<SEC-DOCUMENT>0000000000-22-002410.txt : 20231204
<SEC-HEADER>0000000000-22-002410.hdr.sgml : 20231204
<ACCEPTANCE-DATETIME>20220303153004
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-22-002410
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20220303

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Lexeo Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001907108
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				854012572
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		345 PARK AVENUE SOUTH
		STREET 2:		FLOOR 6
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10010
		BUSINESS PHONE:		(212) 547-9879

	MAIL ADDRESS:	
		STREET 1:		345 PARK AVENUE SOUTH
		STREET 2:		FLOOR 6
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10010
PUBLIC REFERENCE ACCESSION NUMBER:		0000950123-22-001044
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                            March 3, 2022

       R. Nolan Townsend
       Chief Executive Officer
       Lexeo Therapeutics, Inc.
       430 East 29th Street, Floor 14
       New York, NY 10016

                                                        Re: Lexeo Therapeutics,
Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted February
4, 2022
                                                            CIK No. 0001907108

       Dear Mr. Townsend:

              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 February 4, 2022

       Prospectus summary
       Overview, page 1

   1.                                                   We note your disclosure
here and throughout that you are focused on "diseases affecting
                                                        both larger-rare and
prevalent patient populations." However, we note your disclosure at
                                                        the bottom of page 4
that depicts CLN2 Batten disease as an "Ultra Rare Disease," which
                                                        appears to be your
indication for your LX1004 product candidate. Please update your
                                                        disclosure here to
clarify that your most advanced product candidate is an "Ultra Rare
                                                        Disease" or otherwise
advise.
 R. Nolan Townsend
FirstName  LastNameR.
Lexeo Therapeutics, Inc.Nolan Townsend
Comapany
March      NameLexeo Therapeutics, Inc.
       3, 2022
March2 3, 2022 Page 2
Page
FirstName LastName
Lead cardiovascular programs, page 2

2.       We note your disclosure at the top of page 3 that, "in [y]our
preclinical studies, LX2020
         resulted in fewer arrhythmias and increased survival." Please revise
your disclosure
         here to clearly state, if true, that the studies preformed to date
were animal trials. In this
         regard, we note your disclosure on page 138.
Our pipeline, page 2

3.       We note the inclusion of product candidates in your pipeline table,
which appear to still be
         in the "discovery" phase. In addition, we note your disclosure
elsewhere on page 33
         where you state you "are primarily focused on the development of
LX2006, LX1001 and
         LX1004" and your intellectual property disclosure on page 151 only
appears to describe
         patents and pending patents related to LX2006, LX1020 and LX1021.
Given the limited
         amount of disclosure related to your programs in discovery, please
explain why these
         programs are sufficiently material to your business to warrant
inclusion in your pipeline
         table. If they are material, please expand your disclosure in your
Business section to
         provide a more fulsome discussion of these programs, including a
description of
         preclinical studies or development activities conducted and expand
your intellectual
         property disclosure if applicable. Alternatively, remove any programs
that are not
         currently material from your pipeline table on pages 2 and 120.
4.       Please revise your pipeline table to include separate columns for
Phase 1, Phase 2 and
         Phase 3 trials or tell us the basis for your belief that you will be
able to conduct Phase 1/2
         and Phase 2/3 trials for all your product candidates.
5.       We note your pipeline table states that LX1004's upcoming milestone is
"1H 2023: Pivotal
         Study Start." However, your disclosure on page 3 indicates that you,
"anticipate receiving
         feedback from the FDA on the design of [y]our potentially pivotal
Phase 2/3 clinical trial
         in the second half of 2022." Please revise your disclosure in the
pipeline table and
         elsewhere, as applicable, to make it clear, if true, that the U.S.
Food and Drug
         Administration (FDA) or other regulators may require you to conduct
sequential trials.
High Transduction Efficiency and Biodistribution, page 4

6.       We note your disclosure here and elsewhere that the AAVrh10 vector is
"optimal for
         delivery and expression of transgenes for the treatment of the
cardiovascular and CNS
         diseases [you] are currently targeting." However, we note your
disclosure on page 129
         that you are collaborating with Weill Cornell Medicine on the
discovery of second and
         third generation cardiac vector technology. Please provide your basis
for your belief that
         the AAVrh10 vector is "optimal" or otherwise advise.
7.       If your disclosure that the AAVrh10 vector has proven to be "effective
at transducing
         myocardial cells and neurons" is based on preclinical studies on
non-human cells, please
         make that clear. In this regard, we note from your disclosure on page
126 that this
         disclosure appears to be based on your preclinical studies on nonhuman
primates and
 R. Nolan Townsend
FirstName  LastNameR.
Lexeo Therapeutics, Inc.Nolan Townsend
Comapany
March      NameLexeo Therapeutics, Inc.
       3, 2022
March3 3, 2022 Page 3
Page
FirstName LastName
         murine models.
Our disease area strategy, page 4

8.       We note your reference in the graphic at the bottom of page 4 to
"early evidence of
         clinical benefit" as well as "promising preclinical data." In
addition, we note your
         disclosure on page 144 that "LX1001 has promise as a therapeutic for
APOE4
         homozygous Alzheimer   s disease patients." As safety and efficacy
determinations are
         solely within the FDA's authority and they continue to be evaluated
throughout all phases
         of clinical trials, please remove these and any such references in
your prospectus. In the
         Business section, you may present objective data resulting from your
trials without
         including conclusions related to efficacy.
Our company and team, page 6

9.       We note that you identify certain "premier institutional investors" in
your company in this
         section. Please limit the disclosure of specific investors to those
identified in the principal
         stockholders table on page 198. Additionally, indicate that
prospective investors should
         not rely on the named investors    investment decision, that these
investors may have
         different risk tolerances and the recent offering was conducted as a
significant discount to
         the IPO price.
Risks associated with our business, page 7

10.      Please revise your risk factor summary to highlight that you currently
do not own or
         license any composition of matter patents or patent applications
covering your LX1001
         and LX1004 product candidates, consistent with your disclosure on page
56. Please add
         similar clarifying disclosure in the "Intellectual property" section
beginning on page 151.
Research collaboration agreement with Weill Cornell Medicine, page 104

11.      We note your disclosure on page 46 that "[y]our collaboration with
Cornell University is
         critical to [y]our business." Please file the Research Collaboration
Agreement with Weill
         Cornell Medicine as an exhibit to the registration statement as
required by Item 601(b)(10)
         of Regulation S-K or tell us why it is not material.
Exclusive license agreement with the Regents of the University of California,
San Diego, page
105

12.      We note your disclosure in this section regarding the UCSD Agreement
and your
         disclosure on page 124 that your foundational science stems in part
from your license
         agreement with UCSD. Please file the agreement as an exhibit to the
registration
         statement, or provide your analysis supporting your conclusion that
filing is not required.
         See Item 601(b)(10) of Regulation S-K for guidance. In addition,
please update your
         disclosure to clarify which product candidate(s) are covered by the
license agreement or
         otherwise advise.
 R. Nolan Townsend
FirstName  LastNameR.
Lexeo Therapeutics, Inc.Nolan Townsend
Comapany
March      NameLexeo Therapeutics, Inc.
       3, 2022
March4 3, 2022 Page 4
Page
FirstName LastName
Stelios Therapeutics Inc. acquisition, page 105

13.      Please file the Stelios Therapeutics Inc. acquisition agreement as an
exhibit to the
         registration statement or tell us why you are not required to do so.
Refer to Item 601(b)(2)
         of Regulation S-K. In addition, please disclose more specific
information about the
         "certain milestones" that must be reached in order for you to pay the
additional $20.5
         million in payments, including identifying the specific product
candidate(s) that relate to
         the agreement or otherwise advise.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgements and Estimates
Determination of Fair Value of Common Stock, page 115

14.      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. Please discuss with
the staff how to
         submit your response.
Our strategy, page 123

15.      We note your statement here that you established "a leading
cardiovascular gene therapy
         pipeline." Please revise to disclose the basis for this statement.
Preclinical safety studies, page 135

16.      We note your disclosure here that, "large body of available data
suggests that HCC
         observed in mice after AAV treatment is unlikely to translate to risks
for humans, as it has
         not been observed in higher species or humans (FDA 2021)." Please
elaborate on and
         clarify what you mean by "large body of available data" and "(FDA
2021)," which
         appears at the end of the sentence.
Phase 1/2 clinical trial results, page 147

17.      We note your disclosure at the top of page 149 discloses that there
were "minimal serious
         adverse events." Please update your disclosure to disclose what the
serious adverse
         events were and how many subjects experienced them.
Manufacturing, page 151

18.      We note your disclosure here that you have partnered with Virovek,
Inc., Millipore
         Corporation and Fujifilm Diosynth Biotechnologies U.S.A., Inc. in
connection with
         manufacturing your vector product candidates. Please update your
disclosure here
         to disclose the material terms of your manufacturing agreements and
please file these
         agreements as exhibits to the registration statement as required by
Item 601(b)(10) of
 R. Nolan Townsend
Lexeo Therapeutics, Inc.
March 3, 2022
Page 5
      Regulation S-K or tell us why they are not material.
License agreements, page 152

19.   Please revise your disclosure to include the aggregate milestone payments
due under each
      of the license agreements with Cornell University.
Agreements with our named executive officers, page 180

20.   Please file the employment agreements you have entered into with your
named executive
      officers. Refer to Item 601(b)(10) of Regulation S-K.
2022 equity incentive plan, page 183

21.   We note your disclosure on page 184 that the administrator of the 2022
Plan has the
      power to modify awards under your 2022 Plan, including the authority to
reprice any
      outstanding option or stock appreciation right, or take any other action
that is treated as a
      repricing. Please clarify if these repricing actions would require
stockholder approval. If
      such actions would not require stockholder approval, please include
appropriate risk factor
      disclosure, including whether proxy advisory firms could find such
repricing without
      stockholder approval contrary to a performance-based pay philosophy.
Certain relationships and related party transactions
Agreements with Ronald G. Crystal, M.D., page 194

22.   Please file the agreements disclosed in this section as exhibits as
required by Item
      601(b)(10) of Regulation S-K, or tell us why you believe they are not
required to be filed.
General

23.   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.
       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
Comapany NameLexeo Therapeutics, Inc.                        Division of
Corporation Finance
                                                             Office of Life
Sciences
March 3, 2022 Page 5
cc:
FirstName Dayne Brown, Esq.
          LastName
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