Full Press Release Details
Capricor Therapeutics Reports First Quarter
2018 Financial Results and Provides Corporate Update
HOPE-2 Clinical Trial is Currently Enrolling
Conference Call and Webcast
Today at 4:30 p.m. ET
LOS ANGELES, May 10, 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 announced its financial results for the first
quarter, which ended March 31, 2018, and provided a corporate update.
"We are excited by the recent initiation
of the HOPE-2 clinical trial 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. "CAP-1002 is one of the very few clinical initiatives
to focus on helping boys and young men who are in later stages of the disease process and whose ability to walk has been seriously
impaired by the loss of muscle function as a result of the disease. We have seen the potential for improvements in muscle function
in both pre-clinical studies and in our earlier HOPE-Duchenne trial, and we have been granted the RMAT and orphan disease designations
by the U.S. Food and Drug Administration (FDA) for CAP-1002 for Duchenne muscular dystrophy."
These designations enable Capricor to work
closely with the FDA in finalizing the regulatory approval pathway for CAP-1002 and to receive expedited FDA reviews.
"We are hopeful that HOPE-2 may potentially
be a registration trial," said Dr. Marb n. "We see CAP-1002 as an important tool in the toolbox to treat Duchenne
muscular dystrophy because it may work synergistically with the emerging disease-modifying therapies. While gene and other therapies
have the potential to restore dystrophin expression and sustain muscle function, there will still be significant inflammation and
fibrosis, which can offset the restorative effects. CAP-1002's primary mechanism of action is immunomodulatory, meaning it
can help balance inflammation in this chronic inflammatory disease."
First Quarter 2018 Highlights and Recent
Clinical and Operational Developments
Anticipated Milestones in 2018
First Quarter 2018 Financial Results
The Company reported a net loss of approximately
$3.7 million, or $0.14 per share, for the first quarter of 2018, compared to a net loss of approximately $3.7 million, or $0.17
per share, for the first quarter of 2017.
As of March 31, 2018, the Company's cash,
cash equivalents and marketable securities totaled approximately $13.2 million, compared to approximately $14.1 million on December
31, 2017. Additionally, in the first quarter of 2018, Capricor raised approximately $2.4 million in net proceeds at an average
price of approximately $1.88 per share under its at-the-market offering program. Capricor believes that its current financial resources
should be sufficient to fund its operations and meet its financial obligations into the first quarter of 2019 based on the Company's
current projections.
Conference Call and Webcast
To participate in the conference call,
please dial 866-717-4562 (domestic) or 210-874-7812 (international) and reference the access code 5795736.
To participate via a webcast, please visit
https://edge.media-server.com/m6/p/qz4u7wox. The webcast will be archived for approximately
30 days and will be available at http://capricor.com/news/events/.
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. For more information, visit www.capricor.com.
Keep up with Capricor on social media:
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, 2017 as filed with the Securities and Exchange Commission on March 22, 2018, and 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. 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 THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
| Three months ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| INCOME | ||||||||
| Collaboration income | $ | - | $ | 683,594 | ||||
| Grant income | 306,750 | 197,214 | ||||||
| Other income | 93,316 | - | ||||||
| TOTAL INCOME | 400,066 | 880,808 | ||||||
| OPERATING EXPENSES | ||||||||
| Research and development | 2,696,517 | 3,257,149 | ||||||
| General and administrative | 1,389,732 | 1,189,238 | ||||||
| TOTAL OPERATING EXPENSES | 4,086,249 | 4,446,387 | ||||||
| LOSS FROM OPERATIONS | (3,686,183 | ) | (3,565,579 | ) | ||||
| OTHER INCOME (EXPENSE) | ||||||||
| Investment income | 14,653 | 4,282 | ||||||
| Interest expense | - | (105,320 | ) | |||||
| TOTAL OTHER INCOME (EXPENSE) | 14,653 | (101,038 | ) | |||||
| NET LOSS | (3,671,530 | ) | (3,666,617 | ) | ||||
| OTHER COMPREHENSIVE INCOME (LOSS) | ||||||||
| Net unrealized gain on marketable securities | 8,709 | 6,187 | ||||||
| COMPREHENSIVE LOSS | $ | (3,662,821 | ) | $ | (3,660,430 | ) | ||
| Net loss per share, basic and diluted | $ | (0.14 | ) | $ | (0.17 | ) | ||
| Weighted average number of shares, basic and diluted | 26,905,331 | 21,399,019 |
| CAPRICOR THEAPEUTICS, INC. |
| SUMMARY BALANCE SHEETS |
| March 31, 2018 (unaudited) | December 31, 2017 | |||||||
| Cash, cash equivalents and marketable securities | $ | 13,164,642 | $ | 14,124,935 | ||||
| Total assets | $ | 15,388,422 | $ | 16,273,789 | ||||
| Total liabilities | $ | 4,854,158 | $ | 5,046,934 | ||||
| Total stockholders' equity - 27,970,879 and 26,270,491 common shares issued and | ||||||||
| outstanding at March 31, 2018 and December 31, 2017, respectively | 10,534,264 | 11,226,855 | ||||||
| Total liabilities and stockholders' equity | $ | 15,388,422 | $ | 16,273,789 |
For more information, please contact:
AJ Bergmann, Chief Financial Officer