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June 19, 2019
Brian Wong
Chief Executive Officer
RAPT Therapeutics, Inc.
561 Eccles Avenue
South San Francisco, CA 94080
Re: RAPT Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted May 24, 2019
CIK No. 0001673772
Dear Mr. Wong:
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
Our CCR4 Franchise, page 1
1. Here and throughout the prospectus, please revise your disclosure to
remove comparisons
of your drug candidates to other product candidates, products and
treatments, unless you
have conducted head-to-head clinical trials, which you should disclose.
For example, we
note your statements on page 2 (i) that disclose that your approach is
designed to avoid "a
side effect experienced with other approaches, including an existing
CCR4 therapy," (ii)
that compare your drug candidates to other "available therapies such as
checkpoint
inhibitors," and (iii) that contrast your drug candidate to Poteligeo
and other Treg-
depleting antibodies, your statements on page 3 that compare your
preclinical drug
candidate to marketed injectable products for the treatment of AD, your
statement on page
Brian Wong
FirstName LastNameBrian Wong
RAPT Therapeutics, Inc.
Comapany NameRAPT Therapeutics, Inc.
June 19, 2019
June 19, 2019 Page 2
Page 2
FirstName LastName
89 that refers to your clinical candidates FLX475 and RPT193 as having
"best-in-class"
potency and your comparison of FLX475 to other antibody therapies on
page 95.
Prospectus Summary
Overview, page 1
2. Please tell us why you believe it is material to investors to include
RPT-GCN2i and HPK1
in your pipeline chart on page 1, as you have not yet identified
specific indications for
these product candidates. In addition, please revise the pipeline
chart to disclose the
specific cancers for which you have submitted an IND or INDs for
FLX475. In this
regard, we note your disclosure on page 2 that "charged" tumors
include non-small cell
lung cancer, triple negative breast cancer, head and neck squamous
cell carcinoma,
nasopharyngeal cancer, gastric cancer, certain Hodgkin and non-Hodgkin
lymphomas, and
cervical cancer. Similarly, please identify the specific allergic
diseases for which you
intend to submit an IND or INDs to the FDA. In this regard, we note
that your chart
indicates that you plan to submit an IND for asthma and "other
allergic diseases."
3. Please remove from the pipeline chart on page 1 the shaded horizontal
bars. Please limit
the bars to displaying the current status of your candidates.
CCR4 Antagonist for Oncology: FLX475, page 2
4. We note your disclosure on page 2 regarding the results of preclinical
tumor models using
FLX475. As FLX475 is in clinical trials, please limit the prospectus
summary discussion
of your results to a description of the clinical trials. In addition,
please disclose which
phase of the FDA approval process you are referring to when you state
that you expect
"proof-of-concept" data in the first half of 2020 for FLX475.
CCR4 Antagonist for Allergic Inflammatory Disease: RPT193, page 3
5. Please revise the first paragraph of this section to clarify whether
you have submitted an
IND for RPT193 to treat atopic dermatitis, and, if not, please
disclose the date you intend
to submit the IND. In addition, please provide a brief explanation of
a "seamless" first in
human trial, and expand your Government Regulation section beginning
on page 117 to
address seamless clinical trials.
6. Please revise your disclosure here and throughout the prospectus to
eliminate any
suggestion that your product candidates have been or will ultimately
be determined safe or
effective, as only the FDA and foreign government equivalent
regulators have the
authority to make these determinations. For example, we note your
discussion in the
second paragraph of this section regarding the safety and efficacy of
RPT193, your statement on page 69 that "FLX475 has also demonstrated
robust single
agent and combination efficacy in preclinical tumor models . . ., "
your statement
regarding RPT193 that "the preclinical safety and efficacy results
combined with the
convenience of oral dosing suggest a profile competitive with standard
of care," and your
Brian Wong
FirstName LastNameBrian Wong
RAPT Therapeutics, Inc.
Comapany NameRAPT Therapeutics, Inc.
June 19, 2019
June 19, 2019 Page 3
Page 3
FirstName LastName
chart and discussion of the safety and efficacy of RPT193 on page 106.
GCN2 and HOK1 Programs for Oncology, page 3
7. Please remove conclusory statements here and throughout the prospectus
regarding the
results of your preclinical and clinical studies. For example, on page
4, you state that
"[y]our lead molecule has demonstrated the ability to restore T cell
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," on
page 69, you state that FLX475 demonstrated a high level of target
engagement, that
FLX475 selectively inhibits the migration of immunosuppressive Treg
into tumors and on
page 91 that, "in preclinical studies, you have demonstrated the
association between EBV
and CCR4 ligand expression, which is believed to be causal to Treg
migration." For
preclinical studies, please disclose a summary of the number and types
of tests conducted
as well as quantitative information regarding the range of results
observed and, for clinical
studies, please disclose the endpoints, whether the results were
statistically significant and
the p-value used.
Our Proprietary Drug Discovery and Development Engine, page 4
8. Please balance your disclosure on page 4 regarding your "deep
expertise in immunology
and drug discovery" by disclosing here your limited operating history
and limited
experience in product development. Similarly, please balance your
disclosure throughout
the prospectus regarding your proprietary drug discovery and
development engine to
address its lack of a track record.
Implications of Being an Emerging Growth Company, page 7
9. 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 be in effect, page
57
10. We note your disclosure on pages 57 and 161 that your restated
certificate of
incorporation will contain an exclusive forum provision. Please revise
your prospectus to
state that there is uncertainty as to whether a court would enforce
such a provision, as
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. Please file a copy of your restated
certificate of
incorporation with your next amendment or tell us when you plan to do
so. Please note
that we may have further comment after review of this document and
your revised
Brian Wong
FirstName LastNameBrian Wong
RAPT Therapeutics, Inc.
Comapany NameRAPT Therapeutics, Inc.
June 19, 2019
June 19, 2019 Page 4
Page 4
FirstName LastName
disclosure.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies, Significant Judgments and Use of Estimates
Stock-Based Compensation Expense
Common Stock Valuations, page 72
11. 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 83
12. Please disclose the material terms of your Pharmacovigilance Agreement
with Merck
Sharp & Dohme Corp. and your Clinical Trial Collaboration and Supply
Agreement with
MSD International GmbH.
Our Lead Oncology Drug Candidate--FLX475
Our Oncology Solution: FLX475
FLX475 Preclinical Data, page 95
13. Please disclose the number of mice tested and the range of results
observed in each of the
preclinical studies of FLX475. Similarly, please disclose whether the
inhibitions of 90%
of Treg migration, corresponding to 75% receptor inhibition, that was
achieved by single
daily doses of 75 mg in your Phase 1 clinical trial of FLX475 in
healthy volunteers
represents the maximum, average or median of the observed results.
FLX475: Clinical Trials, page 98
14. Please disclose whether the two subjects who met the stopping criteria
at the highest dose
experienced serious adverse events, and, if they did, please disclose
the events. In
addition, please disclose the number of patients in each cohort.
Our Lead Inflammation Drug Candidate--RPT193
Our Allergic Disease Solution: RPT193
RPT193, page 106
15. Please disclose the number of mice tested in each of your RPT193
preclinical studies and
state whether the results observed were statistically significant
based upon the p-values
you selected. In this regard, we note that you have added p-values to
the graphs on pages
107 to 109. Similarly, in your disclosure regarding your RPT-GCN2i
preclinical studies,
please disclose the number of tests run in each of your studies and,
for the tests that used
mice, how many mice were tested in these studies. In addition, please
disclose whether
Brian Wong
RAPT Therapeutics, Inc.
June 19, 2019
Page 5
the results were statistically significant based upon the selected
p-values.
General
16. 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.
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
June 19, 2019 Page 5 Office of
Healthcare & Insurance
FirstName LastName