GERMANTOWN, Md., May 9, 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 three
months ended March 31, 2016 and
provided a business update.
Business Highlights
- On May 6, 2016, the Company
closed a public offering resulting in net proceeds of $7.42 million. The net proceeds will be
used for general corporate purposes, including the Phase 2 NSI-189
major depressive disorder (MDD) clinical trial and ongoing research
and development activities.
- In March 2016, we commenced the
NSI-189 Phase 2 clinical trial for the treatment of Major
Depressive Disorder (MDD).
- In February 2016, we strengthened
our management team with the appointment of Richard Daly as our President and Chief
Executive Officer.
- In January 2016, we announced an
initiative to pursue collaborations for our stem cell therapy
programs in order to utilize additional expertise, expedite
clinical and regulatory pathways and secure alternative
funding.
"The Company's ability to raise significant capital from
institutional investors provides us a cash runway to continue to
fund our clinical development programs, specifically the NSI-189
Phase 2 MDD clinical trial," said Richard
Daly, CEO. "We recently commenced our Phase 2 MDD trial
which confirms the Company is on track to have results in the
second half of 2017. We are committed to continue to execute our
clinical and corporate strategy to create additional stakeholder
value."
Small Molecule Pharmaceutical Compounds Clinical
Development
Lead asset, NSI-189 Phase 2 clinical trial for the treatment of
major depressive disorder (MDD)
- In March 2016, we commenced our
NSI-189 Phase 2 clinical trial for the treatment of MDD, a
double-blind, randomized, placebo-controlled, 220 subject study.
For information on the trial please visit
https://clinicaltrials.gov/show/NCT02695472.
Cell Therapy Platform Clinical Developments
- 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 that our proprietary neural stems 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 in the chronic spinal cord injury trial.
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. 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 and 2 safety trials 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. 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
- During the three months ended March 31, 2016, the company completed dosing the
third of three planned cohorts, each cohort included three
patients, for a total of nine patients in a Phase 1 open label,
dose-escalation trial evaluating safety and the maximum tolerated
dose. The trial is being conducted by Neuralstem China, at BaYi
Brain Hospital in Beijing,
China.
Results of Operations for the Quarter Ended March 31, 2016:
Cash, cash equivalents and short-term investments on hand was
approximately $7.6 million at
March 31, 2015, compared to
approximately $12.2 million at
December 31, 2015. The decrease
was primarily due to our ongoing operating expenses primarily
related to preparations for the initiation of our NSI-189 Phase 2
clinical trial for the treatment of MDD.
On May 06, 2016, we closed a
public offering of 20,000,000 shares of common stock and 20,000,000
common stock purchase warrants at a public offering price of
$0.40 per each share and common stock
purchase warrant. We received aggregate gross proceeds of
$8.0 million and net proceeds of
approximately $7,420,000 from the
offering. Based upon our cash at March 31,
2016, and the proceeds from our May public offering, we
expect to be able to fund our operations through December 31, 2016.
In the quarter ended March 31,
2016, we reported a net loss of approximately $6.6 million or $0.07 per share, compared to a loss of
approximately $5.1 million or
$0.06 per share in the first quarter
of 2015. Our operating loss in the quarter ended March 31, 2016 was approximately $6.2 million compared to a loss of $4.6 million in the same quarter of 2015.
The increase in operating loss was primarily attributable to the
severance accrual and acceleration of stock based compensation
expense related to the departure of our previous CEO. A decrease of
approximately $0.1 million in
research and development expense was offset by an increase of
approximately $1.7 million in general
and administrative expenses.
Research and development expenses decreased approximately
$117,000 or 4% for the period ended
March 31, 2016 compared to the
comparable period of 2015 primarily as a result of a decrease in
pre-clinical and clinical costs partially offset by an increase in
headcount and stock based compensation.
General and administrative expenses increased approximately
$1,737,000 or 121% for the period
ended March 31, 2016 compared to the
comparable period of 2015 primarily due to a severance accrual and
increased stock based compensation resulting from the accelerated
vesting of options, both related to the termination of our former
Chief Executive Officer.
In addition, in the first quarter of 2016 we recognized
approximately $0.4 million of other
expenses primarily comprised of interest expenses related to our
long-term debt.
Neuralstem,
Inc.
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Unaudited
Condensed Consolidated Balance Sheets
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March 31,
2016
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December 31,
2015
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ASSETS
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CURRENT
ASSETS
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Cash and cash
equivalents
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$
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7,620,746
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$
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4,716,533
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Short-term
investments
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-
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7,517,453
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Trade and other
receivables
|
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39,167
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|
|
|
37,316
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Prepaid
expenses
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1,077,762
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|
|
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1,159,782
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Total current
assets
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8,737,675
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13,431,084
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Property and
equipment, net
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336,974
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343,200
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Patents,
net
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1,066,577
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1,103,467
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Other
assets
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57,692
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|
|
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71,797
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Total
assets
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$
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10,198,918
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$
|
14,949,548
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LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY
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CURRENT
LIABILITIES
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Accounts payable and
accrued expenses
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$
|
2,627,137
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$
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1,455,826
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Accrued
bonuses
|
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|
287,046
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|
|
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161,362
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Current portion of
long term debt, net of fees and discount
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4,466,081
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4,634,742
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Other current
liabilities
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241,008
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173,542
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Total current
liabilities
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7,621,272
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6,425,472
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Long term debt, net
of fees, discount and current portion
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2,546,296
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|
|
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3,391,808
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Other long term
liabilities
|
|
|
200,739
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|
|
|
164,990
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Total
liabilities
|
|
|
10,368,307
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|
|
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9,982,270
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STOCKHOLDERS'
EQUITY (DEFICIT)
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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, 92,044,042 and 92,005,705
shares outstanding in 2016 and 2015, respectively
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920,440
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920,057
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Additional paid-in
capital
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177,473,335
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176,002,832
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Accumulated other
comprehensive income
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1,298
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3,071
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Accumulated
deficit
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(178,564,462)
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(171,958,682)
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Total
stockholders' equity (deficit)
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(169,389)
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4,967,278
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Total liabilities
and stockholders' equity (deficit)
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|
$
|
10,198,918
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$
|
14,949,548
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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
March 31,
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2016
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2015
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Revenues
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$
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2,500
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$
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2,917
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Operating
expenses:
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Research and
development expenses
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3,065,590
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|
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|
3,182,823
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|
General and
administrative expenses
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|
3,170,522
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|
|
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1,433,074
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Total operating
expenses
|
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|
6,236,112
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|
|
4,615,897
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Operating
loss
|
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(6,233,612)
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|
|
(4,612,980)
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Other income
(expense):
|
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|
|
|
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|
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Interest
income
|
|
|
11,136
|
|
|
|
13,569
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|
Interest
expense
|
|
|
(386,506)
|
|
|
|
(453,734)
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Other
income
|
|
|
3,199
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|
|
|
-
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Total other income
(expense)
|
|
|
(372,171)
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|
|
|
(440,165)
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|
|
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Net loss
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|
$
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(6,605,783)
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|
|
$
|
(5,053,145)
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Net loss per share -
basic and diluted
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|
$
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(0.07)
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$
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(0.06)
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Weighted average
common shares outstanding - basic and diluted
|
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92,009,782
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|
89,654,634
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|
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|
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Comprehensive
loss:
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Net loss
|
|
$
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(6,605,783)
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|
|
$
|
(5,053,145)
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|
Foreign currency
translation adjustment
|
|
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(1,773)
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|
|
|
13
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Comprehensive
loss
|
|
$
|
(6,607,556)
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|
$
|
(5,053,132)
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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 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, 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 currently
conducting a Phase 2 efficacy study for MDD.
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 30 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, Form 10-Q for the period ended March 31, 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-fiscal-first-quarter-2016-results-and-business-update-300264839.html
SOURCE Neuralstem, Inc.