ROCKVILLE, Md., May 12, 2014 /PRNewswire/ -- Neuralstem,
Inc. (NYSE MKT: CUR) today reported its financial results for the
three months ended March 31, 2014 and
provided a business and clinical update.
"During the first quarter of 2014, we continued to advance the
NSI-566 cell therapy platform through human clinical trials. We
have completed treatment of the fourth cohort in our ALS Phase II
escalating dose trials, in collaboration with our sites at
University of Michigan, Emory and Massachusetts
General. Patients 10, 11 and 12 each received a total of 8 million
cells (20 bilateral injections of 400,000 cells) into the cervical
region of the spinal cord. As our Principal Investigator, Dr.
Eva Feldman, noted in her complete
Phase I data analysis this past quarter, we believe that increasing
total cell dose, by increasing the number of injections and the
number of cells per injection, may increase both the duration and
magnitude of the potential benefit. This is consistent with our
hypothesized neuroprotective mechanism-of-action for this cell
therapy," said Karl Johe, PhD,
Neuralstem's Chairman of the Board and Chief Scientific Officer.
"We are now treating the fifth and final cohort in the Phase II ALS
trial. During May, these patients will undergo lumbar
transplantation and then return for the cervical treatment during a
second surgery approximately four weeks later. Each of these
patients will then 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 from the last surgery. Our hope and expectation is
that the data from this trial will enable a registration trial that
can start in early 2015."
Dr. Johe continued: "The second indication for NSI-566 in the
U.S. is chronic spinal cord injury (cSCI). This FDA-approved trial
will be conducted in its entirety at the University of California, San Diego, School of
Medicine, under the guidance of Principal Investigator,
Joseph Ciacci, MD. The Phase I trial
is being made possible, in part, by generous financial support from
UCSD. The eight patients will have AIS-A level impairment, or
complete paralysis, between one and two years after injury.
"Turning to Neuralstem's neurogenic small molecule drug
program, we are currently completing our review of the data from
our NSI-189 Phase Ib randomized placebo controlled trial to treat
major depressive disorder. While that task is ongoing, the early
review is encouraging enough that we have already committed to
filing a Phase II trial application and hope to start that trial
later this year," concluded Dr. Johe.
"2014 is a pivotal year for Neuralstem," said Richard Garr, Neuralstem's President & CEO.
"We are advancing to new clinical levels on both the small molecule
and cell therapy platforms in multiple indications. Along with our
collaborators, we are proud to be pushing for breakthroughs in the
field of neurogenic medicine."
Mr. Garr added: "As the Company's clinical programs mature, my
fellow Directors and I were pleased to have welcomed Dr.
Catherine Sohn and Mr. Sandy Smith to our Board. Dr. Sohn formerly
spearheaded global commercialization for one of the world's largest
pharmaceutical companies, and Mr. Smith was directly responsible
for launching 12 new products in diverse therapeutic areas for one
of the world's most successful rare disease companies. Their
expertise will prove invaluable as we build the infrastructure
necessary to move our company to the next level of
development."
First Quarter Clinical Program and Business
Highlights
In March, a study entitled, "Behavioral and Histopathological
Assessment of Adult Ischemic Rat Brains after Intracerebral
Transplantation of NSI-566RSC Cell Lines" was published in the
peer-reviewed journal, PLOS ONE. The study, whose lead author was
Cesar V. Borlongan, PhD, Professor,
Department of Neurosurgery, Morsani College of Medicine and
Director of University of South
Florida's Center of Excellence for Aging and Brain Repair,
showed that ischemic-stroke rats transplanted with NSI-566 in the
brain experienced functional improvements. Furthermore, the grafts
survived and differentiated into neurons. The researchers concluded
that NSI-566 are potent cell donors for transplantation therapy to
treat paralysis in stroke patients.
In March, the final results from the NSI-566/ALS Phase I trial
were published in the peer-reviewed journal, ANNALS OF NEUROLOGY.
In "Intraspinal Neural Stem Cell Transplantation in Amyotrophic
Lateral Sclerosis: Phase I Trial Outcomes," results were updated
from Phase I interim data, reported earlier, to include data from
the last six patients in the trial. These six patients were the
first to receive cervical stem cell transplants. The results showed
that NSI-566 cells can be safely transplanted in both the lumbar
and cervical spinal cord segments, did not accelerate disease
progression, and warrant further study on dosing and therapeutic
efficacy.
In March, President and CEO Richard
Garr presented an NSI-566 clinical trials program update at
the eighth annual Bio-Europe Spring Conference 2014.
In February, Richard Garr
presented an NSI-566 clinical update at the sixteenth annual
BIO CEO & Investor Conference
2014.
In January, Neuralstem announced that the first patient was
treated, on December 27, 2013, in the
NSI-566 Phase I/II trial to treat motor deficits from ischemic
stroke at BaYi Brain Hospital in Beijing. The trial is sponsored by
Neuralstem's wholly owned subsidiary, Neuralstem China (Suzhou
Sun-Now Biopharmaceutical Co. Ltd.), which was formed to develop
Neuralstem's cell therapy products in China. The stroke motor deficit trial,
expected to last two years, is the first in which Neuralstem's
cells are being transplanted directly into the patient's brain.
In January, Neuralstem appointed Catherine Sohn, Doctor of Pharmacy (Pharm.D.),
to its Board of Directors. Dr. Sohn is the former Senior Vice
President of Business Development and Strategic Alliance, GSK
Consumer Healthcare, at GlaxoSmithKline, where she spearheaded
global commercialization for this $8
billion division and led a series of international licensing
deals. Earlier during her 28-year tenure at GlaxoSmithKline, Dr.
Sohn established the U.S. Vaccine Business Unit, leading to the
launch of the company's first vaccine in the U.S., which grew to
more than $100 million in sales. She
was also involved in the U.S. launch of the company's CNS product,
Paxil, which subsequently grew to more than $1 billion in sales.
In January, Neuralstem closed a $20
million registered direct offering from leading
institutional investors, including dedicated healthcare investors,
with proceeds intended to fund its ongoing clinical trials and for
working capital and general corporate purposes.
In January, Richard Garr
presented a business overview and NSI-566 clinical update at the
sixth annual 2014 Biotech Showcase.
Subsequent Events:
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, ascending-dose study has a one-year completion goal and
will enroll up to eight 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) between one and two years post injury. NSI-566/cSCI
patients will also receive post-surgery immunosuppressive therapy
as tolerated and physical therapy for three months. The trial study
period will end six months post-surgery for each patient.
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. Dr. Feldman also
provided the first public update on Phase II of the trial.
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.
First Quarter Financial Results
For the first quarter of 2014, the Company reported a net loss
of approximately $5,919,000 or
$0.07 per share, compared with a net
loss of approximately $3,590,000 or
$0.05 per share, for the comparable
2013 period. The increase in net loss was primarily comprised
of a $2,286,000 increase in operating
loss due to a non-cash charge of approximately $2,018,000 related to a consultant achieving a
performance based milestone which resulted in a term extension of
certain common stock purchase warrants and an increase of
approximately $227,000 in legal and
professional fees, partially offset by a $233,000 decrease in
project and lab expenses related to certain projects not continuing
into the first quarter of 2014 and the cost of certain studies in
2014 being subsidized by third parties.
The net loss in the first quarter of 2014 also included other
expenses comprised of approximately $432,000 in interest expense related to our long
term debt and a $334,000 non-cash
expense related to the change in the fair value of the our
derivative instruments. The first quarter of 2013 included a
$667,000 non-cash expense related to
the modification of certain stock purchase warrants.
Our cash, cash equivalents and short-term investments on hand
was approximately $33,343,000 at
March 31, 2014, compared to
approximately $16,846,000 at
December 31, 2013. The
increase of approximately $16,497,000, was primarily due to our raising
$18.7 million through our
January 2014 registered direct
offering coupled with $1.4 million of
proceeds from the exercise of certain common stock purchase
warrants, partially offset by cash used in operations.
Neuralstem,
Inc.
|
|
|
|
|
Unaudited
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
March
31,
2014
|
|
December 31,
2013
|
|
|
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$
18,342,736
|
|
$
16,846,052
|
Short-term
investments
|
15,000,000
|
|
-
|
Billed and unbilled
receivables
|
11,359
|
|
10,000
|
Deferred financing
fees, current portion
|
435,547
|
|
507,334
|
Prepaid
expenses
|
319,616
|
|
255,733
|
Total current
assets
|
34,109,258
|
|
17,619,119
|
|
|
|
|
Property and
equipment, net
|
310,375
|
|
230,971
|
Patents,
net
|
1,190,625
|
|
1,137,701
|
Deferred financing
fees, net of current portion
|
248,688
|
|
360,848
|
Other
assets
|
64,850
|
|
64,897
|
Total
assets
|
$
35,923,796
|
|
$
19,413,536
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts payable and
accrued expenses
|
$
1,771,111
|
|
$
1,662,058
|
Current portion of
long term debt, net of discount
|
2,849,812
|
|
2,763,121
|
Derivative instruments
|
-
|
|
1,417,527
|
Other current
liabilities
|
53,280
|
|
93,426
|
Total current
liabilities
|
4,674,203
|
|
5,936,132
|
|
|
|
|
Long term debt, net
of discount and current portion
|
4,192,538
|
|
4,934,210
|
Other long term
liabilities
|
160,338
|
|
124,995
|
Total
liabilities
|
9,027,079
|
|
10,995,337
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
Preferred stock,
7,000,000 shares authorized, zero shares issued and
outstanding
|
-
|
|
-
|
Common stock, $0.01
par value; 150 million shares authorized, 86,688,613 and 77,886,031
shares outstanding in 2014 and 2013,respectively
|
866,886
|
|
778,860
|
Additional paid-in
capital
|
160,368,948
|
|
136,058,135
|
Accumulated other
comprehensiveincome
|
5,977
|
|
7,241
|
Accumulated
deficit
|
(134,345,094)
|
|
(128,426,037)
|
Total
stockholders' equity
|
26,896,717
|
|
8,418,199
|
Total liabilities
and stockholders' equity
|
$
35,923,796
|
|
$
19,413,536
|
Neuralstem,
Inc.
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive
Loss
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
Revenues
|
$
4,167
|
|
$
102,500
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development expenses
|
1,571,221
|
|
1,748,347
|
|
General and
administrative expenses
|
3,519,359
|
|
1,195,840
|
|
Depreciation and
amortization
|
90,488
|
|
50,093
|
|
Total operating
expenses
|
5,181,068
|
|
2,994,280
|
|
Operating
loss
|
(5,176,901)
|
|
(2,891,780)
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
income
|
24,718
|
|
9,925
|
|
Interest
expense
|
(432,741)
|
|
(48,257)
|
|
Warrant modification
expense
|
-
|
|
(666,736)
|
|
Gain (loss) from
change in fair value of derivative instruments
|
(334,133)
|
|
6,518
|
|
Other
income
|
-
|
|
243
|
|
Total other income
(expense)
|
(742,156)
|
|
(698,307)
|
|
|
|
|
|
|
Net loss
|
$
(5,919,057)
|
|
$
(3,590,087)
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.07)
|
|
$
(0.05)
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
85,750,298
|
|
68,700,709
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
Net loss
|
$
(5,919,057)
|
|
$
(3,590,087)
|
|
Foreign currency
translation adjustment
|
(1,264)
|
|
-
|
|
Comprehensive
loss
|
$
(5,920,321)
|
|
$
(3,590,087)
|
|
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 is in Phase II clinical trials for amyotrophic
lateral sclerosis (ALS), often referred to as Lou Gehrig's disease. Neuralstem has been
awarded orphan status designation by the FDA for its ALS cell
therapy. The company has received approval to commence an
FDA-approved Phase I safety trial in chronic spinal cord injury at
the University of California, San
Diego, School of Medicine. Neuralstem is also targeting
additional major central nervous system conditions with its NSI-566
cell therapy platform, including ischemic stroke and acute 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 a Phase I safety trial
evaluating NSI-189, its first neurogenic small molecule product
candidate, for the treatment of major depressive disorder
(MDD). 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 the Form 10-Q for the
period ended March 31, 2014.
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SOURCE Neuralstem, Inc.