SEC Comment Letter for IOMAI CORP (CIK 0001125001) — Nov 1, 2005
IOMAI CORP (CIK 0001125001)
Date: Nov. 1, 2005 · CIK: 0001125001 · Accession: 0000000000-05-055587
AI Filing Summary & Sentiment
File numbers found in text: 333-128765
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Via Facsimile and U.S. Mail
Mail Stop 6010
November 1, 2005
Stanley C. Erck
Chief Executive Officer
Iomai Corporation
20 First Field Road, Suite 250
Gaithersburg, Maryland 20878
Re: Iomai Corporation
Registration Statement on Form S-1
Filed October 3, 2005
File Number 333-128765
Dear Mr. Erck:
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.
FORM S-1
General
1. We note your graphic following the cover page of the
prospectus.
Please provide us with proofs of all graphic, visual, or
photographic
information you will provide in the printed prospectus prior to
its
use. Please note we may have comments regarding any additional
graphics or visuals you may include.
2. 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.
3. Please note that when you file a pre-effective amendment that
includes your price range, it must be bona 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.
4. Please note that where we provide examples to illustrate what
we
mean by our comments, they are examples and not complete lists.
If
our comments are applicable to portions of the filing that we have
not cited as examples, please make the appropriate changes in
accordance with our comments.
5. We note that you have requested confidential treatment for
several
of your exhibits under Rule 406 of the Securities Act; we will
furnish comments for your request under separate cover. Please be
advised, we will not act on any request for acceleration of
effectiveness until we have cleared comments on your request for
confidential treatment.
Cover page
6. Please delete the phrase "Sole Book-Running Manager" from your
cover page.
Prospectus Summary, page 1
7. Please eliminate jargon and technical terms from the forepart
of
the prospectus and provide a "Plain English" explanation or
substitute. For example, these words and phrases appear in your
summary in other parts of the prospectus:
* "immunostimulation"
* "adjuvants"
* "pathogen-specific antigens"
If you must include technical terms in the body of your prospectus
that are understood only by industry experts you must make every
effort to concisely explain these terms where you first use them.
8. Please balance the discussion of the advantages your technology
offers with potential disadvantages.
9. We note that you have cited increased efficacy as a potential
advantage. Since the FDA is the party that makes the decisions as
to
efficacy and your products are still in clinical trials, please
delete this as an advantage.
10. You have indicated that you will begin enrollment of Phase 3
clinical trials for the needle-free travelers` diarrhea vaccine
patch
if you complete your Phase 2 trials on your anticipated timeline.
When do you anticipate you will complete the Phase 2 trials?
Risk Factors
11. We note the disclosure in your Business section that you have
not
observed any serious side effects with regard to the needle-free
travelers` diarrhea vaccine patch. If you have experienced
serious
side effects in the trials of your other product candidates,
please
include a risk factor describing these side effects. Otherwise,
revise the Business section to indicate that you have not observed
any serious side effects in the clinical trials of these product
candidates.
As part of our product development efforts, we may make
significant
... page 8
12. We note that you have identified several risks in the above
risk
factors. For example, in the risk factor "As part of our product
development efforts, we may make significant changes..." you
discuss
* Uncertainty as to whether the dry patch will perform as well as
the
wet patch;
* You may have to repeat clinical trials resulting in increased
costs;
* You may have to conduct clinical trials of your IS patch with
flu
vaccines developed by different manufacturers resulting in
increased
costs;
* Uncertainty as to the equivalency between your own strain of LT
and
that supplied by a contact manufacturer; and
* Changes to your product candidates may not be covered by
existing
patents.
Please revise to discuss each risk as a separate discussion. The
discussion should follow a caption that identifies the risk and
potential consequences.
We will need additional funding, and we cannot guarantee that we
will
find ..., page 11
13. We note you expect to raise additional funds in the future by
possibly issuing equity securities, it appears certain that
certain
investors will experience dilution of their interest. Please
revise
the first sentence below the bullet points to state further
dilution
to stockholders will result.
14. Please indicate how long you expect your existing capital
resources without proceeds from the offering will be sufficient to
conduct your operations.
If we are unable to protect the confidentiality of our proprietary
information ..., page 15
15. Please disclose who has the financial obligation to protect
the
TCI patent.
We depend on our key personnel, the loss of whom would adversely
affect our ..., page 16
16. If you have had problems attracting or retaining qualified
employees, please revise to describe the problems you have
experienced. 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.
We have no experience in sales..., page 19
17. We note your plans to enter into marketing arrangement with
third
parties or major pharmaceutical companies. Please revise to
clarify
that these types of arrangements might not be available on
acceptable
terms or at all.
Investors in this offering will pay a much higher price than the
book
value ..., page 23
18. Please revise this risk factor to explain that investors who
purchase shares will:
* Pay a price per share that substantially exceeds the value of
your
assets after subtracting its liabilities; and
* Contribute ___% of the total amount to fund the company but will
own only ___% of the shares outstanding.
Use of Proceeds, page 25
19. Please revise to disclose the stage of development you expect
to
achieve with the designated proceeds. Additionally, we note that
the
proceeds designated for each use is significantly higher than the
expected expenditures you have disclosed on pages 38 and 39.
Please
explain the discrepancies.
Management`s Discussion and Analysis of Financial Condition and
Results of Operations
Overview, page 33
20. We note you expect to raise additional funds through the
issuance
of additional equity or incurrence of debt. Please revise to
state
when you expect to raise these additional funds, for example, is
your
expectation to raise additional funds in the next 24 months?
Results of Operations, page 35
21. In your discussion of the comparison of the six months ended
June
30, 2005 and 2004 you have indicated the reasons for increases in
general and administrative expenses, yet these expenses remained
constant from one period to the next. Were there other expenses
that
decreased during this period, offsetting these increase? Please
explain.
22. In your discussion of the comparison of the years ended
December
31, 2004 and December 31, 2005 you state that the principal source
of
the increase in grant revenues for 2005 was the award of the two
new
grants by the NIH. You have stated earlier that this grant was
awarded in January 2005. If you are referring to different
grants,
then please revise your disclosure to clarify.
Liquidity and Capital Resources, page 42
23. Please provide disclosures to reconcile the amount of long-
term
debt reported here to the total amount of debt reported on your
balance sheet. If the amount reported here does not include
interest
payments, please include them or justify how they do not represent
material future obligations, which should be included pursuant to
Item 303(a)(5) of Regulation S-K and Financial Reporting Release
67.
24. Please include the minimum annual maintenance fee and the four
lump sum royalty payments that you are required to pay WRAIR, as
noted on page 56, or tell us how they do not represent material
future obligations, which should be included pursuant to Item
303(a)(5) of Regulation S-K and Financial Reporting Release 67.
25.
Critical Accounting Policies and Estimates, page 43
26. Please disclose the fair value of vested and unvested options,
outstanding as of the most recent balance sheet date presented,
based
on the estimated IPO price.
27. Please disclose the stock-based compensation expense that you
anticipate recognizing in future periods for options outstanding
as
of the most recent balance sheet, as this would appear to
represent a
known trend or uncertainties contemplated by Item 303(a)(3)(ii) of
Regulation S-K.
Business
28. Please revise to include a discussion of the material terms of
your agreements with Dow Chemical. The discussions should include
the following:
* Each parties rights and obligations under the agreement;
* Any amounts paid or received to date, including payments in the
form of securities;
* Any potential payments to be made or received;
* Expiration and termination provisions;
* The existence of royalty provisions and the amount of any
minimum
royalty payments.
29. Additionally, on page 52 you state that you conducted a
clinical
trial for your needle-free flu vaccine patch in collaboration with
a
large pharmaceutical company. Please identify the pharmaceutical
company and describe the material terms of the arrangement. If
you
have a written agreement with this company, file the agreement or
provide us with an analysis supporting your determination that it
is
not required to be filed.
30. We note the discussion of your agreement with Walter Reed on
page
56. Please make the following revisions to the discussion:
* Quantify the amounts paid to date;
* Quantify the annual maintenance fee and minimum royalty
payments;
* Quantify the aggregate potential milestone payments;
* Identify your product candidates that are dependent on the TCI
technology;
* Disclose when the agreement expires and termination provisions;
* Include a discussion of the stock issued to WRAIR in conjunction
with the agreement. The discussion should disclose the value of
the
stock when issued
31. Please provide third party support for the following
statements:
* Each flu season, approximately 15 million to 60 million people
in
the United States become ill with influenza. This infection rate
results in approximately 36,000 deaths and approximately 200,000
hospitalizations in the United States annually. Approximately 80
million people in the United States are vaccinated against the flu
annually.
* An estimated 9,000 to 45,000 individuals aged 65 and over die
from
influenza and influenza related pneumonia in the United States
each
year.
* Each year more than 50 million individuals from the United
States,
Western Europe and Japan/Australia visit regions where infection
by
ETEC is common, resulting in an estimated 10 million cases of
traveler` diarrhea caused by LT-secreting ETEC strains.
32. Please note that the supporting documentation should be marked
to
indicate the text that supports your statements.
33. Additionally, you have included a number of statistics
attributed
to the Centers for Disease Control and Kalorama Information.
Please
provide these reports marked to indicate the text supporting the
statements in your registration statement.
Facilities, page 61
34. Please revise to disclose the amount of your annual lease
payment
for your Gaithersburg, Maryland facility. You should also file
the
lease agreement as an exhibit to your registration statement.
Management, page 62
35. Please note that Item 401 of Regulation S-K requires a brief
description of the business experience of your officers and
directors
during each of the last five years. Please revise this section to
include the applicable dates for Messrs. Ellingsworth, Frech,
Seid,
Barrett, Gordon Douglas, Richard Douglas, and Himawan.
36. Please disclose any familial relationship that may exist
between
R. Gordon Douglas and Richard Douglas or advise us if there is
none.
Executive Compensation, page 66
37. We note that all of the executive officers you describe in
this
section receive either discretionary bonuses or stock option
awards
as part of their compensation. Please describe how these
individuals` performance is determined and what factors are
considered in evaluating it. For example, if the grants are based
on
company performance, please describe how company performance is
measured.
Principal Stockholders, page 74
38. Please identify the natural persons who have voting and
dispositive power over the shares held by each of the entities
listed
under the heading "Five percent stockholders" on page 75.
Description of Capital Stock, page 75
Warrants, page 83
39. Please state whether the expiration date may be extended and,
if
so, how. Please also clarify whether the warrants are callable
and,
if so, how and when you could call the warrants.
Underwriting, page 84
40. We note you plan to conduct a directed share offering. Please
provide us with any material you intend to use to sell to
potential
purchasers such as a "friends and family" letter. Tell us when you
intend to send them to these potential purchasers. In addition,
tell
us the procedures you will employ in making the offering and how
you
will assure that this offer will meet the requirements of Section
5
of the Securities Act and Rule 134. We may have further comments.
41. We note that certain of the underwriters may distribute
prospectuses electronically. Please tell us the procedures they
will
use in their selling efforts and how they intend to comply with
the
requirements of Section 5 of the Securities Act of 1933,
particularly
with regard to how offers and final confirmations will be made and
how and when purchasers will fund their purchases. Provide us
copies
of all electronic communications including the proposed web pages.
42. Please tell us and briefly disclose in the prospectus whether
you
intend to use any forms of prospectus other than print and
electronic
version, such as CD-ROMs, videos, etc., and provide all such
prospectuses for our examination. Please refer to SEC Releases
No.
33-7233 and NO. 33-7289. We may have additional comments.
43. Please indicate if your underwriters have arrangements with a
third party to host or access your preliminary prospectus on the
Internet. If so, identify the party and provide the address of
the
website. Please also describe the material terms of the agreement
and provide us with a copy of any written agreement. You should
also
provide us with copies of all information concerning your company
or
the offering that appears on the third party website. We ma