Full Press Release Details
Capricor Presents Fourth Quarter and
Full Year 2017 Financial Results and Corporate Update
Planning to Initiate HOPE-2 Clinical
To Host Conference Call
and Webcast Today at 4:30 p.m. ET
LOS ANGELES, March 14, 2018 - Capricor
Therapeutics (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics
for the treatment of Duchenne muscular dystrophy and other rare disorders, today reported its fourth quarter and full year 2017
financial results. It also provided a corporate update.
"This has been an exciting year for
Capricor as we have made significant inroads in the clinical development of CAP-1002, our lead cell therapy product, to treat Duchenne
muscular dystrophy," said Linda Marb n, Ph.D., Capricor president and chief executive officer. "We have achieved
several important milestones that facilitate our progress in the research, development and potential commercialization of CAP-1002.
We will soon be initiating the HOPE-2 clinical trial designed to test CAP-1002 in boys and young men whose ability to walk has
been impaired by Duchenne muscular dystrophy. This trial is one of the very few to focus on those patients that are non-ambulant
and in the later stages of the disease process."
Fourth Quarter Highlights and Recent Clinical and Operational
Anticipated Events and Milestones in 2018
Fourth Quarter and Full Year Financial Results
For the fourth quarter of 2017, after giving
effect to the forgiveness of the California Institute of Regenerative Medicine (CIRM) loan payable, the company reported net income
of approximately $12.3 million, or $0.42 per diluted share, compared to a net loss of approximately $(4.5) million, or $(0.21)
per diluted share, for the fourth quarter of 2016.
For the year ended December 31, 2017, after
giving effect to the forgiveness of the CIRM loan payable, the company reported net income of approximately $2.4 million, or $0.09
per diluted share, compared to a net loss of approximately $(18.8) million, or $(1.01) per diluted share for the year ended December
31, 2016. As of December 31, 2017, the company's cash, cash equivalents and marketable securities totaled approximately $14.1 million
compared to approximately $16.2 million on December 31, 2016.
In the fourth quarter of 2017, the company
notified CIRM of its election to abandon the ALLSTAR (CIRM-funded) project pursuant to the Loan Agreement and entered into an Amendment
whereby the total loan balance was forgiven by CIRM, thereby terminating the company's obligation to repay the loan balance.
The company classified the forgiveness of the loan payable, a non-cash income, of approximately $15.7 million as "other income"
in its Consolidated Statement of Operations.
Based on current plans and projections,
Capricor expects that its cash, cash equivalents and marketable securities will fund its research and development programs and
other operations through the fourth quarter of 2018.
Conference Call and Webcast
To participate in the conference call,
please dial 866-717-4562 (U.S.) or 210-874-7812 (international) and enter the conference ID of 4139889. To join via webcast, please
visit: https://edge.media-server.com/m6/p/gwkzzdrc. 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
therapeutics for the treatment of rare disorders. Capricor's lead candidate, CAP-1002, is an allogeneic 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. The HOPE-Duchenne trial was funded in part by CIRM. For more information,
visit www.capricor.com.
Keep up with Capricor on social
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; 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 September 30, 2017, as filed with the Securities
and Exchange Commission on November 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. CAP-2003 has not yet been approved for clinical investigation.
CAPRICOR THEAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
| Three months ended December 31 | Years ended December 31 | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| INCOME | ||||||||||||||||
| Collaboration income | $ | - | $ | 683,595 | $ | 1,367,186 | $ | 3,190,106 | ||||||||
| Grant income | 344,575 | 223,335 | 1,115,430 | 808,512 | ||||||||||||
| Other income | 131,224 | - | 183,724 | - | ||||||||||||
| TOTAL INCOME | 475,799 | 906,930 | 2,666,340 | 3,998,618 | ||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 2,518,395 | 2,665,904 | 10,766,095 | 16,042,082 | ||||||||||||
| General and administrative | 1,237,827 | 1,154,355 | 4,762,642 | 4,933,054 | ||||||||||||
| TOTAL OPERATING EXPENSES | 3,756,222 | 3,820,259 | 15,528,737 | 20,975,136 | ||||||||||||
| LOSS FROM OPERATIONS | (3,280,423 | ) | (2,913,329 | ) | (12,862,397 | ) | (16,976,518 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 11,768 | (1,940 | ) | 38,494 | 14,407 | |||||||||||
| Interest expense | (80,307 | ) | (102,905 | ) | (398,807 | ) | (344,665 | ) | ||||||||
| Forgiveness of loan payable | 15,654,133 | - | 15,654,133 | - | ||||||||||||
| Impairment of in-process research and development | - | (1,500,000 | ) | - | (1,500,000 | ) | ||||||||||
| TOTAL OTHER INCOME (EXPENSE) | 15,585,594 | (1,604,845 | ) | 15,293,820 | (1,830,258 | ) | ||||||||||
| NET INCOME (LOSS) | 12,305,171 | (4,518,174 | ) | 2,431,423 | (18,806,776 | ) | ||||||||||
| OTHER COMPREHENSIVE INCOME (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | 3,027 | 2,601 | 8,096 | (5,861 | ) | |||||||||||
| COMPREHENSIVE INCOME (LOSS) | $ | 12,308,198 | $ | (4,515,573 | ) | $ | 2,439,519 | $ | (18,812,637 | ) | ||||||
| Net income (loss) per share - basic | $ | 0.48 | $ | (0.21 | ) | $ | 0.10 | $ | (1.01 | ) | ||||||
| Weighted average number of shares - basic | 25,810,249 | 21,399,019 | 23,193,278 | 18,551,013 | ||||||||||||
| Net income (loss) per share - diluted | $ | 0.42 | $ | (0.21 | ) | $ | 0.09 | $ | (1.01 | ) | ||||||
| Weighted average number of shares - diluted | 29,471,009 | 21,399,019 | 26,788,076 | 18,551,013 |
CAPRICOR THEAPEUTICS, INC.
SUMMARY BALANCE SHEETS
| December 31, 2017 | December 31, 2016 | |||||||
| Cash, cash equivalents and marketable securities | $ | 14,124,935 | $ | 16,194,888 | ||||
| Total assets | $ | 16,273,789 | $ | 18,747,355 | ||||
| Total deferred revenue | - | 1,367,186 | ||||||
| Total liabilities | $ | 5,046,934 | $ | 22,750,509 | ||||
| Total stockholders' equity (deficit) - 26,270,491 and 21,399,019 common shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively | 11,226,855 | (4,003,154 | ) | |||||
| Total liabilities and stockholders' equity | $ | 16,273,789 | $ | 18,747,355 |
For more information, please contact:
AJ Bergmann, Chief Financial Officer