SEC Comment Letter for Molecular Insight Pharmaceuticals, Inc. (CIK 0001340752) — Dec 14, 2005
Molecular Insight Pharmaceuticals, Inc. (CIK 0001340752)
Date: Dec. 14, 2005 · CIK: 0001340752 · Accession: 0000000000-05-062171
AI Filing Summary & Sentiment
File numbers found in text: 333-129570
Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 6010
December 14, 2005
David S. Barlow, Chairman
Molecular Insight Pharmaceuticals, Inc.
160 Second Street
Cambridge, Massachusetts 02142
Re: Molecular Insight Pharmaceuticals, Inc.
Form S-1 Registration Statement
File No. 333-129570
Dear Mr. Barlow:
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 document
1. We note that your filing contains numerous omissions throughout
the prospectus which relate to the offering price range or the
number
of shares you will sell. These omissions include but are not
limited
to:
* Summary Financial Data
* Use Of Proceeds
* Capitalization
* Dilution
* The Option Grants Table
* Shares Eligible For Future Sale
* The Principal Stockholders Table
* Description of Capital Stock
Rule 430A requires you to include this information in your filing
based upon an estimate of the offering price within a bona fide
range
you disclose on the cover page and based upon an estimate of the
number of shares you will sell. We consider a bona fide range to
be
$2 if the price is under $20 and 10% if it is above $20. You
should
include the required information in an amendment prior to
circulating
a "red herring" prospectus.
2. Provide us with copies of all the graphic, photographic or
artistic materials you intend to include in the prospectus prior
to
its printing and use. Please note that we may have comments.
Please
also note that all textual information in the graphic material
should
be brief and comply with the plain English guidelines regarding
jargon and technical language.
3. Comments on your application for confidential treatment will be
provided in a separate letter when they are available. Please
note
that we will not be in a position to accelerate effectiveness
until
all issues relating to your confidential treatment request have
been
resolved.
4. In a number of places in your document you have used technical
jargon that is not likely to be understood by your readers.
Technical jargon should not appear in the forefront of the
prospectus. Please refer to Rule 421 of Regulation C. In the
remainder of the prospectus you should minimize the use of jargon.
If you cannot convey information without using jargon, please
explain
what the jargon means at the first place the terms appear. Here
are
some examples of technical jargon that need to be addressed:
* radiotherapeutics
* radiolabeled fatty acid analog
* Phase 2b
* Phase 2a
* Neuroendocrine tumors
* Pheochromocytoma
* Carcinoid
* Tumor angiogenesis
* Neuroblastoma
* Negative predictive value
* Metabotropic glutamate receptors and inhibitors
* Polymer precursers
To the extent that these terms cannot be replaced by suitable
alternatives, please revise to explain the meaning of these terms
the
first time each one is used.
Prospectus Summary - page 1
5. The disclosure here and in the "Business" section contains a
number of statistical claims as well as claims regarding the size
of
the market for your proposed products. Please provide us with
copies of the documents you are relying on in support of these
claims. You should mark them to show the location of the
information
supporting each claim in the prospectus. We may have additional
comments after reviewing the supporting materials.
6. The disclosure currently included in your summary is
unbalanced.
While you have included a discussion of your positive opinions and
beliefs regarding your proposed products and anticipated results
of
clinical studies, you have not included any discussion of the
negative aspects of your business, and have not clearly indicated
that positive results are not assured. Please limit the
discussion
of your disclosed products to the targeted indication and the
stage
of clinical trials. Move the remaining details, including any
discussion of the results of clinical trials, to the Business
section
and balance this disclosure with a discussion explaining that
later
stage testing might not support the results of earlier testing.
Additionally, revise the disclosure to discuss the negative
aspects
of your business. The negative aspects should include your
history
of losses, expect to incur additional losses for at least the next
several years and the fact that you do not have FDA approval for
any
for any of your products. The discussion of the negative aspects
should be disclosed as prominently as the positive aspects and
should
not be separated from the discussion of the positive aspects.
7. Additionally, balance the discussion of your business strategy
with a discussion of risks and obstacles you will encounter in
implementing this strategy.
Risk Factors - page 8
If approved, the commercialization of our product candidates,
including Zemiva, may not be profitable. - page 9
8. Please revise the subheading to be more descriptive of the
actual
risk described in the body of the risk factor.
We do not have patent rights to the composition of Zemiva, and if
we
cannot gain and exploit a period of marketing exclusivity... -
page
10
9. In the first full paragraph of page 56 you indicate that the
original patent protecting the composition of BMIPP expired in
2003.
Please address this fact in the risk factor.
Our proprietary rights may not adequately protect our technologies
and product candidates. - page 10
10. Currently, this subheading states a simple fact but does not
identify a specific risk or its potential adverse consequences.
Please revise it so that does.
11. The information in the body of the risk factor is so generic
that
it could be included in a prospectus for any company in your
industry
without losing any meaning. Please revise it so that it discusses
a
risk that is specific to you and your proposed products. That is,
the discussion of proprietary rights should be discussing the
actual
risks involved with your proposed products rather than trade
secrets
law in general.
12. The revised risk factor should also include a factual context
for
the risk and its consequences. For example, do you have any
reason
to believe that there might be a problem with any of your proposed
products? Is the risk described in this risk factor simply a more
general discussion of the specific risk discussed in the risk
factor
immediately above it? If so, the two risk factors should be
combined, and the specific risk should be identified as an example
of
the broader risk. As currently written the risk factor is too
amorphous to be meaningful.
Our ability to commercialize our potential products will depend on
our ability to sell such products without infringing the patent or
proprietary rights of third parties... - page 12
13. The information in the body of this risk factor is also so
generic that it could be included in a prospectus for any company
in
your industry without losing any meaning. Please revise it in the
same manner as we requested that you revise the one above. If you
have any reason to believe that there might be a problem with one
of
your proposed products, you should identify the problem and
discuss
it specifically.
If another party obtains orphan drug exclusivity for the drugs and
indications we are targeting, we may be precluded from
commercializing our product candidates for those indications. -
page
12
14. Since the risk factor relates solely to Ultratrace MIBG, you
should revise the risk factor subheading to be specific about what
the risk actually is.
15. Although you mentioned this product on page 3 of the summary,
you
have not provided the reader with any information that would put
this
risk factor in context. You should revise the risk factor to
clarify
whether the disease it is intended to target falls within the
statutory criteria. You should also disclose whether you have any
knowledge regarding whether any other companies are developing
products to address the same disease indication as you are. If
you
do, you need to briefly disclose this information in the risk
factor
so that a potential investor can fully analyze the risk.
We may need to raise additional funds in order to finance the
commercialization of our potential products... - page 13
16. Please relocate this risk factor so that it appears with all
of
the other risk factors related to your financial condition.
We have no commercial manufacturing facility and no experience in
manufacturing products for commercial purposes. - page 14
17. This risk factor subheading is a simple statement of fact that
does not identify a specific risk or its potential adverse
consequences. Please revise the subheading so that it briefly
summarizes the risk and adverse consequences discussed in the risk
factor.
18. Please identify the manufacturer referenced in the risk factor
and indicate whether you plan on expanding the agreement with this
manufacturer to cover your other needs, and whether you anticipate
developing your own manufacturing facility. Also indicate whether
there are a limited number, or a large number, of manufacturers
capable of producing the BMIPP molecule. If there are a limited
number, discuss the potential adverse impact this could have on
your
future operations.
19. Under "Use of Proceeds" on page 27 you state that you may use
a
portion of the proceeds from this offering to "fund investment in
manufacturing capacity...in collaboration with our anticipated
commercial manufacturing partner(s)." Please expand the risk
factor
to address this use of proceeds and the adequacy of the sums
available for this purpose.
There are a limited number of manufacturers that can produce our
lead
product candidate, Zemiva. - page 14
20. On page 2 you state that Zemiva is a radiolabeled fatty acid
analog "that is also known as BMIPP." Accordingly, we don`t
understand why this is a separate risk from the one identified
immediately above it in the prospectus and commented on above.
Please revise or advise.
21. It is unclear from the risk factor and disclosure elsewhere in
the document as to whether you are competing with other companies
to
find manufacturers for this product. Are you, or will you be, the
only company looking for a manufacturer for this product? Is
there
something about this product that makes it difficult to
manufacture?
Does it require ingredients that are difficult to obtain? You
need
to expand the factual context to include enough information to
fully
appreciate the risk and its consequences.
We have a limited operating history and potential financial
results
are uncertain. - page 15
22. Since you have been in business since 1997, we do not
understand
why you say you have a limited "operating history." Are you
trying
to say that you have not generated revenue? If so, this appears
to
be the same risk discussed in the risk factor immediately above
this
one. Also, it is unclear what you mean when you say that your
"business model is still emerging." Please explain what this
means.
If this is the same risk as the one immediately preceding it,
please
combine them and eliminate the overlap. If it is a separate risk,
please provide an appropriate subheading and expand the risk
factor
to clearly identify and discuss a specific risk. As currently
written, this risk factor is too ambiguous to be meaningful. The
disclosure in the revised risk factor should also be quantified to
the extent practicable.
We have little control over the scientists and consultants at the
various academic and research institutions with whom we have
relationships. - page 17
23. Please revise the subheading to identify a specific risk and
its
potential adverse consequences.
24. Please expand and revise the body of the risk factor to
provide a
factual context for evaluating this risk. The information you
have
included is too vague and ambiguous to be meaningful. You say
that
these persons conduct research at your request. Does this mean
that
you subcontract your research and development activities out to
others, or are the persons you refer to members of an advisory
board
you have set up? Are these individuals or entities that
supplement
research done by your own employees? Also, describe the types of
agreements you have with these persons and entities. As currently
written, the risk factor raises more questions than it answers.
We depend on government funding, which if lost or reduced, could
have
an adverse effect on our research and development. - page 17
25. Please disclose what percentage the $4.5 million you have
received in grants represents to the total you have expanded on
research to date. While the subheading says you "depend" on
government funding, the first sentence says that you have relied
on
government research grants for a "portion" of your funding. In
addition, most of the information currently included in the body
of
the risk factor does not relate to the risk identified in the
subheading. Please revise the risk factor accordingly.
Our competitors may develop products that are less expensive,
safer
or more effective... - page 18
26. Please revise the risk factor to name your most significant
competitors. Also identify the products they are developing that
will compete with your potential products and compare the
development
stage of their products with your proposed products. With the
exception of the discussion of Cardiolite and Myoview, the
information in this risk factor is too vague and ambiguous to be
meaningful. If these products are your competition, we think you
can
safely delete a good deal of the information included in this risk
factor without losing any meaning.
We could be negatively impacted by the application or enforcement
of
federal and state fraud and abuse laws, including anti-kickback
laws
and other federal and state anti-referral laws, page 21
27. Please describe the activities that you engage in that may be
determined to be in violation of the anti-kickback and anti-
referral
laws.
If we choose to acquire new complementary businesses, products or
technologies, we may be unable to complete these acquisitions or
to
successfully integrate them in a cost-effective and non-disruptive
manner. - page 22
28. The information in the risk factor is both vague and
applicable
to every company that makes an acquisition. Please revise the
risk
factor to tie the risk to your particular situation, products,
etc.
If you cannot do this, you should consider deleting the risk
factor.
Use of Proceeds - page 27
29. In the second paragraph you say you intend to use the majority
of
the net proceeds of this offering to continue the development and
prepare for the commercialization of Zemiva, and to initiate and
expand the clinical development of Ultratrace MIBG. Please
disclose
the amounts you intend to use for each of these purposes and
discuss
how far you anticipate these proceeds will get you in your
progress
towards commercialization.
30. Please expand the fifth bullet to briefly discuss what you
mean
when you refer to funding "investment in manufacturing capacity."
We