View:
United States securities and exchange commission logo
September 24, 2020
Adrian Gottschalk
Chief Executive Officer
Foghorn Therapeutics Inc.
100 Binney Street, Suite 610
Cambridge, MA 02142
Re: Foghorn
Therapeutics Inc.
Draft Registration
Statement on Form S-1
Submitted August
28, 2020
CIK No. 0001822462
Dear Mr. Gottschalk :
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. You state that you are
"the only company with the ability to study and drug the chromatin
regulatory system at
scale, in context, and in an integrated way." As none of your product
candidates have been
approved, please remove here, page 70, and throughout your
registration statement
any statement that you are capable to drug the chromatin regulatory
system. Please also
provide the basis for the remainder of your statement, namely that
you are "the only
company with the ability to study... the chromatin regulatory system at
scale, in context, and
in an integrated way."
Adrian Gottschalk
FirstName LastNameAdrian
Foghorn Therapeutics Inc. Gottschalk
Comapany 24,
September NameFoghorn
2020 Therapeutics Inc.
September
Page 2 24, 2020 Page 2
FirstName LastName
2. Please state here that you have no products approved for commercial
sale.
Our Programs, page 3
3. We note the references to a certain undisclosed partner program and
other "additional
discovery programs" in your pipeline table. The pipeline table should
be limited to
current material product candidates. Please remove from your pipeline
tables items that
have not yet been identified and are not currently material.
Our Additional Preclinical and Discovery Programs, page 4
4. Please discuss here the prospect for development and advancement of
these discovery
programs in the near term.
Our Strategy, page 5
5. We note that you plan to "[r]apidly advance [your] lead precision
oncology product
candidates, FHD-286 and FHD-609, through clinical development in
patients with select
solid tumors and hematological cancers." Please remove any implication
here and
throughout your registration statement that you will be able to
accelerate the FDA clinical
review process.
We rely, and expect to continue to rely, on third parties, including
independent clinical
investigators, page 34
6. We note that you rely upon third parties to conduct certain aspects of
your discovery,
preclinical studies and development and clinical trials and to monitor
and manage data for
your ongoing preclinical and clinical programs. Please attach as
exhibits and summarize
any material agreements in connection with these activities.
Management s Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-based Compensation, page 67
7. 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 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. Please discuss with the staff how to
submit your response.
Clinical Plans for FHD-286 in AML and Uveal Melanoma, page 90
8. Please provide a narrative to your graphic on page 91. In addition,
please remove any
implication that you will be able to accelerate the clinical review
process (i.e., "rapid entry
into definitive efficacy trials").
Adrian Gottschalk
Foghorn Therapeutics Inc.
September 24, 2020
Page 3
Intellectual Property, page 102
9. We note based on your discussion starting at F-27 that you have
entered into license
agreements with Dana-Farber Cancer Institute and the Board of Trustees
of the Leland
Stanford Junior University. To the extent these agreements are
material to your business,
please discuss the material terms of these agreements here. Please
also attach these
agreements as exhibits.
License Agreement with Merck, page 104
10. We note that you may receive royalty rates "ranging from the low
single digits to the low
double digits." Please expand your disclosure to provide a more
defined range of royalties
that does not exceeds ten percentage points (e.g., teens or low
teens).
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 Eric Atallah at (202) 551-3663 or Jeanne Baker at (202)
551-3691 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 LastNameAdrian Gottschalk Sincerely,
Comapany NameFoghorn Therapeutics Inc.
Division of
Corporation Finance
September 24, 2020 Page 3 Office of Life
Sciences
FirstName LastName