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United States securities and exchange commission logo
August 18, 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. 3 to
Draft Registration
Statement on Form S-1
Submitted August
16, 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. 3 to Draft Registration Statement on Form S-1
Cover Page
1. We note your response
to prior comment 1 and revised disclosure on page 78. Please
revise your cover page
disclosure to clarify your proposed offering is contingent upon
Nasdaq Listing.
Prospectus Summary
Overview, page 1
2. We note your statement
that you have best in class science in the discovery and
development of any next
generation genetic medicine candidates. Given the development
R. Nolan Townsend
Lexeo Therapeutics, Inc.
August 18, 2023
Page 2
stage of product candidates and length of the drug approval process, it
is premature and
inappropriate to speculate or imply that your science is
best-in-class. Please remove
this statement.
Our Pipeline, page 2
3. We note the revisions to the pipeline table on pages 2 and 121.The point
of the arrow for
each product candidate should end at its current status. For example
only, where the
LX2020 study has not yet commenced Phase 1, the arrow should end in
preclinical until
your Phase 1 trial begins. In addition, it appears that you have not
completed the discovery
of LX2022 as you state you "plan to complete candidate selection for
LX2022 in 2024,"
the arrow should not go all the way to the end of "discovery."
Our manufacturing approach, page 130
4. We note your response to prior comments 3 and 5 and reissue in part.
Please revise your
disclosure to clarify the "next-generation sequencing analysis" that was
preformed. Your
disclosure should clarify which "HEK systems" you compared your process
to. For
example only, to the extent your analysis evaluated more than one HEK
system, your
disclosure should state the percentage of impurities observed for each
system. In addition,
we note your disclosure that "[b]ased on information from a third-party
contract
development and manufacturing organization and internal estimates, we
believe our
manufacturing process is approximately 10 times more yield efficient than
an HEK
process to manufacture AAVrh10." Please revise your disclosure to clarify
the specific
types of information and estimates you relied upon to support your belief
that your
process is "10 times more efficient" or otherwise advise.
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,
FirstName LastNameR. Nolan Townsend
Division of
Corporation Finance
Comapany NameLexeo Therapeutics, Inc.
Office of Life
Sciences
August 18, 2023 Page 2
cc: Dayne Brown, Esq.
FirstName LastName