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October 16, 2019
Mark A. Goldsmith
Chief Executive Officer
Revolution Medicines, Inc.
700 Saginaw Drive
Redwood City, CA 94063
Re: Revolution Medicines, Inc.
Draft Registration Statement on Form S-1
Submitted September 19, 2019
CIK No. 0001628171
Dear Dr. Goldsmith:
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
Prospectus Summary
Overview, page 1
1. Please revise here and throughout to avoid conclusory statements
regarding your product
candidates and the results of your clinical tests and preclinical
studies by describing how
you conducted the tests, the number of tests conducted and the range of
results observed.
For example, we note your disclosure on page 1 that RMC-4630 is a
"potent and selective
inhibitor of SHP2," your statement on page 4 regarding your "ability to
inhibit various
oncogenic RAS(ON) mutants" and your statement on page 108 that you have
"substantial
preclinical evidence that SHP2 is a central node that can be targeted to
disrupt signaling
pathways that may involve activation of multiple RTKs."
Mark A. Goldsmith
FirstName LastNameMark A. Goldsmith
Revolution Medicines, Inc.
Comapany NameRevolution Medicines, Inc.
October 16, 2019
Page 2
October 16, 2019 Page 2
FirstName LastName
2. We note your disclosure on page 1 and throughout regarding your "deep"
pipeline and
your "deep differentiated pipeline." Please balance this disclosure
here and throughout by
disclosing that you have only one product candidate that is in
clinical testing and that all
of your other potential product candidates are in the preclinical and
development stage.
Similarly, please balance your disclosure on page 3 that you believe
that RMC-4630 is
well positioned to become the backbone of targeted therapy
combinations for the
treatment of various RAS-dependent tumors and your disclosure on page
109, which
describes how each category of your product candidates acts to inhibit
cancer cells, by
addressing your early stage of clinical testing, preclinical studies
and the development of
product candidates.
3. Please revise your pipeline chart to include a column for each
clinical stage. In this
regard, we note that you have combined Phases 1 and 2 into a single
column.
4. Please revise to include a brief definition here of what you mean by
"frontier cancer
targets."
Implications of being an emerging growth company, page 6
5. 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.
Risk Factors
Risks related to our common stock and this offering
Our amended and restated certificate of incorporation will provide for an
exclusive forum, page
65
6. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware as the exclusive forum for certain litigation, including
any "proceeding
brought on [y]our behalf." Please disclose whether this provision
applies to actions
arising under the Securities Act or Exchange Act. In that regard, we
note that Section 27
of the Exchange Act creates exclusive federal jurisdiction over all
suits brought to enforce
any duty or liability created by the Exchange Act or the rules and
regulations thereunder,
and Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state
courts over all suits brought to enforce any duty or liability created
by the Securities Act
or the rules and regulations thereunder. If the provision applies to
Securities Act claims,
please also revise your prospectus to state that there is uncertainty
as to whether a court
would enforce such provision and that investors cannot waive
compliance with the federal
securities laws and the rules and regulations thereunder. If this
provision does not apply
to actions arising under the Securities Act or Exchange Act, please
also ensure that the
exclusive forum provision in the governing documents states this
clearly, 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. In addition, we note
that, on page 65,
Mark A. Goldsmith
FirstName LastNameMark A. Goldsmith
Revolution Medicines, Inc.
Comapany NameRevolution Medicines, Inc.
October 16, 2019
October 16, 2019 Page 3
Page 3
FirstName LastName
you state that your amended and restated certificate of incorporation
will provide for an
exclusive forum in the Court of Chancery of the State of Delaware and
in the U.S. federal
district courts, and, on page 179, you identify only the Court of
Chancery of the State of
Delaware as the exclusive forum. Please revise for consistency.
Use of Proceeds, page 70
7. Please revise to disclose an estimate of how far in the development of
your multiple RAS
programs the proceeds from this offering will allow you to reach.
Also, please disclose
the total estimated cost of each of the specified purposes for which
the net proceeds are
intended to be used, and, if material amounts of other funds are
necessary to accomplish
the specified purposes, provide an estimate of the amounts of such
other funds and the
sources thereof.
Capitalization, page 73
8. Please revise to disclose the appropriate short-term nature of the
marketable securities
included in your capitalization table as of September 30, 2019, or
remove as necessary. If
material, also include disclosure of your accounting and policy for
such securities in your
pending unaudited interim financial statements as of September 30,
2019.
Management's discussion and analysis of financial condition and results of
operations
Critical accounting policies, significant judgments, and use of estimates
Stock-based compensation, page 99
9. 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 shares
leading up to the
initial public offer and the estimated offering price. This
information will help facilitate
our review of your accounting for equity issuances including stock
compensation.
Business
Our pipeline
Our SHP2 inhibitor, RMC-4630, page 111
10. On page 111, please disclose the type of animal tested, the length of
the test, the exact
number of animals in each test, the dose the animals received in each
test, and whether
graphs (a) through (d) show the average or mean results. Similarly,
please identify the
animals tested in the studies described on pages 112 to 115. Also,
please disclose the
number of mice tested in Figure 7 on page 116. In addition, in your
discussion of these
studies and throughout the prospectus, please remove your assessments
that the studies
were effective or that your product candidates are or will be
effective as only the FDA and
foreign government equivalent regulators have the authority to
determine whether the
product candidate is effective or safe.
Mark A. Goldsmith
Revolution Medicines, Inc.
October 16, 2019
Page 4
Our RAS(ON) portfolio
Our RAS (ON) inhibitor programs, page 120
11. Please tell us how many times you tested the inhibitors in the studies
described in Figures
13 to 20 on pages 122 to 127 and whether the graphs demonstrate the
average or mean of
the studies conducted. In addition, please revise to remove
comparisons of your inhibitors
to other inhibitors unless you have conducted a head-to-head clinical
trial. In this regard,
we note your comparison of RMC-5552 to other mTOR active site
inhibitors on
page 127. Also, in Figure 21, please disclose the number of mice
tested and whether the
results observed were statistically significant.
Collaboration agreement with Sanofi, page 128
12. We note that you are responsible for 20% of the expenses associated
with the
identification, validation and optimization of SHP2 inhibitors for
2018-2020 pursuant to
the research plan and budget under the collaboration agreement with
Sanofi. Please
provide quantitative information regarding these costs, and revise
your prospectus
summary and throughout to clarify that you are responsible for 20% of
the costs
associated with the identification, validation and optimization of
SHP2 inhibitors for 2018
to 2020. In addition, please describe the material terms of the
Quality Agreement and
Clinical Supply Agreement with Sanofi or tell us why you believe this
is not necessary. In
this regard, we note your disclosure on page 171.
Financial Statements
Notes to Financial Statements
7. Acquisition of Warp Drive, page F-22
13. Provide us your consideration of whether disaggregating the $55.8
million in-process
research and development asset by individual programs would provide
useful information,
if such information is available.
You may contact Bonnie Baynes at 202-551-4924 or Lisa Vanjoske at
202-551-3614 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Sonia Bednarowski at 202-551-3666 or Dietrich King at 202-551-8071 with
any other
questions.
FirstName LastNameMark A. Goldsmith Sincerely,
Comapany NameRevolution Medicines, Inc.
Division of
Corporation Finance
October 16, 2019 Page 4 Office of Life
Sciences
FirstName LastName