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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): November 18, 2008
StemCells, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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000-19871
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94-3078125 |
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(State or other jurisdiction
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(Commission
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(I.R.S. Employer |
of incorporation)
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File Number)
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Identification No.) |
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3155 Porter Drive, Palo Alto, California
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94304 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: 650.475.3100
Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
TABLE OF CONTENTS
Item 8.01. Other Events.
On November 18, 2008, StemCells, Inc. (the Company) announced that, on November 17, 2008,
the Company sold and issued to certain investors 13,793,104 shares of Common Stock and warrants to
purchase up to 10,344,828 shares of Common Stock (the Offering). The terms of the Offering are
described in the Companys Form 8-K filed on November 12, 2008.
In connection with the consummation of the Offering, the Company is hereby furnishing, as
Exhibit 99.1 to this Current Report on Form 8-K, the section entitled Risk Factors, as disclosed
in the Companys Prospectus Supplement filed on November 12, 2008, for the purpose of updating the
Companys disclosures under the Securities Exchange Act of 1934.
The Companys press release announcing the closing of the Offering is filed as Exhibit 99.2 to
this Current Report on Form 8-K, and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1
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Risk Factors |
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99.2
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Press release of StemCells, Inc. dated November 18, 2008. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
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November 18, 2008 |
StemCells, Inc.
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/s/ Ken Stratton
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Name: |
Ken Stratton |
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Title: |
General Counsel |
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Exhibit Index
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Exhibit |
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Number |
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Description |
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99.1
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Risk Factors |
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99.2
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Press Release of StemCells, Inc., dated November 18, 2008. |
exv99w1
Exhibit
99.1
Risk factors
This Exhibit may contain forward looking statements within
the meaning of Section 27A of the Securities Act and Section 21E of
the Securities Exchange Act that involve substantial risks and uncertainties. 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, including any related litigation; 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 risks to which we are subject,
including uncertainty as to whether the U.S. Food and Drug Administration (FDA) or other regulatory authorities will
permit us to proceed with clinical testing of proposed products despite the novel and unproven nature of our technologies;
the risk that our initial clinical trial and any other clinical trials or studies could be substantially delayed beyond
their expected dates or cause us to incur substantial unanticipated costs; uncertainties in our ability to obtain the
capital resources needed to continue our current research and development operations and to conduct the research,
preclinical development and clinical trials necessary for regulatory approvals; the uncertainty regarding our ability to
obtain a corporate partner or partners, if needed, to support the development and commercialization of our potential
cell-based therapeutics products; the uncertainty regarding the outcome of our Phase I clinical trial in NCL and any other
clinical trials or studies we may conduct in the future; the uncertainty regarding the validity and enforceability of our
issued patents; the risk that we may not be able to manufacture additional master and working cell banks when needed; the
uncertainty whether any products that may be generated in our cell-based therapeutics programs will prove clinically safe
and effective; the uncertainty whether we will achieve revenue from product sales or become profitable; uncertainties
regarding our obligations with respect to our former encapsulated cell therapy facilities in Rhode Island; obsolescence of
our technologies; competition from third parties; intellectual property rights of third parties; litigation risks; and
other risks to which we are subject. All forward-looking statements attributable to us or to persons acting on our behalf
are expressly qualified in their entirety by the cautionary statements and risk factors set forth elsewhere in this Exhibit.
Investing
in our common stock and warrants involves a high degree of risk. 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 relating to our HuCNS-SC product candidate, such as a significant clinical
trial failure, could substantially depress our stock price and prevent us from raising additional
capital.
At present our ability to progress as a company is significantly dependent on a single product
candidate, our HuCNS-SC cells (purified human neural stem cells), and on a single early stage
clinical trial, our Phase I clinical trial for neuronal ceroid lipofuscinosis (NCL, also often
referred to as Batten disease). Any clinical, regulatory or other development that significantly
delays or prevents us from completing this trial, any material safety issue or adverse side effect
to any study participant in this trial, or the failure of this trial to show the results expected
would likely depress our stock price significantly and could prevent us from raising the
substantial additional capital we will need to further develop our cellular technologies. Moreover,
any material adverse occurrence in our first clinical trial for Batten disease could substantially
impair our ability to initiate clinical trials to test our HuCNS-SC cells in patients with spinal
cord injuries, myelin disorders or other potential indications. This, in turn, could adversely
impact our ability to raise additional capital and pursue our planned research and development
efforts in both our CNS and liver programs.
We have limited capital resources and we may not obtain the significant additional capital needed
to sustain our research and development efforts.
We have limited liquidity and capital resources and must obtain significant additional capital
resources in order to sustain our product development efforts, acquire businesses, technologies and
intellectual property rights which may be important to our business, continue preclinical and
clinical testing of our investigative products, pursue regulatory approvals, acquire capital
equipment, laboratory and office facilities, establish production capabilities, maintain and
enforce our intellectual property portfolio, and support our 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, license, lease, 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.
We intend to pursue opportunities for additional fundraising in the future through equity or
debt financings, corporate alliances or combinations, grants or collaborative research
arrangements, or any combination of these. However, external financing in the current financial
environment may be particularly difficult, and the source, timing and availability of any future
fundraising will depend principally upon market conditions, interest rates and, more specifically,
on progress in our research, preclinical and clinical development programs. Funding may not be
available when needed at all or on terms acceptable to us. While we actively manage our programs
and resources in order to conserve cash between fundraising opportunities, we believe we will need
to secure additional capital in order to conduct our operations beyond 2009. If we exhaust our
cash reserves and are unable to realize adequate additional fundraising, we may be unable to meet
operating obligations and be required to initiate bankruptcy proceedings or delay, scale back or
eliminate some or all of our research and product development programs.
Our product development programs are based on novel technologies and are inherently risky.
We are subject to the risks of failure inherent in the development of products based on new
technologies. The novel nature of these therapies creates significant challenges in regard to
product development and optimization, manufacturing, government regulation, third party
reimbursement, and market acceptance. For example, the pathway to regulatory approval for
cell-based therapies, including our product candidates, may be more complex and lengthy than the
pathway for conventional drugs. These challenges may prevent us from developing and commercializing
products on a timely or profitable basis or at all.
Our technology is at an early stage of discovery and development, and we may fail to develop any
commercially acceptable or profitable products.
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 revenue to achieve or sustain
profitability in the future. We have yet to develop any products that have been approved for
marketing, and we do not expect to become profitable within the next several years, but rather
expect to incur additional and increasing operating losses. Before commercializing any medical
product, we will need to obtain regulatory approval
1
from the FDA or from equivalent foreign agencies after conducting extensive preclinical studies and
clinical trials that demonstrate that the product candidate is safe and effective. Except for the
NCL trial currently being conducted at Oregon Health & Science University (OHSU), we have had no
experience conducting human clinical trials. We expect that none of our cell-based therapeutic
product candidates will be commercially available for several years, if at all.
While the FDA has permitted us to initiate our Phase I clinical trial of our proprietary
HuCNS-SC product candidate in NCL, and the Institutional Review Board of OHSU has approved the
protocol and we have completed dosing the six patients planned for the trial, there can be no
assurance that the trial will be completed or result in a successful outcome. We may elect to delay
or discontinue other studies or clinical trials based on unfavorable results. Any product developed
from, or based on, cellular technologies may fail to:
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survive and persist in the desired location; |
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provide the intended therapeutic benefit; |
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engraft 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
in animals may not be indicative of future clinical results in humans.
Ultimately 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. Even if we do succeed in developing products, we will face
many potential obstacles such as the need to develop or obtain manufacturing, marketing and
distribution capabilities. Furthermore, because transplantation of cells is a new form of therapy,
the marketplace may not accept any products we may develop.
Moreover, because our cell-based therapeutic products will be derived from tissue of
individuals other than the patient (that is, they will be non-self or allogeneic transplant
products), patients will likely require the use of immunosuppressive drugs. While immunosuppression
is now standard in connection with allogeneic transplants of various kinds, such as heart or liver
transplants, long-term maintenance on immunosuppressive drugs can result in complications such as
infection, cancer, cardiovascular disease, and renal dysfunction. An immunosuppression regimen is
currently being used with our therapeutic product candidate in our Phase I clinical trial for NCL.
Our success will depend in large part on our ability to develop and commercialize products that
treat diseases other than neuronal ceroid lipofuscinosis (Batten disease).
Although we have initially focused on evaluating our neural stem cell product for the
treatment of infantile and late infantile NCL (Batten disease), this disease is rare and the market
for treating this disease is small. Accordingly, even if we obtain marketing approval for our
HuCNS-SC product candidate for infantile and late infantile NCL, in order to achieve profitability,
we will likely need to obtain approval to treat additional diseases that present more significant
market opportunities.
Acquisitions of companies, businesses or technologies may substantially dilute our stockholders and
increase our operating losses.
We may make acquisitions of businesses, technologies or intellectual property rights or
otherwise modify our business model in ways we believe to be necessary, useful or complementary to
our current product development efforts and cell-based therapeutics business. Any such acquisition
or change in business activities may require assimilation of the operations, products or product
candidates and personnel of the acquired business and the training and integration of its
employees, and could substantially increase our operating costs, without any offsetting increase in
revenue. Acquisitions may not provide the intended technological, scientific or business benefits
and could disrupt our operations and divert our limited resources and managements attention from
our current operations, which could harm our existing product development efforts. We would likely
issue equity securities to pay for any future acquisitions. The issuance of equity securities for
an acquisition could be substantially dilutive to our stockholders. In addition, our results of
operations may suffer because of acquisition-related costs or the post-acquisition costs of funding
the development of an acquired technology or product candidates or operation of the acquired
business, or due to amortization or impairment costs for acquired goodwill and other intangible
assets. Any investment made in, or funds advanced to, a potential acquisition target could also
significantly adversely affect our results of operation and could further reduce our limited
capital resources. Any acquisition or action taken in anticipation of a potential acquisition or
other change in business activities could substantially depress the price of our stock.
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We have payment obligations resulting from real property owned or leased by us in Rhode Island,
which diverts funding from our cell-based therapeutics 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 $1,523,000 in 2007; 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 $400,000 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 we 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 are currently seeking to sublease the pilot manufacturing facility, but may not be
able to sublease or sell the facility in the future. These continuing costs significantly reduce
our cash resources and adversely affect our ability to fund further development of our cellular
technologies. 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, 2007, the
reserve was $6,143,000. For the year 2007, we incurred $1,420,000 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.
We may be unable to obtain partners to support our cell-based therapeutic product development
efforts when needed to commercialize our technologies.
Equity and debt financings alone may not be sufficient to fund the cost of developing our
cellular technologies, and we may need to rely on partnering or other arrangements to provide
financial support for our cellular discovery and development efforts. In addition, in order to
successfully develop and commercialize our technologies, we may need to enter into various
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 such 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 rights to third parties, such as exclusive marketing
rights to one or more products, may require us to issue securities to our collaborators and may
contain other terms that are burdensome to us or result in a decrease in our stock price.
If we are unable to protect our patents and proprietary rights, our business, financial condition
and results of operations may be materially harmed.
We either own or exclusively license a number of patents and pending patent applications
related to various stem and progenitor cells, including human neural stem cell cultures, as well as
methods of deriving and using them. The process of obtaining 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 either before or after
issuing the patent. For example, 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. In the United States, third
parties may seek to invalidate or render unenforceable issued patents through a U.S. PTO
reexamination process or through the courts; currently two of our patents are the subject of a
reexamination proceeding and six of our patents are the subject of litigation. In addition, changes
to the laws protecting intellectual property rights could adversely impact the perceived or actual
value of our Company. Consequently, we do not know whether any of our pending applications will
result in the issuance of patents, whether any of our issued patents will be invalidated or
restricted, whether any existing or future patents will provide sufficient protection or
significant commercial advantage, or whether others will circumvent these patents, whether or not
lawfully. In addition, our patents may not afford us adequate protection from competing products.
Moreover, because patents issue for a limited term, our patents may expire before we can
commercialize a product covered by the issued patent claims or before we can utilize the patents
profitably. Some of our most important patents begin to expire in 2015.
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If we learn of third parties who infringe our patent rights, we may decide to initiate legal
proceedings to enforce these rights. Patent litigation, including the pending litigation to which
we are a party, is inherently unpredictable and highly risky and may
result in unanticipated challenges to the validity or enforceability of our intellectual property, antitrust
claims or other claims against us, which could result in the loss of these intellectual property
rights. Litigation proceedings can be very time-consuming for management and are also very costly
and the parties we bring actions against may have significantly greater financial resources than
our own. We may not prevail in these proceedings and if we do not prevail we could be liable for
damages as well as the costs and attorney fees of our opponents.
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 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
and progenitor cells and other technologies potentially relevant to, or necessary for, our expected
products. We cannot predict which, if any, of these applications will issue as patents or how many
of these issued patents will be found valid and enforceable. There may also be existing issued
patents which we are currently unaware of which would be infringed by the commercialization of one
or more of our product candidates. If so, we may be prevented from commercializing these products
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, or potentially
prevent us from continuing certain operations.
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 cell-based therapeutic 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 alternative 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.
We have obtained rights from companies, 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, and many pharmaceutical
companies have made significant commitments to the CNS field. We believe cellular therapies, if
proven safe and effective, will have unique properties that will make them desirable over small
molecule drugs, none of which currently replace damaged tissue. However, any cell-based therapeutic
to treat diseases of, or injuries to, the CNS is likely to face intense competition from the small
molecule sector, biologics, as well as medical devices. We expect to compete with a host of
companies, some of which are privately owned and some of which have resources far greater than
ours.
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. Liver
transplantation may remain the standard of care even if we successfully develop a cellular therapy.
In addition, new therapies may become available before we successfully develop a cell-based therapy
for liver disease.
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Development of our technologies is subject to, and restricted by, extensive government regulation,
which could impede our business.
Our research and development efforts, as well as any ongoing or future clinical trials, and
the manufacturing and marketing of any products we may develop, will be subject to, and restricted
by, extensive regulation by governmental authorities in the United States and other countries. The
process of obtaining FDA and other necessary regulatory approvals is lengthy, expensive and
uncertain. FDA and other legal and regulatory requirements applicable to the development and
manufacture of the cells and cell lines required for our preclinical and clinical products could
substantially delay or prevent us from producing the cells needed to initiate additional clinical
trials. We 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 human tissue, including fetal tissue. The U.S. federal and state governments and other
jurisdictions impose restrictions on the acquisition and use of fetal tissue, including those
incorporated in federal Good Tissue Practice, or cGTP, regulations. These regulatory and other
constraints could prevent us from obtaining cells and other components of our products in the
quantity or quality needed for their development or commercialization. These restrictions change
from time to time and may become more onerous. Additionally, we may not be able to identify or
develop reliable sources for the cells necessary for our potential products that is, sources
that follow all state and federal laws and guidelines for cell procurement. Certain components used
to manufacture our stem and progenitor cell product candidates will need to be manufactured in
compliance with the FDAs Good Manufacturing Practices, or cGMP. Accordingly, we will need to enter
into supply agreements with companies that manufacture these components to cGMP standards.
Noncompliance with applicable requirements both before and after approval, if any, can subject
us, our third party suppliers and manufacturers, and our other collaborators to administrative and
judicial sanctions, such as, among other things, warning letters, fines and other monetary
payments, recall or seizure of products, criminal proceedings, suspension or withdrawal of
regulatory approvals, interruption or cessation of clinical trials, total or partial suspension of
production or distribution, injunctions, limitations on or the elimination of claims we can make
for our products, and refusal of the government to enter into supply contracts or fund research, or
delay in approving or refusal to approve new drug applications.
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 heads of key departments or functions within the
company. 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 test animals as well as
hazardous chemicals and potentially hazardous biological materials such as human tissue. Their use
subjects us to environmental and safety laws and regulations such as those governing laboratory
procedures, exposure to blood-borne pathogens, use of laboratory 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.
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The development, manufacturing and commercialization of cell-based therapeutic 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 result in substantial
litigation costs and damage awards against us. We have obtained liability insurance that covers our
clinical trials, and we will need to increase our insurance coverage if and when we begin
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.
The manufacture of cell-based therapeutic products is novel, highly regulated, critical to our
business, and dependent upon specialized key materials.
The proliferation and manufacture of cell-based therapeutic products are complicated and
difficult processes, dependent upon substantial know-how and subject to the need for continual
process improvements to be competitive. Our manufacturing experience is limited and the
technologies are comparatively new. In addition, our ability to scale-up manufacturing to satisfy
the various requirements of our planned clinical trials, such as GTP, GMP and release testing
requirements, is uncertain. Manufacturing disruptions may occur and despite efforts to regulate and
control all aspects of manufacturing, the potential for human or system failure remains.
Manufacturing irregularities or lapses in quality control could have a serious adverse effect on
our reputation and business, which could cause a significant loss of stockholder value. Many of the
materials that we use to prepare our cell-based products are highly specialized, complex and
available from only a limited number of suppliers or derived from a biological origin. At present,
some of our material requirements are single sourced, and the loss of one or more of these sources
may adversely affect our business if we are unable to obtain alternatives or alternative sources at
all or upon terms that are acceptable to us.
Because 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 adversely affected.
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. 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 or other relevant
authority has not granted marketing approval. Moreover, in some cases, government and other third
party payors have refused to provide reimbursement for uses of approved products for disease
indications for which the FDA or other relevant authority has 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 cellular technologies. 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 to change regulatory and reimbursement standards
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 payors for health
care goods and services may take in response to such proposals or legislation. We cannot predict
the effect of government control and health care reimbursement practices on our business.
Ethical and other concerns surrounding the use of stem or progenitor-based cell therapy may
negatively affect regulatory approval or public perception of our product candidates, which could
reduce demand for our products or depress our stock price.
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 or progenitor
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 from commercializing
products. Existing and potential U.S. government regulation of embryonic tissue may lead
researchers to leave the field of stem cell research or the country altogether, in order to assure
that their careers will not be impeded by restrictions on their work. Similarly, these factors may
induce graduate students to choose other fields less vulnerable to changes in regulatory oversight,
thus exacerbating the risk that we may not be able to attract and retain the scientific personnel
we need in 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.
6
Our corporate documents and Delaware law contain provisions that could make it difficult for us to
be acquired in a transaction that might be beneficial to our stockholders.
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 stockholder approval.
These provisions in our corporate documents, along with certain provisions under 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 stockholders.
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 per share of our common stock has been and is likely to continue to be highly
volatile due to the risks and uncertainties described in this Exhibit, as well as other factors, including:
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our ability to develop and test our technologies; |
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our ability to patent or obtain licenses to necessary technologies; |
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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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competition in our industry; |
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economic and other external factors or other disasters or crises; |
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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 November 11, 2008, the trading price of our common stock as
reported on The Nasdaq Global Market ranged from a high of $3.63 to a low of $0.66. 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 or acquire
businesses or technologies.
We are contractually obligated to issue shares in the future, diluting the interest of current
stockholders.
On
November 17, 2008 we issued warrants to purchase up to 10,344,828
shares of our common stock at an exercise price of $2.30 per share. In addition, as of September 30, 2008, there were outstanding warrants
to purchase 1,255,000 shares of our common stock, at a weighted average exercise price of $1.90 per
share. Also as of September 30, 2008, there were outstanding options to purchase 8,471,887 shares
of our common stock, at a weighted average exercise price of $2.33 per share, and 1,650,000
restricted stock units. 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
stockholders.
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exv99w2
Exhibit 99.2
STEMCELLS, INC. CLOSES $20 MILLION EQUITY FINANCING
PALO ALTO, Calif. November 18, 2008 StemCells, Inc. (NASDAQ: STEM) announced today that it has
closed the sale of 13,793,104 units to certain institutional investors at a price of $1.45 per
unit, for gross proceeds of $20.0 million. Each unit consists of one share of common stock and one
five-year warrant to purchase 0.75 share of common stock at an exercise price of $2.30 per share.
The units were sold in a registered direct offering under the Companys effective shelf
registration statement previously filed with the Securities and Exchange Commission (SEC). The
Company received total proceeds, net of offering expenses and placement agency fees, of
approximately $18.5 million. The proceeds will be used for general corporate purposes, including
working capital, product development and capital expenditures, as well as for other strategic
purposes. At September 30, 2008, the Company had cash, cash equivalents, and marketable debt
securities of approximately $21.3 million, and together with the net proceeds of this offering,
would have a pro forma cash balance of approximately $39.8 million.
It is no secret that development-stage biotechnology companies like StemCells need to raise
capital from time to time. The capital markets are extremely volatile and impossible to predict,
so we are pleased to have strengthened our cash reserves in such turbulent times, said Martin
McGlynn, President and Chief Executive Officer. We will continue to focus our efforts on managing
our resources prudently and building long-term shareholder value.
About StemCells, Inc.
StemCells, Inc. is a clinical-stage biotechnology company focused on the discovery, development and
commercialization of cell-based therapeutics to treat diseases of the central nervous system and
liver. The Companys product development programs seek to repair or repopulate CNS and liver tissue
that has been damaged or lost as a result of disease or injury. StemCells has pioneered the
discovery and development of HuCNS-SC® cells, its highly purified, expandable population
of human neural stem cells. StemCells has completed enrollment and dosing of a six patient Phase I
clinical trial of its proprietary HuCNS-SC product candidate as a treatment for neuronal ceroid
lipofuscinosis (NCL) and expects the trial to be completed in January 2009. NCL, which is often
referred to as Batten disease, is a rare and fatal neurodegenerative disease that affects infants
and young children. StemCells owns or has exclusive rights to more than 50 issued or allowed U.S.
patents and more than 150 granted or allowed non-U.S. patents. Further information about the
Company is available on its web site at: www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes
forward-looking statements regarding, among other things, the future business operations of
StemCells, Inc. (the Company) and its ability to conduct clinical trials as well as its research
and product development efforts. These forward-looking statements speak only as of the date of this
news release. The Company does not undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof. Such statements reflect
managements current views and are based on certain assumptions that may or may not ultimately
prove valid. The Companys actual results may vary materially from those contemplated in such
forward-looking statements due to risks and uncertainties to which the Company is subject,
including uncertainty as to whether the FDA or other applicable regulatory agencies will permit the
Company to continue clinical testing in NCL or in future clinical trials of proposed therapies for
other diseases or conditions despite the novel and unproven nature of the Companys technologies;
uncertainties regarding the Companys ability to obtain the increased capital resources needed to
continue its current research and development operations and to conduct the research, preclinical
development and clinical trials necessary for regulatory approvals; uncertainty regarding the
validity and enforceability of the Companys patents; uncertainty as to whether HuCNS-SC and any
products that may be generated in the future in the Companys cell-based programs will prove safe
and clinically effective and not cause tumors or other adverse side effects; uncertainties
regarding the Companys manufacturing capabilities given its increasing preclinical and clinical
commitments; uncertainties as to whether the Company will achieve revenues from product sales or
become profitable; and other factors that are described under the heading Risk Factors in Item 1A
of Part II of the Companys Quarterly Report on Form 10-Q.
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CONTACT:
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StemCells, Inc.
Rodney Young
Chief Financial Officer
650-475-3100, Ext. 105
irpr@stemcellsinc.com |
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SOURCE:
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StemCells, Inc. |