GERMANTOWN, Md., March 16, 2015 /PRNewswire/ -- Neuralstem, Inc.
(NYSE MKT: CUR) (the "Company" or "Neuralstem") today reported its
financial results for the fourth quarter and year ended
December 31, 2014.
"Neuralstem has progressed into a clinical development stage
company focused on the central nervous system (CNS)," said
Richard Garr, Neuralstem President
and CEO. "During 2014 we added two established industry leaders as
Independent Directors, Catherine Angell
Sohn, Pharm.D. and Sandford Drexel
Smith. Dr. Sohn is the former Senior Vice President of
Business Development and Strategic Alliance, GSK Consumer
Healthcare, at GlaxoSmithKline. Mr. Smith is the former Executive
Vice President of Genzyme Corporation. The Company moved forward
two lead clinical assets: our small molecule neurogenic drug
candidate NSI-189 and our spinal derived neural stem cell
therapeutic candidate NSI-566. We established and/or grew
clinical research programs with leading investigators at
Emory University, University of California, San Diego (UCSD),
University of Michigan and Massachusetts General Hospital. Our investigators
published and presented proof of principle data in both lead assets
as highlighted below. In 2015, we plan to begin clinical
development of our NSI-189 small molecule drug in a second
indication for the treatment of cognitive deficit from
schizophrenia, and we plan to initiate a Phase II clinical trial
for the ongoing development program for the treatment of major
depressive disorder (MDD). The cell therapy programs in amyotrophic
lateral sclerosis (ALS), chronic spinal cord injury (cSCI) and
stroke will also move forward. We expect this to be another
important year continuing our development and progress across both
platforms."
2014 Clinical Program and Business Highlights
Neurogenic Small Molecule Platform Clinical
Development
- NSI-189 Phase II clinical trial for the treatment of MDD is
expected to commence in the second quarter of 2015.
Maurizio Fava, M.D., Slater Family
Professor of Psychiatry at Harvard Medical
School, Massachusetts General
Hospital is the principal investigator for the 150-patient,
multi-site clinical trial.
- Top-line data for the NSI-189 Phase Ib MDD trial.
The data was presented at the American Society of
Clinical Psychopharmacology (ASCP) and the International College of Neuropyschopharmacology
(CiNP) annual meetings. The randomized, placebo-controlled,
dose-escalation study showed clinically meaningful and
statistically significant results in depressive and cognitive
measurements at the end of the 28-day dosing period.
Moreover, therapeutic benefits were sustained over the 8-week
follow-up period signaling possible hippocampal neurogenesis.
- NSI-189 MDD biomarker data. In November 2014, researchers presented Phase Ib
blood-based biomarker data and analysis for MDD in a poster at the
CNS Summit, which identified a rapid and persistently efficacious
response.
- Expansion of NSI-189 development program to a second
indication for the treatment of cognitive deficit in
schizophrenia. Cognitive deficit in schizophrenia is a
prominent characteristic of the disorder that is correlated with
the occurrence of hippocampal atrophy in this patient population.
Commencement of the Company's NSI-189 cognitive deficit in
schizophrenia Phase Ib trial is expected in 2015.
Cell Therapy Platform Clinical Development
NSI-566 spinal cord-derived stem cell therapy under
development for the treatment of ALS
- Top-line data for the Phase II NSI-566 ALS trial.
Topline ALS Phase II data were released on March 12, 2015. Our top-line data in the Phase II
ALS clinical trial met the primary safety endpoints and established
what we believe to be the maximum tolerated dose of 16 million
cells delivered in 40 injections. The secondary efficacy
endpoints of ALSFRS and grip strength at nine months post-surgery
demonstrated statistical significance in a comparison between
responders and non-responders at nine months post-surgery; and as
in the Phase I trial, disease stabilization was seen in the
responders. We plan to present the full Phase II trial data
later in 2015. This dose-escalating trial treated 15 ambulatory
patients in five cohorts. Each of the three patients in the final
cohort received a total dose of 40 injections of 400,000 cells, 20
injections each in the cervical and lumbar regions, for a total 16
million transplanted cells per patient. A larger, controlled Phase
II trial is expected to commence in 2015.
- Phase I cell survival study data. In November 2014, a long-term NSI-566 ALS Phase I
cell survival study, entitled "Analysis of graft survival in a
trial of stem cell transplant in ALS," was published in the journal
"Annals of Clinical and Translational Neurology." Researchers
concluded that NSI-566 cells survived for the entire post-operative
period of each of the autopsied patients studied from nine to
thirty months post-transplantation. They also concluded that
long-term immunosuppression was most likely not required for
long-term survival of the cells.
NSI-566 spinal cord-derived cell therapy under development
for the treatment of cSCI
- Commencement of Phase I cSCI. The first two
patients have been treated in a Phase I trial for cSCI at the UCSD
School of Medicine, supported by the UCSD Sanford Stem Cell
Clinical Center. The four-patient stem cell transplantation safety
trial is currently enrolling patients and expects to report full
data in the fourth quarter of 2015, following a six-month
post-surgery study for each patient.
NSI-566 spinal cord derived stem cell therapy under
development for the treatment of motor deficits in stroke
- Advancement in Phase I/II ischemic stroke trial.
Neuralstem continued to enroll patients in its collaborative Phase
I/II ischemic stroke trial with BaYi Brain Hospital in Beijing. The Phase II, controlled
proof-of-concept study, is expected to commence in 2015. The trial
is sponsored by Neuralstem's wholly owned subsidiary, Suzhou
Sun-Now Biopharmaceutical Co. Ltd. ("Neuralstem China"), which was
formed to develop Neuralstem's cell therapy products in
China.
NSI-532.IGF second generation gene engineered cell
therapy
- Expansion of cell therapy development program to include a
second cell line engineered to express human insulin-like
growth factor 1 (IGF-1). NSI-532.IGF cells are a
cortical neural stem cell line engineered to deliver IGF-1, which
is intended to provide an extra therapeutic benefit. This is the
first instance in which Neuralstem is working to demonstrate the
ability of it cells to act as a stable CNS delivery vehicle for
gene therapy.
- NSI-532.IGF preclinical Alzheimer's data. In
October 2014, the first data were
presented at the Congress of Neurological Surgeons Annual Meeting.
In a presentation titled, "Peri-hippocampal stem cell
transplantation rescues cognitive decline in Alzheimer's disease,"
University of Michigan Medical School
researchers concluded that Neuralstem's NSI-532.IGF cells rescued
spatial learning and memory deficits in mice with an animal model
of Alzheimer's disease.
2014 Business Highlights
Board of Directors: Neuralstem appointed two independent
directors to its Board of Directors in 2014, Catherine Angell Sohn, Pharm.D. and Sandford Drexel Smith. Dr. Sohn is the former
Senior Vice President of Business Development and Strategic
Alliance, GSK Consumer Healthcare, at GlaxoSmithKline. Mr. Smith is
the former Executive Vice President of Genzyme Corporation.
Financial: In January 2014,
Neuralstem closed a $20 million
registered direct offering with proceeds intended to fund its
ongoing clinical trials and corporate operations.
Financial Results for the Year Ended December 31, 2014
Cash, cash equivalents and short-term investments on hand was
approximately $27.5 million at
December 31, 2014, compared to
approximately $16.8 million at
December 31, 2013. The increase
was primarily due to our raising approximately $19.5 million, net, through the sale of our
common stock and warrants, and approximately $4.2 million, net, from our October 2014 debt amendment transaction,
partially offset by cash used in our operations.
In the year ended December 31,
2014, we reported a net loss of approximately $22.6 million or $0.26 per share, compared to a loss of
approximately $19.8 million or
$0.27 per share in the year ended
December 31, 2013. Our
operating loss in the year ended December
31, 2014 was approximately $17.4
million, compared to a loss of approximately $12.5 million in the year ended December 31, 2013. The increase in
operating loss was primarily attributable to an increase of
approximately $3.7 million in general
and administrative expenses coupled with an increase of
approximately $1.0 million in
research and development expenses.
The increase in research and development expenses was primarily
attributable to an increase of approximately $0.7 million in payroll and related expenses due
to increased salaries and headcount, an increase of approximately
$0.1 million in project and lab
expenses and an increase of approximately $0.1 million in travel and related expenses due
to our clinical trial activities. These increased expenses
are all related to a ramping-up 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 of approximately $2.0 million in non-cash stock based compensation
expenses primarily related to financial advisory and consultant
services' achieving a performance based milestone that resulted in
a term extension of certain common stock purchase warrants, an
increase of approximately $1.0
million in legal and professional fees related to
patent, litigation and other corporate matters, an increase of
approximately $0.6 million in
consulting fees primarily related to new business development
efforts and an increase of approximately $0.2 million in payroll and related expenses due
to current year headcount increases.
In addition, in the year ended December
31, 2014 we recorded approximately $5.2 million of other expenses, primarily
comprised of approximately $3.1
million related to our extension of certain common stock
purchase warrants, approximately $1.6
million of interest expenses principally related to our
long-term debt, a loss of approximately $0.4
million on our debt amendment transaction and
approximately $0.3 million related to
the change in fair value of the Company's warrant liabilities,
partially offset by approximately $0.3
million of income from a milestone payment from a legal
settlement.
Neuralstem,
Inc.
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
|
|
|
December
31,
|
|
2014
|
|
2013
|
|
|
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$ 12,518,980
|
|
$ 16,846,052
|
Short term
investments
|
15,007,478
|
|
-
|
Trade and other
receivables
|
225,524
|
|
10,000
|
Deferred financing
fees, current portion
|
135,694
|
|
507,334
|
Prepaid
expenses
|
274,106
|
|
255,733
|
Total current
assets
|
28,161,782
|
|
17,619,119
|
|
|
|
|
Property and
equipment, net
|
301,265
|
|
230,971
|
Patents,
net
|
1,233,172
|
|
1,137,701
|
Deferred financing
fees, net of current portion
|
89,143
|
|
360,848
|
Other
assets
|
58,713
|
|
64,897
|
Total
assets
|
$ 29,844,075
|
|
$ 19,413,536
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts payable and
accrued expenses
|
$
2,504,978
|
|
$ 1,196,190
|
Accrued
bonuses
|
646,960
|
|
465,868
|
Current portion of
long term debt, net of discount
|
730,012
|
|
2,763,121
|
Derivative
instruments
|
-
|
|
1,417,527
|
Other current
liabilities
|
126,745
|
|
93,426
|
Total current
liabilities
|
4,008,695
|
|
5,936,132
|
|
|
|
|
Long term debt, net
of discount and current portion
|
8,056,470
|
|
4,934,210
|
Other long term
liabilities
|
59,574
|
|
124,995
|
Total
liabilities
|
12,124,739
|
|
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, 87,789,679
and 77,886,031 shares issued and outstanding in 2014 and 2013,
respectively
|
877,897
|
|
778,860
|
Additional paid-in
capital
|
167,890,220
|
|
136,058,135
|
Accumulated other
comprehensive income
|
6,000
|
|
7,241
|
Accumulated
deficit
|
(151,054,781)
|
|
(128,426,037)
|
Total
stockholders' equity
|
17,719,336
|
|
8,418,199
|
Total liabilities
and stockholders' equity
|
$ 29,844,075
|
|
$ 19,413,536
|
Neuralstem,
Inc.
|
|
|
|
|
Consolidated
Statements of Operations and Comprehensive Loss
|
|
|
|
|
|
Year Ended
December 31,
|
|
2014
|
|
2013
|
|
|
|
|
Revenues
|
$
18,833
|
|
$
110,000
|
|
|
|
|
Operating
expenses:
|
|
|
|
Research and
development costs
|
8,134,753
|
|
7,134,301
|
General and
administrative expenses
|
8,971,299
|
|
5,254,915
|
Depreciation and
amortization
|
348,630
|
|
244,725
|
Total operating
expenses
|
17,454,682
|
|
12,633,941
|
Operating
loss
|
(17,435,849)
|
|
(12,523,941)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest
income
|
67,651
|
|
68,000
|
Interest
expense
|
(1,620,776)
|
|
(1,394,274)
|
Warrant modification
expense
|
(3,109,850)
|
|
(5,017,156)
|
Loss from change in
fair value of derivative instruments
|
(334,133)
|
|
(965,329)
|
Loss on debt
extinguishment
|
(445,787)
|
|
-
|
Litigation
settlement
|
250,000
|
|
838
|
Total other income
(expense)
|
(5,192,895)
|
|
(7,307,921)
|
|
|
|
|
Net loss
|
$
(22,628,744)
|
|
$
(19,831,862)
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.26)
|
|
$
(0.27)
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
87,086,345
|
|
72,279,210
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
Net loss
|
$
(22,628,744)
|
|
$
(19,831,862)
|
Foreign currency
translation adjustment
|
(1,241)
|
|
7,241
|
Comprehensive
loss
|
$
(22,629,985)
|
|
$
(19,824,621)
|
About Neuralstem
Neuralstem's patented technology enables the production of
multiple types of central nervous system (CNS) stem cells in
commercial quantities for the potential treatment of certain CNS
diseases and conditions.
The human neural stem cell lines Neuralstem has generated for
chemical screening has led to the discovery and patenting of
compounds that may stimulate the brain's capacity to generate
neurons, possibly reversing pathologies associated with certain 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 launch 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 in an ongoing
clinical trial for the treatment of amyotrophic lateral sclerosis
(ALS, or Lou Gehrig's disease).
Phase II surgeries were completed in July
2014. A later stage trial is anticipated to commence in 2015
at multiple centers. Neuralstem received orphan designation by the
FDA for NSI-566 in ALS. In addition to ALS, NSI-566 is also being
tested in a Phase I trial in chronic spinal cord injury at
University of California, San Diego
School of Medicine. NSI-566 is also in clinical development for the
treatment of neurological diseases such as ischemic stroke and
acute spinal cord injury.
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, filed
with the Securities and Exchange Commission (SEC) on March 16, 2015, and in other reports filed with
the SEC.
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SOURCE Neuralstem, Inc.