SEC Comment Letter for Pathogenics, Inc. (CIK 0001320731) — Apr 20, 2005
Pathogenics, Inc. (CIK 0001320731)
Date: April 20, 2005 · CIK: 0001320731 · Accession: 0000000000-05-019451
AI Filing Summary & Sentiment
File numbers found in text: 333-123431
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Mail Stop 0309
April 20, 2005
Fredric P. Zotos
President and Chief Executive Officer
Pathogenics, Inc.
99 Derby Street - Suite 200
Hingham, MA 02043
Re: Pathogenics, Inc.
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. When you file your first pre-effective amendment to this
registration statement, you will need to comply with the plain
English requirements of Rule 421 of Regulation C. 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.
Prospectus Cover Page
2. Information presented on the cover page should be limited to
the
information specified in Item 501(a) of Regulation S-B.
Accordingly,
please delete all but the first sentence of the first paragraph,
the
second paragraph, and the fourth paragraph. The deleted
information
appears to belong in the "Plan of Distribution" portion of the
document instead.
3. Please tell us how the selling shareholders determined that
they
would sell the stock at a price of $0.10 per share.
4. Please tell us whether you believe the $0.10 per share price
represents or did represent the fair value of your common stock.
In
addition, please tell us what the fair value of your common stock
was
when you issued the convertible preferred stock. Finally, for
each
of the above, please describe to us how you determined the fair
value
of your common stock.
5. Please state that the selling shareholders are underwriters and
provide the information specified for underwriters in Item 501.
Prospectus Summary - page 5
6. Please provide us with written factual documentation for each
of
the factual or statistical claims you make in the fourth and fifth
paragraphs of page 5. You should mark the documents to show the
location of the specific information you are relying on. We may
have
additional comments after reviewing the material.
7. In the last paragraph of page 5 you state that you are
currently
"developing" N-Chlorotaurine. Please expand the disclosure to
explain what your current development activities consist of.
Also,
please explain what a "Phase II clinical pilot study" is.
8. Currently, the summary does not contain a balanced presentation
of
your company and its operations. You need to balance your
discussion
by briefly discussing the principal problems and risks your
company
faces. These would include, for example, your lack of financing,
that you are newly organized, the minimal extent of your product
development to date, lack of revenues, etc.
9. Please revise the disclosure to clearly distinguish what you
have
done in the past and what you are doing now from what you hope to
do
in the future. Your current disclosure makes it appear that what
you
hope to do in the future is actually occurring in the present.
Where
similar disclosure appears elsewhere in the prospectus, you should
make parallel changes.
10. Please revise the last paragraph on page 5 to clarify whether
you
have conducted or paid for the clinical pilot studies and when and
where they were conducted. In this regard, we have noted the
limited
expenses you incurred during the past two years.
11. Please revise the first paragraph of page 6 to describe the
consulting services provided by Mr. Mackey. Also disclose when
the
shares were issued.
12. We note that you are selling the convertible preferred stock
in a
number of "tranches," and that most of the convertible preferred
stock you are going to issue privately to the selling shareholders
has not yet been issued. Please tell us the legal and factual
basis
for your belief that you completed your private placement of the
convertible securities prior to filing this registration
statement.
13. It appears that this filing is a registration for resale of
the
securities underlying convertible securities you will issue in a
delayed private offering of the convertible securities. We do not
consider the registration of such securities to be a valid
secondary
offering, even if the price and number of shares to be issued is
set.
Please provide us with your analysis of the legal and factual
basis
permitting the registration of the underlying securities at the
present time. We may have further comment after reviewing your
response.
14. Disclose the aggregate number of shares of common stock that
the
convertible preferred shares may be converted into and the date on
which the preferred is convertible.
15. Please tell us whether any of the selling shareholders are
broker-dealers or affiliates of broker-dealers. If so, they
should
also be identified as such in the filing.
Risk Factors - page 7
16. In this section and elsewhere in the registration statement
you
state that you "cannot assure you that," "there can be no
assurance
that," "there is no assurance that," and "the Company can give no
assurances that" various things will or will not happen.
Statements
such as these are legalistic and redundant. Please delete them.
Instead, please be certain that you have adequately explained why
you
cannot make the assurance or prediction.
17. Additionally, describe the consequences if the event(s) that
you
cannot assure or predict will occur do not occur. For example:
* On page 8, you state that you cannot assure that the
registration
statement will be effective by June 18, 2005. Please revise to
discuss the amount of the penalty you could incur and what would
happen if you do not have the funds to pay for it. Also discuss
what
would happen if you abandoned your business plan.
18. Many of your risk factor subheadings are simple statements of
fact that do not identify a specific risk and its potential
adverse
consequences to an investor or the company. You will need to
revise
them so that they do. In addition, the subheading should
accurately
summarize the content of the body of the risk factor. The
subheading
should not be repeated in the body of the risk factor. Each
subheading should be a complete sentence using proper
capitalization
and punctuation. Here are some examples of subheadings that need
to
be revised:
* "Risk of continuing our operations without additional financing
and/or in the event we are forced to pay penalties to the
convertible
preferred stock holders" - page 8
* "The Company may be forced to pay penalties in connection with
the
registration of the convertible preferred stock" - page 8
* "To develop NCT and/or other technologies we may in-license in
the
future, we may need to enter into collaborative agreements with
other
companies which may limit our control of our technologies" - page
9
* "We will need government approval before we will be able to
market
N-Chlorotaurine or other technologies the company may choose to
develop in the future" - page 11
* "Our industry is competitive and as such competitive pressures
could prevent us from obtaining profits" - page 12
Risk of continuing our operations without additional financing
and/or
in the event we are forced to pay penalties to the convertible
preferred stock holders - page 8
19. Please disclose what will happen if the five companies do not
follow through on their purchase commitments.
20. Disclose and quantify the amount of dividends you will owe on
the
convertible preferred stock and whether you intend to pay them in
cash or additional shares of stock.
21. Please revise the risk factor to discuss the amount of funds
currently on hand, your commitments for expenditures, and the
factual
basis for your belief that the funds from the privately placed
securities will be adequate to continue your operations until the
fourth quarter of 2005. Quantify the disclosure to the extent
practicable. In addition, disclose the specific purposes to which
you will put the proceeds of the private placement and how this
will
enable you to implement your business plan.
22. You say that there is a risk you will not be able to meet your
current and future liabilities and remain in operation until you
receive the additional money from the subsequent sales of
convertible
preferred stock. Please discuss this situation in greater detail.
23. We note further that while the sales of preferred stock may
bring
in $275,000, your CEO`s salary is $200,000 and the offering
expenses
are estimated to be $38,000. In view of your rent and other
expenses, including Mr. Mackey`s consulting agreement, it does not
appear that there will be any funds available for research and
development. Please address this in the risk factor, the Use of
Proceeds section of the document and Management`s Discussion and
Analysis as appropriate.
The company may be forced to pay penalties in connection with the
registration of the convertible preferred stock - page 9
24. Please revise the risk factor to eliminate any risk that can
no
longer occur, such as the possibility you wouldn`t file the
registration statement by March 18, 2005.
25. Please quantify the amount of penalties you could be required
to
pay and disclose whether you currently have sufficient funds to
pay
them.
Our independent public accounting firm has expressed substantial
doubt as to whether our company can continue as a going concern -
page 9
26. In the second sentence of the risk factor you say that "these
factors among others" indicate that you may be unable to continue
as
a going concern. Please revise the risk factor to identify these
"other" factors. Also, discuss how you intend to "generate
sufficient cash flow to conduct...operations" and how you intend
to
obtain additional sources of capital and financing.
We lack an operating history which you can use to evaluate us,
making
investment in our company risky - page 9
27. Please delete the term "long standing" from the first sentence
of
the risk factor.
Use of Proceeds - page 13
28. Please disclose the amount of proceeds from the sale of the
convertible preferred stock that will be used for each of the
identified purposes. Please also disclose 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.
Interest of Named Experts and Counsel - page 18
Experts - page 18
29. Please consider whether it is appropriate to mention the
financial statements as of December 31, 2003, as there is no
balance
sheet presented as of that date. In addition, please provide
disclosure addressing the periods from each company`s inception
through December 31, 2004.
License Agreement for Patent Rights - page 24
30. Please 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.
31. Please clarify how the agreement was assigned to the company
effective in December 2002 at which time the company`s charter was
revoked.
32. Please state whether the licensors have agreed to the
assignment
to Pathogenics, Inc.
Business - page 25
33. Please explain what the following terms mean: "novel
endogenous
anti-infective," "rhinosinusitis," "viral conjunctivitis" and
"crural
ulcers."
34. Please disclose the factual basis for your belief that NCT
represents a "unique and optimal compromise between sufficient
microbicidal activity and low toxicity and is therefore ideally
suited for the local treatment of infections in humans" and that
it
has "several significant advantages over existing therapies."
Background: Infectious Diseases - page 25
35. The connection between your proposed product and the
information
cited in this section is unclear. For example, in the paragraph
above this section, you indicate that your proposed product has
shown
"an affect[sic]" in rhinosinusitis, viral conjunctivitis, otitis
externa and crural ulcers. Are you suggesting that these are
among
"the world`s leading cause[s] of premature death?" You also
appear
to be suggesting that these infections are causing increases in
deaths in the U.S. Please either draw a connection between the
discussion of your proposed product, or delete this section.
36. It is unclear why you are citing information from 1987-1992
and
sources published in 1998 and 2000. Please tell us why this
information is relevant in 2005 and why you are not relying on
more
current information.
37. If you continue to include this information in the document,
please provide us with a copy of each article marked to show the
location of the information you are relying on.
Potential Market for NCT - page 26
38. It is unclear why you are citing sales information from 1996
and
projections made in 2000 or earlier as support for your claims.
Please revise the document to provide current information. Also,
provide us with a copy of the supporting document, marked to show
the
location of the information you are relying on.
Antimicrobial Resistance - page 26
39. Please provide us with copies, marked to show the location of
the
information you are relying on, of each article cited on pages 26-
27.
N-Chlorotaurine - page 28
40. Currently, the disclosure in this section contains a great
deal
of technical jargon which is not likely to be familiar to readers
outside your industry. Please revise it to replace technical
jargon
with plain English explanations wherever possible. For example,
we
do not understand why you refer to "leukocytes (white blood cells)
and erythrocytes (red blood cells)." The technical jargon is
unnecessary because you can simply refer to red and white blood
cells
without including the jargon. When that is not possible, please
explain what each term means at the first place it appears. Here
are
some examples:
* "main long-lived oxidant produced by human granulocytes and
monocytes"
* "innate immunity"
* "endogenous antiseptic"
* "NCT derivatives"
* "oxidizing mechanism of action"
* "cytotoxicity"
* "endothelial cells"
* "pharma-screening"
* "formulation development program"
* "active halogen compounds"
* "endogenous amino acid derivative"
* "genotoxicity screening"
41. Please expand the discussion in the fourth paragraph of page
28
to explain the significance of the screening results. Also,
explain
what you mean by the phrase "revealed no signs for biological
activity."
42. We do not understand your references to "Phase I" and "Phase
II"
in the last paragraph of page 28. Please explain what activities
each term refers to. We note that you have not applied for FDA
approval of any clinical testing, so we are concerned that the use
of
these terms may confuse readers of the document.
43. In the first paragraph of page 32, you discuss a