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United States securities and exchange commission logo
November 24, 2023
Arthur Kuan
Chief Executive Officer
CG Oncology, Inc.
400 Spectrum Center Drive, Suite 2040
Irvine, CA 92618
Re: CG Oncology, Inc.
Draft Registration
Statement on Form S-1
Submitted October
27, 2023
CIK No. 0001991792
Dear Arthur Kuan:
We have reviewed your
draft registration statement and have the following comment(s).
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 a comment applies 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 this
letter 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 your
prospectus summary to explain briefly at first use each of the scientific
or technical terms. By
way of example only, we note the following terms:
Transurethral
resection
In situ
Duration of
response
2. We note your disclosure
that you have observed "encouraging interim results in [y]our
ongoing open-label
Phase 2 CORE-001 clinical trial of cretostimogene in combination
with pembrolizumab in
high-risk BCG-unresponsive NMIBC patients." Please remove the
term encouraging
here, and elsewhere, regarding the results as this may create an
inference that a
product candidate is more likely to be found to be safe and
effective. Please limit
the discussion to the objective clinical data, such as the endpoints.
Arthur Kuan
FirstName LastNameArthur Kuan
CG Oncology, Inc.
Comapany 24,
November NameCG
2023 Oncology, Inc.
November
Page 2 24, 2023 Page 2
FirstName LastName
3. We note your reference to interim results. Please revise your
disclosure to note, as you do
on page 26, that interim, topline or preliminary results that you
report may differ from
future results of the same studies or trials.
4. Please specify whether the referenced trials, here and elsewhere, were
powered for
statistical significance.
5. Please disclose whether any of the observations of adverse events from
the trials were
considered serious adverse events. In addition, please advise, if
true, that adverse events
greater than or equal to Grade 3 TRAEs are considered serious adverse
events or
otherwise advise.
6. We note that in your ongoing open-label Phase 2 CORE-001 clinical
trial, you observed
"one TRAE leading to a patient discontinuation of pembrolizumab."
Please revise your
disclosure to specify the type of TRAE that was observed and how it
was graded.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 88
7. To the extent you track research and development expenses by
indication or treatment
setting as depicted in your pipeline table, revise to provide a
breakdown on that basis. If
you do not track by indication or treatment setting, disclose that
fact.
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 93
8. 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 initial public offering and the estimated offering price.
This information will help
facilitate our review of your accounting for equity issuances
including stock
compensation. Please discuss with the staff how to submit your
response. Revise your
MD&A as well as Recent Sales of Unregistered Securities section on
page II-2 to provide
a tabular presentation of your option grants and how they were valued.
Combination of Cretostimogene Plus Pembrolizumab for High-risk BCG-unresponsive
CIS-
containing NMIBC, page 113
9. We note your disclosure regarding the clinical trial collaboration and
supply agreement
with Merck. Please describe the material terms of this agreement, and
file this agreement
in accordance with Item 601(b)(10) of Regulation S-K, or otherwise
advise.
Intellectual Property, page 118
10. Please revise your disclosure to specify the nature of your pending
patent
applications (e.g., composition of matter, method of use or process).
Arthur Kuan
CG Oncology, Inc.
November 24, 2023
Page 3
Management
Executive Officers and Directors, page 129
11. We note your disclosure that Mr. DiPalma worked as a consultant and
senior advisor since
March 2021 and became CFO in March 2023. We also note your disclosure on
page 158
that Mr. DiPalma is a managing director at Danforth and appears to be
compensated
through this position. Please revise your disclosure to clarify whether
Mr. DiPalma is
working on a full-time basis for your company.
General
12. 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.
Please contact Eric Atallah at 202-551-3663 or Kevin Vaughn at
202-551-3494 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jimmy McNamara at 202-551-7349 or Joshua Gorsky at 202-551-7836 with
any other
questions.
Sincerely,
FirstName LastNameArthur Kuan
Division of
Corporation Finance
Comapany NameCG Oncology, Inc.
Office of Life
Sciences
November 24, 2023 Page 3
cc: Matthew T. Bush
FirstName LastName