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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