corresp
VIA EDGAR
U.S. Securities and Exchange Commission
Mail Stop 6010
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
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Attention:
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Jim B. Rosenberg, Senior Assistant |
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Chief Accountant |
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Re:
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SEC Comment Letter, dated December 21, 2007 |
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StemCells, Inc. |
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Form 10-K for the Year Ended December 30, 2006 |
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File No. 000-19871 |
Ladies and Gentlemen:
On behalf of StemCells, Inc. (the Company), this letter is being submitted to the Staff of the
Securities and Exchange Commission (the Commission) in response to the comments in the Staffs
letter dated December 21, 2007 (the December 21 Letter) regarding the Companys 10-K for the year
ended December 31, 2006 filed on March 15, 2007 (the 2006 10-K).
For reference purposes, the comments as reflected in the December 21 Letter are reproduced in bold
in this letter, and the corresponding responses of the Company are shown below each comment.
Accordingly, we supplementally advise you as follows:
General
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We note that you have included certain license agreements as exhibits to the Form 10-K and
not others. For example, you do not include as exhibits your agreements with the California
Institute of Technology and the Oregon Health & Science University. Please provide us with an
analysis supporting your determination as to how you have determined which of your license
agreements are material contracts required to be filed as exhibits. |
3155 Porter Drive Palo Alto, CA 94304
(650) 475-3100 (650) 475-3101 FAX
Company Response:
We do not believe all our license agreements are material to our business. Most were entered into
in the ordinary course of business. They are customary for businesses such as ours and our
business is not substantially dependent on them. Factors we consider in determining whether a
particular license agreement is material include whether the licensed patents have claims that
cover our existing or contemplated therapeutic products, whether the license is likely to generate
significant revenue for the Company, and whether the license is likely to cost the Company
significant expense.
Under these standards, the Company does not consider the license agreements with either the
California Institute of Technology (Cal Tech) or the Oregon Health & Science University (OHSU) as
material to our business. The Cal Tech agreement covers patents that claim inventions that are not
being pursued by the Company at this time, such as neural crest cells and neurogenin, but which may
be relevant in the future or which may cover competitor products. However, even if the Company
were to develop a product covered by the Cal Tech licensed patents, the total license fees owed by
the Company to Cal Tech would be immaterial to our business, with a royalty rate of 1% or less on
net sales and capped. Since entering into the Cal Tech license agreement, the Company has stopped
the prosecution of some of these patents. Given the ancillary nature of these technologies, the
Company recently decided to terminate the agreement with respect to patent applications outside the
United States. Meanwhile, the OHSU license relates to an animal mouse model that we do not
currently use and to U.S. Patent No. 6,132,708, which discloses the use of pancreatic cells for
liver regeneration, a technology we are not presently developing. The Company plans to take steps
to terminate this agreement in 2008. In contrast, we consider the ReNeuron agreement to be
material based on the substantial proceeds we received as partial consideration under the
agreement, which included a payment to us in the form of shares of ReNeuron stock, the sale of some
of which has already generated in excess of $3 million in proceeds. Similarly, we consider the
NeuroSpheres license agreement to be material because many of the patents and patent applications
licensed from NeuroSpheres are foundational to our neural stem cell program. Collectively these
patents account for at least two thirds of our issued patents worldwide. Moreover, this license
includes patents that we have, in turn, licensed to others and used as the basis for our patent
infringement litigation against Neuralstem.
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On page 20 of the Form 10-K you refer to consulting agreements with SAB members. Only one of
these agreements has been included as an exhibit to the Form 10-K, that with Dr. Weissman. In
addition, a consulting agreement with Judi R. Lum is included as an exhibit but not described
or referred to in the Form 10-K discussion. Please provide us with an analysis supporting
your determination as to how you have determined which consulting agreements are material
contracts. In addition, you refer to various research collaborations in the Form 10-K, with
organizations such as the Reeve-Irvine Center at the University of California, Oregon Health &
Science University, the Yale University School of Medicine and NIH. We note that you have not
included any collaboration agreements as exhibits to the Form 10-K. Please provide us with an
analysis supporting your determination as to how you have determined that these collaboration
agreements are not material contracts required to be filed as exhibits. |
February 29,2008
Page 3
Company Response:
We believe all of our consulting agreements and collaboration agreements were made in the ordinary
course of our business. We also believe, based upon the judgment and experiences of our management
team, that all of these agreements contain terms and conditions that are customary for the
biotechnology industry. Our business is not substantially dependent on any of our consulting or
collaboration agreements. However, we have disclosed the identity of our collaborators as well
as the basic scope of these collaborations insofar as this helps illustrate the direction of our
research and development efforts as well as the quality of our collaborators.
Even so, we consider certain consulting agreements to be material contracts under Item
601(b)(10)(ii)(A) of Regulation S-K if they involve officers, directors or other affiliates. Our
agreement with Judi Lum was filed because she had been, before her entering into her consulting
agreement with us, our Chief Financial Officer. Similarly, we consider our agreement with Dr.
Weissman to be material because he is a director of the Company.
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In the description of legal proceedings in the Form 10-K you describe an action by Geron
Corporation in which the result is that two patents being maintained by the company would be
in altered form. In addition, you described a dispute with Neuralstem over four patents.
Please revise your disclosure to briefly describe these patents in the section titled
Patents, Proprietary Rights and Licenses to the extent you have not already done so and to
disclose the patent description or number in Item 3. Legal Proceedings. In addition, please
revise your disclosure in Item 3. Legal Proceedings to explain what it means to be in
somewhat altered form. |
Company Response:
In future filings, beginning with the Companys Form 10-K for the period ending December 31, 2007
(our 2007 10-K), the Company will provide enhanced disclosure about its patent disputes
consistent with this request. Our 2007 10-K will read substantially as follows:
In July 2006, we filed suit against Neuralstem, Inc., in the Federal District Court for the
District of Maryland, alleging that Neuralstems activities violate claims in four of the
patents we exclusively licensed from NeuroSpheres. Neuralstem has filed a motion for
dismissal or summary judgment in the alternative, citing Title 35, Section 271(e)(1) of the
United States Code, which says that it is not an act of patent infringement to make, use or
sell a patented invention solely for uses reasonably related to the development and
submission of information to the FDA. Neuralstem argues that because it does not have any
therapeutic products on the market yet, the activities complained of fall within the
protection of Section 271(e)(1) that is, basically, that the suit is premature. This issue
will be decided after discovery is complete. Subsequent to filing its motion to dismiss, in
December 2006, Neuralstem petitioned the U.S. Patent and Trademark Office (PTO) to reexamine
two of the patents in our infringement action against Neuralstem, namely U.S. Patent No.
6,294,346 (claiming the use of human neural stem cells for drug screening) and U.S. Patent
No. 7,101,709 (claiming the use of human neural stem cells for screening biological agents).
In April 2007, Neuralstem petitioned the PTO to reexamine the remaining two patents in the
suit, namely U.S. Patent No. 5,851,832 (claiming methods for proliferating human neural
February 29,2008
Page 4
stem cells) and U.S. Patent No. 6.,497,982 872 (claiming methods for transplanting human
neural stem cells). These requests were granted by the PTO and, in June 2007, the parties
voluntarily agreed to stay the pending litigation while the PTO considers them reexamination
requests. In October 2007, Neuralstem petitioned the PTO to reexamine a fifth patent,
namely U.S. Patent No. 6,103,530, which claims a culture medium for proliferating mammalian
neural stem cells. In September 2007, the PTO issued first office actions in each of the
first four reexaminations. The Company has since filed its first responses in to each of
these, and expects all four patents to re-issue in 2008.
In 2003, Geron Corporation filed an opposition to two of our issued European patent cases,
namely EP0594669 (claiming, among other things, methods for proliferating and using human
neural stem cells as therapeutic and drug screening agents) and EP0669973 (claiming, among
other things, methods for proliferating and differentiating human neural stem cells). Both
oppositions were heard in 2005, and the patents were maintained in somewhat altered form by
the Opposition Division of the European Patent Office. In essence the scope of each patent
was limited to proliferation using specific growth factors and each had to disclaim
derivation of human neural stem cells from human embryonic tissue in order to comply with
the European law which precludes the patenting of embryonic stem cells. The time for appeal
has run in each case. U.S. counterparts to these patents are part of our issued patent
portfolio; they are not subject to opposition, because that procedure does not exist under
U.S. patent law, although other types of proceedings may be available to third parties to
contest our U.S. patents.
Research and Development Programs, Page 5
Overview, Page 5
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We believe that your disclosures about historical research and development expenses and
estimated future expenses related to your major research and development projects could be
enhanced for investors. Please refer to the Division of Corporation Finance Current Issues
and Rulemaking Projects Quarterly Update under section VIII Industry Specific Issues
Accounting and Disclosure by Companies Engaged in Research and Development Activities. You
can find it at the following website address:
http://www.sec.gov/divisions/corpfin/cfcrq032001.htm. Please revise your MD&A to disclose the
following information for each of your major research and development projects. |
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The current status of the project; |
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The costs incurred during each period presented and to date on each
project; |
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The nature, timing and estimated costs of the efforts necessary to
complete each project; |
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The anticipated completion dates of each project; |
February 29,2008
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The risks and uncertainties associated with completing development on
schedule, and the consequences to operations, financial position and liquidity if
each project is not completed timely; and finally |
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The period in which material net cash inflows from significant projects
are expected to commence for each project. |
Regarding b., if you do not maintain any research and development costs by project, disclose that
fact and explain why management does not maintain and evaluate research and development costs by
project. Provide other quantitative or qualitative disclosure that indicates the amount of the
companys resources are being used on the project.
Regarding c. and d., disclose the amount or range of estimated costs and timing to complete the
phase in process and each future phase. To the extent that information is not estimable, disclose
those facts and circumstances indicating the uncertainties that preclude you from making a
reasonable estimate.
Company Response:
We evaluate research and development (R&D) costs by type of cost incurred rather than by project,
primarily because our R&D personnel work across multiple programs and multiple projects rather than
dedicated to any single project. Our R&D personnel work across programs and projects because our
technology is such that improvements and discoveries that benefit one project or program are likely
to substantively improve other projects and potentially other programs. Moreover, because of the
early stage of our R&D efforts, much of our work is basic research, which is very difficult to
meaningfully categorize or relate to specific development projects or programs. However, per the
Staffs request, and in order to disclose to investors how the Company manages its R&D expenses, we
will expand our disclosure in Managements Discussion and Analysis in our future filings, beginning
with our 2007 10-K, substantially as follows:
Before we can derive revenue or cash inflows from the commercialization of any of our
product candidates, we will need to: (i) conduct substantial in vitro testing and
characterization of our proprietary cell types, (ii) undertake preclinical and clinical
testing for specific disease indications; (iii) develop, validate and scale-up manufacturing
processes to produce these cell-based therapeutics, and (iv) pursue required regulatory
approvals. These steps are risky, expensive and time consuming.
Overall, we expect our R&D expenses to be substantial and to increase for the foreseeable
future as we continue the development and clinical investigation of our current and future
product candidates. However, expenditures on R&D programs are subject to many uncertainties,
including whether we develop our product candidates with a partner or independently. We
cannot forecast with any degree of certainty which of our current product candidates will be
subject to future collaboration, when such collaboration agreements will be secured, if at
all, and to what degree such arrangements would affect our development plans and capital
requirements. In addition, there are numerous factors associated with the successful
commercialization of any of our cell-based therapeutics, including future trial design and
regulatory requirements, many of which cannot be
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determined with accuracy at this time given the stage of our development and the novel
nature of stem cell technologies. The regulatory pathways, both in the United States and
internationally, are complex and fluid given the novel and, in general, clinically unproven
nature of stem cell technologies. At this time, due to such uncertainties and inherent
risks, we cannot estimate in a meaningful way the duration of, or the costs to complete, our
R&D programs or whether, when or to what extent we will generate revenues or cash inflows
from the commercialization and sale of any of our product candidates. While we are
currently focused on advancing each of our product development programs, our future R&D
expenses will depend on the determinations we make as to the scientific and clinical
prospects of each product candidate, as well as our ongoing assessment of the regulatory
requirements and each product candidates commercial potential.
Given the early stage of development of our product candidates, any estimates of when we may
be able to commercialize one or more of these products would not be meaningful. Moreover,
any estimate of the time and investment required to develop potential products based upon
our proprietary HuCNS-SC and hLEC technologies will change depending on the ultimate
approach or approaches we take to pursue them, the results of preclinical and clinical
studies, and the content and timing of decisions made by the FDA and other regulatory
authorities. There can be no assurance that we will be able to develop any product
successfully, or that we will be able to recover our development costs, whether upon
commercialization of a developed product or otherwise. We cannot provide assurance that any
of these programs will result in products that can be marketed or marketed profitably. If
certain of our development-stage programs do not result in commercially viable products, our
results of operations could be materially adversely affected.
Our R&D expenses consist primarily of salaries and related personnel expenses, costs
associated with clinical trials and regulatory submissions; costs associated with
preclinical activities such as toxicology studies; certain patent-related costs such as
licensing; facilities-related costs such as depreciation; lab equipment and supplies.
Clinical trial expenses include payments to vendors such as clinical research organizations,
contract manufacturers, clinical trial sites, laboratories for testing clinical samples and
consultants. Cumulative R&D costs incurred since we refocused our activities on developing
cell-based therapeutics (fiscal years 2000 through 2007) were approximately $XX million.
Over this period, the majority of these cumulative costs were related to: (i)
characterization of our proprietary HuCNS-SC cell, (ii) expenditures for toxicology and
other preclinical studies, preparation and submission of our Investigational New Drug (IND)
application for our Phase I trial for NCL to the FDA, and obtaining
FDA clearance; and (iii)
expenditures in connection with our HuCNS-SC Phase I clinical trial.
We use and manage our R&D resources, including our employees and facilities, across various
projects rather than on a project-by-project basis for the following reasons. The
allocations of time and resources change as the needs and priorities of individual projects
and programs change, and many of our researchers are assigned to more than one project at
any given time. Furthermore, we are exploring multiple possible uses for each of our
proprietary cell types, so much of our R&D effort is complementary to and supportive of each
of these projects. Lastly, much of our R&D effort is focused on manufacturing processes,
which can result in process improvements useful across cell types. We also
February 29,2008
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use external service providers to assist in the conduct of our clinical trials, to
manufacture certain of our product candidates and to provide various other R&D related
products and services. Many of these costs and expenses are complementary to and supportive
of each of our programs. Because we do not have a development collaborator for any of our
product programs, we are currently responsible for all costs incurred with respect to our
product candidates.
R&D expense totaled approximately $XXXX in 2007, as compared to $XXXX in 2006 and $XXXX in
2005. At December 31, 2007, we had XX full-time employees working in research and
development and laboratory support services as compared to XX at December 31, 2006 and XX at
December 31, 2005.
2007 versus 2006. The increase of approximately $XXXX, or XX%, from 2006 to 2007 was
primarily attributable to the continued expansion of our operations in cell processing and
clinical development, including an increase in external services and clinical study costs of
approximately $XXXX, and an increase in personnel costs of approximately $XXXX, of which
approximately $XXXX was attributable to stock-based compensation expense. The remainder of
the increase in 2007 was due to increases in supplies, rent, and other operating expenses.
2006 versus 2005. The increase of approximately $XXXX, or XX%, from 2005 to 2006 was
primarily attributable to expansion of our operations in cell processing and clinical
development, which consisted of an increase in personnel costs of approximately $XXXX, an
increase in external services of approximately $XXXX, an increase in supplies and other
expenses of $XXXX and the cost of additional space leased in 2006 allocated to research and
development. Of the approximately $XXXX increase in personnel costs, approximately $XXXX was
attributable to stock-based compensation expense. The remaining increase was primarily
attributable to increased head count.
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Please be advised that, in connection with the Staffs comments in the December 21 Letter and the
Companys responses thereto, the Company hereby acknowledges the Staffs position that (i) the
Company is responsible for the adequacy and accuracy of the disclosure in the above-referenced
filing; (ii) the Staffs comments or changes to disclosure in response to the Staffs comments do
not foreclose the Commission from taking any action with respect to the filing; and (iii) the
Company may not assert the Staff comments as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United States.
We hope that the foregoing has been responsive to the Staffs comments. If you should have any
questions about this letter or require any further information, please call the undersigned at
(650) 475-3122.
Very truly yours,
/s/ Kenneth B. Stratton
General Counsel