Full Press Release Details
Capricor Therapeutics Reports First Quarter
2019 Financial Results and Provides Corporate Update
On Track to Report Interim Data from
HOPE-2 Clinical Trial in Early Q3
To Host Conference Call and Webcast Today
LOS ANGELES, May 13, 2019 - 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 2019 and provided a corporate update.
"We continue with 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. Our HOPE-2 clinical trial, which is testing the safety and efficacy of CAP-1002
in boys and young men in the advanced stages of Duchenne, has enrolled 20 patients to date. Previous pre-clinical and clinical
studies have shown that CAP-1002 is generally safe, well-tolerated and demonstrated significant and sustained signals of improvement
in cardiac and skeletal muscle function in patients with Duchenne muscular dystrophy. We will be conducting an interim analysis
in early Q3 and look forward to sharing that data with the patient and investor community."
Capricor has been granted RMAT
and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for CAP-1002 for the treatment of Duchenne muscular
CAP-2003 is comprised of proprietary extracellular
vesicles, including exosomes, which are derived from cardiosphere-derived cells. Exosomes are nano-sized, membrane-enclosed vesicles,
that are secreted by cells and contain bioactive molecules, including proteins, RNAs and microRNAs. Exosomes act as messengers
to regulate the functions of neighboring cells. Because of these unique capacities, researchers are increasingly viewing exosomes
as both a potential therapeutic and a vehicle to deliver gene and other therapies to targeted tissues in the human body.
"We continue to be encouraged by
exciting developments in the exosomes field and we continue to explore their use as a potential therapeutic and as a delivery vehicle
for genes and other drugs to targeted tissues," said Dr. Marb n.
First Quarter Highlights and Recent
Clinical and Operational Developments
Anticipated Events and Milestones in 2019
First Quarter Financial Results
The Company reported a net loss of approximately
$2.5 million, or $0.08 per share, for the first quarter of 2019, compared to a net loss of approximately $3.7 million, or $0.14
per share, for the first quarter of 2018.
As of March 31, 2019, the Company's
cash, cash equivalents and marketable securities totaled approximately $7.2 million compared to approximately $7.3 million on December
31, 2018. Additionally, in the first quarter of 2019, Capricor raised approximately $1.4 million in net proceeds at an average
price of approximately $0.66 per share under its at-the-market offering program. The Company's at-the-market offering program
expired on April 23, 2019.
Capricor believes that its current financial
resources should be sufficient to fund its operations and meet its financial obligations into the fourth 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: 4575759
To participate via a webcast, please visit:
https://edge.media-server.com/m6/p/zxabvq2r. The webcast will be archived for approximately 30 days and will be available
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 the California Institute
for Regenerative Medicine. For more information, visit www.capricor.com.
Keep up with Capricor on social media: www.facebook.com/capricortherapeutics,
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, 2018 as filed with the Securities and Exchange Commission on March 29, 2019, and as amended by its Amendment No. 1 to Annual
Report on Form 10-K/A filed with the Securities and Exchange Commission on April 1, 2019. 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| Three months ended March 31, | ||||||||
| 2019 | 2018 | |||||||
| REVENUE | ||||||||
| Revenue | $ | 230,504 | $ | 400,066 | ||||
| OPERATING EXPENSES | ||||||||
| Research and development | 1,811,182 | 2,696,517 | ||||||
| General and administrative | 976,490 | 1,389,732 | ||||||
| TOTAL OPERATING EXPENSES | 2,787,672 | 4,086,249 | ||||||
| LOSS FROM OPERATIONS | (2,557,168 | ) | (3,686,183 | ) | ||||
| OTHER INCOME (EXPENSE) | ||||||||
| Investment income | 37,823 | 14,653 | ||||||
| NET LOSS | (2,519,345 | ) | (3,671,530 | ) | ||||
| OTHER COMPREHENSIVE INCOME (LOSS) | ||||||||
| Net unrealized gain (loss) on marketable securities | (12,393 | ) | 8,709 | |||||
| COMPREHENSIVE LOSS | $ | (2,531,738 | ) | $ | (3,662,821 | ) | ||
| Net loss per share, basic and diluted | $ | (0.08 | ) | $ | (0.14 | ) | ||
| Weighted average number of shares, basic and diluted | 32,903,837 | 26,905,331 |
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
| March 31, 2019 (unaudited) | December 31, 2018 | |||||||
| Cash, cash equivalents and marketable securities | $ | 7,170,220 | $ | 7,256,416 | ||||
| Total assets | $ | 8,617,505 | $ | 9,247,065 | ||||
| Total liabilities | $ | 4,877,203 | $ | 4,631,478 | ||||
| Total stockholders' equity - 33,661,346 and 31,387,729 common shares issued and | ||||||||
| outstanding at March 31, 2019 and December 31, 2018, respectively | 3,740,302 | 4,615,587 | ||||||
| Total liabilities and stockholders' equity | $ | 8,617,505 | $ | 9,247,065 |
For more information, please contact:
AJ Bergmann, Chief Financial Officer