SEC Comment Letter for CALLISTO PHARMACEUTICALS INC (CIK 0001142380) — Apr 29, 2005
CALLISTO PHARMACEUTICALS INC (CIK 0001142380)
Date: April 29, 2005 · CIK: 0001142380 · Accession: 0000000000-05-021081
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File numbers found in text: 333-123863
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Mail Stop 3-9 April
29,
2005
Gary Jacob
Chief Executive Officer
Callisto Pharmaceuticals, Inc.
420 Lexington Avenue, Suite 1609
New York, NY 10170
Re: Callisto Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 5, 2005
File Number 333-123863
Dear Mr. Jacob:
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.
General
1. Please note that where we provide examples to illustrate what
we
mean by our comments, they are examples and not exhaustive lists.
If
our comments are applicable to portions of the filing that we have
not cited as examples, make the appropriate changes in accordance
with our comments.
2. We note that your 10-KSB indicates that your public float
exceeds
$40 million. Please provide us with an analysis supporting the
Company`s decision to file a Form 10-KSB instead of a 10-K. We
note
that the float disclosed on the prior 10-K was nearly $70
million."
3. Please include page numbers on the filing.
Form S-3
Summary
4. Please consider presenting this information using more simple
language that investors will understand. As a few examples only,
terms such as "osteolytic bone disease," "anthracycline,"
"refractory," and similarly complex terms should be replaced with
more simple terms or defined the first time they are used so that
investors can easily understand your disclosure. Please review
the
section and the risk factors and revise the section accordingly.
5. We note your use of the term "Phase I/II" regarding your
recently
completed and currently ongoing clinical trials regarding your two
respective products. The use of the term "Phase I/II" should only
be
used if your trial met all the FDA requirements for a Phase II
study.
Please tell us whether or not your Phase I/II trial met all of the
requirements of Phase II clinical trials. We note that Phase II
trials typically involve administering the product under
development
to 100-300 participants, allowing for the evaluation of the
effectiveness of the drug and determining the short-term side
effects
and risks. Has the FDA agreed that your respective studies were
designed to meet the requirements of Phase II trials? For any of
your studies not designed to meet all requirements of FDA approved
Phase II clinical trials, please delete the references to "Phase
I/II," replace the references with the term "Phase I" and explain
that the trials are designated to provide information related to
the
efficacy, not the effectiveness, of the product candidate. This
comment also applies to your references to "Phase II/III"
throughout
the prospectus.
Recent Developments
6. Please explain what you mean by "IRB approval."
Risk Factors
7. When disclosing a risk factor, you should customize it with
specific reasons why you may be exposed to a particular risk so as
to
make the disclosure more meaningful. As one example only, the
disclosure in "If our agreements with ANORMED or the University of
Texas...," you should expand and customize the risk factor to
disclose whether there are any facts or circumstances that could
cause you to miss a payment or otherwise have either of these
agreements terminated, rather than generically referring to their
possible termination because of a missed payment.
Please review all of your risk factors to ensure that your
disclosure
is customized for the Company and is as specific as possible. In
your response letter, please identify all places where revisions
are
made in response to this comment.
8. In your heading, please eliminate the sentence "the risks
described below are not the only ones affecting us." All material
risk factors should be disclosed.
"We have incurred significant losses..."
9. Please update your financial data in this risk factor to
include
numbers for the first quarter of this year.
"We will need to raise substantial additional capital..."
10. Please disclose the amount of cash you expend on a monthly
basis.
If there is a significant variability, please include a range.
"Delays in clinical testing..."
11. Please disclose any delays you have experienced in clinical
trials to this point.
"The commercial success of our products..."
12. To the extent that there are facts or circumstances that would
support the concerns set forth in the bullet points in this
section,
please disclose those facts in this risk factor.
"If our product candidates are unable to compete effectively..."
13. If there are any products on the market or in development that
would be competitive with your products, please describe those
products and disclose any advantages that those products might
have
relative to your products.
"We may need others to market and commercialize our product
candidates..."
14. Please disclose if you have any current plans to enter
international markets.
"If the FDA does not approve our contract manufacturers`
facilities..."
"We rely upon third parties to conduct clinical trials..."
15. Currently, this risk factor describes the potential problems
associated with collaborations. However, if the Company is
currently
dependent upon collaborators in a material way (such as the third
party manufacturers and clinical trial providers you describe in a
subsequent risk factor), this risk factor should also discuss the
risks associated with that dependence. You should describe the
specific collaboration upon which you are dependent so that
investors
can understand the dependence and the risks associated with losing
the collaboration. You should also describe the alternatives the
Company would face if the collaboration were lost.
"If we fail to attract and keep senior management..."
16. To the extent that you have experienced problems attracting
and
retaining key personnel in the recent past, please revise to
describe
these problems. Additionally, if any key employee has plans to
retire or leave your company in the near future, please revise the
discussion to disclose this information.
"If we fail to acquire and develop..."
17. Please disclose whether acquisitions are a material component
of
your business model or business strategy and also disclose whether
the Company has any current intentions to acquire another company.
"We will need to increase the size of our organization..."
18. Please disclose the number of new employees that the Company
plans to hire to fulfill its strategy for the next two years.
19. In addition, you indicate that you will broaden expertise and
extend manufacturing capabilities. Please expand this discussion
to
disclose specifically what your plans are in these regards.
"Risks related to our intellectual property"
20. With respect to your concerns regarding intellectual property,
please disclose what intellectual property that you possess and
any
specific concerns that you may have, either with regard to
invalidation or claims that you have infringed upon the rights of
others.
21. Please disclose when your material patents will expire.
Risks associated with our common stock
"We are at risk of securities class action litigation"
22. To the extent that there are any facts or circumstances that
might indicate that a party is considering bringing a class action
suit against the company or if one has been filed, disclose those
facts in this risk factor.
Selling Securityholders
23. We call to your attention the requirements of Form S-3 with
respect to the information required by Item 507 (selling
shareholders). We note that certain entities listed as selling
shareholders in the Selling Securityholder Table may be broker-
dealers that have obtained the shares other than as compensation
for
services. In that event, such selling shareholders are deemed
underwriters under the Securities Act of 1933. In that case,
please
revise your registration statement to include those parties as an
underwriter in the section titled "Plan of Distribution" and in
such
other places that would be appropriate. Furthermore, if there are
affiliates of broker-dealers identified as Selling Shareholders,
they
should be identified as such and your disclosure should be revised
to
include the following representations: (i) the Selling Shareholder
purchased in the ordinary course of business and (ii) at the time
of
the purchase, the Selling Shareholder had no agreements or
understanding to distribute securities.
24. Please disclose the natural persons who have dispositive
control
over the shares held by The Pharmaceutical/Medical Technology
Fund,
Atlas, Alexandra and the 2 Orion entities.
Exhibits
25. Please file your legal opinion and any other exhibits that
need
to be filed as soon as possible.
Signatures
26. On the signature page, please include the signature of the
Chief
Accounting Officer.
FORM 10-K for the period ending December 31, 2004
General
27. Please amend your Form 10-K in response to the following
comments. In addition, please note that our foregoing comments
should also be considered when amending the 10-K.
Item 1. Description of Business, p.3
28. In view of the fact that neither of your lead products has
been
approved by the FDA and that both are currently in clinical trials
only, please do not assert that the Company`s products are safe or
effective. As one example only, in your description of each
product,
you state your belief that Annamycin "is effective against several
different in vivo tumor models..." Please delete such statements
throughout the registration statement and limit your discussion to
what was observed and measured.
29. To the extent that you are substantially dependent on any
third
party for services, please describe the material terms of your
agreements with them in your Business section and file your
contracts
with them as exhibits to the registration statement. With respect
to
any third party collaborators, please disclose the approximate
number
of parties performing these services and discuss the obstacles you
would encounter if you were required to replace any party. Please
also disclose the term and termination provisions for each such
agreement.
30. Please disclose the identity of the party licensing patents
disclosed in this section. Additionally, describe the material
terms
of each of the licensing agreements, including:
* Total amounts and types of payments paid to date;
* Existence of royalty provisions;
* Aggregate potential milestone payments;
* Expiration date;
* Termination provisions; and
* Material rights and obligations of each party to these
agreements.
Completed Clinical Studies, p.4
31. In your discussion of clinical trials, you should introduce
the
discussion with disclosure describing what will be required to
demonstrate through larger-scale clinical trials that these
product
candidates are safe and effective for use in a diverse population
before you can seek regulatory approvals for their commercial
sale.
For example, if Phase III trials need to be conduced with 200-300
people, you should state this fact explicitly so that investors
can
understand the results of your test on 13 patients in its
appropriate
context. You should describe such requirements as they apply to
each
of the facts that you state regarding the results. We may have
further comments on your disclosure.
Propriety Rights, p. 7
32. Please disclose when your material patents will expire.
Management`s Discussion and Analysis, p. 18
33. Currently, your MD&A Overview discusses cumulative losses and
your recent private placement. In a recent release called
"Commission Statement about Management`s Discussion and Analysis
of
Financial Condition and Results of Operations," the staff stated
that
"the development of MD&A disclosure should begin with management`s
identification and evaluation of what information, including the
potential effects of known trends, commitments, events, and
uncertainties, is important to providing investors and others an
accurate understanding of the company`s current and prospective
financial position and operating results." Release Nos. 33-8056;
34-
45321; FR-61.
Accordingly, the MD&A overview should include disclosure on the
key
points that are covered in greater detail in the MD& A section,
with
emphasis on the key trend and analytical points as well as on the
"potential effects of known trends, commitments, events and
uncertainties..." We may have further comments on your revisions.
Critical Accounting Policies, page 20
34. Please revise your disclosure herein, giving consideration to
Commission Release No. 33-8350: "Interpretation- Commission
Guidance
Regarding Management`s Discussion and Analysis of Financial
Condition
and Results of Operations," which you can find on our website at
www.sec.gov/rules/interp/33-8350.htm. Specifically, please address
the nature of the uncertainty surrounding your accounting policy
for
stock-based compensation and the impact of the assumptions and
estimates that may materially impact your financial condition or
operating performance. In particular, please address these factors
as
they relate to your issuance of warrants and stock to non-
employees,
which appear significant to your operations.
Results of Operations, page 21
35. We acknowledge the discussion of your product development
pipeline in Item 1. However, 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 expand those disclosures
by
referring 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.
Specifically, please disclose the costs incurred during each
period
presented and to date for each of your major research and
development
projects. If you do not maintain research and development costs
by
project, disclose that fact and explain why management does not
maintain and evaluate research and development costs by project.
Please provide other quantitative or qualitative disclosures that
indicate the amount of resources that the company utilizes for
those
projects.
Liquidity and Capital Resources, page 22
36. Please assess whether the milestone payments under the various
arrangements discussed in your "Results of Operations" section and
Item 1 meet the criteria as purchase obligations, as well as
whether
you should include those milestone payments in your contractual
obligations table. If, as a result of that assessment, you do not
include those milestone payments in the table, please discuss
herein,
to the extent material, the nature of the product development
events
and the amount and timing of event milestone commitments that you
are
reasonably likely to pay. In addition, please clarify, in a
footnote, the nature of the obligations included in the table, as
it
is unclear if the