SEC Comment Letter 0000000000-23-013792 to CG Oncology, Inc. (CGON) (CIK 0001991792) (CGON)
CG Oncology, Inc. (CGON) (CIK 0001991792)
Date: Dec. 18, 2023 · CIK: 0001991792 · Accession: 0000000000-23-013792
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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.
FirstName LastNameArthur Kuan
Comapany NameCG Oncology, Inc.
December 18, 2023 Page 2
FirstName LastName
Arthur Kuan
CG Oncology, Inc.
December 18, 2023
Page 2
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