Plan to Report Interim Data from HOPE-2
Clinical Trial in Early Q3
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
Marbán, 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. Marbán. “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
- Resumed per protocol dosing of patients already enrolled in the
HOPE-2 clinical trial of CAP-1002, the company’s novel cell therapy
candidate to treat Duchenne muscular dystrophy. It is our intention
to conduct an interim analysis on available data in early Q3 2019.
The HOPE-2 study is a Phase II, randomized, double-blind,
placebo-controlled study in patients in the later stages of
Duchenne muscular dystrophy, a fatal genetic disease with few
treatment options. HOPE-2 will evaluate the safety and efficacy of
repeat doses of CAP-1002, which consists of allogeneic
cardiosphere-derived cells, or CDCs. CAP-1002 has been shown to
exert potent immunomodulatory activity and stimulate cellular
regrowth. Enrollment of new patients will depend on various factors
but will not commence until additional funding is secured.
- Capricor put a voluntary hold on dosing in December to develop
a plan to manage potential allergic reactions after a patient had a
serious adverse event in the form of anaphylaxis. After an
approximate one-month period, we lifted our voluntary dosing hold
in the HOPE-2 trial. The investigation suggests that the patient
may have been allergic to something contained in the
investigational product, including an excipient, or inactive
ingredient, in the formulation. To reduce the risk of future
events, we initiated a pre-medication strategy that is commonly
used by doctors to prevent and treat allergic reactions. The Data
and Safety Monitoring Board (DSMB) and HOPE-2 clinical trial
steering committee support this approach, and the FDA and DSMB
approved resuming enrollment in the study.
- In December 2018, Capricor met with the FDA , as part of the
expedited review afforded under the Regenerative Medicine Advanced
Therapy (RMAT) designation which the FDA granted to CAP-1002 in
February 2018. The FDA grants the RMAT designation to regenerative
medicine therapies intended to treat a serious condition and for
which preliminary clinical evidence indicates a potential to
address unmet medical needs for that condition.
- The Journal of Neurology published a study reporting
significant improvements in Duchenne muscular dystrophy patients
treated with Capricor’s novel cell therapy, CAP-1002. The Phase
I/II, randomized, controlled, open-label trial found that CAP-1002
demonstrated improvement in cardiac muscle function and reduction
in cardiac scarring that were statistically-significant and
sustained improvement of skeletal muscle functions in patients with
Duchenne muscular dystrophy. The HOPE-Duchenne trial also found no
serious safety issues, according to the study published in the
January 23, 2019, online issue of Neurology, the medical journal of
the American Academy of Neurology.
Anticipated Events and Milestones in
2019
- Plan to report interim data from
the HOPE-2 clinical trial in early Q3 2019
- Continue to conduct pre-clinical
research for CAP-2003 to treat various diseases of inflammation and
fibrosis.
- Continue to explore strategic
alternatives, with respect to one or more of our product
candidates.
Fourth Quarter and Full Year Financial
Results
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 Capricor on social media:
www.facebook.com/capricortherapeutics,
www.instagram.com/capricortherapeutics/ and
https://twitter.com/capricor
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 |
(UNAUDITED) |
|
|
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 THEAPEUTICS,
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
+1-310-358-3200abergmann@capricor.com
Capricor Therapeutics (NASDAQ:CAPR)
Historical Stock Chart
From Aug 2024 to Sep 2024
Capricor Therapeutics (NASDAQ:CAPR)
Historical Stock Chart
From Sep 2023 to Sep 2024