GERMANTOWN, Md., Nov. 9, 2015 /PRNewswire/ -- Neuralstem,
Inc. (Nasdaq: CUR) a biopharmaceutical company leveraging its
unique human neural stem cell-derived platform to identify and
develop novel neurogenic therapies for diseases of the central
nervous system (CNS), today reported its financial results and
business update for the three and nine months ended September 30, 2015.
Neurogenic Oral, Small Molecule Program with NSI-189 –
Advancing to Phase 2.
- NSI-189 Major Depressive Disorder (MDD) Program:
Neuralstem filed its Phase II clinical trial protocol for the
treatment of MDD with the FDA in September, 2015. Maurizio Fava, M.D., Slater Family Professor of
Psychiatry at Harvard Medical School,
Massachusetts General Hospital will be the principal investigator.
The Company expects to enroll its first patient in this study in
the first quarter of 2016.
- NSI-189 for the treatment of cognitive deficit in
schizophrenia: The Company plans to commence a Phase Ib
clinical trial protocol for the treatment of cognitive deficit in
schizophrenia in 2016.
Neurogenic Stem Cell Therapy Program with NSI-566 – Combined
Phase 1 and 2 data presented.
- NSI-566 human neural stem cell therapy, under development
for the treatment of ALS: 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,
presented nine-month Phase II and combined Phase I and Phase II
data at the American Neurological Association (ANA) Annual Meeting
in September. The data showed that the intra-spinal transplantation
of the human neural stem cells (NSI-566) was safe and
well-tolerated. There appeared to be no acceleration in disease
progression due to the therapeutic intervention with NSI-566. The
Company is currently in discussions with the FDA for a larger,
controlled, registration directed clinical trial.
- NSI-566 spinal cord-derived cell therapy under development
for the treatment of chronic spinal cord injury (cSCI): In
October, Joseph Ciacci, M.D., UCSD
School of Medicine, presented initial safety data from the Phase I
stem cell transplantation clinical trial with NSI-566. Dr. Ciacci
reported that there had been no serious adverse events, that
implantation of stem cells in cSCI patients is feasible and, that
implantation of stem cells in the spinal cord injury patients has
been safe and well tolerated. The last surgery was completed in
July and now patients are currently in a 6-month post-observation
period. The trial is being conducted at the UCSD School of
Medicine, supported and funded by the UCSD Sanford Stem Cell
Clinical Center.
- NSI-566 spinal cord derived stem cell therapy under
development for the treatment of motor deficits in stroke:
Neuralstem continues to proceed in its collaborative Phase I/II
ischemic stroke trial with BaYi Brain Hospital in Beijing. The Phase II portion of the study, a
controlled proof-of-concept study, is expected to commence in 2016.
The trial is sponsored by Neuralstem's wholly owned subsidiary,
Suzhou Neuralstem Biopharmaceuticals Co., Ltd. ("Neuralstem
China").
Neuralstem Adds Depth to its Senior Management Team with
Appointment of Industry Veterans as Second Asset Advances toward
Phase 2.
- Neuralstem appointed Andrew
Moniz as Vice President, Clinical Trials Operations in
September 2015. Mr. Moniz joins the
Company from Worldwide Clinical Trials, Inc. where he was Vice
President, Global Clinical Operations. Worldwide Clinical Trials is
a global CRO providing full-service drug development services to
the pharmaceutical and biotechnology industries.
- Jonathan Lloyd Jones, CPA, MBA,
joined the company in May as Chief Financial Officer. Mr.
Lloyd Jones was most recently Chief
Financial Officer at Columbia Laboratories (Juniper
Pharmaceuticals, NASDAQ: JNP), Before then, Mr. Lloyd Jones was CFO and VP of Corporate
Development at TetraLogic Pharmaceuticals, a venture-backed
pharmaceutical company and Vice President, Finance, at
TransMolecular, a privately-held, clinical stage biotech company.
From 1996-2006, Mr. Lloyd Jones was
Sr. Director, Corporate Development at Genzyme Corporation
(now Sanofi).
"We are delighted that Jonathan and Andrew have joined us," said
Richard Garr, President and CEO,
Neuralstem, Inc. "Their extensive industry experience in clinical
development, financial, and business development will be invaluable
as Neuralstem advances its two lead products through clinical
development."
Results of Operations for the Third Quarter Ended
September 30, 2015
Cash, cash equivalents and short-term investments on hand was
approximately $18.1 million at
September 30, 2015, compared to
approximately $27.5 million at
December 31, 2014. The decrease
was primarily due to our cash used in operations partially offset
by our raising approximately $6.0
million, net through the issuance of our common stock from
warrant exercises and from the sale of our common stock.
For the three months ended September 30,
2015, we reported a net loss of approximately $5.6 million or $0.06 per share, compared to a net loss of
approximately $4.5 million or
$0.05 per share in the comparable
quarter of 2014. Our operating loss for the three months
ended September 30, 2015 was
approximately $5.2 million compared
to a loss of approximately $4.1
million in the same quarter of 2014. The increase in
operating loss was due to an approximately $1.3 million increase in research and development
expenses partially offset by an approximately $0.2 million decrease in general and
administrative expenses.
The increase in research and development expenses was primarily
attributable to an increase of approximately $1.3 million in project and laboratory expenses.
These increased expenses are all related to the expansion 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 legal expenses associated
with reduced litigation expenses
Results of Operations for the Nine Months Ended September 30, 2015
For the nine months ended September 30,
2015, we reported a net loss of approximately $16.1 million or $0.18 per share, compared to a net loss of
approximately $17.1 million or
$0.20 per share in the comparable
period of 2014. Our operating loss for the nine months ended
September 30, 2015 was approximately
$14.8 million compared to a loss of
approximately $12.8 million in the
same period of 2014. The increase in operating loss was due
to an approximately $4.1 million
increase in research and development expenses partially offset by
an approximately $2.1 million
decrease in general and administrative expenses.
The increase in research and development expenses was primarily
attributable to an increase in project and laboratory expenses, and
an increase in payroll and related expenses due to increased
salaries and headcount. These increased expenses are all
related to the expansion of our pre-clinical and clinical trial
efforts and are expected to continue into subsequent
periods.
The decrease in general and administrative expense was primarily
due to a decrease in non-cash stock based compensation and a
decrease in legal fees related to reduced litigation expense.
The decrease in non-cash stock based compensation is largely the
result of a first quarter 2014 expense of approximately
$2.0 million in non-cash stock based
compensation expense related to a financial advisory and consulting
services provider achieving a performance based milestone that
resulted in a term extension of certain common stock purchase
warrants. These decreases were partially offset by an
increase in payroll related expenses due to increased salaries and
headcount.
In addition, for the three and nine months ended September 2015, we recognized approximately
$0.5 million and $1.4 million respectively, of interest expense
related to our long-term debt.
Neuralstem,
Inc.
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Unaudited
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
September 30,
2015
|
|
December 31,
2014
|
|
|
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$
13,130,795
|
|
$
12,518,980
|
Short-term
investments
|
5,017,453
|
|
15,007,478
|
Trade and other
receivables
|
19,159
|
|
225,524
|
Deferred financing
fees, current portion
|
107,096
|
|
135,694
|
Prepaid
expenses
|
1,289,195
|
|
274,106
|
Total current
assets
|
19,563,698
|
|
28,161,782
|
|
|
|
|
Property and
equipment, net
|
335,863
|
|
301,265
|
Patents,
net
|
1,147,153
|
|
1,233,172
|
Deferred financing
fees, net of current portion
|
22,825
|
|
89,143
|
Other
assets
|
72,163
|
|
58,713
|
Total
assets
|
$
21,141,702
|
|
$
29,844,075
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts payable and
accrued expenses
|
$
2,036,769
|
|
$
2,504,978
|
Accrued
bonuses
|
767,989
|
|
646,960
|
Current portion of
long-term debt, net of discount
|
4,457,768
|
|
730,012
|
Other current
liabilities
|
207,292
|
|
126,745
|
Total current
liabilities
|
7,469,818
|
|
4,008,695
|
|
|
|
|
Long-term debt, net
of discount and current portion
|
4,625,394
|
|
8,056,470
|
Other long-term
liabilities
|
143,730
|
|
59,574
|
Total
liabilities
|
12,238,942
|
|
12,124,739
|
|
|
|
|
Commitments and
contingencies (Note 6)
|
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STOCKHOLDERS'
EQUITY
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|
|
|
Preferred stock,
7,000,000 shares authorized, zero shares issued and
outstanding
|
-
|
|
-
|
Common stock, $0.01
par value; 300 million shares authorized, 91,786,290 and
87,789,679 shares outstanding in 2015 and 2014,
respectively
|
917,863
|
|
877,897
|
Additional paid-in
capital
|
175,174,708
|
|
167,890,220
|
Accumulated other
comprehensive income
|
3,720
|
|
6,000
|
Accumulated
deficit
|
(167,193,531)
|
|
(151,054,781)
|
Total
stockholders' equity
|
8,902,760
|
|
17,719,336
|
Total liabilities
and stockholders' equity
|
$
21,141,702
|
|
$
29,844,075
|
|
|
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|
See accompanying
notes to unaudited condensed consolidated financial
statements.
|
Neuralstem,
Inc.
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Unaudited
Condensed Consolidated Statements of Operations and Comprehensive
Loss
|
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|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2015
|
|
2014
|
|
2015
|
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2014
|
|
|
|
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|
Revenues
|
$
2,500
|
|
$
5,000
|
|
$
7,917
|
|
$
14,167
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expenses
|
3,392,086
|
|
2,109,880
|
|
9,887,750
|
|
5,747,922
|
General and
administrative expenses
|
1,807,934
|
|
2,001,865
|
|
4,925,389
|
|
7,061,129
|
Total operating
expenses
|
5,200,020
|
|
4,111,745
|
|
14,813,139
|
|
12,809,051
|
Operating
loss
|
(5,197,520)
|
|
(4,106,745)
|
|
(14,805,222)
|
|
(12,794,884)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
24,149
|
|
13,127
|
|
53,802
|
|
55,267
|
Interest
expense
|
(464,197)
|
|
(361,619)
|
|
(1,377,004)
|
|
(1,191,976)
|
Warrant modification
expense
|
|
|
-
|
|
|
|
(3,109,850)
|
Loss from change in
fair value of derivative instruments
|
-
|
|
-
|
|
-
|
|
(334,133)
|
Other income
(expense)
|
-
|
|
-
|
|
(10,326)
|
|
250,000
|
Total other income
(expense)
|
(440,048)
|
|
(348,492)
|
|
(1,333,528)
|
|
(4,330,692)
|
|
|
|
|
|
|
|
|
Net loss
|
$
(5,637,568)
|
|
$
(4,455,237)
|
|
$ (16,138,750)
|
|
$
(17,125,576)
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.06)
|
|
$
(0.05)
|
|
$
(0.18)
|
|
$
(0.20)
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
91,569,826
|
|
87,366,234
|
|
90,532,073
|
|
86,777,197
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
Net loss
|
$
(5,637,568)
|
|
$
(4,455,237)
|
|
$ (16,138,750)
|
|
$
(17,125,576)
|
Foreign currency
translation adjustment
|
(2,275)
|
|
3
|
|
(2,280)
|
|
(1,131)
|
Comprehensive
loss
|
$
(5,639,843)
|
|
$
(4,455,234)
|
|
$ (16,141,030)
|
|
$
(17,126,707)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying
notes to unaudited condensed consolidated financial
statements.
|
About Neuralstem
Neuralstem's patented technology enables the commercial-scale
production of multiple types of central nervous system stem cells,
which are under development for the potential treatment of central
nervous system diseases and conditions.
Neuralstem's ability to generate human neural stem cell lines
for chemical screening has led to the discovery and patenting of
compounds that Neuralstem believes may stimulate the brain's
capacity to generate neurons, potentially reversing pathologies
associated with certain central nervous system (CNS) conditions.
The company has completed Phase Ia and Ib 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 II study for MDD.
Neuralstem's first stem cell product candidate, NSI-566, a human
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 that
met primary safety endpoints. In addition to ALS, NSI-566 is also
in a Phase I study for the treatment of chronic spinal cord injury
at UC San Diego School of Medicine, as well as in clinical
development to treat ischemic stroke.
Neuralstem's next generation stem cell product, NSI-532.IGF,
consists of human cortex-derived neural stem cells that have been
engineered to secrete human insulin-like growth factor 1 (IGF-1).
In animal data presented at the Congress of Neurological Surgeons
2014 Annual Meeting, the cells rescued spatial learning and memory
deficits in an animal model of Alzheimer's disease.
For more information, please visit www.neuralstem.com or connect
with us on Twitter, Facebook and LinkedIn
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, 2014, and
Form 10-Q for the three and nine months ended September 30, 2015, filed with the Securities and
Exchange Commission (SEC), and in other reports filed with the
SEC.
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SOURCE Neuralstem, Inc.