SEC Comment Letter for Coley Pharmaceutical Group, Inc. (CIK 0001319197) — May 17, 2005
Coley Pharmaceutical Group, Inc. (CIK 0001319197)
Date: May 17, 2005 · CIK: 0001319197 · Accession: 0000000000-05-024295
AI Filing Summary & Sentiment
File numbers found in text: 333-124176
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Via Facsimile and U.S. Mail
Mail Stop 03-09
May 17, 2005
Robert L. Bratzler
President and Chief Executive Officer
Coley Pharmaceutical Group, Inc.
93 Worcester Street, Suite 101
Wellesley, MA 02481
Re: Coley Pharmaceutical Group, Inc.
Registration Statement on Form S-1
Filed April 20, 2005
File Number 333-124176
Dear Mr. Bratzler:
We have reviewed your filing and have the following comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
FORM S-1
General
1. Please provide us proofs of all graphic, visual, or
photographic
information you will provide in the printed prospectus prior to
its
use, for example in a preliminary prospectus. Please note we may
have comments regarding these materials.
2. Please note that when you file a pre-effective amendment
containing pricing-related information, we may have additional
comments. As you are likely aware, you must file this amendment
prior to circulating the prospectus.
3. Please note that when you file a pre-effective amendment that
includes your price range, it must be bona fide. We interpret
this
to mean that your range may not exceed $2 if you price below $20
and
10% if you price above $20.
4. Please note that where we provide examples to illustrate what
we
mean by our comments, they are examples and not complete lists.
If
our comments are applicable to portions of the filing that we have
not cited as examples, please make the appropriate changes in
accordance with our comments.
5. We note that you have requested confidential treatment for
several
of your exhibits under Rule 406 of the Securities Act; we will
furnish comments for your request under separate cover. Please be
advised, we will not act on any request for acceleration of
effectiveness until we have cleared comments on your request for
confidential treatment.
Cover page
6. Please tell us supplementally what percentage of the shares
that
will be outstanding after the public offering will be held by
Pfizer.
We may have further comment.
Prospectus Summary, page 1
7. As you have chosen to include a summary of your strategy,
please
balance this discussion by including a discussion of the risks and
obstacles you must address in implementing this strategy. This
discussion should be at least as prominent as the discussion of
your
strategy. Additionally, include a discussion of your history of
losses, accumulated deficit, that you have no commercially viable
products or FDA approved products, and that you expect to continue
incurring substantial losses for the foreseeable future and may
never
achieve profitability to further balance the discussion in the
summary.
8. Please limit the discussion of your product candidates to the
designed indication, stage of clinical trials and identification
of
any collaborative partners. The current discussion is too
detailed
for the summary. Results of clinical trials are not appropriate
for
disclosure in the summary.
9. Please eliminate jargon and technical terms from the forepart
of
the prospectus and provide a "Plain English" explanation or
substitute. For example, these words and phrases appear in your
summary and in other parts of the prospectus:
* "randomized"
* "vaccine adjuvant"
* "solid and hematologic malignancies"
* "renal cell carcinoma"
* "cutaneous T-cell lymphoma"
* "basal cell carcinoma"
* "squamous cell carcinoma"
* "adenocarcinoma"
* "subcutaneous injection"
* "toxicities"
If you must include technical terms in the body of your prospectus
that are understood only by industry experts you must make every
effort to concisely explain these terms where you first use them.
Risk Factors
10. To the extent material, please consider including a separate
stand alone risk factor pertaining to operations of your foreign
subsidiaries, Coley Ltd. and Coley GmbH. Please consider
including
in your risk factor a discussion of foreign currency risks,
financial
reporting results, interest on euro-denominated debt and interest
rate risk among others.
11. We note the proceeds from the up front payment from the Pfizer
agreement are dependent on receipt of antitrust clearance of your
license agreement. In an appropriate location in your document,
discuss the antitrust clearance, including the criteria that will
be
used to determine whether clearance is warranted and who makes
such
determination. Also, consider including a risk factor discussing
the
consequences if the clearance is not obtained.
12. On page 25 we note the bullet point indicating that the
understanding of the intentions of your collaborative partners are
forward looking statements. Please revise to elaborate by
including
a risk factor describing your understanding of these intentions
and
the potential consequences if your understanding is not correct.
We have limited sources of revenue and if we are unable to secure
additional ..., page 8
13. If you do not receive the proceeds from Pfizer, please
indicate
how long you could continue to run your operations. Similarly,
provide this information in the discussion of "Funding
Requirements"
on pages 42 - 43.
Our TLR Therapeutic product candidates are at an early stage of
product ..., page 11
14. To the extent you are aware of any undesirable side effects or
other characteristics of any of your lead products that may delay
or
preclude regulatory approval or limit their commercial use, please
disclose them in a separate risk factor.
We depend on third-party contractors in the conduct of our
preclinical studies ..., page 14
15. You indicate that you rely on third parties to conduct your
clinical trials. In addition to Pfizer, please identify the third
parties that you substantially rely on for conducting your
clinical
trials and to perform data collection and analysis. Also, to the
extent you have any agreements with such parties, please so
indicate
and describe in your Business section the material terms of the
agreements. You should also file the agreements as exhibits to
your
document.
16. In addition, if you have experienced delays or other
difficulties
due to a clinical research organization`s ability to perform,
please
describe the situation and actual or expected consequences.
Because we have limited manufacturing experience, we depend on
third-
party ..., page 14
17. Please identify any sole source suppliers that you or your
manufacturers rely on for the production of the compounds you need
for preclinical and clinical purposes. To the extent you have any
formal agreements with them, please describe the material terms of
such agreements under the Manufacturing section on page 77. You
should also file the agreements as exhibits to your document. If
you
believe you are not substantially dependent on these suppliers,
provide us with an analysis supporting your determination.
18. If you do not have any long term agreements, please disclose
this
information and disclose when any short-term supply agreements
expire. Additionally, please indicate if these parties currently
meet your manufacturing requirements.
If we are unable to retain our management, scientific staff and
scientific advisors ..., page 15
19. To the extent known, please disclose the projected time frame
of
your hiring the additional scientific and technical personnel.
As we evolve from a company primarily involved in drug research
...,
page 15
20. As currently written, this risk factor could apply to any
issuer
or offering. See Item 503(c) of Regulation S-K. While we
understand
that the risks you describe in this subsection are risks the
company
encounters because it is in the drug development business, you
should
state how this risk relates specifically to your company.
If the combination of patents, trade secrets and contractual
provisions ..., page 16
21. Please revise the discussion to identify your product
candidates
that would be affected if Dynavax`s actions are successful.
If third parties successfully assert that we have infringed their
patents ..., page 17
22. The last sentence of this discussion disclosed a separate
risk.
Please revise to include it as a separate risk factor. The
discussion should identify the personnel you consider to be key
and
the related work product that would be affected if they were to
leave
the company.
If we are unable to protect our trade secrets, we may be unable to
protect our ..., page 18
23. If your business has been materially and adversely affected by
the disclosure of proprietary information, please discuss the
situation and its consequences.
If we fail to comply with our obligations in the agreements under
which ..., page 18
24. In addition, with respect to patents you obtained from third
parties, please disclose who has the obligations to take necessary
actions to protect patents under your license agreements. If you
do
not have the obligation to take action, do you have the right to
take
necessary actions if the other party does not?
There is a substantial risk of product liability claims in our
business. If we are ..., page 20
25. Please indicate if you believe your $10 million product
liability
insurance coverage is adequate.
If there are substantial sales of our common stock, our stock
price
could ..., page 22
26. Please revise the third paragraph of your risk factor to
include
the conversion price of the warrants. If the warrants are
exercisable at varying prices, please provide the range or
weighted
exercise price.
Use of Proceeds, page 26
27. Please disclose the approximate amount and timing of the
proceeds
you plan to use for the purposes you list in this section.
Additionally, please specify how much you anticipate spending for
product development, which products you expect to develop using
these
proceeds and indicate where in the drug development process you
expect to be after the expenditure of these proceeds.
Management`s Discussion and Analysis of Financial Condition and
Results of Operations
Overview, page 32
28. We note your statement that Pfizer will fund nearly all future
development as it relates to ProMune. Please disclose what costs
Coley Pharmaceutical Group will be responsible for going forward
under the license agreement with Pfizer.
Clinical Development Strategy and Ongoing Clinical Programs, page
33
29. Please revise your statement, "[a]fter antitrust clearance of
our
license agreement with Pfizer..." As currently worded the
statement
presupposes authorities will give you antitrust clearance.
Research and Development Cost Allocations, page 34
30. Please expand your disclosure to include additional
information.
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#secviii.
Please
disclose the following information for each of your major research
and development projects:
a. We note that you do not track internal R&D costs on a project
basis. Please revise this discussion to include the external
costs
by project to the extent available;
b. The nature, timing and estimated costs of the efforts necessary
to
complete the project;
c. The anticipated completion dates;
d. The risks and uncertainties associated with completing
development
on schedule, and the consequences to operations, financial
position
and liquidity if the project is not completed timely; and finally
e. The period in which material net cash inflows from significant
projects are expected to commence.
Liquidity and Capital Resources, page 40
31. We note you have yet to fill in the blank indicating the
number
of years your current cash and cash equivalents together with the
proceeds from this offering will last. Notwithstanding your
determination of this figure, please indicate if you expect to
raise
additional funds in the next 24 months. If you are unable to
determine whether you will or not, please disclose the reasons.
Business
General
32. We note your license agreement with the Trustees of Boston
University. Please describe the material provisions of this
agreement in the Business section. Your discussion should
include:
* All material rights and obligations of the parties to the
agreement;
* Duration of the agreement;
* Quantification of all payments made to date and aggregate
potential
payments;
* Termination provisions, including consequences of early
termination; and
* Any other terms that may be considered material.
Please include a discussion of these material provisions in
your
next amendment. We may have further comment.
33. To the extent that you discuss the results of clinical trials,
discuss whether the results were statistically significant.
Disclose
p values, where applicable, and the meaning of the p values.
Additionally, the discussion of the results should be qualified by
a
statement that later stage clinical trials might not support these
results.
Overview, page 45
34. Please revise the first sentence in the fifth paragraph to
state
after you receive antitrust clearance you expect Pfizer will
initiate
a Phase III clinical trial of ProMune. Also, make similar changes
throughout the document where appropriate.
ProMune for Cancer, page 49
35. We note your statement, "[t]he worldwide cancer drug market is
expected to increase from $39 billion in 2003 to $50 billion by
2007." You should only include the size of your potential target
market in which you will compete. Please confirm the $39 billion
and
$50 billion accurately reflects your target market or revise
accordingly.
36. On page 56 you state that subcutaneous administration of
ProMune
is safe. Safety and efficacy are determinations that only the FDA
can make. Please revise to delete this statement. We do not
object
to the statement that it appeared to be relatively well tolerated
by
most patients.
Pfizer Collaboration, page 66
37. Please revise to disclose when the last of the licensed
patents
is scheduled to expire.
sanofi-aventis Collaboration, page 67
38. Please disclose the duration of your agreement with sanofi-
aventis.
Other Commercial Collaborations, page 68
39. Please disclose the duration of your agreements with
GlaxoSmithKline plc and Chiron Corporation.
40. Please disclose the total aggregate amount you may be entitled
to
receive under the terms of your license agreement with Qiagen (now
Merial Limited). Additionally, disclose the duration of this
agreement.
Government Contracts and Grants, page 68
41. Please revise to disclose the amounts already received under
each
of these contracts or grants.
Technology In-Licenses, page 69
42. Please revise to identify your product candidates that are
dependent on each of these licenses.
43. Quantify the royalties to UIRF that are past due.
44. If you made up front payments to acquire these licenses,
please
disclose the payments made to date and any payments you still need
to
make.
Intellectual Property, page 71
45. Please describe the 42