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): May 23, 2014 (May 23, 2014)
Neuralstem,
Inc.
(Exact name of registrant as specified
in Charter)
| Delaware |
|
000-1357459 |
|
52-2007292 |
(State or other jurisdiction of
incorporation or organization) |
|
(Commission File No.) |
|
(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 May 23, 2014, Neuralstem, Inc. (“Company”)
announced that data from the NSI-189 Phase Ib study in major depressive disorder will be presented at the American Society of Clinical
Psychopharmacology Annual Meeting in Hollywood, Florida on June 17th, 2014. A copy of the press release is attached
to this report as Exhibit 99.01.
| Item 9.01 | Financial Statement and Exhibits. |
Exhibit
Number |
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Description |
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| 99.01 |
|
Press Release Dated May 23, 2014 |
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.
| |
NEURALSTEM, INC |
| |
|
|
|
| |
By: |
|
/s/ I. Richard Garr |
| |
|
|
I. Richard Garr |
| |
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|
Chief Executive Officer |
Dated: May 23, 2014
INDEX
OF EXHIBITS
Exhibit
Number |
|
Description |
| |
|
|
| 99.01 |
|
Press Release Dated May 23, 2014 |
| Contact: |
|
| Planet Communications - Media Relations: |
|
| Deanne Eagle |
917.837.5866 |
| MDC Group - Investor Relations: |
|
| Susan Roush |
747.222.7012 |
| David Castaneda |
414.351.9758 |
NEURALSTEM DEPRESSION TRIAL DATA TO BE
PRESENTED AT THE AMERICAN SOCIETY OF CLINICAL PSYCHOPHARMACOLOGY ANNUAL MEETING
GERMANTOWN, MD, May 23, 2014 —
Neuralstem, Inc. (NYSE MKT: CUR) announced that data from the NSI-189 Phase Ib study in major depressive disorder (MDD) will be
presented at the American Society of Clinical Psychopharmacology Annual Meeting in Hollywood, Florida, on June 17th
at 4:15 EDT. NSI-189 is Neuralstem’s first-in-class, lead neurogenic small molecule compound. In pre-clinical studies, NSI-189
was shown to promote the formation of new neurons (neurogenesis) in animals and in human hippocampus-derived neural stem cells.
In “A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation Study Evaluating the Effects of NSI-189
Phosphate, A Neurogenic Compound, in Patients with Major Depressive Disorder (MDD),” found on page 73 of the abstract book
http://ascpmeeting.org/wp-content/uploads/2014/05/ASCP-Oral-Abstract-Book-Online.pdf, study author, Marlene Freeman, MD,
Medical Director, Clinical Trials Network and Institute, Massachusetts General Hospital, and Associate Professor of Psychiatry,
Harvard Medical School, will discuss trial results, including that depressed patients on two different doses showed clinically
meaningful reductions in depressive and cognitive symptoms across all measures against placebo. Furthermore, these improvements
appeared to persist throughout the follow up period. Based on the results, the investigators, including lead study author, Maurizio
Fava, MD, Executive Vice Chair, Department of Psychiatry, Executive Director, Clinical Trials Network and Institute, Massachusetts
General Hospital, concluded that a neurogenesis-based platform could identify promising new treatments for major depressive disorder.
“We are honored that the highly prestigious
American Society of Clinical Psychopharmacology selected our data for presentation at their Annual Meeting,” said Karl Johe,
PhD, Neuralstem’s Chairman and Chief Scientific Officer. “This is extremely robust Phase Ib data. As the abstract points
out, trial patients on active therapy experienced meaningful reductions in their depressive and cognitive symptoms across all clinical
measurements,including the Montgomery-Asberg Depression Rating Scale (MADRS); the Clinician Global Impression – Improvement
(CGI-I); the Symptoms of Depression Questionnaire (SDQ) and the Cognitive and Physical Functioning Questionnaire (CPFQ). We are
eager to share the complete data in the June 17th presentation, as well as biomarker data from trial, which will be
presented at the International College of Neuropsychopharmacology World Congress in Vancouver on June 24th.”
About Major Depressive Disorder
Major depressive disorder (MDD), also called
major depression, is characterized by a combination of symptoms that interfere with a person's ability to function normally. MDD
affects approximately 14.8 million American adults and is the leading cause of disability in the U.S. for ages 15-44, according
to the National Institute of Mental Health. While most treatments modulate brain neurotransmitter levels to treat brain chemistry,
new research suggests that brain physiology could also be involved. Depressed patients have reduced volume in the hippocampus,
a part of the brain that generates new neurons. Neuralstem believes that stimulating the generation of new neurons in the hippocampus
could potentially address the pathology of the depression itself.
About Neuralstem
Neuralstem's patented technology enables
the production of neural stem cells of the 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 glial cells. Neuralstem’s NSI-566 spinal
cord-derived stem cell therapy is in Phase II clinical trials for amyotrophic lateral sclerosis (ALS), often referred to as Lou
Gehrig's disease. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy.
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 and ischemic
stroke. The company has received FDA approval to commence a Phase I safety trial in chronic spinal cord injury.
Neuralstem also maintains the ability to
generate stable human neural stem cell lines suitable for 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 neurons,
possibly reversing pathologies associated with certain central nervous system conditions. The company has completed a Phase
I safety trial evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive
disorder (MDD). 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 March 31, 2014.
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