GERMANTOWN, Md., Aug. 8, 2014 /PRNewswire/ -- Neuralstem,
Inc. (NYSE MKT: CUR) today reported its financial results for the
three months and six months ended June 30,
2014 and provided a business and clinical update.
"We are pleased to report that 2014 has already seen the company
achieve several major milestones. In late July, we completed the
last of the surgeries in the NSI-566/ALS Phase II trial. Each of
the patients in the final cohort have received a total of 16
million NSI-566 neural stem cells, through 40 surgical injections
of 400,000 cells per injection. The trial will conclude after an
observation period of six months," said Karl Johe, PhD, Neuralstem's Chairman and Chief
Scientific Officer.
"Our FDA-approved NSI-566 Phase I trial to treat chronic spinal
cord injury (cSCI) is scheduled to commence in the coming weeks at
the University of California, San
Diego, School of Medicine, following approval by UCSD's
Institutional Review Board during the second quarter," said Dr.
Johe. "The open-label, ascending-dose study of patients with
thoracic spinal cord injuries utilizes the same proprietary spinal
platform and floating cannula developed for the ALS trials, as well
as the same NSI-566 spinal cord cells. Patients in this trial will
have an American Spinal Injury Association AIS-A level of
impairment (considered to be in complete paralysis) and will be
between one and two years post injury. The trial is generously
supported by, and will be conducted in its entirety at, UCSD under
the guidance of Principal Investigator, Joseph Ciacci, MD."
Dr. Johe continued: "During the second quarter, the company
achieved another major milestone when data from the Ib trial of our
neurogenic small molecule compound to treat MDD was presented at
two prestigious academic conferences held in June: the American
Society of Clinical Psychopharmacology (ASCP) Annual Meeting, and
the International College of
Neuropyschopharmacology (CINP) Annual Meeting. The extremely robust
NSI-189 Phase Ib data showed statistical significance; and
clinically meaningful improvement of both depression and cognitive
symptoms in the active therapy patients, compared to placebo across
all clinical measurements. Further, the improvements persisted
eight weeks after 28-day treatment stopped.
"We believe the biomarker data (quantitative EEG), which was
included in the CINP conference presentation, confirms that NSI-189
is affecting key circuitry common in both mood control and
cognition, involving hippocampal neurogenesis and synaptogenesis,"
added Dr. Johe. "Combined with the significant clinical
improvements of the patients, these findings validate our
hypothesis that NSI-189 stimulates the neurogenesis of hippocampal
stem cells, altering the fine structures within the hippocampus in
a manner that is long-lasting. We are encouraged that NSI-189 may
be affecting the physical structure of the human brain in these
depression patients and may modify progression of cognitive
impairment diseases, as well.
"With such positive data supporting this novel
neurogenesis-based platform, we and fellow investigators, including
lead study author, Dr. Maurizio
Fava, Executive Vice Chair, Department of Psychiatry,
Executive Director, Clinical Trials Network and Institute,
Massachusetts General Hospital, are
preparing the Phase II trial application. We plan to launch a
multi-site NSI-189/Phase II MDD study late in the first quarter of
2015. This next clinical trial will test two doses (40mg once a day
and 40mg twice a day), along with a randomized, double-blinded,
placebo control group, in approximately 150 patients with confirmed
diagnosis of recurrent MDD, with the aim of confirming these
extremely promising results in a larger clinical setting,"
concluded Dr. Johe.
"We closed the second quarter of 2014 with a cash position of
nearly $30 million, which gives a
solid foundation to execute on the company's business plan through
mid-2016," said Richard Garr,
Neuralstem's President and CEO. "As Neuralstem's products advance
in the clinic in both cell therapy and neurogenic pharmaceuticals,
we are building the infrastructure necessary to accelerate our
programs towards NSI-566 and NSI-189 commercialization. To that
end, my fellow Directors and I were pleased to welcome Sandy Smith as a Director during the second
quarter. Sandy is the former President, International Group, and
Executive Vice President of Genzyme Corporation. His experience
directing global commercialization for one of the world's most
successful rare disease companies, where he was directly
responsible for launching 12 new products in diverse therapeutic
areas, will prove invaluable as we take the company to the next
level. Sandy's appointment follows that of Catherine Sohn, PharmD, who spearheaded global
commercialization at GlaxoSmithKline, one of the world's largest
pharmaceutical companies. We are already benefitting from this
level of expertise and experience being added to Neuralstem's
Board. We are extremely pleased to have Sandy's and Cathy's
guidance during this time of pivotal inflection points for our
product development in both the Company's cell therapy and small
molecule programs.
"During this past quarter, we further strengthened our global IP
portfolio with the issuance of a neurogenic small molecule patent,
validated in 34 countries, by the European Patent Organisation. We
also received notice of issuance of the second U.S. patent for the
floating spinal cannula surgical device used in cell therapy. This
brings our total patents to 87 issued and 59 pending," said
Garr.
"Dr. Johe and I would like to acknowledge with deep gratitude
the brave patients and their families and caregivers who are
allowing this breakthrough cell therapy and novel neurogenic drug
advancements in the clinic. We also thank our exceptional
collaborators, among them: NSI-189/psychiatric/small molecule trial
consultant, Maurizio Fava, MD,
NSI-566/ALS principal investigator, Eva L.
Feldman, MD, PhD, and NSI-566/cSCI lead collaborator,
Martin Marsala, MD, PhD. We also
want to acknowledge the leading institutions that serve as
sites for this ground-breaking work, including the University of Michigan, Emory
University, Massachusetts
General, and University of California,
San Diego," concluded Garr.
Second Quarter Clinical Program and Business
Highlights
In June, Neuralstem's NSI-189/MDD Phase Ib data was reported at
the annual meetings of both the American Society of Clinical
Psychopharmacology (ASCP), and the International College of Neuropyschopharmacology
(CINP).
- "A Phase Ib Randomized, Double-Blind, Placebo-Controlled,
Multiple-Dose Escalation Study Evaluating the Effects of NSI-189
Phosphate, A Neurogenic Compound, in Patients with Major Depressive
Disorder (MDD)," was presented at the ASCP Annual Meeting by
Marlene Freeman, MD, Medical
Director, Clinical Trials Network and Institute, Massachusetts General Hospital, and Associate
Professor of Psychiatry, Harvard Medical
School. Data showed a clinically meaningful reduction in
cognitive and depressive symptoms across all measures in depressed
patients on NSI-189 active therapy against the control group,
continuing for the duration of the trial, eight weeks after the
28-day treatment had stopped. A large effect was reported in all
four scales employed in the study that are commonly used to assess
clinical levels of depression and improvement: Montgomery-Asberg
Depression Rating Scale (MADRS), Clinician Global
Impression–Improvement (CGI-I), Symptoms of Depression
Questionnaire (SDQ), and Cognitive and Physical Functioning
Questionnaire (CPFQ). Based on the results, the investigators
concluded that a neurogenesis-based platform could identify
promising new treatments for MDD.
- "Effects of NSI-189, a neurogenic compound, on quantitative
electroencephalography (qEEG) in patients with major
depressive disorder (MDD) during a phase 1b randomized,
double-blinded, placebo controlled, multiple ascending dose study"
was the title of a poster presented by [Brett English, PharmD, PhD, Adjunct Assistant
Professor at USC School of Pharmacy and
Senior Director for Scientific Affairs at PAREXEL] at the
CINP Annual Meeting. The NSI-189/MDD Phase Ib qEEG data showed
significantly increased brain wave patterns in the hippocampal
region of the brain, and increased electrical coherence in the
prefrontal cortical region, which is a pro-cognitive signal.
Researchers concluded that these electrophysiological changes are
consistent with the neurogenic hypothesis of the drug mechanism,
which involves long-term structural changes in the
hippocampus.
In June, Neuralstem received issuance of EPO Patent # 2470182
(Synthesis of a Neurostimulative Piperazine), that was validated in
34 countries: Austria,
Belgium, Bulgaria, Switzerland, Cyprus, Czech
Republic, Germany,
Denmark, Estonia, Spain, Finland, France, Great
Britain, Greece,
Croatia, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco, Macedonia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia and Turkey, for a total of 35 European
patents.
In June, Neuralstem shares were added to the broad-market
Russell 3000® Index. Annual
reconstitution of Russell's U.S. indexes captures the 4,000 largest
U.S. stocks as of the end of May, ranking them by total market
capitalization. Membership in the Russell 3000, which remains in
place for one year, brings automatic inclusion in the large-cap
Russell 1000® Index or small-cap Russell
2000® Index as well as the appropriate
growth and value style indexes.
In May, Sandford Drexel Smith was
appointed to Neuralstem's Board of Directors. Mr. Smith is the
former President, International Group, and Executive Vice President
of Genzyme Corporation. As President of the International Group,
Mr. Smith opened markets in Latin
America, China,
India, Russia and Eastern
Europe, establishing more than 45 offices worldwide, and was
responsible for the launch of 12 new products in diverse
therapeutic areas. He grew Genzyme's international business to
$3.1 billion, or 60% of the company's
total revenues. In 2011, Genzyme was acquired by Sanofi, one of the
world's largest healthcare companies.
In May, Neuralstem's President and CEO, Richard Garr, presented a talk entitled,
"Sustainable Growth of Regenerative Medicine: Ensuring Long Term
Development and Patient Access to Transformative Cell Therapies,"
at the World Stem Cells & Regenerative Medicine Congress, in
London, UK.
In April, the FDA-approved NSI-566 Phase I trial to treat
chronic spinal cord injury (cSCI) was approved to commence at the
University of California, San Diego,
School of Medicine by its Institutional Review Board. The
open-label study will enroll patients with thoracic spinal cord
injuries who have an American Spinal Injury Association AIS-A level
of impairment (patients who are considered to be in complete
paralysis) and are between one and two years post injury.
NSI-566/cSCI patients will also receive post-surgery
immunosuppressive therapy as tolerated for three months.
In April, NSI-566/ALS Principal Investigator, Eva Feldman, PhD, MD, presented published Phase
I data at the Keystone Symposia, "Engineering Cell Fate and
Function." Dr. Feldman took part in a workshop, organized in
collaboration with California Institute for Regenerative Medicine,
called "Clinical Progress for Stem Cell Therapies."
In April, the United States Patent Office issued Patent
#8,708,962, the second U.S. patent for the floating spinal cannula
and method of use, to which Neuralstem holds exclusive license.
Second Quarter Financial Results
For the three months ended June 30,
2014, the Company reported a net loss of approximately
$6,751,000 or $0.08 per share, compared with a net loss of
approximately $6,252,000 or
$0.09 per share, for the comparable
2013 period. The increase in net loss was due primarily due to
a $278,000 increase in operating loss
due to an increase in legal, consulting and professional fees
included in our general and administrative expenses related to
patent, litigation and other corporate matters. This is
coupled with a $227,000 increase in
other expenses primarily due to a $705,000 increase in non-cash expense related to
modifications of certain stock purchase warrants, partially offset
by $250,000 of income from a legal
settlement in the current period and prior period
including a $188,000 non-cash expense
for the change in fair value of our warrant liability.
For the six months ended June 30,
2014, the Company reported a net loss of approximately
$12,670,000 or $0.15 per share, compared with a net loss of
approximately $9,842,000 or
$0.14 per share, for the comparable
2013 period. The increase in net loss was due primarily due to a
$2,561,000 increase in operating loss
comprised of a $1,878,000 to an
increase in non-cash stock based compensation mainly due to a
consultant achieving a performance based milestone which resulted
in a term extension of certain common stock purchase warrants along
with a $390,000 increase in legal,
consulting and professional fees included in our general and
administrative expenses related to patent, litigation and other
corporate matters. This is coupled with a $268,000 increase in other expenses primarily due
to a $343,000 increase in interest
expense due to the prior year only including 3 months of expense
related to our March 2013 debt
issuance; a $152,000 increase in
non-cash expense for the change in fair value of our warrant
liability partially offset by $250,000 of income from a legal settlement in the
current period.
Our cash, cash equivalents and short-term investments on hand
was approximately $30,232,000 at
June 30, 2014, compared to
$16,846,000 at December 31, 2013. The increase of
approximately $13,386,000 was
primarily due to our raising net $18.7
million through our January
2014 registered direct offering coupled with approximately
$1.7 million from the exercise of
certain common stock purchase warrants and options partially offset
by cash used in our operations.
Neuralstem,
Inc.
|
|
|
|
|
Unaudited
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
June
30,
2014
|
|
December 31,
2013
|
|
|
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$
15,232,456
|
|
$ 16,846,052
|
Short-term
investments
|
15,000,000
|
|
-
|
Billed and unbilled
receivables
|
24,468
|
|
10,000
|
Deferred financing
fees, current portion
|
389,297
|
|
507,334
|
Prepaid
expenses
|
196,209
|
|
255,733
|
Total current
assets
|
30,842,430
|
|
17,619,119
|
|
|
|
|
Property and
equipment, net
|
310,050
|
|
230,971
|
Patents,
net
|
1,247,498
|
|
1,137,701
|
Deferred financing
fees, net of current portion
|
169,712
|
|
360,848
|
Other
assets
|
58,859
|
|
64,897
|
Total
assets
|
$
32,628,549
|
|
$ 19,413,536
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts payable and
accrued expenses
|
$
2,025,694
|
|
$
1,662,058
|
Current portion of
long term debt, net of discount
|
2,952,333
|
|
2,763,121
|
Derivative
instruments
|
-
|
|
1,417,527
|
Other current
liabilities
|
13,139
|
|
93,426
|
Total current
liabilities
|
4,991,166
|
|
5,936,132
|
|
|
|
|
Long term debt, net
of discount and current portion
|
3,415,984
|
|
4,934,210
|
Other long term
liabilities
|
192,707
|
|
124,995
|
Total
liabilities
|
8,599,857
|
|
10,995,337
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
Preferred stock,
7,000,000 shares authorized, zero shares issued and
outstanding
|
-
|
|
-
|
Common stock, $0.01
par value; 300 million shares authorized, 86,837,455 and 77,886,031
shares outstanding in 2014 and 2013, respectively
|
868,375
|
|
778,860
|
Additional paid-in
capital
|
164,250,586
|
|
136,058,135
|
Accumulated other
comprehensiveincome
|
6,107
|
|
7,241
|
Accumulated
deficit
|
(141,096,376)
|
|
(128,426,037)
|
Total
stockholders' equity
|
24,028,692
|
|
8,418,199
|
Total liabilities
and stockholders' equity
|
$
32,628,549
|
|
$ 19,413,536
|
Neuralstem,
Inc.
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive
Loss
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
Revenues
|
$
5,000
|
|
$
2,500
|
|
$
9,167
|
|
$
105,000
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expenses
|
1,947,558
|
|
1,906,387
|
|
3,518,779
|
|
3,654,734
|
General and
administrative expenses
|
1,481,948
|
|
1,281,210
|
|
5,001,307
|
|
2,477,050
|
Depreciation and
amortization
|
86,732
|
|
50,505
|
|
177,220
|
|
100,598
|
Total operating
expenses
|
3,516,238
|
|
3,238,102
|
|
8,697,306
|
|
6,232,382
|
Operating
loss
|
(3,511,238)
|
|
(3,235,602)
|
|
(8,688,139)
|
|
(6,127,382)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
17,422
|
|
16,635
|
|
42,140
|
|
26,560
|
Interest
expense
|
(397,616)
|
|
(439,271)
|
|
(830,357)
|
|
(487,528)
|
Warrant modification
expense
|
(3,109,850)
|
|
(2,405,206)
|
|
(3,109,850)
|
|
(3,071,942)
|
Gain (loss) from
change in fair value of derivative instruments
|
-
|
|
(188,317)
|
|
(334,133)
|
|
(181,799)
|
Other
income
|
250,000
|
|
131
|
|
250,000
|
|
374
|
Total other income
(expense)
|
(3,240,044)
|
|
(3,016,028)
|
|
(3,982,200)
|
|
(3,714,335)
|
|
|
|
|
|
|
|
|
Net loss
|
$
(6,751,282)
|
|
$ (6,251,630)
|
|
$ (12,670,339)
|
|
$ (9,841,717)
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.08)
|
|
$
(0.09)
|
|
$
(0.15)
|
|
$
(0.14)
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
87,186,586
|
|
69,864,599
|
|
86,477,797
|
|
69,591,602
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
Net loss
|
$
(6,751,282)
|
|
$ (6,251,630)
|
|
$ (12,670,339)
|
|
$ (9,841,717)
|
Foreign currency
translation adjustment
|
130
|
|
-
|
|
(1,134)
|
|
-
|
Comprehensive
loss
|
$
(6,751,152)
|
|
$ (6,251,630)
|
|
$ (12,671,473)
|
|
$ (9,841,717)
|
About Neuralstem
Neuralstem's patented technology enables the production of
neural stem cells of the brain and spinal cord in commercial
quantities, and the ability to control the differentiation of these
cells constitutively into mature, physiologically relevant human
neurons and glial cells. Neuralstem's NSI-566 spinal cord-derived
stem cell therapy Phase II clinical trials for amyotrophic lateral
sclerosis (ALS), often referred to as Lou
Gehrig's disease, concluded final surgeries in July 2014. Neuralstem has been awarded orphan
status designation by the FDA for its ALS cell therapy.
In addition to ALS, the company is also targeting major central
nervous system conditions with its NSI-566 cell therapy platform,
including spinal cord injury and ischemic stroke. The company has
received approvals from the FDA and the Institutional Review Board
of University of California, San Diego,
to commence a Phase I safety trial in chronic spinal cord
injury.
Neuralstem also maintains the ability to generate stable human
neural stem cell lines suitable for systematic screening of large
chemical libraries. Through this proprietary screening technology,
Neuralstem has discovered and patented compounds that may stimulate
the brain's capacity to generate neurons, possibly reversing
pathologies associated with certain central nervous system
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 launch a Phase II NSI-189/MDD study in 2015.
Additional indications might include traumatic brain injury (TBI),
Alzheimer's disease, and post-traumatic stress disorder (PTSD).
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 may contain forward-looking statements made
pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Investors are cautioned that such
forward-looking statements in this press release regarding
potential applications of Neuralstem's technologies constitute
forward-looking statements that involve risks and uncertainties,
including, without limitation, 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, 2013 and Form 10Q, for the period
ended June 30, 2014.
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SOURCE Neuralstem, Inc.