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United States securities and exchange commission logo
December 3, 2020
David Kirn
Chief Executive Officer
4D Molecular Therapeutics Inc.
5858 Horton Street #455
Emeryville, CA 94608
Re: 4D Molecular
Therapeutics Inc.
Registration
Statement on Form S-1
Filed November 17,
2020
File No. 333-250150
Dear Dr. Kirn:
We have reviewed your 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Prospectus Summary
Our Therapeutic Vector Evolution Platform, page 2
1. We note your revisions
in response to prior comment 4. Please revise your disclosure on
pages 2 and 118 where
you discuss your head-to-head comparisons with conventional
AAV vectors to state,
if true, that you have not conducted any clinical studies in patients
comparing your targeted
and evolved vectors to conventional AAV vectors. Please also
revise your disclosure
on pages 2 and 118 that you "expect" to demonstrate the superior
capabilities of your
targeted and evolved vectors and product candidates as you advance
through clinical trials
to remove the expectation regarding how your vectors and product
candidates will perform
in clinical trials as such statements are speculative.
David Kirn
FirstName LastNameDavid Kirn
4D Molecular Therapeutics Inc.
Comapany3,
December Name4D
2020 Molecular Therapeutics Inc.
December
Page 2 3, 2020 Page 2
FirstName LastName
Our Product Candidate Pipeline, page 3
2. We note the added table depicting your most advanced discovery and
research programs.
Additionally, we note that your filing does not include a discussion
of 4D-3XX or 4D-
7XX, which implies that these programs are not sufficiently material
to your operations to
warrant discussion. Please delete the references to these programs
from your summary.
3. We note your response to comment 7 and believe TVP and Lead
Optimization should be
depicted together under a column heading such as discovery or research
and
development. A textual discussion of the program is a more appropriate
place to make the
distinctions regarding different tasks within a particular phase.
Business
Competition and Differentiation: AAV Gene Therapy for wet AMD and Diabetic
Retinopathy,
page 155
4. We note your response to prior comment 12. Please revise your
statement that 4D-150
would be the only AAV gene therapy asset in wet AMD and DR that has
shown superior
transduction on human retinal cells ex vivo versus conventional AAV
vectors such as
AAV2 to clarify, if true, that your statement is based solely on in
vitro studies you
conducted comparing R100 to AAV2 discussed on page 138.
Principal Stockholders, page 222
5. Please revise your disclosure to identify the natural person or
persons who have voting
and investment control of the shares held by the entities affiliated
with BVF.
10. Redeemable Convertible Preferred Stock
Funding Agreement with CFF (unaudited), page F-39
6. We note the $10.0 million received from CFF is to "be used to advance
the development
program for 4D-710, the Company s lead product in cystic fibrosis,
or any other
therapeutic approved by the Program Advisory Group ( PAG ) to
alleviate pulmonary
complications of cystic fibrosis". With reference to the specific
terms of the Funding
Agreement, please address the need to separately classify the $10.0
million as restricted
cash. Refer to Rule 5-02.1 of Regulation S-X.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Jenn Do at 202-551-3743 or Jeanne Baker at
202-551-3691 if you have
David Kirn
4D Molecular Therapeutics Inc.
December 3, 2020
Page 3
questions regarding comments on the financial statements and related matters.
Please contact
Ada Sarmento at 202-551-3798 or Suzanne Hayes at 202-551-3675 with any other
questions.
FirstName LastNameDavid Kirn Sincerely,
Comapany Name4D Molecular Therapeutics Inc.
Division of
Corporation Finance
December 3, 2020 Page 3 Office of Life
Sciences
FirstName LastName