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United States securities and exchange commission logo
June 14, 2021
Adam Simpson
Chief Executive Officer
Icosavax, Inc.
1616 East Lake Avenue E
Suite 208
Seattle, WA 98102
Re: Icosavax, Inc.
Draft Registration
Statement on Form S-1
Filed May 14, 2021
CIK 0001786255
Dear Mr. Simpson:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note your claim that
RSV and hMPV are two of the "leading" causes of pneumonia.
However, your
disclosure on page 97 indicates that fewer than 20% of adults hospitalized
with pneumonia had the
RSV or hMPV pathogen and that three pathogens were more
common. Please explain
to us why it is appropriate to describe RSV and hMPV as
"leading" causes of
pneumonia in older adults or revise your disclosure.
2. You have provided
expected dates for the beginning of clinical trials in instances where it
Adam Simpson
FirstName LastNameAdam Simpson
Icosavax, Inc.
Comapany
June NameIcosavax, Inc.
14, 2021
June 14,
Page 2 2021 Page 2
FirstName LastName
is unclear whether you have completed clinical trials and/or submitted
INDs. Please
refrain from making predictions that assume successful preclinical
trails and FDA
approvals of INDs. Also, remove statements indicating when data is
expected with
respect to trials that have not yet started.
3. Please explain the meaning of the term "bivalent" the first time it is
used.
IVX-A12 (RSV-hMPV vaccine candidate), a bivalent combination of IVX-121 (RSV
vaccine
candidate) and IVX-241 (hMPV vaccine candidate), page 3
4. We note your disclosure that you intend to submit an IND to the FDA
for IVX-A12, a
combination of IVX-121 and IVX-241, following completion of your
clinical trial of IVX-
121 (assuming favorable results). Please revise here and in the
Business section to
disclose whether you have discussed this development plan with the FDA
and, if so,
whether you have received any feedback.
Please also revise to briefly discuss the potential for immunologic
interference between
your two product candidates that are anticipated to comprise IVX-A12,
as discussed on
page 15.
Our Programs, page 3
5. Please revise the disclosure accompanying your pipeline chart to
reflect your disclosure
elsewhere in your prospectus that your product candidates and
underlying technology are
licensed from the University of Washington and NIH.
6. Please explain the current status of IVX-121. The footnote indicates
that its development
will transition to evaluation as part of IVX-A12, does this mean that
you will not be
developing IVX-121 as a standalone product candidate? Please also
explain why it is not
depicted as a solid line, as the other candidates are.
7. We note you describe IVX-A12 as your "lead product candidate."
However, we note it is
not the most advanced in terms of development. Please explain what
make it your "lead
candidate."
SARS-CoV-2, page 3
8. Please revise your disclosure in this section to disclose whether you
have submitted an
clinical trial application for IVX-411. Please also revise to reflect
your disclosure on
pages 20-21 and 108 indicating that SK Bioscience also has a license
to develop product
candidates based on the same UW VLP technology that you have licensed
and has
initiated a Phase 1 clinical trial in South Korea for a product
candidate that is similar to
IVX-411.
Our Team and Investors, page 4
9. We note that you identify various entities as investors in your
company here and on page
Adam Simpson
FirstName LastNameAdam Simpson
Icosavax, Inc.
Comapany
June NameIcosavax, Inc.
14, 2021
June 14,
Page 3 2021 Page 3
FirstName LastName
91. However, certain of these entities do not appear to be among your
principal
stockholders as disclosed on page 156. If material, please expand your
disclosure to
describe the nature of each such entity's investment in you and
explain to us why
including this information is appropriate. Please also explain in the
response your plans to
update investors about any changes these entities make with respect to
their investments in
your company.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 6
10. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
Risk Factors
Intellectual property discovered through government funded programs may be
subject to federal
regulations such as march-in rights..., page 47
11. Please revise this risk factor to disclose your product candidates
and/or technology that are
subject to march-in rights.
Management s Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Common Stock Valuation, page 86
12. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features. Please discuss with the staff how to
submit your response.
Intellectual Property, page 112
13. Please revise to disclose the jurisdictions of your foreign patents
and patent applications.
License Agreement with respect to RSV and Other Pathogens, page 115
14. Your disclosure at the bottom of page 115 states that you must meet a
minimum royalty
requirement in the "low to mid figures range" following
commercialization. Please revise
to provide more specificity.
Material Agreements, page 115
15. Provisions providing the contracting party the right to terminate the
agreement for failure
to meet milestone events are material to investors. Please expand your
descriptions of the
Adam Simpson
Icosavax, Inc.
June 14, 2021
Page 4
license agreements in this section to disclose the required milestone
events and the dates
by which you are required to achieve them.
Please also revise to (i) disclose which of your product candidates
are subject to the
license agreements described in this section and (ii) quantify amounts
paid to date under
each license agreement.
You may contact Julie Sherman at 202-551-3640 or Brian Casio at
202-551-3676 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Alan Campbell at 202-551-4224 or Suzanne Hayes at 202-551-3675 with any
other
questions.
FirstName LastNameAdam Simpson Sincerely,
Comapany NameIcosavax, Inc.
Division of
Corporation Finance
June 14, 2021 Page 4 Office of Life
Sciences
FirstName LastName