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United States securities and exchange commission logo
February 22, 2021
Jo o Siffert, M.D.
President and Chief Executive Officer
Design Therapeutics, Inc.
6005 Hidden Valley Road, Suite 110
Carlsbad, CA 92011
Re: Design
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted January
26, 2021
CIK No. 0001807120
Dear Dr. Siffert:
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 January 26, 2021
Prospectus Summary
Overview, page 1
1. Please revise your
disclosure in the first sentence on page 1 to highlight that
your operations are
preclinical.
2. We note references to
preclinical data that your product candidates have "consistently
restored frataxin (FXN)
levels in cells from FA patients," "reduced nuclear foci in DM1
patient muscle cells"
and similar statements indicating findings of efficacy. Please revise
to remove any
statements that suggest the efficacy of your candidates, as these
determinations are the
exclusive authority of the FDA or other regulators. Also, please
Jo o Siffert, M.D.
Design Therapeutics, Inc.
February 22, 2021
Page 2
limit the prospectus summary discussion of preclinical studies to an
objective description
of the endpoints of your studies and trials and whether they were met.
For example, rather
than stating that your "FA GeneTACs have consistently restored
frataxin (FXN) levels in
cells from FA patients," present your trial observations without
concluding that the FA
GeneTACs caused the observations. Similarly revise the disclosure
throughout your
filing.
3. Revise the table on page 4 to reflect that you have not yet submitted
an IND with respect
to Friedreich ataxia (GAA) and Myotonic dystrophy (CTG).
4. We note that you have included in your product pipeline table your
GeneTAC platform
discovery programs. Given the early-stage development of these
programs, 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 on pages 118-
119 to provide a more fulsome discussion of these programs, including
a description of
preclinical studies or other development activities conducted.
Alternatively, remove any
programs that are not currently material from your pipeline table.
Management's Discussion and Analysis
Common Stock Valuations, page 98
5. Once you have an estimated offering price or range, please explain to
us the reasons for
any significant 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
and beneficial conversion features. Please discuss with the staff how
to submit your
response.
Business
License Agreement, page 120
6. We note your disclosure with respect to the WARF License Agreement
that your royalty
obligation will terminate on the date of expiration of the
last-to-expire of the licensed
patents in the relevant country. Please revise to clarify when the
patents underlying such
royalty terms are expected to expire. In addition, revise to disclose
the aggregate
amounts, if any, paid to date under the WARF License Agreement.
7. Please briefly describe any of the material terms of the rights retained
by the U.S.
government. If there are any material march-in-rights, address the
portion of your business
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that would be impacted by exercise of such rights, and describe the
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Intellectual Property, page 122
8. Please revise your intellectual property disclosure to clearly
describe on an individual
basis the type of patent protection granted for each technology, the
expiration of each
patent held, and the jurisdiction, including any foreign jurisdiction,
of each pending or
issued patent. In addition, please clarify whether each such patent is
owned or licensed.
In this regard, it may be useful to provide this disclosure in tabular
form to support the
narrative already included.
9. Please revise here to disclose the type of intellectual property right
protection applicable
to your GeneTAC Platform. In your revised disclosure, please clarify
the source of
protection for your "proprietary" platform, explain why the platform
is "proprietary," and
disclose the duration of the underlying intellectual property
protection.
Description of Capital Stock
Choice of Forum, page 175
10. Please ensure that the exclusive forum provision in your amended and
restated certificate
of incorporation to be effective immediately prior to the closing of
this offering clearly
states that this provision does not apply to actions arising under the
Securities Act or
Exchange Act, or tell us how you will inform investors in future
filings that the provision
does not apply to any actions arising under the Securities Act or
Exchange Act.
General
11. 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 Jeanne Bennett at 202-551-3606 or Vanessa Robertson at
202-551-
3649 if you have questions regarding comments on the financial statements and
related
matters. Please contact Kasey Robinson at 202-551-5880 or Jeffrey Gabor at
202-551-2544 with
any other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Kenneth Rollins, Esq.