Filed Pursuant to
Rule 424(b)(5)
Registration
No. 333-196567
PROSPECTUS SUPPLEMENT
(To Prospectus dated June 19, 2014)
20,000,000 Shares of Common Stock
and
Warrants to Purchase
20,000,000 Shares of
Common Stock
We are offering 20,000,000 shares
of our common stock and warrants to purchase 20,000,000 shares of our common stock. Each share of our common stock is being
sold together with one warrant to purchase one share of common stock. Each warrant will have an exercise price of $0.40 per share,
will be immediately exercisable and will expire on the fifth anniversary of the original issuance date. The shares of our common
stock and warrants are immediately separable and will be issued separately, but will be purchased together in this offering.
Our common stock is traded on The Nasdaq
Capital Market
under the symbol “CUR.” On April 29, 2016, the last reported sale price of our common stock was
$0.60 per share.
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Per Share and Warrant
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Total
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Public offering price
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$
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0.40
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$
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8,000,000
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Underwriting discounts and commissions
(1)
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$
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0.024
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$
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480,000
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Proceeds to us, before expenses
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$
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0.376
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$
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7,520,000
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___________________________
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(1)
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In addition, we have agreed to reimburse the underwriters for certain expenses. See “Underwriting” on page S-19 of this prospectus supplement for additional information.
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Investing in our securities involves
a high degree of risk. See the section entitled “Risk Factors” appearing on pages S-8 of this prospectus supplement
and elsewhere in this prospectus supplement and the accompanying base prospectus for a discussion of information that should be
considered in connection with an investment in our securities.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy
of this prospectus supplement. Any representation to the contrary is a criminal offense.
The underwriters expect to deliver the shares of common stock and the warrants to purchase common stock
to the purchasers on or about May 6, 2016.
Sole Book-Running
Manager
Roth Capital
Partners
Co-Manager
The date of this prospectus supplement is May 3, 2016
TABLE OF CONTENTS
Prospectus Supplement
Prospectus
ABOUT THIS PROSPECTUS SUPPLEMENT
This prospectus supplement
is part of the registration statement on Form S-3 (File No. 333-196567) that we filed with the Securities and Exchange Commission,
or the SEC, using a “shelf” registration process to register sales of our securities under the Securities Act of 1933,
as amended, or the Securities Act. This document consists of two parts. The first part is this prospectus supplement, including
the documents incorporated by reference, which describes the specific terms of this offering. The second part is the accompanying
prospectus filed with the SEC as part of the registration statement that was declared effective by the SEC on June 19, 2014, including
the documents incorporated by reference, that gives more general information, some of which may not apply to this offering. Generally,
when we refer only to the “prospectus,” we are referring to both parts combined.
This prospectus supplement
may add to, update or change information in the accompanying prospectus and the documents incorporated by reference into this prospectus
supplement or the accompanying prospectus. To the extent there is a conflict between the information contained in this prospectus
supplement and the accompanying prospectus, you should rely on information contained in this prospectus supplement, provided that
if any statement in, or incorporated by reference into, one of these documents is inconsistent with a statement in another document
having a later date, the statement in the document having the later date modifies or supersedes the earlier statement. Any statement
so modified will be deemed to constitute a part of this prospectus only as so modified, and any statement so superseded will be
deemed not to constitute a part of this prospectus.
We sometimes collectively
refer to the shares of common stock and warrants offered hereby as the “securities.”
This prospectus supplement,
the accompanying prospectus and the documents incorporated into each by reference include important information about us, the securities
being offered and other information you should know before investing in our securities. You should also read and consider information
in the documents to which we have referred you in the section of this prospectus entitled “Where You Can Find More Information.”
You should rely only
on this prospectus supplement, the accompanying prospectus and the information incorporated or deemed to be incorporated by reference
in this prospectus supplement and the accompanying prospectus as well as any free writing prospectus. We and the underwriters have
not authorized anyone to provide you with information that is in addition to or different from that contained or incorporated by
reference in this prospectus supplement and the accompanying prospectus. If anyone provides you with different or inconsistent
information, you should not rely on it. This prospectus supplement, the accompanying prospectus and any related free writing prospectus
do not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom
it is unlawful to make such offer or solicitation in such jurisdiction. You should not assume that the information contained or
incorporated by reference in this prospectus supplement or the accompanying prospectus is accurate as of any date other than as
of the date of this prospectus supplement or the accompanying prospectus, as the case may be, or in the case of the documents incorporated
by reference, the date of such documents regardless of the time of delivery of this prospectus supplement and the accompanying
prospectus or any sale of our securities. Our business, financial condition, liquidity, results of operations and prospects may
have changed since those dates.
We further note that
the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated
by reference into this prospectus supplement or the accompanying prospectus were made solely for the benefit of the parties to
such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not
be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate
only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately
representing the current state of our affairs.
The industry and market
data contained or incorporated by reference in this prospectus supplement and the accompanying prospectus are based either on our
management’s own estimates or on independent industry publications, reports by market research firms or other published independent
sources. Although we believe that such data contained herein from such sources is reliable, there can be no assurance or guarantee
as to the accuracy or completeness of the information obtained from these sources. Unless otherwise indicated, all information
contained or incorporated by reference in this prospectus supplement and the accompanying prospectus concerning our industry in
general or any segment thereof, including information regarding our general expectations and market opportunity, is based on management’s
estimates using internal data, data from industry related publications, consumer research and marketing studies and other externally
obtained data.
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights
selected information appearing elsewhere in this prospectus supplement or in the accompanying prospectus or incorporated by reference
into this prospectus supplement and the accompanying prospectus and does not contain all of the information that may be important
to you or that you should consider before investing in our securities. Before making an investment decision, you should read this
prospectus supplement, the accompanying prospectus and the information incorporated by reference in this prospectus supplement
and the accompanying prospectus in their entirety, including “Risk Factors” beginning on page S-8 of this prospectus
supplement.
As used in this
prospectus supplement, unless context otherwise requires, the words “we,” “us,” “our,” “the
Company,” “Neuralstem” and “Registrant” refer to Neuralstem, Inc. and its subsidiary Also, any reference
to “common share” or “common stock,” refers to our $0.01 par value common stock.
Our Business
Overview
We are focused on the
research, development and commercialization of central nervous system therapies based on our proprietary human neuronal stem cells
and our stem-cell derived small molecule compounds. We are headquartered in Germantown, Maryland and have a wholly-owned subsidiary
in China, Suzhou Neuralstem Biopharmaceutical Co. Ltd., or Neuralstem China.
Our technology base
has produced three primary assets: our NSI-189 small molecule program, our NSI-566 stem cell therapy program and our novel and
proprietary new chemical entity screening platform.
Our patented technology
enables the commercial-scale production of multiple types of central nervous system stem cells, which are under development for
the potential treatment of central nervous system diseases and conditions. In addition, this ability to generate human neural stem
cell lines provides a platform for chemical screening and discovery of novel compounds that we believe may stimulate the brain's
capacity to generate neurons, potentially reversing pathologies associated with certain central nervous system conditions. This
proprietary screening platform led to our discovery of NSI-189.
We have developed and
maintain what we believe is a strong portfolio of patents and patent applications that form the proprietary base for our research
and development efforts. We own or exclusively license more than 100 U.S. and foreign issued patents and over 40 U.S. and foreign
patent applications in the field of regenerative medicine, related to our stem cell technologies as well as our small molecule
compounds.
We believe our technology
base, in combination with our expertise, and collaborative projects with major research institutions, could facilitate the development
and commercialization of products for use in the treatment of a wide array of central nervous system disorders including neurodegenerative
conditions and regenerative repair of acute disease.
There can be no assurances
that we will ultimately produce any viable products or processes or that our screen platform will lead to the discovery of any
additional product candidates. Even if we are able to produce a commercially viable product, there are strong competitors in this
field and our products may not be able to successfully compete against them.
All of our research
efforts to date are at the pre-clinical or clinical stage of development. We are focused on leveraging our key assets, including
our intellectual property, proprietary technology, scientific team and facilities, to advance our technologies and clinical programs.
In addition, we are pursuing strategic collaborations with members of academia and industry to further advance and discover additional
product candidates.
Pre-Clinical and Clinical Programs and Development
In January 2016, we
announced a strategic refocusing to concentrate our resources on the NSI-189 small molecule program. As part of this refocusing,
the Company announced that we will seek external funding to defray all, or substantially all, of the costs associated with the
NSI-566 stem cell therapy program. We are in active conversations with a number of sources of funding to achieve this goal and
minimize any delay in progressing our stem cell therapy programs.
We have devoted substantially
all our efforts to the pre-clinical and clinical development of our small molecule compounds and our stem cell therapeutics. Below
is a description of our most advanced clinical programs, their intended indication, current stage of development and our expected
future development plans:
Status*
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(1)
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Phase II MDD clinical trial results are expected to be provided during 2H17
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(2)
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Second Indication to be determined in 2Q16.
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(3)
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Ongoing preclinical studies in NSI-189 and other undisclosed compounds. Multiple NSI-189 proof of principal studies and publications to be submitted in 2016.
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(4)
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Active efforts to pursue partnerships or alternative funding such as through grants for NSI-566 (stem cell).
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NSI – 189 (small molecule)
Major Depressive Disorder
Major depressive disorder,
or MDD (also known as recurrent depressive disorder, clinical depression, major depression, unipolar depression, or unipolar disorder),
is a mental disorder characterized by episodes of all-encompassing low mood accompanied by low self-esteem and loss of interest
or pleasure in normally enjoyable activities. MDD affects approximately 14.8 million American adults, or about 6.7% of the U.S.
population age 18 and older in a given year. Additionally, the incidence of first line therapy failure creates a robust market
for branded molecules in second/third line therapy. These factors combine to create a significant opportunity for a differentiated
therapeutic agent.
NSI-189 is being developed
for the treatment of MDD and other psychiatric and/or cognitive impairment indications associated with hippocampal atrophy. NSI-189
is the lead compound in our neurogenic small molecule drug platform. We believe that NSI-189 may provide an effective treatment
for patients suffering from MDD by promoting neurogenesis.
NSI - 566 (Stem Cells)
Amyotrophic Lateral Sclerosis
Amyotrophic lateral
sclerosis, or ALS, is a disease of the nerve cells in the brain and spinal cord that control voluntary muscle movement. Approximately
6,400 people in the U.S. are diagnosed with ALS each year. The incidence of ALS is two per 100,000 people, and it is estimated
that more than 20,000 Americans may be living with ALS at any given time. In ALS, nerve cells (neurons) waste away or die, and
can no longer send messages to muscles. This eventually leads to muscle weakening, twitching, and an inability to move the arms,
legs, and body. The condition slowly gets worse. When the muscles in the chest area stop working, it becomes hard or impossible
to breathe. NSI-566 is under development as a potential treatment for ALS by providing cells designed to nurture and protect the
patients’ remaining motor neurons; and possibly repair some motor neurons which have not yet died but which are diseased.
We received orphan designation by the FDA for NSI-566 in ALS.
Chronic Spinal Cord Injury
A spinal cord injury,
or SCI, generally refers to any injury to the spinal cord that is caused by trauma instead of disease although in some cases, it
can be the result of diseases. It is estimated that there are 12,500 new cases of SCI per year and that at any given time, there
are between 240,000 and 337,000 people in the United States that are living with SCI. Chronic spinal cord injury refers to the
time after the initial hospitalization. SCIs are most often traumatic, caused by lateral bending, dislocation, rotation, axial
loading, and hyperflexion or hyperextension of the cord or cauda equina. Motor vehicle accidents are the most common cause of SCIs,
while other causes include falls, work-related accidents, sports injuries, and penetrations such as stab or gunshot wounds. In
certain instances, SCIs can also be of a non-traumatic origin, as in the case of cancer, infection, intervertebral disc disease,
vertebral injury and spinal cord vascular disease. We believe that NSI-566 may provide an effective treatment for chronic spinal
cord injury by “bridging the gap” in the spinal cord circuitry created in traumatic spinal cord injury and providing
new cells to help transmit the signal from the brain to points at or below the point of injury.
Motor Deficits Due to Ischemic Stroke
Ischemic strokes, the
most common type of stroke, occur as a result of an obstruction within a blood vessel supplying blood to the brain. Approximately
15 million people worldwide suffer stroke of which it is estimated that 87% of all strokes are ischemic strokes. Post-stroke motor
deficits include paralysis in arms and legs and can be permanent. We believe that NSI-566 may provide an effective treatment for
restoring motor deficits resulting from ischemic stroke by both creating new circuitry in the area of injury and through repairing
and or nurturing diseased cells to improve function in patients.
Our Technologies
Small Molecule Pharmaceutical Compounds
Utilizing
our proprietary stem cell derived, screening capability, we have developed and patented a series of small molecule compounds. We
believe the low molecular weight organic compounds can efficiently cross the blood/brain barrier by oral administration. In mice,
research indicated that the small molecule compounds both stimulate neurogenesis of the hippocampus and increase its volume. Our
collaborators at Massachusetts General Hospital have presented the human data from the MDD trial which showed clinically meaningful
and statistically significant improvement in depressive and cognitive scales. We believe the small molecule compounds may assist
promoting synaptogenesis or neurogenesis in the human hippocampus documented in indications such as MDD.
We are the exclusive
owner of over 55 U.S. and foreign issued patents and over 10 U.S. and foreign applications related to our small molecule compounds.
Stem Cells
Our
technology enables the isolation and large-scale expansion of regionally specific, human neural stem cells from all areas of the
developing human brain and spinal cord, thus enabling the generation of physiologically relevant human neurons of all types. We
believe that our stem cell technology will assist the body in producing new cells to replace malfunctioning or dead cells as a
way to treat disease and injury. Many significant and currently untreatable human diseases arise from the loss or malfunction of
specific cell types in the body. Our focus is the development of effective methods to generate replacement cells from neural stem
cells. We believe that replacing damaged, malfunctioning or dead neural cells with fully functional ones may be a useful therapeutic
strategy in treating many diseases and conditions of the central nervous system. We own or exclusively license 50 U.S. and foreign
issued patents and 13 U.S. and foreign patent applications related to our stem cell technologies.
Recent Developments
Business Highlights
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We enhanced our executive team with the appointment of Richard Daly as President and Chief Executive Officer, Jonathan Lloyd Jones as Chief Financial Officer and Andy Moniz as Vice President of Clinical Operations.
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In January 2016, we announced an initiative to pursue collaborations for our stem cell therapy programs to utilize additional expertise, expedite clinical and regulatory pathways and secure funding.
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In March 2016, we commenced our NSI-189 Phase 2 clinical trial for the treatment of MDD.
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Small Molecule Pharmaceutical Compounds
Clinical Development
Lead asset, NSI-189 Phase 2 clinical trial
for the treatment of MDD
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In March 2016, we commenced our NSI-189 Phase 2 clinical trial for the treatment of MDD. The double-blind, randomized, placebo-controlled, 220 subject study is expected to enroll the first subject in the second quarter of 2016.
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Stem Cells
Cell Therapy Platform Clinical Development
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In January 2016, Dr. Karl Johe, Founder and Chief Scientific Officer, presented at the Phacilitate Cell & Gene Therapy World Conference. He concluded that the collective trial data analysis showed the cells consistently demonstrated biological activity in all three program indications: ALS, chronic spinal cord injury (cSCI), and motor deficits due to ischemic stroke.
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NSI-566 Phase 1 safety trial for the treatment
of cSCI
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In January 2016, we reported preliminary six-month follow-up Phase 1 safety data on all four subjects. The stem cell treatment demonstrated feasibility and safety. A self-reported ability to contract some muscles below the level of injury was confirmed via clinical and electrophysiological follow-up examinations in one of the four patients treated.. This study was completed with the collaboration of the UCSD School of Medicine, supported by the UCSD Sanford Stem Cell Clinical Center.
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NSI-566 Phase 1 and 2 safety trials for
the treatment of ALS
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In September 2015, nine-month Phase 2 and combined Phase 1 and Phase 2 data on the NSI-566 trial in ALS were presented at the American Neurological Association Annual Meeting by the principal investigator, Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health. The data showed that the intraspinal transplantation of the cells was safe and well tolerated. In January 2016, we announced that we are in discussions with various governmental, State and non-profit organizations regarding funding grants for the next trial; the initiation of the trial will be dependent upon significant funding from such sources.
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NSI-566 Phase 1 safety trial for the treatment
of motor deficits in stroke
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We completed dosing the third planned cohort in a Phase 1 clinical trial at BaYi Brain Hospital in Beijing. The trial is being conducted by Neuralstem China, at BaYi Brain Hospital in Beijing, China.
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Financial Condition
Our cash and cash equivalent and short
term investments balance of approximately $12.2 million as at December 31, 2015 are only sufficient to fund operations through
June 2016. We will require additional capital to conduct research and development, establish and conduct clinical and pre-clinical
trials, enter into commercial-scale manufacturing arrangements and to provide for marketing and distribution of our products.
Taking into account the proceeds from this offering, we will need to raise additional capital within 12 months to fund our operations.
We cannot assure you that we will be able to secure additional financing after this offering or that the expected income will
materialize. Several factors will affect our ability to raise additional funding, including, but not limited to market conditions,
interest rates and, more specifically, our progress in our exploratory, preclinical and future clinical development programs.
Our Corporate Information
We were incorporated in Delaware in 2001.
Our principal executive offices are located at 20271 Goldenrod Lane, Germantown, Maryland 20876,
and our telephone number
is (301) 366-4841. Our website is located at
www.neuralstem.com
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The Offering
Common stock offered by us
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20,000,000 shares
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Warrants offered by us
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Warrants to purchase up to 20,000,000 shares of our common stock. Each warrant will have an exercise
price of $0.40 per share and will be immediately exercisable and will expire on the fifth anniversary of the original issuance
date.
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Common stock to be outstanding after this offering
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112,005,705 shares (or 132,005,705 shares if the warrants sold in this offering are exercised in full).
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Use of proceeds
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We intend to use the net proceeds received from the sale of our securities to fund regulatory, pre-clinical and clinical activities and general corporate purposes, including working capital and the repayment of debt. Please see “Use of Proceeds” on page S-12.
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Risk factors
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See “Risk Factors” beginning on page S-8 of this prospectus supplement, as well as the other information included in or incorporated by reference in this prospectus supplement and the accompanying prospectus, for a discussion of risks you should carefully consider before investing in our securities.
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Dividend Policy
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We do not anticipate paying any cash dividends on our common stock.
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Nasdaq Capital Market symbol
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“CUR”
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The number of shares
of our common stock to be outstanding after this offering set forth above is based on 92,005,705 shares of our common stock outstanding
as of December 31, 2015. The number of shares of our common stock to be outstanding after this offering set forth above, excludes
the following:
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17,102,947 shares underlying outstanding options issued pursuant to our equity compensation and inducement plans having a weighted average exercise price of $2.08 per share;
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19,652,096 shares of our common stock issuable upon exercise of outstanding warrants having a weighted average exercise price of $2.34 per share;
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150,906 shares of our common stock reserved for issuance upon the vesting and termination of certain transfer restrictions with regard to restricted stock units and restricted stock awards;
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2,631,791 shares of our common stock reserved for issuance pursuant to future grants and award under our equity compensation and inducement plans;
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50,000 shares of our common stock underlying options issued to a consultant on January 11, 2016 pursuant to our equity compensation plans and having an exercise price of $1.03;
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912,898 shares of common stock underlying options issued to employees and executives pursuant to our equity compensation plans and having a weighted exercise price of $1.01;
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97,046 shares of our common stock underlying options issued to a non-executive director pursuant to our director compensation policy for services from April 1, 2016 to June 30, 2016, and having an exercise price of $0.74;
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2,750,000 shares of our common stock underlying an inducement grant issued to our new Chief Executive Officer pursuant to our inducement grant plan and having an exercise price of $0.69; and
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20,000,000 shares of common stock reserved for issuance upon exercise of the warrants offered hereby.
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RISK FACTORS
Investing
in our common stock involves a high degree of risk. Before making an investment decision, you should carefully consider the risks
described below, together with all of the other information included in this prospectus supplement, the accompanying prospectus,
and the information incorporated by reference herein and therein.
For a discussion
of additional risks associated with our business, our intellectual property, government regulation and approval of our product
candidates, our industry and an investment in our common stock, see the section entitled “Risk Factors” in our most
recent Annual Report on Form 10-K, as filed with the SEC on March 14, 2016, and any other subsequently filed document that is also
incorporated or deemed to be incorporated by reference in this prospectus supplement.
If
any of the risks described below, or those incorporated by reference into this prospectus actually occur, our business, financial
condition or results of operations could suffer. In that case, the trading price of our common stock may decline and you may lose
all or part of your investment. The risks and uncertainties we have described are not the only ones we face. Additional risks and
uncertainties not presently known to us or that we currently deem immaterial may also affect our business, financial condition
and results of operations. Certain statements below are forward-looking statements. See the information included under the heading
“Note Regarding Forward-Looking Statements.”
We require the proceeds from this
offering to continue our operations.
Our cash and cash
equivalents and short term investments balance at December 31, 2015 was approximately $12.2 million. Our ability to continue as
a going concern is wholly dependent upon completing this offering and thereafter obtaining sufficient financing to fund our operations
as needed. Taking into account the proceeds from this offering, we will be required to raise additional capital within 12 months
to fund our operations. We have no committed sources of additional capital and our access to capital funding is always uncertain.
Accordingly, despite our ability to secure capital in the past, there is no assurance that additional equity or debt financing
will be available to us when needed. In the event that we are not able to secure additional financing, we may be forced to curtail
operations, delay or stop ongoing clinical trials, cease operations altogether or file for bankruptcy.
Our auditors have expressed substantial
doubt about our ability to continue as a going concern.
Our auditors’
report on our December 31, 2015 financial statements expressed an opinion that our capital resources as of the date of their audit
report were not sufficient to sustain operations or complete our planned activities for the upcoming year unless we raised additional
funds. Regardless of the amount of the net proceeds that we receive from this offering, if any, our independent registered public
accounting firm may conclude, in connection with the audit of our consolidated financial statements for the year ended December 31,
2016, or any other subsequent period, that there is substantial doubt regarding our ability to continue as a going concern. If
our independent registered public accounting firm issues a “going concern” opinion, it could impair our ability to
finance our operations through the sale of equity, incurring debt, or other financing alternatives. If we fail to raise sufficient
additional capital, we will not be able to completely execute our business plan and our business would be jeopardized. Additionally,
if we required to cease operations, it is likely that purchasers of our common stock would lose their entire investment.
If we fail to raise sufficient capital
in this offering and subsequent offerings, if any, we will not be able to pay our secured debt holder which may result in a foreclosure
of all our assets.
We
have a substantial level of debt. As of December 31, 2015, we had approximately $8,335,000 in aggregate principal amount of long-term
indebtedness outstanding. Under our amended loan and security agreement, we are required to make monthly interest and principal
payments of approximately $435,000 per month from January 2016 through March 2017 and make a balloon payment for the remaining
principal in April 2017. As security for such indebtedness, we have pledged substantially all of our assets, including our intellectual
property. We will be required to raise sufficient capital in this offering and subsequent offerings, if any, to repay the debt.
Even assuming that much is raised, we will need to raise additional capital to fund our operations. If we fail to raise sufficient
capital, we may be unable to make the required payments pursuant to the terms of our long-term indebtedness which would result
in a default and permit holders of our indebtedness to accelerate the maturity and require immediate repayment and lead to potential
foreclosure on the assets securing the debt. If we are unable to repay our indebtedness as it becomes due, we may become insolvent
and be unable to continue operations.
If we are
unable to meet the continued listing requirements for the Nasdaq Capital Market, our securities will be subject to delisting.
On
April 20, 2016, we received a written notice from the Nasdaq Stock Market LLC that we are not in compliance with Nasdaq Listing
Rule 5550(a)(2), as the minimum bid price of our common stock has been below $1.00 per share for 30 consecutive business days.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have a period of 180 calendar days, or until October 17, 2016, to regain
compliance with the minimum bid price requirement. To regain compliance, the closing bid price of our common stock must meet or
exceed $1.00 per share for at least ten consecutive business days during this 180 calendar day period. In the event we do not regain
compliance by October 17, 2016, we may be eligible for an additional 180 calendar day grace period if we meet the initial listing
standards, with the exception of bid price, for the Nasdaq Capital Market, and provide written notice to Nasdaq of our intention
to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If we do not regain
compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq will provide
notice that our common stock will be subject to delisting. We will then be entitled to appeal the determination to a Nasdaq Listing
Qualifications Panel and request a hearing. We cannot be sure that our share price will comply with the requirements for continued
listing of our shares on the Nasdaq Capital Market in the future or that we will comply with the other continued listing requirements.
If our shares lose their status on the Nasdaq Capital Market, we believe that our shares would likely be eligible to be quoted
on the inter-dealer electronic quotation and trading system operated by Pink OTC Markets Inc., commonly referred to as the Pink
Sheets and now known as the OTCQB market. These markets are generally considered not to be as efficient as, and not as broad as,
the Nasdaq Capital Market. If our common stock is delisted, this would, among other things, substantially impair our ability to
raise additional funds and could result in a loss of institutional investor interest and fewer development opportunities for us.
If we are
unable to successfully execute our new refocused business strategy or integrate our new management team, our business could be
harmed.
During 2016, the strategic
direction of our company and executive management team have undergone significant change. In January 2016, we announced a new strategic
refocusing to concentrate our resources on the NSI-189 small molecule program. As part of this refocusing, we announced that we
will seek external funding to defray all, or substantially all, of the costs associated with the NSI-566 stem cell therapy program.
During 2016, we also received the resignation of our former President and Chief Executive Officer and founder. In addition, in
February 2016, Richard Daly joined our company as our new President and Chief Executive Officer and was appointed to the board
and, in May 2015, Jonathan Lloyd joined our company as our new Chief Financial Officer. Our success depends largely on the development
and execution of our refocused business strategy by our senior management team as well as the acceptance of such refocused strategy
and team by our stakeholders. The recent transitions in our executive team may be disruptive to our business, and if we are unable
to manage orderly transitions, our business may be adversely affected. Additionally, since our management team consists of a limited
number of individuals, the loss of these members of our senior management team or key personnel would likely harm our ability to
implement our business strategy and respond to the rapidly changing market conditions in which we operate. There may be a limited
number of persons with the requisite skills to serve in these positions, and we cannot assure you that we would be able to identify
or employ such qualified personnel on acceptable terms, if at all. We cannot assure you that we will be able to successfully execute
our refocused business strategy or that management will succeed in working together as a team. In the event we are unsuccessful,
our business and prospects could be harmed.
Our management will have broad discretion
over the use of the net proceeds from this offering, you may not agree with how we use the proceeds and the proceeds may not be
invested successfully.
Our management will
have broad discretion as to the use of the net proceeds from this offering and could use them for purposes other than those contemplated
currently and described under “Use of Proceeds” on page S-12. Accordingly, you will be relying on the judgment of our
management with regard to the use of these net proceeds, and you will not have the opportunity, as part of your investment decision,
to assess whether the proceeds are being used appropriately. It is possible that, pending their use, we may invest the net proceeds
in a way that does not yield a favorable, or any, return for our company.
There may be future sales or other
dilution of our equity, which may adversely affect the market price of our common stock.
We are generally not
restricted from issuing additional common stock, including any securities that are convertible into or exchangeable for, or that
represent the right to receive, common stock. The market price of our common stock could decline as a result of sales of common
stock or securities that are convertible into or exchangeable for, or that represent the right to receive, common stock after this
offering or the perception that such sales could occur.
You will experience immediate and
substantial dilution in the net tangible book value per share of our common stock.
The public offering
price of our common stock being offered and the exercise price of the warrants are substantially higher than the net tangible
book value per share of our common stock outstanding prior to this offering. Therefore, if you purchase our common stock and warrants
in this offering at the public offering price of $0.40 per share, you will incur an immediate substantial dilution of $0.30 in
net tangible book value per share from the price you paid. If the warrants offered hereby or outstanding options or warrants to
purchase our common stock are exercised, you will experience additional dilution. For a further description of the dilution that
you will experience immediately after this offering, see “Dilution.”
Holders of warrants will have no rights as common stockholders
until such holders exercise their warrants and acquire our common stock.
Until holders of warrants
acquire shares of our common stock upon exercise of the warrants, holders of warrants will have no rights with respect to the shares
of our common stock underlying such warrants. Upon exercise of the warrants, the holders will be entitled to exercise the rights
of a common stockholder only as to matters for which the record date occurs after the exercise date.
There is no public market for the warrants to purchase
common stock being sold in this offering.
There is no established
public trading market for the warrants being sold in this offering, and we do not expect a market to develop. In addition, we do
not intend to apply for listing of the warrants on the Nasdaq Stock Market or on any other national securities exchange or trading
system. Without an active market, the liquidity of the warrants will be limited.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement,
the accompanying prospectus and the other documents we have filed with the SEC that are incorporated herein by reference contain
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties,
as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those
expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements
that could be deemed forward-looking statements, including any projections of financing needs, revenue, expenses, earnings or losses
from operations, or other financial items, any statements of the plans, strategies and objectives of management for future operations,
any statements concerning product research, development and commercialization plans and timelines, any statements regarding safety
and efficacy of product candidates, any statements of expectation or belief and any statements of assumptions underlying any of
the foregoing. In addition, forward-looking statements may contain the words “believe,” “anticipate,” “expect,”
“estimate,” “intend,” “plan,” “project,” “will be,” “will continue,”
“will result,” “seek,” “could,” “may,” “might,” or any variations of
such words or other words with similar meanings. All forward-looking statements attributable to us or to persons acting on our
behalf are expressly qualified in their entirety by the cautionary statements and risk factors set forth in the “Risk Factors”
section and elsewhere in this prospectus supplement, in the accompanying prospectus and in our Annual Report on Form 10-K for the
year ended December 31, 2015.
Given these uncertainties,
you should not place undue reliance on these forward-looking statements. You should read this prospectus supplement, the accompanying
prospectus and the documents incorporated by reference in this prospectus supplement and the accompanying prospectus with the understanding
that our actual future results may be materially different from what we expect. Except as required by law, we do not undertake
any obligation to update or revise any forward-looking statements contained in this prospectus supplement, the accompanying prospectus
or such other documents, whether as a result of new information, future events or otherwise.
USE OF PROCEEDS
We estimate that the
net proceeds from this offering, after deducting underwriting discounts and commissions and estimated offering expenses payable
by us, will be approximately $7.42 million.
Except as otherwise
described in any free writing prospectus that we may authorize to be furnished to you, we currently intend to use the net proceeds
from this offering to fund our ongoing study and other clinical trials of our product candidates, and to augment our working capital
for general corporate purposes. General corporate purposes may include, but are not limited to, discontinuation of our certain
programs and operations, repayment of existing or future indebtedness, financing of capital expenditures and potential future acquisitions
and strategic investments.
We had outstanding
as of December 31, 2015, $8.3 million of principal amount of indebtedness incurred under our loan and security agreement with Hercules
Technology III, L.P., the proceeds of which were used to fund our clinical trials and for general working capital. Our monthly
payments on the outstanding indebtedness under the loan and security agreement consist of amortization of principal together with
interest at an annual rate of 10.25% until maturity in April 2017. We anticipate using a portion of the proceeds from this offering
to repay such indebtedness.
We have not determined
the amounts we plan to spend on any of the areas listed above or the timing of these expenditures. As a result, our management
will have broad discretion to allocate the net proceeds from this offering. Pending application of the net proceeds as described
above, we expect to invest the net proceeds in short-term, interest-bearing, investment-grade securities.
DIVIDEND POLICY
Our business requires
significant funding. We currently plan to invest all available funds and any future earnings in our business and do not anticipate
paying any cash dividends on our common stock in the foreseeable future. We currently are prohibited by the terms of our outstanding
indebtedness from paying dividends on our common stock, except with the prior consent of our lenders.
DILUTION
Our net tangible book
value as of December 31, 2015, was approximately $3.9 million, or approximately $0.04 per share. Net tangible book value per share
is equal to the amount of our total tangible assets, less total liabilities, divided by the aggregate number of shares of our common
stock outstanding as of December 31, 2015. Dilution in net tangible book value per share represents the difference between the
amount per share paid by purchasers of shares of common stock and the net tangible book value per share of our common stock immediately
after this offering.
After giving effect to the sale of the securities in this offering at the public offering prices of $0.40
per share and warrant, and after deducting the underwriting discounts and commissions and estimated offering expenses we must pay,
our as adjusted net tangible book value as of December 31, 2015 would have been approximately $11.4 million, or $0.10 per share.
This represents an immediate increase in net tangible book value of $0.06 per share to existing stockholders and immediate dilution
in net tangible book value of $0.30 per share to new investors purchasing our common stock and warrants in this offering. The following
table illustrates this dilution on a per share basis:
Offering price per share
|
|
|
|
|
|
$
|
0.40
|
|
Net tangible book value per share as of December 31, 2015
|
|
$
|
0.04
|
|
|
|
|
|
Increase in net tangible book value per share attributable to this offering
|
|
$
|
0.06
|
|
|
|
|
|
As adjusted, net tangible book value per share as of December 31, 2015 after giving effect to this public offering
|
|
|
|
|
|
$
|
0.10
|
|
Dilution per share to new investors
|
|
|
|
|
|
$
|
0.30
|
|
The foregoing discussion
and table do not take into account further dilution to new investors that could occur upon the exercise of outstanding options
or warrants having a per share exercise price less than the per share offering price to the public in this offering. In addition,
we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient
funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or
convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.
The foregoing discussion
and table are based on 92,005,705 shares of common stock issued and outstanding as of December 31, 2015, and excludes:
|
·
|
17,102,947 shares underlying outstanding options issued pursuant to our equity compensation and inducement plans having a weighted average exercise price of $2.08 per share;
|
|
·
|
19,652,096 shares of our common stock issuable upon exercise of outstanding warrants having a weighted average exercise price of $2.34 per share;
|
|
·
|
150,906 shares of our common stock reserved for issuance upon the vesting and termination of certain transfer restrictions with regard to restricted stock units and restricted stock awards;
|
|
·
|
2,631,791 shares of our common stock reserved for issuance pursuant to future grants and/or award under our equity compensation and inducement plans; and
|
|
·
|
20,000,000 shares of common stock reserved for issuance upon exercise of the warrants offered hereby.
|
The foregoing discussion
and table also exclude the following stock and option transactions that were entered into subsequent to December 31, 2015:
|
·
|
50,000 shares of our common stock underlying options issued to a consultant on January 11, 2016 pursuant to our equity compensation plan and having an exercise price of $1.03;
|
|
·
|
912,898 shares of our common stock underlying options issued to employees and executives pursuant to our equity compensation plans and having a weighted exercise price of $1.01;
|
|
·
|
97,046 shares of our common stock underlying options issued to a non-executive director
pursuant to our director compensation policy for services from April 1, 2016 to June 30, 2016, and having an exercise price
of $0.74; and
|
|
·
|
2,750,000 shares of our common stock underlying an inducement grant issued to our new Chief Executive Officer pursuant to our inducement grant plan and having an exercise price of $0.69.
|
CAPITALIZATION
The following table
sets forth our cash and cash-equivalents and our capitalization as of December 31, 2015 as follows:
|
·
|
On an actual basis; and
|
|
·
|
On an as-adjusted basis to give effect to our issuance and sale of 20,000,000 shares and warrants
to purchase 20,000,000 shares of common stock in this offering at the public offering price of $0.40 per share and warrant, after
deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and excluding the
proceeds, if any, from the exercise of warrants issued pursuant to this offering.
|
The following table
excludes any capital transactions, other than the offering, that have occurred subsequent to December 31, 2015.
You should read
the information in the following table in conjunction with our consolidated financial statements and the related notes and the
section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained
in our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC and incorporated by reference in
this prospectus supplement and the accompanying prospectus.
|
|
As of December 31, 2015
|
|
(In thousands, except share and per share information)
|
|
Actual
|
|
|
As adjusted for this
offering
|
|
Cash and cash equivalents
|
|
$
|
4,717
|
|
|
$
|
12,137
|
|
Short term investments
|
|
|
7,517
|
|
|
|
7,517
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of long-term debt, net of discount
|
|
$
|
4,635
|
|
|
$
|
4,635
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, net of discount and current portion
|
|
$
|
3,392
|
|
|
$
|
3,392
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity
|
|
|
|
|
|
|
|
|
Preferred stock, 7,000,000 shares authorized, no shares issued and outstanding actual and as adjusted
|
|
|
—
|
|
|
|
—
|
|
Common stock, par value $0.01 per share; 300,000,000 shares authorized, 92,005,705 shares issued and outstanding, actual; 112,005,705 shares issued and outstanding as adjusted
|
|
$
|
920
|
|
|
$
|
940
|
|
Additional paid-in capital
|
|
$
|
176,003
|
|
|
$
|
183,403
|
|
Accumulated other comprehensive income
|
|
|
3
|
|
|
|
3
|
|
Accumulated deficit
|
|
|
(171,959
|
)
|
|
|
(171,959
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity
|
|
$
|
4,967
|
|
|
$
|
12,387
|
|
|
|
|
|
|
|
|
|
|
Total capitalization
|
|
$
|
12,994
|
|
|
$
|
20,414
|
|
The foregoing discussion
and table are based on 92,005,705 shares of common stock issued and outstanding as of December 31, 2015, and excludes:
|
·
|
17,102,947 shares underlying outstanding options issued pursuant to our equity compensation and inducement plans having a weighted average exercise price of $2.08 per share;
|
|
·
|
19,652,096 shares of our common stock issuable upon exercise of outstanding warrants having a weighted average exercise price of $2.34 per share;
|
|
·
|
150,906 shares of our common stock reserved for issuance upon the vesting and termination of certain transfer restrictions with regard to restricted stock units and restricted stock awards;
|
|
·
|
2,631,791 shares of our common stock reserved for issuance pursuant to future grants and/or award under our equity compensation and inducement plans; and
|
|
·
|
20,000,000 shares of common stock reserved for issuance upon exercise of the warrants offered hereby.
|
The foregoing discussion
and table also exclude the following stock and option transactions that were entered into subsequent to December 31, 2015:
|
·
|
50,000 shares of common stock underlying options issued to a consultant on January 11, 2016 pursuant to our equity compensation plans and having an exercise price of $1.03;
|
|
·
|
912,898 shares of our common stock underlying options issued to employees and executives pursuant to our equity compensation plans and having a weighted exercise price of $1.01;
|
|
·
|
97,046 shares of our common stock underlying options issued to a non-executive director
pursuant to our director compensation policy for services from April 1, 2016 to June 30, 2016, and having an exercise price
of $0.74; and
|
|
·
|
2,750,000 shares of our common stock underlying an inducement grant issued to our new Chief Executive Officer pursuant to our inducement grant plan and having an exercise price of $0.69.
|
DESCRIPTION OF WARRANTS
The following is a
brief summary of certain terms and conditions of the warrants and is subject in all respects to the provisions contained in the
warrants.
Form.
The warrants
will be issued as individual warrants to each of the investors. You should review a copy of the form of warrant, which will be
attached as an exhibit to our Current Report on Form 8-K being filed with the Securities and Exchange Commission in connection
with this offering, for a complete description of the terms and conditions of the warrants.
Exercisability.
The warrants are exercisable immediately after the date of issuance, and at any time to the date that is five years from the date
of issuance, at which time any unexercised warrants will expire and cease to be exercisable. The warrants will be exercisable,
at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and by payment in full in
immediately available funds for the number of shares of common stock purchased upon such exercise. If at any time after the initial
exercise date, a registration statement registering the issuance of the shares of common stock underlying the warrants under the
Securities Act of 1933, as amended, is not then effective or available, the holder may exercise the warrant through a cashless
exercise, in whole or in part, in which case the holder would receive upon such exercise the net number of shares of common stock
determined according to the formula set forth in the warrant. No fractional shares of common stock will be issued in connection
with the exercise of a warrant. In lieu of fractional shares, we will either pay the holder an amount in cash equal to the fractional
amount multiplied by the exercise price or round up to the next whole share.
Exercise Limitation.
A holder will not have the right to exercise any portion of the warrant if the holder (together with its affiliates) would beneficially
own in excess of 4.99% of the number of shares of our stock outstanding immediately after giving effect to the exercise, as such
percentage ownership is determined in accordance with the terms of the warrants. However, any holder may increase or decrease such
percentage to any other percentage not in excess of 9.99% upon notice to us, provided that any increase in this limitation will
not be effective until 61 days after such notice from the holder to us.
Exercise Price;
Anti-Dilution
.
Each warrant will be exercisable
for the purchase of a share of common stock at an exercise price of $0.40 per whole share, payable in U.S. dollars. The exercise
price is subject to adjustment in the event of sales of our common shares at a price per share less than the exercise price then
in effect (or securities convertible or exercisable into common shares at a conversion or exercise price less than the exercise
price then in effect). In addition, the exercise price and the number of shares issuable upon exercise are subject to adjustment
in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events
affecting our common shares, and also upon any distributions of assets, including cash, stock or other property to our stockholders.
Transferability.
Subject to applicable laws, the warrants may be offered for sale, sold, transferred or assigned without our consent. There is currently
no trading market for the warrants and a trading market is not expected to develop.
Exchange Listing.
There is no established public trading market for the warrants, and we do not intend to apply to list the warrants on any securities
exchange or automated quotation system
Fundamental Transactions.
In the event of a fundamental transaction, as described in the warrants and generally including any reorganization, recapitalization
or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties
or assets, our consolidation or merger with or into another person, the holders of the warrants will be entitled to receive upon
exercise of the warrants the kind and amount of securities, cash or other property that the holders would have received had they
exercised the warrants immediately prior to such fundamental transaction.
A “Fundamental
Transaction” is defined under the warrants as (i) we or any of our subsidiaries shall directly or indirectly (1) consolidate
or merge with or into any other entity other than a subsidiary of ours, or (2) sell, lease, license, other than for purposes
of granting a security interest assign, transfer, convey or otherwise dispose of all or substantially all of our respective properties
or assets to any other person or entity, or (3) allow any other entity to make a purchase, tender or exchange offer that is
accepted by the holders of more than 50% of the outstanding shares of our voting stock (4) reorganize, recapitalize or reclassify
our common stock or enter into any compulsory share exchange pursuant to which the common stock is effectively converted into or
exchanged for cash or other property or (5) consummate a stock or share purchase agreement or other business combination with
any other entity whereby such other person or entity acquires more than 50% of the outstanding shares of our voting stock.
Rights as a Stockholder.
Except as otherwise provided in the warrants or by virtue of such holder’s ownership of shares of our common stock, the holder
of a warrant does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder
exercises the warrant.
UNDERWRITING
We have entered into
an underwriting agreement with the several underwriters listed in the table below. Roth Capital Partners, LLC is acting as the
representative of the underwriters. We refer to the several underwriters listed in the table below as the ‘‘underwriters.’’
Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriters, and each of the
underwriters has agreed, severally and not jointly, to purchase from us, shares of our common stock and warrants. Our common stock
trades on The Nasdaq Capital Market under the symbol ‘‘CUR.’’
Pursuant to the terms
and subject to the conditions contained in the underwriting agreement, we have agreed to sell to the underwriters named below,
and each underwriter, severally and not jointly, has agreed to purchase from us, the respective number of shares of common stock
and common stock purchase warrants set forth opposite its name below:
Underwriter
|
|
Number of Shares
|
|
|
Number of Warrants
|
|
Roth Capital Partners, LLC
|
|
|
15,000,000
|
|
|
|
15,000,000
|
|
Brean Capital, LLC
|
|
|
5,000,000
|
|
|
|
5,000,000
|
|
Total
|
|
|
20,000,000
|
|
|
|
20,000,000
|
|
The underwriting agreement
provides that the obligations of the underwriters to pay for and accept delivery of the shares of common stock and warrants offered
by this prospectus supplement are subject to the approval of certain legal matters by their counsel and to other conditions. The
underwriters are obligated to take and pay for all of the shares of common stock and warrants offered by this prospectus supplement
if any such shares or warrants are taken.
Discounts, Commissions and Expenses
The underwriters propose
to offer the shares of common stock and warrants purchased pursuant to the underwriting agreement to the public at the public offering
prices set forth on the cover page of this prospectus supplement and to certain dealers at those prices less a concession not in
excess of $0.012 per share. After this offering, the concessions may be changed by the underwriters. No such change shall
change the amount of proceeds to be received by us as set forth on the cover page of this prospectus supplement.
In connection with
the sale of the common stock and warrants to be purchased by the underwriters, the underwriters will be deemed to have received
compensation in the form of underwriting discounts and commissions. The underwriters' discounts and commissions will be 6.0% of
the gross proceeds of this offering, or $0.024 per share of common stock and warrant, based on the public offering prices
per set forth on the cover page of this prospectus supplement.
We have also agreed
to reimburse Roth Capital Partners, LLC at closing for costs and expenses (including legal) incurred by it in connection with the
offering up to a maximum of $100,000.
The following table
shows the underwriting discounts and commissions payable to the underwriters by us in connection with this offering.
|
|
Per Share and Warrant
|
|
Public offering price
|
|
$
|
0.40
|
|
Underwriting discounts and commissions
|
|
$
|
0.024
|
|
Indemnification
Pursuant to the underwriting
agreement, we have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities
Act, or to contribute to payments that the underwriters or such other indemnified parties may be required to make in respect of
those liabilities.
Lock-Up Agreements
We and our directors
and executive officers have agreed not to (i) sell, offer to sell, contract or agree to sell, hypothecate, pledge, grant any
option to purchase or otherwise dispose of or agree to dispose of, directly or indirectly, or file (or participate in the filing
of) a registration statement with the SEC in respect of, or establish or increase a put equivalent position or liquidate or decrease
a call equivalent position within the meaning of Section 16 of the Securities Exchange Act of 1934, as amended, and the rules and
regulations of the Commission promulgated thereunder (the “
Exchange Act
”) with respect to, any common stock
or any other securities that are substantially similar to our common stock, or any securities convertible into or exchangeable
or exercisable for, or any warrants or other rights to purchase, the foregoing; (ii) enter into any swap or other arrangement
that transfers to another, in whole or in part, any of the economic consequences of ownership of our common stock or any other
securities that are substantially similar to our common stock, or any securities convertible into or exchangeable or exercisable
for, or any warrants or other rights to purchase, the foregoing, whether any such transaction is to be settled by delivery of our
common stock or such other securities, in cash or otherwise; or (iii) publicly announce an intention to effect any transaction
specified in clause (i) or (ii), without the prior written consent of Roth Capital Partners for a period of 60 days following
the date of this prospectus supplement, subject to an 18-day extension under certain circumstances (the "Lock-up Period").
The restrictions contained in the preceding sentence shall not apply, (i) with respect to the Company, to (a) the securities to
be sold in this offering, (b) the issuance of Common Stock upon the exercise of options or warrants disclosed as outstanding in
the registration statement (excluding exhibits thereto), or this prospectus supplement, (c) the issuance of employee stock options
not exercisable during the Lock-Up Period and the grant of restricted stock awards or restricted stock units pursuant to equity
incentive plans described in the registration statement (excluding exhibits thereto) and this prospectus supplement, or (d) the
issuance of Common Stock or other securities to consultants as consideration for services in an aggregate amount of up to 250,000
shares or share equivalents; and (ii) with respect to our directors and executive officers, (t) bona fide gifts, provided that
the recipient thereof agrees in writing with Roth Capital Partners to be bound by the terms of such Lock-Up Period, (u) dispositions
to any trust for the direct or indirect benefit of the director or executive officer and/or the immediate family of such director
or executive officer, provided that such trust agrees in writing with Roth Capital Partners to be bound by the terms of such Lock-Up
Period, (v) transfers of our common stock or securities convertible into our common stock on death by will or intestacy, (w) sales
or transfers of our common stock or securities convertible into our common stock pursuant to a trading plan entered into prior
to the date hereof pursuant to Rule 10b5-1 under the Exchange Act (x) transfers of securities acquired in open market transactions
after the completion of this offering, (y) transfers between an executive officer or director and any corporation, partnership,
limited liability company or any other business entity directly or indirectly controlled by such executive officer or director,
or (z) the inclusion of securities issued or issuable to a director or executive officer in a registration statement on Form S-8.
Electronic Distribution
This prospectus supplement
and the accompanying prospectus may be made available in electronic format on websites or through other online services maintained
by the underwriters or by their affiliates. In those cases, prospective investors may view offering terms online and prospective
investors may be allowed to place orders online. Other than this prospectus supplement and the accompanying prospectus in electronic
format, the information on the underwriters' websites or our website and any information contained in any other websites maintained
by the underwriters or by us is not part of this prospectus supplement, the accompanying prospectus or the registration statement
of which this prospectus supplement and the accompanying prospectus forms a part, has not been approved and/or endorsed by
us or the underwriter in its capacity as underwriter, and should not be relied upon by investors.
Other Relationships
Some of the underwriters
and their affiliates have provided in the past to us and our affiliates, and may provide from time to time in the future, certain
financial advisory, investment banking and other services in the ordinary course of their business, for which they have received
and may continue to receive customary fees and commissions. In addition, from time to time, the underwriters and their affiliates
may effect transactions for their own account or the accounts of customers, and hold on behalf of themselves or their customers,
long or short positions in our debt or equity securities or loans, and may do so in the future.
In December 2015 we
entered into an engagement letter with Brean Capital, LLC, pursuant to which we paid Brean Capital, LLC $150,000 for their services
as our corporate finance advisor, which amount is deemed underwriting compensation in connection with this offering.
Price Stabilization, Short Positions and Penalty Bids
In connection with
the offering the underwriters may engage in stabilizing transactions, syndicate covering transactions and penalty bids in accordance
with Regulation M under the Exchange Act:
|
·
|
Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum.
|
|
·
|
Syndicate covering transactions involve purchases of the common stock in the open market after the distribution has been completed in order to cover syndicate short positions. This position can only be closed out by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on the price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering.
|
|
·
|
Penalty bids permit the underwriters to reclaim a selling concession from a syndicate member when the common stock originally sold by the syndicate member is purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.
|
These stabilizing transactions,
syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market price of our common stock
or preventing or retarding a decline in the market price of the common stock. As a result, the price of our common stock may be
higher than the price that might otherwise exist in the open market. These transactions may be discontinued at any time
Neither we nor the
underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions described
above may have on the price of our shares of common stock. In addition, neither we nor the underwriters make any representation
that the underwriter will engage in these transactions or that any transaction, if commenced, will not be discontinued without
notice.
Selling Restrictions
European Economic Area
This prospectus supplement
and the accompanying prospectus does not constitute an approved prospectus under Directive 2003/71/EC and no such prospectus is
intended to be prepared and approved in connection with this offering. Accordingly, in relation to each Member State of the European
Economic Area which has implemented Directive 2003/71/EC (each, a “Relevant Member State”) an offer to the public of
any shares of common stock and warrants which are the subject of the offering contemplated by this prospectus supplement and the
accompanying prospectus may not be made in that Relevant Member State except that an offer to the public in that Relevant Member
State of any shares of common stock and warrants may be made at any time under the following exemptions under the Prospectus Directive,
if and to the extent that they have been implemented in that Relevant Member State:
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(a)
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to any legal entity which is a qualified investor as defined in the Prospectus Directive;
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(b)
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to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive), subject to obtaining the prior consent of the representatives of the underwriter for any such offer; or
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(c)
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in any other circumstances which do not require any person to publish a prospectus pursuant to Article 3 of the Prospectus Directive.
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For the purposes of
this provision, the expression an “offer to the public” in relation to any shares of common stock and warrants in any
Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer
and any shares of common stock and warrants to be offered so as to enable an investor to decide to purchase any shares of common
stock and warrants, as the expression may be varied in that Member State by any measure implementing the Prospectus Directive in
that Member State and the expression “Prospectus Directive” means Directive 2003/71/EC (and any amendments thereto
including the 2010 PD Amending Directive to the extent implemented in each Relevant Member State) and includes any relevant implementing
measure in each Relevant Member State and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.
United Kingdom
This prospectus supplement
and the accompanying prospectus are not an approved prospectus for purposes of the UK Prospectus Rules, as implemented under the
EU Prospectus Directive (2003/71/EC), and have not been approved under section 21 of the Financial Services and Markets Act
2000 (as amended) (the “FSMA”) by a person authorized under FSMA. The financial promotions contained in this prospectus
supplement and the accompanying prospectus are directed at, and this prospectus supplement and the accompanying prospectus are
only being distributed to, (1) persons who receive this prospectus supplement and the accompanying prospectus outside of the
United Kingdom, and (2) persons in the United Kingdom who fall within the exemptions under articles 19 (investment professionals)
and 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005 (all such persons together being referred to as “Relevant Persons”). This prospectus
supplement and the accompanying prospectus must not be acted upon or relied upon by any person who is not a Relevant Person. Any
investment or investment activity to which this prospectus supplement and the accompanying prospectus relate is available only
to Relevant Persons and will be engaged in only with Relevant Persons. This prospectus supplement and the accompanying prospectus
and their contents are confidential and should not be distributed, published or reproduced (in whole or in part) or disclosed by
recipients to any other person that is not a Relevant Person.
The underwriter has
represented, warranted and agreed that:
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(a)
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it has only communicated or caused to be communicated and will only communicate or cause to be communicated any invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA in connection with the issue or sale of any of the shares of common stock and warrants in circumstances in which section 21(1) of the FSMA does not apply to the issuer; and
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(b)
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it has complied with and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to the shares of common stock and warrants in, from or otherwise involving the United Kingdom.
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LEGAL MATTERS
The validity of the
issuance of the securities offered hereby will be passed upon for us by the Silvestre Law Group, P.C., Westlake Village, California
and certain other legal matters will be passed upon for us by Blank Rome, New York, New York. The Silvestre Law Group, P.C. or
its affiliates or principals own 54,000 shares of our common stock and 450,000 of our common stock purchase warrants. The underwriters
are being represented in connection with this offering by Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, P.C., New York, New York.
EXPERTS
The financial statements
incorporated in this prospectus by reference from our Annual Report on Form 10-K have been audited by Stegman & Company,
an independent registered public accounting firm, as stated in their report, which is incorporated herein by reference. Such
financial statements have been so incorporated in reliance upon the report of such firm given upon their authority as experts in
accounting and auditing. Stegman & Company has no interest in the securities being registered in this filing.
WHERE YOU CAN FIND MORE INFORMATION
We are a public company
and file annual, quarterly and current reports, proxy statements and other information with the SEC. You may obtain copies
of our public filings, as noted in the paragraph below or by writing or telephoning us at:
Neuralstem, Inc.
Attn: Investor Relations
20271 Goldenrod Lane
Germantown, Maryland 20876
Phone: (301)-366-4960
We file annual, quarterly
and other reports, proxy statements and other information with the SEC. Our SEC filings are available to the public over the Internet
at the SEC’s website at
http://www.sec.gov
. You may also read and copy any
document we file at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330 for further information on the Public Reference Room. You can also inspect reports, proxy statements and other
information about us at the offices of the National Association of Securities Dealers, Reports Section, 1735 K Street, N.W., Washington,
D.C. 20006. We maintain a website at
http://www.neuralstem.com
. Information contained
in or accessible through our website does not constitute a part of this prospectus.
This prospectus supplement
and the accompanying prospectus are part of a registration statement on Form S-3 that we filed with the SEC registering the
securities that may be offered and sold hereunder. The registration statement, including exhibits thereto, contains additional
relevant information about us and these securities that, as permitted by the rules and regulations of the SEC, we have not
included in this prospectus supplement or the accompanying prospectus. A copy of the registration statement can be obtained at
the address set forth above. You should read the registration statement for further information about us and these securities.
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC permits us
to “incorporate by reference” the information contained in documents we file with the SEC, which means that we can
disclose important information to you by referring you to those documents rather than by including them in this prospectus supplement
or the accompanying prospectus. Information that is incorporated by reference is considered to be part of this prospectus supplement,
and you should read it with the same care that you read this prospectus supplement. Later information that we file with the SEC
will automatically update and supersede the information that is either contained, or incorporated by reference, in this prospectus
supplement, and will be considered to be a part of this prospectus supplement from the date those documents are filed.
We incorporate by reference
into this prospectus supplement the following documents and information filed with the SEC:
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Our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 14, 2016, for the year ended December 31, 2015;
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Our Definitive Proxy Statement on Form 14A for our 2016 Annual Meeting of Stockholders, filed with the SEC on April 28, 2016;
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Our Current Reports on Form 8-K filed with the Commission on January 11, January 27, February 19, March 4 (2 filings), March 14, March 16 and April 13, 2016 (excluding any information furnished in such reports under Item 2.02, Item 7.01 or Item 9.01); and
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the description of our common stock and related rights contained in our registration statement on Form 8-A (File No. 001-33672), including any amendment or report filed for the purpose of updating such description.
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We also incorporate
by reference into this prospectus supplement all additional documents that we file with the SEC under the terms of Section 13(a),
13(c), 14 or 15(d) of the Securities Exchange Act of 1934 that are made after the date of this prospectus supplement and before
the termination of the offering of securities offered by this prospectus supplement. We are not, however, incorporating, in each
case, any documents or information that we are deemed to furnish and not file in accordance with SEC rules.
You may request a copy
of any of the documents incorporated by reference into this prospectus supplement, at no cost, by writing or telephoning us at
the following address: Neuralstem, Inc., Attn: Investor Relations, 20271 Goldenrod Lane, Germantown, Maryland 20876 Phone: (301)
366-4960.
PROSPECTUS
NEURALSTEM, INC.
$100,000,000
Common Stock,
Preferred stock,
Warrants
Units
We may from time to time in one or more
offerings, offer and sell one or any combination of the securities we describe in this prospectus, either individually or as units
comprised of one or more of the offered securities.
This prospectus may not be used to sell securities unless accompanied by
a prospectus supplement, which will describe the method and the terms of the offering
. We will provide you with specific amount,
price and terms of the applicable offered securities in one or more supplements to this prospectus. You should read this prospectus
and any supplement carefully before you purchase any of our securities.
These securities may be offered and sold
in the same offering or in separate offerings; to or through underwriters, dealers, and agents; or directly to purchasers. The
names of any underwriters, dealers, or agents involved in the sale of our securities, their compensation and any over-allotment
options held by them will be described in the applicable prospectus supplement, see “Plan of Distribution.”
Our common stock is listed on the NYSE
MKT under the symbol “CUR.” On June 5, 2014, the closing price of our common stock on the NYSE MKT was $4.64 per share.
Our principal executive offices are located at 20271 Goldenrod Lane, Germantown, Maryland 20876,
and our telephone number
is (301) 366-4841.
INVESTING IN OUR SECURITIES INVOLVES
RISKS. YOU SHOULD REVIEW CAREFULLY THE RISKS AND UNCERTAINTIES DESCRIBED UNDER THE HEADING “
RISK FACTORS
” ON
PAGE 5 AND CONTAINED IN THE APPLICABLE PROSPECTUS SUPPLEMENT AND ANY RELATED FREE WRITING PROSPECTUS AND UNDER SIMILAR HEADINGS
IN THE OTHER DOCUMENTS THAT ARE INCORPORATED BY REFERENCE INTO THIS PROSPECTUS.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus
is truthful or complete. Any representation to the contrary is a criminal offense.
This prospectus is dated June 19, 2014
Table of Contents
ABOUT THIS PROSPECTUS
Unless the
context requires otherwise or unless otherwise noted, all references in this prospectus or any prospectus supplement to
“our
company,” “we,” “our,” “Neuralstem” and “us” refer to Neuralstem, Inc. and
its subsidiaries.
This prospectus is a part of a registration
statement that we filed with the Securities and Exchange Commission, or SEC, utilizing a “shelf” registration process.
Under this shelf process, we may sell the securities described in this prospectus in one or more offerings. This prospectus
provides you with a general description of the securities we may offer. Each time we sell securities under this shelf registration,
we will provide a prospectus supplement that will contain specific information about the terms of that offering. We may also
authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these offerings.
The prospectus supplement and any related free writing prospectus that we may authorize to be provided to you may also add, update
or change information contained in this prospectus or in any documents that we have incorporated by reference into this prospectus.
You should read this prospectus, any applicable prospectus supplement and any related free writing prospectus, together with the
information incorporated herein by reference as described under the headings “Where You Can Find More Information”
and “Incorporation by Reference.”
You should rely only on the information
that we have provided or incorporated by reference in this prospectus, any applicable prospectus supplement and any related free
writing prospectus that we may authorize to be provided to you. We have not authorized any dealer, salesman or other person
to give any information or to make any representation other than those contained or incorporated by reference in this prospectus,
any applicable prospectus supplement or any related free writing prospectus that we may authorize to be provided to you.
You must not rely upon any information or representation not contained or incorporated by reference in this prospectus or the accompanying
prospectus supplement. We take no responsibility for, and can provide no assurance as to the reliability of, any other information
that others may give you.
This prospectus and the accompanying supplement
to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered
securities to which they relate, nor do this prospectus and the accompanying supplement to this prospectus constitute an offer
to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such
offer or solicitation in such jurisdiction. You should not assume that the information contained in this prospectus, any
applicable prospectus supplement or any related free writing prospectus is accurate on any date subsequent to the date set forth
on the front of the document or that any information we have incorporated by reference is correct on any date subsequent to the
date of the document incorporated by reference, even though this prospectus, any applicable prospectus supplement or any related
free writing prospectus is delivered or securities sold on a later date.
FORWARD-LOOKING STATEMENTS
This prospectus, including the documents
that we incorporate by reference, contains forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). The words “anticipate,” “believe,” “ensure,” “expect,”
“if,” “intend,” “estimate,” “probable,” “project,” “forecasts,”
“predict,” “outlook,” “aim,” “will,” “could,” “should,”
“would,” “may,” “likely” and similar expressions, and the negative thereof, are intended to
identify forward-looking statements. Our forward-looking statements are based on assumptions that we believe to be reasonable but
that may not prove to be accurate. The statements do not include the potential impact of future transactions, such as an acquisition,
disposition, merger, joint venture or other transaction that could occur. We undertake no obligation to publicly update or revise
any forward-looking statement.
Discussions
containing these forward-looking statements may be found, among other places, in the Sections entitled “Business,”
“Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
incorporated by reference from our most recent Annual Report on Form 10-K and in our Quarterly Reports on Form 10-Q,
as well as any amendments thereto, filed with the SEC.
Such statements are based on currently
available operating, financial and competitive information and are subject to various risks, uncertainties and assumptions that
could cause actual results to differ materially from those anticipated or implied in our forward-looking statements due to a number
of factors including, but not limited to, those set forth below under the section entitled “Risk Factors” in our most
recent Annual Report on Form 10-K for the year ended December 31, 2013 and our Quarterly Report on Form 10-Q for the
three-month period ended March 31, 2014, as updated by annual, quarterly and other reports and documents we file with the SEC after
the date of this prospectus and that are incorporated by reference herein or in the applicable prospectus supplement. Given
these risks, uncertainties and other factors, many of which are beyond our control, you should not place undue reliance on these
forward-looking statements.
Except as required by law, we assume no
obligation to update these forward-looking statements publicly, or to revise any forward-looking statements to reflect events or
developments occurring after the date of this prospectus, even if new information becomes available in the future.
THE COMPANY
Overview
We are focused on the development and commercialization
of treatments based on human neuronal stem cells and our small molecule compounds. We are headquartered in Germantown, Maryland
and have a wholly-owned subsidiary in China.
We have developed and maintain a portfolio
of patents and patent applications that form the proprietary base for our research and development efforts. We own or exclusively
license fifty-one (51) U.S. or foreign issued patents and fifty-nine (59) U.S. and foreign patent applications in the field of
regenerative medicine, related to our stem cell technologies as well as our small molecule compounds. At times we have licensed
the use of our intellectual property to third parties.
We believe our technology base, in combination
with our know-how, and collaborative projects with major research institutions, will facilitate the development and commercialization
of products for use in the treatment of a wide array of neurodegenerative conditions and in regenerative repair of acute disease.
Regenerative medicine is a young and emerging
field. Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function
lost due to age, disease, damage, or congenital defects. There can be no assurances that we will ultimately produce viable commercialized
products and processes. Even if we are able to produce a commercially viable product, there are strong competitors in this field
and our products may not be able to successfully compete against them.
All of our research efforts to date are
at the pre-clinical or clinical stage of development. We are focused on leveraging our key assets, including our intellectual property,
our scientific team and our facilities in order to advance our technologies. In addition, we are pursuing strategic collaborations
with members of academia and industry.
Clinical Programs
We have devoted substantially all our efforts
to the development of our stem cell and small molecule compounds and their pre-clinical and clinical development. Below is a description
of our four most advanced clinical programs, their intended indication, current stage of development and our expected future development
plans.
Program
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Indication
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Development Status
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Future
Development Plan
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NSI - 566
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Amyotrophic Lateral Sclerosis (ALS)
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Ongoing Phase II clinical trials
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Anticipated to complete patient dosing in our Phase II clinical trials during the third quarter of 2014.
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NSI – 566
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Chronic Spinal Cord Injury
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Approved to commence Phase I clinical trials.
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Phase I Trial expected to commence during the third quarter of 2014.
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NSI – 566
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Motor deficits due to ischemic stroke
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Ongoing combined Phase I/II clinical trials in China.
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Dosing commenced during the fourth quarter of 2013.
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NSI – 189
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Major Depressive Disorder
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Completed Phase Ia, Phase Ib trials.
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Phase II trial investigational new drug application or IND expected to be filed in the third quarter of 2014 with the trial commencing in late 2014 or early 2015.
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NSI - 566 (Stem Cells).
Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic lateral sclerosis, or ALS,
is a disease of the nerve cells in the brain and spinal cord that control voluntary muscle movement. In ALS, nerve cells (neurons)
waste away or die, and can no longer send messages to muscles. This eventually leads to muscle weakening, twitching, and an inability
to move the arms, legs, and body. The condition slowly gets worse. When the muscles in the chest area stop working, it becomes
hard or impossible to breathe. We believe that NSI-566 may provide an effective treatment for ALS by providing cells which nurture
and protect the patients’ remaining motor neurons; and possibly repair some motor neurons which were not dead, but diseased.
We conducted the Phase I trial for our
proposed treatment of ALS at Emory University in Atlanta Georgia. The purpose of the Phase I trial was to evaluate the safety and
transplantation technique of our proposed treatment and procedure. The treating of patients in the Phase I trial, as designed,
was completed in August of 2012. We commenced Phase II clinical trial in September of 2013. The Phase II dose escalation trial
is designed to treat up to 15 ambulatory patients in six different dosing cohorts, under an accelerated dosing and treatment schedule.
To date, we have treated the first four cohorts. We anticipate completing the Phase II dosing during the third quarter of 2014.
Although initial data from the Phase I trial appears promising, the outcome of the trial is uncertain and this trial or future
trials may ultimately be unsuccessful.
Chronic Spinal Cord Injury
A spinal cord injury or SCI generally refers
to any injury to the spinal cord that is caused by trauma instead of disease although in some cases, it can be the result of diseases.
Chronic Spinal Cord Injury refers to the time after the initial hospitalization. Spinal cord injuries are most often traumatic,
caused by lateral bending, dislocation, rotation, axial loading, and hyperflexion or hyperextension of the cord or cauda equina.
Motor vehicle accidents are the most common cause of SCIs, while other causes include falls, work-related accidents, sports injuries,
and penetrations such as stab or gunshot wounds. In certain instances, SCIs can also be of a non-traumatic origin, as in the case
of cancer, infection, intervertebral disc disease, vertebral injury and spinal cord vascular disease. We believe that NSI-566 may
provide an effective treatment for Chronic Spinal Cord Injury by “bridging the gap” in the spinal cord created in traumatic
spinal cord injury and providing new cells to help transmit the signal from the brain to points at or below the point of injury.
During the first quarter of 2013, we received
approval from the United States food and drug Administration or FDA to commence our proposed Phase I clinical trial to treat chronic
spinal cord injury. The entire trial will take place at The University California, San Diego. We anticipate the trial will commence
during the third quarter of 2014.
Motor Deficits Due to Ischemic Stroke
Ischemic strokes, the most common type
of stroke, occur as a result of an obstruction within a blood vessel supplying blood to the brain. Post-stroke motor deficits include
paralysis in arms and legs and can be permanent. We believe that NSI-566 may provide an effective treatment for restoring motor
deficits resulting from Ischemic Stroke by both creating new circuitry in the area of injury and through repairing and or nurturing
diseased cells to improve function in patients.
In September of 2012, we received approval
to commence human clinical trials to treat motor deficits due to ischemic stroke. The trial will be conducted by our wholly owned
subsidiary, Neuralstem China, at BaYi Brain Hospital in Beijing, China and will utilize our spinal cord stem cells. The trial approval
includes a combined phase I/II/III design and will test direct injections of NSI-566 into the brain, the same cell product used
in our recently-completed Phase I ALS trial in the United States. The trial commenced in the fourth quarter of 2013 and is designed
to enroll up to 118 patients. The first phase of the trial is structured to confirm the maximum safe tolerated dose.
NSI - 189 (Small Molecule Pharmaceutical
Compound).
Major
Depression Disorder
Major
depressive disorder or MDD (also known as recurrent depressive disorder, clinical depression, major depression, unipolar depression,
or unipolar disorder) is a mental disorder characterized by episodes of all-encompassing low mood accompanied by low self-esteem
and loss of interest or pleasure in normally enjoyable activities. NSI-189 is being developed for the treatment of major depressive
disorder and other psychiatric and/or cognitive impairment indications. NSI-189 is the lead compound in our neurogenerative small
molecule drug platform. We believe that NSI-189 may provide an effective treatment for patients suffering from MDD by structurally
rebuilding the hippocampus.
In
February of 2011, we commenced the Phase I clinical trial (Phase Ia portion), NSI-189, at California Clinical Trials, LLC, in Glendale,
California. The purpose of the Phase Ia portion of the trial was to evaluate the safety of the drug in healthy volunteers. The
Phase Ia portion tested a single oral administration of NSI-189 in 24 healthy volunteers and was completed in October of 2011.
In December of 2011, we received approval from the FDA to commence the Phase Ib portion of the trial. The purpose of the Phase
Ib portion of the clinical trial is to determine the safety of the drug at several dosings in actual MDD patients. The Phase Ib
portion consists of patients with MDD receiving daily doses for 28 consecutive days. In June of 2012, we dosed our first patient
in the Phase Ib portion of the trial. To date, we have completed dosing all cohorts of patients in the Phase Ib portion of the
trial and the data is being reviewed. While the final data analysis will not be completed until late May, the early look at the
unblended data was encouraging enough that the Company has committed to conducting a phase two trial. We expect to file the IND
for the phase two in the third or fourth quarter of 2014 and expect that the Phase II trial would start before the end of the first
quarter of 2015.
Technology
Stem Cells.
Our
technology enables the isolation and large-scale expansion of human neural stem cells from all areas of the developing human brain
and spinal cord, thus enabling the generation of physiologically relevant human neurons of all types. We believe that our stem
cell technology will assist the body in producing new cells to replace malfunctioning or dead cells as a way to treat disease and
injury. Many significant and currently untreatable human diseases arise from the loss or malfunction of specific cell types in
the body. Our focus is the development of effective methods to generate replacement cells from neural stem cells. We believe that
replacing damaged, malfunctioning or dead neural cells with fully functional ones may be a useful therapeutic strategy in treating
many diseases and conditions of the central nervous system or CNS, including: Alzheimer's disease, Parkinson's disease, Multiple
Sclerosis, Lou Gehrig’s disease or ALS, depression, and injuries to the spinal cord. We own or exclusively license thirty-three
(33) U.S. and foreign issued patents and thirty-nine (39) U.S. and foreign patent applications related to our stem cell technologies.
To
date we have focused our research efforts on applications involving spinal cord stem cells. We believe that, if successfully developed,
stem cell therapeutics have the potential to provide a broad therapeutic approach comparable to traditional pharmaceuticals and
genetically engineered biologics. We have established “proof of principle” in animal models for important spinal cord
cell applications: ALS and Traumatic spinal cord injury. Of these applications, we have completed our first Phase I trial with
regard to ALS and commenced initial Phase II trials in the third quarter of 2013. We have also received approval from the FDA to
commence a Phase I trial in Chronic Spinal Cord Injury (patients one to two years out from their injury) in complete (no sensory
of motor function from the site of the injury down) thoracic patients. We expect this trial to start during the third quarter of
2014. In the fourth quarter of 2013 we filed an IND to start a trial to treat acute spinal cord injury (within several weeks of
the injury) in Seoul Korea. If approved as submitted, this trial will treat complete patients, who are those who have no sensory
or motor function below the point of the injury and also progressively incomplete patients, who have varying degrees of each. Also,
if approved as submitted, this trial will treat cervical area injuries. We expect this trial to start in the second half of 2014.
Small Molecule Pharmaceutical Compounds.
We have developed and patented a series
of small molecule compounds (low molecular weight organic compounds which can efficiently cross the blood/brain barrier). We believe
that these small molecule compounds will stimulate the growth of new neurons in the hippocampus and provide a treatment for depression,
and possibly other cognitive impacting diseases. In mice, our research indicated that our small molecule compounds both stimulate
neurogenesis of the hippocampus and increase its volume. Additionally, our research also indicates that our small molecule compounds
stimulate neurogenesis of human hippocampus-derived neural stem cells in vitro. Based on this research, we believe that our small
molecule compounds may assist in reversing atrophy in the human hippocampus. Such atrophy has been seen in major depression and
other disorders.
Our small molecule compounds are covered
by eighteen (18) exclusively owned U.S. and foreign issued patents and twenty-one (21) exclusively owned U.S. and foreign patent
applications related to our small molecule compounds.
Research
We have devoted substantial resources to
our research programs in order to isolate and develop a series of neural stem cell banks that we believe can serve as a basis for
our therapeutic products. Our efforts are directed at developing therapies utilizing our stem cells and small molecule regenerative
drugs. This research is conducted internally, through the use of third party laboratories and consulting companies under our direct
supervision, and through collaboration with academic institutes.
Operating Strategy
We generally employ
an outsourcing strategy where we outsource our Good Laboratory Practices or GLP preclinical development activities and Good Manufacturing
Practices or GMP manufacturing and clinical development activities to contract research organizations or CROs and contract manufacturing
organizations or CMOs as well as all non-critical corporate functions. Manufacturing is also outsourced to organizations with approved
facilities and manufacturing practices. This outsource model allows us to better manage cash on hand and minimize non-vital expenditures.
It also allows for us to operate with relatively fewer employees and lower fixed costs than that required by other companies conducting
similar business.
Manufacturing
We currently manufacture our cells both
in-house and on an outsource basis. We outsource the manufacturing of our pharmaceutical compounds to third party manufacturers.
We manufacture cells in-house which are not required to meet stringent FDA requirements. We use these cells in our research and
collaborative programs. We outsource all the manufacturing and storage of our stem cells and pharmaceuticals compound to be used
in clinical and pre-clinical works, and which are accordingly subject to higher FDA requirements, to Charles River Laboratories,
Inc., of Wilmington, Massachusetts (stem cells) and Albany Molecular Resources, Inc. (“AMRI”) (small molecule). Both
the Charles River and AMRI facilities have the capacity to be used for manufacturing under the FDA determined GMP standards in
quantities sufficient for our current and anticipated pre-trial and clinical trial needs. We have no quantity or volume commitment
with either Charles River Laboratories or AMRI and our cells and pharmaceutical compounds are ordered and manufactured on an as
needed basis. Additionally, during the first quarter of 2014, we relocated our headquarters to a facility with GMP manufacturing
capability. We anticipate the facility will be ready to commencing manufacturing of our stem cells for our clinical trials by the
second quarter of 2015. Such increased manufacturing will supplement our current outsource supply of both stem cells and pharmaceutical
compounds. We believe such additional manufacturing capacity will be beneficial as our clinical trials expand by indication, geographic
region and to larger patient populations.
Employees
As of March 31, 2014, we had 15 full-time
employees and one (1) full-time independent contractor. Of these full-time employees and contractor, 11 work on research and development
and five (5) in administration. We also use the services of numerous outside consultants in business and scientific matters.
Our Corporate Information
We were incorporated in Delaware. Our
principal executive offices are located at 20271 Goldenrod Lane, Germantown, Maryland 20876,
and our telephone number is
(301) 366-4841. Our website is located at
www.neuralstem.com
.
RISK FACTORS
Investing in our securities involves a
high degree of risk. You should carefully consider and evaluate all of the information included and incorporated by reference
or deemed to be incorporated by reference in this prospectus or the applicable prospectus supplement, including the risk factors
incorporated by reference herein from our Annual Report on Form 10-K for the year ended December 31, 2013 and our Quarterly
Report on Form 10-Q for the three-month period ended March 31, 2014, as updated by annual, quarterly and other reports and
documents we file with the SEC after the date of this prospectus and that are incorporated by reference herein or in the applicable
prospectus supplement. Our business, results of operations or financial condition could be adversely affected by any of these risks
or by additional risks and uncertainties not currently known to us or that we currently consider immaterial.
USE OF PROCEEDS
Except as otherwise provided in the applicable
prospectus supplement, we intend to use the net proceeds from the sale of the securities covered by this prospectus for general
corporate purposes, which may include working capital, capital expenditures, research and development expenditures, clinical trial
expenditures, acquisitions of new technologies or businesses, repayment of outstanding debt, and investments. Additional information
on the use of net proceeds from the sale of securities covered by this prospectus may be set forth in the prospectus supplement
relating to the specific offering.
DIVIDEND POLICY
We have never paid cash dividends on our
common stock. Moreover, we do not anticipate paying periodic cash dividends on our common stock for the foreseeable future. We
intend to use all available cash and liquid assets in the operation and growth of our business. Any future determination about
the payment of dividends will be made at the discretion of our board of directors and will depend upon our earnings, if any, capital
requirements, operating and financial conditions and on such other factors as our board of directors deems relevant.
DESCRIPTION OF SECURITIES TO BE REGISTERED
Description of the Capital Stock
As of the date of this prospectus, our
authorized capital stock consists of 150,000,000 shares designated as common stock, $0.01 par value, and 7,000,000 shares designated
as preferred stock, $0.01 par value. As of May 30, 2014, there were 86,837,455 shares of common stock issued and outstanding and
no shares of preferred stock outstanding. Additionally, as of such date, we have reserved for issuance pursuant to outstanding
options, warrants and convertible securities, as well for future grants under our equity compensation plans, 44,285,358 shares
of common stock.
The following is a summary of the material
provisions of the common stock and preferred stock provided for in our certificate of incorporation and bylaws. For additional
detail about our capital stock, please refer to our certificate of incorporation and bylaws, each as amended, copies of which are
incorporated by reference into the registration statement to which this prospectus relates.
Common stock
The holders of common stock are entitled
to one vote per share on all matters to be voted upon by the stockholders and there are no cumulative rights. Subject to preferences
that may be applicable to any outstanding preferred stock, the holders of common stock are entitled to receive ratably any dividends
that may be declared from time to time by the board of directors out of funds legally available for that purpose. However, we are
not currently paying any dividends. In the event of our liquidation, dissolution or winding up, the holders of common stock are
entitled to share ratably in all assets remaining after payment of liabilities, subject to prior distribution rights of preferred
stock then outstanding. The common stock has no preemptive or conversion rights or other subscription rights. There are no redemption
or sinking fund provisions applicable to the common stock. The outstanding shares of common stock are fully paid and non-assessable,
and any shares of common stock to be issued upon an offering pursuant to this prospectus and the related prospectus supplement
will be fully paid and nonassessable upon issuance.
The transfer agent and registrar for our
common stock is American Stock Transfer and Trust Company. Our common stock is listed for quotation on the NYSE MKT under the symbol
“CUR.”
Preferred stock
The following description of preferred
stock and the description of the terms of any particular series of preferred stock that we choose to issue hereunder and that will
be set forth in the related prospectus supplement are not complete. These descriptions are qualified in their entirety by reference
to our certificate of incorporation and the certificate of designation relating to that series. The rights, preferences, privileges
and restrictions of the preferred stock of each series will be fixed by the certificate of designation relating to that series.
The prospectus supplement also will contain a description of certain U.S. federal income tax consequences relating to the purchase
and ownership of the series of preferred stock that is described in the prospectus supplement.
We currently have no shares of preferred
stock outstanding. Our board of directors has the authority, without further action by the stockholders, to issue up to 7,000,000
shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions granted to or imposed
upon the preferred stock. Any or all of these rights may be greater than the rights of the common stock.
The board of directors, without stockholder
approval, can issue preferred stock with voting, conversion or other rights that could negatively affect the voting power and other
rights of the holders of common stock. Preferred stock could thus be issued quickly with terms calculated to delay or prevent a
change in control of us or make it more difficult to remove our management. Additionally, the issuance of preferred stock may have
the effect of decreasing the market price of the common stock.
The prospectus supplement for a series of preferred stock will
specify:
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the price of and maximum number of shares;
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the designation of the shares;
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the annual dividend rate, if any, whether the dividend rate is fixed or variable, the date or dates on which dividends will accrue, the dividend payment dates, and whether dividends will be cumulative;
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the price and the terms and conditions for redemption, if any, including redemption at our option or at the option of the holders, including the time period for redemption, and any accumulated dividends or premiums;
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the liquidation preference, if any, and any accumulated dividends upon the liquidation, dissolution or winding up of our affairs;
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any sinking fund or similar provision, and, if so, the terms and provisions relating to the purpose and operation of the fund;
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the terms and conditions, if any, for conversion or exchange of shares of any other class or classes of our capital stock or any series of any other class or classes, or of any other series of the same class, or any other securities or assets, including the price or the rate of conversion or exchange and the method, if any, of adjustment;
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any or all other preferences and relative, participating, optional or other special rights, privileges or qualifications, limitations or restrictions.
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Preferred stock will be fully paid and nonassessable upon issuance.
Anti-Takeover Effects of Some Provisions of Delaware Law
Provisions of Delaware law could make the
acquisition of our company through a tender offer, a proxy contest or other means more difficult and could make the removal of
incumbent officers and directors more difficult. We expect these provisions to discourage coercive takeover practices and inadequate
takeover bids and to encourage persons seeking to acquire control of our company to first negotiate with our board of directors.
We believe that the benefits provided by our ability to negotiate with the proponent of an unfriendly or unsolicited proposal outweigh
the disadvantages of discouraging these proposals. We believe the negotiation of an unfriendly or unsolicited proposal could result
in an improvement of its terms.
We are subject to Section 203 of the
Delaware General Corporation Law, an anti-takeover law. In general, Section 203 prohibits a publicly held Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years
following the date the person became an interested stockholder, unless:
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Prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;
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The stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding (a) shares owned by persons who are directors and also officers, and (b) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
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On or subsequent to the date of the transaction, the business combination is approved by the board and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least two-thirds of the outstanding voting stock that is not owned by the interested stockholder.
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Generally, a “business combination”
includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. An
“interested stockholder” is a person who, together with affiliates and associates, owns or, within three years prior
to the determination of interested stockholder status, did own 15% or more of a corporation’s outstanding voting securities.
We expect the existence of this provision to have an anti-takeover effect with respect to transactions our board of directors does
not approve in advance. We also anticipate that Section 203 may also discourage attempts that might result in a premium over
the market price for the shares of common stock held by stockholders.
Anti-Takeover Effects of Provisions of Our Charter Documents
Our amended and restated bylaws provides
for our board of directors to be divided into three classes serving staggered terms. Approximately one-third of the board of directors
will be elected each year. The provision for a classified board could prevent a party who acquires control of a majority of the
outstanding voting stock from obtaining control of the board of directors until the second annual stockholders meeting or longer,
following the date the acquirer obtains the controlling stock interest. The classified board provision could discourage a potential
acquirer from making a tender offer or otherwise attempting to obtain control of our company and could increase the likelihood
that incumbent directors will retain their positions. Our amended and restated bylaws provides any director or the entire Board
may be removed from office at any time, with or without cause, by the affirmative vote of the holders of at least a majority of
the voting power of the issued and outstanding shares of capital stock of the corporation then entitled to vote in the election
of directors.
Our amended and restated bylaws establish
an advance notice procedure for stockholder proposals to be brought before an annual meeting of our stockholders, including proposed
nominations of persons for election to the board of directors. At an annual meeting, stockholders may only consider proposals or
nominations specified in the notice of meeting or brought before the meeting by or at the direction of the board of directors.
Stockholders may also consider a proposal or nomination by a person who was a stockholder of record on the record date for the
meeting, who is entitled to vote at the meeting and who has given to our Secretary timely written notice, in proper form, of his
or her intention to bring that business before the meeting. The amended and restated bylaws do not give the board of directors
the power to approve or disapprove stockholder nominations of candidates or proposals regarding other business to be conducted
at a special or annual meeting of the stockholders. However, our bylaws may have the effect of precluding the conduct of business
at a meeting if the proper procedures are not followed. These provisions may also discourage or deter a potential acquirer from
conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control
of our company.
Our amended and restated bylaws provide
that only our board of directors, the chairperson of the board or the chief executive officer (or president, in the absence of
a chief executive officer) or holders of more than twenty percent (20%) of the total voting power of the outstanding shares of
capital stock may call a special meeting of stockholders. The restriction on the ability of stockholders to call a special meeting
means that a proposal to replace the board also could be delayed until the next annual meeting.
Description of the Warrants
We may issue warrants for the purchase
of our preferred stock or common stock, or any combination thereof. Warrants may be issued independently or together with our preferred
stock or common stock and may be attached to, or separate from, any offered securities. Each series of warrants will be issued
under a separate warrant agreement to be entered into between us and the warrant holder or a bank or trust company, as warrant
agent. In the event we engage a warrant agent, the warrant agent will act solely as our agent in connection with the warrants.
The warrant agent will not have any obligation or relationship of agency or trust for or with any holders or beneficial owners
of warrants. This summary of certain provisions of the warrants is not complete. For the terms of a particular series of warrants,
you should refer to the prospectus supplement and the warrant agreement for that particular series.
The prospectus supplement relating to a particular series of
warrants to purchase our common stock or preferred stock will describe the terms of the warrants, including the following:
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the title of the warrants;
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the exercise price of the warrants;
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the offering price for the warrants, if any;
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the aggregate number of warrants;
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the designation and terms of the common stock or preferred stock that may be purchased upon exercise of the warrants;
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if applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each security;
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if applicable, the date from and after which the warrants and any securities issued with the warrants will be separately transferable;
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the number of shares of common stock or preferred stock that may be purchased upon exercise of a warrant and the exercise price for the warrants;
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the dates on which the right to exercise the warrants shall commence and expire;
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if applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;
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the currency or currency units in which the offering price, if any, and the exercise price are payable;
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if applicable, a discussion of material U.S. federal income tax considerations;
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the antidilution provisions of the warrants, if any;
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the redemption or call provisions, if any, applicable to the warrants;
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any provisions with respect to the holder’s right to require us to repurchase the warrants upon a change in control or similar event; and
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any additional terms of the warrants, including procedures, and limitations relating to the exchange, exercise and settlement of the warrants.
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Holders of equity warrants will not be entitled:
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to vote, consent or receive dividends;
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receive notice as stockholders with respect to any meeting of stockholders for the election of our directors or any other matter; or
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exercise any rights of our stockholders.
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Description of the Units
We may issue units comprised of one or
more of the other classes of securities described in this prospectus in any combination. Each unit will be issued so that the holder
of the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations
of a holder of each included security. The prospectus supplement will describe:
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the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances the securities comprising the units may be held or transferred separately;
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a description of the terms of any agreement governing the units;
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a description of the provisions for the payment, settlement, transfer or exchange of the units; and
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a discussion of material federal income tax considerations, if applicable; and
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The descriptions of the units in this prospectus
and in any prospectus supplement are summaries of the material provisions of the applicable agreements. These descriptions do not
restate those agreements in their entirety and may not contain all the information that you may find useful. We urge you to read
the applicable agreements because they, and not the summaries, define your rights as holders of the units.
PLAN OF DISTRIBUTION
We may sell the offered securities in any
of the ways described below or in any combination or any other way set forth in an applicable prospectus supplement from time to
time:
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to or through underwriters or dealers;
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through one or more agents; or
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directly to purchasers or to a single purchaser.
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The distribution of the securities may be effected from time
to time in one or more transactions:
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at a fixed price, or prices, which may be changed from time to time;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices; or
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Each prospectus supplement will describe
the method of distribution of the securities and any applicable restrictions.
The prospectus supplement with respect
to the securities of a particular series will describe the terms of the offering of the securities, including the following:
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the name or names of any underwriters, dealers or agents and the amounts of securities underwritten or purchased by each of them;
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the public offering price of the securities and the proceeds to us and any discounts, commissions or concessions allowed or reallowed or paid to dealers; and
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any exchanges on which the securities may be listed.
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Any offering price and any discounts or
concessions allowed or reallowed or paid to dealers may be changed from time to time.
Only the agents or underwriters named in
each prospectus supplement are agents or underwriters in connection with the securities being offered thereby.
We may authorize underwriters, dealers
or other persons acting as our agents to solicit offers by certain institutions to purchase securities from us pursuant to delayed
delivery contracts providing for payment and delivery on the date stated in each applicable prospectus supplement. Each contract
will be for an amount not less than, and the aggregate amount of securities sold pursuant to such contracts shall not be less nor
more than, the respective amounts stated in each applicable prospectus supplement. Institutions with whom the contracts, when authorized,
may be made include commercial and savings banks, insurance companies, pension funds, investment companies, educational and charitable
institutions and other institutions, but shall in all cases be subject to our approval. Delayed delivery contracts will be subject
only to those conditions set forth in each applicable prospectus supplement, and each prospectus supplement will set forth any
commissions we pay for solicitation of these contracts.
Agents, underwriters and other third parties
described above may be entitled to indemnification by us against certain civil liabilities, including liabilities under the Securities
Act of 1933, or to contribution from us with respect to payments that the agents, underwriters or other third parties may be required
to make in respect of these civil liabilities. Agents, underwriters and such other third parties may be customers of, engage in
transactions with, or perform services for us in the ordinary course of business.
One or more firms, referred to as “remarketing
firms,” may also offer or sell the securities, if a prospectus supplement so indicates, in connection with a remarketing
arrangement upon their purchase. Remarketing firms will act as principals for their own accounts or as our agents. These remarketing
firms will offer or sell the securities in accordance with the terms of the securities. Each prospectus supplement will identify
and describe any remarketing firm and the terms of its agreement, if any, with us and will describe the remarketing firm’s
compensation. Remarketing firms may be deemed to be underwriters in connection with the securities they remarket. Remarketing firms
may be entitled under agreements that may be entered into with us to indemnification by us against certain civil liabilities, including
liabilities under the Securities Act of 1933, and may be customers of, engage in transactions with, or perform services for, us
in the ordinary course of business.
Certain underwriters may use this prospectus
and any accompanying prospectus supplement for offers and sales related to market-making transactions in the securities. These
underwriters may act as principal or agent in these transactions, and the sales will be made at prices related to prevailing market
prices at the time of sale.
The securities we offer may be new issues
of securities and may have no established trading market. The securities may or may not be listed on a securities exchange. Underwriters
may make a market in these securities, but will not be obligated to do so and may discontinue any market making at any time without
notice. We can make no assurance as to the liquidity of, or the existence of trading markets for, any of the securities.
Certain persons participating in an offering
may engage in overallotment, stabilizing transactions, short covering transactions and penalty bids in accordance with rules and
regulations under the Securities Exchange Act of 1934. Overallotment involves sales in excess of the offering size, which create
a short position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not
exceed a specified maximum. Short covering transactions involve purchases of the securities in the open market after the distribution
is completed to cover short positions. Penalty bids permit the underwriters to reclaim a selling concession from a dealer when
the securities originally sold by the dealer are purchased in a short covering transaction to cover short positions. Those activities
may cause the price of the securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue any
of the activities at any time.
We also may sell any of the securities
through agents designated by us from time to time. We will name any agent involved in the offer or sale of these securities and
will list commissions payable by us to these agents in the applicable prospectus supplement. These agents will be acting on a best
efforts basis to solicit purchases for the period of its appointment, unless stated otherwise in the applicable prospectuses.
LEGAL MATTERS
The validity of the issuance of the securities
offered hereby will be passed upon for us by The Silvestre Law Group, P.C. Westlake Village, California. The Silvestre Law
Group, P.C. or its affiliates or principals own 54,000 shares of common stock and 150,000 common stock purchase warrants.
EXPERTS
The financial statements incorporated in
this prospectus by reference from the Company’s Annual Report on Form 10-K have been audited by Stegman & Company,
an independent registered public accounting firm, as stated in their report, which is incorporated herein by reference. Such
financial statements have been so incorporated in reliance upon the report of such firm given upon their authority as experts in
accounting and auditing. Stegman & Company has no interest in the shares being registered in this filing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration
statement to register the securities offered by this prospectus under the Securities Act. This prospectus is part of that registration
statement, but omits certain information contained in the registration statement, as permitted by SEC rules. For further information
with respect to our Company and this offering, reference is made to the registration statement and the exhibits and any schedules
filed with the registration statement. Statements contained in this prospectus as to the contents of any document referred to are
not necessarily complete and in each instance, if the document is filed as an exhibit, reference is made to the copy of the document
filed as an exhibit to the registration statement, each statement being qualified in all respects by that reference. You may obtain
copies of the registration statement, including exhibits, as noted in the paragraph below or by writing or telephoning us at:
NEURALSTEM, INC
20271 Goldenrod Lane, 2nd Floor
Germantown, MD 20876
Attn: Shareholder Services
Tel: 301.366.4960
We file annual, quarterly and other reports,
proxy statements and other information with the SEC. Our SEC filings are available to the public over the Internet at the SEC’s
website at
http://www.sec.gov
. You may also read and copy any document we file
at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for
further information on the Public Reference Room. You can also inspect reports, proxy statements and other information about us
at the offices of the National Association of Securities Dealers, Reports Section, 1735 K Street, N.W., Washington, D.C. 20006.
We maintain a website at http://www.neuralstem.com. Information contained in or accessible through our website does not
constitute a part of this prospectus.
In addition to announcing material financial information through
our website, press releases, SEC filings and public conference calls and webcasts, we also intend to use the following social media
channels as a means of disclosing information about the company, its services and other matters and for complying with our disclosure
obligations under Regulation FD:
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Neuralstem’s Twitter Account (
https://twitter.com/Neuralstem_Inc
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Neuralstem’s Facebook Page (
https://www.facebook.com/Neuralstem
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Neuralstem’s Company Blog (
http://neuralstem.com/neuralstem-ceo-blog
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Neuralstem’s Google+ Page (
https://plus.google.com/u/0/b/104875574397171789280/104875574397171789280/posts
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Neuralstem’s LinkedIn Company Page (
http://www.linkedin.com/company/neuralstem-inc-
)
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The information we post through these social media channels
may be deemed material. Accordingly, investors should monitor these accounts and the blog, in addition to following the company’s
press releases, SEC filings and public conference calls and webcasts. This list may be updated from time to time.
We have not incorporated by reference into
this prospectus the information in, or that can be accessed through, our website, and you should not consider it to be a part of
this prospectus.
INFORMATION INCORPORATED BY REFERENCE
We incorporate information into this prospectus
by reference, which means that we disclose important information to you by referring you to another document filed separately with
the SEC. The information incorporated by reference is deemed to be part of this prospectus, except for any such information superseded
by information contained in later-filed documents or directly in this prospectus. This prospectus incorporates by reference the
documents set forth below that we have previously filed with the SEC (excluding those portions of any Form 8-K that are not
deemed “filed” pursuant to the General Instructions of Form 8-K). These documents contain important information
about us and our financial condition.
We incorporate by reference into this prospectus
the information contained in the documents listed below, which are considered to be a part of this prospectus:
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Our Annual Report on Form 10-K for the year ended December 31, 2013 which was filed with the Commission on March 10, 2014;
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Our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2014, which was filed with the Commission on May 12, 2014;
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Our Definitive Proxy Statement on Form 14A for our 2014 Annual Meeting of Stockholders, filed with the SEC on April 24, 2014;
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Our Current Reports on Form 8-K filed on, January 6, January 9, January 13, January 14, January 17, January 31, February 11, March 10, March 17, March 28, April 16, May 12, and May 23 of 2014 (excluding any information furnished in such reports under Item 2.02, Item 7.01 or Item 9.01);
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The description of our common stock contained in our registration statement on Form 8-A (Registration No. 001-33672), as amended , filed with the Commission on August 23, 2007.
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All reports and other documents we subsequently
file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of this offering, including
all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness
of the registration statement, but excluding any information furnished to, rather than filed with, the SEC, will also be incorporated
by reference into this prospectus and deemed to be part of this prospectus from the date of the filing of such reports and documents.
We will provide without charge to each
person, including any beneficial owner, to whom this prospectus is delivered, upon written or oral request, a copy of any or all
documents that are incorporated by reference into this prospectus, but not delivered with the prospectus, other than exhibits to
such documents unless such exhibits are specifically incorporated by reference into the documents that this prospectus incorporates.
You should direct written requests to: NEURALSTEM, INC, 20271 Goldenrod Lane, 2nd Floor, Germantown, MD 20876, Attn: Shareholder
Services, Tel: 301.366.4960
20,000,000 Shares of Common Stock
and
Warrants to Purchase 20,000,000 Shares of
Common Stock
PROSPECTUS SUPPLEMENT
Sole Book-Running
Manager
Roth Capital
Partners
Co-Manager
Brean Capital
The date of this prospectus supplement is May 3, 2016
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