GERMANTOWN, Md., Aug. 10, 2015 /PRNewswire/ -- Neuralstem, Inc.
(Nasdaq: CUR) a biopharmaceutical company developing neural stem
cell-derived small molecule and cell therapy treatments for central
nervous system diseases, reported its financial results and
business update for the three and six months ended June 30, 2015.
Neurogenic Small Molecule Program
- NSI-189 Phase II in Major Depressive Disease (MDD):
Neuralstem is developing regulatory and clinical plans for a
multicenter, Phase II clinical trial of NSI-189 for the treatment
of MDD. Maurizio Fava, M.D., Slater
Family Professor of Psychiatry at Harvard
Medical School, Massachusetts General Hospital will be the
principal investigator. The study is anticipated to enroll
approximately 200 patients and expected to begin in the second half
of 2015.
- NSI-189 for the treatment of cognitive deficit in
schizophrenia: The Company plans to begin a Phase Ib clinical
trial for the treatment of cognitive deficit in schizophrenia.
Cell Therapy Program
- NSI-566 spinal cord-derived stem cell therapy, under
development for the treatment of ALS: In March, the company
announced topline data, concluding that the Phase II ALS clinical
trial met the primary safety endpoints and established what we
believe to be the maximum-safe-tolerated dose of 16 million cells
administered via 40 injections. The Company's collaborators are
currently completing a final report on the study. The Company
expects to initiate a larger controlled clinical study this
year.
- NSI-566 spinal cord-derived cell therapy under development
for the treatment of chronic spinal cord injury (cSCI): The
four-patient, stem cell transplantation Phase I safety study dosed
the last patient in July. Each patient is evaluated over a 6-month
post-operative 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 is
expected to commence in 2015. The trial is sponsored by
Neuralstem's wholly owned subsidiary, Suzhou Neuralstem
Biopharmaceuticals Co., Ltd. ("Neuralstem China").
Business Highlights
In May, the Company announced the appointment of Jonathan Lloyd Jones to the position of Chief
Financial Officer. Mr. Lloyd
Jones brings more than 25 years of corporate finance and
business development experience to the company. Mr. Lloyd Jones is a Chartered Accountant and holds
an MBA degree from the Wharton School of the University of Pennsylvania and a BSc from the
University of Bradford.
Neuralstem was approved for listing on the NASDAQ Capital Market
under the symbol "CUR." The company's common stock started
trading on the NASDAQ on June 13,
2015.
The U.S. District Court for the District of Maryland dismissed StemCells, Inc.'s patent
infringement case with prejudice in StemCells, Inc. v.
Neuralstem, Inc. in favor of Neuralstem on July 22, 2015.
Results of Operations for the Second Quarter Ended
June 30, 2015
Cash, cash equivalents and short-term investments on hand was
approximately $23.7 million at
June 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 June 30,
2015, we reported a net loss of approximately $5.4 million or $0.06 per share, compared to a net loss of
approximately $6.8 million or
$0.08 per share in the comparable
quarter of 2014. Our operating loss for the three months
ended June 30, 2015 was approximately
$5.0 million compared to a loss of
approximately $3.5 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 coupled with an
approximately $0.2 million increase
in general and administrative expenses.
The increase in research and development expenses was primarily
attributable to an increase of approximately $0.9 million in project and laboratory expenses,
an increase of approximately $0.3
million in payroll and related expenses due to increased
salaries and headcount and an increase of approximately
$0.1 million in consulting
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 increase in general and administrative expenses was
primarily attributable to an increase in payroll and related
expenses due to increased salaries and headcount.
Results of Operations for the Six Months Ended June 30, 2015
For the six months ended June 30,
2015, we reported a net loss of approximately $10.5 million or $0.12 per share, compared to a net loss of
approximately $12.7 million or
$0.15 per share in the comparable
period of 2014. Our operating loss for the six months ended
June 30, 2015 was approximately
$9.6 million compared to a loss of
approximately $8.7 million in the
same period of 2014. The increase in operating loss was due
to an approximately $2.9 million
increase in research and development expenses partially offset by
an approximately $1.9 million
decrease in general and administrative expenses.
The increase in research and development expenses was primarily
attributable to an increase of approximately $2.0 million in project and laboratory expenses,
and an increase of approximately $0.6
million 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 increases were also coupled with an approximately $0.1 million increase in non-cash stock based
compensation expense.
The decrease in general and administrative expense was primarily
due to a decrease of approximately $1.8
million in non-cash stock based compensation and a decrease
of approximately $0.5 million in
legal fees resulting from insurance claims related to 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 increases
of approximately $0.3 million in
payroll related expenses due to increased salaries and
headcount.
In addition, for the three and six months ended June 2015, we recognized approximately
$0.5 million and $0.9 million respectively, of interest expense
related to our long-term debt.
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Neuralstem,
Inc.
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Unaudited
Condensed Consolidated Balance Sheets
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June 30,
2015
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December 31,
2014
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|
|
|
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ASSETS
|
|
|
|
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CURRENT
ASSETS
|
|
|
|
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Cash and cash
equivalents
|
$
8,649,127
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|
$ 12,518,980
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Short-term
investments
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15,032,419
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|
15,007,478
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Trade and other
receivables
|
18,818
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|
225,524
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Deferred financing
fees, current portion
|
121,202
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|
135,694
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Prepaid
expenses
|
904,222
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|
274,106
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Total current
assets
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24,725,788
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28,161,782
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Property and
equipment, net
|
342,969
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|
301,265
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Patents,
net
|
1,205,456
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1,233,172
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Deferred financing
fees, net of current portion
|
40,830
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89,143
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Other
assets
|
57,259
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58,713
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Total
assets
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$
26,372,302
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$ 29,844,075
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LIABILITIES AND
STOCKHOLDERS' EQUITY
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CURRENT
LIABILITIES
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Accounts payable and
accrued expenses
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$
2,099,952
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$
2,504,978
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Accrued
bonuses
|
490,749
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646,960
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Current portion of
long term debt, net of discount
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3,170,469
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730,012
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Other current
liabilities
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148,536
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126,745
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Total current
liabilities
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5,909,706
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4,008,695
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Long term debt, net
of discount and current portion
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5,812,322
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8,056,470
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Other long term
liabilities
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110,848
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|
59,574
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Total
liabilities
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11,832,876
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12,124,739
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STOCKHOLDERS'
EQUITY
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Preferred stock,
7,000,000 shares authorized, zero shares issued and
outstanding
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-
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-
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Common stock, $0.01
par value; 300 million shares authorized, 90,359,761 and 87,789,679
shares outstanding in 2015 and 2014,respectively
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903,598
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877,897
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Additional paid-in
capital
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175,185,796
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167,890,220
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Accumulated other
comprehensive income
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5,995
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6,000
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Accumulated
deficit
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(161,555,963)
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(151,054,781)
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Total
stockholders' equity
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14,539,426
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17,719,336
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Total liabilities
and stockholders' equity
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$
26,372,302
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$ 29,844,075
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Neuralstem,
Inc.
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Unaudited
Condensed Consolidated Statements of Operations and Comprehensive
Loss
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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2015
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2014
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2015
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2014
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Revenues
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$
2,500
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$
5,000
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$
5,417
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$
9,167
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Operating
expenses:
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|
|
|
|
|
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Research and
development expenses
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3,312,841
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1,999,921
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6,495,664
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|
3,630,286
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General and
administrative expenses
|
1,684,381
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|
1,516,317
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3,117,455
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5,067,020
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Total operating
expenses
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4,997,222
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3,516,238
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9,613,119
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8,697,306
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Operating
loss
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(4,994,722)
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(3,511,238)
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(9,607,702)
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(8,688,139)
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Other income
(expense):
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|
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Interest
income
|
16,084
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|
17,422
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|
29,653
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|
42,140
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Interest
expense
|
(459,073)
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|
(397,616)
|
|
(912,807)
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|
(830,357)
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Warrant modification
expense
|
|
|
(3,109,850)
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|
|
|
(3,109,850)
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Loss from change in
fair value of derivative instruments
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-
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-
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|
-
|
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(334,133)
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Other income
(expense)
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(10,326)
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|
250,000
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|
(10,326)
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|
250,000
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Total other income
(expense)
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(453,315)
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|
(3,240,044)
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(893,480)
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|
(3,982,200)
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|
|
|
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Net loss
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$
(5,448,037)
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$ (6,751,282)
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|
$
(10,501,182)
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|
$
(12,670,339)
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|
|
|
|
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Net loss per share -
basic and diluted
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$
(0.06)
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|
$
(0.08)
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|
$
(0.12)
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$
(0.15)
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Weighted average
common shares outstanding - basic and diluted
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90,791,285
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87,186,586
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90,004,597
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86,477,797
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Comprehensive
loss:
|
|
|
|
|
|
|
|
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Net loss
|
$
(5,448,037)
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$ (6,751,282)
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|
$
(10,501,182)
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$
(12,670,339)
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Foreign currency
translation adjustment
|
(18)
|
|
130
|
|
(5)
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|
(1,134)
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|
Comprehensive
loss
|
$
(5,448,055)
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|
$ (6,751,152)
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|
$
(10,501,187)
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|
$
(12,671,473)
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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 and a Phase Ib study for
cognitive deficit in schizophrenia in 2015.
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, that
met primary safety endpoints. In addition to ALS, NSI-566 is also
in a Phase I trial in 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 six months ended June 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.