established itself as one of the leading companies investigating the field of extracellular
vesicles and 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 Phase I/II HOPE and Phase II ALLSTAR
clinical trials were 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; regulatory developments involving products, including the ability to obtain regulatory approvals
or otherwise bring products to market; 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, in its Registration Statement on Form S-3, as
filed with the Securities and Exchange Commission on September 28, 2015, together with the prospectus included therein and prospectus
supplements thereto, and in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, as filed with the Securities
and Exchange Commission on August 14, 2017. 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 (unaudited)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| INCOME | ||||||||||||||||
| Collaboration income | $ | - | $ | 683,595 | $ | 1,367,186 | $ | 2,506,511 | ||||||||
| Grant income | 260,771 | 63,186 | 770,855 | 585,177 | ||||||||||||
| Other income | 52,500 | - | 52,500 | - | ||||||||||||
| TOTAL INCOME | 313,271 | 746,781 | 2,190,541 | 3,091,688 | ||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 1,862,369 | 4,727,111 | 8,247,700 | 13,376,178 | ||||||||||||
| General and administrative | 1,088,635 | 1,259,744 | 3,524,815 | 3,778,699 | ||||||||||||
| TOTAL OPERATING EXPENSES | 2,951,004 | 5,986,855 | 11,772,515 | 17,154,877 | ||||||||||||
| LOSS FROM OPERATIONS | (2,637,733 | ) | (5,240,074 | ) | (9,581,974 | ) | (14,063,189 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 10,393 | 5,410 | 26,726 | 16,347 | ||||||||||||
| Interest expense | (107,653 | ) | (98,749 | ) | (318,500 | ) | (241,760 | ) | ||||||||
| TOTAL OTHER INCOME (EXPENSE) | (97,260 | ) | (93,339 | ) | (291,774 | ) | (225,413 | ) | ||||||||
| NET LOSS | (2,734,993 | ) | (5,333,413 | ) | (9,873,748 | ) | (14,288,602 | ) | ||||||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | 1,276 | (3,855 | ) | 5,069 | (8,462 | ) | ||||||||||
| COMPREHENSIVE LOSS | $ | (2,733,717 | ) | $ | (5,337,268 | ) | $ | (9,868,679 | ) | $ | (14,297,064 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.29 | ) | $ | (0.44 | ) | $ | (0.81 | ) | ||||
| Weighted average number of shares, basic and diluted | 23,378,141 | 18,286,816 | 22,311,369 | 17,594,749 |
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
| September 30, 2017 (unaudited) | December 31, 2016 | |||||||
| Cash, cash equivalents and marketable securities | $ | 13,894,937 | $ | 16,194,888 | ||||
| Total assets | $ | 15,793,539 | $ | 18,747,355 | ||||
| Total deferred revenue | - | 1,367,186 | ||||||
| Total liabilities | $ | 20,064,313 | $ | 22,750,509 | ||||
| Total stockholders' equity (deficit) - 25,100,388 and 21,399,019 common shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | (4,270,774 | ) | (4,003,154 | ) | ||||
| Total liabilities and stockholders' equity | $ | 15,793,539 | $ | 18,747,355 |
For more information, please contact:
AJ Bergmann, Vice President of Finance