PR Newswire
LOS ANGELES, Aug. 10, 2017
LOS ANGELES, Aug. 10, 2017 /PRNewswire/ -- 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 Marbán, 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. Marbán.
Second Quarter 2017 and Recent Highlights
CAP-1002 for Duchenne Muscular Dystrophy
CAP-1002 for Adult Heart Conditions
Corporate
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 30 days.
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
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 investigation.
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
+1-310-358-3200
[email protected]
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SOURCE Capricor Therapeutics, Inc.
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