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July 17, 2019
Brian Wong
Chief Executive Officer
RAPT Therapeutics, Inc.
561 Eccles Avenue
South San Francisco, CA 94080
Re: RAPT Therapeutics, Inc.
Registration Statement on Form S-1
Filed July 5, 2019
File No. 333-232572
Dear Mr. Wong:
We have reviewed your 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 amending your registration statement
and providing the
requested information. 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 any amendment to your registration statement and the
information you
provide in response to these comments, we may have additional comments. Unless
we note
otherwise, our references to prior comments are to comments in our June 19,
2019 letter.
Registration Statement on Form S-1
CCR4 Antagonist for Oncology: FLX475, page 2
1. We note your response to comment 4. Please remove conclusory statements
from your
prospectus summary regarding the results of your preclinical studies and
instead please
provide a balanced summary of the studies, including the range of
results observed, a
summary of how the study was conducted and a discussion that results in
preclinical
studies do not necessarily predict the results in clinical studies. For
example, on page 2,
you state that FLX475 was shown to bind to CCR4 and inhibit recruitment
of Treg into
tumors without affecting healthy tissue, increase the number of CD8+
effector T cells in
the tumor, improve tumor control and lead to tumor reduction or
eradication, and on page
4, you state that your preclinical studies have demonstrated the ability
to restore T cell
Brian Wong
FirstName LastNameBrian Wong
RAPT Therapeutics, Inc.
Comapany NameRAPT Therapeutics, Inc.
July 17, 2019
July 17, 2019 Page 2
Page 2
FirstName LastName
proliferation and function in nutrient-deprived conditions, to
overcome immune
suppression induced by myeloid-derived suppressor cells, and to elicit
antitumor
responses in animal models.
2. We note your response to comment 6. Please revise your disclosure here
and throughout
your prospectus to remove statements that imply an expectation of
regulatory approval,
including claims regarding the safety and efficacy of your product
candidates, as these
statements are inappropriate given the stage of development. For
example, on page 2, you
compare RPT193 to currently marketed injectable biologics and state
that RPT193 is as
safe and effective as these current standard of care, and on page 113,
you provide a chart
that addresses the safety and efficacy of RPT193 and compares this
product candidate to
the current standard of care and emerging clinical-stage drug
candidates.
Prospectus Summary
Our CCR4 Franchise, page 2
3. We note your response to comment 1. In this section and throughout the
prospectus,
please remove comparisons of your drug candidates to other product
candidates, products
and treatments. For example, on page 2, you state that your approach
is designed to avoid
depleting immune cells and broadly suppressing the immune system, "a
side effect
experienced with other approaches, " and you state that your product
is designed to avoid
adverse safety affect and discuss the adverse safety events that have
been observed in
other products and treatments. Similarly, on page 3, you compare your
preclinical
pharmacology and toxicology results for RPT193 to existing and
emerging clinical stage
drug candidates.
Risk Factors
Risks Related to Our Common Stock and this Offering
Our amended and restated certificate of incorporation will be in effect, page
58
4. We note your disclosure on pages 59 and 171 that the exclusive forum
provision in the
amended and restated certificate of incorporation that will be in
effect upon the closing of
this offering does not apply to claims brought under the Exchange Act.
However, we note
that your form of amended and restated bylaws, filed as Exhibit 3.6,
contains an exclusive
forum provision is Section 48 of Article XV that is inconsistent with
your disclosure and
Section VII of your form of amended and restated certificate of
incorporation filed as
Exhibit 3.4. Please revise your disclosure in the prospectus to
discuss the provision in the
bylaws and revise Section 48 of Article XV so that it is consistent
with your certificate of
incorporation or otherwise ensure that your disclosure accurately
describes any exclusive
forum provision that will be in effect when the offering is completed.
In addition, please
disclose on page 170 that stockholders will not be deemed to have
waived the company's
compliance with the federal securities laws.
Brian Wong
FirstName LastNameBrian Wong
RAPT Therapeutics, Inc.
Comapany NameRAPT Therapeutics, Inc.
July 17, 2019
July 17, 2019 Page 3
Page 3
FirstName LastName
Business , page 85
5. We note your response to comment 7. Please revise here and throughout
the prospectus to
remove conclusory statements regarding the results of your preclinical
and clinical
studies. Instead, when disclosing observed results of your preclinical
and clinical trials,
please disclose the range of results observed, how the studies and
tests were conducted,
the endpoints of the clinical trials and whether the results were
statistically significant.
For example on page 85, you state that FLX475 "selectively inhibits
the migration of
immunosuppressive regulatory T cells (Treg) into tumors," and, on page
87, you state that
FLX475 "blocks the migration of Treg specifically into tumors, but not
healthy tissues,
without depleting Treg throughout the body."
Our Lead Oncology Drug Candidate--FLX475
FLX475 Preclinical Data
FLX475 Inhibition of Treg in a Mouse Model of a "Charged" Tumor , page 100
6. We note your disclosure that the highest level of inhibition of Treg
migration and increase
in CD8+ effector cells was observed in your preclinical studies at 10
mg/kg given once
daily, which achieved concentrations that inhibit 90% of in vitro Treg
migration ("IC90")
throughout the dosing period. Please disclose whether all seven mice
in each experiment
received the same dose and the range of results observed. Similarly,
for each preclinical
study conducted, including the preclinical studies for RPT193 and your
other product
candidates, disclose the range of results observed, and, if you used a
p-value in the study,
disclose the p-value used and whether the results were statistically
significant. For
example, we note your disclosure that you observed in four independent
experiments with
five mice per experimental arm that the treatment with checkpoint
inhibitors led to a
statistically significant increase in the expression of CCR4 ligands
but you do not disclose
the p-value used to determine statistical significance or the range of
results observed.
Clinical Trial Collaboration and Supply Agreement, page 124
7. We note your response to comment 12. Please disclose the key terms of
your clinical trial
collaboration and supply agreement with Merck, including the term of
the agreement, any
cost sharing of the clinical trials and provisions related to the
ownership of the materials
and data used and generated in the clinical trials as well as any new
intellectual property
developed pursuant to the agreement.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
Brian Wong
RAPT Therapeutics, Inc.
July 17, 2019
Page 4
statement.
You may contact Sasha Parikh at 202-551-3627 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 Dietrich King at 202-551-8071 with
any other
questions.
FirstName LastNameBrian Wong Sincerely,
Comapany NameRAPT Therapeutics, Inc.
Division of Corporation
Finance
July 17, 2019 Page 4 Office of Healthcare &
Insurance
FirstName LastName