ROCKVILLE, Md., Nov. 17 /PRNewswire-FirstCall/ -- Neuralstem, Inc.
(NYSE Amex: CUR) today provided a financial and business update for
the third quarter ended September 30, 2009. (Logo:
http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO ) For the
third quarter of 2009, the Company reported a net loss of
$5,096,983, or $0.15 per share, compared with a net loss of
$3,177,957 or $0.10 per share, for the comparable 2008 period. The
increase was due to a non-cash charge related to a change in
accounting for certain warrants, offset in part by reductions in
other expense categories. Net loss attributable to common
stockholders for the first nine months of 2009 was $7,380,751 or
$0.22 per share, compared with $8,410,081, or $0.26 per share, for
the comparable period in 2008, resulting from a year to date gain
in accounting for warrants, partially offset by increases in
non-cash stock-based compensation expense, R&D and legal fees.
Cash, cash equivalents and short-term marketable securities at
September 30, 2009 totaled approximately $2.4 million, compared
with approximately $4.9 million at December 31, 2008. As of
September 30, 2009, the Company estimated that cash on hand would
be sufficient to meet its operating needs into the first quarter of
2010, including estimated costs associated with the clinical trials
for its ALS programs planned for commencement in the U.S. in 2010.
For the nine months ended September 30, 2009, cash used in
operating activities totaled $3,613,084, a decrease of $1,118,358
or 24% compared to the same period in the prior year, primarily
attributable to an increase of short term financing by vendors,
employees and other service providers and a reduction in spending,
particularly in research. Clinical Program, Patent and General
Business Update In September the U.S. Food and Drug Administration
(FDA) approved Neuralstem's Investigational New Drug (IND)
application to commence a Phase I trial to treat Amyotrophic
Lateral Sclerosis (ALS or Lou Gehrig's disease) with its spinal
cord stem cells. The Company expects to begin trials in the first
quarter of 2010. Neuralstem CEO and President, Richard Garr,
stated, "The beginning of our clinical trial program is a major
step toward achieving Neuralstem's goal of treating ALS, a fatal
neurodegenerative disease for which currently there is no effective
treatment or cure. While this trial aims to primarily establish
safety and feasibility data in treating ALS patients, we also hope
to be able to measure a slowing down of the ALS degenerative
process. This trial will be in the extremely capable hands of Dr.
Eva L. Feldman, M.D., Ph.D., Director of the University of Michigan
Health System ALS Clinic and the Program for Neurology Research
& Discovery, and Dr. Jonathan Glass, Director of the Emory
Neuromuscular Laboratory and Director of the Emory ALS Center, both
of whom are world-renowned for their study and treatment of ALS
patients. We believe that there is no better team to conduct this
study for us," said Garr. Their participation is subject to formal
IRB approval by their institutions. The Company also announced that
it has received notice of allowance from the United States Patent
and Trademark Office (USPTO) for its patent entitled
"Transplantation of Human Neural Cells For Treatment Of
Neurodegenerative Conditions," number 11/281,640. "We are gratified
to add this important core technology patent to our portfolio,"
said Neuralstem President & CEO Richard Garr. "The
transplantation of our neural stem cells to treat degenerative
conditions of the nervous system is at the heart of Neuralstem's
mission." "Most importantly," said Neuralstem Chief Scientific
Officer, Dr. Karl Johe, "the claims in this patent cover the
manufacturing process of our future products from all regions of
the human central nervous system (brain and spinal cord) through
July of 2026." In August the company reported that its Exchange
listing compliance plan submitted in July had been accepted by the
NYSE AMEX LLC (the Exchange). The Company outlined a plan for
regaining compliance and in accepting Neuralstem's plan, the
Exchange has granted the Company an extension until December 6,
2010 to become compliant. About Neuralstem, Inc. Neuralstem's
patented technology enables, for the first time, the ability to
produce neural stem cells of the human brain and spinal cord in
commercial quantities, and the ability to control the
differentiation of these cells into mature, physiologically
relevant human neurons and glia. The company is targeting major
central nervous system diseases including: Ischemic Spastic
Paraplegia, Traumatic Spinal Cord Injury, Huntington's disease and
Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou
Gehrig's disease. Neuralstem plans to initiate a Phase I clinical
trial to treat ALS with its stem cells. ALS is a progressive fatal
neurodegenerative disease that affects nerve cells in the brain,
leading to the degeneration and death of the motor neurons in the
spinal cord that control muscle movement. Pre-clinical work has
shown Neuralstem's cells to extend the life of rats with ALS (as
reported in the journal TRANSPLANTATION, October 16, 2006, in
collaboration with Johns Hopkins University researchers), and also
to reverse paralysis in rats with Ischemic Spastic Paraplegia (as
reported in NEUROSCIENCE, June 29, 2007, in collaboration with
researchers at University of California San Diego). 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, 2008 and the quarterly
report on Form 10-Q for the period ended June 30, 2009. Neuralstem,
Inc. Balance Sheets September 30, December 31, 2009 2008
(Unaudited) ----------- ------------ ASSETS CURRENT ASSETS Cash and
cash equivalents $2,420,715 $4,903,279 Prepaid expenses 160,204
136,287 --------- --------- Total current assets 2,580,919
5,039,566 --------- --------- Property and equipment, net 136,086
163,930 Intangible assets, net 264,342 212,265 Other assets 70,525
52,972 ---------- ---------- Total assets $3,051,872 $5,468,733
========== ========== LIABILITIES AND STOCKHOLDERS' (DEFICIT)
EQUITY CURRENT LIABILITIES Accounts payable, accrued expenses and
salaries $2,353,257 $1,265,488 LONG-TERM LIABILITIES Fair value of
warrant obligations 5,622,339 - --------- --------- Total
liabilities 7,975,596 1,265,488 --------- --------- STOCKHOLDERS'
(DEFICIT) EQUITY Preferred stock, 7,000,000 shares authorized, zero
shares issued and outstanding - - Common stock, $0.01 par value;
150 million shares authorized, 34,829,234 and 33,751,300 shares
outstanding in 2009 and 2008 respectively 348,292 337,513
Additional paid-in capital 59,311,203 61,352,527 Accumulated
deficit (64,583,219) (57,486,795) ----------- ----------- Total
stockholders' (deficit) equity (4,923,724) 4,203,245 ----------
--------- Total liabilities and stockholders' (deficit) equity
$3,051,872 $5,468,733 ========== ========== Statements of
Operations (Unaudited) Three Months Nine Months Ended September 30,
Ended September 30, 2009 2008 2009 2008 ---- ---- ---- ----
Revenues $- $- $- $- Operating expenses: Research and development
costs 1,308,565 1,766,040 4,195,366 4,598,611 General, selling and
administrative expenses 1,191,480 1,400,795 3,898,666 3,802,673
Depreciation and amortization 22,537 17,223 64,757 46,760 ------
------ ------ ------ 2,522,582 3,184,058 8,158,789 8,448,044
--------- --------- --------- --------- Operating loss (2,522,582)
(3,184,058) (8,158,789) (8,448,044) ---------- ----------
---------- ---------- Nonoperating (expense) income: Interest
income 6,274 6,101 17,054 37,963 Interest expense (194) - (194) -
(Loss) gain from change in fair value of warrant obligations
(2,580,481) - 761,178 - ---------- --- ------- --- (2,574,401)
6,101 778,038 37,963 ---------- ----- ------- ------ Net loss
attributable to common shareholders $(5,096,983) $(3,177,957)
$(7,380,751) $(8,410,081) =========== =========== ===========
=========== Net loss per share, basic and diluted $(0.15) $(0.10)
$(0.22) $(0.26) ====== ====== ====== ====== Weighted average common
shares outstanding, basic and diluted 34,562,322 32,151,300
34,027,542 32,008,533 ========== ========== ========== ==========
http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO
http://photoarchive.ap.org/ DATASOURCE: Neuralstem, Inc. CONTACT:
John Conron, Chief Financial Officer of Neuralstem, Inc.,
+1-301-633-7709; Dan Schustack, CEOcast, Inc., Investor Relations,
+1-212-732-4300; or Deanne Eagle, Media, +1-917-837-5866 Web Site:
http://www.neuralstem.com/
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