e424b5
Filed Pursuant to Rule 424(b)(5)
Registration No.
333-128797
PROSPECTUS SUPPLEMENT
(To Prospectus dated November 16, 2005)
11,750,820 Shares
STEMCELLS, INC. LOGO
Common Stock
We are offering 11,750,820 shares of our common stock
pursuant to this prospectus supplement. The common stock will be
sold at a negotiated price of $3.05 per share. Our common
stock is quoted on The Nasdaq National Market under the symbol
STEM. On March 31, 2006, the last reported
sales price of our common stock on The Nasdaq National Market
was $3.58 per share.
Investing in our common stock involves a high degree of risk.
Before buying any shares, you should read the discussion of
material risks of investing in our common stock under the
heading Risk factors beginning on page S-4 of
this prospectus supplement.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus supplement or the accompanying prospectus. Any
representation to the contrary is a criminal offense.
We have retained UBS Securities LLC to act as our exclusive
placement agent in connection with the arrangement of this
transaction. We have agreed to pay the placement agent the
placement agent fees set forth in the table below, which assumes
that we sell all of the 11,750,820 shares we are offering.
We have also agreed to reimburse the placement agent for certain
of its expenses as described under Plan of
distribution in this prospectus supplement. The placement
agent is not required to arrange for the sale of any specific
number or dollar amount of shares but will use reasonable
efforts to arrange for the sale of all of the shares.
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Per share | |
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Total | |
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Offering price
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$ |
3.05 |
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35,840,001 |
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Placement agent fees
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$ |
0.183 |
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2,150,400 |
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Proceeds, before expenses, to us
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$ |
2.867 |
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$ |
33,689,601 |
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We expect the total offering expenses, excluding placement agent
fees, to be approximately $500,000 for all sales pursuant to
this prospectus supplement. Because there is no minimum offering
amount required as a condition to the closing of this offering,
the actual public offering amount, placement agent fees and
proceeds to us are not presently determinable and may be
substantially less than the maximum amounts set forth above.
Delivery of the shares will be made on or about April 6,
2006.
UBS Investment Bank
as Placement Agent
The date of this prospectus supplement is April 3, 2006.
This prospectus supplement is not complete without, and may not
be utilized except in connection with, the accompanying
prospectus dated November 16, 2005 and any amendments to
such prospectus. This prospectus supplement provides
supplemental information regarding us, 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. You may obtain the information incorporated by
reference into this prospectus supplement and the accompanying
prospectus without charge by following the instructions under
Where you can find more information. You should
carefully read both this prospectus supplement and the
accompanying prospectus, as well as the additional information
described under Incorporation of certain documents by
reference, before deciding to invest in shares of our
common stock.
You should rely only on the information contained and
incorporated by reference in this prospectus supplement and the
accompanying prospectus. We have not, and the placement agent
has not, authorized anyone to give you different or additional
information. You should not assume that the information included
or incorporated by reference in this prospectus supplement and
accompanying prospectus is accurate as of any date after the
respective dates of the documents containing the information.
TABLE OF CONTENTS
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Unless the context requires otherwise, the words
StemCells, we, company,
us and our refer to StemCells, Inc. and
our subsidiary.
s-i
Prospectus supplement 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 shares 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.
BUSINESS OVERVIEW
We are focused on the discovery and development of stem cell
therapeutics to treat damage to or degeneration of major organ
systems such as the central nervous system, liver and pancreas.
Our aim is to return patients to productive lives and
significantly reduce the substantial health care costs often
associated with these diseases and disorders. We seek to
identify and purify rare stem cells, develop methods and
processes to expand and bank them as transplantable cells, and
then demonstrate their safety and efficacy as therapeutic
agents. In October 2005, we received clearance from the US Food
and Drug Administration (FDA) to initiate a Phase I
clinical trial to evaluate the safety and preliminary efficacy
of our human neural stem cells
(HuCNS-SCtm)
as a treatment for infantile and late infantile neuronal ceroid
lipofuscinosis (NCL), two forms of a group of disorders often
referred to as Batten disease. In March 2006, we received
approval from the Institutional Review Board of the Oregon
Health & Science University to begin our Phase I
clinical trial at OHSU Doernbecher Childrens Hospital in
Portland.
Stem cells are cells that can produce all the functional mature
cell types found in normal organs of healthy individuals.
Progenitor cells are cells that have already developed from the
stem cells, but can still produce one or more types of mature
cells within an organ. We use cells derived from donated fetal
or adult tissue sources, which are supplied to us in compliance
with all applicable state and federal regulations. We are not
developing embryonic stem cells for therapeutic use. Neither are
we involved in any activity directed toward human cloning; our
programs are all directed toward the use of tissue-derived cells
for treating or curing diseases and injuries.
We have successfully identified, purified and characterized the
human neural stem cell. Our neural stem cell product, HuCNS-SC,
is about to begin clinical development for its first indication.
We have also identified candidate stem or progenitor cells of
the liver and the pancreas. Our candidate liver stem cell, when
transplanted into a mouse model of liver degeneration, shows
long-term engraftment evidenced by secretion of human hepatic
proteins. Based on this data, we plan to develop this cell for
potential therapeutic applications to liver diseases.
S-1
We believe that, if successfully developed, our stem cell
technologies will create the basis for therapies that would
address a number of conditions with significant unmet medical
needs. Many diseases, such as Alzheimers,
Parkinsons, lysosomal storage diseases and other
degenerative diseases of the brain or central nervous system,
involve the failure of organs that cannot be transplanted. Other
diseases, such as hepatitis and diabetes, involve organs such as
the liver or pancreas that can be transplanted, but there is a
very limited supply of those organs available for transplant. We
estimate that these neural, liver and pancreatic conditions
affect more than 55 million people in the United States and
account for more than $325 billion annually in health care
costs.1
OUR CORPORATE INFORMATION
We were incorporated in Delaware. Our principal executive
offices are located at 3155 Porter Drive, Palo Alto, California
94304, and our telephone number is (650) 475-3100. We
maintain an Internet website at www.stemcellsinc.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.
1 This
estimate is based on information from the Alzheimers
Association, the Alzheimers Disease Education &
Referral Center (National Institute on Aging), the National
Institutes of Healths National Institute on Neurological
Disorders and Stroke, the Foundation for Spinal Cord Injury
Prevention, Care & Cure, the Centers for Disease
Control and Prevention, the Spinal Cord Injury Information
Network, the American Association of Diabetes Educators, the
Wisconsin Chapter of the Huntingtons Disease Society of
America, the Cincinnati Childrens Hospital Medical Center,
JAIDs, the American Liver Foundation, the Northwest
Parkinsons Foundation and the Parkinsons Action
Network.
S-2
The offering
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Common stock we are offering |
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11,750,820 shares |
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Common stock to be outstanding after this offering |
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77,146,842 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, as well as acquisitions
and other strategic purposes. See Use of proceeds. |
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Nasdaq National Market symbol |
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STEM |
The number of shares of common stock shown above to be
outstanding after this offering is based on the
65,396,022 shares outstanding as of December 31, 2005
and excludes:
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6,608,109 shares of our common stock subject to options
outstanding as of December 31, 2005 having a weighted
average exercise price of $3.02 per share; |
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1,583,543 shares of our common stock that have been
reserved for issuance in connection with future grants under our
stock option plans as of December 31, 2005; and |
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2,521,400 shares of our common stock that have been
reserved for issuance upon exercise of outstanding warrants as
of December 31, 2005 having a weighted average exercise
price of $1.92 per share. |
S-3
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
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 RELATED TO OUR BUSINESS
Any adverse development in the initial clinical trial for our
stem cell technology could substantially depress our stock price
and prevent us from raising the capital we will need to further
develop our stem cell technology.
To an unusual extent, our ability to progress as a company is
significantly dependent on a single early stage clinical trial.
Any clinical, regulatory or other development that prevents or
delays us from conducting our initial clinical trial for Batten
disease, or any safety issue or adverse side effect to any
patient that occurs during the trial, or the failure of this
initial trial to enroll patients and proceed to completion as
anticipated or to show the results expected by investors, would
likely significantly depress our stock price and could prevent
us from raising the substantial additional capital we will
require to further develop our stem cell technologies.
Our financial situation is precarious and, based on currently
estimated operating expenses, our existing capital resources may
not be sufficient to fund our operations beyond the next
eighteen months.
We have incurred significant operating losses and negative cash
flows since inception. We have not achieved profitability and
may not be able to realize sufficient revenues to achieve or
sustain profitability in the future. We do not expect to be
profitable in the next several years, but rather expect to incur
additional and increasing operating losses. We have limited
liquidity and capital resources and must obtain significant
additional capital resources in order to sustain our product
development efforts and for acquisition of technologies and
intellectual property rights, preclinical and clinical testing
of our anticipated products, pursuit of regulatory approvals,
acquisition of capital equipment, laboratory and office
facilities, establishment of production capabilities,
maintaining and enforcing our intellectual property portfolio,
general and administrative expenses and other working capital
requirements. We rely on cash reserves and proceeds from equity
and debt offerings, proceeds from the transfer or sale of our
intellectual property rights, equipment, facilities or
investments, and government grants and funding from
collaborative arrangements, if obtainable, to fund our
operations. If we exhaust our cash reserves and are unable to
realize adequate financing, we may be unable to meet operating
obligations and be required to initiate bankruptcy proceedings.
Our existing capital resources may not be sufficient to fund our
operations beyond the next eighteen months. We intend to pursue
opportunities to obtain additional financing in the future
through equity and debt financings, corporate alliances, grants
and collaborative research arrangements. The source, timing and
availability of any future financing will depend principally
upon market conditions, interest rates and, more specifically,
on our progress in our exploratory, preclinical and future
clinical development programs. Funding may not be available when
needed at all or on terms acceptable to us. Lack of
necessary funds may require us to delay, scale back or eliminate
some or all of our research and product development programs
and/or our capital expenditures or to license our potential
products or technologies to third parties.
S-4
Risk factors
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 the therapies creates significant challenges in
regards to product development and optimization, manufacturing,
government regulation, third party reimbursement and market
acceptance. For example, the FDA has relatively little
experience with stem cell-based therapeutics, and the pathway to
regulatory approval for our product candidates may accordingly
be more complex and lengthy than the pathway for new
conventional drugs. These challenges may prevent us from
developing and commercializing products on a timely or
profitable basis or at all.
Our technology is at an early stage of discovery and
development, and we may fail to develop any commercially
acceptable or profitable products.
We have yet to develop any products. Before we may market any
product, we must obtain regulatory approval from the FDA and
equivalent foreign agencies after conducting extensive
preclinical studies and clinical trials that demonstrate that
our product candidates are safe and effective for each disease
for which we seek approval. We have no experience in conducting
clinical trials. We expect that none of our cellular therapy
product candidates will be commercially available for several
years, if at all.
Our programs are still at the preclinical phase for our
candidate human liver stem cell, and at the discovery phase for
our candidate human pancreas stem cell. While the US Food and
Drug Administration (FDA) has permitted us to go forward
with our proposed Phase I clinical trial of our proprietary
neural stem cell therapy product HuCNS SC in Batten
disease, and the Institutional Review Board of the Oregon
Health & Science University has approved the protocol,
that trial has not yet enrolled or treated any patients and
there can be no assurance that the clinical investigators will
be able to identify suitable candidates for the trial or of a
successful outcome of the trial if candidates are enrolled. We
may fail to discover the stem cells we are seeking, to develop
any products, to obtain regulatory approvals, to enter clinical
trials, or to commercialize any products. We may elect to delay
or discontinue preclinical studies or clinical trials based on
unfavorable results. Any product using stem cell technology may
fail to:
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survive and persist in the desired location; |
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provide the intended therapeutic benefits; |
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properly integrate into existing tissue in the desired
manner; or |
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achieve therapeutic benefits equal to or better than the
standard of treatment at the time of testing. |
In addition, our products may cause undesirable side effects.
Results of preclinical research may not be indicative of the
results that will be obtained in later stages of preclinical or
clinical research. If regulatory authorities do not approve our
products or if we fail to maintain regulatory compliance, we
would be unable to commercialize our products, and our business
and results of operations would be harmed. Furthermore, because
stem cells are a new form of therapy, the marketplace may not
accept any products we may develop. If we do succeed in
developing products, we will face many potential obstacles such
as the need to obtain regulatory approvals and to develop or
obtain manufacturing, marketing and distribution capabilities.
In addition, we will face substantial additional risks such as
product liability claims.
Moreover, because our cell therapy treatments will be derived
from tissue of individuals other than the patient (that is, they
will be non-self or allogeneic
transplant products), patients will require the use of
immunosuppressive drugs such as cyclosporine, FK506, or others
to prevent rejection of the cells. While immunosuppression is
now standard in connection with allogeneic transplants of
various kinds, long-term maintenance on immunosuppressive drugs
can produce complications that include
S-5
Risk factors
infection, cancer, cardiovascular disease, renal dysfunction and
other side effects depending upon which immunosuppressive
regimen is employed. Immunosuppression has not been tested with
our therapies since we have not yet conducted any clinical
trials.
Our success will depend in large part on our ability to
develop and commercialize products that treat diseases other
than Batten disease.
Although we have initially focused on evaluating our neural cell
therapy product for the treatment of infantile and late
infantile forms of NCL (Batten disease), this disease is rare,
and the market for treating this disease is small. Accordingly,
even if we obtain marketing approval for HuCNS-SC for Batten
disease, in order to achieve profitability, if at all, we will
need to obtain approval for HuCNS-SC and other potential
products to treat additional diseases that present more
significant market opportunities.
We have payment obligations resulting from real property
owned or leased by us in Rhode Island, which diverts funding
from our stem cell research and development.
Prior to our reorganization in 1999 and the consolidation of our
business in California, we carried out our former encapsulated
cell therapy programs in Lincoln, Rhode Island, where we also
had our administrative offices. Although we have vacated the
Rhode Island facilities, we remain obligated to make lease
payments and payments for operating costs for our former science
and administrative facility, which we have leased through
June 30, 2013. These costs, before sub-tenant rental
income, amounted to approximately $1,450,000 in 2005; our rent
payments will increase over the term of the lease, and our
operating costs may increase as well. In addition to these costs
of our former science and administrative facility, we are
obligated to make debt service payments and payments for
operating costs of approximately $450,000 per year for our
former encapsulated cell therapy pilot manufacturing facility,
which we own. We have currently subleased a portion of the
science and administrative facility, and are seeking to sublease
the remaining portion, but we cannot be sure that we will be
able to keep any part of the facility subleased for the duration
of our obligation. We have currently subleased the entire pilot
manufacturing facility to a privately-held biotechnology
company, but may not be able to sublease or sell the facility in
the future once the current sublease agreements expire. These
continuing costs significantly reduce our cash resources and
adversely affect our ability to fund further development of our
stem cell technology. In addition, changes in real estate market
conditions and assumptions regarding the length of time it may
take us to either fully sublease, assign or sell our remaining
interest in the our former research facility in Rhode Island may
have a significant impact on and cause large variations in our
quarter to quarter results of operations. In 1999, in connection
with exiting our former research facility in Rhode Island, we
created a reserve for the estimated lease payments and operating
expenses related to it. The reserve is periodically re-evaluated
and adjusted based on assumptions relevant to real estate market
conditions and the estimated time until we can either fully
sublease, assign or sell our remaining interests in the
property. At December 31, 2005, the reserve was $7,306,000.
In 2005 and 2004, we incurred $1,079,000 and $1,152,000 in
operating expenses net of sub-tenant income for this facility.
Expenses for this facility will fluctuate based on changes in
tenant occupancy rates and other operating expenses related to
the lease. Even though it is our intent to sublease, assign,
sell or otherwise divest ourselves of our interests in the
facility at the earliest possible time, we cannot determine with
certainty a fixed date by which such events will occur. In light
of this uncertainty, based on estimates, we will periodically
re-evaluate and adjust the reserve, as necessary, and we may
make significant adverse adjustments to the reserve in the
future.
S-6
Risk factors
We may need but fail to obtain partners to support our stem
cell development efforts and to commercialize our technology.
Equity and debt financings alone may not be sufficient to fund
the cost of developing our stem cell technologies, and we may
need to rely on our ability to reach partnering arrangements to
provide financial support for our stem cell discovery and
development efforts. In addition, in order to successfully
develop and commercialize our technology, we may need to enter
into a wide variety of arrangements with corporate sponsors,
pharmaceutical companies, universities, research groups and
others. While we have engaged, and expect to continue to engage,
in discussions regarding such arrangements, we have not reached
any agreement, and we may fail to obtain any such agreement on
terms acceptable to us. Even if we enter into these
arrangements, we may not be able to satisfy our obligations
under them or renew or replace them after their original terms
expire. Furthermore, these arrangements may require us to grant
certain rights to third parties, including exclusive marketing
rights to one or more products, may require us to issue
securities to our collaborators or may contain other terms that
are burdensome to us. If any of our collaborators terminates its
relationship with us or fails to perform its obligations in a
timely manner, the development or commercialization of our
technology and potential products may be adversely affected.
Because the patient population for NCL, or Batten disease, is
very small, we may encounter difficulties in enrolling subjects
in our first planned clinical trial.
The first clinical application we are pursuing NCL (also
known as Batten disease) has a very small patient
population. From this small population, we must locate and
enroll patients that satisfy the specific enrollment criteria
for our planned clinical trial for this indication. This
clinical trial may be delayed significantly or terminated if we
are unable to enroll a sufficient number of qualified patients.
We have a history of operating losses, and we may fail to
obtain revenues or become profitable.
We expect to continue to incur substantial operating losses in
the future in order to conduct our research and development
activities, and, if those activities are successful, to fund
clinical trials and other expenses. These expenses include the
cost of acquiring technology, product testing, acquiring
regulatory approvals, establishing production, marketing, sales
and distribution programs and administrative expenses. We have
not earned any revenues from sales of any product. All of our
past revenues have been derived from, and any revenues we may
obtain for the foreseeable future are expected to be derived
from, cooperative agreements, research grants, investments and
interest on invested capital. We currently have no cooperative
agreements, we have only one current research grant for our stem
cell technology, and we may not obtain any such agreements or
additional grants in the future or receive any revenues from
them.
If we are unable to protect our patents and proprietary
rights, our business, financial condition and results of
operations will be harmed.
We own or license a number of patents and pending patent
applications related to various stem and progenitor cells and
methods of deriving and using them, including human neural stem
cell cultures. Patent protection for products such as those we
propose to develop is highly uncertain and involves complex and
continually evolving factual and legal questions. The
governmental authorities that consider patent applications can
deny or significantly reduce the patent coverage requested in an
application before or after issuing the patent. Consequently, we
do not know whether any of our pending applications will result
in the issuance of patents, if any existing or future patents
will provide sufficient protection or significant commercial
advantage or if others will circumvent these patents. We cannot
be certain that we were the first to discover the inventions
covered by each of our pending
S-7
Risk factors
patent applications or that we were the first to file patent
applications for such inventions because patent applications are
secret until they are published, and because publication of
discoveries in the scientific or patent literature often lags
behind actual discoveries. Patents may not issue from our
pending or future patent applications or, if issued, may not be
of commercial benefit to us. In addition, our patents may not
afford us adequate protection from competing products. Third
parties may challenge our patents or governmental authorities
may declare them invalid or reduce their scope. In the event
that a third party has also filed a patent application relating
to inventions claimed in our patent applications, we may have to
participate in proceedings to determine priority of invention.
Even if a patent issues, a court could decide that the patent
was issued invalidly. Because patents issue for a limited term,
our patents may expire before we utilize them profitably. Our
most important patents begin to expire in 2015. Under the
procedures of the European Patent Office, third parties may
oppose our issued European patents during the relevant
opposition period. These proceedings and oppositions could
result in substantial uncertainties and cost for us, even if the
eventual outcome is favorable to us, and the outcome might not
be favorable to us. One party has opposed two of our granted
European patents. Both oppositions were heard in 2005, and the
patents were maintained in somewhat altered form. The time for
appeal has not yet run and there can be no assurance that the
opposing party will not appeal. While we are confident that,
should the decision be appealed by the opposing party, it will
be upheld, there can be no guarantee of this. If we are
ultimately unsuccessful in our defense of the opposed patents,
all claimed rights in the opposed patents will be lost in
Europe. US counterparts to these patents are part of our issued
patent portfolio; they are not subject to opposition, since that
procedure does not exist under US patent law, but other types of
proceedings may be available to third parties to contest our US
patents. See Item 1. Business Patents,
Proprietary Rights and Licences and Item 3.
Legal proceedings in our Annual Report on
Form 10-K for our
fiscal year ending December 31, 2005.
If we learn of third parties who infringe our patent rights, we
may need to initiate legal proceedings to enforce our patent
rights. These proceedings may entail significant costs, and
these third parties may have significantly greater financial
resources than us. We may not prevail in these proceedings.
Proprietary trade secrets and unpatented know-how are also
important to our research and development activities. We cannot
be certain that others will not independently develop the same
or similar technologies on their own or gain access to our trade
secrets or disclose such technology or that we will be able to
meaningfully protect our trade secrets and unpatented know-how.
We require our employees, consultants, and significant
scientific collaborators and sponsored researchers to execute
confidentiality agreements upon the commencement of an
employment or consulting relationship with us. These agreements
may, however, fail to provide meaningful protection or adequate
remedies for us in the event of unauthorized use, transfer or
disclosure of such information or technology.
If others are first to discover and patent the stem cells we
are seeking to discover, we could be blocked from further work
on those stem cells.
Because the first person or entity to discover and obtain a
valid patent to a particular stem or progenitor cell may
effectively block all others, it will be important for us or our
collaborators to be the first to discover any stem cell that we
are seeking to discover. Failure to be the first could prevent
us from commercializing all of our research and development
affected by that patent.
If we are unable to obtain necessary licenses to third-party
patents and other rights, we may not be able to commercially
develop our expected products.
A number of pharmaceutical, biotechnology and other companies,
universities and research institutions have filed patent
applications or have received patents relating to cell therapy,
stem cells and other
S-8
Risk factors
technologies potentially relevant to or necessary for our
expected products. We cannot predict which, if any, of the
applications will issue as patents, and there may be existing
patents of which we are currently unaware which the
commercialization of our product candidates would infringe. If
third party patents or patent applications contain valid claims
that our technology infringes upon their technology, we may be
prevented from commercializing that technology unless the third
party is willing to grant a license to us. We may be unable to
obtain licenses to the relevant patents at a reasonable cost, if
at all, and may also be unable to develop or obtain alternative
non-infringing technology. If we are unable to obtain such
licenses or develop non-infringing technology at a reasonable
cost, our business could be significantly harmed. Also, any
infringement lawsuits commenced against us may result in
significant costs, divert our managements attention and
result in an award against us for substantial damages.
We are aware of intellectual property rights held by third
parties that relate to products or technologies we are
developing. For example, some aspects of our stem cell product
candidates involve the use of growth factors, antibodies and
other reagents that may, in certain cases, be the subject of
third party rights. Before we commercialize any product using
these growth factors, antibodies or reagents, we may need to
obtain license rights from third parties or use alternative
growth factors, antibodies and reagents that are not then the
subject of third party patent rights. We currently believe that
the commercialization of our products as currently planned will
not infringe these third party rights, or, alternatively, that
we will be able to obtain necessary licenses or otherwise use
alternate non-infringing technology. However, third parties may
nonetheless bring suit against us claiming infringement. If we
are unable to prove that our technology does not infringe their
patents, or if we are unable to obtain necessary licenses or
otherwise use alternative non-infringing technology, we may not
be able to commercialize any products. Also, if we use
alternative non-infringing technology, we may need to
demonstrate comparability in subsequent clinical trials.
We have obtained rights from universities and research
institutions to technologies, processes and compounds that we
believe may be important to the development of our products.
These licensors, however, may cancel our licenses or convert
them to non-exclusive licenses if we fail to use the relevant
technology or otherwise breach these agreements. Loss of these
licenses could expose us to the risk that our technology
infringes the rights of third parties. We can give no assurance
that any of these licenses will provide effective protection
against our competitors.
We compete with companies that have significant advantages
over us.
The market for therapeutic products to treat diseases of, or
injuries to, the central nervous system (CNS) is large, and
competition is intense. The majority of the products currently
on the market or in development are small molecule
pharmaceutical compounds. Many of the worlds large
pharmaceutical companies, including Merck, Pfizer, Abbott,
Bristol-Myers Squibb, Novartis and GlaxoSmithKline, have made
significant commitments to the CNS field. Any cell-based therapy
to treat diseases of, or injuries to, the CNS is likely to face
intense competition from the small molecule sector. In addition,
a number of biotechnology companies with resources far greater
than ours may also emerge as competitors. These include Genzyme,
Amgen, Cephalon, Shire Pharmaceuticals, BioMarin, Celgene,
Biogen Idec, and Titan Pharmaceuticals/ Schering AG. Finally, we
also expect to compete with smaller biotechnology companies,
such as NeuralStem, Geron, NeuroNova, ReNeuron, and ES Cell
International, some of which are privately owned.
We believe that our human neural stem cells may have application
to many or most of the Lysosomal Storage Diseases
(LSDs) with CNS involvement. We have received FDA
approval for our first IND to treat the infantile and late
infantile forms of NCL (also known as Batten disease), which are
among the LSDs that affect the CNS, and our Phase I
clinical trial is expected to begin at Doernbecher
Childrens Hospital at Oregon Health & Safety
University. There can be no assurance that the trial
S-9
Risk factors
will demonstrate either safety or efficacy of our HuCNS-SC.
There are, so far as we know, no approved therapies for Batten
disease or any of the other CNS-specific LSDs, but other
companies, including Genzyme, BioMarin, and Shire, have products
approved to treat peripheral aspects of some of the other LSDs,
and other products are in clinical trials.
In the liver field, there are no broad-based therapies for the
treatment of liver disease at present. The primary therapy is
liver transplantation, which is limited by the availability of
matched donor organs. Liver-assist devices, when and if they
become available, could also be used to help patients while they
await suitably matched organs for transplantation. In addition,
new therapies may become available before we successfully
develop a cell-based therapy for liver disease.
In the field of diabetes, a number of major companies currently
market products for the treatment of diabetes and are also
engaged in the research and development of new therapies. Such
companies include Eli Lilly, Novo Nordisk, J&J, Amylin,
ViaCell, and Serono. Consequently, should we successfully
develop a cell-based therapy for diabetes, we would expect to
face severe competition from these and similar companies.
Development of our technology is subject to and restricted by
extensive government regulation, which could impede our
business.
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 US Food and
Drug Administration and other necessary regulatory approvals is
lengthy, expensive and uncertain. We or our collaborators may
fail to obtain the necessary approvals to commence or continue
clinical testing or to manufacture or market our potential
products in reasonable time frames, if at all. In addition, the
US 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
and progenitor cells obtained from fetal tissue. The federal and
state governments and other jurisdictions impose restrictions on
the use of fetal tissue, including those incorporated in the
recent federal current 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 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 guidelines for cell procurement.
Certain components used to manufacture our stem cell product
candidates will need to be manufactured in compliance with the
FDAs Good Manufacturing Practices, or cGMP. Accordingly,
we will need to enter into supply agreements with companies that
manufacture these components to cGMP standards.
Although we do not use embryonic stem cells, government
regulation and threatened regulation of embryonic tissue may
lead top researchers to leave the field of stem cell research,
or the country, in order to assure that their careers will not
be impeded by restrictions on their work. Similarly, these
factors may induce the best graduate students to choose other
fields less vulnerable to changes in regulatory oversight, thus
exacerbating the risk, discussed below, that we may not be able
to attract and retain the scientific personnel we need in face
of the competition among pharmaceutical, biotechnology and
health care companies, universities and research institutions
for what may become a shrinking class of qualified individuals.
In addition, we cannot assure you that constraints on the use of
embryonic stem cells will not be extended to use of fetal stem
cells. Moreover, it is possible that
S-10
Risk factors
concerns regarding research using embryonic stem cells will
negatively impact our stock price and our ability to attract
collaborators and investors.
We may apply for status under the Orphan Drug Act for some of
our therapies to gain a seven-year period of marketing
exclusivity for those therapies. The US Congress in the past has
considered, and in the future again may consider, legislation
that would restrict the extent and duration of the market
exclusivity of an orphan drug. If enacted, such legislation
could prevent us from obtaining some or all of the benefits of
the existing statute even if we were to apply for and obtain
orphan drug status with respect to a potential product.
We are dependent on the services of key personnel.
We are highly dependent on the principal members of our
management and scientific staff and some of our outside
consultants, including the members of our scientific advisory
board, our chief executive officer, our vice presidents and the
director of our liver stem cell program. Although we have
entered into employment agreements with some of these
individuals, they may terminate their agreements at any time. In
addition, our operations are dependent upon our ability to
attract and retain additional qualified scientific and
management personnel. We may not be able to attract and retain
the personnel we need on acceptable terms given the competition
for experienced personnel among pharmaceutical, biotechnology
and health care companies, universities and research
institutions.
Our activities involve hazardous materials and experimental
animal testing; improper handling of these animals and materials
by our employees or agents could expose us to significant legal
and financial penalties.
Our research and development activities involve the controlled
use of hazardous chemicals and potentially hazardous biological
materials such as human tissue and animals. Their use subjects
us to environmental and safety laws and regulations such as
those governing laboratory procedures, exposure to blood-borne
pathogens, use of animals and the handling of biohazardous
materials. Compliance with current or future laws and
regulations may be expensive and the cost of compliance could
adversely affect us.
Although we believe that our safety procedures for using,
handling, storing and disposing of hazardous and potentially
hazardous materials comply with the standards prescribed by
California and federal regulations, the risk of accidental
contamination or injury from these materials cannot be
eliminated. In the event of such an accident or of any violation
of these or future laws and regulations, state or federal
authorities could curtail our use of these materials; we could
be liable for any civil damages that result, the cost of which
could be substantial; and we could be subjected to substantial
fines or penalties. In addition, any failure by us to control
the use, disposal, removal or storage, or to adequately restrict
the discharge, or to assist in the cleanup, of hazardous
chemicals or hazardous, infectious or toxic substances could
subject us to significant liability. Any such liability could
exceed our resources and could have a material adverse effect on
our business, financial condition and results of operations.
Moreover, an accident could damage our research and
manufacturing facilities and operations and result in serious
adverse effects on our business.
The manufacture, development and commercialization of stem
cell products expose us to product liability claims, which could
lead to substantial liability.
By developing and, ultimately, commercializing medical products,
we are exposed to the risk of product liability claims. Product
liability claims against us could entail substantial litigation
costs and damage awards against us. We are in the process of
obtaining liability insurance that covers our clinical trials,
and we will need to increase our insurance coverage if and when
we begin
S-11
Risk factors
commercializing products. We may not be able to obtain insurance
on acceptable terms, if at all, and the policy limits on our
insurance policies may be insufficient to cover our liability.
Since health care insurers and other organizations may not
pay for our products or may impose limits on reimbursements, our
ability to become profitable could be reduced.
In both domestic and foreign markets, sales of potential
products are likely to depend in part upon the availability and
amounts of reimbursement from third party health care payor
organizations, including government agencies, private health
care insurers and other health care payors, such as health
maintenance organizations and self-insured employee plans. There
is considerable pressure to reduce the cost of therapeutic
products, and government and other third party payors are
increasingly attempting to contain health care costs by limiting
both coverage and the level of reimbursement for new therapeutic
products and by refusing, in some cases, to provide any coverage
for uses of approved products for disease indications for which
the US Food and Drug Administration has not granted marketing
approval. Significant uncertainty exists as to the reimbursement
status of newly approved health care products or novel therapies
such as ours. Even if we obtain regulatory approval to market
our products, we can give no assurance that reimbursement will
be provided by such payors at all or without substantial delay
or, if such reimbursement is provided, that the approved
reimbursement amounts will be sufficient to enable us to sell
products we develop on a profitable basis. Changes in
reimbursement policies could also adversely affect the
willingness of pharmaceutical companies to collaborate with us
on the development of our stem cell technology. In certain
foreign markets, pricing or profitability of prescription
pharmaceuticals is subject to government control. We also expect
that there will continue to be a number of federal and state
proposals to implement government control over health care
costs. Efforts at health care reform are likely to continue in
future legislative sessions. We do not know what legislative
proposals federal or state governments will adopt or what
actions federal, state or private payers for health care goods
and services may take in response to health care reform
proposals or legislation. We cannot predict the effect
government control and other health care reforms may have on our
business.
We have limited liquidity and capital resources and may not
obtain the significant capital resources we will need to sustain
our research and development efforts.
We have limited liquidity and capital resources and must obtain
substantial additional capital to support our research and
development programs, for acquisition of technology and
intellectual property rights and, to the extent we decide to
undertake these activities ourselves, for preclinical and
clinical testing of our anticipated products, pursuit of
regulatory approvals, establishment of production capabilities,
maintaining and enforcing our intellectually property portfolio,
establishment of marketing and sales capabilities and
distribution channels, and general administrative expenses. If
we do not obtain the necessary capital resources, we may have to
delay, reduce or eliminate some or all of our research and
development programs or license our technology or any potential
products to third parties rather than commercialize them
ourselves. We intend to pursue our needed capital resources
through equity and debt financings, corporate alliances, grants
and collaborative research arrangements. We may fail to obtain
the necessary capital resources from any such sources when
needed or on terms acceptable to us. Our ability to complete
successfully any such arrangements will depend upon market
conditions and, more specifically, on continued progress in our
research and development efforts.
S-12
Risk factors
Ethical and other concerns surrounding the use of stem cell
therapy may negatively affect regulatory approval or public
perception of our product candidates, which could reduce demand
for our products.
The use of stem cells for research and therapy has been the
subject of debate regarding related ethical, legal and social
issues. Although these concerns have mainly been directed to the
use of embryonic stem cells, which we do not use, the
distinction between embryonic and non-embryonic stem cells is
frequently overlooked; moreover, our use of human stem cells
from fetal sources might raise these or similar concerns.
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. Also, existing regulatory
constraints on the use of embryonic stem cells may in the future
be extended to use of fetal stem cells, and these constraints
might prohibit or restrict us from conducting research or
commercializing products. Government regulation and threatened
regulation of embryonic tissue could also harm our ability to
attract and retain qualified scientific personnel by causing top
researchers to leave the country or the field of stem cell
research altogether; and by encouraging the best graduate
students to choose other fields that are less vulnerable to
changes in regulatory oversight.
Our corporate documents and Delaware law contain provisions
that may make it difficult for us to be acquired in a
transaction that would be beneficial to our shareholders.
Our board of directors has the authority to issue shares of
preferred stock and to fix the rights, preferences, privileges
and restrictions of these shares without shareholder approval.
In addition, we have adopted a rights plan that generally
permits our existing shareholders to acquire additional shares
at a substantial discount to the market price in the event of
certain attempts by third parties to acquire us. These rights,
along with certain provisions in our corporate documents and
Delaware law, may make it more difficult for a third party to
acquire us or discourage a third party from attempting to
acquire us, even if the acquisition might be beneficial to our
shareholders.
Risks Related to the Securities Market
Our stock price has been, and will likely continue to be,
highly volatile, which may negatively affect our ability to
obtain additional financing in the future.
The market price of our stock has been and is likely to continue
to be highly volatile due to the risks and uncertainties
described in this section of the prospectus, as well as other
factors, including:
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our ability to develop and test our technology; |
|
Ø |
our ability to patent or obtain licenses to necessary technology; |
|
Ø |
conditions and publicity regarding the industry in which we
operate, as well as the specific areas our product candidates
seek to address; |
|
Ø |
competition in our industry; |
|
Ø |
price and volume fluctuations in the stock market at large that
are unrelated to our operating performance; and |
|
Ø |
comments by securities analysts, or our failure to meet market
expectations. |
In September 2005 the Nasdaq Stock Market approved our
application to move the listing of our common stock from the
Nasdaq Capital Market (previously known as the Nasdaq SmallCap
Market) to the Nasdaq National Market. The stock began trading
on the Nasdaq National Market on September 30, 2005 under
the same symbol, STEM. Over the two-year period ended
December 31,
S-13
Risk factors
2005, the closing price of our common stock as reported on the
Nasdaq Markets ranged from a high of $6.77 to a low of $1.24. As
a result of this volatility, your investment in our stock is
subject to substantial risk. Furthermore, the volatility of our
stock price could negatively impact our ability to raise capital
in the future.
We are contractually obligated to issue shares in the future,
diluting the interest of current shareholders.
As of December 31, 2005, there were outstanding warrants to
purchase 2,521,400 shares of our common stock, at a
weighted average exercise price of $1.92 per share. As of
December 31, 2005, there were also outstanding options to
purchase 6,608,109 shares of our common stock, at a
weighted average exercise price of $3.02 per share.
Moreover, we expect to issue additional options to purchase
shares of our common stock to compensate employees, consultants
and directors, and may issue additional shares to raise capital,
to acquire other companies or technologies, to pay for services,
or for other corporate purposes. Any such issuances will have
the effect of diluting the interest of current shareholders.
S-14
Note regarding forward-looking statements
This prospectus supplement, the accompanying prospectus, any
free writing prospectus used in connection with this offering
and the documents incorporated by reference herein and therein
may contain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as
amended (the Securities Act), and Section 21E
of the Securities Exchange Act of 1934, as amended (the
Exchange Act). These statements may be identified by
the use of forward-looking words or phrases such as
anticipate, believe, could,
expect, intend, look
forward, may, planned,
potential, should, will and
would. These forward-looking statements reflect our
current expectations and are based upon currently available
data. The Private Securities Litigation Reform Act of 1995
provides a safe harbor for such forward-looking
statements. In order to comply with the terms of the safe
harbor, we note that a variety of factors could cause actual
results and experience to differ materially from the anticipated
results or other expectations expressed in the forward-looking
statements. Such statements include, without limitation, all
statements as to expectation or belief and statements as to our
future results of operations, the progress of our research,
product development and clinical programs, the need for, and
timing of, additional capital and capital expenditures,
partnering prospects, costs of manufacture of products, the
protection of and the need for additional intellectual property
rights, effects of regulations, the need for additional
facilities and potential market opportunities.
S-15
Use of proceeds
We estimate that the net proceeds from the sale of the
11,750,820 shares of common stock we are offering will be
approximately $33.2 million, assuming that we sell the
maximum number of shares 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 shares sold, placement agent fees and
proceeds to us are not presently determinable and may be
substantially less than the maximum amount set forth above.
We intend to use the net proceeds of our sales of common stock
in this offering for general corporate purposes, including
working capital, product development and capital expenditures. A
portion of the net proceeds may also be used for the acquisition
of businesses, products and technologies that are complementary
to ours, or for other strategic purposes. There are currently no
commitments or agreements with respect to any such material
acquisition.
Price range of common stock
Our common stock trades on The Nasdaq National Market under the
symbol STEM. From the time that public trading of
our common stock commenced on April 1, 1992 until
December 22, 2002 and since September 30, 2005, our
common stock has traded on The Nasdaq National Market. Our
common stock was traded on The Nasdaq Capital Market (previously
known as The Nasdaq SmallCap Market) between December 23,
2002 and September 29, 2005. The following table sets
forth, for the periods indicated, the high and low intraday
sales prices per share of our common stock as reported by The
Nasdaq National Market and The Nasdaq Capital Market, as
applicable. These prices do not include retail markups,
markdowns or commissions.
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|
|
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|
|
|
|
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High | |
|
Low | |
| |
Fiscal year ended December 31, 2004
|
|
|
|
|
|
|
|
|
|
First quarter
|
|
$ |
2.69 |
|
|
$ |
1.56 |
|
|
Second quarter
|
|
|
2.20 |
|
|
|
1.30 |
|
|
Third quarter
|
|
|
1.87 |
|
|
|
1.24 |
|
|
Fourth quarter
|
|
|
4.87 |
|
|
|
1.53 |
|
Fiscal year ended December 31, 2005
|
|
|
|
|
|
|
|
|
|
First quarter
|
|
$ |
6.77 |
|
|
$ |
3.00 |
|
|
Second quarter
|
|
|
4.60 |
|
|
|
2.59 |
|
|
Third quarter
|
|
|
6.58 |
|
|
|
4.20 |
|
|
Fourth quarter
|
|
|
5.54 |
|
|
|
3.40 |
|
Fiscal year ending December 31, 2006
|
|
|
|
|
|
|
|
|
|
First quarter
|
|
$ |
4.07 |
|
|
$ |
3.45 |
|
The last reported sales price of our common stock on The Nasdaq
National Market on March 31, 2006 was $3.58 per share.
As of December 31, 2005, there were outstanding
65,396,022 shares of our common stock.
S-16
Dividend policy
We have never declared or paid any cash dividends on our common
stock. We anticipate that we will continue to retain our
earnings, if any, for use in the operation of our business.
Accordingly, we do not expect to pay any cash dividends on our
common stock for the foreseeable future.
S-17
Capitalization
The following table sets forth our cash and cash equivalents and
capitalization as of December 31, 2005:
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Ø |
on an actual basis; and |
|
Ø |
on an adjusted basis to give effect to the sale of
11,750,820 shares of our common stock, the maximum number
of shares we are offering pursuant to this prospectus
supplement, at an offering price of $3.05 per share, after
deducting placement agent fees and estimated offering expenses
payable by us. |
|
|
|
|
|
|
|
|
|
|
|
|
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As of | |
|
|
December 31, 2005 | |
|
|
| |
|
|
Actual | |
|
As adjusted | |
| |
|
|
(in thousands, except share | |
|
|
and per share data) | |
Cash and cash equivalents
|
|
$ |
34,541 |
|
|
$ |
67,731 |
|
|
|
|
|
|
|
|
Long-term obligations, less current portion
|
|
$ |
8,915 |
|
|
$ |
8,915 |
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
Common stock, $0.01 par value per share;
125,000,000 shares authorized; 65,396,022 shares
issued and outstanding, actual; 77,146,842 shares issued
and outstanding, as adjusted
|
|
|
654 |
|
|
|
772 |
|
|
Additional paid in capital
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|
|
217,919 |
|
|
|
250,991 |
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|
Accumulated deficit
|
|
|
(185,944 |
) |
|
|
(185,944 |
) |
|
Accumulated other comprehensive loss
|
|
|
(254 |
) |
|
|
(254 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
32,375 |
|
|
|
65,565 |
|
|
|
|
|
|
|
|
Total capitalization
|
|
$ |
41,290 |
|
|
$ |
74,480 |
|
|
|
|
|
|
|
|
Because there is no minimum offering amount required as a
condition to the closing of this offering, the actual number of
shares sold, the proceeds to us and our capitalization after
this offering are not presently determinable and may be
substantially different from the amounts set forth above.
The number of shares of common stock shown above to be
outstanding after this offering is based on the
65,396,022 shares outstanding as of December 31, 2005
and excludes:
|
|
Ø |
6,608,109 shares of our common stock subject to options
outstanding as of December 31, 2005 having a weighted
average exercise price of $3.02 per share; |
|
Ø |
1,583,543 shares of our common stock that have been
reserved for issuance in connection with future grants under our
stock option plans as of December 31, 2005; and |
|
Ø |
2,521,400 shares of our common stock that have been
reserved for issuance upon exercise of outstanding warrants as
of December 31, 2005 having a weighted average exercise
price of $1.92 per share. |
S-18
Dilution
If you invest in our common stock, you will experience dilution
to the extent of the difference between the price per share you
pay in this offering and the net tangible book value per share
of our common stock immediately after this offering. Our net
tangible book value as of December 31, 2005 was
approximately $31.4 million, or $0.48 per share of
common stock. Net tangible book value per share is equal to our
total tangible assets minus total liabilities, all divided by
the number of shares of common stock outstanding as of
December 31, 2005. Assuming we sell 11,750,820 shares
of common stock, the maximum number of shares we are offering
pursuant to this prospectus supplement, at an offering price of
$3.05 per share, and after deducting placement agency fees
and our estimated offering expenses, our as adjusted net
tangible book value would have been approximately
$64.6 million, or approximately $0.84 per share of
common stock, as of December 31, 2005. This represents an
immediate increase in net tangible book value of approximately
$0.36 per share to existing stockholders and an immediate
dilution of approximately $2.21 per share to new investors.
The following table illustrates this calculation on a per share
basis:
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|
Offering price per share
|
|
|
|
|
|
$ |
3.05 |
|
|
Net tangible book value per share as of December 31, 2005
|
|
$ |
0.48 |
|
|
|
|
|
|
Increase per share attributable to the offering
|
|
|
0.36 |
|
|
|
|
|
|
|
|
|
|
|
|
As adjusted net tangible book value per share after this offering
|
|
|
|
|
|
|
0.84 |
|
|
|
|
|
|
|
|
Dilution per share to new investors
|
|
|
|
|
|
$ |
2.21 |
|
|
|
|
|
|
|
|
Because there is no minimum offering amount required as a
condition to the closing of this offering, the dilution per
share to new investors may be more than that indicated above in
the event that the actual number of shares sold, if any, is less
than the maximum number of shares we are offering.
The number of shares of common stock outstanding used for
existing stockholders in the table and calculations above is
based on 65,396,022 shares outstanding as of
December 31, 2005 and excludes:
|
|
Ø |
6,608,109 shares of our common stock subject to options
outstanding as of December 31, 2005 having a weighted
average exercise price of $3.02 per share; |
|
Ø |
1,583,543 shares of our common stock that have been
reserved for issuance in connection with future grants under our
stock option plans as of December 31, 2005; and |
|
Ø |
2,521,400 shares of our common stock that have been
reserved for issuance upon exercise of outstanding warrants as
of December 31, 2005 having a weighted average exercise
price of $1.92 per share. |
The exercise of outstanding options and warrants having an
exercise price less than the offering price will increase
dilution to new investors.
S-19
Plan of distribution
Pursuant to a placement agency agreement between us and UBS
Securities LLC, we have engaged UBS Securities LLC as our
exclusive placement agent to solicit offers to purchase our
common stock in this offering. The placement agent is not
purchasing or selling any of the shares we are offering, and it
is not required to arrange the purchase or sale of any specific
number or dollar amount of common stock, but it has agreed to
use reasonable efforts to arrange for the sale of the shares.
The placement agent proposes to arrange for the sale of the
shares of common stock we are offering pursuant to this
prospectus supplement to one or more investors through purchase
agreements directly between the purchasers and us. All of the
shares will be sold at the same price and, we expect, at a
single closing. 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
and other factors. It is possible that not all of the shares we
are offering pursuant to this prospectus supplement will be sold
at the closing, in which case our net proceeds would be reduced.
We expect that the sale of the shares will be completed on the
date indicated on the cover page of this prospectus supplement.
In connection with this offering, the placement agent may
distribute this prospectus supplement and the accompanying
prospectus electronically.
We will pay the placement agent a placement agent fee equal to
6.0% of the gross proceeds of this offering. The following table
shows the per share and total placement agent fees we will pay
to the placement agent in connection with the sale of the
shares, assuming the purchase of all of the shares we are
offering.
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Per share
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$ |
0.183 |
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Total
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$ |
2,150,400 |
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Because there is no minimum offering amount required as a
condition to the closing of this offering, the actual total
placement agent fees are not presently determinable and may be
substantially less than the maximum amount set forth above, but
we have agreed to pay a minimum total placement agent fee of
$1.0 million. In addition, we have granted the placement
agent a right of first refusal until September 2006 to act as
sole book-running lead manager for any public offering of our
equity, equity-linked or debt securities.
We estimate the total expenses of this offering which will be
payable by us, excluding the placement agent fees, will be
approximately $500,000.
Investors in this offering will pay the purchase price of the
shares directly to us.
UBS Securities LLC, in its capacity as placement agent, may be
deemed to be an underwriter for purposes of the Securities Act.
NO SALES OF SIMILAR SECURITIES
We and our executive officers and directors have entered into
lock-up agreements with
the placement agent. Under these agreements, we and each of
these persons may not, without the prior written approval of the
placement agent, subject to exceptions, offer, sell, contract to
sell or otherwise dispose of or hedge our common stock or
securities convertible into or exercisable or exchangeable for
our common stock. These restrictions will be in effect for a
period of 90 days after the date of this prospectus
supplement. However, these restrictions do not prohibit us from
issuing securities in
S-20
Plan of distribution
connection with a partnership, research, licensing,
collaboration, joint venture or similar arrangement, or an
acquisition of another business or entity or its stock, assets
or technology, so long as the recipients agree to be locked up
for the remainder of the
lock-up period. In
addition, the maximum number of shares of common stock we may
issue during the
lock-up period pursuant
to these transactions is limited to 20% of the number of shares
of common stock outstanding immediately before the first of such
transactions. At any time and without public notice, the
placement agent may in its sole discretion release all or some
of the securities from these
lock-up agreements.
INDEMNIFICATION AND CONTRIBUTION
We have agreed to indemnify the placement agent and its
controlling persons against certain liabilities, including
liabilities under the Securities Act. If we are unable to
provide this indemnification, we will contribute to payments the
placement agent and its controlling persons may be required to
make in respect of those liabilities.
NASDAQ NATIONAL MARKET QUOTATION
Our common stock is quoted on The Nasdaq National Market under
the symbol STEM.
PRICE STABILIZATION
In connection with this offering, the placement agent may engage
in activities that stabilize, maintain or otherwise affect the
price of our common stock. These activities may maintain the
market price of our common stock at a level above that which
might otherwise prevail in the open market. The placement agent
is not required to engage in these activities and, if commenced,
may end any of these activities at any time. The placement agent
may carry out these transactions on The Nasdaq National Market,
in the over-the-counter
market or otherwise.
In addition, in connection with this offering, the placement
agent may engage in passive market making transactions in our
common stock on The Nasdaq National Market prior to the pricing
and completion of this offering. Passive market making consists
of displaying bids on The Nasdaq National Market no higher than
the bid prices of independent market makers and making purchases
at prices no higher than these independent bids and effected in
response to order flow. Net purchases by a passive market maker
on each day are generally limited to a specified percentage of
the passive market makers average daily trading volume in
the common stock during a specified period and must be
discontinued when such limit is reached. Passive market making
may cause the price of our common stock to be higher than the
price that otherwise would exist in the open market in the
absence of these transactions. If passive market making is
commenced, it may be discontinued at any time.
AFFILIATIONS
The placement agent and its affiliates have provided and may
provide certain commercial banking, financial advisory and
investment banking services for us for which they receive fees.
The placement agent and its affiliates may from time to time in
the future engage in transactions with us and perform services
for us in the ordinary course of their business.
S-21
Where you can find more information
We file annual, quarterly and current reports, proxy statements
and other information with the SEC. Our SEC filings are
available to the public over the Internet at the SECs
website at http://www.sec.gov. The SECs website
contains reports, proxy and information statements and other
information regarding issuers, such as us, that file
electronically with the SEC. You may also read and copy any
document we file with the SEC at the SECs Public Reference
Room at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You may also obtain copies of these
documents at prescribed rates by writing to the SEC. Please call
the SEC at
1-800-SEC-0330 for
further information on the operation of its Public Reference
Room.
Incorporation of certain documents by reference
The SEC allows us to incorporate by reference into
this prospectus supplement the information we have filed with
the SEC. The information we incorporate by reference into this
prospectus supplement is an important part of this prospectus
supplement. Any statement in a document we incorporate by
reference into this prospectus supplement or the accompanying
prospectus will be considered to be modified or superseded to
the extent a statement contained in this prospectus supplement
or any other subsequently filed document that is incorporated by
reference into this prospectus supplement modifies or supersedes
that statement. The modified or superseded statement will not be
considered to be a part of this prospectus supplement or
accompanying prospectus, as applicable, except as modified or
superseded.
We incorporate by reference into this prospectus supplement the
information contained in the documents listed below, which is
considered to be a part of this prospectus supplement:
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our Annual Report on
Form 10-K for the
year ended December 31, 2005, including any amendment filed
for the purpose of updating such Annual Report; and |
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the description of our common stock and related rights contained
in our registration statements on
Form 8-A (file no.
000-19871) filed under the Exchange Act, including any amendment
or report filed for the purpose of updating such description. |
We also incorporate by reference all documents filed pursuant to
Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act
after the date of this prospectus supplement and prior to the
termination of this offering; provided, however, that we are not
incorporating any information furnished under Item 2.02,
Item 7.01 or Item 9.01 of any current report on
Form 8-K we may
subsequently file.
Statements made in this prospectus supplement or the
accompanying prospectus or in any document incorporated by
reference in this prospectus supplement or the accompanying
prospectus as to the contents of any contract or other document
referred to herein or therein are not necessarily complete, and
in each instance reference is made to the copy of such contract
or other document filed as an exhibit to the documents
incorporated by reference, each such statement being qualified
in all material respects by such reference.
S-22
You may request a copy of these filings, at no cost, by writing
or telephoning us at the following address:
StemCells, Inc.
3155 Porter Drive
Palo Alto, CA 94304
Attention: Investor Relations
Phone: (650) 475-3100
email: irpr@stemcellsinc.com
Copies of these filings are also available, without charge, on
our Internet website at www.stemcellsinc.com after they
are filed electronically with the SEC.
S-23
Legal matters
Various legal matters with respect to the validity of the shares
of common stock offered by this prospectus supplement will be
passed upon for us by Ropes & Gray LLP. Dewey
Ballantine LLP is counsel for the placement agent in connection
with this offering.
Experts
The financial statements and managements assessment of the
effectiveness of internal control over financial reporting
incorporated by reference in this prospectus and elsewhere in
the registration statement have been audited by Grant Thornton
LLP, independent registered public accountants, as indicated in
their reports with respect thereto, and are included herein in
reliance upon the authority of said firm as experts in giving
said reports.
S-24
PROSPECTUS
$100,000,00
StemCells, Inc.
Common Stock
We may sell from time to time up to $100,000,000 of our common
stock in one or more transactions. We will provide specific
terms of these securities and offerings in supplements to this
prospectus. You should read this prospectus and any supplement
carefully before you invest.
The securities offered in this prospectus involve a high
degree of risk. You should carefully consider the Risk
Factors set forth herein beginning on page 2 and in
our future filings made with the Securities and Exchange
Commission, which are incorporated by reference in this
prospectus, in determining whether to purchase our
securities.
Our common stock is currently listed on the Nasdaq National
Market with the ticker symbol: STEM. On
October 31, 2005, the closing price of one share of our
common stock on the Nasdaq National Market was $4.57.
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.
The date of this Prospectus is November 16, 2005.
You should rely only on the information contained or
incorporated by reference in this prospectus. We have not
authorized anyone to provide you with different information.
This prospectus may only be used where it is legal to sell these
securities. You should not assume that the information contained
in this prospectus is accurate as of any date other than the
date on the front of this prospectus. Our business, financial
condition, results of operations and prospects may have changed
since that date.
TABLE OF CONTENTS
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i
Summary
The following summary is qualified in its entirety by the
more detailed information and financial statements appearing
elsewhere or incorporated by reference in this prospectus.
Without limiting the generality of the foregoing, prospective
investors should carefully consider factors set forth under the
caption Risk Factors below.
OUR COMPANY
We are engaged in research aimed at the development of therapies
that would use stem and progenitor cells to treat, and possibly
cure, human diseases and injuries such as neurodegenerative
diseases (for instance, Batten, Parkinsons, and
Alzheimers diseases, and other metabolic genetic
disorders), demyelinating disorders (for instance, Multiple
Sclerosis), spinal cord injuries, stroke, hepatitis, chronic
liver failure, and diabetes. We believe that our stem cell
technologies, if successfully developed, may provide the basis
for effective therapies for these and other conditions. Our aim
is to return patients to productive lives and significantly
reduce the substantial health care costs often associated with
these diseases and disorders. The body uses certain key cells
known as stem cells to produce all the functional mature cell
types found in normal organs of healthy individuals. Progenitor
cells are cells that have already developed from the stem cells,
but can still produce one or more types of mature cells within
an organ. We use cells derived from fetal or adult tissue
sources, and are not developing embryonic stem cells for
therapeutic use. Neither are we involved in any activity
directed toward human cloning; our programs are all directed
toward the use of tissue-derived cells for treating or curing
diseases and injuries.
Many diseases, such as Alzheimers, Parkinsons,
lysosomal storage diseases and other degenerative diseases of
the brain or nervous system, involve the failure of organs that
cannot be transplanted. Other diseases, such as hepatitis and
diabetes, involve organs such as the liver or pancreas that can
be transplanted, but there is a very limited supply of those
organs available for transplant. We estimate that these neural,
liver and pancreatic conditions affect more than 50 million
people in the United States and account for more than
$300 billion annually in health care costs.
Our stem cell discovery engine relies upon our
state-of-the-art cell
sorting capabilities and our library of known and proprietary
monoclonal antibodies to human proteins. Using this library of
monoclonal antibodies, we have successfully identified,
purified, and characterized the human central nervous system
stem cell. We have also used our proprietary monoclonal
antibodies to make significant advances in our search for stem
or progenitor cells of the liver and the pancreas. We have
established an intellectual property position in all three areas
of our stem cell research the nervous system, the liver
and the pancreas by patenting our discoveries and entering
into exclusive in-licensing arrangements. We believe that, if
successfully developed, our platform of stem cell technologies
may create the basis for therapies that would address a number
of conditions with significant unmet medical needs. We are
concentrating our efforts on the preclinical and clinical
development of our neural stem cell program and research
endeavors in characterizing the candidate stem/progenitor cells
for the liver and pancreas programs.
In late December 2004, we submitted our first Investigational
New Drug application (IND) to the U.S. Food and Drug
Administration (FDA) for a clinical trial using our
proprietary human neural stem cells to treat Batten disease. On
October 19, 2005, the Company received clearance from the
FDA to begin a Phase I safety and preliminary efficacy
trial. The Company plans to seek Institutional Review Board
(IRB) approval from a number of leading medical
institutions. Such approval is needed before the clinical trial
may begin.
Our principal executive offices are located at StemCells, Inc.,
3155 Porter Drive, Palo Alto, CA 94304 and our phone number is
(650) 475-3100.
1
Risk factors
Investing in our common stock is risky. In addition to the
other information in this prospectus, the following risk factors
should be considered carefully in evaluating us and our
business. If any of the following risks were to occur, our
business, financial condition or results of operations would
likely suffer. In that event, the trading price of our common
stock could decline, and you could lose all or a part of your
investment.
RISKS RELATED TO OUR BUSINESS
Our financial situation is precarious and, based on currently
estimated operating expenses, our existing capital resources may
not be sufficient to fund our operations beyond 2006.
We have incurred significant operating losses and negative cash
flows since inception. We have not achieved profitability and
may not be able to realize sufficient revenues to achieve or
sustain profitability in the future. We do not expect to be
profitable in the next several years, but rather expect to incur
additional operating losses. We have limited liquidity and
capital resources and must obtain significant additional capital
resources in order to sustain our product development efforts
and for acquisition of technologies and intellectual property
rights, preclinical and clinical testing of our anticipated
products, pursuit of regulatory approvals, acquisition of
capital equipment, laboratory and office facilities,
establishment of production capabilities, general and
administrative expenses and other working capital requirements.
We rely on cash reserves and proceeds from equity and debt
offerings, proceeds from the transfer or sale of our
intellectual property rights, equipment, facilities or
investments, and government grants and funding from
collaborative arrangements, if obtainable, to fund our
operations. If we exhaust our cash reserves and are unable to
realize adequate financing, we may be unable to meet operating
obligations and be required to initiate bankruptcy proceedings.
Our existing capital resources may not be sufficient to fund our
operations beyond 2006. The financial statements do not include
any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and
classification of liabilities that may result from the outcome
of this uncertainty.
We intend to pursue opportunities to obtain additional financing
in the future through equity and debt financings, grants and
collaborative research arrangements. The source, timing and
availability of any future financing will depend principally
upon market conditions, interest rates and, more specifically,
on our progress in our exploratory, preclinical and future
clinical development programs. Funding may not be available when
needed at all or on terms acceptable to us. Lack of
necessary funds may require us to delay, scale back or eliminate
some or all of our research and product development programs
and/or our capital expenditures or to license our potential
products or technologies to third parties.
Institutional Review Boards (IRBs) at the clinical sites to
which we apply may fail to approve the clinical protocol for our
Phase I clinical trial of our proprietary neural cell
therapy product in Batten disease.
We filed our first Investigational New Drug application, or IND,
with the U.S. Food and Drug Administration (FDA) in
late December 2004 for our proposed Phase I clinical trial
of our proprietary neural cell therapy product HuCNS
SC to treat Batten disease. The FDA recently informed us
that it has approved our IND. We plan to seek Institutional
Review Board (IRB) approval from a number of leading
medical institutions. Such approval is needed before the
clinical trial may begin. There can be no guarantee that we will
obtain IRB approval.
2
Risk factors
Our technology is at an early stage of discovery and
development, and we may fail to develop any commercially
acceptable products.
We have yet to develop any products. Our stem cell technology is
still at the discovery phase for the liver and pancreas stem
cells and, while the FDA has approved our IND with respect to
our human neural (brain) stem cells, as described above we
need to obtain IRB approval before we can proceed with our
clinical trial.
We may fail to discover the stem cells we are seeking, to
develop any products, to obtain regulatory approvals, to enter
clinical trials, or to commercialize any products. Any product
using stem cell technology may fail to:
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survive and persist in the desired location; |
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provide the intended therapeutic benefits; |
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properly integrate into existing tissue in the desired
manner; or |
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achieve therapeutic benefits equal to or better than the
standard of treatment at the time of testing. |
In addition, our products may cause undesirable side effects.
Results of early pre-clinical research may not be indicative of
the results that will be obtained in later stages of
pre-clinical or clinical research. If regulatory authorities do
not approve our products or if we fail to maintain regulatory
compliance, we would have limited ability to commercialize our
products, and our business and results of operations would be
harmed. Furthermore, because stem cells are a new form of
therapy, the marketplace may not accept any products we may
develop. If we do succeed in developing products, we will face
many potential obstacles such as the need to obtain regulatory
approvals and to develop or obtain manufacturing, marketing and
distribution capabilities. In addition, we will face substantial
additional risks such as product liability claims.
Moreover, because our cell therapy treatments will be derived
from tissue of individuals other than the patient (that is, they
will be non-self or allogeneic
transplant products), patients will require the use of
immunosuppressive drugs such as cyclosporine, FK506, or others
to prevent rejection of the cells. While immunosuppression is
now standard in connection with allogeneic transplants of
various kinds, long-term maintenance on immunosuppressive drugs
can produce complications that include infection, cancer,
cardiovascular disease, renal dysfunction and other side effects
depending upon which immunosuppressive regimen is employed.
Immunosuppression has not been tested with our therapies since
we have not yet conducted any clinical trials.
We have payment obligations resulting from real property
owned or leased by us in Rhode Island, which diverts funding
from our stem cell research and development.
Prior to our reorganization in 1999 and the consolidation of our
business in California, we carried out our former encapsulated
cell therapy programs in Lincoln, Rhode Island, where we also
had our administrative offices. Although we have vacated the
Rhode Island facilities, we remain obligated to make lease
payments and payments for operating costs of approximately
$1,450,000 per year before sub-tenant rent income for our
former science and administrative facility, which we have leased
through June 30, 2013, and debt service payments and
payments for operating costs of approximately $500,000 per
year for our former encapsulated cell therapy pilot
manufacturing facility, which we own. We have currently
subleased a portion of the science and administrative facility,
and are seeking to sublease the remaining portion, but we cannot
be sure that we will be able to keep any part of the facility
subleased for the duration of our obligation. We have currently
subleased the entire pilot manufacturing facility to a
privately-held biotechnology company, but may not be able to
sublease or sell the facility in the future once the current
sublease agreements expire. These continuing costs
3
Risk factors
significantly reduce our cash resources and adversely affect our
ability to fund further development of our stem cell technology.
In addition, changes in real estate market conditions and
assumptions regarding the length of time it may take us to
either fully sublease, assign or sell our remaining interest in
the our former research facility in Rhode Island may have a
significant impact on and cause large variations in our quarter
to quarter results of operations. In 1999, in connection with
exiting our former research facility in Rhode Island, we created
a reserve for the estimated lease payments and operating
expenses related to it. The reserve has been re-evaluated and
adjusted based on assumptions relevant to real estate market
conditions and the estimated time until we could either fully
sublease, assign or sell our remaining interests in the
property. At September 30, 2005, the reserve was
$5,520,000. The Company incurred $845,000 in operating expenses
for the nine month period ending September 30, 2005, which
was recorded against the reserve. Expenses for this facility
will fluctuate based on changes in tenant occupancy rates and
other operating expenses related to the lease. Even though it is
our intent to sublease, assign, sell or otherwise divest
ourselves of our interests in the facility at the earliest
possible time, we cannot determine with certainty a fixed date
by which such events will occur. In light of this uncertainty,
based on estimates, we will periodically re-evaluate and adjust
the reserve, as necessary.
We may need but fail to obtain partners to support our stem
cell development efforts and to commercialize our technology.
Equity and debt financings alone may not be sufficient to fund
the cost of developing our stem cell technologies, and we may
need to rely on our ability to reach partnering arrangements to
provide financial support for our stem cell discovery and
development efforts. In addition, in order to successfully
develop and commercialize our technology, we may need to enter
into a wide variety of arrangements with corporate sponsors,
pharmaceutical companies, universities, research groups and
others. While we have engaged, and expect to continue to engage,
in discussions regarding such arrangements, we have not reached
any agreement, and we may fail to obtain any such agreement on
terms acceptable to us. Even if we enter into these
arrangements, we may not be able to satisfy our obligations
under them or renew or replace them after their original terms
expire. Furthermore, these arrangements may require us to grant
certain rights to third parties, including exclusive marketing
rights to one or more products, may require us to issue
securities to our collaborators or may contain other terms that
are burdensome to us. If any of our collaborators terminates its
relationship with us or fails to perform its obligations in a
timely manner, the development or commercialization of our
technology and potential products may be adversely affected.
We have a history of operating losses, and we may fail to
obtain revenues or become profitable.
We expect to continue to incur substantial operating losses in
the future in order to conduct our research and development
activities, and, if those activities are successful, to fund
clinical trials and other expenses. These expenses include the
cost of acquiring technology, product testing, acquiring
regulatory approvals, establishing production, marketing, sales
and distribution programs and administrative expenses. We have
not earned any revenues from sales of any product. All of our
past revenues have been derived from, and any revenues we may
obtain for the foreseeable future are expected to be derived
from, cooperative agreements, research grants, investments and
interest on invested capital. We currently have no cooperative
agreements, we have only one current research grant for our stem
cell technology, and we may not obtain any such agreements or
additional grants in the future or receive any revenues from
them.
4
Risk factors
If we are unable to protect our patents and proprietary
rights, our business, financial condition and results of
operations will be harmed.
We own or license a number of patents and pending patent
applications related to various stem and progenitor cells and
methods of deriving and using them, including human neural stem
cell cultures. Patent protection for products such as those we
propose to develop is highly uncertain and involves complex and
continually evolving factual and legal questions. The
governmental authorities that consider patent applications can
deny or significantly reduce the patent coverage requested in an
application before or after issuing the patent. Consequently, we
do not know whether any of our pending applications will result
in the issuance of patents, if any existing or future patents
will provide sufficient protection or significant commercial
advantage or if others will circumvent these patents. We cannot
be certain that we were the first to discover the inventions
covered by each of our pending patent applications or that we
were the first to file patent applications for such inventions
because patent applications are secret until they are published
and because publication of discoveries in the scientific or
patent literature often lags behind actual discoveries. Patents
may not issue from our pending or future patent applications or,
if issued, may not be of commercial benefit to us. In addition,
our patents may not afford us adequate protection from competing
products. Third parties may challenge our patents or
governmental authorities may declare them invalid. In the event
that a third party has also filed a patent application relating
to inventions claimed in our patent applications, we may have to
participate in proceedings to determine priority of invention.
This could result in substantial uncertainties and cost for us,
even if the eventual outcome is favorable to us, and the outcome
might not be favorable to us. Even if a patent issues, a court
could decide that the patent was issued invalidly. Further,
patents issue for a limited term, and our patents may expire
before we utilize them profitably. Under the procedures of the
European Patent Office, third parties may oppose our issued
European patents during the relevant opposition period. Such
oppositions could result in substantial uncertainties and cost
for us, even if the eventual outcome is favorable to us, and the
outcome might not be favorable to us. One party has opposed two
of our granted European patents. If we are unsuccessful in our
defense of the opposed patents, all claimed rights in the
opposed patents will be lost in Europe.
Proprietary trade secrets and unpatented know-how are also
important to our research and development activities. We cannot
be certain that others will not independently develop the same
or similar technologies on their own or gain access to our trade
secrets or disclose such technology or that we will be able to
meaningfully protect our trade secrets and unpatented know-how.
We require our employees, consultants, and significant
scientific collaborators and sponsored researchers to execute
confidentiality agreements upon the commencement of an
employment or consulting relationship with us. These agreements
may, however, fail to provide meaningful protection or adequate
remedies for us in the event of unauthorized use, transfer or
disclosure of such information or technology.
If others are first to discover and patent the stem cells we
are seeking to discover, we could be blocked from further work
on those stem cells.
Because the first person or entity to discover and obtain a
valid patent to a particular stem or progenitor cell may
effectively block all others, it will be important for us or our
collaborators to be the first to discover any stem cell that we
are seeking to discover. Failure to be the first could prevent
us from commercializing all of our research and development
affected by that patent.
5
Risk factors
If we are unable to obtain necessary licenses to third-party
patents and other rights, we may not be able to commercially
develop our expected products.
A number of pharmaceutical, biotechnology and other companies,
universities and research institutions have filed patent
applications or have received patents relating to cell therapy,
stem cells and other technologies potentially relevant to or
necessary for our expected products. We cannot predict which, if
any, of the applications will issue as patents. If third party
patents or patent applications contain valid claims that our
technology infringes upon their technology, we may be unable to
obtain licenses to these patents at a reasonable cost, if at
all, and may also be unable to develop or obtain alternative
technology. If we are unable to obtain such licenses at a
reasonable cost, our business could be significantly harmed. We
have obtained rights from universities and research institutions
to technologies, processes and compounds that we believe may be
important to the development of our products. These licensors,
however, may cancel our licenses or convert them to
non-exclusive licenses if we fail to use the relevant technology
or otherwise breach these agreements. Loss of these licenses
could expose us to the risks of third-party patents and/or
technology. We can give no assurance that any of these licenses
will provide effective protection against our competitors.
We compete with companies that have significant advantages
over us.
The market for therapeutic products to treat diseases of, or
injuries to, the central nervous system (CNS) is large, and
competition is intense. The majority of the products currently
on the market or in development are small molecule
pharmaceutical compounds. Many of the worlds large
pharmaceutical companies, including Merck, Pfizer, Abbott,
Bristol-Myers Squibb, Novartis and GlaxoSmithKline, have made
significant commitments to the CNS field. Any cell-based therapy
to treat diseases of, or injuries to, the CNS is likely to face
intense competition from the small molecule sector. In addition,
a number of biotechnology companies with resources far greater
than ours may also emerge as competitors. These include Genzyme,
Amgen, Cephalon, Shire Pharmaceuticals, BioMarin, Celgene,
Biogen Idec, and Titan Pharmaceuticals/ Schering AG. Finally, we
also expect to compete with smaller biotechnology companies,
such as NeuralStem, Geron, NeuroNova, ReNeuron, and ES Cell
International, some of which are privately owned.
We believe that our human neural stem cells may have application
to many or most of the Lysosomal Storage Diseases
(LSDs) with CNS involvement. We have received
approval for our first IND to treat the Infantile and Late
Infantile forms of Batten disease, which are among the LSDs that
affect the CNS. However, we will need to obtain IRB approval
prior to initiating our clinical trial, and we have no assurance
as to when IRB approval will be obtained. There are, so far as
we know, no approved therapies for Batten Disease or any of the
other CNS-specific LSDs, but other companies, including Genzyme,
BioMarin, and Shire, have products approved to treat peripheral
aspects of some of the other LSDs, and other products are in
clinical trials.
In the field of diabetes, a number of major companies currently
market products for the treatment of diabetes and are also
engaged in the research and development of new therapies. Such
companies include Eli Lilly, Novo Nordisk, J&J, Amylin,
ViaCell, and Serono. Consequently, should we successfully
develop a cell-based therapy for diabetes, we would expect to
face severe competition from these and similar companies.
In the liver field, there are no broad-based therapies for the
treatment of liver disease at present. The primary therapy is
liver transplantation, which is limited by the availability of
matched donor organs. Liver-assist devices, when and if they
become available, could also be used to help patients while they
await suitably matched organs for transplantation.
6
Risk factors
Development of our technology is subject to and restricted by
extensive government regulation, which could impede our
business.
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. We or our collaborators may fail to obtain the
necessary approvals to commence or continue 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
and progenitor cells obtained from fetal tissue. The federal and
state governments and other jurisdictions impose restrictions on
the use of fetal tissue. 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 guidelines for cell procurement.
Further, we may not be able to obtain such cells in the quantity
or quality sufficient to satisfy the commercial requirements of
our potential products. As a result, we may be unable to develop
or produce our products in a profitable manner.
Although we do not use embryonic stem cells, government
regulation and threatened regulation of embryonic tissue may
lead top researchers to leave the field of stem cell research,
or the country, in order to assure that their careers will not
be impeded by restrictions on their work. Similarly, these
factors may induce the best graduate students to choose other
fields less vulnerable to changes in regulatory oversight, thus
exacerbating the risk, discussed below, that we may not be able
to attract and retain the scientific personnel we need in face
of the competition among pharmaceutical, biotechnology and
health care companies, universities and research institutions
for what may become a shrinking class of qualified individuals.
In addition, we cannot assure you that constraints on the use of
embryonic stem cells will not be extended to use of fetal stem
cells. Moreover, it is possible that concerns regarding research
using embryonic stem cells will impact our ability to attract
collaborators and investors and our stock price.
We may apply for status under the Orphan Drug Act for some of
our therapies to gain a seven-year period of marketing
exclusivity for those therapies. The U.S. Congress in the
past has considered, and in the future again may consider,
legislation that would restrict the extent and duration of the
market exclusivity of an orphan drug. If enacted, such
legislation could prevent us from obtaining some or all of the
benefits of the existing statute even if we were to apply for
and be granted orphan drug status with respect to a potential
product.
We are dependent on the services of key personnel.
We are highly dependent on the principal members of our
management and scientific staff and some of our outside
consultants, including the members of our scientific advisory
board, our chief executive officer, our vice presidents and the
directors of our neural stem cell and liver stem cell programs.
Although we have entered into employment agreements with some of
these individuals, they may terminate their agreements at any
time. In addition, our operations are dependent upon our ability
to attract and retain additional qualified scientific and
management personnel. We may not be able to attract and retain
the personnel we need on acceptable terms given the competition
for experienced personnel among pharmaceutical, biotechnology
and health care companies, universities and research
institutions.
7
Risk factors
We need to improve our financial control procedures.
Managements Annual Report on Internal Controls Over
Financial Reporting found deficiencies in the operating
effectiveness of our internal controls over financial reporting.
Such deficiencies collectively constituted significant
deficiencies and a material weakness under standards established
by the American Institute of Certified Public Accountants,
resulting in more than a remote likelihood that a material
misstatement of the annual or interim financial statements of
the Company would not be prevented or detected. In the opinion
of Grant Thornton LLP, our independent auditors,
managements assessment that we did not maintain effective
internal control over financial reporting as of
December 31, 2004, is fairly stated, in all material
respects. It is also the opinion of Grant Thornton that because
of the effect of the material weakness identified by management
(i.e., instances where both the preparation and review of
general journal entries were performed by the same individual)
on the achievement of the objectives of the control criteria, we
have not maintained effective internal control over financial
reporting as of December 31, 2004, based on criteria
established in Internal Control Integrated Framework
issued by the Committee of Sponsoring Organizations of the
Treadway Commission. We have already taken remedial steps, and
will continue our on-going evaluation of internal controls and
attempts to improve our internal controls over financial
reporting as necessary to assure their effectiveness, but there
can be no assurance that we will succeed or that other
deficiencies will not be identified.
Since health care insurers and other organizations may not
pay for our products or may impose limits on reimbursements, our
ability to become profitable could be reduced.
In both domestic and foreign markets, sales of potential
products are likely to depend in part upon the availability and
amounts of reimbursement from third party health care payor
organizations, including government agencies, private health
care insurers and other health care payors, such as health
maintenance organizations and self-insured employee plans. There
is considerable pressure to reduce the cost of therapeutic
products, and government and other third party payors are
increasingly attempting to contain health care costs by limiting
both coverage and the level of reimbursement for new therapeutic
products and by refusing, in some cases, to provide any coverage
for uses of approved products for disease indications for which
the FDA has not granted marketing approval. Significant
uncertainty exists as to the reimbursement status of newly
approved health care products or novel therapies such as ours.
We can give no assurance that reimbursement will be provided by
such payors at all or without substantial delay or, if such
reimbursement is provided, that the approved reimbursement
amounts will be sufficient to enable us to sell products we
develop on a profitable basis. Changes in reimbursement policies
could also adversely affect the willingness of pharmaceutical
companies to collaborate with us on the development of our stem
cell technology. In certain foreign markets, pricing or
profitability of prescription pharmaceuticals is subject to
government control. We also expect that there will continue to
be a number of federal and state proposals to implement
government control over health care costs. Efforts at health
care reform are likely to continue in future legislative
sessions. We do not know what legislative proposals federal or
state governments will adopt or what actions federal, state or
private payers for health care goods and services may take in
response to health care reform proposals or legislation. We
cannot predict the effect government control and other health
care reforms may have on our business.
We have limited liquidity and capital resources and may not
obtain the significant capital resources we will need to sustain
our research and development efforts.
We have limited liquidity and capital resources and must obtain
substantial additional capital to support our research and
development programs, for acquisition of technology and
intellectual property rights and, to the extent we decide to
undertake these activities ourselves, for pre-clinical and
8
Risk factors
clinical testing of our anticipated products, pursuit of
regulatory approvals, establishment of production capabilities,
establishment of marketing and sales capabilities and
distribution channels, and general administrative expenses. If
we do not obtain the necessary capital resources, we may have to
delay, reduce or eliminate some or all of our research and
development programs or license our technology or any potential
products to third parties rather than commercialize them
ourselves. We intend to pursue our needed capital resources
through equity and debt financings, corporate alliances, grants
and collaborative research arrangements. We may fail to obtain
the necessary capital resources from any such sources when
needed or on terms acceptable to us. Our ability to complete
successfully any such arrangements will depend upon market
conditions and, more specifically, on continued progress in our
research and development efforts.
RISKS RELATED TO THE SECURITIES MARKET
Our stock price has been, and will likely continue to be,
highly volatile, which may negatively affect our ability to
obtain additional financing in the future.
The market price of our stock has been and is likely to continue
to be highly volatile due to the risks and uncertainties
described in this section of the prospectus, as well as other
factors, including:
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conditions and publicity regarding the industry in which we
operate, as well as the specific areas our product candidates
seek to address; |
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price and volume fluctuations in the stock market at large that
are unrelated to our operating performance; and |
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comments by securities analysts, or our failure to meet market
expectations. |
Over the two-year period ended October 31, 2005, our common
stock was listed on the Nasdaq Capital Market (previously known
as the Nasdaq SmallCap Market) until September 30, 2005,
when it began listing on the Nasdaq National Market. During such
two-year period, the closing price of our common stock as
reported on the Nasdaq Capital Market and the Nasdaq National
Market ranged from a high of $6.26 to a low of $1.24. As a
result of this volatility, your investment in our stock is
subject to substantial risk. Furthermore, the volatility of our
stock price could negatively impact our ability to raise capital
in the future.
As of October 31, 2005, our common stock is listed on the
Nasdaq National Market. To keep our listing on this market, we
must meet Nasdaqs listing maintenance standards. If we are
unable to continue to meet Nasdaqs listing maintenance
standards, our common stock could be delisted from the Nasdaq
National Market. If our common stock were delisted, we likely
would seek to list the common stock on the Nasdaq Capital
Market, the American Stock Exchange or a regional stock
exchange. Listing on such other market or exchange could reduce
the liquidity for our common stock. If were we unable to list
our common stock on such other market or exchange, trading of
our common stock likely would be conducted in the
over-the-counter market
on an electronic bulletin board established for unlisted
securities or directly through market makers in our common
stock. If our common stock were to trade in the
over-the-counter
market, an investor would find it more difficult to dispose of,
or to obtain accurate quotations for the price of, the common
stock.
We are contractually obligated to issue shares in the future,
diluting your interest in us.
As of September 30, 2005, there were outstanding and
exercisable warrants to purchase 3,341,212 shares of our common
stock, at a weighted average exercise price of $2.10 per
share. As of September 30, 2005, there were also
outstanding options to purchase 6,641,401 shares of
our common stock, at a weighted average exercise price of
$3.00 per share. Moreover, we expect to issue additional
options to purchase shares of our common stock to compensate
employees, consultants and directors,
9
Risk factors
and may issue additional shares to raise capital, to acquire
other companies or technologies, to pay for services, or for
other corporate purposes. Any such issuances will have the
effect of further diluting the interest of the purchasers of the
securities being sold in this offering.
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Note regarding forward-looking statements
This prospectus and the documents incorporated in this
prospectus by reference may contain forward-looking
statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the Securities
Act), and Section 21E of the Securities Exchange Act
of 1934, as amended (the Exchange Act). These
statements may be identified by the use of forward-looking words
or phrases such as anticipate, believe,
could, expect, intend,
look forward, may, planned,
potential, should, will, and
would. These forward-looking statements reflect our
current expectations and are based upon currently available
data. The Private Securities Litigation Reform Act of 1995
provides a safe harbor for such forward-looking
statements. In order to comply with the terms of the safe
harbor, we note that a variety of factors could cause actual
results and experience to differ materially from the anticipated
results or other expectations expressed in the forward-looking
statements. Such statements include, without limitation, all
statements as to expectation or belief and statements as to our
future results of operations, the progress of our research,
product development and clinical programs, the need for, and
timing of, additional capital and capital expenditures,
partnering prospects, costs of manufacture of products, the
protection of and the need for additional intellectual property
rights, effects of regulations, the need for additional
facilities and potential market opportunities. Our actual
results may vary materially from those contained in such
forward-looking statements because of the risks to which we are
subject, including those listed above.
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Use of proceeds
Unless otherwise indicated in the applicable prospectus
supplement, we anticipate that the net proceeds from the sale of
the securities offered under this prospectus will be used for
working capital and general corporate purposes, as well as in
connection with selected acquisitions that may be considered in
the future or for other strategic purposes. Pending the
application of the net proceeds, we expect to invest the
proceeds in investment-grade, interest-bearing instruments or
other securities.
12
Plan of distribution
General. We may sell the securities offered hereby
to or through underwriters, through agents or dealers, directly
to one or more purchasers, or through a combination of such
methods. A prospectus supplement or supplements will describe
the terms of the offering of these securities, including:
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the name or names of any underwriters, agents or dealers, if any; |
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the number of securities involved; |
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the purchase price of the securities and the proceeds we will
receive from the sale; |
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any over-allotment options under which underwriters may purchase
additional securities from us; |
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any agency fees or underwriting discounts and other items
constituting underwriters, agents or dealers
compensation; |
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any public offering price; |
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any discounts or concessions allowed or reallowed or paid to
dealers; and |
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other information material to the transaction. |
Underwriters. If underwriters are used in the sale
of the securities, we will execute an underwriting agreement
relating to the securities that we will offer. The obligations
of the underwriters to purchase the securities will be subject
to the conditions set forth in the applicable underwriting
agreement. Unless otherwise set forth in the applicable
prospectus supplement, the underwriting agreement will provide
that the obligations of the underwriters will be subject to
certain conditions precedent and that the underwriters with
respect to a sale of the securities will be obligated to
purchase all the securities if any are purchased.
The securities subject to the underwriting agreement will be
acquired by the underwriters for their own account and may be
resold by them from time to time in one or more transactions,
including negotiated transactions, at a fixed public offering
price or at varying prices determined at the time of sale.
Underwriters may be deemed to have received compensation from us
in the form of underwriting discounts or commissions and may
also receive commissions from the purchasers of these securities
for whom they may act as agent. Underwriters may sell these
securities to or through dealers. These dealers may receive
compensation in the form of discounts, concessions or
commissions from the underwriters or commissions from the
purchasers for whom they may act as agent. Any initial public
offering price and any discounts or concessions allowed or
reallowed or paid to dealers may be changed from time to time.
We also may sell the securities in connection with a remarketing
upon their purchase, in connection with a redemption or
repayment, by a remarketing firm acting as principal for its own
account or as our agent. Remarketing firms may be deemed to be
underwriters in connection with the securities that they
remarket.
During and after an offering through underwriters, the
underwriters may purchase and sell the securities in the open
market. These transactions may include over-allotment and
stabilizing transactions and purchases to convey syndicate short
positions created in connection with the offering. The
underwriters may also impose a penalty bid, which means that
selling concessions allowed to syndicate members or other
broker-dealers for the offered securities sold for their account
may be reclaimed by the syndicate if the offered securities are
repurchased by the syndicate in stabilizing or covering
transactions. These activities may stabilize, maintain or
otherwise affect the market price of the offered securities,
which may be higher than the price that might otherwise prevail
in the open market. If commenced, the underwriters may
discontinue these activities at any time.
13
Plan of distribution
Agents. We may also sell any of the securities
through agents designated by us from time to time. We will name
any agent involved in the offer or sale of these securities and
will list commissions payable by us to these agents in the
prospectus supplement. These agents will be acting on a best
efforts basis to solicit purchases for the period of their
appointment, unless we state otherwise in the applicable
prospectus supplement.
Direct Sales. We may sell any of the securities
directly to purchasers. In this case, we will not engage
underwriters or agents in the offer and sale of these securities.
Indemnification. We may indemnify underwriters,
dealers or agents who participate in the distribution of the
securities against certain liabilities, including liabilities
under the Securities Act of 1933, as amended, and agree to
contribute to payments which these underwriters, dealers or
agents may be required to make.
Listing. Our common stock is currently listed on
the Nasdaq National Market under the symbol STEM. No
underwriters will be obligated to make a market in our
securities. We cannot predict the activity or liquidity of any
trading in our securities.
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Where you can find more information
We file annual, quarterly and special reports, proxy statements
and other information with the SEC. Our SEC filings are
available over the Internet at the SECs web site at
http://www.sec.gov. You may also read and copy any
document we file with the SEC at its public reference facility:
Public Reference Room
100 F Street, N.E.
Washington, D.C. 20549
You may also obtain copies of the documents at prescribed rates
by writing to the Public Reference Section of the SEC, 100 F
Street, N.E., Washington, DC 20549. Please call
1-800-SEC-0330 for
further information on the operations of the public reference
facility and copying charges.
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Incorporation of certain documents by reference
The SEC allows us to incorporate by reference the
information we file with them, which means that we can disclose
important information to you by referring you to those
documents. The information incorporated by reference is
considered to be part of this prospectus, and the information
that we file later with the SEC will automatically update and
supersede this information. We incorporate by reference in this
prospectus the following documents filed by us with the SEC:
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Our Annual Report on
Form 10-K for the
year ended December 31, 2004, including any amendment filed
for the purpose of updating such Annual Report; |
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Our Quarterly Reports on
Form 10-Q for the
quarters ended March 31, 2005, June 30, 2005 and
September 30, 2005 including any amendment filed for the
purpose of updating such Quarterly Reports; |
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A Proxy Statement for Annual Meeting of Stockholders on
Schedule 14A filed with the SEC on March 23, 2005; |
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The description of our common stock contained in our
registration statements on
Form 8-A (File
No. 1- 19871) filed under the Exchange Act, including any
amendment or report filed for the purpose of updating such
description; and |
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Our Current Reports on
Form 8-K filed
with the SEC on November 1, 2005, October 20, 2005,
September 27, 2005, September 8, 2005,
September 1, 2005, August 3, 2005, July 6, 2005,
April 27, 2005, March 15, 2005, March 4, 2005,
February 1, 2005 and January 11, 2005. |
Any statement made in a document incorporated by reference or
deemed incorporated herein by reference is deemed to be modified
or superseded for purposes of this prospectus if a statement
contained in this prospectus or in any other subsequently filed
document which is also incorporated or deemed incorporated by
reference herein modifies or supersedes that statement. Any such
statement so modified or superseded shall not be deemed, except
as so modified or superseded, to constitute a part of this
prospectus. We also incorporate by reference all documents filed
pursuant to Sections 13(a), 13(c), 14 or 15(d) of the
Exchange Act after the date of this prospectus and prior to the
termination of this offering; provided, however, that we are not
incorporating any information furnished under any of
Item 2.02 or Item 7.01 of any current report on
Form 8-K.
Statements made in this prospectus or in any document
incorporated by reference in this prospectus as to the contents
of any contract or other document referred to herein or therein
are not necessarily complete, and in each instance reference is
made to the copy of such contract or other document filed as an
exhibit to the documents incorporated by reference, each such
statement being qualified in all material respects by such
reference.
You may request a copy of these filings, at no cost, by writing
or telephoning us at the following address:
StemCells, Inc.
3155 Porter Drive
Palo Alto, Ca 94304
Attention: Investor Relations
Phone: (650) 475-3100
email: irpr@stemcellsinc.com
Copies of these filings are also available, without charge, on
our Internet website at www.stemcellsinc.com as soon as
reasonably practicable after they are filed electronically with
the SEC.
16
Legal opinion
For the purpose of this offering, Ropes & Gray LLP,
Boston, Massachusetts, is giving its opinion on the validity of
the securities offered hereby.
Experts
The financial statements incorporated in this prospectus by
reference from the Companys Annual Report on
Form 10-K for each
of the two years ended December 31, 2003 and 2004 have been
audited by Grant Thornton LLP, independent registered public
accounting firm, as stated in their reports, each of which is
incorporated herein by reference and has been so incorporated in
reliance upon such reports given upon their authority as experts
in accounting and auditing.
The financial statements of StemCells, Inc. for the year ended
December 31, 2002 appearing in the Companys Annual
Report on
Form 10-K for the
year ended December 31, 2004, have been audited by
Ernst & Young LLP, independent registered public
accounting firm, as set forth in their report thereon, included
therein, and incorporated herein by reference. Such financial
statements are incorporated herein by reference in reliance upon
such report given upon the authority of such firm as experts in
accounting and auditing.
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