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): February 9, 2011
Neuralstem,
Inc.
(Exact
name of registrant as specified in Charter)
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Delaware
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000-1357459
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52-2007292
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(State
or other jurisdiction of
incorporation
or organization)
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(Commission
File No.)
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(IRS
Employee Identification No.)
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9700
Great Seneca Highway, Rockville, Maryland 20850
(Address
of Principal Executive Offices)
(301)
366-4841
(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):
o Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
7.01 Regulation FD
Disclosure
On
February 9, 2011, Neuralstem, Inc. (“Company”) announced that the U.S. Food and
Drug Administration's Office of Orphan Products Development has granted it
orphan drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS)
with its human spinal cord derived neural stem cells (NSI-566RSC), currently in
a Phase I safety study to evaluate the safety of the product and the surgical
route of administration in a wide range of ALS patients. A copy
of the press release is attached to this report as Exhibit 99.01.
The
information contained in this Current Report on Form 8-K and the exhibits
attached hereto shall not be deemed to be “filed” for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section, nor shall such information
or such exhibits be deemed incorporated by reference in any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as shall be
expressly set forth by specific reference in such a filing. The information set
forth in this form 8-K and its exhibits shall not be deemed an admission as to
the materiality of any information within this report.
Item
9.01 Financial Statement
and Exhibits.
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Exhibit
Number
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Description
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99.01
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Press
Release Dated February 9, 2011
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant 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
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