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United States securities and exchange commission logo
September 2, 2021
Dipal Doshi
President and Chief Executive Officer
Entrada Therapeutics, Inc.
6 Tide Street
Boston, MA 02210
Re: Entrada
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Filed August 6,
2021
File No. 377-05320
Dear Mr. Doshi:
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 6, 2021
Prospectus Summary, page 1
1. On page 2 you state
that your EEV Platform has allowed you to develop highly efficient
and highly specific
EEV therapeutic candidates. Please remove all statements that
present your
conclusions regarding the efficacy of your product candidate as this is a
determination within
the authority of the U.S. Food and Drug Administration and
comparable regulatory
bodies or advise why this disclosure is appropriate.
2. In the pipeline table
on page 3 please increase the size of the headings for the Phase 1,
Phase 2 and Phase 3
clinical trials. Additionally, we note that you have included programs
in the discovery phase
for which no product candidate has been identified in your pipeline
table, specifically,
every program except ENTR-601-44 and ENTR-501. Please provide us
Dipal Doshi
FirstName LastNameDipal
Entrada Therapeutics, Inc. Doshi
Comapany 2,
September NameEntrada
2021 Therapeutics, Inc.
September
Page 2 2, 2021 Page 2
FirstName LastName
your analysis as to why these programs are material enough to be
included in your
pipeline table. Alternatively, remove them from your table.
3. We note that you completed IND-enabling studies for ENTR-501. Please
revise page 4 to
explain why you are exploring partnership opportunities for this
program.
Risk Factors
Our rights to develop and commercialize any therapeutic candidates are
subject..., page 58
4. Please revise this risk factor to highlight the consequences of losing
the OSIF license
specifically.
Use of Proceeds, page 88
5. Please revise to disclose an estimate of how far in your development
of each of EEV
pipeline this offering will allow you to reach with respect to each
material program,
including specific phases of preclinical and clinical trials. Also,
please disclose the total
estimated cost of each of the specified purposes for which the net
proceeds are intended to
be used, and, if material amounts of other funds are necessary to
accomplish the specified
purposes, provide an estimate of the amounts of such other funds and
the sources thereof.
Results of Operations
Researc and Development Expenses, page 104
6.
We note the significant increase in your research and development
expenses and from
pages 111 and 120 that you have multiple products/programs in the
pipeline at varying
stages of development. Please revise to disclose your research and
development expenses
for your lead product candidates. To the extent that you do not track
expenses by product
candidate, please disclose that fact.
Business, page 110
7. We note your statement on page 116 and elsewhere that in preclinical
models
approximately 50% of the EEV-conjugated material escaped the endosome
to reach the
intracellular disease target, which indicates a potential for
significant improvement over
the 1-2% observed in current biologics. If this comparison is not a
head-to-head
comparison please remove it as comparisons to available products and
other product
candidates are not appropriate unless you have conducted head-to-head
trials.
8. Please provide more information concerning your preclinical studies
beginning on page
123, including any serious adverse effects. Provide p-values for any
studies powered for
statistical significance and explain how statistical significance
relates to FDA standards of
efficacy.
9. Please revise page 137 to state the jurisdictions covered by your
issued and pending
patents and clarify which patents are in-licensed.
Dipal Doshi
Entrada Therapeutics, Inc.
September 2, 2021
Page 3
10. In connection with your description of the OSIF License Agreement on page
139, please
revise to provide the amount of the certain license maintenance fees
prior to the
commercialization of the first licensed product, if material, and the
grounds for
termination. We also note that you say the term will expire on the
expiration of the last to
expire of the exclusively licensed patent rights, or the end of your
obligation to pay
royalties under the OSIF License Agreement. Please revise to clarify when
these patent
rights are expected to expire. Additionally, you state that your
obligation to pay royalties
ends on a licensed product-by-licensed product and country-by-country
basis, on the later
of expiration of the last to expire of the valid claims of the
exclusively licensed patent
rights covering such licensed product in such country, or ten years after
the first
commercial sale of such licensed product in such country. Please revise
to clarify when
these claims are expected to expire.
Description of Capital Stock, page 182
11. Please revise page 182 to provide the amount of shares entitled to
registration rights.
General
12. 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 Al Pavot at 202-551-3738 or Jeanne Bennett at
202-551-3606 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Celeste Murphy at 202-551-3257
with any other
questions.
Sincerely,
FirstName LastNameDipal Doshi
Division of
Corporation Finance
Comapany NameEntrada Therapeutics, Inc.
Office of Life
Sciences
September 2, 2021 Page 3
cc: Arthur R. McGivern, Esq.
FirstName LastName