Neuralstem Reports Third Quarter Financial Results And Provides Update On Clinical Programs And Business Highlights

  Neuralstem Reports Third Quarter Financial Results And Provides Update On
                  Clinical Programs And Business Highlights

PR Newswire

ROCKVILLE, Md., Nov. 9, 2012

ROCKVILLE, Md., Nov.9, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR)
reported its financial results for the three months and nine months ended
September 30, 2012 and provided an update on clinical programs and business
highlights.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"In the third quarter, the company achieved three significant clinical
milestones. The first was the completion of the eighteenth and final surgery
in our ALS Phase I trial. All ALS trial assessments show the NSI-566 neural
stem cells and intraspinal transplantation procedure, the first in the world,
to be safe. The trial's principal investigator, Dr. Eva Feldman, said she
believes we are seeing evidence of a treatment effect in some Phase I patients
over a sustained period of time. We look forward to advancing to the next ALS
trials, to increase both number of patients treated and NSI-566 dosage, and
effectively evaluate efficacy. To that end, we are working diligently with our
investigators to file an IND with the FDA for a Phase II ALS trial by
year-end," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors
and Chief Scientific Officer.

"The second significant clinical milestone was approval to begin our ischemic
stroke trial in China. Our collaborators in Beijing, at the world-class BaYi
Brain Hospital are on schedule to start enrollment early in the first quarter
for a combined Phase I/II clinical trial to treat motor deficits due to
ischemic stroke with NSI-566. The first part of the study, Phase I, will be
open-label and enroll up to 18 patients who will be assigned to one of three
cohorts. Each cohort will receive ascending doses of NSI-566 directly into the
brain at the stroke area (another first for Neuralstem), to define the maximal
safe dose, before proceeding to the Phase II/proof-of-concept study to
evaluate efficacy," said Dr. Johe. "One of several independent Neuralstem
studies presented at The Society for Neuroscience's annual meeting
demonstrated significant recovery of motor and neurological functions in
ischemic stroke rats with NSI-566; a second ischemic stroke study demonstrated
safety and feasibility in a chronic model in mini-pigs. Together, with the
extensive human safety data established in our ALS trial, these two studies
demonstrate strong proof-of-principle data that our NSI-566 cells are ready to
test in humans to treat paralysis in stroke patients. A rat spinal cord injury
study, reported in the peer-reviewed scientific journal CELL, demonstrated
that NSI-566 cells induce regeneration of injured spinal cord axons into the
graft and serve as a bridge to reconnect to gray matter motor neurons for many
spinal cord segments below an injury, inducing significant recovery of motor
functions."

Dr. Johe concluded: "The third significant clinical milestone was the FDA
approval for dosing the second cohort of major depressive disorder patients in
the Phase Ib trial of NSI-189. Our lead neurogenic drug, NSI-189 is a
first-in-class orally active drug that stimulates new neuron growth and
increased volume in the hippocampus, which we believe can help patients with
MDD and other psychological and cognitive conditions. We are on track to
complete the Ib, an ascending-dose, 28-day-cycle safety trial designed in
collaboration with Dr. Maurizio Fava of Harvard University and Massachusetts
General, during the first quarter of 2013."

Neuralstem's President and CEO Richard Garr added: "The third quarter of 2012
marked business milestones as well. We saw a major addition to our patent
estate with U.S. patent number 8,236,299, with a patent life into 2030,
titled: 'Transplantation of Human Neural Cells for Treatment of
Neurodegenerative Conditions.' This is significant in that it covers processes
involved in our first potential transplantation product, including claims
covering processes for dissociating our neural stem cells from central nervous
system tissue; culturing the cells; expanding the cells in vitro and
transplanting the cells into the spinal cord of a patient to treat a wide
array of neurodegenerative conditions, including ALS."

Mr. Garr continued: "The company granted its first licenses for use of our
proprietary Spinal Cord Delivery Platform and Floating Cannula. As the
industry standard for delivering therapeutic agents to the spinal cord, we
expect to continue to announce licenses of the surgical devices to both
industry and academia as they now begin to explore the possibilities our
technology has enabled. We are also continuing discussions for licensing and
partnership opportunities for our neurogenic small molecule program, for which
we are seeing strong interest. Our goal is to move NSI-189 and our preclinical
library of additional novel neurogenic compounds forward in multiple
indications, which range from Alzheimer's disease and anti-aging (nootropic)
to chronic traumatic encephalopathy and post-traumatic stress disorder. We
believe this can best be accomplished through partnering with industry."

Clinical Program and Business Highlights

Cellular Therapy: NSI-566 Phase I Clinical Trial in ALS (amyotrophic lateral
sclerosis, or Lou Gehrig's disease) at Emory University Hospital

  oIn August, Neuralstem completed the final transplantation of its
    ground-breaking Phase I safety trial of NSI-566 spinal cord neural stem
    cells for the treatment of ALS. Phase I is scheduled to conclude six
    months after this final surgery of returning patient #18.
  oIn July, patient 17 was the second ALS patient to return to the trial,
    receiving five injections in the cervical region in addition to the ten
    previously received in the lumbar region of the spinal cord, for a total
    of 15 injections of neural stem cells.
  oSubsequent Event: In October, principal investigator and president of the
    American Neurological Association (ANA) Eva Feldman, MD, PhD, updated data
    on the trial at the ANA annual meeting. She called the transplantations "a
    paradigm shift in the treatment of ALS" and presented interim results on
    all 18 procedures in 15 patients.

Cellular Therapy: NSI-566 Phase I/II Clinical Trial in Ischemic Stroke at BaYi
Brain Hospital

  oIn August, Neuralstem was approved to commence a clinical trial to treat
    motor deficits due to ischemic stroke with NSI-566 at BaYi Brain Hospital,
    in Beijing, China, through its subsidiary, Neuralstem China. The trial
    approval includes a combined phase I/II design of up to 118 patients, and
    will test direct injections into the brain of NSI-566. It is scheduled to
    commence in the first quarter of 2013.

Cellular Therapy: NSI-566 Pre-clinical Programs

  oIn September, a peer-reviewed article in the leading scientific journal
    CELL reported that Neuralstem NSI-566 cells induced significant functional
    improvement in permanent rat spinal cord injury, with paralyzed rats
    regaining use of lower limbs. The study, entitled "Long-Distance Growth
    and Connectivity of Neural Stem Cells After Severe Spinal Cord Injury:
    Cell-Intrinsic Mechanisms Overcome Spinal Inhibition," reports that the
    animals recovered significant locomotor function, regaining movement in
    all lower extremity joints, and that the transplanted neural stem cells
    turned into neurons which grew a "remarkable" number of axons that
    extended for "very long distances" over 17 spinal segments, making
    connections both above and below the point of severance.
  oSubsequent Event: In October, NSI-566/animal ischemic stroke data was
    presented in two independent studies at The Society for Neuroscience's
    Annual Meeting. "Histopathological Assessment of Adult Ischemic Rat Brains
    after 4 Weeks of Intracerebral Transplantation of NSI-566RSC Cell Line,"
    conducted in the laboratory of Dr. Cesar Borlongan at the Center of
    Excellence for Aging and Brain Repair at the University of South Florida
    College of Medicine, showed significant recovery of motor and neurological
    functions in ischemic stroke rats with NSI-566. The other ischemic stroke
    study presented was conducted by Dr. Martin Marsala at the
    Neuroregeneration Laboratory at University of California San Diego, and
    entitled "Survival and Differentiation of Human Neural Stem Cells
    (NSI-566RSC) After Grafting into Ischemia-Injured Porcine Brain."
    Neuralstem presented three additional posters of preclinical data at the
    meeting.

Neurogenic Small Molecule NSI-189: Phase I Clinical Trial in Major Depressive
Disorder (MDD)

  oSubsequent Event: In October, Neuralstem began dosing the second cohort of
    eight patients, upon receiving FDA approval, in the Phase Ib trial. The
    trial is testing the safety of escalated dosing for 28 daily
    administrations of the company's lead neurogenic small molecule drug,
    NSI-189, in the treatment of major depressive disorder.

Corporate News

  oIn September, Neuralstem granted the first licenses for use of its Spinal
    Cord Delivery Platform and Floating Cannula, used in the ALS Phase I trial
    for delivering therapeutic agents to the spinal cord.
  oIn September, Chairman and Chief Scientific Officer Dr. Karl Johe
    presented "Novel Neurogenic Drugs Targeting Hippocampal Degeneration" at
    the 6^th Neurodegenerative Conditions Research and Development conference,
    and President and CEO Richard Garr presented corporate and clinical
    updates at the 2012 Aegis Healthcare Conference and the 2012 Rodman and
    Renshaw Annual Healthcare Conference.
  oIn July, Neuralstem received a notice of issuance for patent application
    number 12/710,097 (subsequently issued patent number 8,236,299) titled:
    "Transplantation of Human Neural Cells for Treatment of Neurodegenerative
    Conditions." This patent, which will expire in the first quarter of 2030,
    covers both the culturing of central nervous system (CNS) cells as well as
    their transplantation into spinal cord tissue to treat neurodegenerative
    conditions, including ALS.
  oDuring the quarter, the company raised $9.76 million through offerings of
    its common stock to fund its ongoing clinical trials, research and
    development, and working capital.
  oSubsequent Events: In October, Neuralstem engaged Locust Walk Partners,
    LLC, a life sciences' commercial licensing and partnering specialist
    advisory firm, to further explore partnership opportunities for a
    clinical-stage neurogenic small molecule program targeting a broad range
    of psychiatric and cognitive disorders.
  oSubsequent Events: In October, Neuralstem received a notice of issuance
    for Vietnam patent number 10524 titled: "Transplantation of Human Neural
    Cells for Treatment of Neurodegenerative Conditions." This issuance brings
    Neuralstem's worldwide patent count to 28 issued and 43 pending.

Third Quarter Financial Results

For the third quarter of 2012, the Company reported a net loss of $2,577,391
or $0.04 per share, compared with a net loss of $3,211,604 or $0.07 per share,
for the comparable 2011 period. The decrease in net loss was primarily due to
an approximately $698,000 reduction in project expenses related to studies
which ended in 2011 coupled with a decrease in non-cash stock based
compensation expense of approximately $181,000 partially offset by increases
in consulting expenses. In addition, in the third quarter of 2012, the Company
recognized approximately $171,000 in revenue from third-party licenses
agreements.

For the nine months ended September 30, 2012, the Company reported a net loss
of $7,406,553, or $0.14 per share, compared with a net loss of $9,962,131 or
$0.21 per share for the comparable 2011 period.The decrease in net loss was
primarily due to a reduction in non-cash stock based compensation expense of
approximately $1,700,000 coupled with decreases of approximately $617,000 in
project expenses and $355,000 in legal expenses and an increase in revenues of
approximately $302,000 partially offset by gains of approximately $412,000
related to a legal settlement and changes in the fair value of certain warrant
obligations in 2011.

Cash and cash equivalents on hand at September 30, 2012 totaled $9,873,395,
compared with $2,352,013 at December 31, 2011. The approximately $7,521,000
increase in cash and cash equivalents over the nine months of 2012 was
primarily due to approximately $13,685,000 of net proceeds from the issuance
of common stock during the nine months ended September, 2012 partially offset
by cash used in operations.

About Neuralstem

Neuralstem's patented technology enables 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 constitutively into
mature, physiologically relevant human neurons and glia. Neuralstem has
recently treated the last patient in an FDA-approved Phase I safety clinical
trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou
Gehrig's disease, and has been awarded orphan status designation by the FDA.

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, ischemic stroke and glioblastoma (brain cancer). The company has
submitted an IND (Investigational New Drug) application to the FDA for a Phase
I safety trial in spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell
lines suitable for the 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 new
neurons, possibly reversing the pathologies of some central nervous system
conditions. The company is in a Phase Ib safety trial evaluating NSI-189, its
first neurogenic small molecule compound, for the treatment of major
depressive disorder (MDD).Additional indications could include chronic
traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress
disorder (PTSD).

For more information, please visit www.neuralstem.com or connect with us on
Twitter and Facebook.

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, 2011 and the quarterly report on
Form 10-Q for the period ended September 30, 2012.



Neuralstem, Inc.
Unaudited Condensed Balance Sheets
                                     September 30, 2012     December 31, 2011
ASSETS
CURRENT ASSETS
Cash and cash equivalents            $      9,873,395  $    2,352,013
Prepaid expenses                     289,788                430,356
Billed and unbilled receivables      833                    234,375
Total current assets                 10,164,016             3,016,744
Property and equipment, net          246,017                292,193
Patent filing fees, net              772,186                701,846
Other assets                         59,533                 75,394
Total assets                         $     11,241,752   $    4,086,177
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable and accrued         $      1,501,345  $    1,843,684
expenses
Accrued bonus expense                479,368                582,675
Other current liabilities            138,987                -
Total current liabilities            2,119,700              2,426,359
Deferred rent, net of current        23,750                 -
portion
Total liabilities                    2,143,450              2,426,359
Commitments and contingencies (Note
5)
STOCKHOLDERS' EQUITY
Preferred stock, 7,000,000 shares
authorized, zero shares issued and   -                      -
outstanding
Common stock, $0.01 par value; 150
million shares authorized,
67,964,314 and 48,682,118 shares     679,643                486,821
outstanding in 2012 and
2011,respectively
Additional paid-in capital           114,297,870            99,645,655
Accumulated deficit                  (105,879,211)          (98,472,658)
Total stockholders' equity           9,098,302              1,659,818
Total liabilities and stockholders'  $     11,241,752   $    4,086,177
equity



Neuralstem, Inc.
Unaudited Condensed Statements of Operations
                  Three Months Ended September    Nine Months Ended September
                  30,                             30,
                  2012             2011           2012           2011
                  $         $        $        $      
Revenues                        103,417                
                  170,833                        405,208       103,417
Operating
expenses:
Research and      1,385,478        2,124,204      4,406,538      5,948,603
development costs
General and
administrative    1,280,606        1,137,995      3,264,146      4,433,703
expenses
Depreciation and  87,908           64,285         164,154        149,548
amortization
Total operating   2,753,992        3,326,484      7,834,838      10,531,854
expenses
Operating loss    (2,583,159)      (3,223,067)    (7,429,630)    (10,428,437)
Other income
(expense):
Litigation        692              -              3,265          250,000
settlement
Interest income   5,411            11,463         21,601         54,497
Interest expense  (335)            -              (1,789)        -
Gain from change
in fair value of  -                -              -              161,809
warrant
obligations
Total other       5,768            11,463         23,077         466,306
income (expense)
                  $         $        $        $      
Net loss                        (3,211,604)                  (9,962,131)
                  (2,577,391)                    (7,406,553)
Net loss per      $         $        $        $      
share - basic and                                 
diluted           (0.04)           (0.07)        (0.14)         (0.21)
Weighted average
common shares     58,363,721       48,488,432     54,751,377     48,225,452
outstanding -
basic and diluted



SOURCE Neuralstem, Inc.

Website: http://www.neuralstem.com
Contact: Deanne Eagle, Media Relations, +1-917-837-5866, or Susan Roush,
Investor Relations, +1-818-222-8330
 
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