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SEC Comment Letter for Advanced Life Sciences Holdings, Inc. (CIK 0001322734) — May 26, 2005

Advanced Life Sciences Holdings, Inc. (CIK 0001322734)
Date: May 26, 2005 · CIK: 0001322734 · Accession: 0000000000-05-026183

AI Filing Summary & Sentiment

File numbers found in text: 333-124396

Date
April 28, 2005
Author
Not clearly detected
Form
UPLOAD
Company
Advanced Life Sciences Holdings, Inc. (CIK 0001322734)

Letter

Mail Stop 3-9 May 26, Michael T. Flavin Chairman and Chief Executive Officer Advanced Life Sciences Holdings, Inc. 1440 Davey Road Woodridge, Illinois 60517

Re: Advanced Life Sciences Holdings, Inc. Registration Statement on Form S-1 Filed April 28, 2005 File Number 333-124396

Dear Mr. Flavin:

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. We note that none of your exhibits have been designated to seek confidential treatment. If you decide to file additional exhibits and seek confidential treatment for those exhibits, please note that 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 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. 6. 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. 7. Throughout the registration statement, you cite various estimates, statistics and other figures. As one example only, on page 41 you state, "The total worldwide market for antibiotics in 2003 was $25 billion... and is estimated to grow to $32 billion by 2010." 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. 8. In light of the fact that none of your products have received regulatory approval, you should be careful in describing your products as safe or effective. Any statements that refer to efficacy, potency or safety should be qualified by language that makes it explicitly clear that clinical trials have not been completed and that any conclusions regarding safety or efficacy may be contradicted by subsequent tests. As one example only, on page of the registration statement, you say that Cethromycin was "shown to be active against upper and lower respiratory tract pathogens." Please revise your disclosure to include qualifying language that will present this information in its proper context. You should also include similar language where such statements are made throughout the registration statement and advise us of where the changes have been made. 9. In addition, certain other types of statements should be deleted from the registration statement altogether. As one example only, on p.42 you state, "We also believe that the compound demonstrates certain competitive advantages over Ketek..." Another such statement is found on page 43, when you state, "cethromycin...would...prove to be an attractive alternative treatment for respiratory tract infections." Statements of opinion that are favorable to the product are not appropriate for the registration statement. In addition, it is premature to make statements indicating that your products may have advantages over other products or product candidates or that they will make an attractive treatment. Please review the registration statement and delete similar statements of favorable opinion or prospects. We may have further comments on your revisions.

Prospectus Summary, page 1 10. Please explain technical terms and phrases such as "pathogens, including penicillin and macro-slide resistant Gram positive bacteria" and "non-nucleoside reverse transcriptase inhibitor" using simple language that investors can understand. Please make revisions to such terms throughout the forepart of the prospectus. We may have further comments on your revisions.

11. Please revise your summary to present the key points in the disclosure that are set forth in the other sections of the registration statement. For example:

* In your collaborations with other companies, describe the role that each participant will play in the collaboration; and * Disclose how the company will generate revenues (product sales directly to the consumer, royalties, milestone payments, etc.); and 12. We note your disclosure about the worldwide market for antibiotics. Would this be your target market? It appears that your market would be significantly smaller as your product candidates are designed to target specific indications. Please provide us with an explanation supporting your use of this information as your target market or revise to provide information about the use of antibiotics for the indications your candidates are attempting to target. Similarly, revise page 41. 13. Much of the disclosure is too detailed for the Summary. Specific information relating to market size for your products, results of clinical tests and other detailed information should be included in the Business section. Please limit the discussion of your product candidates to an identification of the target indication and the stage of clinical development.

14. Please revise "Risks Affecting Us" to also disclose that your auditors opinion has a going concern qualification and that you have negative working capital.

Risk Factors, p. 7 General 15. In the header, please delete the sentence "The following risks and uncertainties may not be the only ones we face." 16. 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 "We will face significant competition...," you have provided mostly generic disclosure relating to competition, such as the possibility that another company may obtain regulatory approval before you do. This risk factor should be customized to disclose any specific competitive advantages that competitors possess, either with respect to the companies or with respect to their products. With respect to speed of approvals, you should disclose if any competitive products are in later-stage clinical trials (or approved), rather than relying upon a generic statement 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. 17. To the extent that any clinical trial participants have experienced adverse effects, please revise to include a separate risk factor disclosing the adverse effects.

"We are heavily dependent on our license agreement...," p. 8 18. Please provide more explicit disclosure relating to the risks you are describing. Similarly revise "We face special risks...," "We depend on outside parties...," Our collaborators and third party manufacturers ..., " and "If we are unable to establish sales and marketing capabilities..." For example, in your discussion of Abbott Labs and Sarawak, you reference payments that you are required to make and the other party`s right to terminate the respective agreements. If it is your intention to convey that you may have difficulty making the payments such that the contracts could be terminated and materially affect the company`s prospects, state this fact explicitly. 19. Please disclose any facts or circumstances that might lead to the types of problems you have set forth in the bullet points.

"We face special risks...," p. 9 20. Please revise your heading to identify the risk and potential consequences. 21. If you are currently in default on the loan from the Sarawak Government, then revise to specifically state that you are in default.

"The future clinical testing of our product candidates could be delayed...," page 10 22. If you have experienced delays in your clinical trials for any of the reasons identified in the bullet point, please revise to disclose the circumstances and the length of the delay. 23. Please disclose whether there are any facts or circumstances that would suggest that delays in clinical testing may be forthcoming.

"We depend on outside parties to conduct our clinical trials...," p.11 24. It is unclear whether you are currently dependent on these contract research organizations or if you intend to rely on them in the future. Please revise to clarify. If you are currently dependent on any individual contract research organizations, please identify them and in the Business section describe the material terms of your arrangements with them. 25. If you have experienced instances where your contract research organizations have failed to perform, please revise to describe the situation and consequences. Similarly, revise "Our collaborators and third party manufacturers..."

"Our collaborators and third party manufacturers..."p.14 26. Are any of the manufacturers sole source suppliers? If they are, please identify these manufacturers. If you have agreements with these manufacturers, please file them as exhibits and provide a discussion of the material terms in the Business section. Alternatively, provide an analysis supporting your determination that you are not substantially dependent on each of the agreements. If you do not have any agreements with these parties, please revise the risk factor discussion to disclose that you do not have any agreements with these parties.

"Even if we successfully develop and obtain approval for cethromycin...," p. 12 27. Please disclose whether there are any facts or circumstances that indicate that the product may not gain market acceptance.

"Our most advanced product candidate... will face significant competition...," p. 13 28. Please disclose any advantages competitive products (or the companies who make them) possess vis a vis cethromycin and the company.

"Because our product candidates and development and collaboration efforts...," p.15 29. If you are aware of any circumstances adversely affecting your intellectual property rights or any claims of infringement, please revise to disclose this information in the risk factor discussion.

"Confidentiality agreements with employees...," p.16 30. If you have experienced any breaches in confidentiality, please revise to disclose this information.

"We will need to increase the size of our organization...,"p. 17 31. To the extent you have had difficulty managing growth in the past, please disclose the problems you have faced, the efforts you undertook to resolve the problems, and whether the problems were resolved satisfactorily.

"If we are unable to attract and retain qualified scientific...," p. 32. 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.

"Our business will expose us to potential product liability risks...," p. 18 33. Please revise the risk factor heading to uses the terms "acquire and maintain," rather than just "maintain.`

"We face regulation and risks related to hazardous materials...," p. 34. If you have experienced any contamination or injury from these materials or chemicals, please revise to describe the situation. 35. Do you have insurance that would cover such damages?

"Our business and operations...," p.18 36. Please disclose any specific weaknesses in your systems that could make you vulnerable to the types of concerns you have described in this risk factor.

Risks related to the offering, p. 19 "Because we have operated as a private company ...," page 21 37. Please revise to explain how this risk factor affects your company. As currently written, it would not affect you any differently than any other company that has recently become a reporting company. For instance, are there any reasons to believe that you might be unable to conclude that you have effective internal controls over financial reporting?

We have never paid cash dividends..., p. 22 38. Please disclose the risks for investors relating to the failure to pay dividends.

Use of Proceeds, p. 24 39. You have allocated $37.2 million of proceeds to various payments. As you have indicated that approximate total proceeds of $86M, you will need to provide more specific disclosure regarding the remaining proceeds. 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. Please be as specific as possible. We may have further comments on your disclosure.

Capitalization, page 26 40. Please include a statement that the table presented sets forth your cash and cash equivalents and capitalization as of March 31, 2005. As cash and cash equivalents do not represent capitalization of a company, please revise the summation of your capitalization within your table to exclude the amount of cash and cash equivalents as of March 31, 2005.

Management`s Discussion and Analysis of the Company, p. 29 General 41. Currently, your MD&A Overview discusses your product pipeline, collaborations and cumulative losses. 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

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

Mail Stop 3-9									May 26,
2005

Michael T. Flavin
Chairman and Chief Executive Officer
Advanced Life Sciences Holdings, Inc.
1440 Davey Road
Woodridge, Illinois 60517

Re:	Advanced Life Sciences Holdings, Inc.
	Registration Statement on Form S-1
      Filed April 28, 2005
	File Number 333-124396

 Dear Mr. Flavin:

      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. We note that none of your exhibits have been designated to seek
confidential treatment.  If you decide to file additional exhibits
and seek confidential treatment for those exhibits, please note
that
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 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.
6. 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.
7. Throughout the registration statement, you cite various
estimates,
statistics and other figures.  As one example only, on page 41 you
state, "The total worldwide market for antibiotics in 2003 was $25
billion... and is estimated to grow to $32 billion by 2010."
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.
8. In light of the fact that none of your products have received
regulatory approval, you should be careful in describing your
products as safe or effective.  Any statements that refer to
efficacy, potency or safety should be qualified by language that
makes it explicitly clear that clinical trials have not been
completed and that any conclusions regarding safety or efficacy
may
be contradicted by subsequent tests.  As one example only, on page
38
of the registration statement, you say that Cethromycin was "shown
to
be active against upper and lower respiratory tract pathogens."
Please revise your disclosure to include qualifying language that
will present this information in its proper context.  You should
also
include similar language where such statements are made throughout
the registration statement and advise us of where the changes have
been made.
9. In addition, certain other types of statements should be
deleted
from the registration statement altogether.  As one example only,
on
p.42 you state, "We also believe that the compound demonstrates
certain competitive advantages over Ketek..."  Another such
statement
is found on page 43, when you state, "cethromycin...would...prove
to
be an attractive alternative treatment for respiratory tract
infections." Statements of opinion that are favorable to the
product
are not appropriate for the registration statement.  In addition,
it
is premature to make statements indicating that your products may
have advantages over other products or product candidates or that
they will make an attractive treatment.  Please review the
registration statement and delete similar statements of favorable
opinion or prospects.  We may have further comments on your
revisions.

Prospectus Summary, page 1
10. Please explain technical terms and phrases such as "pathogens,
including penicillin and macro-slide resistant Gram positive
bacteria" and "non-nucleoside reverse transcriptase inhibitor"
using
simple language that investors can understand.  Please make
revisions
to such terms throughout the forepart of the prospectus.  We may
have
further comments on your revisions.

11. Please revise your summary to present the key points in the
disclosure that are set forth in the other sections of the
registration statement.  For example:

* In your collaborations with other companies, describe the role
that
each participant will play in the collaboration; and
* Disclose how the company will generate revenues (product sales
directly to the consumer, royalties, milestone payments, etc.);
and
12. We note your disclosure about the worldwide market for
antibiotics.  Would this be your target market?  It appears that
your
market would be significantly smaller as your product candidates
are
designed to target specific indications.  Please provide us with
an
explanation supporting your use of this information as your target
market or revise to provide information about the use of
antibiotics
for the indications your candidates are attempting to target.
Similarly, revise page 41.
13. Much of the disclosure is too detailed for the Summary.
Specific
information relating to market size for your products, results of
clinical tests and other detailed information should be included
in
the Business section.  Please limit the discussion of your product
candidates to an identification of the target indication and the
stage of clinical development.

14. Please revise "Risks Affecting Us" to also disclose that your
auditors opinion has a going concern qualification and that you
have
negative working capital.

Risk Factors, p. 7
General
15. In the header, please delete the sentence "The following risks
and uncertainties may not be the only ones we face."
16. 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 "We will face significant competition...," you have
provided mostly generic disclosure relating to competition, such
as
the possibility that another company may obtain regulatory
approval
before you do.
This risk factor should be customized to disclose any specific
competitive advantages that competitors possess, either with
respect
to the companies or with respect to their products.  With respect
to
speed of approvals, you should disclose if any competitive
products
are in later-stage clinical trials (or approved), rather than
relying
upon a generic statement 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.
17. To the extent that any clinical trial participants have
experienced adverse effects, please revise to include a separate
risk
factor disclosing the adverse effects.

"We are heavily dependent on our license agreement...," p. 8
18. Please provide more explicit disclosure relating to the risks
you
are describing.  Similarly revise "We face special risks...," "We
depend on outside parties...," Our collaborators and third party
manufacturers ..., " and "If we are unable to establish sales and
marketing capabilities..."  For example, in your discussion of
Abbott
Labs and Sarawak, you reference payments that you are required to
make and the other party`s right to terminate the respective
agreements.  If it is your intention to convey that you may have
difficulty making the payments such that the contracts could be
terminated and materially affect the company`s prospects, state
this
fact explicitly.
19. Please disclose any facts or circumstances that might lead to
the
types of problems you have set forth in the bullet points.

"We face special risks...," p. 9
20. Please revise your heading to identify the risk and potential
consequences.
21. If you are currently in default on the loan from the Sarawak
Government, then revise to specifically state that you are in
default.

"The future clinical testing of our product candidates could be
delayed...," page 10
22. If you have experienced delays in your clinical trials for any
of
the reasons identified in the bullet point, please revise to
disclose
the circumstances and the length of the delay.
23. Please disclose whether there are any facts or circumstances
that
would suggest that delays in clinical testing may be forthcoming.

"We depend on outside parties to conduct our clinical trials...,"
p.11
24. It is unclear whether you are currently dependent on these
contract research organizations or if you intend to rely on them
in
the future.  Please revise to clarify.  If you are currently
dependent on any individual contract research organizations,
please
identify them and in the Business section describe the material
terms
of your arrangements with them.
25. If you have experienced instances where your contract research
organizations have failed to perform, please revise to describe
the
situation and consequences.  Similarly, revise "Our collaborators
and
third party manufacturers..."

"Our collaborators and third party manufacturers..."p.14
26. Are any of the manufacturers sole source suppliers?  If they
are,
please identify these manufacturers.  If you have agreements with
these manufacturers, please file them as exhibits and provide a
discussion of the material terms in the Business section.
Alternatively, provide an analysis supporting your determination
that
you are not substantially dependent on each of the agreements.  If
you do not have any agreements with these parties, please revise
the
risk factor discussion to disclose that you do not have any
agreements with these parties.

"Even if we successfully develop and obtain approval for
cethromycin...," p. 12
27. Please disclose whether there are any facts or circumstances
that
indicate that the product may not gain market acceptance.

"Our most advanced product candidate... will face significant
competition...," p. 13
28. Please disclose any advantages competitive products (or the
companies who make them) possess vis a vis cethromycin and the
company.

"Because our product candidates and development and collaboration
efforts...," p.15
29. If you are aware of any circumstances adversely affecting your
intellectual property rights or any claims of infringement, please
revise to disclose this information in the risk factor discussion.

"Confidentiality agreements with employees...," p.16
30. If you have experienced any breaches in confidentiality,
please
revise to disclose this information.

 "We will need to increase the size of our organization...,"p. 17
31. To the extent you have had difficulty managing growth in the
past, please disclose the problems you have faced, the efforts you
undertook to resolve the problems, and whether the problems were
resolved satisfactorily.

"If we are unable to attract and retain qualified scientific...,"
p.
17
32. 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.

"Our business will expose us to potential product liability
risks...," p. 18
33. Please revise the risk factor heading to uses the terms
"acquire
and maintain," rather than just "maintain.`

"We face regulation and risks related to hazardous materials...,"
p.
18
34. If you have experienced any contamination or injury from these
materials or chemicals, please revise to describe the situation.
35. Do you have insurance that would cover such damages?

"Our business and operations...," p.18
36. Please disclose any specific weaknesses in your systems that
could make you vulnerable to the types of concerns you have
described
in this risk factor.

Risks related to the offering, p. 19
"Because we have operated as a private company ...," page 21
37. Please revise to explain how this risk factor affects your
company.  As currently written, it would not affect you any
differently than any other company that has recently become a
reporting company.  For instance, are there any reasons to believe
that you might be unable to conclude that you have effective
internal
controls over financial reporting?

We have never paid cash dividends..., p. 22
38. Please disclose the risks for investors relating to the
failure
to pay dividends.

Use of Proceeds, p. 24
39. You have allocated $37.2 million of proceeds to various
payments.
As you have indicated that approximate total proceeds of $86M, you
will need to provide more specific disclosure regarding the
remaining
proceeds.  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.  Please be as specific as possible.  We may have further
comments on your disclosure.

Capitalization, page 26
40. Please include a statement that the table presented sets forth
your cash and cash equivalents and capitalization as of March 31,
2005.  As cash and cash equivalents do not represent
capitalization
of a company, please revise the summation of your capitalization
within your table to exclude the amount of cash and cash
equivalents
as of March 31, 2005.

Management`s Discussion and Analysis of the Company, p. 29
General
41. Currently, your MD&A Overview discusses your product pipeline,
collaborations and cumulative losses.  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