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April 17, 2019
Edward Kaye
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re: Stoke Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted March 26, 2019
CIK No. 0001623526
Dear Dr. Kaye:
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
Market and industry data, page ii
1. We note your disclosure that you commissioned a report by Health
Advances LLC.
Please file a consent by Health Advances LLC as an exhibit to your
registration statement
pursuant to Rule 436 of the Securities Act.
Prospectus summary
Company overview, page 1
2. You state that current treatments for Dravet syndrome provided by your
competitors
perform "very poorly." Please provide us with your basis for this
characterization of their
performance or revise your disclosure.
Edward Kaye
FirstName LastNameEdward Kaye
Stoke Therapeutics, Inc.
Comapany NameStoke Therapeutics, Inc.
April 17, 2019
April 2 2019 Page 2
Page 17,
FirstName LastName
Advantages of TANGO, page 2
3. Please revise this section and throughout to remove comparisons of
your ASOs to other
product candidates, products and treatments if you have not conducted
head-to-head
clinical trials. For example, we note your statement on page 2 that
TANGO may have
several key advantages over existing and emerging therapeutic
modalities, your disclosure
on page 88 that your product candidate "has the potential to result in
significantly
improved outcomes compared to existing antipileptic drugs," and your
disclosure on page
102 that "[b]y comparison to the approved drug SPINRAZA, STK-001
possesses less
predicted off-target activities."
Our precision medicine platform
Treatment of autosomal dominant haploinsufficiency diseases with TANGO, page 2
4. Your statement on page 3 that ASO delivery to the CNS is particularly
well-precedented
with one FDA-approved drug creates the implication that your drug
candidate will also be
approved by the FDA. In addition, your statement on page 2 that your
technology can
provide a single-drug approach for diseases that are caused by many
loss-of-function
mutations in a single gene, the inclusion of your "TANGO Technology"
as a current or
emerging medicine in your chart on page 90 and your statement on page
100 that your
precision medicine approach may have a profound impact on individuals
and families
imply that your current and future product candidates will be approved
by the FDA. Such
statements are inappropriate given the stage of development of your
product candidates.
Revise these statements and all other similar statements to eliminate
such implication.
Our Programs
Dravet syndrome--STK-001, page 3
5. We note your disclosure on page 3 that you plan to apply for Orphan
Drug Designation
from the FDA and that you plan to discuss expedited regulatory
pathways with regulatory
authorities such as Fast Track Designation and Breakthrough Therapy
Designation.
Please disclose here and throughout, if true, that the FDA has not
given any indication as
to whether your product candidate will receive an orphan drug
designation or be permitted
to use expedited regulatory pathways.
Implications of being an emerging growth company and smaller reporting company,
page 5
6. Please 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.
Edward Kaye
FirstName LastNameEdward Kaye
Stoke Therapeutics, Inc.
Comapany NameStoke Therapeutics, Inc.
April 17, 2019
April 3 2019 Page 3
Page 17,
FirstName LastName
Risk factors
Risks related to our intellectual property
Our owned and in-licensed patents and patent applications, page 36
7. Please clarify what you mean by your disclosure that your in-licensed
patent and patent
applications generally cover the use of STK-001 but do not
specifically cover STK-001 or
its use.
Risks related to our common stock and this offering
Anti-takeover provision in our charter documents, page 57
8. We note your disclosure here and on page 147 that your restated
certificate of
incorporation will contain an exclusive forum provision. Please
disclose whether these
provisions apply to actions arising under the Securities Act or
Exchange Act. If these
provisions do not apply to actions arising under the Securities Act or
Exchange Act,
please also ensure that the exclusive forum provisions in the
certificate of incorporation
state this clearly. Please also file a copy of your amended and
restated certificate of
incorporation with your next amendment or tell us when you plan to do
so. Note that we
may have further comment after review of this document and your
revised disclosure.
Use of Proceeds, page 61
9. Please clarify what you mean by "demonstrate clinical proof of
concept" by clarifying
whether you are referring to preclinical studies or clinical trials.
Management's discussion and analysis of financial condition and results of
operations
Critical accounting policies and significant judgments and estimates
Determination of the fair value of common stock, page 81
10. Once you have an estimated offering price or range, please explain to
us the reasons for
any differences between the recent valuations of your common stock
leading up to the
IPO 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.
Business, page 86
11. Please revise to disclose the material terms of your sponsored
research agreement with the
University of Michigan, and file the agreement as an exhibit to your
registration
statement, if required.
Our precision medicine platform
Tango mechanisms of action, page 93
12. Please balance the disclosure in this section by stating that you have
only one product
Edward Kaye
FirstName LastNameEdward Kaye
Stoke Therapeutics, Inc.
Comapany NameStoke Therapeutics, Inc.
April 17, 2019
April 4 2019 Page 4
Page 17,
FirstName LastName
candidate and that this product candidate is still in preclinical
studies.
Dravet syndrome disease overview
STK-001: Preclinical data, page 100
13. Please revise your disclosure of your preclinical studies by
identifying the number of mice
in each group, as opposed to a range, and the number of groups tested
as well as the range
of results observed. In addition, please identify the range of
increases in the Nav1.1
protein that was observed in your study with monkeys and the number of
monkeys
sacrificed at 3 days and at 29 days after dosing.
14. Please clarify what you mean by "non-Good Laboratory Practice" on page
103, and
disclose whether you will be able to use the results of this test as
part of your IND
submission to the FDA .
Additional product opportunities, page 104
15. Please revise your disclosure on page 104 and similar statements
throughout that refer to
your "broader pipeline of first-in-class medicines" as this statement
and other similar
statements throughout are inappropriate given the stage of development
of your product
candidate. In this regard, we note that you have identified only one
product candidate,
which is still in the preclinical stage.
Intellectual property
License agreements
Cold Spring Harbor Laboratory, page 109
16. Please quantify your royalty obligations under the CSHL and
Southampton
Agreements and the and the percentage of the sublicense revenue if you
sublicense rights
under the CSHL Agreement.
Notes to Consolidated Financial Statements
8. Convertible preferred stock
Liquidation , page F-18
17. Considering that the company may be subject to an involuntary event,
which may trigger
payment to the preferred stockholders, please provide us your analysis
under ASR 268
supporting your classification of convertible preferred stock within
permanent equity.
General
18. Please provide us mockups of any pages that include any additional
pictures or graphics to
be presented, including any accompanying captions. Please keep in
mind, in scheduling
your printing and distribution of the preliminary prospectus, that we
may have comments
after our review of these materials.
Edward Kaye
Stoke Therapeutics, Inc.
April 17, 2019
Page 5
You may contact Rolf Sundwall at 202-551-3105 or Jim Rosenberg at
202-551-3679 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Sonia Bednarowski at 202-551-3666 or Justin Dobbie at 202-551-3469 with
any other
questions.
FirstName LastNameEdward Kaye Sincerely,
Comapany NameStoke Therapeutics, Inc.
Division of
Corporation Finance
April 17, 2019 Page 5 Office of Healthcare
& Insurance
FirstName LastName