SEC Comment Letter for Pathogenics, Inc. (CIK 0001320731) — Jul 25, 2005
Pathogenics, Inc. (CIK 0001320731)
Date: July 25, 2005 · CIK: 0001320731 · Accession: 0000000000-05-038117
AI Filing Summary & Sentiment
File numbers found in text: 333-123431
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Mail Stop 6010
July 25, 2005
Fredric P. Zotos
President and Chief Executive Officer
Pathogenics, Inc.
99 Derby Street - Suite 200
Hingham, MA 02043
Re: Pathogenics, Inc.
Amendment No. 1 to Form SB-2 Registration Statement
File No. 333-123431
Dear Mr. Zotos:
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.
Comments applicable to the entire filing
1. Your response to comment 1 indicates that you revised the
document
in response to the comment. However, all of the problems we
identified in your original filing continue to appear in this
amendment. When you file your next pre-effective amendment to
this
registration statement, please comply with the plain English
requirements of Rule 421 of Regulation C as we previously
requested.
Among the matters you need to address are the improper use of
capitalization, excessive use of parenthetical phrases, the
inclusion
of defined terms, improper use of acronyms, excessively long
sentences, legalistic and overly complex explanations, highly
technical business terminology and the inclusion of complex
information copied directly from legal documents. Please revise
your
entire document accordingly.
2. We note that you added a glossary to this amendment. Please
refer
to Rule 421(b)(3) of Regulation C which specifies that you should
not
include a glossary unless the meaning of terms is unclear from the
context and only if it facilitates understanding of the
disclosure.
We do not think your glossary does that. We also continue to
believe
that you need to eliminate the technical jargon in the forefront
of
the prospectus and minimize it in the body of the prospectus. The
meaning of each technical term that remains in the document should
be
clear from the context. If you need to explain what it means, do
so
the first time the term appears. If you retain the glossary,
please
relocate it so that it appears at the end of your document.
Prospectus Cover Page
3. We note your response to comment 2 in our previous letter
indicating that you revised the cover page as we requested.
However,
the cover page still contains information that is not specified in
Item 501(a) of Regulation S-B. Please revise as we previously
requested.
4. Please refer to the third paragraph on the cover page. While
most
of the information in it does not belong on the cover page, we
have
particularly noted the language regarding responsibility for
misstatements. It is inappropriate to suggest that you are not
responsible for any misstatements contained in this document.
Please
delete the statement from the document.
Prospectus Summary - page 5
5. We are unable to locate the information you say you included in
response to comment 6. In addition, we requested that you provide
us
with specific information that has not been provided. Please
provide
the information we previously requested. You need to provide us
with
the supporting documentation for all factual and statistical
claims
you make in this document, including, but not limited to, the
claims
on page 35. You should mark those supporting documents to show
the
location of each fact or statistic you are relying on for the
claims
made in the prospectus. Including citations in the prospectus is
not
an appropriate response to this comment and we suggest that you
delete the citations since readers will not have access to the
cited
documents.
6. Please refer to your response to comment 7. We do not agree
with
your analysis. The general nature and status of the studies you
are
conducting are material to investors and should be briefly
described
here. Please revise as we previously requested.
7. We note that in your response to comment 7 you highlight the
word
"confidentially." This suggests that you believe you have
requested
some sort of confidential treatment for your response. Please
note
that requests for confidential treatment of information contained
in
correspondence are governed by Rule 83. Since your response did
not
comply with the rule, the information in the response is not
confidential. However, as noted above, confidential treatment
would
not have been available for information required to be disclosed
to
investors.
8. Your response to comment 7 includes references to "Phase 2b
pilot
study" and "Phase 2a pilot study." These references to phases do
not
appear to be related to the Phase I, Phase II and Phase III
characterizations used by the FDA. Accordingly, we think it is
inappropriate and confusing to use this language in your
prospectus,
and the revised disclosure in the summary should not include it.
9. In the last paragraph on page 5 you say that neither of your
proposed product candidates has received marketing approval from
the
FDA. In fact, you have not completed pre-clinical development of
either product and have not yet applied for an IND to conduct
clinical trials. Please revise the disclosure to more accurately
summarize the developmental status of your proposed products.
10. Please explain what the term "clinical proof of concept" means
in
the first sentence of this paragraph.
11. In the second sentence you say that your strategy is to
license
your products out for "further clinical development, registration,
sales and marketing" to more established pharmaceutical companies.
Please explain what activities are included in "further clinical
development" and "registration."
12. Please delete the word "substantially" from the fourth
sentence
of the same paragraph. You have only identified two potential
products.
13. Please quantify, to the extent practicable, the amount of
funds
you will need to continue your research and commercialize your
products. Investors need to have a general idea of the amount of
funds you will need to accomplish this. In this regard, we note
that
you say, in the second sentence, that you intend to license your
products out, so it is unclear what you mean when you refer to
"continuing development" and "commercialization" of your products.
Please be more specific about the activities included in each of
these areas.
14. Please relocate the third full paragraph on page 7 so that it
appears immediately following the last paragraph on page 5. You
should also provide a descriptive subheading for the information
included in the paragraph.
15. We note your response to comment 10. Please revise the
prospectus to include the information we previously requested. In
addition, the disclosure should be quantified to the extent
practicable. Include the amounts that have been spent on the
research to date by each party, and each party`s obligations to
fund
current and future research. In addition, clarify whether any of
the
research conducted to date will be available to you to include in
an
IND application to the FDA. We may have further comments after
reviewing your response.
16. We have considered your response to comment 11, but we are
unable
to locate the information you say you added. Please revise the
first
paragraph of page 6 to describe the consulting services provided
by
Mr. Mackey, and when the shares were issued, as we previously
requested, or tell us where the information is located.
17. Please quantify the amount of the penalty that you face as a
result of the fact that the registration statement was not
effective
prior to the date specified in your agreement and where you will
obtain the funds to pay it.
18. Please tell us why you are registering an amount of shares
equal
to 50% of the number of shares into which the preferred stock is
convertible to cover dividends. You should also revise the
disclosure to include the dividend rate and terms.
19. Please disclose the purposes to which you have put the funds
received from the private placement, and the amount used for each
purpose. Please provide the factual basis for your statement, in
the
third paragraph on page 7, that you have sufficient funds to
continue
your operations until the fourth quarter of 2005. We assume this
means that you expect your funds to last through the third
quarter,
and we note that you are already half way through the third
quarter.
Please expand the disclosure to explain how you will finance your
operations after the completion of the third quarter.
Risk Factors - page 7
We may not be able to meet our current and future liabilities and
remain in operation until we receive the money from the receipt of
money [sic] in connection with subsequent tranches. - page 9
20. Please disclose why you owe the purchasers of the convertible
preferred stock $95,000. Is this the amount of the penalty?
21. We are unable to locate the information you say you added in
response to comment 21. Please include it as we previously
requested
or tell us where it is located. Please note that you need to
address
each issue we raised in the comment.
22. We note your response to comment 23. Your response does not
address the issues raised in our comment and we hereby reissue it.
We will be forced to pay penalties in connection with the
registration of the convertible preferred stock, which will cause
dilution to our existing shareholders - page 10
23. We are unable to locate the revision you made in response to
comment 25. Please quantify the amount of penalties you currently
owe and the number of shares you will need to issue to cover the
penalty.
Our independent public accounting firm has expressed substantial
doubt as to whether our company can continue as a going concern -
page 10
24. We are unable to locate the revisions you made in response to
comment 26 in our previous letter. Please revise the risk factor
as
we previously requested.
N-chlorotaurine...may not be effective as an anti-infective, may
cause side effects... - page 14
25. Please delete the reference to "Phase II pilot studies."
This
language is inappropriate and confusing since you have not filed
an
IND with the FDA and therefore cannot conduct Phase I, Phase II or
Phase III clinical trials. In addition, we are not aware that the
FDA uses the term "Phase II pilot study." Please revise the
disclosure here and in the remainder of the prospectus
accordingly.
Use of Proceeds - page 16
26. Please expand the disclosure to disclose the amount of the
proceeds to be paid to Mr. Mackey pursuant to his consulting
agreement. Please also disclose, as we previously requested,
whether additional funds will be necessary to carry out these
activities, and if so, an estimate of the amount and the
anticipated
source of funds you will use for them.
27. Please tell us whether the $20,000 loan from Messrs. Mackey
and
Sklar, discussed on page 31, is to be repaid from the proceeds of
the
offering. If so, provide the information specified in
Instructions 1
and 2 to Item 504 of Regulation S-B.
28. It appears from the disclosure on page 31 that you intend to
use
proceeds from the private placement to pay Jodi Nelson the
consulting
fees discussed on that page. Please revise the table to include
these amounts.
29. Please revise the disclosure to clarify the amount of the
proceeds you have already received and expended and the purposes
to
which those funds have been put.
License Agreement for Patent Rights in connection with N-
chlorotaurine - page 29
30. Please indicate whether Messrs. Zotos and Ferrari have a
continuing relationship with Atlantic Ventures, Inc. Also, tell
us
who the owners of Atlantic Ventures, Inc are. We may have
additional
comments.
31. We have noted your response to comment 30 but we are unable to
locate the information you say you added. As we previously
requested, provide a chronology of the development of the rights
under the license since October of 2001. That is, describe the
development activities that have been undertaken, when they
occurred
and by whom.
Business - page 32
32. It is not clear why you have included the list of journal
articles that begins at the top of page 33. Please provide us
with a
copy of each article. In addition, please explain what
information
you are trying to convey to investors and why it is material to an
investment decision in your company. We may have additional
comments
after reviewing your response.
33. We note your response to comment 41, but we are unable to
locate
the revisions you say you made. If you are referring to the next
to
last paragraph on page 33, it not only does not address the issues
we
raised; it consists almost entirely of technical jargon that will
be
meaningless to most readers and it is not clear what information
you
hope an investor will gain from it. Please revise the disclosure
accordingly.
34. Please refer to the first full paragraph on page 34. You say
that the inventors/licensors will be conducting further pre-
clinical
and clinical trials on your behalf, and that the trials will be
supported by you, the Austrian Science Fund and the Jubilee
Research
Fund of the Austrian National Bank. You need to discuss the
material
terms of your agreements with each of the above entities,
including
the financial obligations of each party, and file the agreements
as
exhibits to the registration statement.
35. Please explain what you mean when you say that these studies
will
"contribute to optimize the topical application of NCT in human
medicine."
36. Please refer to the last paragraph on page 34. There you say
that the IND support studies are "scheduled for completion 24
months
from the start of the project." It does not appear appropriate to
say that a project is "scheduled for completion" in a specific
period
of time when it has not yet begun. If you are trying to say that
you
anticipate that, once they begin, it will take approximately 24
months to complete the IND support studies, say so. Also,
disclose
when you intend to begin these studies and where you will obtain
the
funds to conduct them.
37. Please revise the disclosure to explain what "Good Clinical
Practice" guidelines are, who issues them, and what their
significance is. You need to clearly indicate that these are not
standards promulgated by the FDA and, if true, will not be
accepted
by the FDA in support of an IND application.
38. It is unclear exactly which country or countries you are
hoping
to obtain regulatory approval from. It appears that you may be
seeking approval from Austrian regulatory authorities. If so, you
need to describe the process for doing so. If you intend to
obtain
approval in the U.S., then you need to describe the procedure for
obtaining FDA approval from the development point you are
currently
at to marketing approval and afterwards.
Research and Development on NCT - page 36
39. Please tell us why you have not included the identity of the
publication(s) in which these studies were published. Also,
please
provide us with a copy of each article. Please disclose in the
document whether the respective researchers have given you
permission
to use their research in support of your IND, whether you funded
this
research, and whether the research discussed i