United States securities and exchange commission logo
January 12, 2021
John Moore
General Counsel
Edgewise Therapeutics, Inc.
3415 Colorado Ave.
Boulder, CO 80304
Re: Edgewise
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted December
18, 2020
CIK No. 0001710072
Dear Dr. Moore:
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
Overview, page 1
1. Your pipeline table
includes three separate pre-clinical phases, which gives the impression
that your product
candidates are farther along in the clinical process. Revise the table to
eliminate the separate
column for POC, as that stage is not sufficiently distinct.
Our Research Programs, page 3
2. Please expand your
disclosure here and at page 122 whether the company anticipates
advancing your research
programs into the next stage of development in the near term.
Please also discuss if
you have devoted significant resources to these programs to date.
John Moore
FirstName LastNameJohn Moore
Edgewise Therapeutics, Inc.
Comapany
January 12,NameEdgewise
2021 Therapeutics, Inc.
January
Page 2 12, 2021 Page 2
FirstName LastName
Risks Related to Our Business, page 4
3. Please expand your disclosure here to explicitly state that you have
not generated any
revenue. We note your disclosure on page 13 in this regard.
4. Please state here that you have limited resources and you are
currently focusing the
majority of your efforts on developing EDG-5506 for particular
indications and that as a
result, you may fail to capitalize on other indications or product
candidates that may
ultimately have proven to be more profitable.
5. Please disclose here that your patent portfolio is pending and that
you do not own any
issued patents or in-license any patents. We note your disclosure on
page 47.
6. Please expand your disclosure here, or where you deem appropriate in
your Prospectus
Summary, to provide more details on the competition you face. We note
your disclosures
on pages 24 and 126 in this regard. You may choose to provide a
cross-reference to these
disclosures.
We may not be able to obtain orphan drug designation or obtain or maintain
orphan drug
exclusivity for our product candidates..., page 35
7. We note that you plan to seek orphan drug designation for your lead
product candidate
and that its potential treatment population is "small and has not been
established with
precision." Please tell us if your operations will materially depend
on your lead product
candidate receiving orphan drug designation. If so, please revise your
prospectus
summary and any other locations you deem appropriate to reflect this
information.
We contract with third parties for the production of our product candidates for
preclinical
studies..., page 59
8. We note that you rely, and expect to continue to rely, on third-party
manufacturers for the
production of your product candidates for preclinical studies and
clinical trials. Please
summarize where you deem appropriate and attach as an exhibit any
material
agreement(s) in connection with this production.
Our amended and restated bylaws that will become effective upon the closing of
this offering
provide that the Court of Chancery..., page 70
9. We note that your amended and restated bylaws will provide that the
Court of Chancery of
the State of Delaware is the exclusive forum for certain claims and
that the federal district
courts will be the exclusive forum for Securities Act claims. You also
state that this
provision "would not apply to suits brought to enforce to enforce a
duty or created by the
Exchange Act." Please ensure that your amended and restated bylaws
reflects this
language.
John Moore
FirstName LastNameJohn Moore
Edgewise Therapeutics, Inc.
Comapany
January 12,NameEdgewise
2021 Therapeutics, Inc.
January
Page 3 12, 2021 Page 3
FirstName LastName
Market, Industry and Other Data, page 74
10. It is not appropriate to directly or indirectly disclaim liability for
statements in your
registration statement. Accordingly, please delete your statement that
your internal
research has not been verified by any third party. Alternatively,
specifically state that you
take liability for such research.
Critical Accounting Policies and Significant Judgments and Estimates
Stock-based Compensation, page 91
11. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock and
conversion prices of preferred stock on issuances 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.
Intellectual Property, page 127
12. We note you state that you "own or in-license a patent portfolio
consisting of over 5 patent
families, including pending U.S. patent applications, pending Patent
Cooperation Treaty
applications and corresponding pending patent applications in a number
of key
international markets." Please disaggregate this information and
provide separate
information on what you in-license and what you own.
Third Party Agreements, page 128
13. Please expand your discussion of your exclusive license agreement with
The Ohio
State Innovation Foundation to include how it relates to your product
candidates. File the
agreement as an exhibit or tell us why you are not required to do so.
See Item
601(b)(10)(ii)(B).
14. Please expand your disclosure to explicitly state whether you have
made any payments
due under your license agreement with The Ohio State Innovation
Foundation.
General
15. Please enlarge or otherwise adjust the text in your pipeline and
research programs charts
on pages 1, 97, and 122 to ensure that all text is legible.
16. 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.
John Moore
Edgewise Therapeutics, Inc.
January 12, 2021
Page 4
You may contact Tracey Houser at (202) 551-3736 or Kevin Vaughn at (202)
551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Courtney Lindsay at (202) 551-7237 or Celeste Murphy at (202) 551-3257
with any
other questions.
FirstName LastNameJohn Moore Sincerely,
Comapany NameEdgewise Therapeutics, Inc.
Division of
Corporation Finance
January 12, 2021 Page 4 Office of Life
Sciences
FirstName LastName