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SEC Comment Letter for SUNESIS PHARMACEUTICALS INC (VIRX) (CIK 0001061027) (VIRX) — Jan 19, 2005

SUNESIS PHARMACEUTICALS INC (VIRX) (CIK 0001061027)
Date: Jan. 19, 2005 · CIK: 0001061027 · Accession: 0000000000-05-003084

AI Filing Summary & Sentiment

File numbers found in text: 333-121646

Date
January 19, 2005
Author
Not clearly detected
Form
UPLOAD
Company
SUNESIS PHARMACEUTICALS INC (VIRX) (CIK 0001061027)

Letter

Mail Stop 3-9 January 19, 2005 Daniel Swisher Chief Executive Officer Sunesis Pharmaceuticals, Inc. 341 Oyster Point Boulevard South San Francisco, California 94080

Re: Sunesis Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed December 23, 2005 File Number 333-121646

Dear Mr. Swisher:

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 we will send you our comments on your pending request for confidential treatment by separate letter. All confidential treatment issues must be resolved before we will consider a request for acceleration of the registration statement. 2. 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 this material.

3. 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. 4. Please note that when you file a pre-effective amendment that includes your price range, it must be bone 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. 5. Please file as promptly as possible all exhibits required by the Exhibit Table provided in Item 601(a) of Regulation S-K. 6. 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. 7. In your response letter, please state our comment and then explain each change that has been made in response to a comment. In addition, you should also reference each page number in which disclosure has been revised in response to a comment so that we can easily place your revised disclosure in its proper context. 8. Throughout the registration statement, you cite various estimates, statistics and other figures. Where you cite your own estimates, please explain how you arrived at those estimates, disclose any third-party sources you relied upon, and provide us with any copies of those sources. Copies delivered should be marked to highlight the relevant information. For all other figures, please identify your sources and provide copies of these sources to us. Set forth below is an illustrative and not an exhaustive list of statements that should be supported: * "sales of gleevec are expected to increase from $1.1 billion...$2.5billion," p.44 * "Examples of TNF inhibitors include...$1.3 billion and $600 million," p. 48. Cover page 9. Please delete the term "Joint Book-Running Managers" from your cover page.

Prospectus Summary, page 1 Overview, p. 1 10. Please explain the term "tethering" the first time it is used.

Our Programs, p. 1 SNS 595 Program, p.1 11. Please explain technical terms and phrases such as "cytotoxic," "cell-cycle inhibitor," "novel mechanism of action," "myelocytic," "kinase" and "fragment-based technologies" using simple language that investors can understand. These terms should be explained the first time they are used. 12. Please disclose the rights you have acquired from Dainippon are through a license agreement.

Risks Related to our Business, page 3 13. Please revise to disclose that you have not generated any operating revenues and you expect to incur losses for the foreseeable future.

The Offering, page 4 14. You have disclosed that none of the information contained in your prospectus was adjusted for the effect of the reverse stock split to be effected prior to the completion of the offering. Please note that if the number of common shares outstanding increases as a result of a stock dividend or stock split or decreases as a result of a reverse stock split, the computations of basic and diluted EPS is to be adjusted retroactively for all periods presented to reflect that change in capital structure, and the per-share computations for those and any prior-period financial statements presented shall be based on the new number of shares. If per-share computations reflect such changes in the number of shares, that fact shall be disclosed. Please refer to ARB No. 43, Chapter 7B, "Capital Accounts--Stock Dividends and Stock Split-Ups" and please revise your presentation and disclosures throughout the filing.

Risk Factors, p. 7 General 15. 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 competitors develop and market products...," you should expand and customize the risk factor to disclose whether SNS-595 suffers from any disadvantages as compared with irinotecan, doxorubicin and the other competitive products you have listed, with a particular emphasis on the factors listed in the bullet points. For example, if any competitive products are in later-stage clinical trials (or approved), you should disclose this fact explicitly rather than relying upon a generic bullet point relating to speed of development.

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.

"There is a high risk that our drug discovery and development activities will not result in commercial products," page 7 16. If you have experienced any of the situations described in your bullet point list, please revise to describe the situation you experienced and the consequences. It may be necessary to include such discussion as a separate risk factor discussion.

"If we fail to maintain our existing, or enter into new, strategic collaborations...," p. 11 "We rely on third parties to conduct our clinical trials...," p. 17. Other than the third party manufacturer and single supplier for SNS-595 that you reference in subsequent risk factors, please identify collaboration agreements upon which you are heavily dependent. Additionally, describe the subject of the agreement. Please also describe any disadvantages that your company has in negotiating collaboration agreements, if any. 18. To the extent that you are substantially dependent on any third party for services, (other than the third party manufacturer and single supplier for SNS-595 that you reference in subsequent risk factors), 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. If you are not substantially dependent on any of third parties, disclose the approximate number of parties performing these services and discuss the obstacles you would encounter if you were required to replace any party. 19. Please discuss the extent to which the third parties upon whom you rely have failed in the past to perform as you expected them to. "If Conflicts of interest arise...," p. 11 20. Please disclose the types of facts or circumstances that might lead a collaborator to breach or fail to perform under any agreement with the Company. 21. If you are aware of any of your collaborators that are developing product candidates that would compete with the candidates that you are developing under the agreement.

"We rely on a third party to manufacture our product candidates...," p. 12 22. In light of your dependence on this third party manufacturer, you should name the manufacturer explicitly, describe the material terms of the contract in the business section and file your agreement with the manufacturer as an exhibit to the registration statement. If you believe you are not required to file the agreement, provide us with a supplemental analysis supporting your determination. The analysis should discuss the availability of alternative sources.

"Our proprietary rights may not adequately...," p.13 "If we are sued for infringing...," p. 15 "We may be subject to damages resulting from claims...," p. 15 23. Please describe any problems you have had in the past with the risks you have posed in this section. Describe any claims that you have infringed on the intellectual property of others, that employees have disclosed trade secrets of employers, and your failures to protect intellectual property rights, among other issues.

"We expect to significantly expand our clinical research...,"p. 24. 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.

"Evolving regulation of corporate governance and public disclosure may result in additional expenses and continuing uncertainty," page 25. This risk factor is generic as it applies to all companies in all industries. Please either revise to tailor the risk factor to your business and your operations or delete it.

"Even if we receive regulatory approval to market our product candidates, the market may not be receptive to our products," page 26. If there are any known side effects to any of your product candidates, please revise to disclose them.

"Foreign governments often impose strict price controls...," p.18 27. If applicable, you should include in your discussion of this risk factor (or in a new risk factor), the fact that regulatory approval in the US may not necessarily mean that you will gain approval in foreign jurisdictions.

"We may be subject to costly claims...," p. 18 "We may incur significant costs complying with environmental laws...," p. 18 28. Please disclose the amount and limits for the insurance you carry for these respective types of claims.

Use of Proceeds, p. 24 29. You have allocated $40 million to clinical and preclinical development of programs. Please revise your disclosure to include more information about this amount, including a breakdown of proceeds by program as you have identified them in the prospectus summary and in the business section. Please also disclose how far the allocated proceeds will take each program or product in the development process.

Capitalization, page 24 30. Within the capitalization table, please revise to include the current portion of long-term debt.

Management`s Discussion and Analysis of the Company, p. 29 General 31. Please disclose your accumulated losses as of December 31, 2004. 32. We note the Company has not provided meaningful estimates of the ultimate cost to bring your product candidates to market. Please consider including at least minimum amounts that you anticipate incurring by project/product candidate and the timing of incurring those minimum amounts. Please also address in your disclosure the following: * The nature, timing and the efforts necessary to complete the project; * The anticipated completion dates; * 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 * The period in which material net cash inflows from significant projects are expected to commence. 33. Please note that if you will make or receive any payment that is material and probable, you must disclose that payment in the MD&A and that information will not be the proper subject of a confidential treatment request. If there are no such payments, advise us of this fact in your response letter. Stock Based Compensation, page 33

34. In order for us to fully understand the equity fair market valuations reflected in your financial statements, please provide an itemized chronological schedule covering all equity instruments issued since January 1, 2004 through the date of your response. Please provide the following information separately for each equity issuance:

* The date of the transaction, * The number of options granted or shares issued, * The exercise price or per share amount paid, * Management`s fair market value per share estimate and how the estimate was made, * An explanation of how the fair value of the convertible preferred stock and common stock relate, given the one-for-one conversion ratio, * The identity of the recipient, indicating if the recipient was a related party, * Nature and terms of concurrent transactions; and, * The amount of any compensation or interest expense element. Please note that because the initial filing did not include an estimated offering price we are deferring evaluation of common stock related compensation until you specify the estimated offering price. Research and Development, page 34 and page 43.

35. We acknowledge your discussion research and development activities. In addition to your current disclosures please include the following information for each of your major research and development projects:

* The costs incurred during each period presented and to date on the project; * The nature and estimated costs of the efforts necessary to complete the project; * 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 * The period in which material net cash inflows from significant projects are expected to commence. To the extent that information requested above is not known or estimable, disclose that fact and the reason why it is not known. 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. Business, p. 41 SNS 595 Program, p.45 36. Where you discuss the results of clinical trials, in addition to including qualifications making it explicitly clear that clinical trials have not been completed and later stage trials may contradict your conclusions regarding safety or efficacy. You should also provide further disclosure about your results, including a brief statistical analysis your results. As one example only, on page 46, you state that SNS-595 showed 99% to 100% inhibition of growth. Please disclose the p-values associated with these results and explain what the p-values mean. If the results are not statistically significant, you should indicate this fact in the disclosure. 37. Please explain what you mean by "PK."

Strategic Collaborations, page 50 38. Please revise the descriptions of your collaboration agreements to quantify the amounts paid to da

Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

Mail Stop 3-9								January 19, 2005

Daniel Swisher
Chief Executive Officer
Sunesis Pharmaceuticals, Inc.
341 Oyster Point Boulevard
South San Francisco, California 94080

Re:	Sunesis Pharmaceuticals, Inc.
	Registration Statement on Form S-1
      Filed December 23, 2005
	File Number 333-121646

 Dear Mr. Swisher:

      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 we will send you our comments on your pending
request for confidential treatment by separate letter. All
confidential treatment issues must be resolved before we will
consider a request for acceleration of the registration statement.
2. 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 this material.

3. 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.
4. Please note that when you file a pre-effective amendment that
includes your price range, it must be bone 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.
5. Please file as promptly as possible all exhibits required by
the
Exhibit Table provided in Item 601(a) of Regulation S-K.
6. 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.
7. In your response letter, please state our comment and then
explain
each change that has been made in response to a comment.  In
addition, you should also reference each page number in which
disclosure has been revised in response to a comment so that we
can
easily place your revised disclosure in its proper context.
8. Throughout the registration statement, you cite various
estimates,
statistics and other figures.  Where you cite your own estimates,
please explain how you arrived at those estimates, disclose any
third-party sources you relied upon, and provide us with any
copies
of those sources.  Copies delivered should be marked to highlight
the
relevant information.  For all other figures, please identify your
sources and provide copies of these sources to us. Set forth below
is
an illustrative and not an exhaustive list of statements that
should
be supported:
*	"sales of gleevec are expected to increase from $1.1
billion...$2.5billion," p.44
*	"Examples of TNF inhibitors include...$1.3 billion and $600
million," p. 48.
Cover page
9. Please delete the term "Joint Book-Running Managers" from your
cover page.

Prospectus Summary, page 1
Overview, p. 1
10. Please explain the term "tethering" the first time it is used.

Our Programs, p. 1
SNS 595 Program, p.1
11. Please explain technical terms and phrases such as
"cytotoxic,"
"cell-cycle inhibitor," "novel mechanism of action," "myelocytic,"
"kinase" and "fragment-based technologies" using simple language
that
investors can understand.  These terms should be explained the
first
time they are used.
12. Please disclose the rights you have acquired from Dainippon
are
through a license agreement.

Risks Related to our Business, page 3
13. Please revise to disclose that you have not generated any
operating revenues and you expect to incur losses for the
foreseeable
future.

The Offering, page 4
14. You have disclosed that none of the information contained in
your
prospectus was adjusted for the effect of the reverse stock split
to
be effected prior to the completion of the offering.  Please note
that if the number of common shares outstanding increases as a
result
of a stock dividend or stock split or decreases as a result of a
reverse stock split, the computations of basic and diluted EPS is
to
be adjusted retroactively for all periods presented to reflect
that
change in capital structure, and the per-share computations for
those
and any prior-period financial statements presented shall be based
on
the new number of shares. If per-share computations reflect such
changes in the number of shares, that fact shall be disclosed.
Please refer to ARB No. 43, Chapter 7B, "Capital Accounts--Stock
Dividends and Stock Split-Ups" and please revise your presentation
and disclosures throughout the filing.

Risk Factors, p. 7
General
15. 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 competitors develop and market products...,"
you should expand and customize the risk factor to disclose
whether
SNS-595 suffers from any disadvantages as compared with
irinotecan,
doxorubicin and the other competitive products you have listed,
with
a particular emphasis on the factors listed in the bullet points.
For example, if any competitive products are in later-stage
clinical
trials (or approved), you should disclose this fact explicitly
rather
than relying upon a generic bullet point relating to speed of
development.

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.

"There is a high risk that our drug discovery and development
activities will not result in commercial products," page 7
16. If you have experienced any of the situations described in
your
bullet point list, please revise to describe the situation you
experienced and the consequences.  It may be necessary to include
such discussion as a separate risk factor discussion.

"If we fail to maintain our existing, or enter into new, strategic
collaborations...," p. 11
"We rely on third parties to conduct our clinical trials...," p.
12
17. Other than the third party manufacturer and single supplier
for
SNS-595 that you reference in subsequent risk factors, please
identify collaboration agreements upon which you are heavily
dependent.   Additionally, describe the subject of the agreement.
Please also describe any disadvantages that your company has in
negotiating collaboration agreements, if any.
18. To the extent that you are substantially dependent on any
third
party for services, (other than the third party manufacturer and
single supplier for SNS-595 that you reference in subsequent risk
factors), 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.  If you are not
substantially
dependent on any of third parties, disclose the approximate number
of
parties performing these services and discuss the obstacles you
would
encounter if you were required to replace any party.
19. Please discuss the extent to which the third parties upon whom
you rely have failed in the past to perform as you expected them
to.
"If Conflicts of interest arise...," p. 11
20. Please disclose the types of facts or circumstances that might
lead a collaborator to breach or fail to perform under any
agreement
with the Company.
21. If you are aware of any of your collaborators that are
developing
product candidates that would compete with the candidates that you
are developing under the agreement.

"We rely on a third party to manufacture our product
candidates...,"
p. 12
22. In light of your dependence on this third party manufacturer,
you
should name the manufacturer explicitly, describe the material
terms
of the contract in the business section and file your agreement
with
the manufacturer as an exhibit to the registration statement.  If
you
believe you are not required to file the agreement, provide us
with a
supplemental analysis supporting your determination.  The analysis
should discuss the availability of alternative sources.

"Our proprietary rights may not adequately...," p.13
"If we are sued for infringing...," p. 15
"We may be subject to damages resulting from claims...," p. 15
23. Please describe any problems you have had in the past with the
risks you have posed in this section.  Describe any claims that
you
have infringed on the intellectual property of others, that
employees
have disclosed trade secrets of employers, and your failures to
protect intellectual property rights, among other issues.

 "We expect to significantly expand our clinical research...,"p.
15
24. 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.

"Evolving regulation of corporate governance and public disclosure
may result in additional expenses and continuing uncertainty,"
page
16
25. This risk factor is generic as it applies to all companies in
all
industries.  Please either revise to tailor the risk factor to
your
business and your operations or delete it.

 "Even if we receive regulatory approval to market our product
candidates, the market may not be receptive to our products," page
17
26. If there are any known side effects to any of your product
candidates, please revise to disclose them.

"Foreign governments often impose strict price controls...," p.18
27. If applicable, you should include in your discussion of this
risk
factor (or in a new risk factor), the fact that regulatory
approval
in the US may not necessarily mean that you will gain approval in
foreign jurisdictions.

"We may be subject to costly claims...," p. 18
"We may incur significant costs complying with environmental
laws...," p. 18
28. Please disclose the amount and limits for the insurance you
carry
for these respective types of claims.

Use of Proceeds, p. 24
29. You have allocated $40 million to clinical and preclinical
development of programs.  Please revise your disclosure to include
more information about this amount, including a breakdown of
proceeds
by program as you have identified them in the prospectus summary
and
in the business section.  Please also disclose how far the
allocated
proceeds will take each program or product in the development
process.

Capitalization, page 24
30. Within the capitalization table, please revise to include the
current portion of long-term debt.

Management`s Discussion and Analysis of the Company, p. 29
General
31. Please disclose your accumulated losses as of December 31,
2004.
32. We note the Company has not provided meaningful estimates of
the
ultimate cost to bring your product candidates to market. Please
consider including at least minimum amounts that you anticipate
incurring by project/product candidate and the timing of incurring
those minimum amounts.  Please also address in your disclosure the
following:
* The nature, timing and the efforts necessary to complete the
project;
* The anticipated completion dates;
* 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
* The period in which material net cash inflows from significant
projects are expected to commence.
33. Please note that if you will make or receive any payment that
is
material and probable, you must disclose that payment in the MD&A
and
that information will not be the proper subject of a confidential
treatment request.  If there are no such payments, advise us of
this
fact in your response letter.
Stock Based Compensation, page 33

34. In order for us to fully understand the equity fair market
valuations reflected in your financial statements, please provide
an
itemized chronological schedule covering all equity instruments
issued since January 1, 2004 through the date of your response.
Please provide the following information separately for each
equity
issuance:

* The date of the transaction,
* The number of options granted or shares issued,
* The exercise price or per share amount paid,
* Management`s fair market value per share estimate and how the
estimate was made,
* An explanation of how the fair value of the convertible
preferred
stock and common stock relate, given the one-for-one conversion
ratio,
* The identity of the recipient, indicating if the recipient was a
related party,
* Nature and terms of concurrent transactions; and,
* The amount of any compensation or interest expense element.
Please note that because the initial filing did not include an
estimated offering price we are deferring evaluation of common
stock
related compensation until you specify the estimated offering
price.
Research and Development, page 34 and page 43.

35. We acknowledge your discussion research and development
activities.  In addition to your current disclosures please
include
the following information for each of your major research and
development projects:

* The costs incurred during each period presented and to date on
the
project;
* The nature and estimated costs of the efforts necessary to
complete
the project;
* 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
* The period in which material net cash inflows from significant
projects are expected to commence.
To the extent that information requested above is not known or
estimable, disclose that fact and the reason why it is not known.
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.
Business, p. 41
SNS 595 Program, p.45
36. Where you discuss the results of clinical trials, in addition
to
including qualifications making it explicitly clear that clinical
trials have not been completed and later stage trials may
contradict
your conclusions regarding safety or efficacy.  You should also
provide further disclosure about your results, including a brief
statistical analysis your results.  As one example only, on page
46,
you state that SNS-595 showed 99% to 100% inhibition of growth.
Please disclose the p-values associated with these results and
explain what the p-values mean.  If the results are not
statistically
significant, you should indicate this fact in the disclosure.
37. Please explain what you mean by "PK."

Strategic Collaborations, page 50
38. Please revise the descriptions of your collaboration
agreements
to quantify the amounts paid to da