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United States securities and exchange commission logo
June 18, 2020
Michel Detheux
Chief Executive Officer
iTeos Therapeutics, Inc.
139 Main Street
Cambridge, MA 02142
Re: iTeos Therapeutics,
Inc.
Draft Registration
Statement on Form S-1
Submitted May 22,
2020
CIK No. 0001808865
Dear Dr. Detheux:
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 submitted May 22, 2020
EOS-448, our FcgR-engaging anti-TIGIT antibody, page 5
1. We note your statement
that in your preclinical studies, EOS-448 had superior binding to
TIGIT and functional
potency compared to a number of anti-TIGIT antibody equivalents.
In your preclinical
assay descriptions on page 135 of the document, you state that EOS-
448 had a higher
binding affinity for CD8+ T cells, but you do not discuss other cells
where TIGIT may be
expressed such as NK cells or Tregs. In addition, the figure on the
left accompanying the
study appears to show that all of the product candidates tested had
extremely similar
results. Please update your disclosure to (i) state that your findings are
based on CD8+ T cells
only and do not include other immune cells where TIGIT is
expressed and (ii)
explain how the figures in the graphic support your assertion that EOS-
Michel Detheux
iTeos Therapeutics, Inc.
June 18, 2020
Page 2
448 has superior binding affinity. Further, we note that your
description of the studies on
page 135 shows that EOS-448 had higher immune cell activation as
determined using an
IL-2 promoter-dependent functional assay, rather than "functional
potency." Please update
your disclosure in the summary section and on page 117 to reflect the
terminology used in
the descriptions of the study.
2. Please balance your discussion of the preliminary clinical trial
results to clarify whether
these results are statistically significant and whether the trial is
designed to assess
efficacy, including whether you have pre-established endpoints for
measuring evidence of
clinical benefit.
Implications of being an emerging growth company and a smaller reporting
company, page 8
3. 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.
Capitalization, page 89
4. Please disclose the nature of the pro forma adjustment for the filing
and effectiveness of
your second amended and restated certificate of incorporation upon the
completion of this
offering.
Business
Strategy, page 118
5. We note your statement that EOS-850 is a potentially "best-in-class"
A2aR
antagonist. This term suggests that EOS-850 is effective and likely to
be approved,
particularly given your claims concerning specificity, potency and
continuous target
coverage. Please delete this reference. If your use of this term was
intended to convey
your belief that EOS-850 is further along in the development process,
you may discuss
that you are not aware of competing products that are further along in
the development
process. Statements such as these should be accompanied by cautionary
language that the
statements are not intended to give any indication that EOS-850 has
been proven effective
or that it will receive regulatory approval.
Phase 1 clinical trial results, page 130
6. We note your disclosure in this section references "response" and
"stable disease" as
FirstName LastNameMichel Detheux
defined by RECIST 1.1 and that the accompanying table includes the terms
"complete
Comapany NameiTeos Therapeutics,"stable disease" and "progressive disease."
Please expand
response", "partial response", Inc.
June 18, 2020 Page 2 to briefly define each of these terms in your document.
your disclosure
FirstName LastName
Michel Detheux
FirstName LastNameMichel Detheux
iTeos Therapeutics, Inc.
Comapany NameiTeos Therapeutics, Inc.
June 18, 2020
Page 3
June 18, 2020 Page 3
FirstName LastName
Collaborations and licenses, page 145
7. Please disclose whether any of the exercised licenses under the Adimab
agreement have
been used to create any of your product candidates discussed in the
prospectus, and would
therefore be covered by the milestone and royalty payment provisions.
Please also
disclose the aggregate amount of all payments made under the Adimab
agreement to date.
Intellectual Property, page 148
8. Please disclose the full name of each jurisdiction where your patent
families are pending.
Please also define the term "PCT."
Certain relationships and related person transactions
Royalty transfer agreement, page 191
9. We note your disclosure that iTeos Belgium SA will pay "a certain
percentage of its net
sales" on any product developed or owned by you. Please quantify the
royalty rate, or
disclose a range no greater than 10 percentage points per tier. Please
also clarify whether
this provision would apply to net sales by your company as a whole, or
only to sales made
by iTeos Belgium SA.
You may contact Tracey Houser at (202) 551-3736 or Daniel Gordon at
(202) 551-
3486 if you have questions regarding comments on the financial statements and
related
matters. Please contact Alan Campbell at (202) 551-4224 or Joe McCann at (202)
551-
6262 with any other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences