SEC Company Response from Microbot Medical Inc. (MBOT) (CIK 0000883975) (MBOT) — Feb 29, 2008
Microbot Medical Inc. (MBOT) (CIK 0000883975)
Date: Feb. 29, 2008 · CIK: 0000883975 · Accession: 0000950134-08-003875
AI Filing Summary & Sentiment
File numbers found in text: 000-19871
Referenced dates: December 21, 2007
Show Raw Text
CORRESP
1
filename1.htm
corresp
February 29, 2008
VIA EDGAR
U.S. Securities and Exchange Commission
Mail Stop 6010
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attention:
Jim B. Rosenberg, Senior Assistant
Chief Accountant
Re:
SEC Comment Letter, dated December 21, 2007
StemCells, Inc.
Form 10-K for the Year Ended December 30, 2006
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 Staff’s
letter dated December 21, 2007 (the “December 21 Letter”) regarding the Company’s 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
1.
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
February 29,2008
Page 2
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.
2.
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.
3.
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 Company’s 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 Neuralstem’s 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
4.
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.
a.
The current status of the project;
b.
The costs incurred during each period presented and to date on each
project;
c.
The nature, timing and estimated costs of the efforts necessary to
complete each project;
d.
The anticipated completion dates of each project;
February 29,2008
Page 5
e.
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
f.
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
company’s 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
Staff’s request, and in order to disclose to investors how the Company manages its R&D expenses, we
will expand our disclosure in Management’s 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
February 29,2008
Page 6
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 eac