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United States securities and exchange commission logo
June 13, 2023
R. Nolan Townsend
Chief Executive Officer
Lexeo Therapeutics, Inc.
345 Park Avenue South, Floor 6
New York, NY 10010
Re: Lexeo Therapeutics,
Inc.
Amendment No. 2 to
Draft Registration
Statement on Form S-1
Submitted May 17,
2023
CIK No. 0001907108
Dear R. Nolan Townsend:
We have reviewed your amended 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.
Amendment No. 2 to Draft Registration Statement on Form S-1
Cover Page
1. Please disclose, if
accurate, that the closing of this offering is contingent upon a Nasdaq
Listing, or otherwise
advise. Please ensure the disclosure is consistent with your
underwriting agreement
Prospectus summary
Overview, page 1
2. We note your response
to prior comment 1, including your revised disclosure stating that
you are using a
"clinically validated vector," and reissue. We further note your risk factor
R. Nolan Townsend
Lexeo Therapeutics, Inc.
June 13, 2023
Page 2
disclosure on page 19 that, "very few products that utilize gene
transfer have been
approved in the United States or Europe. There have been a limited
number of clinical
trials using AAVrh10." Given your current stage of development and
your risk factor
disclosure on page 19, it appears to be premature to make the claim
your vector is
"clinically validated." Please revise this disclosure to remove this
statement.
Our manufacturing approach, page 129
3. We note your disclosure that you believe your manufacturing process
"has an improved
safety profile over traditional adherent HEK manufacturing." Please
revise your disclosure
to clarify and describe traditional "HEK manufacturing." In addition,
we note you
reference that you "have observed reduced incorporation of
non-transgene DNA plasmid
DNA impurities, from 15% observed in some HEK systems to 0.2% in
[y]our process."
Please revise your disclosure to discuss the specific studies you are
referencing.
4. We note your graphic at the bottom of page 130 appears to measure
"MOI" on the x-axis.
Please revise your narrative disclosure to explain and define MOI.
5. We note your disclosure that "[b]ased on [y]our estimates, [you]
believe [y]our
manufacturing process is approximately 10 times more cost efficient
than traditional
adherent HEK manufacturing." Please update your disclosure to further
explain your basis
for this claim.
Preclinical safety studies, page 143
6. We note your disclosure discussing a "hypothetical model" and a
graphic at the bottom of
page 146. Please update your disclosure to clarify what "NHP PKP2
background
subtracted" means and how it was modeled. Please update your
disclosure to clarify the
material assumptions and discuss any limitations underlying such
projections by your
"hypothetical model" or otherwise advise.
2023 equity incentive plan, page 201
7. We note your response to prior comment 5 and your disclosure that the
administrator under the 2023 Plan has the power to modify outstanding
awards under your
2023 Plan, including the authority to reprice any outstanding option or
stock appreciation
right, cancel and re-grant any outstanding option or stock appreciation
right in exchange
for new stock awards, cash or other consideration, or take any other
action that is treated
as a repricing under generally accepted accounting principles, with the
consent of any
materially adversely affected participant. Please clearly disclose if
any such repricings
FirstName LastNameR. Nolan Townsend
could be implemented without stockholder approval. If so, please include
appropriate risk
Comapany NameLexeo
factor disclosure,Therapeutics, Inc. proxy advisory firms could find
such repricing
including whether
without
June 13, stockholder
2023 Page 2 approval contrary to a performance-based pay
philosophy.
FirstName LastName
R. Nolan Townsend
FirstName LastNameR.
Lexeo Therapeutics, Inc.Nolan Townsend
Comapany
June NameLexeo Therapeutics, Inc.
13, 2023
June 13,
Page 3 2023 Page 3
FirstName LastName
General
8. Many of your tables and graphics include print that is not legible.
For example only, your
graphic at the top of page 141 and your graphic at the bottom of page
142 contain text that
is too small to be legible. Please revise your graphics throughout
your prospectus as
applicable to ensure that the text is legible.
You may contact Eric Atallah at 202-551-3663 or Lynn Dicker at
202-551-3616 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jason Drory at 202-551-8342 or Tim Buchmiller at 202-551-3635 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Dayne Brown, Esq.