<SEC-DOCUMENT>0001193125-24-000774.txt : 20240222
<SEC-HEADER>0001193125-24-000774.hdr.sgml : 20240222
<ACCEPTANCE-DATETIME>20240102172152
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-24-000774
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		3
FILED AS OF DATE:		20240102

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			CG Oncology, Inc.
		CENTRAL INDEX KEY:			0001991792
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				371611499
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		400 SPECTRUM CENTER DRIVE
		STREET 2:		SUITE 2040
		CITY:			IRVINE
		STATE:			CA
		ZIP:			92618
		BUSINESS PHONE:		(949) 419-6203

	MAIL ADDRESS:	
		STREET 1:		400 SPECTRUM CENTER DRIVE
		STREET 2:		SUITE 2040
		CITY:			IRVINE
		STATE:			CA
		ZIP:			92618
</SEC-HEADER>
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
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<TD VALIGN="top" COLSPAN="3"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman">12670 High Bluff&nbsp;Drive</P> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:1pt">&nbsp;</P></TD></TR>
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<TD VALIGN="top" COLSPAN="3"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman">Tel:&nbsp;+1.858.523.5400&nbsp;Fax:&nbsp;+1.858.523.5450</P>
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<TD VALIGN="top" COLSPAN="3"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman">FIRM / AFFILIATE OFFICES</P> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:1pt">&nbsp;</P></TD></TR>
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<TD VALIGN="top" ROWSPAN="2"><FONT STYLE="font-size:10pt"><B><U>VIA EDGAR</U></B></FONT></TD>
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<TD VALIGN="top" COLSPAN="3" ROWSPAN="7"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Jimmy McNamara</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Office
of Life Sciences</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation Finance</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S.
Securities and Exchange Commission</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F Street N.E.</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>Re:</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>CG Oncology, Inc. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>Amendment No.&nbsp;1 to Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>Submitted December&nbsp;4, 2023 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>CIK No.&nbsp;0001991792 </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dear
Mr.&nbsp;McNamara: </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">We are in receipt of the letter dated December&nbsp;18, 2023 from the staff of the U.S. Securities and Exchange
Commission (the &#147;<B><I>Staff</I></B>&#148;) with respect to the above-referenced confidential draft Amendment No.&nbsp;1 to Draft Registration Statement. We are responding to the Staff&#146;s comments on behalf of CG Oncology, Inc.
(&#147;<B><I>CG Oncology</I></B>&#148; or the &#147;<B><I>Company</I></B>&#148;) as set forth below. Simultaneously with the submission of this letter, the Company is publicly filing via EDGAR a Registration Statement on Form <FONT
STYLE="white-space:nowrap">S-1</FONT> (the &#147;<B><I>Registration Statement</I></B>&#148;) responding to the Staff&#146;s comments and updating its disclosures in the Registration Statement. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company&#146;s responses set forth in this letter are numbered to correspond to the numbered comments in the Staff&#146;s letter. All
terms used but not defined herein have the meanings assigned to such terms in the Registration Statement. For ease of reference, we have set forth the Staff&#146;s comments and the Company&#146;s response for each item below. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>January&nbsp;2, 2024 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Page 2 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt;margin-bottom:0pt">


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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><U>Amendment No.&nbsp;1 to Draft Registration Statement on Form
<FONT STYLE="white-space:nowrap">S-1</FONT> </U></I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><U>Prospectus Summary </U></I></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><U>Overview, page 1 </U></I></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><I>1.</I></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your disclosure on page 2 that cretostimogene has received fast track designation from the FDA for
the treatment of high-risk, <FONT STYLE="white-space:nowrap">BCG-unresponsive</FONT> 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. </I></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">CG Oncology&#146;s Response: The Company has revised page 2 of the Registration Statement in response to the Staff&#146;s comment. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><U>Summary Financial Data </U></I></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><U>Balance Sheet Data,
page 13 </U></I></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><I>2.</I></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>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&#146; equity. Please explain why the automatic conversion of your Series F redeemable convertible preferred stock has not been reflected in pro forma stockholders&#146; equity, and revise to address this apparent inconsistency between
these disclosures. </I></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">CG Oncology&#146;s Response: The Company has revised page&nbsp;13 of the Registration Statement
in response to the Staff&#146;s comment. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><U>Capitalization, page 80 </U></I></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>

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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><I>3.</I></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>Your disclosure on page 80 states that your pro forma column reflects &#147;the automatic conversion of all
outstanding shares of our redeemable convertible preferred stock into 366,277,131 shares of our common stock.&#148; However, it does not appear as though your Series F redeemable convertible preferred stock that was issued on July&nbsp;28, 2023 has
been included in your actual or pro forma columns. Please revise to address this apparent inconsistency. </I></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">CG
Oncology&#146;s Response: The Company has revised page&nbsp;80 of the Registration Statement in response to the Staff&#146;s comment. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><U>Management
</U></I></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><U>Executive Officers, page 133 </U></I></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><I>4.</I></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your response to comment 11, including your revised disclosure on page 134 that Mr.&nbsp;DiPalma
works on a part-time basis as your CFO. Please include risk factor disclosure concerning Mr.&nbsp;DiPalma&#146;s part-time status and the number of hours of service hours per month he is expected to provide. </I></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">CG Oncology&#146;s Response: The Company&#146;s respectfully advises the Staff that while technically part time, Mr.&nbsp;DiPalma plans to
devote the necessary hours to manage the Company&#146;s accounting team and financial reporting following the completion of the offering and listing on the Nasdaq stock exchange. The Company expects that Mr.&nbsp;DiPalma&#146;s level of support will
be substantially on par with the level that a full-time CFO would spend supporting a public company. The Company has revised page 43 of the Registration Statement in response to the Staff&#146;s comment, including to reflect the foregoing. </P>
</DIV></Center>


<p style="margin-top:1em; margin-bottom:0em; page-break-before:always"> </p>
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">

 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>January&nbsp;2, 2024 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Page 3 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g551455g0102074107405.jpg" ALT="LOGO">
 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">********* </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Any comments or questions regarding the foregoing should be directed to the undersigned at (858)
<FONT STYLE="white-space:nowrap">523-3962.</FONT> Thank you in advance for your cooperation in connection with this matter. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:55%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">Very truly yours, </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:55%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">/s/ Matthew T. Bush </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:55%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">Matthew T. Bush </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:55%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">of LATHAM&nbsp;&amp; WATKINS LLP </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">cc:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Arthur Kuan, <I>CG Oncology, Inc.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Stephen DiPalma, <I>CG Oncology, Inc.</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Cheston J. Larson,<I> Latham</I><I></I><I>&nbsp;&amp; Watkins LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Anthony Gostanian,<I> Latham</I><I></I><I>&nbsp;&amp; Watkins LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Charles S. Kim, <I>Cooley LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Denny Won, <I>Cooley LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Kristin VanderPas, <I>Cooley LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Dave Peinsipp, <I>Cooley LLP</I> </P>
</DIV></Center>

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