Full Press Release Details
Capricor Therapeutics Reports Third Quarter
2018 Financial Results and Provides Corporate Update
To Host Conference Call and Webcast Today
LOS ANGELES, November 13, 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 third quarter of 2018, which ended September 30, 2018, and provided a corporate update.
"Capricor continues its progress
in the clinical development of our novel cell therapy, CAP-1002, to treat Duchenne muscular dystrophy, and we are moving forward
with our exosome-based therapy, CAP-2003," said Linda Marb n, Ph.D., Capricor CEO. "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, is well
underway with 11 sites recruiting participants and more sites expected to begin enrollment before the end of the year. 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."
Capricor has been granted RMAT
and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for CAP-1002. The company's leaders and
key opinion leaders in the Duchenne community are scheduled to meet with the FDA in December under Capricor's RMAT designation
to discuss milestones for development and commercialization of CAP-1002.
Capricor has 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 pleased to see that the power
of exosomes is beginning to be recognized by the academic and the biotech communities," said Dr. Marb n. "Pre-clinical
studies indicate CAP-2003 has potential as a treatment for diseases of inflammation and fibrosis, which may mean it can potentially
serve as both a therapy for those diseases and as a delivery vehicle for gene and other therapies to treat those diseases."
Third Quarter Highlights and Recent Clinical and Operational
Anticipated Events and Milestones in Fourth Quarter of 2018
Third Quarter Results
The Company reported a net loss of approximately
$4.1 million, or $0.14 per share, for the third quarter of 2018, compared to a net loss of approximately $2.7 million, or $0.12
per share, for the third quarter of 2017.
As of September 30, 2018, the Company's
cash, cash equivalents and marketable securities totaled approximately $10.4 million, compared to approximately $14.1 million on
December 31, 2017. Additionally, in the third quarter of 2018, Capricor raised approximately $1.1 million in net proceeds at an
average price of approximately $1.44 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 second 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: 4974294.
To participate via a webcast, please visit: https://edge.media-server.com/m6/p/msqxw8py.
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 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, 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 June 30, 2018, as filed with the Securities
and Exchange Commission on August 13, 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.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| INCOME | ||||||||||||||||
| Collaboration income | $ | - | $ | - | $ | - | $ | 1,367,186 | ||||||||
| Grant income | 172,589 | 260,771 | 766,641 | 770,855 | ||||||||||||
| Other income | 46,658 | 52,500 | 256,633 | 52,500 | ||||||||||||
| TOTAL INCOME | 219,247 | 313,271 | 1,023,274 | 2,190,541 | ||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | 3,131,999 | 1,862,369 | 9,217,423 | 8,247,700 | ||||||||||||
| General and administrative | 1,259,180 | 1,088,635 | 3,826,972 | 3,524,815 | ||||||||||||
| TOTAL OPERATING EXPENSES | 4,391,179 | 2,951,004 | 13,044,395 | 11,772,515 | ||||||||||||
| LOSS FROM OPERATIONS | (4,171,932 | ) | (2,637,733 | ) | (12,021,121 | ) | (9,581,974 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Investment income | 35,792 | 10,393 | 89,905 | 26,726 | ||||||||||||
| Interest expense | - | (107,653 | ) | - | (318,500 | ) | ||||||||||
| TOTAL OTHER INCOME (EXPENSE) | 35,792 | (97,260 | ) | 89,905 | (291,774 | ) | ||||||||||
| NET LOSS | (4,136,140 | ) | (2,734,993 | ) | (11,931,216 | ) | (9,873,748 | ) | ||||||||
| OTHER COMPREHENSIVE INCOME (LOSS) | ||||||||||||||||
| Net unrealized gain on marketable securities | 1,922 | 1,276 | 8,587 | 5,069 | ||||||||||||
| COMPREHENSIVE LOSS | $ | (4,134,218 | ) | $ | (2,733,717 | ) | $ | (11,922,629 | ) | $ | (9,868,679 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.14 | ) | $ | (0.12 | ) | $ | (0.41 | ) | $ | (0.44 | ) | ||||
| Weighted average number of shares, basic and diluted | 30,610,064 | 23,378,141 | 28,862,665 | 22,311,369 |
CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
| September 30, 2018 (unaudited) | December 31, 2017 | |||||||
| Cash, cash equivalents and marketable securities | $ | 10,371,917 | $ | 14,124,935 | ||||
| Total assets | $ | 12,232,816 | $ | 16,273,789 | ||||
| Total liabilities | $ | 5,252,394 | $ | 5,046,934 | ||||
| Total stockholders' equity - 30,748,872 and 26,270,491 common shares issued and | ||||||||
| outstanding at September 30, 2018 and December 31, 2017, respectively | 6,980,422 | 11,226,855 | ||||||
| Total liabilities and stockholders' equity | $ | 12,232,816 | $ | 16,273,789 |
For more information, please contact:
AJ Bergmann, Chief Financial Officer