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United States securities and exchange commission logo
August 19, 2020
Joshua T. Brumm
President and Chief Executive Officer
Dyne Therapeutics, Inc.
830 Winter Street
Waltham, MA 02451
Re: Dyne Therapeutics,
Inc.
Draft Registration
Statement on Form S-1
Submitted July 23,
2020
CIK No. 0001818794
Dear Mr. Brumm:
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 July 23, 2020
Prospectus summary
Overview, page 1
1. Please revise the
"Overview" section on page 1 to highlight that your operations are
preclinical in nature.
Our portfolio, page 3
2. We note the inclusion
of your Cardiac/Metabolic programs in your pipeline table on page
3. Given the status of
development and the limited disclosure on page 116 regarding these
Joshua T. Brumm
FirstName LastNameJoshua T. Brumm
Dyne Therapeutics, Inc.
Comapany
August 19, NameDyne
2020 Therapeutics, Inc.
August
Page 2 19, 2020 Page 2
FirstName LastName
programs, it seems premature to highlight these programs prominently
in your Summary
pipeline table. Accordingly, please revise to remove these programs
from the Summary
table or advise.
Our strategy, page 4
3. We note your disclosure on page 5 that your strategy is to "rapidly"
advance your lead
programs in DM1, DMD and FSHD to clinical proof-of-concept and
approval. Please
revise these statements and any similar disclosure to remove any
implication that you will
be successful in commercializing your programs in a rapid or
accelerated manner as such
statements are speculative.
Use of proceeds, page 85
4. Please revise to disclose the approximate amount of proceeds that you
intend to allocate
toward each of the programs you identify in the Summary pipeline
table. In your revised
disclosure, please indicate how far the proceeds from the offering
will allow you to
proceed with the continued development of each of your programs.
Business, page 113
5. Please revise the prospectus to remove any statements that suggest the
safety and efficacy
of your platforms, as these determinations are the exclusive authority
of the FDA or other
regulators. For example, we note your statements that in murine and
non-human primate
studies, you have "effectively delivered" antisense oligonucleotides
and
phosphorodiamidate morpholino oligomers to genetic targets within
muscle tissue
resulting in "durable, disease-modifying, functional benefit" across
multiple indications
and disease models, and that your proprietary Fabs are engineered to
bind to TfR1 to
enable targeted "effective delivery" of nucleic acids.
Clinically validated linker, page 114
6. Please provide support for your statement that the Val-Cit linker has
been clinically
validated as safe and effective in approved products.
Our strategy, page 117
7. We note the following statement: "If our clinical trials are
successful, we plan to meet
with regulatory authorities to discuss expedited regulatory approval
strategies." Please
remove this statement from the prospectus, as it implies that
expedited approval may be
obtained, which is not within the company's control or known at this
time.
Myotonic dystrophy type 1 (DM1), page 125
8. The illustration provided on page 125, the second figure on page 129,
and the image on
page 133 contains text that is illegible. Please revise accordingly.
Joshua T. Brumm
Dyne Therapeutics, Inc.
August 19, 2020
Page 3
Intellectual Property, page 143
9. For the patent applications disclosed on page 144, please revise to
provide the
identification of all applicable jurisdictions where patents
applications are pending.
License agreement with the University of Mons, page 147
10. Please disclose when the latest to expire patent is scheduled to expire.
Financial Statements
Commitments and contingencies
Other contractual obligations, page F-25
11. We note your disclosure of your agreement with University of Mons on
page 147. Please
revise your filing to disclose the material terms of the agreement, such
as a description of
any significant milestones and anticipated patent expiration dates.
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 Eric Atallah at 202-551-3663 or Al Pavot at 202-551-3738
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Laura Crotty at 202-551-7614 or Jeffrey Gabor at 202-551-2544 with any other
questions.
Sincerely,
FirstName LastNameJoshua T. Brumm
Division of
Corporation Finance
Comapany NameDyne Therapeutics, Inc.
Office of Life
Sciences
August 19, 2020 Page 3
cc: Stuart M. Falber, Esq.
FirstName LastName