As
filed with the Securities and Exchange Commission on August 6,
2008
File
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-8
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
NEURALSTEM,
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
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52-2007292
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(State
or Other Jurisdiction of
Incorporation
or Organization)
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(I.R.S.
Employer
Identification
No.)
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9700
Great Seneca Highway
Rockville,
Maryland 20850
(Address
of Principal Executive Offices)(Zip Code)
Neuralstem,
Inc. 2005 Stock Plan as Amended and Restated on June 28,
2007
&
Neuralstem,
Inc. 2007 Stock Plan
(Full
Title of the Plan)
Paracorp
Inc
40
E. Division Street Suite A
Dover,
DE 19901
(Name
and Address of Agent For Service)
(888)-372-7273
(Telephone
Number, Including Area Code, of Agent For Service)
Copies
to:
Raul
Silvestre
Law
Offices of Raul Silvestre & Associates, APLC
31200
Via Colinas, Suite 200
Westlake
Village, CA 91362
(818)597-7552
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ¨
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Accelerated filer ¨
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Non-accelerated filer ¨
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(Do
not check if a smaller reporting company)
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Smaller reporting company x
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CALCULATION
OF REGISTRATION FEE
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Title
of Each Class of Securities To Be Registered
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Amount To Be
Registered (1)
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Proposed Maximum
Offering Price Per
Share (2)
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Proposed Maximum
Aggregate Offering
Price (2)
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Amount of
Registration Fee
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Common
Stock, $0.01 par value per share(3)
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3,347,333
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$
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1.55
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$
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5,188,366
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$
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203.90
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Common
Stock, $0.01 par value per share(4)
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5,200,000
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$
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1.55
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$
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8,060,000
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$
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316.76
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Common
Stock, $0.01 par value per share(5)
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652,667
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$
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1.55
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$
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1,011,633
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$
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39.76
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Common
Stock, $0.01 par value per share(6)
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950,000
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$
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1.55
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$
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1,472,500
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$
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57.87
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Total
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10,150,000
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$
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15,732,500
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$
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618.29
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(1)
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Pursuant
to Rule 416, promulgated under the Securities Act of 1933, as
amended, this registration statement covers an indeterminate number
of
securities to be offered as a result of any adjustment from stock
splits,
stock dividends or similar transactions.
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(2)
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Computed
in accordance with Rules 457(c) and 457(h) under the Securities Act
of
1933, as amended. The proposed maximum offering price per share of
$1.55
was computed by averaging the high and low prices of a share of the
Registrant’s common stock as reported on the American Stock Exchange on
July 31, 2008.
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(3)
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Consists
of shares of Common Stock issuable upon exercise of options granted
under
the 2005 Stock Plan, as amended and restated.
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(4)
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Consist
of shares of Common Stock issuable upon exercise of options granted
under
the 2007 Stock Plan.
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(5)
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Consist
of shares of Common Stock reserved for future grants under the 2005
Stock
Plan, as amended and restated.
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(6)
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Consist
of Shares of Common Stock reserved for future grants under the 2007
Stock
Plan
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EXPLANATORY
NOTE
Neuralstem,
Inc. (the “Registrant”) has prepared this Registration Statement in accordance
with the requirements of Form S-8 under the Securities Act of 1933, as amended
(the “Securities Act”), to register an aggregate of 1,602,667 shares of our
common stock, par value $0.01 per share, that may be issued pursuant to: (i)
2005 Stock Plan, as amended (“2005 Plan”), and; (ii) 2007 Stock Plan (“2007
Plan”)(collectively the “Plans”) in the future.
This
Registration Statement also includes a reoffer prospectus prepared in accordance
with Part I of Form S-3 (in accordance with Instruction C of the General
Instructions to Form S-8). The reoffer prospectus may be utilized for
reofferings and resales on a continuous or a delayed basis in the future by
shareholders of 8,547,333 common shares with respect to grants previously made
under the Plans. The reoffer prospectus does not contain all of the information
included in the Registration Statement, certain items of which are contained
in
exhibits to the Registration Statement as permitted by the rules and regulations
of the Securities and Exchange Commission. Statements contained in this reoffer
prospectus as to the contents of any agreement, instrument or other document
referred to are not necessarily complete. With respect to each such agreement,
instrument or other document filed as an exhibit to the Registration Statement,
we refer you to the exhibit for a more complete description of the matter
involved, and each such statement shall be deemed qualified in its entirety
by
this reference.
PART I
INFORMATION
REQUIRED IN THE SECTION 10(a) PROSPECTUS
Item
1. |
Plan
Information. |
The
document(s) containing the information specified in Part I of Form S-8 will
be
sent or given to participants in the Plans as specified by Rule 428(b)(1) under
the Securities Act. Such documents are not being filed with the Securities
and
Exchange Commission, but constitute, along with the documents incorporated
by
reference into this Registration Statement, a prospectus that meets the
requirements of Section 10(a) of the Securities Act.
Item
2. |
Registrant
Information and Employee Plan Annual
Information.
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The
Registrant will furnish, without charge, to each person to whom the prospectus
is delivered, upon the written or oral request of such person, a copy of any
and
all of the documents incorporated by reference in Item 3 of Part II of this
Registration Statement. All such documents are incorporated by reference in
the
Section 10(a) prospectus. The Registrant will also furnish, without charge,
to each employee, upon the written or oral request of such employee, a copy
of
other documents required to be delivered pursuant to Rule 428(b) under the
Securities Act. Requests should be directed to the Chief Financial Officer
at
the Registrant’s principal executive offices located at 9700 Great Seneca
Highway, Rockville, MD, having a general telephone number of (301)
366-4841.
REOFFER
PROSPECTUS
8,547,333
SHARES OF COMMON STOCK
OF
NEURALSTEM, INC.
This
reoffer prospectus relates to 8,547,333 shares of our common stock, par value
$0.01 per share, which may be offered for sale from time to time by certain
shareholders of Neuralstem, Inc. (“Neuralstem”), as described under the caption
“Selling Shareholders.” These selling shareholders are current or former
directors, officers or employees of Neuralstem. We will not receive any proceeds
from the sale of shares of common stock pursuant to this reoffer prospectus.
The
selling shareholders acquired the common stock pursuant to grants under the
Plans, and these shareholders may resell all, a portion, or none of the shares
of common stock from time to time.
The
shares of common stock are “control securities” and/or “restricted securities”
under the Securities Act of 1933, as amended (the “Securities Act”), before
their sale under this reoffer prospectus. This reoffer prospectus has been
prepared for the purpose of registering the shares under the Securities Act
to
allow for future sales by selling shareholders, on a continuous or delayed
basis, to the public without restriction. Each shareholder that sells shares
of
our common stock pursuant to this reoffer prospectus may be deemed to be an
“underwriter” within the meaning of the Securities Act. In addition, any
commissions received by a broker or dealer in connection with resales of shares
may be deemed to be underwriting commissions or discounts under the Securities
Act.
You
should read this reoffer prospectus and any accompanying prospectus supplement
carefully before you make your investment decision. The sales may occur in
transactions on the American Stock Exchange at prevailing market prices or
in
negotiated transactions. We will not receive any proceeds from any of these
sales. We are paying the expenses incurred in registering the shares, but all
selling and other expenses incurred by each of the selling shareholders will
be
borne by that shareholder.
Investing
in the common stock involves risks. See “Risk
Factors” beginning on page 5.
Our
common stock is currently listed for trading on the American Stock Exchange
(“AMEX”) under the symbol “CUR.” The last reported sale price of our common
stock on the AMEX on July 31, 2008 was $1.56 per share.
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.
The
date
of this reoffer prospectus is August 6, 2008.
TABLE
OF CONTENTS
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Page No.
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THE
COMPANY
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3 |
OFFERING
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4 |
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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5 |
RISK
FACTORS
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5 |
USE
OF PROCEEDS
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13 |
SELLING
SHAREHOLDERS
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13 |
PLAN
OF DISTRIBUTION
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13 |
LEGAL
MATTERS
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14 |
AVAILABLE
INFORMATION
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14 |
INCORPORATED
DOCUMENTS
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15 |
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
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15 |
THE
COMPANY
The
summary description of our business may not contain all information that may
be
important to you. You should read this entire prospectus, including the
information set forth herein under the heading “Risk Factors” and our financial
statements and related notes, included or incorporated by reference in this
prospectus, before making an investment decision.
References
in this reoffer prospectus to “we,” “us,” “our,” “Neuralstem,” the “registrant”
or the “company,” unless the context requires otherwise, refer to Neuralstem,
Inc.
Neuralstem
is focused on the development and commercialization of treatments based on
transplanting human neural stem cells.
We
have
developed and maintain a portfolio of patents and patent applications that
form
the proprietary base for our research and development efforts in the area of
neural stem cell research. We own or exclusively license four (4) issued patents
and thirteen (13) patent pending applications in the field of regenerative
medicine and related technologies. We believe our technology base, in
combination with our know-how, and collaborative projects with major research
institutions provides a competitive advantage and will facilitate the successful
development and commercialization of products for use in the treatment of a
wide
array of neurodegenerative conditions and in regenerative repair of acute
disease.
This
is a
young and emerging field. There can be no assurances that our intellectual
property portfolio 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 product may not be able to
successfully compete against them.
All
of
our research efforts to date are at the level of basic research or in the
pre-clinical stage of development. We are focused on leveraging our key assets,
including our intellectual property, our scientific team, our facilities and
our
capital, to accelerate the advancement of our stem cell technologies. In
addition, we are pursuing strategic collaborations with members of academia.
We
are headquartered in Rockville, Maryland.
In
addition to our core tissue based technology we have begun developing a
Small-Molecule compound. The company has performed preliminary in vitro and
in
vivo tests on the compound with regard to neurogenesis. Based on the results
of
these tests we have applied for a U.S. patent on the compound.
Our
technology is the ability to isolate human neural stem cells from most areas
of
the developing human brain and spinal cord and our technology includes the
ability to grow them into physiologically relevant human neurons of all types.
Our two issued core patents entitled: (i) Isolation, Propagation, and Directed
Differentiation of Stem Cell from Embryonic and Adult Central Nervous System
of
Mammals; and (ii) In Vitro Generation of Differentiated Neurons from Cultures
of
Mammalian Multi-potential CNS Stem Cell contain claims which cover the process
of deriving the cells and the cells created from such process.
What
differentiates our stem cell technology from others is that our patented
processes do not require us to “push” the cells towards a certain fate by adding
specific growth factors. Our cells actually “become” the type of cell they are
fated to be. We believe this process and the resulting cells create a technology
platform that allows for the efficient isolation and ability to produce, in
commercially reasonable quantities, neural stem cells from the human brain
and
spinal cord.
Our
technology allows for cells to grow in cultured dishes, also known as in
vitrogrowth, without mutations or other adverse events that would compromise
their usefulness.
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 therapeutic products. Our efforts to date have been directed at methods
to
identify, isolate and culture large varieties of stem cells of the human nervous
system, and to develop therapies utilizing these stem cells. This research
is
conducted both internally and through the use of third party laboratory
consulting companies under our direct supervision.
As
of
March 31, 2008, Of these employees three work on Research and development and
four in administration. We also use the services of numerous outside consultants
in business and scientific matters. We believe that we have good relations
with
our employees and consultants.
OFFERING
Shares
of common stock outstanding prior to this ffering
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32,151,300(1)
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Shares
of common stock issuable upon exercise of outstanding options which
may be
offered pursuant to this prospectus
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8,547,333
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Use
of Proceeds
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We
will not receive any proceeds from the sale of the shares of common
stock
offered in this prospectus. We will receive proceeds to the extent
that
currently outstanding options are exercised for cash. We will use
the
exercise proceeds, if any, for working capital and general corporate
purposes.
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Risk
Factors
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The
purchase of our common stock involves
a high degree of risk. You should carefully review and consider
"Risk Factors" beginning on page 5.
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American
Stock Exchange Symbol
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CUR
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________________________________
(1)
As of
July 31, 2008. Does not include common shares issuable upon exercise of
outstanding options or warrants.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
We
caution readers that this reoffer prospectus and the portions of the documents
incorporated by reference into this reoffer prospectus include “forward-looking
statements” as that term is used in the Private Securities Litigation Reform Act
of 1995. Forward-looking statements are based on current expectations rather
than historical facts and they are indicated by words or phrases such as
“anticipate,” “could,” “may,” “might,” “potential,” “predict,” “should,”
“estimate,” “expect,” “project,” “believe,” “plan,” “envision,” “continue,”
“intend,” “target,” “contemplate,” or “will” and similar words or phrases or
comparable terminology. We have based such forward-looking statements on our
current expectations, assumptions, estimates and projections. While we believe
these expectations, assumptions, estimates and projections are reasonable,
such
forward-looking statements are only predictions and involve known and unknown
risks and uncertainties, and other factors that may cause actual results,
performance or achievements to be materially different from any future results,
performance or achievements expressed or implied by such forward-looking
statements, many of which are beyond our control. Some of the factors that
could
affect our financial performance, cause actual results to differ from our
estimates, or underlie such forward-looking statements are as set forth below
and in various places in this reoffer prospectus and in the portions of the
documents incorporated by reference, including under the heading “Risk Factors”
in this reoffer prospectus. These factors include:
When
reading any forward-looking statement you should remain mindful that actual
results or developments may vary substantially from those expected as expressed
in or implied by such statement for a number of reasons or factors, including
but not limited to:
·
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the
success of our research and development activities, the development
of a
viable commercial production model, and the speed with which regulatory
authorizations and product launches may be achieved;
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·
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whether
or not a market for our product develops and, if a market develops,
the
rate at which it develops;
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·
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our
ability to successfully sell our products if a market
develops;
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·
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our
ability to attract and retain qualified personnel to implement our
growth
strategies;
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our
ability to develop sales, marketing, and distribution
capabilities;
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our
ability to obtain reimbursement from third party payers for the products
that we sell;
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the
accuracy of our estimates and
projections;
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our
ability to fund our short-term and long-term financing
needs;
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·
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changes
in our business plan and corporate strategies;
and
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·
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other
risks and uncertainties discussed in greater detail in the section
captioned “Risk Factors”
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Each
forward-looking statement should be read in context with and in understanding
of
the various other disclosures concerning our company and our business made
elsewhere in this report as well as our public filings with the Securities
and
Exchange Commission. You should not place undue reliance on any forward-looking
statement as a prediction of actual results or developments. We are not
obligated to update or revise any forward-looking statements contained in this
report or any other filing to reflect new events or circumstances unless and
to
the extent required by applicable law.
Our
business faces certain risks. The risks described below may not be the only
risks we face. Additional risks that we do not yet know of or that we currently
think are immaterial may also impair our business. If any of the events or
circumstances described as risks below or elsewhere in this report actually
occurs, our business, results of operations or financial condition could be
materially and adversely affected.
We
have
described below a number of uncertainties and risks which, in addition to
uncertainties and risks presented elsewhere in this reoffer prospectus, may
adversely affect our business, operating results and financial condition.
The uncertainties and risks enumerated below as well as those presented
elsewhere in this prospectus should be considered carefully in evaluating our
company and our business and the value of our securities.
Risks
Relating to the Company's Stage of Development
Since
the Company has a limited operating history and has significantly shifted its
operations and strategies since inception, you cannot rely upon the Company's
limited historical performance to make an investment
decision.
Since
inception in 1996 and through March 31, 2008, the Company has raised in
aggregate, approximately $56,133,826 capital and recorded accumulated losses
totaling $47,930,499. On March 31, 2008, the Company had a working capital
surplus of $7,884,907 and stockholder's equity of $8,203,377. Our net losses
for
the two most recent fiscal years have been $7,063,272 and $3,147,488 for 2007
and 2006 respectively. Our net loss for the three month period ended March
31,
2008 was $2,274,453. We had no revenues for the three months ended March 31,
2008.
The
Company's ability to generate revenues and achieve profitability depends upon
its ability to complete the development of its stem cell products, obtain the
required regulatory approvals, manufacture, and market and sell its products.
In
part because of the Company’s past operating results, no assurances can be given
that the Company will be able to accomplish all or any these goals.
Although
the Company has generated some revenue to date, the Company has not generated
any revenue from the commercial sale of its proposed stem cell products. Since
inception, the Company has engaged in several related lines of business and
has
discontinued operations in certain areas. For example, in 2002, the Company
lost
a material contract with the Department of Defense and was forced to close
its
principal facility and lay off almost all of its employees in an attempt to
focus the Company’s strategy on its stem cell technology. This limited and
changing history may not be adequate to enable you to fully assess the Company's
current ability to develop and commercialize its technologies and proposed
products, obtain approval from the U.S. Food and Drug Administration (“FDA”),
achieve market acceptance of its proposed products and respond to competition.
No assurances can be given as to exactly when, if at all, the Company will
be
able to fully develop, commercialize market, sell and derive material revenues
from its proposed products in development.
The
Company will
need to raise additional capital to continue operations, and failure to do
so
will impair the Company's ability to fund operations, develop its technologies
or promote its products.
The
Company has relied almost entirely on external financing to fund operations.
Such financing has historically come primarily from the sale of common and
preferred stock and convertible debt to third parties, the exercise of investor
warrants and to a lesser degree from grants, loans and revenue from license
and
royalty fees. The Company anticipates, based on current proposed plans and
assumptions relating to its operations (including the timetable of, and costs
associated with, new product development) and financings the Company has
undertaken prior to the date of this prospectus, that its current working
capital will be sufficient to satisfy contemplated cash requirements for
approximately twelve months, assuming that the Company does not engage in an
extraordinary transaction or otherwise face unexpected events or contingencies,
any of which could affect cash requirements. As of March 31, 2008, the Company
had cash and cash equivalents on hand of $8,257,850. Presently, the Company
has
a monthly cash burn rate of approximately $400,000. Accordingly, the Company
will need to raise additional capital to fund anticipated operating expenses
and
future expansion after such period. Among other things, external financing
will
be required to cover the further development of the Company's technologies
and
products and other operating costs. The Company cannot assure you that financing
whether from external sources or related parties will be available if needed
or
on favorable terms. If additional financing is not available when required
or is
not available on acceptable terms, the Company may be unable to fund operations
and planned growth, develop or enhance its technologies, take advantage of
business opportunities or respond to competitive market pressures. Any negative
impact on the Company's operations may make capital raising more difficult
and
may also resulting a lower price for the Company's securities.
The
Company may have difficulty raising needed capital in the future as a result
of,
among other factors, the Company's limited operating history and business risks
associated with the Company.
The
Company's business currently generates limited amounts of cash which will not
be
sufficient to meet its future capital requirements. The Company's management
does not know when this will change. The Company has expended and will continue
to expend substantial funds in the research, development and clinical and
pre-clinical testing of the Company's stem cell technologies and products.
The
Company will require additional funds to conduct research and development,
establish and conduct clinical and pre-clinical trials, commercial-scale
manufacturing arrangements and to provide for the marketing and distribution.
Additional funds may not be available on acceptable terms, if at all. If
adequate funds are unavailable from any available source, the Company may have
to delay, reduce the scope of or eliminate one or more of its research,
development or commercialization programs or product launches or marketing
efforts which may materially harm the Company's business, financial condition
and results of operations.
The
Company's long term capital requirements are expected to depend on many factors,
including:
·
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continued
progress and cost of its research and development
programs;
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·
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progress
with pre-clinical studies and clinical
trials;
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·
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time
and costs involved in obtaining regulatory
clearance;
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·
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costs
involved in preparing, filing, prosecuting, maintaining and enforcing
patent claims;
|
·
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costs
of developing sales, marketing and distribution channels and its
ability
to sell the Company's stem cell
products;
|
·
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costs
involved in establishing manufacturing capabilities for commercial
quantities of its products;
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·
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competing
technological and market
developments;
|
·
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market
acceptance of its stem cell
products;
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·
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costs
for recruiting and retaining employees and consultants;
and
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·
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Costs
for educating and training physicians about its stem cell
products.
|
The
Company may consume available resources more rapidly than currently anticipated,
resulting in the need for additional funding. The Company may seek to raise
any
necessary additional funds through the exercising of warrants, options, equity
or debt financings, collaborative arrangements with corporate partners or other
sources, which may be dilutive to existing stockholders or otherwise have a
material effect on the Company's current or future business prospects. If
adequate funds are not available, the Company may be required to significantly
reduce or refocus its development and commercialization efforts.
The
Company relies on stem cell technologies that it may not be able to commercially
develop, which will prevent the Company from generating revenues, operating
profitably or providing investors any return on their
investment.
The
Company has concentrated its research on its stem cell technologies, and the
Company's ability to generate revenue and operate profitably will depend on
it
being able to develop these technologies for human applications. These are
emerging technologies with, as yet, limited human applications. The Company
cannot guarantee that it will be able to develop its stem cell technologies
or
that such development will result in products or services with any significant
commercial utility. The Company anticipates that the commercial sale of such
products or services, and royalty/licensing fees related to its technology,
will
be the Company’s primary sources of revenues. If the Company is unable to
develop its technologies, investors will likely lose their entire
investment.
Inability
to complete pre-clinical and clinical testing and trials will impair the
viability of the Company.
The
Company is in its development stage and has not yet applied for approval by
the
FDA to conduct clinical trials. Even if the Company successfully files an IND
and receives approval from the FDA to commence trials, the outcome of
pre-clinical, clinical and product testing of the Company's products is
uncertain, and if the Company is unable to satisfactorily complete such testing,
or if such testing yields unsatisfactory results, the Company will be unable
to
commercially produce its proposed products. Before obtaining regulatory
approvals for the commercial sale of any potential human products, the Company's
products will be subjected to extensive pre-clinical and clinical testing to
demonstrate their safety and efficacy in humans. No assurances can be given
that
the clinical trials of the Company's products, or those of licensees or
collaborators, will demonstrate the safety and efficacy of such products at
all,
or to the extent necessary to obtain appropriate regulatory approvals, or that
the testing of such products will be completed in a timely manner, if at all,
or
without significant increases in costs, program delays or both, all of which
could harm the Company's ability to generate revenues. In addition, the
Company's proposed products may not prove to be more effective for treating
disease or injury than current therapies. Accordingly, the Company may have
to
delay or abandon efforts to research, develop or obtain regulatory approval
to
market its proposed products. Many companies involved in biotechnology research
and development have suffered significant setbacks in advanced clinical trials,
even after promising results in earlier trials. The failure to adequately
demonstrate the safety and efficacy of a therapeutic product under development
could delay or prevent regulatory approval of the product and could harm the
Company's ability to generate revenues, operate profitably or produce any return
on an investment in the Company.
The
Company's additional financing requirements could result in dilution to existing
stockholders.
At
present, the Company is not able to finance it operations through the sales
of
its product. Accordingly, the Company will be required to secure additional
financing. If the Company is able to obtain such additional financings such
financing may be dilutive to current shareholders. The Company has the authority
to issue additional shares of common stock and preferred stock, as well as
additional classes or series of ownership interests or debt obligations which
may be convertible into any one or more classes or series of ownership
interests. The Company is authorized to issue 150,000,000 shares of common
stock
and 7,000,000 shares of preferred stock. Such securities may be issued without
the approval or other consent of the Company's stockholders.
Risks
Relating to Intellectual Property and Government
Regulation
The
Company may not be able to withstand challenges to its intellectual property
rights, such as patents, should contests be initiated in court or at the U.S
Patent and Trademark Office.
The
Company relies on its intellectual property, including its issued and applied
for patents, as the foundation of its business. The intellectual property rights
of the Company may come under challenge, and no assurances can be given that,
even though issued, the Company's current and potential future patents will
survive claims commencing in the court system alleging invalidity or
infringement on other patents. For example, in 2005, the Company's neural stem
cell technology was challenged in the U.S. Patent and Trademark Office by a
competitor. Although the Company prevailed in this particular matter upon
re-examination by the patent office, these cases are complex, lengthy and
expensive, and could potentially be adjudicated adversely to the Company,
removing the protection afforded by an issued patent. The viability of the
Company's business would suffer if such patent protection were limited or
eliminated. Moreover, the costs associated with defending or settling
intellectual property claims would likely have a material adverse effect on
the
Company. In May of 2008, we initiated litigation with StemCells, Inc. relating
to our intellectual property. At present, the litigation is in its initial
stages and any likely outcome is difficult to predict. It is not known when
nor
on what basis this matter will be concluded.
The
Company may not be able to adequately protect against piracy of intellectual
property in foreign jurisdictions.
Considerable
research in the area of stem cell therapies is being performed in countries
outside of the United States, and a number of the Company's competitors are
located in those countries. The laws protecting intellectual property in
some of those countries may not provide protection for the Company's trade
secrets and intellectual property adequate to prevent its competitors from
misappropriating the Company's trade secrets or intellectual property. If
the Company's trade secrets or intellectual property are misappropriated in
those countries, the Company may be without adequate remedies to address the
issue.
The
Company's products may not receive FDA approval, which would prevent the Company
from commercially marketing its products and producing
revenues.
The
FDA
and comparable government agencies in foreign countries impose substantial
regulations on the manufacture and marketing of pharmaceutical products through
lengthy and detailed laboratory, pre-clinical and clinical testing procedures,
sampling activities and other costly and time-consuming procedures. Satisfaction
of these regulations typically takes several years or more and varies
substantially based upon the type, complexity and novelty of the proposed
product. The Company cannot yet accurately predict when it might first submit
any Investigational New Drug, or IND, application to the FDA, or whether any
such IND application would be granted on a timely basis, if at all, nor can
the
Company assure you that it will successfully complete any clinical trials in
connection with any such IND application. Further, the Company cannot yet
accurately predict when it might first submit any product license application
for FDA approval or whether any such product license application would be
granted on a timely basis, if at all. As a result, the Company cannot
assure you that FDA approvals for any products developed by it will be granted
on a timely basis, if at all. Any such delay in obtaining, or failure to obtain,
such approvals could have a material adverse effect on the marketing of the
Company's products and its ability to generate product revenue.
Because
the Company or its collaborators must obtain regulatory approval to market
its
products in the United States and other countries, the Company cannot predict
whether or when it will be permitted to commercialize its
products.
Federal,
state and local governments and agencies in the United States (including the
FDA) and governments in other countries have significant regulations in place
that govern many of the Company's activities. The Company is or may become
subject to various federal, state and local laws, regulations and
recommendations relating to safe working conditions, laboratory and
manufacturing practices, the experimental use of animals and the use and
disposal of hazardous or potentially hazardous substances used in connection
with its research and development work. The preclinical testing and clinical
trials of the products that the Company or its collaborators develop are subject
to extensive government regulation that may prevent the Company from creating
commercially viable products from its discoveries. In addition, the sale by
the
Company or its collaborators of any commercially viable product will be subject
to government regulation from several standpoints, including manufacturing,
advertising and promoting, selling and marketing, labeling, and distributing.
If, and to the extent that, the Company is unable to comply with these
regulations, its ability to earn revenues will be materially and negatively
impacted.
Risks
Relating to Competition
The
Company's competition includes both public and private organizations and
collaborations among academic institutions and large pharmaceutical companies,
most of which have significantly greater experience and financial resources
than
the Company does.
The
biotechnology industry is characterized by intense competition. The Company
competes against numerous companies, many of which have substantially greater
financial and other resources than it has. Several such enterprises have
initiated cell therapy research programs and/or efforts to treat the same
diseases targeted by the Company. Companies such as Geron Corporation, Genzyme
Corporation, StemCells, Inc., Advanced Cell Technology, Inc., Aastrom
Biosciences, Inc. and Viacell, Inc., as well as others, have substantially
greater resources and experience in the Company's fields than it does, and
are
well situated to compete with us effectively. Of course, any of the world's
largest pharmaceutical companies represent a significant actual or potential
competitor with vastly greater resources than the Company's.
Risks
Relating to the Company's Reliance on Third Parties
The
Company's outsource model depends on collaborators, non-employee consultants,
research institutions, and scientific contractors to help it develop and test
its proposed products. Our ability to develop such relationships could impair
or
delay our ability to develop products.
The
Company's strategy for the development, clinical testing and commercialization
of its proposed products is based on an outsource model. This model requires
that the Company enter into collaborations with corporate partners, research
institutions, scientific contractors and licensors, licensees and others in
order to further develop its technology and develop products. In the event
the
Company is not able to enter into such relationships in the future, our: ability
to develop products may be seriously hindered; or we would be required to expend
considerable money and research to bring such research and development functions
in house. Either outcome could result in our inability to develop a commercially
feasible product or in the need for substantially more working capital to
complete the research in-house. Also, we are currently dependent on
collaborators for a substantial portion of our research and development.
Although our collaborative agreements do not impose any duties or obligations
on
us other than the licensing of our technology, the failure of any of these
collaborations may hinder our ability to develop products in a timely fashion.
By way of example, our collaboration with John Hopkins University, School of
Medicine yielded findings that contributed to our patent application entitled
Transplantation of Human Cells for Treatment of Neurological Disorder. Had
the
collaboration not have existed, our ability to apply for such patent would
have
been greatly hindered. We currently have 4 key collaborations. They are
with:
|
·
|
The
University of California, San Diego;
|
|
·
|
University
of Central Florida; and
|
|
·
|
John
Hopkins University.
|
|
·
|
University
of Michigan
|
As
we are
under no financial obligation to provide additional funding under any of these
collaborations, our primary risk is that no results are derived from their
research.
We
intend to rely upon the third-party FDA-approved manufacturers for our stem
cells. Should these manufacturers fail to perform as expected, we will need
to
develop or procure other manufacturing sources, which would cause delays or
interruptions in our product supply and result in the loss of significant sales
and customers.
We
currently have no internal manufacturing capability, and will rely extensively
on FDA-approved licensees, strategic partners or third party contract
manufacturers or suppliers. We current have an agreement with Charles River
Laboratories for the manufacturing and storage of our cells. The agreement
is a
paid for services agreement and does not require us to purchase a minimum amount
of cells. In the event Charles River Laboratories fails to provide suitable
cells, we would be forced to either manufacture the cells ourselves or seek
other third party vendors. Should we be forced to manufacture our stem cells,
we
cannot give any assurance that we will be able to develop an internal
manufacturing capability or procure third party suppliers. In the event we
must
seek alternative third party suppliers, they may require us to purchase a
minimum amount of cells, could be significantly more expensive than our current
supplier, or could require other unfavorable terms. Any such event would
materially impact our prospects and could delay our development. Moreover,
we
cannot give you any assurance that any contract manufacturers or suppliers
we
procure will be able to supply our products in a timely or cost effective manner
or in accordance with applicable regulatory requirements or our
specifications
General
Risks Relating to the Company's Business
The
Company may be subject to litigation that will be costly to defend or pursue
and
uncertain in its outcome.
The
Company's business may bring it into conflict with its licensees, licensors,
or
others with whom it has contractual or other business relationships or with
its
competitors or others whose interests differ from the Company's. If the Company
is unable to resolve those conflicts on terms that are satisfactory to all
parties, the Company may become involved in litigation brought by or against
it.
That litigation is likely to be expensive and may require a significant amount
of management's time and attention, at the expense of other aspects of the
Company's business. The outcome of litigation is always uncertain, and in some
cases could include judgments against us that require the Company to pay
damages, enjoin it from certain activities, or otherwise affect its legal or
contractual rights, which could have a significant adverse effect on its
business. By way of example, in May of 2008, we filed a complaint against
one of our competitors, StemCells Inc., alleging that U.S. Patent
No.
7,361,505 (the “‘505 patent”), allegedly exclusively licensed to StemCells,
Inc., is
invalid, not infringed, and unenforceable. On the same day, StemCells, Inc.
filed a complaint alleging that we had infringed, contributed to the
infringement of, and or induced the infringement of two patents owned by or
exclusively licensed to StemCells relating to stem cell culture compositions.
At
present, the litigation is in its initial stages and any likely outcome is
difficult to predict. It is not known when nor on what basis this matter will
be
concluded.
The
Company may not be able to obtain third-party patient reimbursement or favorable
product pricing, which would reduce its ability to operate
profitably.
The
Company's ability to successfully commercialize certain of its proposed products
in the human therapeutic field may depend to a significant degree on patient
reimbursement of the costs of such products and related treatments at acceptable
levels from government authorities, private health insurers and other
organizations, such as health maintenance organizations. The Company cannot
assure you that reimbursement in the United States or foreign countries will
be
available for any products it may develop or, if available, will not be
decreased in the future, or that reimbursement amounts will not reduce the
demand for, or the price of, its products with a consequent harm to the
Company's business. The Company cannot predict what additional regulation or
legislation relating to the health care industry or third-party coverage and
reimbursement may be enacted in the future or what effect such regulation or
legislation may have on the Company's business. If additional regulations are
overly onerous or expensive or if health care related legislation makes its
business more expensive or burdensome than originally anticipated, the Company
may be forced to significantly downsize its business plans or completely abandon
its business model.
The
Company's products may be expensive to manufacture, and they may not be
profitable if the Company is unable to control the costs to manufacture
them.
The
Company's products may be significantly more expensive to manufacture than
most
other drugs currently on the market today due to a fewer number of potential
manufactures, greater level of needed expertise, and other general market
conditions affecting manufacturers of stem cell based products. The
Company would hope to substantially reduce manufacturing costs through process
improvements, development of new science, increases in manufacturing scale
and
outsourcing to experienced manufacturers. If the Company is not able to make
these, or other improvements, and depending on the pricing of the product,
its
profit margins may be significantly less than that of most drugs on the market
today. In addition, the Company may not be able to charge a high enough price
for any cell therapy product it develops, even if they are safe and effective,
to make a profit. If the Company is unable to realize significant profits from
its potential product candidates, its business would be materially
harmed.
In
order to secure market share and generate revenues, the Company's proposed
products must be accepted by the health care community, which can be very slow
to adopt or unreceptive to new technologies and
products.
The
Company's proposed products and those developed by its collaborative partners,
if approved for marketing, may not achieve market acceptance since hospitals,
physicians, patients or the medical community in general may decide not to
accept and utilize these products. The products that the Company is attempting
to develop represents substantial departures from established treatment methods
and will compete with a number of more conventional drugs and therapies
manufactured and marketed by major pharmaceutical companies. The degree of
market acceptance of any of the Company's developed products will depend on
a
number of factors, including:
·
|
the
Company's establishment and demonstration to the medical community
of the
clinical efficacy and safety of its proposed products;
|
|
|
·
|
the
Company's ability to create products that are superior to alternatives
currently on the market;
|
|
|
·
|
the
Company's ability to establish in the medical community the potential
advantage of its treatments over alternative treatment methods;
and
|
|
|
·
|
Reimbursement
policies of government and third-party
payors.
|
If
the
health care community does not accept the Company's products for any of the
foregoing reasons, or for any other reason, the Company's business would be
materially harmed.
We
depend on two key employees for our continued operations and future success.
A
loss of either employee could significantly hinder our ability to move forward
with our business plan.
The
loss
of either of our key executive officers, Richard Garr and Karl Johe, would
be
significantly detrimental to us.
·
|
We
currently do
not
maintain “key person” life insurance on the life of Mr. Garr. As a result,
the Company will not receive any compensation upon the death or incapacity
of this key individuals;
|
|
|
·
|
We
currently do
maintain “key person” line insurance on the life of Mr. Johe. As a result,
the Company will receive approximately $1,000,000 in the event of
his
death or incapacity.
|
In
addition, the Company's anticipated growth and expansion into areas and
activities requiring additional expertise, such as clinical testing, regulatory
compliance, manufacturing and marketing, will require the addition of new
management personnel and the development of additional expertise by existing
management personnel. There is intense competition for qualified personnel
in
the areas of the Company's present and planned activities, and there can be
no
assurance that the Company will be able to continue to attract and retain the
qualified personnel necessary for the development of its business. The failure
to attract and retain such personnel or to develop such expertise would
adversely affect the Company's business.
The
Company has entered into long-term contracts with key personnel and
stockholders, with significant anti-termination provisions, which could make
future changes in management difficult or expensive.
Messrs.
Garr and Johe have entered into seven (7) year employment agreements with the
Company which expire on November 1, 2012 and which include termination
provisions stating that if either employee is terminated for any reason other
than a voluntary resignation, then all compensation due to such employee under
the terms of the respective agreement shall become due and payable immediately.
These provisions will make the replacement of either of these employees very
costly to the Company, and could cause difficulty in effecting a change in
control of the Company. Termination prior to full term on the contracts would
cost the Company as much as $1,800,000 per contract, and immediate vesting
of
all outstanding options.
The
Company has no product liability insurance, which may leave it vulnerable to
future claims that the Company will be unable to
satisfy.
The
testing, manufacturing, marketing and sale of human therapeutic products entails
an inherent risk of product liability claims, and the Company cannot assure
you
that substantial product liability claims will not be asserted against it.
The
Company has no product liability insurance. In the event the Company is forced
to expend significant funds on defending product liability actions, and in
the
event those funds come from operating capital, the Company will be required
to
reduce its business activities, which could lead to significant
losses.
The
Company cannot assure you that adequate insurance coverage will be available
in
the future on acceptable terms, if at all, or that, if available, the Company
will be able to maintain any such insurance at sufficient levels of coverage
or
that any such insurance will provide adequate protection against potential
liabilities.
The
Company has limited director and officer insurance and commercial insurance
policies. Any significant claim would have a material adverse effect on its
business, financial condition and results of operations. Insurance availability,
coverage terms and pricing continue to vary with market conditions. The Company
endeavors to obtain appropriate insurance coverage for insurable risks that
it
identifies, however, the Company may fail to correctly anticipate or quantify
insurable risks, may not be able to obtain appropriate insurance coverage,
and
insurers may not respond as the Company intends to cover insurable events that
may occur. The Company has observed rapidly changing conditions in the insurance
markets relating to nearly all areas of traditional corporate insurance. Such
conditions may result in higher premium costs, higher policy deductibles, and
lower coverage limits. For some risks, the Company may not have or maintain
insurance coverage because of cost or availability.
Risks
Relating to the Company's Common Stock
Our
common shares are sporadically or “thinly” traded, so you may be unable to sell
at or near ask prices or at all if you need to sell your shares to raise money
or otherwise desire to liquidate your shares
Our
common shares have historically been sporadically or “thinly” traded, meaning
that the number of persons interested in purchasing our common shares at or
near
ask prices at any given time may be relatively small or non-existent. This
situation is attributable to a number of factors, including the fact that we
are
a small company which is relatively unknown to stock analysts, stock brokers,
institutional investors and others in the investment community that generate
or
influence sales volume, and that even if we came to the attention of such
persons, they tend to be risk-averse and would be reluctant to follow an
unproven development stage company such as ours or purchase or recommend the
purchase of our shares until such time as we became more seasoned and viable.
As
a consequence, there may be periods of several days or more when trading
activity in our shares is minimal or non-existent, as compared to a seasoned
issuer which has a large and steady volume of trading activity that will
generally support continuous sales without a material reduction in share price.
We cannot give you any assurance that a broader or more active public trading
market for our common shares will develop or be sustained, or that current
trading levels will be sustained. Due to these conditions, we can give you
no
assurance that you will be able to sell your shares at or near ask prices or
at
all if you need money or otherwise desire to liquidate your shares.
The
market price for our common shares is particularly volatile given our status
as
a relatively unknown company with a small and thinly-traded public float,
limited operating history and lack of revenues or profits to date could lead
to
wide fluctuations in our share price. The price at which you purchase our common
shares may not be indicative of the price that will prevail in the trading
market. You may be unable to sell your common shares at or above your purchase
price, which may result in substantial losses to you. The volatility in our
common share price may subject us to securities
litigation.
The
market for our common shares is characterized by significant price volatility
when compared to seasoned issuers, and we expect that our share price will
continue to be more volatile than a seasoned issuer. The volatility in our
share
price is attributable to a number of factors. First, as noted above, our common
shares are sporadically or thinly traded. As a consequence of this lack of
liquidity, the trading of relatively small quantities of shares by our
shareholders may disproportionately influence the price of those shares in
either direction. The price for our shares could, for example, decline
precipitously in the event that a large number of our common shares are sold
on
the market without commensurate demand, as compared to a seasoned issuer which
could better absorb those sales without a material reduction in share price.
Secondly, we are a speculative or “risky” investment due to our limited
operating history and lack of significant revenues to date, and uncertainty
of
future market acceptance for our products if successfully developed. As a
consequence of this enhanced risk, more risk-adverse investors may, under the
fear of losing all or most of their investment in the event of negative news
or
lack of progress, be more inclined to sell their shares on the market more
quickly and at greater discounts than would be the case with the stock of a
seasoned issuer. Additionally, in the past, plaintiffs have often initiated
securities class action litigation against a company following periods of
volatility in the market price of its securities. We may in the future be the
target of similar litigation. Securities litigation could result in substantial
costs and liabilities and could divert management’s attention and
resources.
The
following factors may add to the volatility in the price of our common
shares: actual or anticipated variations in our quarterly or annual
operating results; government regulations, announcements of significant
acquisitions, strategic partnerships or joint ventures; our capital commitments;
and additions or departures of our key personnel. Many of these factors are
beyond our control and may decrease the market price of our common shares,
regardless of our operating performance. We cannot make any predictions or
projections as to what the prevailing market price for our common shares will
be
at any time, including as to whether our common shares will sustain their
current market prices, or as to what effect that the sale o f shares or the
availability of common shares for sale at any time will have on the prevailing
market price.
The
Company faces risks related to compliance with corporate governance laws and
financial reporting standards.
The
Sarbanes-Oxley Act of 2002, as well as related new rules and regulations
implemented by the Securities and Exchange Commission and the Public Company
Accounting Oversight Board, require changes in the corporate governance
practices and financial reporting standards for public companies. These new
laws, rules and regulations, including compliance with Section 404 of the
Sarbanes-Oxley Act of 2002 relating to internal control over financial reporting
(“Section 404”), will materially increase the Company's legal and financial
compliance costs and made some activities more time-consuming and more
burdensome.
The
Company does not intend to pay cash dividends on its common stock in the
foreseeable future.
Any
payment of cash dividends will depend upon the Company's financial condition,
results of operations, capital requirements and other factors and will be at
the
discretion of the Board of Directors. The Company does not anticipate paying
cash dividends on its common stock in the foreseeable future. Furthermore,
the
Company may incur additional indebtedness that may severely restrict or prohibit
the payment of dividends.
Our
issuance of additional common shares or preferred shares, or options or warrants
to purchase those shares, could dilute your proportionate ownership and voting
rights and negatively impact the value of your investment in our common
shares as the result of preferential voting rights or veto powers, dividend
rights, disproportionate rights to appoint directors to our board, conversion
rights, redemption rights and liquidation provisions granted to the preferred
shareholders, including the grant of rights that could discourage or prevent
the
distribution of dividends to you, or prevent the sale of our assets or a
potential takeover of our company.
We
are
entitled under our certificate of incorporation to issue up to 150,000,000
common and 7,000,000 “blank check” preferred shares. As of March 31, 2008,
we have issued an outstanding 32,075,875 common shares, 19,805,848 common shares
reserved for issuance upon the exercise of current outstanding options and
warrants, 652,667 common shares reserved for issuances of additional grants
under our 2005 incentive stock plan, and 950,000 shares reserved for issuance
of
grants under our 2007 stock plan. Accordingly, we will be entitled to issue
up
to 96,515,610 additional common shares and 7,000,000 additional
preferred shares. Our board may generally issue those common and preferred
shares, or options or warrants to purchase those shares, without further
approval by our shareholders based upon such factors as our board of directors
may deem relevant at that time. Any preferred shares we may issue shall have
such rights, preferences, privileges and restrictions as may be designated
from
time-to-time by our board, including preferential dividend rights, voting
rights, conversion rights, redemption rights and liquidation provisions. It
is
likely that we will be required to issue a large amount of additional securities
to raise capital to further our development and marketing plans. It is also
likely that we will be required to issue a large amount of additional securities
to directors, officers, employees and consultants as compensatory grants in
connection with their services, both in the form of stand-alone grants or under
our various stock plans. We cannot give you any assurance that we will not
issue
additional common or preferred shares, or options or warrants to purchase those
shares, under circumstances we may deem appropriate at the time.
Our
stock price has fluctuated and may continue to
fluctuate.
The
market price of our common stock has fluctuated somewhat in the past. The market
price of our common stock may continue to be subject to fluctuations in the
future in response to a variety of factors, including:
·
|
the
business environment, including the operating results and stock
prices of
companies in our industry,
|
|
|
·
|
our
liquidity needs and constraints,
|
|
|
·
|
trading
on the AMEX,
|
|
|
·
|
fluctuations
in operating results,
|
|
|
·
|
future
announcements concerning our business or that of our competitors
or
customers,
|
|
|
·
|
our
acquisition or disposition of a license,
|
|
|
·
|
developments
in the financial markets, and
|
|
|
·
|
general
conditions in the biotech
industry.
|
Furthermore,
stock prices for many companies fluctuate widely for reasons that may be
unrelated to their operating results. Those fluctuations and general economic,
political and market conditions, such as recessions, terrorist or other military
actions, or international currency fluctuations, as well as public perception
of
equity values of publicly-traded companies, may adversely affect the market
price of our common stock.
USE
OF PROCEEDS
We
will
not receive any proceeds from the sale of the shares by the selling
shareholders. The proceeds from the sale of the common stock offered under
this
reoffer prospectus are solely for the account of the selling shareholders named
in this prospectus.
SELLING
SHAREHOLDERS
This
reoffer prospectus relates to shares of common stock that are being registered
for reoffers and resales by our directors, officers and employees who have
acquired or may acquire shares pursuant to the Plans . The selling shareholders
may resell all, a portion, or none of the shares of common stock from time
to
time. Since each selling shareholder may sell all or some portion of the shares
of common stock he or she beneficially owns, and since some of the selling
shareholders have not yet been identified, only an estimate (assuming that
he or
she sells all of the shares offered hereby) can be given as to the number of
shares of common stock that will be beneficially owned by the known selling
shareholders after this offering. To our knowledge, none of the selling
shareholders are broker-dealers or affiliates of broker-dealers.
The
table
below consists of a list of certain of the selling shareholders and the number
of shares beneficially owned by each selling shareholder as of June 17,
2008. In addition to these selling shareholders, there are certain executive
officers, directors and/or their respective permitted transferees who might
resell control securities but who are not known as of the date of this reoffer
prospectus. This reoffer prospectus may be amended or supplemented from time
to
time to add selling shareholders from such group to or delete the names of
selling shareholders from the following table or to otherwise amend or
supplement the information in the table set forth below.
Name
|
|
Position
|
|
Shares Beneficially Owned Before Offering
|
|
Number of Shares Being
|
|
Shares Beneficially Owned After Offering
|
|
|
|
|
|
Number
|
|
Percentage(1)
|
|
Offered
|
|
Number
|
|
Percentage(1)
|
|
Thomas
Freeman
|
|
|
Consultant
|
|
|
149,000
|
|
|
|
*
|
|
149,000
|
|
|
-
|
|
|
|
*
|
William
Oldaker
|
|
|
Director
|
|
|
165,000
|
(2)
|
|
|
* |
|
155,000
|
|
|
70,100
|
|
|
|
*
|
I.
Richard Garr
|
|
|
Officer
and Director
|
|
|
2,322,085
|
(3)
|
|
7.22
|
%
|
|
3,300,000
|
|
|
1,422,085
|
|
|
4.42
|
%
|
Karl
Johe
|
|
|
Officer
and Director
|
|
|
2,669,484
|
(4)
|
|
8.30
|
%
|
|
3,633,333
|
|
|
1,769,484
|
|
|
5.50
|
%
|
Deanne
Eagle
|
|
|
Employee
|
|
|
50,000
|
|
|
|
* |
|
50,000
|
|
|
-
|
|
|
|
*
|
John
Conron
|
|
|
Officer
|
|
|
165,000
|
(5)
|
|
|
* |
|
1,150,000
|
|
|
15,000
|
|
|
|
*
|
Scott
Ogilvie
|
|
|
Director
|
|
|
35,000
|
(6)
|
|
|
* |
|
95,000
|
|
|
-
|
|
|
|
*
|
Margaret
McElroy
|
|
|
Employee
|
|
|
15,000
|
|
|
|
* |
|
15,000
|
|
|
-
|
|
|
|
*
|
Total
|
|
|
|
|
|
5,570,569
|
|
|
|
|
|
8,547,333
|
|
|
3,276,669
|
|
|
|
|
*
|
Less
than 1%.
|
(1)
|
Pursuant
to Rules 13d-3 and 13d-5 of the Exchange Act, beneficial ownership
includes any common shares as to which a shareholder has sole or
shared
voting power or investment power, and also any common shares which
the
shareholder has the right to acquire within 60 days, including upon
exercise of common shares purchase options or warrants. There were
32,151,300 common shares outstanding as of July 30,
2008.
|
(2)
|
Does
not include options to purchase 60,000 common shares that vest after
October
6, 2008.
|
(3)
|
Does
not include options to purchase 2,400,000 common shares that vest
after
October 6, 2008.
|
(4)
|
Does
not include options to purchase 2,733,333 common shares that vest
after
October 6, 2008.
|
(5)
|
Does
not include options to purchase 1,000,000 common shares that vest
after
October 6, 2008.
|
(6)
|
Does
not include options to purchase 60,000 common shares that vest after
October 6, 2008.
|
Sales
of
the shares may be effected by or for the account of the selling stockholders
from time to time in transactions (which may include block transactions) on
the
American Stock Exchange, in negotiated transactions, through a combination
of
such methods of sale, or otherwise, at fixed prices that may be changed, at
market prices prevailing at the time of sale or at negotiated prices. The
selling stockholders may effect such transactions by selling the shares directly
to purchasers, through broker-dealers acting as agents of the selling
stockholders, or to broker-dealers acting as agents for the selling
stockholders, or to broker-dealers who may purchase shares as principals and
thereafter sell the shares from time to time in transactions (which may include
block transactions) on the American Stock Exchange, in negotiated transactions,
through a combination of such methods of sale, or otherwise. In effecting sales,
broker-dealers engaged by a selling stockholder may arrange for other
broker-dealers to participate. Such broker-dealers, if any, may receive
compensation in the form of discounts, concessions or commissions from the
selling stockholders and/or the purchasers of the shares for whom such
broker-dealers may act as agents or to whom they may sell as principals, or
both
(which compensation as to a particular broker-dealer might be in excess of
customary commissions).
The
selling stockholders and any broker-dealers or agents that participate with
the
selling stockholders in the distribution of the shares may be deemed to be
"underwriters" within the meaning of the Securities Act of 1933. Any commissions
paid or any discounts or concessions allowed to any such persons, and any
profits received on the resale of the shares purchased by them may be deemed
to
be underwriting commissions or discounts under the Securities Act of
1933.
We
have
agreed to bear all expenses of registration of the shares other than legal
fees
and expenses, if any, of counsel or other advisors of the selling stockholders.
The selling stockholders will bear any commissions, discounts, concessions
or
other fees, if any, payable to broker-dealers in connection with any sale of
their shares.
We
have
agreed to indemnify the selling stockholders, or their transferees or assignees,
against certain liabilities, including liabilities under the Securities Act
of
1933 or to contribute to payments the selling stockholders or their respective
pledgees, donees, transferees or other successors in interest, may be required
to make in respect thereof.
In
addition to any shares sold hereunder, selling shareholders may sell shares
of
common stock in compliance with Rule 144. There is no assurance that the selling
shareholders will sell all or a portion of the common stock offered
hereby.
The
selling shareholders may agree to indemnify any broker-dealer or agent that
participates in transactions involving sales of the shares against certain
liabilities in connection with the offering of the shares arising under the
Securities Act.
We
have
notified the selling shareholders of the need to deliver a copy of this
prospectus in connection with any sale of the shares.
LEGAL
MATTERS
The
validity of the shares of common stock being offered hereby has been passed
upon
for us by the Law Offices of Raul Silvestre & Associates, APLC
AVAILABLE
INFORMATION
We
have
filed with the Commission a registration statement on Form S-8 under the
Securities Act with respect to the shares of common stock offered hereby. This
reoffer prospectus, which constitutes a part of the registration statement,
does
not contain all of the information set forth in the registration statement
or
the exhibits filed therewith. For further information about us and the common
stock offered hereby, reference is made to the registration statement and the
exhibits filed therewith. Statements contained in this reoffer prospectus
regarding the contents of any contract or any other document that is filed
as an
exhibit to the registration statement are not necessarily complete, and each
such statement is qualified in all respects by reference to the full text of
such contract or other document filed as an exhibit to the registration
statement.
We
are
subject to the informational reporting requirements of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), and file reports, proxy statements
and other information with the Commission. These reports, proxy statements
and
other information can be inspected and copied at the Public Reference Room
of
the Commission, located at 100 F Street, NE, Washington, D.C. 20549. The
Commission maintains a website that contains reports, proxy and information
statements and other information regarding registrants, including us, that
file
electronically with the Commission. The address of this website is www.sec.gov.
In addition, you may obtain information on the operation of the Public Reference
Room by calling the Commission at 1-800-SEC-0330.
A
copy of
any document incorporated by reference in the registration statement of which
this reoffer prospectus forms a part but which is not delivered with this
reoffer prospectus will be provided by us without charge to any person to whom
this reoffer prospectus has been delivered upon the oral or written request
of
that person. Requests should be directed to the attention of the Chief Financial
Officer at the Registrant’s principal executive offices located at 9700 Great
Seneca Highway, Rockville, MD, having a general telephone number of (301)
366-4841.
You
should only rely on the information incorporated by reference or provided in
this reoffer prospectus or any prospectus supplement. We have not authorized
anyone else to provide you with different information. The common stock is
not
being offered in any state where the offer is not permitted. You should not
assume that the information in this reoffer prospectus or any prospectus
supplement is accurate as of any date other than the date on the front of this
prospectus.
INCORPORATED
DOCUMENTS
We
are
incorporating by reference certain information that we have filed with the
Commission under the informational requirements of the Exchange Act, which
means
that we disclose important information to you by referring you to another
document filed separately with the Commission. The information contained in
the
documents we are incorporating by reference is considered to be part of this
reoffer prospectus and the information that we later file with the Commission
will automatically update and supersede the information contained or
incorporated by reference into this reoffer prospectus. We are incorporating
by
reference:
|
·
|
Our
Annual Report on Form 10-KSB filed with the Commission on March 27,
2008,
for the year ended December 31,
2007;
|
|
·
|
Our
Definitive Proxy Statement on Schedule 14A, filed with the Commission
on
Aril 24, 2008, 2008;
|
|
·
|
Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008,
filed with the Commission on May 15, 2008;
|
|
·
|
Our
Current Report on Form 8-K, filed with the Commission on June 12,
2008;
|
|
·
|
Our
Current Report on Form 8-K, filed with the Commission on June 15,
2008;
and
|
|
·
|
The
description of our common stock contained in our Registration Statement
on
Form SB-2 (Registration No. 333-142451), as amended (the
"Registration Statement"), filed under the Securities Act of 1933,
as
amended, with the Securities and Exchange Commission (the "Commission")
on
April 30, 2007 and declared effective May 4, 2007.
|
In
addition, all documents filed by us pursuant to Sections 13(a), 13(c), 14 and
15(d) of the Exchange Act after the date hereof, and prior to the filing of
a
post-effective amendment which indicates that all securities offered hereunder
have been sold or which deregisters all securities then remaining unsold, shall
be deemed to be incorporated by reference in this reoffer prospectus and to
be a
part hereof from the date of filing of such documents with the Commission.
Any
statement contained in a document incorporated by reference herein shall be
deemed to be modified or superseded for purposes of this reoffer prospectus
to
the extent that a statement contained herein, or in a subsequently filed
document incorporated by reference herein, modifies or supersedes such
statement. Any such statement so modified or superseded shall not be deemed,
except as so modified or superseded, to constitute part of this reoffer
prospectus.
We
will
provide without charge to each person to whom a reoffer prospectus is delivered,
upon written or oral request by such person, a copy of any or all of the
documents that have been incorporated by reference in but not delivered with
the
reoffer prospectus. Written requests should be sent to:
NEURALSTEM,
INC.
Attn:
Chief Financial Officer
9700
Great Seneca Highway
Rockville,
MD,
Oral
requests should be made by telephoning (301) 366-4841.
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES
ACT LIABILITIES
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to our directors, officers or persons controlling us, we have been
advised that it is the Commission’s opinion that such indemnification is against
public policy as expressed in the Securities Act, as amended, and is, therefore,
unenforceable.
REOFFER
PROSPECTUS
8,547,333
SHARES OF COMMON STOCK
OF
NEURALSTEM, INC.
PART
II
INFORMATION
REQUIRED IN THE REGISTRATION STATEMENT
Item 3.
|
Incorporation
of Documents by Reference.
|
The
following documents are incorporated by reference into this registration
statement:
|
·
|
Our
Annual Report on Form 10-KSB filed with the Commission on March 27,
2008,
for the year ended December 31,
2007;
|
|
·
|
Our
Definitive Proxy Statement on Schedule 14A, filed with the Commission
on
Aril 24, 2008;
|
|
·
|
Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008,
filed with the Commission on May 15, 2008;
|
|
·
|
Our
Current Report on Form 8-K, filed with the Commission on June 12,
2008;
|
|
·
|
Our
Current Report on Form 8-K, filed with the Commission on June 15,
2008;
and
|
|
·
|
The
description of our common stock contained in our Registration Statement
on
Form SB-2 (Registration No. 333-142451), as amended (the
"Registration Statement"), filed under the Securities Act of 1933,
as
amended, with the Commission on April 30, 2007 and declared effective
May
4, 2007.
|
In
addition, all documents filed by the Registrant pursuant to Sections 13(a),
13(c), 14 and 15(d) of the Securities Exchange Act of 1934 after the date
hereof, and prior to the filing of a post-effective amendment which indicates
that all securities offered hereunder have been sold or which deregisters all
securities then remaining unsold, shall be deemed to be incorporated by
reference in this registration statement and to be a part hereof from the date
of filing of such documents with the Commission. Any statement contained in
a
document incorporated by reference herein shall be deemed to be modified or
superseded for purposes of this registration statement to the extent that a
statement contained herein, or in a subsequently filed document incorporated
by
reference herein, modifies or supersedes such statement. Any such statement
so
modified or superseded shall not be deemed, except as so modified or superseded,
to constitute part of this registration statement.
Item 4.
|
Description
of Securities.
|
Not
applicable.
Item 5.
|
Interests
of Named Experts and
Counsel.
|
Not
applicable.
Item 6.
|
Indemnification
of Directors and Officers.
|
The
Corporation Laws of the State of Delaware and the Company's Bylaws provide
for
indemnification of the Company's Directors for expenses actually and necessarily
incurred by them in connection with the defense of any action, suit or
proceeding in which they, or any of them, are made parties, or a party, by
reason of having been Director(s) or Officer(s) of the corporation, or of such
other corporation, except, in relation to matter as to which any such Director
or Officer or former Director or Officer or person shall be adjudged in such
action, suit or proceeding to be liable for negligence or misconduct in the
performance of duty. Furthermore, the personal liability of the Directors
is limited as provided in the Company's Articles of Incorporation.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers or persons controlling the Company pursuant
to the foregoing provisions, the Company has been informed that in the opinion
of the Securities and Exchange Commission such indemnification is against public
policy as expressed in the Securities Act of 1933 and is therefore
unenforceable.
Item 7.
|
Exemption
from Registration Claimed.
|
The
restricted securities that are being reoffered and resold pursuant to the
reoffer prospectus included herein were issued pursuant to the Plans and were
deemed to be exempt from registration under the Securities Act in reliance
on
Section 4(2) of the Securities Act, or Regulation D promulgated thereunder,
as transactions by an issuer not involving a public offering.
|
4.1
|
2005
Stock Plan, as amended and restated (1)
|
|
|
|
|
4.2
|
2007
Stock Plan(1)
|
|
5.1
|
Opinion
of Law Offices of Raul Silvestre & Associates, APLC
|
|
|
|
|
23.1
|
Consent
of Law Offices of Raul Silvestre & Associates, APLC (contained in its
opinion filed as Exhibit 5.1 to this registration
statement)
|
|
|
|
|
23.2
|
Consent
of Stegman & Company
|
|
|
|
|
23.3
|
Consent
of David Banerjee
|
|
|
|
|
24.1
|
Power
of Attorney (included in the signature page of this registration
statement)
|
(1)
|
Previously
filed as an Exhibit to the Registrant’s Quarterly Report on form 10-QSB
for the period ended June 30, 2007 and filed with the Commission
on August
14, 2007.
|
a.
The
undersigned Registrant hereby undertakes:
(1)
To
file,
during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i)
To
include any prospectus required by section 10(a)(3) of the Securities Act of
1933;
(ii)
To
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding
the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20% change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the effective
registration statement.
(iii)
To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement;
Provided,
however, That: (A)
Paragraphs (a)(1)(i) and (a)(1)(ii) of this section do not apply if the
information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the Commission
by
the Registrant pursuant to section 13 or section 15(d) of the Securities
Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)) that are incorporated by
reference in the registration statement.
(2)
That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3)
To
remove
from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the
offering.
b.
The
undersigned Registrant hereby undertakes that, for purposes of determining
any
liability under the Securities Act of 1933, each filing of the Registrant’s
annual report pursuant to section 13(a) or section 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall
be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to
be
the initial bona fide offering thereof.
c.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers and controlling persons of the Registrant
pursuant to the foregoing provisions, or otherwise, the Registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act
of
1933 and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
Registrant of expenses incurred or paid by a director, officer or controlling
person of the Registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the Registrant will, unless
in
the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Securities
Act of 1933 and will be governed by the final adjudication of such
issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the Registrant certifies
that
it has reasonable grounds to believe that it meets all of the requirements
for
filing on Form S-8 and has duly caused this registration statement to be
signed on its behalf by the undersigned, thereunto duly authorized, in the
city
of Rockville, state of Maryland on this 6th
day of
August, 2008.
NEURALSTEM,
INC.
|
|
|
By:
|
/s/
I.
Richard Garr
|
|
I.
Richard Garr
|
|
Chief
Executive Officer
|
POWER
OF ATTORNEY
Each
person whose signature appears below constitutes and appoints I. Richard Garr
and John Conron, or any one of them, as his or her true and lawful
attorneys-in-fact and agents with full power of substitution and resubstitution
for him or her and in his or her name, place and stead in any and all capacities
to execute in the name of each such person who is then an officer or director
of
the Registrant any and all amendments (including post-effective amendments)
to
this registration statement, and any registration statement relating to the
offering hereunder pursuant to Rule 462 under the Securities Act of 1933
and to file the same with all exhibits thereto and other documents in connection
therewith with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents and each of them full power and authority to do
and
perform each and every act and thing required or necessary to be done in and
about the premises as fully as he or she might or could do in person, hereby
ratifying and confirming all that said attorneys-in-fact and agents, or any
of
them, or their or his substitute or substitutes, may lawfully do or cause to
be
done by virtue thereof.
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
has been signed by the following persons in the capacities and on the date
indicated.
Signatures
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/
I. Richard Garr
|
|
Chief
Executive Officer (Principal Executive
|
|
August
6, 2008
|
I.
Richard Garr
|
|
Officer)
|
|
|
|
|
|
|
|
/s/
John Conron
|
|
Chief
Financial Officer (Principal Financial
|
|
|
John
Conron
|
|
and
Accounting Officer)
|
|
|
|
|
|
|
|
/s/
Karl Johe
|
|
Chairman
of the Board, Director
|
|
|
Karl
Johe
|
|
|
|
|
|
|
|
|
|
/s/
Scott Ogilvie
|
|
Director
|
|
|
Scott
Ogilvie
|
|
|
|
|
|
|
|
|
|
/s/
William Oldaker
|
|
Director
|
|
|
William
Oldaker
|
|
|
|
|
EXHIBIT
INDEX
Exhibit
|
|
Description
|
|
|
|
|
|
2005
Stock Plan, as amended and restated (1)
|
|
|
|
4.2
|
|
2007
Stock Plan(1)
|
|
|
|
5.1
|
|
Opinion
of Law Offices of Raul Silvestre & Associates, APLC
|
|
|
|
23.1
|
|
Consent
of Law Offices of Raul Silvestre & Associates, APLC (contained in its
opinion filed as Exhibit 5.1 to this registration
statement)
|
|
|
|
23.2
|
|
Consent
of Stegman & Company
|
|
|
|
23.3
|
|
Consent
of David Banerjee
|
|
|
|
24.1
|
|
Power
of Attorney (included in the signature page of this registration
statement)
|
(1)
|
Previously
filed as an Exhibit to the Registrant’s Quarterly Report on form 10-QSB
for the period ended June 30, 2007 and filed with the Commission
on August
14, 2007.
|