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United States securities and exchange commission logo
August 30, 2023
Brian Thomas, Ph.D.
Chief Executive Officer
Metagenomi Technologies, LLC
1545 Park Avenue
Emeryville, CA 94608
Re: Metagenomi
Technologies, LLC
Draft Registration
Statement on Form S-1
Submitted August 3,
2023
CIK 0001785279
Dear Brian Thomas:
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 filed August 3, 2023
Cover Page
1. Please disclose on the
prospectus cover page whether your offering is contingent upon
final approval of your
Nasdaq listing. Please ensure the disclosure is consistent with your
underwriting agreement.
Overview, page 1
2. Revise your Overview
discussion to clarify that you have no approved products and that
all of your product
candidates are preclinical.
3. We note there are other
companies using CRISPR/CAS technology, alternative nuclease-
Brian Thomas, Ph.D.
FirstName LastNameBrian
Technologies, Thomas, Ph.D.
Metagenomi LLC
Comapany
August 30, NameMetagenomi
2023 Technologies, LLC
August
Page 2 30, 2023 Page 2
FirstName LastName
based genome editing technologies, recombinase DNA and RNA gene
writing, epigenetic
editing, etc. Please explain your belief that your toolbox "uniquely"
positions you to
access the entire genome when you have indicated that there are
private companies about
which little is known.
Figure 1. Our Toolbox, page 2
4. Please increase the font size of the text within the table.
5. Please remove the statement claiming your base editors will accelerate
therapeutic
development, as it appears speculative.
Figure 2: Therapeutic Translation., page 4
6. Please revise this graphic to separate the "Clinical" column into
Phase I, Phase II and
Phase III to clearly represent what development stages must be
completed prior to
commercialization of your therapeutic candidates. In addition, please
combine your
columns labeled "lead optimization" and "IND-enabling" into one
preclinical development
column.
7. We note the inclusion of therapeutic candidates for renal disease and
autoimmune/immuno-oncology in your pipeline table. Given the limited
disclosure
related to these programs, please explain why they are sufficiently
material to your
business to warrant inclusion in your pipeline table. If they are
material, please expand
your disclosure in the Business section to provide a more fulsome
discussion of these
programs, including a description of development activities conducted.
Alternatively,
remove any programs that are not currently material from your pipeline
table on pages 4
and 158.
8. We note that the gene for cardiovascular disease is "undisclosed." If
this gene has been
determined, please revise your table, to identify the gene and
describe this program.
Critical Accounting Policies and Significant Judgments and Estimates, page 116
9. We note the following disclosure from page 223: "The grant date fair
value of all awards
made under our 2023 Plan and all other cash compensation paid by us to
any non-
employee director in any calendar year for services as a non-employee
director shall not
exceed $ ; provided, however, that such amount shall be $
for the calendar year
in which the applicable non-employee director is initially elected or
appointed to the board
of directors." Please revise hereunder to disclose the extent to which
any stock-based
compensation has been awarded during 2023 (also noting the grants in
March and June
2023 as disclosed on page F-43) and provide the fair valuations of
each award. 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
Brian Thomas, Ph.D.
FirstName LastNameBrian
Technologies, Thomas, Ph.D.
Metagenomi LLC
Comapany
August 30, NameMetagenomi
2023 Technologies, LLC
August
Page 3 30, 2023 Page 3
FirstName LastName
differences between the recent valuations of your common stock leading
up to the initial
public offering and the estimated offering price. This information
will help facilitate our
review of your accounting for equity issuances including stock
compensation.
Business
Our Metagenomics Platform, page 131
10. Please remove references to your genome editing systems potentially
being "best-in-class"
and "first-in-class" as it does not appear that your platform has
resulted in any FDA
approved therapies and future approved therapies are speculative.
Moderna Strategic Collaboration and License Agreement, page 181
11. We note your disclosure stating you are eligible to receive royalties
ranging from a mid-
single digit to a "low double-digit" percentage of annual net sales
from licensed products.
As drafted, it is unclear if "low double-digit" refers to a range
within ten percentage points
of a mid-single digit percentage. Please revise your disclosure to
limit the royalty range to
ten percentage points.
12. Given your disclosure that you received a non-refundable upfront
payment of $40.0
million, a $5.0 million payment for the first year of research costs,
Moderna's obligation
to reimburse you for up to $5.0 million in annual research and
development costs, your
eligibility to receive development, regulatory and sales milestone
payments and royalty
payments, explain the statement that you will work with Moderna on the
co-development
and commercialization of products with respect to the DT Co-Co program
and share costs
and profits equally. Explain how sharing profits equally is consistent
with a royalty
provision. Will the milestone payments be considered part of Moderna's
share of the
costs? Will the royalty payments to Metagenomi be considered part of
its share in the
profits?
Our License and Collaboration Agreements, page 181
13. For each agreement discussed in this section, please disclose the
aggregate amounts paid
to date and the aggregate amount of remaining potential payments under
each agreement.
Affini-T Development, Option and License Agreement, page 182
14. Please file the Development, Option and License Agreement entered into
with Affini-T as
an exhibit to your registration statement or tell us why you do not
believe such a filing is
required.
15. Explain the distinction between a regulatory milestone and
developmental milestone.
Additionally, given that you are eligible to receive a milestone of
933,650 based on an
achievement of a regulatory milestone event, regardless of the value
of the shares at the
time of the event, please disclose the trigger event or tell us why
you believe such
information is not material.
Brian Thomas, Ph.D.
Metagenomi Technologies, LLC
August 30, 2023
Page 4
Intellectual Property
Patent Portfolio, page 188
16. Please specify the type of protection (e.g., composition of matter,
method of use or
process) for each patent or patent application disclosed in this
section.
Principal Stockholders, page 233
17. Please revise the table on page 234 to identify the natural person(s)
with voting
and/or dispositive control over the shares held by Humboldt Fund I,
LP, and Sake
Holdings LLC.
General
18. 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 Jenn Do at 202-551-3743 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tyler Howes at 202-551-3370 or Suzanne Hayes at 202-551-3675 with any
other
questions.
FirstName LastNameBrian Thomas, Ph.D. Sincerely,
Comapany NameMetagenomi Technologies, LLC
Division of
Corporation Finance
August 30, 2023 Page 4 Office of Life
Sciences
FirstName LastName