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Capricor Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update Plan to Report Interim Data from HOPE-2 Clinical Trial in Early Q3 To Host Conference Call and Webcast Today

Key Takeaway: Capricor Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update Plan to Report Interim Data from HOPE-2 Clinical Trial in Early Q3 To Host Conference Call and Webcast Today LOS ANGELES, March 28, 2019 - Capricor Therapeutics

Full Press Release Details

Capricor Therapeutics Reports Fourth
Quarter and Full Year 2018
Financial Results and Provides Corporate Update
Plan to Report Interim Data from HOPE-2
Clinical Trial in Early Q3
To Host Conference Call and Webcast Today
LOS ANGELES, March 28, 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 fourth quarter and full year 2018 and provided a corporate update.
"This has been a busy year for Capricor
as 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. "We began our HOPE-2 trial, were granted
RMAT designation and had a positive meeting with FDA late last year. To date, 20 young
men and boys in advanced stages of Duchenne muscular dystrophy have been enrolled in the randomized, double-blind, placebo-controlled
trial. We are now planning on conducting an interim analysis in early Q3 and look forward to sharing that data with the patient
and investor community."
Additionally, in 2018, Capricor entered
into a collaboration with the U.S. Army Institute of Surgical Research (USAISR), which is studying the potential for CAP-2003 to
address trauma-related injuries and conditions. 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 are encouraged to see an increased
interest in exosomes in the field as a potential therapeutic and as a delivery vehicle for genes and other drugs to targeted tissues,"
said Dr. Marb n. "This exciting collaboration with USAISR may allow us to further the clinical development of CAP-2003
and we continue to work with them and other branches of the US military on potential future opportunities for continued development."
Fourth Quarter Highlights and Recent
Clinical and Operational Developments
Anticipated Events and Milestones in 2019
Fourth Quarter and Full Year Financial
For the fourth quarter of 2018, the company
reported a net loss of approximately $(3.3) million, or $(0.11) per diluted share, compared to, after giving effect to the forgiveness
of the California Institute of Regenerative Medicine (CIRM) loan payable, net income of approximately $12.3 million, or $0.42 per
diluted share, for the fourth quarter of 2017.
For the year ended December 31, 2018, the
company reported a net loss of approximately $(15.2) million, or $(0.52) per diluted share, compared to, after giving effect to
the forgiveness of the CIRM loan payable, net income of approximately $2.4 million, or $0.09 per diluted share, for the year ended
December 31, 2017. As of December 31, 2018, the company's cash, cash equivalents and marketable securities totaled approximately
$7.3 million compared to approximately $14.1 million on December 31, 2017. Additionally, in 2018, Capricor raised approximately
$6.7 million in net proceeds at an average price of approximately $1.48 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 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: 7167797.
To participate via a webcast, please visit: https://edge.media-server.com/m6/p/zkf3ocjd.
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. 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
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, 2017 as filed with the Securities and Exchange Commission on March 22, 2018, 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, 2018, as filed with the Securities
and Exchange Commission on November 14, 2018. 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 December 31, Years ended December 31,
2018 2017 2018 2017
REVENUE
Revenue $ 648,082 $ 475,799 $ 1,671,356 $ 2,666,340
TOTAL REVENUE 648,082 475,799 1,671,356 2,666,340
OPERATING EXPENSES
Research and development 2,849,377 2,518,395 12,066,800 10,766,095
General and administrative 1,104,670 1,237,827 4,931,642 4,762,642
TOTAL OPERATING EXPENSES 3,954,047 3,756,222 16,998,442 15,528,737
LOSS FROM OPERATIONS (3,305,965 ) (3,280,423 ) (15,327,086 ) (12,862,397 )
OTHER INCOME (EXPENSE)
Investment income 46,086 11,768 135,991 38,494
Interest expense - (80,307 ) - (398,807 )
Forgiveness of loan payable - 15,654,133 - 15,654,133
TOTAL OTHER INCOME (EXPENSE) 46,086 15,585,594 135,991 15,293,820
NET INCOME (LOSS) (3,259,879 ) 12,305,171 (15,191,095 ) 2,431,423
OTHER COMPREHENSIVE INCOME (LOSS)
Net unrealized gain on marketable securities (7,814 ) 3,027 773 8,096
COMPREHENSIVE INCOME (LOSS) $ (3,267,693 ) $ 12,308,198 $ (15,190,322 ) $ 2,439,519
Net income (loss) per share - basic $ (0.11 ) $ 0.48 $ (0.52 ) $ 0.10
Weighted average number of shares - basic 31,038,018 25,810,249 29,410,973 23,193,278
Net income (loss) per share - diluted $ (0.11 ) $ 0.42 $ (0.52 ) $ 0.09
Weighted average number of shares - diluted 31,038,018 29,471,009 29,410,973 26,788,076
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
December 31, 2018 December 31, 2017
Cash, cash equivalents and marketable securities $ 7,256,416 $ 14,124,935
Total assets $ 9,247,065 $ 16,273,789
Total liabilities $ 4,631,478 $ 5,046,934
Total stockholders' equity - 31,387,729 and 26,270,491 common shares issued and
outstanding at December 31, 2018 and December 31, 2017, respectively 4,615,587 11,226,855
Total liabilities and stockholders' equity $ 9,247,065 $ 16,273,789
For more information, please contact:
AJ Bergmann, Chief Financial Officer
Last updated: Mar 28, 2019