Current Report Filing (8-k)
November 10 2014 - 4:02PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event
reported): November 10, 2014
Neuralstem,
Inc.
(Exact name of registrant as specified
in Charter)
Delaware |
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000-1357459 |
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52-2007292 |
(State or other jurisdiction of
incorporation or organization) |
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(Commission File No.) |
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(IRS Employee Identification No.) |
20271
Goldenrod Lane, 2nd Floor
Germantown, Maryland 20876
(Address of Principal Executive Offices)
(301)
366-4960
(Issuer Telephone
number)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On November 10, 2014, Neuralstem, Inc.
(“Company”) announced the publication of results evaluating long term cell survival and differentiation of NSI-566
transplanted human spinal-cord derived neural stem cells (HSSC) in Annals of Clinical and Translational Neurology. A copy
of the press release is attached to this report as Exhibit 99.01.
Item 9.01 Financial
Statement and Exhibits.
Exhibit
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Description |
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99.01 |
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Press Release Dated November 10, 2014 |
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SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Issuer has duly caused this Report on Form 8-K to be signed on its behalf by the undersigned hereunto
duly authorized.
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NEURALSTEM, INC |
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By: |
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/s/ I. Richard Garr |
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I. Richard Garr
Chief Executive Officer |
Dated: November 10, 2014
INDEX
OF EXHIBITS
Exhibit
Number |
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Description |
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99.01 |
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Press Release Dated November 10, 2014 |
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Exhibit 99.01
NEURALSTEM ANNOUNCES PUBLICATION OF LONG
TERM CELL SURVIVAL FROM PHASE I NSI-566 ALS STUDY IN THE JOURNAL “ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY”
Study Concludes NSI-566 Cells Survived
for up to 2.5 Years After Transplantation
GERMANTOWN, MD, November 10, 2014 -- Neuralstem, Inc. (NYSE
MKT: CUR) announced the publication of results evaluating long term cell survival and differentiation of NSI-566 transplanted human
spinal-cord derived neural stem cells (HSSC) in Annals of Clinical and Translational Neurology (access now available). The
study concluded that Neuralstem’s investigational Phase I NSI-566 HSSCs survived for up to 2.5 years post-transplant in six
of the amyotrophic lateral sclerosis (ALS) Phase I patients. This was the first-ever clinical study approved to transplant HSSCs
in the spinal cord.
In the article, “Analysis of graft survival in a trial
of stem cell transplant in ALS,” researchers found no correlation of DNA content to survival period after immunosuppressant
medications had been discontinued. These data demonstrate that transplanted HSSCs can survive for a prolonged period, even in the
absence of immunosuppression. This suggests that continued immunosuppression is not necessary for the continued survival of the
transplanted cells. All six patients accessed in this publication received NSI-566 cells as part of a clinical study, but subsequently
died from their disease or other causes. Using advanced imaging technology, NSI-566 DNA was identified in all cases. The percentage
of donor DNA ranged from 0.67% to 5.04% of total DNA. Neuralstem’s previously-published Phase I results determined NSI-566
cell therapy was safe and well-tolerated.
“The success of our therapy is
predicated upon our cells ability to survive long-term and differentiate, providing neurotrophic support in the spinal cord and
acting as ‘nurse’ cells for the patients' own motor neurons that are attacked by the disease,” said Karl Johe,
PhD, Neuralstem Chairman and Chief Scientific Officer. “ This new study presents an elegant demonstration that the NSI-566
cells survived long term and differentiated as expected, enabling their promise as a neuroprotective, and neurorestorative, treatment
for ALS and other neurodegenerative conditions.”
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About Neuralstem
Neuralstem's patented technology enables
the production of multiple types of brain and spinal cord neural stem cells in commercial quantities for the potential treatment
of central nervous system diseases and conditions. Neuralstem’s first stem cell product, NSI-566, a spinal cord-derived neural
stem cell line, is in an ongoing clinical trial to treat 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 status designation by the FDA for NSI-566 in ALS. In addition to ALS, NSI-566 is also in a Phase I trial in chronic
spinal cord injury at UC San Diego School of Medicine. NSI-566 is also in clinical development to treat neurological diseases such
as ischemic stroke and acute spinal cord injury.
Neuralstem’s second 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.
Additionally, Neuralstem’s ability
to generate human neural stem cell lines 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 central nervous system (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 major depressive disorder (MDD) 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 September 30, 2014.
# # #
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Contact:
Neuralstem – Investor Relations:
Danielle Spangler
301.366.1481
Planet Communications - Media Relations:
Deanne Eagle
917.837.5866
MDC Group - Investor Relations:
Susan Roush
747.222.7012
David Castaneda
414.351.9758
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