GERMANTOWN, Md., March 14, 2016 /PRNewswire/ -- Neuralstem, Inc.
(Nasdaq: CUR), a biopharmaceutical company focused on the
development of central nervous system therapies based on its neural
stem cell technology, reported its financial results for the fourth
quarter and year ended December 31,
2015.
Clinical Program and Business Highlights
Business Highlights
- The Company strengthened its executive team with the
appointment of Richard Daly as
President and Chief Executive Officer, Jonathan Lloyd Jones as Chief Financial Officer
and Andy Moniz as Vice President of
Clinical Operations.
- In January 2016, the Company
announced an initiative to pursue collaborations for its stem cell
therapy programs to utilize additional expertise, expedite clinical
and regulatory pathways and secure funding.
- Recently, the FDA approved the commencement of the NSI-189
Phase 2 clinical trial for the treatment of Major Depressive
Disorder.
"The FDA approval to commence our Phase 2 Major Depressive
Disorder (MDD) trial is a meaningful milestone for the Company,"
commented Richard Daly. "We
believe NSI-189 may provide this large patient population with an
alternative therapy without many of the typical side effects of
current commercial drugs. Our strengthened team provides
incremental expertise and we are committed to executing a
diligently run trial to deliver data in the second half of
2017."
Neurogenic Small Molecule Platform Clinical
Development
Lead asset, NSI-189 Phase 2 clinical trial for the treatment
of major depressive disorder (MDD)
- In late February 2016, the FDA
approved the commencement of our NSI-189 Phase 2 clinical trial for
the treatment of major depressive disorder. The double-blind,
randomized, placebo-controlled, 220 subject study is expected to
enroll the first subject in the second quarter of 2016. For
information on the trial please visit
https://clinicaltrials.gov/show/NCT02695472.
Cell Therapy Platform Clinical Development
- In January 2016, Karl Johe, Founder and Chief Scientific Officer,
presented at the Phacilitate Cell & Gene Therapy World
Conference. He concluded that the collective trial data analysis
showed the cells consistently demonstrated biological activity in
all three program indications: amyotrophic lateral sclerosis (ALS),
chronic spinal cord injury (cSCI), and motor deficits due to
ischemic stroke.
NSI-566 Phase 1 safety trial for the treatment of
cSCI
- In January 2016, the Company
reported preliminary six-month follow-up Phase 1 safety data on all
four subjects. The stem cell treatment demonstrated feasibility and
safety. A self-reported ability to contract some muscles below the
level of injury was confirmed via clinical and electrophysiological
follow-up examinations in one of the four patients treated. There
was no change in the clinical status of the three other
patients. This study was completed with the collaboration of
the UCSD School of Medicine, supported by the UCSD Sanford Stem
Cell Clinical Center; substantially all of the clinical costs of
this study have been funded by grants arranged through the
University.
NSI-566 Phase 1 / 2 safety trial for the treatment of
amyotrophic lateral sclerosis (ALS)
- In September 2015, nine-month
Phase 2 and combined Phase 1 and Phase 2 data on the NSI-566 trial
in amyotrophic lateral sclerosis (ALS) was presented at the
American Neurological Association Annual Meeting by the principal
investigator, Eva Feldman, MD, PhD,
Director of the A. Alfred Taubman Medical Research Institute and
Director of Research of the ALS Clinic at the University of Michigan Health. The data
showed that the intraspinal transplantation of the cells was safe
and well tolerated. In January 2016,
the Company announced that it is in discussions with various
governmental, State and non-profit organizations regarding funding
grants for the next trial; the initiation of the trial will be
dependent upon significant funding from such sources.
NSI-566 Phase 1 safety trial for the treatment of motor
deficits in stroke
- The Company completed dosing the second of three planned
cohorts in a Phase 1/2 clinical trial at BaYi Brain Hospital in
Beijing. The trial is being
conducted by Neuralstem China, at BaYi Brain Hospital in
Beijing, China.
Financial Results for the Year Ended December 31, 2015
Cash, cash equivalents and short-term investments on hand was
approximately $12.2 million at
December 31, 2015, compared to
approximately $27.5 million at
December 31, 2014. The decrease
was associated with cash used in our operations.
In the year ended December 31,
2015, we reported a net loss of approximately $20.9 million or $0.23 per share, compared to a loss of
approximately $22.6 million or
$0.26 per share in the year ended
December 31, 2014.
Our operating loss in the year ended December 31, 2015 was approximately $19.2 million, compared to a loss of
approximately $17.5 million in the
year ended December 31, 2014.
The increase in operating loss was primarily attributable to an
increase of approximately $4.3
million in research and development expenses partially
offset by a decrease of general and administrative expenses of
approximately $2.6 million.
The increase in research and development expenses was primarily
attributable to an increase in headcount, and an increase clinical,
pre-clinical and CMC expenses, all related to the ramp-up of our
pre-clinical and clinical trial efforts and are expected to
continue into subsequent periods.
The decrease in general and administrative expenses was
primarily attributable to a decrease in non-cash stock based
compensation expense and a decrease in legal, consulting and other
external advisory fees. These were partially offset by an increase
in personnel and related expenses associated with changes in
headcount.
We had 92.0 million and 87.8 million common shares issued and
outstanding at December 31, 2015 and
2014, respectively.
Neuralstem,
Inc.
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
|
|
|
December
31,
|
|
2015
|
|
2014
|
|
|
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$
4,716,533
|
|
$
12,518,980
|
Short term
investments
|
7,517,453
|
|
15,007,478
|
Trade and other
receivables
|
37,316
|
|
225,524
|
Deferred financing
fees, current portion
|
89,562
|
|
135,694
|
Prepaid
expenses
|
1,159,782
|
|
274,106
|
Total current
assets
|
13,520,646
|
|
28,161,782
|
|
|
|
|
Property and
equipment, net
|
343,200
|
|
301,265
|
Patents,
net
|
1,103,467
|
|
1,233,172
|
Deferred financing
fees, net of current portion
|
9,154
|
|
89,143
|
Other
assets
|
71,797
|
|
58,713
|
Total
assets
|
$
15,048,264
|
|
$
29,844,075
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts payable and
accrued expenses
|
$
1,455,826
|
|
$
2,504,978
|
Accrued
bonuses
|
161,362
|
|
646,960
|
Current portion of
long-term debt, net of discount
|
4,634,742
|
|
730,012
|
Other current
liabilities
|
263,104
|
|
126,745
|
Total current
liabilities
|
6,515,034
|
|
4,008,695
|
|
|
|
|
Long-term debt, net
of discount and current portion
|
3,391,808
|
|
8,056,470
|
Other long term
liabilities
|
174,144
|
|
59,574
|
Total
liabilities
|
10,080,986
|
|
12,124,739
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
Preferred stock,
7,000,000 shares authorized, zero shares issued and
outstanding
|
-
|
|
-
|
Common stock, $0.01
par value; 300 million shares authorized, 92,005,705 and 87,789,679
shares issued and outstanding in 2015 and 2014,
respectively
|
920,057
|
|
877,897
|
Additional paid-in
capital
|
176,002,832
|
|
167,890,220
|
Accumulated other
comprehensive income
|
3,071
|
|
6,000
|
Accumulated
deficit
|
(171,958,682)
|
|
(151,054,781)
|
Total
stockholders' equity
|
4,967,278
|
|
17,719,336
|
Total liabilities
and stockholders' equity
|
$
15,048,264
|
|
$
29,844,075
|
|
|
|
|
Neuralstem,
Inc.
|
|
|
|
|
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|
Consolidated
Statements of Operations and Comprehensive Loss
|
|
|
|
|
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|
Year Ended
December 31,
|
|
2015
|
|
2014
|
|
2013
|
|
|
|
|
|
|
Revenues
|
$
10,417
|
|
$
18,833
|
|
$
110,000
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development costs
|
12,637,278
|
|
8,361,559
|
|
7,285,752
|
General and
administrative expenses
|
6,529,667
|
|
9,093,123
|
|
5,348,189
|
Total operating
expenses
|
19,166,945
|
|
17,454,682
|
|
12,633,941
|
Operating
loss
|
(19,156,528)
|
|
(17,435,849)
|
|
(12,523,941)
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
Interest
income
|
69,549
|
|
67,651
|
|
68,000
|
Interest
expense
|
(1,816,206)
|
|
(1,620,776)
|
|
(1,394,274)
|
Warrant modification
expense
|
-
|
|
(3,109,850)
|
|
(5,017,156)
|
Loss from change in
fair value of derivative instruments
|
-
|
|
(334,133)
|
|
(965,329)
|
Loss on debt
extinguishment
|
-
|
|
(445,787)
|
|
-
|
Other
expense
|
(716)
|
|
-
|
|
-
|
Litigation
settlement
|
-
|
|
250,000
|
|
838
|
Total other income
(expense)
|
(1,747,373)
|
|
(5,192,895)
|
|
(7,307,921)
|
|
|
|
|
|
|
Net loss
|
$ (20,903,901)
|
|
$ (22,628,744)
|
|
$ (19,831,862)
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.23)
|
|
$
(0.26)
|
|
$
(0.27)
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
90,866,938
|
|
87,086,345
|
|
72,279,210
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
Net loss
|
$ (20,903,901)
|
|
$ (22,628,744)
|
|
$ (19,831,862)
|
Foreign currency
translation adjustment
|
(2,929)
|
|
(1,241)
|
|
7,241
|
Comprehensive
loss
|
$ (20,906,830)
|
|
$ (22,629,985)
|
|
$ (19,824,621)
|
|
|
|
|
|
|
About Neuralstem
Neuralstem's patented technology enables the commercial-scale
production of multiple types of central nervous system stem cells,
which are being developed as potential therapies for multiple
central nervous system diseases and conditions.
Neuralstem's ability to generate neural stem cell lines from
human hippocampus, which were used for systematic chemical
screening for neurogenesis effect, has led to the discovery and
patenting of molecules that Neuralstem believes may stimulate the
brain's capacity to generate new neurons, potentially reversing
pathophysiologies associated with certain central nervous system
(CNS) conditions.
The Company has completed Phase 1a and 1b trials evaluating
NSI-189, its first neurogenic small molecule product candidate, for
the treatment of major depressive disorder (MDD), and is expecting
to initiate a Phase 2 efficacy study for MDD in 2016.
Neuralstem's first stem cell product candidate, NSI-566, a
spinal cord-derived neural stem cell line, is under development for
treatment of amyotrophic lateral sclerosis (ALS). Neuralstem has
completed two clinical studies, in a total of thirty patients,
which met primary safety endpoints. In addition to ALS, NSI-566 is
also in a Phase 1 study to treat paralysis due to chronic spinal
cord injury, as well as in a Phase 1 study to treat paralysis from
ischemic stroke.
Cautionary Statement Regarding Forward Looking Information:
This news release contains "forward-looking statements" made
pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements
relate to future, not past, events and may often be identified by
words such as "expect," "anticipate," "intend," "plan," "believe,"
"seek" or "will." Forward-looking statements by their nature
address matters that are, to different degrees, uncertain. Specific
risks and uncertainties that could cause our actual results to
differ materially from those expressed in our forward-looking
statements include risks inherent in the development and
commercialization of potential products, uncertainty of clinical
trial results or regulatory approvals or clearances, need for
future capital, dependence upon collaborators and maintenance of
our intellectual property rights. Actual results may differ
materially from the results anticipated in these forward-looking
statements. Additional information on potential factors that could
affect our results and other risks and uncertainties are detailed
from time to time in Neuralstem's periodic reports, including the
Annual Report on Form 10-K for the year ended December 31, 2015, and filed with the Securities
and Exchange Commission (SEC) on March 14,
2016, and in other reports filed with the SEC.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neuralstem-reports-fourth-quarter-and-year-end-2015-fiscal-results-and-business-update-300235424.html
SOURCE Neuralstem, Inc.