Full Press Release Details
Therapeutics Reports Second Quarter 2019 Financial Results and Provides Corporate Update
Results from HOPE-2 Interim Analysis Reported in July
Conference Call and Webcast Today at 4:30 p.m. ET
August 6, 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 second quarter 2019 and provided a corporate update.
has been a very exciting quarter as we previously reported the outcome of our pre-specified interim analysis of our HOPE-2 clinical
trial which showed meaningful results across several independent measures," said Linda Marb n, Ph.D., Capricor
president and chief executive officer. In the randomized, double-blind placebo controlled study, we observed improvements in assessments
of skeletal, pulmonary and cardiac function. For the later stage DMD patients for which the HOPE-2 trial is focused on, we hope
that our therapeutic may one day be an important treatment option for these boys and young men. We will continue to discuss the
evolution of this program with the U.S. Food and Drug Administration (FDA) and look forward to sharing those updates as they become
Capricor has been granted RMAT
and Orphan Drug Designation by the FDA for CAP-1002 for the treatment of Duchenne muscular dystrophy.
"These designations will enable us
to work closely with the FDA in finalizing the regulatory approval pathway for CAP-1002 and to receive expedited FDA reviews,"
Dr. Marb n said. "While our major focus this quarter has been on CAP-1002, we continue to be encouraged by exciting
developments in our exosome platform technology and we continue to explore their use as a potential therapeutic in a variety of
different inflammatory conditions, including DMD" said Dr. Marb n.
Capricor's exosome technology, CAP-2003,
is comprised of proprietary extracellular vesicles, including exosomes, and are sourced from CDCs and other cell types. 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.
Second Quarter Highlights and Recent
Clinical and Operational Developments
Anticipated Events and Milestones in 2019
Second Quarter Financial Results
The Company reported a net loss of approximately
$2.0 million, or $0.59 per share, for the second quarter of 2019, compared to a net loss of approximately $4.1 million, or $1.42
per share, for the second quarter of 2018.
As of June 30, 2019, the Company's
cash, cash equivalents and marketable securities totaled approximately $5.9 million compared to approximately $7.3 million on December
31, 2018. Additionally, so far in the third quarter of 2019, Capricor has raised approximately $1.3 million in net proceeds at
an average price of approximately $5.06 per share under its July 2019 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 2020 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: 5837419.
To participate via a webcast, please visit:
https://edge.media-server.com/mmc/p/6qw63bhf. The webcast will be archived for approximately 30 days and will be available
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy is a devastating
genetic disorder that causes muscle degeneration and leads to death, generally before the age of 30, most commonly from heart failure.
It occurs in one in every 3,600 live male births across all races, cultures and countries. Duchenne muscular dystrophy afflicts
approximately 200,000 boys and young men around the world. Treatment options are limited, and there is no cure.
CAP-1002 consists of allogeneic
cardiosphere-derived cells, or CDCs, a type of progenitor cell that has been shown in pre-clinical and clinical studies to exert
potent immuno-modulatory activity, and is being investigated for its potential to modify the immune system's activity to
encourage cellular regeneration. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered
to over 150 human subjects across several clinical trials.
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 DMD. 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.
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 and in its Quarterly Report on Form 10-Q
as filed with the Securities and Exchange Commission on May 14, 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
CAP-1002 is an Investigational New Drug
and is not approved for any indications. CAP-2003 has not yet been approved for clinical investigation.
For more information, please contact:
AJ Bergmann, Chief Financial Officer
CAPRICOR THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| REVENUE | ||||||||||||||||
| Revenue | $ | 410,353 | $ | 403,960 | $ | 640,857 | $ | 804,025 | ||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 1,644,110 | 3,388,908 | 3,455,292 | 6,085,424 | ||||||||||||
| General and administrative | 831,933 | 1,178,060 | 1,808,423 | 2,567,792 | ||||||||||||
| TOTAL OPERATING EXPENSES | 2,476,043 | 4,566,968 | 5,263,715 | 8,653,216 | ||||||||||||
| LOSS FROM OPERATIONS | (2,065,690 | ) | (4,163,008 | ) | (4,622,858 | ) | (7,849,191 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 21,956 | 39,460 | 59,779 | 54,113 | ||||||||||||
| Loss on disposal of fixed asset | (2,720 | ) | - | (2,720 | ) | - | ||||||||||
| NET LOSS | (2,046,454 | ) | (4,123,548 | ) | (4,565,799 | ) | (7,795,078 | ) | ||||||||
| OTHER COMPREHENSIVE INCOME (LOSS) | ||||||||||||||||
| Net unrealized gain (loss) on marketable securities | - | (2,044 | ) | (12,393 | ) | 6,665 | ||||||||||
| COMPREHENSIVE LOSS | $ | (2,046,454 | ) | $ | (4,125,592 | ) | $ | (4,578,192 | ) | $ | (7,788,413 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.59 | ) | $ | (1.42 | ) | $ | (1.35 | ) | $ | (2.79 | ) | ||||
| Weighted average number of shares, basic and diluted | 3,457,833 | 2,903,177 | 3,374,557 | 2,797,441 |
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
| June 30, 2019 (unaudited) | December 31, 2018 | |||||||
| Cash, cash equivalents and marketable securities | $ | 5,890,963 | $ | 7,256,416 | ||||
| Total assets | $ | 7,306,844 | $ | 9,247,065 | ||||
| Total liabilities | $ | 4,943,061 | $ | 4,631,478 | ||||
| Total stockholders' equity - 3,467,459 and 3,138,748 common shares issued and | ||||||||
| outstanding at June 30, 2019 and December 31, 2018, respectively | 2,363,783 | 4,615,587 | ||||||
| Total liabilities and stockholders' equity | $ | 7,306,844 | $ | 9,247,065 |