Full Press Release Details
Capricor Therapeutics
Reports Second Quarter 2017 Financial
Results and Provides Corporate Update
Announced Statistically-Significant Improvements
in Skeletal and Cardiac Muscle Function in
Patients Treated with CAP-1002 in the HOPE-Duchenne Trial
Plans to Commence Clinical Trial of I.V.
CAP-1002 in Duchenne Muscular Dystrophy in the
Company to Host Conference Call and Webcast
Today at 4:30 p.m. ET
LOS ANGELES, August 10, 2017 - Capricor
Therapeutics, Inc. (NASDAQ: CAPR) today announced its financial results for the second quarter ended June 30, 2017 and
provided an update on its business.
"In April, we reported positive interim
results from our ongoing HOPE-Duchenne clinical trial which have ignited the interest of patients, advocates and thought leaders
who constitute the greater Duchenne muscular dystrophy community. These results are particularly notable given the patients'
advanced disease as approximately 70% of trial participants were wheelchair-dependent at entry," said Linda Marb n,
Ph.D., president and CEO of Capricor. "A key finding in HOPE-Duchenne was that, as compared to usual care controls, patients
treated with CAP-1002 demonstrated improvement in skeletal muscle function according to the Performance of the Upper Limb (PUL)
test, a validated instrument."
"Having now obtained clarity from
the U.S. Food and Drug Administration (FDA) on a development plan that could potentially support a Biologics License Application
(BLA) for CAP-1002, we are preparing to conduct our next clinical trial in DMD, which will evaluate the ability of intravenous
CAP-1002 to improve skeletal muscle function as measured by the PUL. We expect this to commence in the fourth quarter of this year,
subject to regulatory approval."
"We also continue to advance our
exosomes technology, with CAP-2003 expected to enter the clinic next year for the treatment of hypoplastic left heart syndrome
(HLHS), a life-threatening congenital cardiac malformation," added Dr. Marb n.
Second Quarter 2017 and Recent Highlights
CAP-1002 for Duchenne Muscular Dystrophy
CAP-1002 for Adult Heart Conditions
Anticipated Events and Milestones
Second Quarter Financial Results
The Company reported a net loss of approximately $3.5 million, or $0.16 per share, for the second quarter of 2017, compared to
a net loss of approximately $4.7 million, or $0.26 per share, for the second quarter of 2016.
As of June 30, 2017, the Company's cash,
cash equivalents and marketable securities totaled approximately $12.3 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 second 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) 868-1282 (domestic) or (847) 413-2405 (international) and reference the
access code 7522998. Slides to accompany the call may be viewed via the webcast link at http://wsw.com/webcast/cc/capr3.
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 developing first-in-class biological therapies.
Capricor's lead candidate, CAP-1002, is a cell-based candidate currently in clinical development for the treatment of Duchenne
muscular dystrophy. Capricor is also 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, and in
its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the Securities and Exchange Commission on
May 15, 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 June 30, | Six months ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| INCOME | ||||||||||||||||
| Collaboration income | $ | 683,592 | $ | 911,458 | $ | 1,367,186 | $ | 1,822,916 | ||||||||
| Grant income | 312,870 | 218,361 | 510,083 | 521,992 | ||||||||||||
| TOTAL INCOME | 996,462 | 1,129,819 | 1,877,269 | 2,344,908 | ||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 3,128,182 | 4,307,948 | 6,385,331 | 8,649,067 | ||||||||||||
| General and administrative | 1,246,942 | 1,434,259 | 2,436,181 | 2,518,955 | ||||||||||||
| TOTAL OPERATING EXPENSES | 4,375,124 | 5,742,207 | 8,821,512 | 11,168,022 | ||||||||||||
| LOSS FROM OPERATIONS | (3,378,662 | ) | (4,612,388 | ) | (6,944,243 | ) | (8,823,114 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 12,052 | 427 | 16,334 | 10,937 | ||||||||||||
| Interest expense | (105,527 | ) | (76,887 | ) | (210,847 | ) | (143,011 | ) | ||||||||
| TOTAL OTHER INCOME (EXPENSE) | (93,475 | ) | (76,460 | ) | (194,513 | ) | (132,074 | ) | ||||||||
| NET LOSS | (3,472,137 | ) | (4,688,848 | ) | (7,138,756 | ) | (8,955,188 | ) | ||||||||
| OTHER COMPREHENSIVE GAIN (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | (2,394 | ) | 1,551 | 3,793 | (4,607 | ) | ||||||||||
| COMPREHENSIVE LOSS | $ | (3,474,531 | ) | $ | (4,687,297 | ) | $ | (7,134,963 | ) | $ | (8,959,795 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.26 | ) | $ | (0.33 | ) | $ | (0.52 | ) | ||||
| Weighted average number of shares, | ||||||||||||||||
| basic and diluted | 22,135,198 | 17,952,323 | 21,769,142 | 17,244,912 |
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
| June 30, 2017 (unaudited) | December 31, 2016 | |||||||
| Cash, cash equivalents and marketable securities | $ | 12,259,417 | $ | 16,194,888 | ||||
| Total assets | $ | 14,218,267 | $ | 18,747,355 | ||||
| Total deferred revenue | - | 1,367,186 | ||||||
| Total liabilities | $ | 20,804,643 | $ | 22,750,509 | ||||
| Total stockholders' equity (deficit) - 22,595,310 and 21,399,019 common shares | ||||||||
| issued and outstanding at June 30, 2017 and December 31, 2016, respectively | (6,586,376 | ) | (4,003,154 | ) | ||||
| Total liabilities and stockholders' equity | $ | 14,218,267 | $ | 18,747,355 |
For more information, please contact:
AJ Bergmann, Vice President of Finance