United States securities and exchange commission logo
December 18, 2023
Arthur Kuan
Chief Executive Officer
CG Oncology, Inc.
400 Spectrum Center Drive, Suite 2040
Irvine, CA 92618
Re: CG Oncology, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted December
4, 2023
CIK No. 0001991792
Dear Arthur Kuan:
We have reviewed your amended draft registration statement and have
the following
comments.
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.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note your disclosure
on page 2 that cretostimogene has received fast track designation
from the FDA for the
treatment of high-risk, BCG-unresponsive NMIBC patients. Please
provide balancing
disclosure, as you note on page 28, that fast track designation by the
FDA for cretostimogene
may not lead to a faster development or regulatory review or
approval process, and
does not increase the likelihood that cretostimogene or any future
product candidate which
may receive fast track designation will receive marketing
approval.
Arthur Kuan
FirstName LastNameArthur Kuan
CG Oncology, Inc.
Comapany18,
December NameCG
2023 Oncology, Inc.
December
Page 2 18, 2023 Page 2
FirstName LastName
Summary Financial Data
Balance Sheet Data, page 13
2. Your disclosure on page 13 states that pro forma column gives effect
to the automatic
conversion of all outstanding shares of your redeemable convertible
preferred stock into
an aggregate of 366,277,131 shares of common stock. However, it
appears the conversion
of your Series F redeemable convertible preferred stock has not been
reflected in pro
forma stockholders equity. Please explain why the automatic
conversion of your Series F
redeemable convertible preferred stock has not been reflected in pro
forma stockholders
equity, and revise to address this apparent inconsistency between
these disclosures.
Capitalization, page 80
3. Your disclosure on page 80 states that your pro forma column reflects
"the automatic
conversion of all outstanding shares of our redeemable convertible
preferred stock into
366,277,131 shares of our common stock." However, it does not appear
as though your
Series F redeemable convertible preferred stock that was issued on
July 28, 2023 has been
included in your actual or pro forma columns. Please revise to address
this apparent
inconsistency.
Management
Executive Officers, page 133
4. We note your response to comment 11, including your revised disclosure
on page 134 that
Mr. DiPalma works on a part-time basis as your CFO. Please include
risk factor disclosure
concerning Mr. DiPalma's part-time status and the number of hours of
service hours per
month he is expected to provide.
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,
Division of
Corporation Finance
Office of Life
Sciences
cc: Matthew T. Bush