Unassociated Document
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PROSPECTUS
SUPPLEMENT
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Filed
pursuant to Rule 424(b)(5)
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(To
Prospectus dated September 9, 2008)
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Registration
No. 333-153387
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800,000
Shares of Common Stock
800,000
Series D Warrants
800,000
Series E Warrants
800,000
Series F Warrants
Placement
Agent Warrant for the Purchase of 40,000 Shares of Common Stock
2,400,000
Shares of Common Stock Underlying the Series D, E and F Warrants
40,000
Shares of Common Stock Underlying the Placement Agent Warrant
NEURALSTEM,
INC.
Pursuant
to this prospectus supplement and the accompanying prospectus, we are offering
up to 800,000 shares of our common stock, par value $0.01 per share
(“Shares”), Series D Common Stock purchase warrants to purchase up to 800,000
shares of our common stock (“Series D Warrants”), Series E Common Stock purchase
warrants to purchase up to 800,000 shares of our common stock (“Series E
Warrants,”) and Series F Common Stock purchase warrants to purchase
up to 800,000 shares of our common stock (“Series F Warrants,”) (collectively
the Series D Warrants, Series E Warrants and Series F Warrants are referred to
as the “Warrants”). A summary description of the Warrants is
contained in the section of this prospectus supplement entitled “Description of
Securities.” The Shares and Warrants are being sold at a
negotiated price of $1.25 per unit. Each unit (“Unit”) consists of:
(i) one Share; (ii) one Series D Warrant, (iii) one Series E Warrant, and (iv)
one Series F Warrant.
The
Series D Warrants have an initial exercise price of $1.25 per share and may be
exercised at any time and from the Closing Date of this offering and through the
one anniversary thereof. The Series E Warrants have an initial
exercise price of $1.25 per share and may be exercised at any time from the
Closing Date of this offering through the three year anniversary
thereof. The Series F Warrants have an initial exercise price of
$1.25 per share and may be exercised at any time from the Closing Date of this
offering and through and including the five year anniversary
thereof.
As
partial compensation for its services in connection with this offering, we will
be issuing the placement agent a warrant to purchase up to 40,000 common shares
at a price of $1.5625 per share (“Placement Agent Warrant”). In addition to the
Shares, Warrants and the Placement Agent Warrant, we are also registering the
2,440,000 common shares underlying the Warrants and Placement Agent
Warrant.
Our
common stock is quoted on the NYSE Amex under the symbol “CUR.” There is
currently no market for the Warrants and none is expected to develop after this
offering. On June 29, 2009, the last reported sales price of our
common stock on the NYSE Amex was $1.04 per share. As of June 29,
2009, the number of outstanding voting and non-voting common shares held by
non-affiliates is 30,674,000. The aggregate market value of our
outstanding voting and non-voting common equity computed by reference to the
average bid and ask price on May 5, 2009 ($1.26) was $38,495,870. The
aggregate market value of all securities offered pursuant to General Instruction
I.B.6. of Form S-3 during the prior 12 calendar month
period that ends on, and includes, the date of this prospectus and the
securities offered hereby is $6,167,520.
Investing
in our securities involves a high degree of risk. Before buying any securities,
you should read the discussion of material risks of investing in our common
stock under the heading “Risk factors” of this prospectus
supplement.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the adequacy or
accuracy of this prospectus supplement or the accompanying prospectus. Any
representation to the contrary is a criminal offense.
We have
retained Midtown Partners & Company, LLC (“Midtown”) to act as our
placement agent in connection with this offering. We have agreed to pay the
placement agent the cash fees set forth in the table below. Additionally, we
have agreed to issue the placement agent a Placement Agent Warrant. A
summary of the Placement Agent Warrant terms are described under the section of
this prospectus supplement entitled “Description of
Securities.” The offering of the Units is being conducted on a
“Best Efforts” basis.
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Maximum
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Offering
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Per
unit
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Amount
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Offering
price
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$
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1.2500
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$
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1,000,000
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Placement
agent fees
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$
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.0875
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$
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70,000
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Proceeds,
before expenses, to us
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$
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1.1625
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$
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930,000
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We
estimate the total expenses of this offering, excluding the placement agent
fees, will be approximately $100,000. Because there is no minimum offering
amount required as a condition to closing in this offering, the actual offering
amount, the placement agent fees and proceeds to us, if any, in this offering
may be substantially less than the maximum offering amounts set forth
above.
Midtown
Partners & Co. LLC
The date
of this prospectus supplement is June 30, 2009.
This
prospectus supplement is not complete without, and may not be utilized except in
connection with, the accompanying prospectus dated September 26, 2008 and any
amendments to such prospectus. This prospectus supplement provides supplemental
information regarding us and updates certain information contained in the
accompanying prospectus and describes the specific terms of this offering. The
accompanying prospectus gives more general information, some of which may not
apply to this offering. We incorporate important information into this
prospectus supplement and the accompanying prospectus by reference.
TABLE
OF CONTENTS
Prospectus
supplement
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Page
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About
This Prospectus
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S-1
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Note
Regarding Forward-Looking Statements
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S-1
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Summary
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S-2
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About
Neuralstem
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S-2
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The
Offering
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S-3
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Risk
Factors
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S-4
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Use
of Proceeds
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S-11
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Determination
of Offering Price
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S-11
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Dividend
Policy
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S-11
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Description
of Securities
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S-11
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Plan of
Distribution
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S-13
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Page
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About
this Prospectus
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1
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Forward-Looking
Statements
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1
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About
Neuralstem
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2
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Risk
Factors
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3
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Use
of Proceeds
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3
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Plan
of Distribution
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3
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Description
of Common Stock
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4
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Description
of Preferred Stock
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5
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Description
of Warrants
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6
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Where
You Can Find More Information
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6
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Incorporation
of Certain Documents by Reference
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7
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Legal
Matters
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7
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Experts
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7
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This
document is in two parts. The first part is this prospectus supplement, which
describes the terms of this offering and also adds to and updates information
contained in the accompanying prospectus and the documents incorporated by
reference into the accompanying prospectus. The second part is the accompanying
prospectus, which gives more general information about the securities we may
offer from time to time under our shelf registration statement, some of which
may not apply to the securities offered by this prospectus supplement. To the
extent there is a conflict between the information contained in this prospectus
supplement, on the one hand, and the information contained in the accompanying
prospectus or any document incorporated by reference therein, on the other hand,
the information in this prospectus supplement shall control.
You
should rely only on the information contained in this prospectus supplement and
contained or incorporated by reference in the accompanying prospectus. We have
not authorized anyone, including the placement agent, and the placement agent
has not authorized anyone, to provide you with different information. We are
offering to sell, and seeking offers to buy, our securities only in
jurisdictions where offers and sales are permitted. The information contained in
this prospectus supplement and contained, or incorporated by reference in the
accompanying prospectus is accurate only as of the respective dates thereof,
regardless of the time of delivery of this prospectus supplement and the
accompanying prospectus, or of any sale of our securities offered hereby. It is
important for you to read and consider all information contained in this
prospectus supplement and the accompanying prospectus, including the documents
incorporated by reference, in making your investment decision. You should also
read and consider the information in the documents we have referred you to in
“Incorporation of Certain Information by Reference” and “Where You Can Find More
Information” in the accompanying prospectus.
Unless
otherwise indicated, “Neuralstem,” the “Company,” “we,” “us,” “our” and similar
terms refer to Neuralstem, Inc.
NOTE
REGARDING FORWARD-LOOKING STATEMENTS
In this
prospectus we make a number of statements, referred to as “forward-looking
statements,” within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 (the "Exchange Act"), which
are intended to convey our expectations or predictions regarding the occurrence
of possible future events or the existence of trends and factors that may impact
our future plans and operating results. These forward-looking statements are
derived, in part, from various assumptions and analyses we have made in the
context of our current business plan and information currently available to use
and in light of our experience and perceptions of historical trends, current
conditions and expected future developments and other factors we believe are
appropriate in the circumstances. You can generally identify forward looking
statements through words and phrases such as “believe,” “expect,” “seek,”
“estimate,” “anticipate,” “intend,” “plan,” “budget,” “project,” “may likely
result,” “may be,” “may continue” and other similar
expressions.
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, and the speed with which regulatory
authorizations and product launches may be achieved;
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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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our
ability to successfully sell our products when and if
developed;
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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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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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changes
in our business plan and corporate strategies;
and
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other
risks and uncertainties discussed in greater detail in the section of this
report 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 prospectus as well as our public filings with the SEC. 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.
SUMMARY
This
summary highlights selected information appearing elsewhere or incorporated by
reference in this prospectus supplement and accompanying prospectus and may not
contain all of the information that is important to you. This prospectus
supplement and the accompanying prospectus include or incorporate by reference
information about the securities we are offering as well as information
regarding our business and detailed financial data. You should read this
prospectus supplement and the accompanying prospectus in their entirety,
including the information incorporated by reference.
ABOUT
NEURALSTEM
Overview
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. On December 18, 2008 we filed our first
Investigational New Drug Application (“IND”) with the U.S. Food and Drug
Administration (“FDA”) to begin a clinical trial to treat amyotrophic lateral
sclerosis (“ALS” or “Lou Gehrig’s Disease”). On February 20, 2009, the FDA
provided us with specific comments, questions and recommendations for
modification to the protocol submitted in our IND. The trial is currently
on clinical hold. We are in the process of analyzing the notice and the FDA’s
comments and recommendations.
In
addition to our core stem cell 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.
Technology
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 vitro growth, without
mutations or other adverse events that would compromise their
usefulness.
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 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 13, 2009, we had 8 full-time employees. Of these employees 4 work on
Research and development and 4 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 9700
Great Seneca Highway, Rockville, Maryland 20850, and our telephone number
is (301) 366-4841. Our website is located at www.neuralstem.com. We have
not incorporated by reference into this prospectus supplement or the
accompanying 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
supplement or the accompanying prospectus.
THE
OFFERING
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Common
stock we are offering
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800,000
shares
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Investor
Warrants
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Warrants
to purchase a total of 2,400,000 Common Shares at $1.25 per share will be
issued to the investors. The Warrants consist of 800,000 Series
D, 800,000 Series E and 800,000 Series F. The Warrants have a
term of 1, 3 and 5 years respectively. All other terms and
conditions of the Warrants are the same.
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Common
stock to be outstanding after this offering(1)
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60,221,062 shares
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Use
of proceeds
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We
intend to use the net proceeds of this offering for general corporate
purposes, including working capital, product development and capital
expenditures. See “Use of proceeds.”
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Placement
Agent Warrant
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Warrants
to purchase 40,000 shares of common stock will be issued to the Placement
Agent as compensation for its services in connection with this offering.
This prospectus supplement also relates to the offering of the shares of
common stock issuable upon exercise of the warrants.
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NYSE
Amex symbol
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CUR
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________________________________________________
(1)
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The
number of shares of common stock shown above to be outstanding after this
offering is based on the 33,751,300 shares outstanding as of June 29, 2009
and assumes the sale of 800,000 common shares in this
offering. The number specifically
excludes:
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(i)
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2,131,265
shares reserved for issuance upon the exercise of the Company’s Series A
Warrants;
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(ii)
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2,228,340
shares reserved for issuance upon the exercise of the Company’s Series B
Warrants;
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(iii)
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3,111,672
shares reserved for issuance upon the exercise of the Company’s Series C
Warrants;
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(iv)
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5,608,485
shares reserved for issuance upon the exercise of free standing option and
warrants;
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(v)
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3,676,659
shares reserved for issuance upon exercise of outstanding options pursuant
to the Company’s 2005 Stock Plan;
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(vi)
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5,320,000
shares reserved for issuance upon exercise of outstanding options pursuant
to the Company’s 2007 Stock Plan;
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(vii)
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323,341
shares reserved for future grants pursuant to the Company’s 2005 Stock
Plan;
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(viii)
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830,000
shares reserved for future grants pursuant to the Company’s 2007 Stock
Plan;
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(ix)
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2,400,000
shares reserved for issuance upon exercise of Series D, E and F warrants;
and
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(x)
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40,000
shares reserved for issuance upon the exercise of the Placement Agent
Warrant.
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RISK
FACTORS
Investing
in our common stock involves a high degree of risk. In addition to the risks
related to our business set forth in this prospectus supplement, the
accompanying prospectus and the other information included and incorporated by
reference in this prospectus supplement and accompanying prospectus, you should
carefully consider the risks described below before purchasing our common stock.
If any of the following risks actually occurs, our business, results of
operations and financial condition will likely suffer. As a result, the trading
price of our common stock may decline, and you might lose part or all of your
investment.
Risks
Relating to Our Stage of Development
We
have a limited operating history and have significantly shifted our operations
and strategies since inception.
Since
inception in 1996 and through December 31, 2008, we have raised $61,690,040 of
capital and recorded accumulated losses totaling $57,486,795. On December 31,
2008, we had a working capital surplus of $3,774,078 and stockholders’ equity of
$4,203,245. Our net losses for the two most recent fiscal years have been
$11,830,798 and $7,063,272 for 2008 and 2007 respectively. We had no revenues
for the twelve months ended December 31, 2008.
Our
ability to generate revenues and achieve profitability will depend upon our
ability to complete the development of our proposed stem cell products, obtain
the required regulatory approvals, manufacture, market, and sell our proposed
products. In part because of our past operating results, no assurances can be
given that we will be able to accomplish any of these goals.
Although
we have generated some revenue in prior years, we have not generated any revenue
from the commercial sale of our proposed stem cell products. Since inception, we
have engaged in several related lines of business and have discontinued
operations in certain areas. For example, in 2002, we lost a material contract
with the Department of Defense and were forced to close our principal facility
and lay off almost all of our employees in an attempt to focus our development
strategy on stem cell technologies. This limited and changing history may not be
adequate to enable you to fully assess our current ability to develop and
commercialize our technologies and proposed products, obtain approval from the
FDA, achieve market acceptance of our proposed products, and respond to
competition. No assurances can be given as to exactly when, if at all, we will
be able to fully develop, commercialize, market, sell and derive material
revenues from our proposed products in development.
We
will need to raise additional capital to continue operations.
Historically
we have generated limited amounts of cash which are not sufficient to meet
current or future operating or capital requirements. We have relied
almost entirely on external financing to fund operations. Such financing has
primarily come primarily from the sale of common stock, and the exercise of
investor warrants. As of March 31, 2009, we had cash and cash
equivalents on hand of $3,567,108 . Presently, we have a monthly cash
burn rate of approximately $400,000. We will need to raise additional
capital to fund anticipated operating expenses and future expansion. Among other
things, external financing will be required to cover the further development of
our technologies and products and general operating costs. On December 18, 2008,
we filed our first IND to commence clinical trials on one of our proposed
products. On February 20, 2009 we received notification from the FDA
that our IND was on hold pending our submission of additional information and
modifications to our IND. In the event the IND is approved, we expect
additional cost related to the trials to be phased in slowly over the following
12 months.
We have
expended and expect to continue to expend substantial cash in the research,
development, clinical and pre-clinical testing of our stem cell technologies
with the goal of ultimately obtaining FDA approval to market our proposed
products. We 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 marketing and distribution. These
funds may not be available on acceptable terms, if at all. If adequate funds are
unavailable, we may have to delay, reduce the scope of, or eliminate one or more
of our research, development or commercialization programs, which may materially
harm our business, financial condition and results of operations.
Our long
term capital requirements are expected to depend on many factors,
including:
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the
continued progress and cost of our research and development
programs;
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the
progress of pre-clinical studies and clinical
trials;
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the
time and costs involved in obtaining regulatory
clearance;
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the
costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims;
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the
costs of developing sales, marketing and distribution channels and our
ability to sell our products if
developed;
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the
costs involved in establishing manufacturing capabilities for commercial
quantities of our proposed
products;
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competing
technological and market
developments;
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market
acceptance of our proposed
products;
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the
costs of recruiting and retaining employees and consultants;
and
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the
costs associated with educating and training physicians about our proposed
products.
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We may
use resources more rapidly than currently anticipated, resulting in the need for
additional funding. We cannot assure you that financing, whether from
external sources or related parties, will be available if needed. If additional
financing is not available when required, or is not available on acceptable
terms, we may not be unable to: fund operations and planned growth, develop or
enhance our technologies, take advantage of business opportunities or respond to
competitive market pressures.
Additional
financing requirements could result in dilution to existing
stockholders.
We are
not able to finance our operations through the sale of our
products. Accordingly, we will be required to secure additional
financing. If we are able to obtain such additional financing, it may be
dilutive to current shareholders. We have authority to issue additional shares
of common stock and preferred stock, or warrants which may be convertible into
any one or more classes or series of capital stock. We are authorized to issue
150,000,000 shares of common stock and 7,000,000 shares of preferred stock. Such
securities may generally be issued without the approval or consent of our
stockholders.
Risks
Relating to Intellectual Property and Government Regulation
We
may not be able to withstand challenges to our intellectual property
rights.
We rely
on our intellectual property, including issued and applied-for patents, as the
foundation of our business. Our intellectual property rights may come under
challenge. No assurances can be given that even though issued, our
current and potential future patents will survive such challenges. For example,
in 2005 our neural stem cell technology was challenged in the U.S. Patent and
Trademark Office. Although we prevailed in this particular matter upon
re-examination by the patent office, these cases are complex, lengthy,
expensive, and could potentially be adjudicated adversely to our interests,
removing the protection afforded by an issued patent. The viability of our
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 our business and future
prospects. At present, there is new litigation with StemCells, Inc. which is in
its initial stages and any likely outcome is difficult to predict.
We
may not be able to adequately protect against the piracy of the intellectual
property in foreign jurisdictions.
We
anticipate conducting research in countries outside of the United
States. A number of our competitors are located in these countries
and may be able to get access to our technology or test results. The
laws protecting intellectual property in some of these countries may not
adequately protect our trade secrets and intellectual property. The
misappropriation of our intellectual property may materially impact our position
in the market and any competitive advantages, if any, that we may
have.
Our
products may not receive FDA approval.
The FDA
and comparable government agencies in foreign countries impose substantial
regulations on the manufacturing 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 vary
substantially based upon the type, complexity and novelty of the proposed
product. On December 18, 2008, we submitted its first IND, application to the
FDA. We cannot assure you when or if such IND application will be
granted, nor can we assure you that if the IND is granted, that we will
successfully complete any clinical trials in connection with such IND. Further,
we cannot yet accurately predict when we might first submit any product license
application for FDA approval or whether any such product license application
will be granted on a timely basis, if at all. Moreover, we cannot
assure you that FDA approvals for any products developed by us will be granted
on a timely basis, if at all. Any delay in obtaining, or failure to obtain, such
approvals could have a material adverse effect on the marketing of our products
and our ability to generate product revenue.
Development
of our technologies is subject to extensive government regulation.
Our
research and development efforts, as well as any future clinical trials, and the
manufacturing and marketing of any products we may develop, will be subject to,
and restricted by, extensive regulation by governmental authorities in the
United States and other countries. The process of obtaining FDA and other
necessary regulatory approvals is lengthy, expensive and uncertain. FDA and
other legal and regulatory requirements applicable to the development and
manufacture of the cells and cell lines required for our preclinical and
clinical products could substantially delay or prevent us from producing the
cells needed to initiate additional clinical trials. We may fail to obtain the
necessary approvals to commence clinical testing or to manufacture or market our
potential products in reasonable time frames, if at all. In addition, the U.S.
Congress and other legislative bodies may enact regulatory reforms or
restrictions on the development of new therapies that could adversely affect the
regulatory environment in which we operate or the development of any products we
may develop.
We base
our research and development on the use of human stem cells obtained from human
tissue. The U.S. federal and state governments and other jurisdictions impose
restrictions on the acquisition and use of human tissue, including those
incorporated in federal Good Tissue Practice, or cGTP, regulations. These
regulatory and other constraints could prevent us from obtaining cells and other
components of our products in the quantity or of the quality needed for their
development or commercialization. These restrictions change from time to time
and may become more onerous. Additionally, we may not be able to identify or
develop reliable sources for the cells necessary for our potential products —
that is, sources that follow all state and federal laws and guidelines for cell
procurement. Certain components used to manufacture our stem and progenitor cell
product candidates will need to be manufactured in compliance with the FDA’s
Good Manufacturing Practices, or cGMP. Accordingly, we will need to enter into
supply agreements with companies that manufacture these components to cGMP
standards. There is no assurance that we will be able to enter into
any such agreements.
Noncompliance
with applicable requirements both before and after approval, if any, can subject
us, our third party suppliers and manufacturers and our other collaborators to
administrative and judicial sanctions, such as, among other things, warning
letters, fines and other monetary payments, recall or seizure of products,
criminal proceedings, suspension or withdrawal of regulatory approvals,
interruption or cessation of clinical trials, total or partial suspension of
production or distribution, injunctions, limitations on or the elimination of
claims we can make for our products, refusal of the government to enter into
supply contracts or fund research, or government delay in approving or refusal
to approve new drug applications.
We
cannot predict if or when we will be permitted to commercialize our products due
to regulatory constraints.
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 our activities. We are 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 our proposed products are subject
to extensive government regulation that may prevent us from creating
commercially viable products. In addition, our sale of any commercially viable
product will be subject to government regulation from several standpoints,
including manufacturing, advertising, marketing, promoting, selling, labeling
and distributing. If, and to the extent that, we are unable to comply with these
regulations, our ability to earn revenues will be materially and negatively
impacted.
Risks
Relating to Our Business
Our
business relies on stem cell technologies that we may not be able to
commercially develop.
We have
concentrated our research on stem cell technologies, and our ability to generate
revenue and operate profitably will depend on being able to develop these
technologies for human applications. These are emerging technologies and have
limited human applications. We cannot guarantee that we will be able to develop
our technologies or that such development will result in products with any
commercial utility or value. We anticipate that the commercial sale of such
products and royalty/licensing fees related to the technology, will be our
primary sources of revenues. If we are unable to develop the technologies,
investors will likely lose their entire investment.
Our
product development programs are based on novel technologies and are inherently
risky.
We are
subject to the risks of failure inherent in the development of products based on
new technologies. The novel nature of these therapies creates significant
challenges in regard to product development and optimization, manufacturing,
government regulation, third party reimbursement, and market acceptance. For
example, the pathway to regulatory approval for cell-based therapies, including
our product candidates, may be more complex and lengthy than the pathway for
conventional drugs. These challenges may prevent us from developing and
commercializing products on a timely or profitable basis or at all.
Our
inability to complete pre-clinical and clinical testing and trials will impair
our viability.
On
December 18, 2008, we submitted our first IND application to the
FDA. On February 20, 2009, the FDA provided us with specific
comments, questions and recommendations for modification to the protocol
submitted in our IND. The trial is on clinical hold. We are in the
process of analyzing the notice and the FDA’s comments and
recommendations. Even if we eventually receive approval from the FDA
to commence clinical trials, the outcome of pre-clinical, clinical and product
testing of our products is uncertain. If we are unable to
satisfactorily complete testing, or if such testing yields unsatisfactory
results, we will be unable to commercially produce our proposed products. Before
obtaining regulatory approvals for the commercial sale of any potential human
products, our 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 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 our ability to generate revenues. In addition, our
proposed products may not prove to be more effective for treating disease or
injury than current therapies. Accordingly, we may have to delay or abandon
efforts to research, develop or obtain regulatory approval to market our
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 our ability to
generate revenues, operate profitably or produce any return on an
investment.
Our
proposed products may not have favorable results in clinical trials or receive
regulatory approval.
Positive
results from pre-clinical studies should not be relied upon as evidence that
clinical trials will succeed. Even if our product candidates achieve positive
results in clinical studies, we will be required to demonstrate through clinical
trials that the product candidates are safe and effective for use in a diverse
population before we can seek regulatory approvals for their commercial sale.
There is typically an extremely high rate of attrition from the failure of
product candidates proceeding through clinical trials. If any product candidate
fails to demonstrate sufficient safety and efficacy in any clinical trial, then
we would experience potentially significant delays in, or be required to
abandon, development of that product candidate. If we delay or abandon our
development efforts of any of our product candidates, then we may not be able to
generate sufficient revenues to become profitable, and our reputation in the
industry and in the investment community would likely be significantly damaged,
each of which would cause our stock price to decrease
significantly.
The
commencement of clinical testing of our potential product candidates may be
delayed.
The
commencement of clinical trials may be delayed for a variety of reasons,
including:
·
|
delays
in demonstrating sufficient safety and efficacy in order to obtain
regulatory approval to commence clinical
trials;
|
·
|
delays
in reaching agreement on acceptable terms with contract research
organizations and clinical trial
sites;
|
·
|
delays
in manufacturing quantities of a product candidate sufficient for clinical
trials;
|
·
|
delays
in obtaining approval of an IND from the FDA or similar foreign
approvals;
|
·
|
delays
in obtaining institutional review board approval to conduct a clinical
trial at a prospective site; and
|
·
|
insufficient
financial resources.
|
In
addition, the commencement of clinical trials may be delayed due to insufficient
patient enrollment, which is a function of many factors, including the size of
the patient population, the nature of the protocol, the proximity of patients to
clinical sites, the availability of effective treatments for the relevant
disease, and the eligibility criteria for the clinical trial. Delays
in the commencement of clinical testing of our product candidates could
significantly increase our product development costs and delay product
commercialization. In addition, many of the factors that may cause, or lead to,
a delay in the commencement of clinical trials may also ultimately lead to a
denial of regulatory approval of a product candidate.
There
are no assurances that we will be able to submit or obtain FDA approval of a
biologics license application.
There can
be no assurance that if the clinical trials of any potential product candidate
are successfully initiated and completed, we will be able to submit a Biologics
License Application (“BLA”) to the FDA or that any BLA we submit will be
approved by the FDA in a timely manner, if at all. If we are unable to submit a
BLA with respect to any future product candidate, or if any BLA we submit is not
approved by the FDA, we will be unable to commercialize that product. The FDA
can and does reject BLAs and requires additional clinical trials, even when
product candidates performed well or achieved favorable results in clinical
trials. If we fail to commercialize our product candidate, we may be unable to
generate sufficient revenues to attain profitability and our reputation in the
industry and in the investment community would likely be damaged, each of which
would cause our stock price to decrease.
The
manufacturing of cell-based therapeutic products is novel, highly regulated,
critical to our business, and dependent upon specialized key
materials.
The
manufacturing of cell-based therapeutic products is a complicated and difficult
process, dependent upon substantial know-how and subject to the need for
continual process improvements. We depend almost exclusively on third
party manufacturers to supply our cells. In addition, our suppliers’
ability to scale-up manufacturing to satisfy the various requirements of our
planned clinical trials is uncertain. Manufacturing irregularities or
lapses in quality control could have a serious adverse effect on our reputation
and business, which could cause a significant loss of stockholder value. Many of
the materials that we use to prepare our cell-based products are highly
specialized, complex and available from only a limited number of suppliers. At
present, some of our material requirements are single sourced, and the loss of
one or more of these sources may adversely affect our business.
Ethical
and other concerns surrounding the use of stem cells may negatively affect
regulatory approval or public perception of our product candidates.
The use
of stem cells for research and therapy has been the subject of debate regarding
ethical, legal and social issues. Negative public attitudes toward
stem cell therapy could result in greater governmental regulation of stem cell
therapies, which could harm our business. For example, concerns regarding such
possible regulation could impact our ability to attract collaborators and
investors. Existing and potential U.S. government regulation of human
tissue may lead researchers to leave the field of stem cell research or the
country altogether, in order to assure that their careers will not be impeded by
restrictions on their work. Similarly, these factors may induce graduate
students to choose other fields less vulnerable to changes in regulatory
oversight, thus exacerbating the risk that we may not be able to attract and
retain the scientific personnel we need in the face of competition among
pharmaceutical, biotechnology and health care companies, universities and
research institutions for what may become a shrinking class of qualified
individuals.
We
may be subject to litigation that will be costly to defend or pursue and
uncertain in its outcome.
Our
business may bring us into conflict with licensees, licensors, or others with
whom we have contractual or other business relationships or with our competitors
or others whose interests differs from ours. If we are unable to resolve these
conflicts on terms that are satisfactory to all parties, we may become involved
in litigation brought by or against it. Any 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 our business. The outcome of litigation is always
uncertain, and in some cases could include judgments against us which could have
a materially adverse effect on our business. By way of example, in
May of 2008, we filed a complaint against 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.
We
may not be able to obtain third-party patient reimbursement or favorable product
pricing.
Our
ability to successfully commercialize certain 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. We cannot assure you that
reimbursement in the United States or foreign countries will be available for
any products developed, or, if available, will not decrease in the future, or
that reimbursement amounts will not reduce the demand for, or the price of, our
products. 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 our business. If additional regulations are overly
onerous or expensive or if health care related legislation makes our business
more expensive or burdensome than originally anticipated, we may be forced to
significantly downsize our business plans or completely abandon the current
business model.
Our
products may not be profitable due to manufacturing costs.
Our
products may be significantly more expensive to manufacture than other drugs or
therapies currently on the market today due to a fewer number of potential
manufacturers, greater level of needed expertise and other general market
conditions affecting manufacturers of stem cell based
products. Accordingly, we may not be able to charge a high enough
price for us to make a profit from the sale of our cell therapy products. If we
are unable to realize significant profits from our potential product candidates,
its business would be materially harmed.
We
are dependent on the acceptance of our products by the health care
community.
Our
proposed products, 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 we are
attempting to develop represent 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 will depend on a number of factors,
including:
·
|
the
clinical efficacy and safety of our proposed
products;
|
·
|
the
superiority of our products to alternatives currently on the
market;
|
·
|
the
potential advantages of our products over alternative treatment methods;
and
|
·
|
the
reimbursement policies of government and third-party
payors.
|
If the
health care community does not accept our products for any reason, our business
would be materially harmed.
We
depend on two key employees for our continued operations and future
success.
The loss
of either of our key executive officers, Richard Garr and Karl Johe, would be
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” life 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, we anticipate growth and expansion into areas and activities requiring
additional expertise, such as clinical testing, regulatory compliance,
manufacturing and marketing. We anticipate the need for additional
management personnel and the development of additional expertise by existing
management personnel. There is intense competition for qualified personnel in
the areas of our present and planned activities, and there can be no assurance
that we will be able to continue to attract and retain the qualified personnel
necessary for the development our business. The failure to attract and retain
such personnel or to develop such expertise would adversely affect our
business.
The
employment contracts of key employees contain significant anti-termination
provisions which could make changes in management difficult or
expensive.
We have
entered into employment agreements with Messrs. Garr and Johe which expire on
November 1, 2012. In the event either individual is terminated prior
to the full term of their respective contracts, for any reason other than a
voluntary resignation, 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
and could cause difficulty in effecting a change in control. Termination prior
to the full term of these contracts would cost us as much as $1,230,000 per
contract and the immediate vesting of all outstanding options and/or warrants
held by Messrs. Garr and Johe.
We
have no product liability insurance, which may leave us vulnerable to future
claims that we will be unable to satisfy.
The
testing, manufacturing, marketing and sale of human therapeutic products entails
an inherent risk of product liability claims, and we cannot assure you that
substantial product liability claims will not be asserted against us. We have no
product liability insurance. In the event we are forced to expend significant
funds on defending product liability actions, and in the event those funds come
from operating capital, we will be required to reduce its business activities,
which could lead to significant losses.
We
cannot assure you that adequate insurance coverage will be available in the
future on acceptable terms.
We have
limited 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. We will endeavor to obtain appropriate insurance
coverage for insurable risks that we identify. In the event a loss
occurs that is not covered, depending on the size of such loss, it could
materially affect our business plan or ability to operate.
Our
outsource model depends on third parties to assist in developing and testing our
proposed products.
Our
strategy for the development, clinical and preclinical testing and
commercialization of our proposed products is based on an outsource model. This
model requires us to enter into collaborations with third parties in order to
further develop the technology and products. In the event we are 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 resources
to bring such 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 currently rely on
third parties to assist us with 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 third parties may hinder our ability to develop products in a timely
fashion.
We
intend to rely upon third-party FDA-approved manufacturers for our stem
cells.
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 currently have an agreement with Charles River
Laboratories International, Inc. (“Charles River”) for the manufacturing and
storage of our cells. In the event Charles River 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 you any assurance that we will be able to develop an internal
manufacturing capability or procure alternative third party suppliers. Moreover,
we cannot give you any assurance that any contract manufacturers or suppliers we
procure will be able to supply our product in a timely or cost effective manner
or in accordance with applicable regulatory requirements or our
specifications.
Our
competition has significantly greater experience and financial
resources.
The
biotechnology industry is characterized by intense competition. We compete
against numerous companies, many of which have substantially greater resources.
Several such enterprises have initiated cell therapy research programs and/or
efforts to treat the same diseases which we target. Although not necessarily
direct competitors, companies such as Geron Corporation, Genzyme Corporation,
StemCells, Inc., Advanced Cell Technology, Inc., Aastrom Biosciences, Inc. and
Viacell, Inc., as well as others, may have substantially greater resources and
experience in our fields which put us at a competitive
disadvantage.
Risks
Relating to Our Common Stock
Our
common shares are sporadically or “thinly” traded.
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
the asking price at any given time may be relatively small or non-existent. This
situation is attributable to a number of factors, including the facts that we
are a small company which is relatively unknown to stock analysts, stock
brokers, institutional investors and others in the investment
community. Even if we came to the attention of such persons, they
tend to be risk-adverse 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 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 if you need money or otherwise desire to liquidate your
investment.
The
market price for our common shares is particularly volatile.
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’s. The volatility in our
share price is attributable to a number of factors. First, 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. Secondly, we are a speculative or “risky” investment due to
our limited operating history, lack of significant revenues to date, and the
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 the sale of shares or the
availability of common shares for sale at any time will have on the prevailing
market price.
We
face risks related to compliance with corporate governance laws and financial
reporting standard.
The
Sarbanes-Oxley Act of 2002, as well as related new rules and regulations
implemented by the SEC 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 make some
activities more time-consuming, burdensome and
expensive. Additionally, in 2008 the SEC extended the compliance
period for non-accredited filers with regard to Section
404(b). Unless further extended, we will be required to include
attestation reports in our annual report for year ending on December 31,
2009. We anticipate this will further increase the costs associated
with our compliance with the Sarbanes-Oxley Act of 2002.
Any
failure to comply with the requirements of the Sarbanes-Oxley Act of 2002, our
ability to remediate any material weaknesses that we may identify during our
compliance program, or difficulties encountered in their
implementation, could harm our operating results, cause us
to fail to meet our reporting obligations or result
in material misstatements in
our financial statements. Any
such failure could
also adversely affect the results of the
periodic management evaluations of our internal controls
and, in the case of a
failure to remediate any material weaknesses that
we may identify, would
adversely affect the annual auditor attestation reports regarding the
effectiveness of our internal control over financial reporting that are required
under Section 404 of the Sarbanes-Oxley Act. Inadequate
internal controls could also cause investors to lose confidence in our reported
financial information, which could have a negative effect on the trading price
of our common stock.
We
have never paid a cash dividend and do not intend to pay cash dividends on our
common stock in the foreseeable future.
We have
never paid cash dividends nor do we anticipate paying cash dividends in the
foreseeable future. Accordingly, any return on your investment will
be as a result of stock appreciation.
Issuance
of additional securities could dilute your proportionate ownership and voting
rights.
We are
entitled under our amended and restated certificate of incorporation to issue up
to 150,000,000 common and 7,000,000 “blank check” preferred shares. As of March
31, 2009, we had issued and outstanding 33,751,300 common shares,
21,980,421common shares reserved for issuance upon the exercise of current
outstanding options and warrants (excluding options and warrants issued under
our equity compensation plans), 669,341common shares reserved for issuance of
additional grants under our 2005 incentive stock plan, and 830,000 shares
reserved for issuance of grants under our 2007 stock plan. Accordingly, we will
be entitled to issue up to 92,768,938 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 option plans, in order to attract
and retain qualified personnel. In the event of issuance, your proportionate
ownership and voting rights may be significantly decreased and the value of your
investment impacted.
USE
OF PROCEEDS
We
estimate that the net proceeds from the sale of the Units will be approximately
$1,000,000, assuming that we sell the maximum number of securities we are
offering pursuant to this prospectus supplement. Because there is no minimum
offering amount required as a condition to the closing of this offering, the
actual number of securities sold, placement agent fees and proceeds to us are
not presently determinable and may be substantially less than the amount set
forth above. In the event the Warrants and Placement Agent Warrant
are exercised, we will receive an additional $3,062,500.
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 and
investments.
DETERMINATION
OF OFFERING PRICE
We
established the price following negotiations with prospective investors and with
reference to the prevailing market price of our common stock, recent trends in
such price, daily average trading volume of our common stock, our current stage
of development, future capital needs and other factors.
DIVIDEND
POLICY
In this
offering, we are offering a maximum of 800,000 Units to investors and a warrant
to purchase up to 40,000 common shares as compensation to the placement agent
for its services in connection with this offering. Each unit
(“Unit”) consisting of: (i) one Share; (ii) one Series D Warrant, (iii) one
Series E Warrant, and (iv) one Series F Warrant. This prospectus supplement also
relates to the offering of shares of our common stock issuable upon exercise, if
any, of the warrants.
Common
Stock
The
material terms and provisions of our common stock are described under the
caption “Description of Common Stock” starting on page 4 of the accompanying
prospectus.
Series
D, E and F Warrants.
The
material terms and provisions of the warrants being offered pursuant to this
prospectus supplement and the accompanying prospectus are summarized below. This
summary does not purport to be complete and is subject to, and qualified in its
entirety by the warrants.
General.
Investors will receive warrants, with a term of one (Series D Warrant), three
(Series E Warrant) and five (Series F Warrant) years, to purchase an aggregate
of 2,400,000 shares of our common stock at an exercise price of $1.25 per
share
Exercisability. The warrants are
exercisable, in whole or in part, at any time and from time to time during the
period commencing at the Closing and ending on the expiration of each Series
respective term. The warrants are exercisable for cash in the event
there is a valid registration statement covering the underlying shares or on a
cashless if there is not a valid registration statement.
Exercise
Price. The
exercise price per share of common stock underlying the warrants is $1.25,
subject to adjustment as described below.
Adjustments. The exercise price and
the number of shares underlying the warrants are subject to appropriate
adjustment in the event of stock splits, stock dividends on our common stock,
stock combinations or similar events affecting our common stock. In addition, in
the event we consummate any merger, consolidation, sale or other reorganization
event in which our common stock is converted into or exchanged for securities,
cash or other property, then following such event, 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 which the holders would have received had
they exercised the warrants immediately prior to such reorganization
event. The exercise price and number of shares underlying the
warrants are not subject to adjustment in the event of a subsequent
financing.
Fractional
Shares. No
fractional shares of common stock will be issued in connection with the exercise
of a warrant. In lieu of fractional shares, we can elect to either pay the
holder an amount in cash equal to the fractional amount multiplied by the market
value of a share of common stock or round up the number of shares to the next
whole share.
Transferability. The Warrants are
transferable pursuant to their terms.
Ownership
Cap and Exercise Restrictions. Under the terms of
each warrant, at no time may a holder of a warrant exercise the warrant if the
acquisition of the number of shares being purchased would result in the holder
owning more than 4.99% of the common stock then outstanding. This maximum
percentage may be increased, subject to sixty one (61) days prior notice to
us by the holder, provided that the maximum percentage may not exceed 9.99% of
our then outstanding shares of common stock following such exercise, excluding
for purposes of such determination shares of common stock issuable upon exercise
of the warrant that have not been exercised
Additional
Provisions. The
above summary of certain terms and provisions of the warrants is qualified in
its entirety by reference to the detailed provisions of the warrants, the form
of which will be filed as an exhibit to a current report on Form 8-K that
will be incorporated herein by reference. No holders of the warrants
will possess any rights as a stockholder under those warrants until the holder
exercises those warrants.
Placement
Agent Warrant
The
material terms and provisions of the warrants being offered pursuant to this
prospectus supplement and the accompanying prospectus are summarized below. This
summary does not purport to be complete and is subject to, and qualified in its
entirety by reference to, all the provisions of the warrants.
General.
The placement agent will receive warrants, with a term of five years, to
purchase an aggregate of 40,000 shares of our common stock at an exercise price
of $1.56250 per share which is equal to 125% of the Warrants exercise
price.
Exercisability. The warrants are
exercisable, in whole or in part, at any time and from time to time during the
period commencing on the closing of the offering and ending on the five year
anniversary thereof. The warrants are only exercisable for
cash.
Exercise
Price. The
exercise price per share of common stock underlying the warrants is $1.5625,
subject to adjustment as described below.
Adjustments. The exercise price and
the number of shares underlying the warrants are subject to appropriate
adjustment in the event of stock splits, stock dividends on our common stock,
stock combinations or similar events affecting our common stock. In addition, in
the event we consummate any merger, consolidation, sale or other reorganization
event in which our common stock is converted into or exchanged for securities,
cash or other property, then following such event, 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 which the holders would have received had
they exercised the warrants immediately prior to such reorganization event. The
exercise price and number of shares underlying the warrants are not subject to
adjustment in the event of a subsequent financing.
Fractional
Shares. No
fractional shares of common stock will be issued in connection with the exercise
of a warrant. In lieu of fractional shares, we can elect to either pay the
holder an amount in cash equal to the fractional amount multiplied by the market
value of a share of common stock or round up the number of shares to the next
whole share.
Transferability. The warrant shall not
be sold, transferred, assigned, pledged, or hypothecated, or be the subject of
any hedging, short sale, derivative, put, or call transaction that would result
in the effective economic disposition of the securities by any person for a
period of 180 days immediately following the date of effectiveness or
commencement of sales of the public offering, except as provided by FINRA Rules.
In accordance with subparagraph (g) (1) of Rule 2710 of the FINRA
Rules, the Placement Agent Warrant shall not be sold during the
offering, or sold, transferred, assigned, pledged, or hypothecated, or be the
subject of any hedging, short sale, derivative, put, or call transaction that
would result in the effective economic disposition of the securities by any
person for a period of 180 days immediately following the date of filing of
this Prospectus Supplement or commencement of sales of the public offering,
except as provided in subparagraph (g)(2) of Rule 2710 of the FINRA
Rules.
Ownership
Cap and Exercise Restrictions. Under the terms of
each warrant, at no time may a holder of a warrant exercise the warrant if the
acquisition of the number of shares being purchased would result in the holder
owning more than 4.99% of the common stock then outstanding. This maximum
percentage may be increased, subject to sixty one (61) days prior notice to
us by the holder, provided that the maximum percentage may not exceed 9.99% of
our then outstanding shares of common stock following such exercise, excluding
for purposes of such determination shares of common stock issuable upon exercise
of the warrant that have not been exercised
Additional
Provisions. The
above summary of certain terms and provisions of the warrants is qualified in
its entirety by reference to the detailed provisions of the warrants, the form
of which will be filed as an exhibit to a current report on Form 8-K that
will be incorporated herein by reference. No holders of the warrants
will possess any rights as a stockholder under those warrants until the holder
exercises those warrants.
PLAN
OF DISTRIBUTION
We have
engaged “Midtown” as our placement agents in connection with this offering. The
placement agent is not purchasing or selling any of the Units we are offering,
and they are not required to arrange the purchase or sale of any specific number
of Units or dollar amount, but they have agreed to use commercially reasonable
efforts to arrange for the sale of the Units.
The terms
of any such offering will be subject to market conditions and negotiations
between us and prospective purchasers. The placement agency agreement
does not give rise to any commitment by the placement agent to purchase any of
our Units, and the placement agent will have no authority to bind us by virtue
of the placement agency agreement. Further, the placement agent does not
guarantee that it will be able to raise new capital in any prospective
offering.
We will
enter into securities purchase agreements directly with the purchasers in
connection with this offering, and we will only sell to purchasers who have
entered into securities purchase agreements.
We will
deliver the Shares being issued to the purchasers electronically upon receipt of
purchaser funds for the purchase of the Shares offered pursuant to this
prospectus supplement. We expect to deliver the Shares being offered
pursuant to this prospectus supplement on or about July 1,
2009. We will deliver the Warrants and Placement Agent Warrant
in physical form.
We have
agreed to pay Midtown a placement agent fee equal to: (i) a cash fee equal to
7.0% of the gross proceeds of this offering; and (ii) a Placement Agent Warrant
equal to 5.0% of the number of Shares sold in this offering. The
Placement Agent Warrant has an exercise price equal to $1.5625, which is 125% of
the exercise price of the Warrants, will expire 5 years from the date of
issuance, and will otherwise comply with the rules of the Financial
Industry Regulatory Authority, or FINRA.
In
compliance with the guidelines of FINRA, the maximum consideration or discount
to be received by the placement agent or any other FINRA member may not exceed
8% of the gross proceeds to us in this offering or any other offering in the
United States pursuant to the Prospectus.
The placement agency
agreement with Midtown will be included as an exhibit to a Current Report on
Form 8-K that we will file with the SEC and that will be incorporated by
reference into the registration statement.
The
estimated offering expenses payable by us, in addition to the placement agent
fees of $70,000, are approximately $100,000, which includes legal, accounting
and printing costs and various other fees associated with registering and
listing the common stock. After deducting certain fees due to the placement
agent and our estimated offering expenses, we expect the net proceeds from this
offering to be approximately $850,000.
PROSPECTUS
NEURALSTEM, INC.
Common
Stock
Preferred
Stock
Warrants
We may
offer to the public, from time to time, in one or more series or
issuances:
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shares
of our common stock;
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shares
of our preferred stock; or
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warrants
to purchase shares of our common stock and/or preferred
stock.
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This
prospectus provides a general description of the securities we may offer. Each
time we sell securities, we will provide specific terms of the securities
offered in a supplement to this prospectus. The prospectus supplement may also
add, update or change information contained in this prospectus. You should read
this prospectus and the applicable prospectus supplement carefully before you
invest in any securities. This prospectus may not be used to consummate a sale
of securities unless accompanied by an applicable prospectus supplement. You
should read both this prospectus and any prospectus supplement together with
additional information described under the heading “Where You Can Find More
Information” before you make your investment decision.
We will
sell these securities directly to our stockholders or to purchasers or through
agents on our behalf or through underwriters or dealers as designated from time
to time. If any agents or underwriters are involved in the sale of any of these
securities, the applicable prospectus supplement will provide the names of the
agents or underwriters and any applicable fees, commissions or
discounts.
Our
common stock is traded on the American Stock Exchange (“AMEX”) under the symbol
“CUR.” On September 20, 2008, the closing price of our common stock was $1.59
per share.
Investing in our securities involves
risks. See “Risk Factors” on page 3.
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. Any
representation to the contrary is a criminal offense.
TABLE OF CONTENTS
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Page
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About
this Prospectus
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1
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Forward-Looking
Statements
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1
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About
Neuralstem
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2
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Risk
Factors
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3
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Use
of Proceeds
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3
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Plan
of Distribution
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3
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Description
of Common Stock
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4
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Description
of Preferred Stock
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5
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Description
of Warrants
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6
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Where
You Can Find More Information
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6
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Incorporation
of Certain Information by Reference
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7
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Legal
Matters
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7
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Experts
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7
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You
should rely only on the information contained in this prospectus. We have not
authorized anyone to give you information different from that contained in this
prospectus. We are not making an offer to sell these securities in any
jurisdiction where the offer is not permitted. The information contained in this
prospectus is accurate only as of the date on the front cover of this
prospectus, regardless of when this prospectus is delivered or when any sale of
our securities occurs. Our business, financial condition, results of operations
and prospects may have changed since that date.
As used
in this prospectus, unless context otherwise requires, the words “we,”
“us,”“our,” “the Company” and “Neuralstem” refer to Neuralstem, Inc. This
summary highlights selected information about Neuralstem and a general
description of the securities we may offer. This summary is not complete and
does not contain all of the information that may be important to you. For a more
complete understanding of us and the terms of the securities we will offer, you
should read carefully this entire prospectus, including the “Risk Factors”
section, the applicable prospectus supplement for the securities and the other
documents we refer to and incorporate by reference. In particular, we
incorporate important business and financial information into this prospectus by
reference.
This
prospectus is a part of a registration statement that we filed with the
Securities and Exchange Commission, or the SEC, using a “shelf” registration
process. Under this shelf registration process, we may offer to sell any
combination of the securities described in this prospectus in one or more
offerings up to a total dollar amount of $25,000,000. 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. The prospectus supplement may also add, update or change information
contained in this prospectus. You should read both this prospectus and any
prospectus supplement, including all documents incorporated herein or therein by
reference, together with additional information described under “Where You Can
Find More Information.”
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 and any accompanying prospectus supplement. You
must not rely upon any information or representation not contained or
incorporated by reference in this prospectus or an accompanying prospectus
supplement. This prospectus and the accompanying prospectus supplement, if any,
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 prospectus supplement 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 and the accompanying prospectus supplement, if any, 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 and any accompanying prospectus supplement is delivered or
securities are sold on a later date.
FORWARD LOOKING
STATEMENTS
This
prospectus, and the documents incorporated into it by reference, contains
forward-looking statements” within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the
"Exchange Act"), which are intended to convey our expectations or predictions
regarding the occurrence of possible future events or the existence of trends
and factors that may impact our future plans and operating results. These
forward-looking statements are derived, in part, from various assumptions and
analyses we have made in the context of our current business plan and
information currently available to use and in light of our experience and
perceptions of historical trends, current conditions and expected future
developments and other factors we believe are appropriate in the circumstances.
You can generally identify forward looking statements through words and phrases
such as“believe”, “expect”, “seek”,
“estimate”, “anticipate”, “intend”, “plan”, “budget”, “project”, “may likely
result”, “may be”, “may continue” and
other similar expressions.
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 product, and the speed with which regulatory
authorizations and product launches may be
achieved;
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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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our
ability to successfully sell our products if a market
develops;
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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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changes
in our business plan and corporate strategies;
and
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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 Prospectus 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 Prospectus or any other filing to reflect new events or circumstances
unless and to the extent required by applicable law.
ABOUT NEURALSTEM
Overview
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 stage of pre-clinical research and
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.
Technology
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.
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 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
June 30, 2008, we had 7 full-time employees. 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.
RISK FACTORS
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, 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.
PLAN OF
DISTRIBUTION
We may
sell securities in any of the ways described below or in any combination of
these:
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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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at
negotiated prices.
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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
initial 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
securities exchanges on which the securities may be
listed.
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Any
public 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 with respect to payments
which the agents or underwriters may be required to make in respect thereof.
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 any remarketing firm and the terms of
its agreement, if any, with us and will describe the 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 may be new issues of securities and may have no established trading
market. The securities may or may not be listed on a national 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 our securities.
Certain
persons participating in this offering may engage in overallotment, stabilizing
transactions, short covering transactions and penalty bids in accordance with
rules and regulations under the Exchange Act. 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 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.
DESCRIPTION OF COMMON
STOCK
We are
authorized to issue 150,000,000 shares of common stock. As of September 3, 2008,
we had 32,151,300 shares of common stock outstanding.
The
following summary of certain provisions of our common stock does not purport to
be complete. You should refer to our restated certificate of incorporation and
our amended and restated by-laws, both of which are on file with the SEC as
exhibits to previous SEC filings. The summary below is also qualified by
provisions of applicable law.
General
Holders
of common stock are entitled to one vote per share on matters on which our
stockholders vote. There are no cumulative voting rights. Holders of common
stock are entitled to receive dividends, if declared by our board of directors,
out of funds that we may legally use to pay dividends. If we liquidate or
dissolve, holders of common stock are entitled to share ratably in our assets
once our debts and any liquidation preference owed to any then-outstanding
preferred stockholders are paid. Our certificate of incorporation does not
provide the common stock with any redemption, conversion or preemptive rights.
All shares of common stock that are outstanding as of the date of this
prospectus and, upon issuance and sale, all shares we are offering by this
prospectus, will be fully-paid and nonassessable.
Classification Of Directors And
Change Of Control
Pursuant
to our amended bylaws, we have a classified board of directors divided into
three classes with staggered three-year terms. Only one class of directors may
be elected each year, while the directors in the other classes continue to hold
office for the remainder of their three-year terms. Each class of the Board is
required to have approximately the same number of directors. The Board may, on
its own, determine the size of the exact number of directors on the Board and
may fill vacancies on the Board. The procedure for electing and removing
directors on a classified board of directors generally makes it more difficult
for stockholders to change control of the Company by replacing a majority of the
classified Board at any one time, and the classified board structure may
discourage a third party tender offer or other attempt to gain control of the
Company and may maintain the incumbency of directors. In addition, under our
amended bylaws, directors may only be removed from office by a vote of the
majority of the shares then outstanding and eligible to vote.
The
bylaws contain advance notice procedures with respect to stockholder proposals
and further limit stockholder rights to nominate candidates for election as
directors. These provisions may discourage stockholders from nominating
directors or bringing any other business at a particular meeting if the
stockholders do not follow the proper procedures. In addition, the procedures
may
Transfer Agent and
Registrar
The
transfer agent and registrar for our common stock is American Stock Transfer and
Trust Company.
American Stock
Exchange
Our
common stock is listed for quotation on the American Stock Exchange under the
symbol “CUR.”
DESCRIPTION OF PREFERRED
STOCK
We are
authorized to issue 7,000,000 shares of undesignated preferred stock. As of
September 3, 2008, no shares of our preferred stock were outstanding. The
following summary of certain provisions of our preferred stock does not purport
to be complete. You should refer to our restated certificate of incorporation
and our amended and restated by-laws, both of which are on file with the SEC as
exhibits to previous SEC filings. The summary below is also qualified by
provisions of applicable law.
Our board
of directors may, without further action by our stockholders, from time to time,
direct the issuance of shares of preferred stock in series and may, at the time
of issuance, determine the rights, preferences and limitations of each series,
including voting rights, dividend rights and redemption and liquidation
preferences. Satisfaction of any dividend preferences of outstanding shares of
preferred stock would reduce the amount of funds available for the payment of
dividends on shares of our common stock. Holders of shares of preferred stock
may be entitled to receive a preference payment in the event of any liquidation,
dissolution or winding-up of our company before any payment is made to the
holders of shares of our common stock. In some circumstances, the issuance of
shares of preferred stock may render more difficult or tend to discourage a
merger, tender offer or proxy contest, the assumption of control by a holder of
a large block of our securities or the removal of incumbent management. Upon the
affirmative vote of our board of directors, without stockholder approval, we may
issue shares of preferred stock with voting and conversion rights which could
adversely affect the holders of shares of our common stock.
If we
offer a specific series of preferred stock under this prospectus, we will
describe the terms of the preferred stock in the prospectus supplement for such
offering and will file a copy of the certificate establishing the terms of the
preferred stock with the SEC. To the extent required, this description will
include:
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the
title and stated value;
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the
number of shares offered, the liquidation preference per share and the
purchase price;
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the
dividend rate(s), period(s) and/or payment date(s), or method(s) of
calculation for such dividends;
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whether
dividends will be cumulative or non-cumulative and, if cumulative, the
date from which dividends will accumulate;
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the
procedures for any auction and remarketing, if any;
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the
provisions for a sinking fund, if any;
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the
provisions for redemption, if applicable;
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any
listing of the preferred stock on any securities exchange or
market;
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whether
the preferred stock will be convertible into our common stock, and, if
applicable, the conversion price (or how it will be calculated) and
conversion period;
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voting
rights, if any, of the preferred stock;
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a
discussion of any material and/or special U.S. federal income tax
considerations applicable to the preferred stock;
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the
relative ranking and preferences of the preferred stock as to dividend
rights and rights upon liquidation, dissolution or winding up of the
affairs of Neuralstem.; and
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any
material limitations on issuance of any class or series of preferred stock
ranking senior to or on a parity with the series of preferred stock as to
dividend rights and rights upon liquidation, dissolution or winding up of
Neuralstem.
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The
preferred stock offered by this prospectus, when issued, will not have, or be
subject to, any preemptive or similar rights.
Transfer Agent and
Registrar
The
transfer agent and registrar for any series or class of preferred stock will be
set forth in each applicable prospectus supplement.
DESCRIPTION OF
WARRANTS
We may
issue warrants to purchase shares of our common stock, preferred stock and/or
debt securities in one or more series together with other securities or
separately, as described in each applicable prospectus supplement. Below is a
description of certain general terms and provisions of the warrants that we may
offer. Particular terms of the warrants will be described in the applicable
warrant agreements and the applicable prospectus supplement to the
warrants.
The
applicable prospectus supplement will contain, where applicable, the following
terms of, and other information relating to, the warrants:
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the
specific designation and aggregate number of, and the price at which we
will issue, the warrants;
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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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the
designation, amount and terms of the securities purchasable upon exercise
of the warrants;
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if
applicable, the exercise price for shares of our common stock and the
number of shares of common stock to be received upon exercise of the
warrants;
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if
applicable, the exercise price for shares of our preferred stock, the
number of shares of preferred stock to be received upon exercise, and a
description of that series of our preferred
stock;
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the
date on which the right to exercise the warrants will begin and the date
on which that right will expire or, if you may not continuously exercise
the warrants throughout that period, the specific date or dates on which
you may exercise the warrants;
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whether
the warrants will be issued in fully registered form or bearer form, in
definitive or global form or in any combination of these forms, although,
in any case, the form of a warrant included in a unit will correspond to
the form of the unit and of any security included in that
unit;
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any
applicable material U.S. federal income tax
consequences;
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the
identity of the warrant agent for the warrants and of any other
depositaries, execution or paying agents, transfer agents, registrars or
other agents;
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the
proposed listing, if any, of the warrants or any securities purchasable
upon exercise of the warrants on any securities
exchange;
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if
applicable, the date from and after which the warrants and the common
stock and/or preferred stock will be separately
transferable;
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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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information
with respect to book-entry procedures, if any;
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the
anti-dilution provisions of the warrants, if any;
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any
redemption or call provisions;
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whether
the warrants are to be sold separately or with other securities as parts
of units; and
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any
additional terms of the warrants, including terms, procedures and
limitations relating to the exchange and exercise of the
warrants.
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Transfer Agent and
Registrar
The
transfer agent and registrar for any warrants will be set forth in the
applicable prospectus supplement.
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
9700
Great Seneca Highway,
Rockville,
Maryland 20850
Attn:
Chief Financial Officer
Tel :
(301) 366-4841
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.
INCORPORATION OF CERTAIN INFORMATION
BY REFERENCE
The
following documents are incorporated by reference into this registration
statement:
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Our
Annual Report on Form 10-KSB filed with the Commission on March 27, 2008,
for the year ended December 31,
2007;
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Our
Definitive Proxy Statement on Schedule 14A, filed with the Commission on
Aril 24, 2008;
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Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008,
filed with the Commission on May 15, 2008;
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Our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, filed
with the Commission on August 14, 2008;
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Our
Current Report on Form 8-K filed with the Commission on February 25,
2008;
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Our
Current Report on Form 8-K filed with the Commission on March 28,
2008;
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Our
Current Report on Form 8-K filed with the Commission on April 16,
2008;
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Our
Current Report on Form 8-K filed with the Commission on May 1,
2008;
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Our
Current Report on Form 8-K filed with the Commission on May 6,
2008;
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Our
Current Report on Form 8-K, filed with the Commission on May 12,
2008;
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Our
Current Report on Form 8-K, filed with the Commission on May 15, 2008;
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Our
Current Report on Form 8-K filed with the Commission on July 31,
2008;
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Our
Current Report on Form 8-K filed with the Commission on September 9,
2008;
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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.
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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.
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,
9700 Great Seneca Highway, Rockville, Maryland 20850 Attn: Chief Financial
Officer Tel: (301) 366-4841
LEGAL MATTERS
The
validity of the shares of common stock being offered hereby will be passed upon
for us by The Law Offices of Raul Silvestre & Associates, Los Angeles,
California.
EXPERTS
Our
financial statements for the period of January 1, 2006 through December 31, 2006
and the related statements of operations, stockholders' equity and cash flows
for such period incorporated by reference in this Prospectus and registration
statement have been audited by David Banerjee, independent registered public
accountant, as set forth in this Prospectus, and are included in reliance upon
such report given upon the authority of such firm as experts in accounting and
auditing. David Banerjee has no interest in the shares being registered in this
filing.
Our
balance sheet as of December 31, 2007 and the related statements of operations,
stockholders' equity and cash flows for the year ended December 31, 2007
incorporated by reference in this Prospectus and registration statement have
been audited by Stegman & Company, independent registered public accounting
firm, as set forth in this Prospectus, and are included in reliance upon such
report given upon the authority of such firm as experts in accounting and
auditing. Stegman & Company has no interest in the shares being registered
in this filing.
NEURALSTEM, INC.
Common
Stock
Preferred
Stock
Warrants
,
2008
We have
not authorized any dealer, salesperson or other person to give any information
or represent anything not contained in this prospectus. You must not rely on any
unauthorized information. If anyone provides you with different or inconsistent
information, you should not rely on it. This prospectus does not offer to sell
any shares in any jurisdiction where it is unlawful. Neither the delivery of
this prospectus, nor any sale made hereunder, shall create any implication that
the information in this prospectus is correct after the date
hereof.