CGON / CG Oncology, Inc. - تصريحات هيئة الأوراق المالية والبورصات، التقرير السنوي، بيان الوكيل

CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months - Robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monothe

Exhibit 99.1 CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months - Robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) treatme

FORM 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 05, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission Fi

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41925 CG Oncology, Inc.

FORM 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 08, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File

CG Oncology Reports Second Quarter 2025 Financial Results and Provides Business Updates - Announced best-in-disease durability data in BOND-003 Cohort C and promising early signal in Cohort P for cretostimogene grenadenorepvec at the American Urologi

Exhibit 99.1 CG Oncology Reports Second Quarter 2025 Financial Results and Provides Business Updates - Announced best-in-disease durability data in BOND-003 Cohort C and promising early signal in Cohort P for cretostimogene grenadenorepvec at the American Urological Association Annual Meeting - - Initiated CORE-008 Cohort CX evaluating the combination of cretostimogene and gemcitabine in patients

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 07, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File Nu

Submission of Matters to a Vote of Security Holders

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 05, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File Nu

Financial Statements and Exhibits, Results of Operations and Financial Condition

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File Num

Convertible Promissory Note between the Registrant's subsidiary, SafeGuard Healthcare, LLC, and SP Healthcare SPV I, LLC dated February 3, 2025

Exhibit 10.1 CERTAIN CONFIDENTIAL INFORMATION (MARKED BY BRACKETS AS “[***]”) HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. THIS NOTE AND THE SECURITIES ISSUABLE UPON THE CONVERSION HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF ANY STA

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41925 CG Oncology, Inc.

CG Oncology Reports First Quarter 2025 Financial Results and Provides Business Updates - Updated BOND-003 clinical results presented at AUA showing best-in-disease durability and tolerability data for Cohort C with 24-month complete response rate of

Exhibit 99.1 CG Oncology Reports First Quarter 2025 Financial Results and Provides Business Updates - Updated BOND-003 clinical results presented at AUA showing best-in-disease durability and tolerability data for Cohort C with 24-month complete response rate of 42.3% by K-M - - Promising early signal in Cohort P with 90.5% high-grade recurrence free survival at 3 and 9 months by K-M - - New enrol

Regulation FD Disclosure, Financial Statements and Exhibits, Other Events

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 26, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File N

CG Oncology Announces Best-in-Disease Durability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene Grenadenorepvec at the American Urological Association Annual Meeting – Robust 24-month complete response rate of 42.

Exhibit 99.1 CG Oncology Announces Best-in-Disease Durability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene Grenadenorepvec at the American Urological Association Annual Meeting – Robust 24-month complete response rate of 42.3% by K-M for cretostimogene monotherapy in BOND-003 Cohort C – – 58.3% of patients showed durable complete responses by K-M at 24 months

SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.__)

SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.

NOTICE OF ANNUAL MEETING OF STOCKHOLDERS QUESTIONS AND ANSWERS ABOUT THESE PROXY MATERIALS AND VOTING PROPOSAL 1: ELECTION OF DIRECTORS PROPOSAL 2: RATIFICATION OF APPOINTMENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM EXECUTIVE OFFICERS EXECUT

SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.

Amended and Restated Non-Employee Director Compensation Program

Exhibit 10.5 CG ONCOLOGY, INC. AMENDED AND RESTATED NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM Non-employee members of the board of directors (the “Board”) of CG Oncology, Inc. (the “Company”) shall receive cash and equity compensation as set forth in this Amended and Restated Non-Employee Director Compensation Program (this “Program”). The cash and equity compensation described in this Program sh

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Table Form S-3 (Form Type) CG Oncology, Inc.

Subsidiaries of the Registrant

Exhibit 21.1 SUBSIDIARIES OF SYNDAX PHARMACEUTICALS, INC. Name Jurisdiction of Incorporation SafeGuard Healthcare, LLC Delaware

Amended and Restated Employment Agreement, effective January 9, 2025, between Arthur Kuan and the Registrant

Exhibit 10.11 AMENDED AND rESTATED Employment Agreement This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Arthur Kuan (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of January 9, 2025 (the “Effective Date”). RECITALS WHEREAS, the Company currently e

Amended and Restated Employment Agreement, effective January 9, 2025, between Vijay Kasturi and the Registrant

Exhibit 10.13 Amended and Restated Employment Agreement This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Vijay Kasturi, M.D. (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of January 9, 2025 (the “Effective Date”). RECITALS WHEREAS, the Company cur

Open Market Sale Agreement, by and between CG Oncology, Inc. and Jefferies LLC, dated March 28, 2025.

Exhibit 1.2 OPEN MARKET SALE AGREEMENTSM March 28, 2025 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: CG Oncology, Inc., a Delaware corporation (the “Company”), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time through Jefferies LLC, as sales agent and/or principal (the “Agent”), shares of the Company’s common stock,

Amended and Restated Employment Agreement, effective January 9, 2025, between Ambaw Bellete and the Registrant

Exhibit 10.12 AMENDED AND RESTATED Employment Agreement This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Ambaw Bellete (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of January 9, 2025 (the “Effective Date”). RECITALS WHEREAS, the Company currently

Form of Indenture, between Registrant and One or More Trustees to be Named.

Exhibit 4.9 CG Oncology, Inc., Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of [•], 20 Debt Securities TABLE OF CONTENTS PAGE ARTICLE 1 DEFINITIONS 1    Section 1.01 Definitions of Terms 1 ARTICLE 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 5 Section 2.01 Designation and Terms of Securities 5 Section 2.02 Form of Securities and Trustee’s Certificate 8 Sectio

Form of Debt Securities Warrant Agreement and Warrant Certificate.

Exhibit 4.8 CG ONCOLOGY, INC. AND       , AS WARRANT AGENT FORM OF DEBT SECURITIES WARRANT AGREEMENT DATED AS OF       CG ONCOLOGY, INC. FORM OF DEBT SECURITIES WARRANT AGREEMENT THIS DEBT SECURITIES WARRANT AGREEMENT (this “Agreement”), dated as of [•], between CG ONCOLOGY, INC., a Delaware corporation (the “Company”), and [•], a [corporation] [national banking association] organized and existing

Financial Statements and Exhibits, Results of Operations and Financial Condition

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 28, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File N

Form of Common Stock Warrant Agreement and Warrant Certificate.

Exhibit 4.5 CG ONCOLOGY, INC. AND , AS WARRANT AGENT FORM OF COMMON STOCK WARRANT AGREEMENT DATED AS OF CG ONCOLOGY, INC. FORM OF COMMON STOCK WARRANT AGREEMENT THIS COMMON STOCK WARRANT AGREEMENT (this “Agreement”), dated as of [•], between CG ONCOLOGY, INC., a Delaware corporation (the “Company”), and [•], a [corporation] [national banking association] organized and existing under the laws of [•

Form of Preferred Stock Warrant Agreement and Warrant Certificate.

Exhibit 4.6 CG ONCOLOGY, INC. AND , AS WARRANT AGENT FORM OF PREFERRED STOCK WARRANT AGREEMENT DATED AS OF CG ONCOLOGY, INC. FORM OF PREFERRED STOCK WARRANT AGREEMENT THIS PREFERRED STOCK WARRANT AGREEMENT (this “Agreement”), dated as of [•], between CG ONCOLOGY, INC., a Delaware corporation (the “Company”), and [•], a [corporation] [national banking association] organized and existing under the l

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-41925 CG Oncology, In

Amended and Restated Employment Agreement, effective January 9, 2025, between Corleen Roche and the Registrant

Exhibit 10.14 Amended and restated Employment Agreement This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Corleen Roche (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of January 9, 2025 (the “Effective Date”). RECITALS WHEREAS, the Company currently

Amended and Restated Employment Agreement, effective January 9, 2025, between Joshua F. Patterson and the Registrant

Exhibit 10.15 AMENDED and restated Employment Agreement This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”) and Joshua F. Patterson (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of January 9, 2025 (the “Effective Date”). RECITALS WHEREAS, the Company curr

As filed with the Securities and Exchange Commission on March 28, 2025

Table of Contents As filed with the Securities and Exchange Commission on March 28, 2025 Registration No.

Insider Trading Policy

Exhibit 19.1 CG Oncology, Inc. Insider Trading Compliance Policy and Procedures Adopted December 13, 2023 Last Amended March 25, 2025 CG Oncology, Inc. (together with its subsidiaries, “CG Oncology”) is a public company. This means CG Oncology is owned by its stockholders, our securities are publicly traded, and we all have an obligation to protect CG Oncology’s value and assets. When you started

CG Oncology Reports 2024 Year End Financial Results and Provides Business Updates - Cretostimogene Monotherapy Demonstrated Sustained, Durable Complete Responses in High-Risk Bacillus Calmette Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Can

Exhibit 99.1 CG Oncology Reports 2024 Year End Financial Results and Provides Business Updates - Cretostimogene Monotherapy Demonstrated Sustained, Durable Complete Responses in High-Risk Bacillus Calmette Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) - - Initiated CORE-008 Clinical Trial of Cretostimogene Monotherapy in High-Risk BCG-Naïve (Cohort A) and BCG-Exposed (Cohort

Cretostimogene Grenadenorepvec Data Continues to Demonstrate Best-in-Class Durability of Response as well as Consistent and Compelling Safety and Efficacy – Latest BOND-003 data show 75.5% of patients achieved a complete response at any time – – Medi

Exhibit 99.1 Cretostimogene Grenadenorepvec Data Continues to Demonstrate Best-in-Class Durability of Response as well as Consistent and Compelling Safety and Efficacy – Latest BOND-003 data show 75.5% of patients achieved a complete response at any time – – Median duration of response exceeds 28 months and is ongoing – – No close contact precautions needed post cretostimogene treatment – IRVINE,

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 24, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File N

JOINT FILING AGREEMENT

EXHIBIT 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that a single Schedule 13G (or any amendment thereto) relating to the Common Stock of CG Oncology, Inc. shall be filed on behalf of each of the undersigned and that this Agreement shall be filed as an exhibit to such Schedule 13G. Dated: February 14, 2025 Decheng Capital Global Life Sciences Fund IV, L.P. By: Decheng Capital Manageme

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 09, 2025 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File

8,000,000 Shares Common Stock

Table of Contents Filed Pursuant to Rule 424(b)(4) Registration No. 333-283725 8,000,000 Shares Common Stock We are offering 7,300,000 shares of our common stock. Charming Jade Limited, the selling stockholder identified in this prospectus, is offering an additional 700,000 shares of our common stock. We will not receive any proceeds from the sale of shares to be offered by the selling stockholder

As filed with the Securities and Exchange Commission on December 11, 2024.

S-1/A As filed with the Securities and Exchange Commission on December 11, 2024. Registration No. 333-283725 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CG ONCOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 2836 37-1611499 (State or other jurisdiction of incor

December 11, 2024

CORRESP December 11, 2024 Morgan Stanley & Co. LLC 1585 Broadway New York, NY 10036 Goldman Sachs & Co. LLC 200 West Street New York, NY 10282 TD Securities (USA) LLC 1 Vanderbilt Avenue New York, New York 10017 Stifel, Nicolaus & Company, Incorporated 787 7th Avenue, 11th Floor New York, New York 10019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street,

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables Form S-1 (Form Type) CG Oncology, Inc.

Power of Attorney (included on signature page)

S-1 Table of Contents As filed with the Securities and Exchange Commission on December 11, 2024.

CG Oncology, Inc. 400 Spectrum Center Drive, Suite 2040 Irvine, CA 92618

CG Oncology, Inc. 400 Spectrum Center Drive, Suite 2040 Irvine, CA 92618 December 11, 2024 VIA EDGAR Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Tamika Sheppard Re: CG Oncology, Inc. Registration Statement on Form S-1 (File No. 333-283725) Request for Acceleration of Effective Date Ladies and Gentle

Form of Underwriting Agreement

Exhibit 1.1 [•] Shares CG ONCOLOGY, INC. COMMON STOCK, PAR VALUE $0.0001 PER SHARE UNDERWRITING AGREEMENT December [•], 2024 December [•], 2024 Morgan Stanley & Co. LLC Goldman Sachs & Co. LLC TD Securities (USA) LLC Stifel, Nicolaus & Company, Incorporated c/o Morgan Stanley & Co. LLC   1585 Broadway   New York, New York 10036 c/o Goldman Sachs & Co. LLC   200 West Street   New York, New York 102

Groundbreaking Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer – 74.5% of patients achieved a complete response at any time – – Median

Exhibit 99.1 Groundbreaking Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer – 74.5% of patients achieved a complete response at any time – – Median duration of response is greater than 27 months and not reached – – Latest data update continued to show favorable safety and tolerabilit

Regulation FD Disclosure

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 5, 2024 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File

As confidentially submitted to the Securities and Exchange Commission on November 14, 2024. This draft registration statement has not been publicly filed with the Securities and Exchange Commission and all information herein remains strictly confiden

Table of Contents As confidentially submitted to the Securities and Exchange Commission on November 14, 2024.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 12, 2024 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission Fil

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41925 CG Oncology, Inc.

CG Oncology Reports Third Quarter 2024 Financial Results and Provides Business Updates - Late-Breaking Abstract on Results of Phase 3 BOND-003 Trial of Cretostimogene Monotherapy in BCG-Unresponsive NMIBC Accepted at the Society of Urologic Oncology

CG Oncology Reports Third Quarter 2024 Financial Results and Provides Business Updates - Late-Breaking Abstract on Results of Phase 3 BOND-003 Trial of Cretostimogene Monotherapy in BCG-Unresponsive NMIBC Accepted at the Society of Urologic Oncology (SUO) 25th Annual Meeting - IRVINE, Calif.

Financial Statements and Exhibits, Results of Operations and Financial Condition

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 08, 2024 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File

CG Oncology Reports Second Quarter 2024 Financial Results and Provides Business Updates – Final positive safety and efficacy findings from CORE-001 study of Cretostimogene Grenadenorepvec in combination with Pembrolizumab in BCG-Unresponsive NMIBC si

Exhibit 99.1 CG Oncology Reports Second Quarter 2024 Financial Results and Provides Business Updates – Final positive safety and efficacy findings from CORE-001 study of Cretostimogene Grenadenorepvec in combination with Pembrolizumab in BCG-Unresponsive NMIBC simultaneously published online by Nature Medicine and featured at ASCO 2024 – – Announced 54% complete response (CR) rate in the intention

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41925 CG Oncology, Inc.

CGON / CG Oncology, Inc. / Unique Diamond Investments Ltd - SC 13G Passive Investment

SC 13G 1 d840327dsc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )* CG Oncology, Inc. (Name of Issuer) Common stock, $0.0001 par value per share (Title of Class of Securities) 156944100 (CUSIP Number) June 30, 2024** (Date of Event Which Requires Filing of this Statement) Check the approp

JOINT FILING AGREEMENT

EX-99.1 2 d840327dex991.htm EX-99.1 Exhibit 99.1 JOINT FILING AGREEMENT The undersigned acknowledge and agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G shall be filed on behalf of each of the undersigned without the necessity of filing additional joint filing statements. The unders

Regulation FD Disclosure, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 24, 2024 CG Oncology, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File Num

CG Oncology to Present Positive Final Results from Phase 2 CORE-001 Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in BCG-Unresponsive High-Risk NMIBC at ASCO 2024 Annual Meeting – 54% complete response (CR) rate at 24-mont

EX-99.1 2 ck0001991792-ex991.htm EX-99.1 Exhibit 99.1 CG Oncology to Present Positive Final Results from Phase 2 CORE-001 Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in BCG-Unresponsive High-Risk NMIBC at ASCO 2024 Annual Meeting – 54% complete response (CR) rate at 24-month landmark and meets primary endpoint of the phase 2 study – IRVINE, Calif., May 24, 2024 (GLOBE

Current Report

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported) May 9, 2024 CG Oncology, Inc.

CG Oncology Reports First Quarter 2024 Financial Results and Provides Business Updates • Cretostimogene Monotherapy Demonstrated 75.2% Complete Response (CR) Rate at Any Time in Bacillus Calmette Guerin (BCG)-Unresponsive, High-Risk Non-Muscle Invasi

Exhibit 99.1 CG Oncology Reports First Quarter 2024 Financial Results and Provides Business Updates • Cretostimogene Monotherapy Demonstrated 75.2% Complete Response (CR) Rate at Any Time in Bacillus Calmette Guerin (BCG)-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) • First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-Risk NMIBC (IR-N

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41925 CG Oncology, Inc.

Current Report

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported) May 3, 2024 CG Oncology, Inc.

CGON / CG Oncology, Inc. / Decheng Capital Global Life Sciences Fund IV, L.P. - SC 13G/A Passive Investment

SC 13G/A 1 tm2411450d1sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1 )* CG Oncology, Inc. (Name of Issuer) Common stock, $0.0001 par value per share (Title of Class of Securities) 156944100 (CUSIP Number) January 29, 2024 (Date of Event Which Requires Filing of this Statement) Check

Exhibit 4.3

Exhibit 4.3 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 As of March 26, 2024, CG Oncology, Inc. (“we,” “us” and “our”) had one class of securities registered pursuant to Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”): our common stock. Description of Common Stock General The following descri

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-41925 CG Oncology, In

CGON / CG Oncology, Inc. / Kissei Pharmaceutical Co., Ltd. - SC 13G Passive Investment

SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* CG Oncology, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 156944100 (CUSIP Number) January 29, 2024 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported) February 15, 2024 CG Oncology, Inc.

JOINT FILING AGREEMENT

EX-99.1 2 d774947dex991.htm EX-99.1 Exhibit 1 JOINT FILING AGREEMENT The undersigned hereby agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned, and any amendments thereto executed by the undersigned shall be filed on behalf of each of the undersigned without the necessity of filing any additional joint filing agreement. The undersigned acknowledge that

CGON / CG Oncology, Inc. / TCG Crossover GP I, LLC - SC 13G Passive Investment

SC 13G 1 d774947dsc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* CG Oncology, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 156944100 (CUSIP Number) January 29, 2024 (Date of Event Which Requires Filing of This Statement) Check the appro

CGON / CG Oncology, Inc. / Decheng Capital Global Life Sciences Fund IV, L.P. - SC 13G Passive Investment

SC 13G 1 tm245429d6sc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* CG Oncology, Inc. (Name of Issuer) Common stock, $0.0001 par value per share (Title of Class of Securities) 156944100 (CUSIP Number) January 29, 2024 (Date of Event Which Requires Filing of this Statement) Check the app

JOINT FILING AGREEMENT

EX-99.1 2 d719787dex991.htm EX-99.1 Exhibit 1 JOINT FILING AGREEMENT The undersigned hereby agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned, and any amendments thereto executed by the undersigned shall be filed on behalf of each of the undersigned without the necessity of filing any additional joint filing agreement. The undersigned acknowledge that

CGON / CG Oncology, Inc. / Foresite Capital Fund V, L.P. - SC 13G Passive Investment

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1 (b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO 13d-2 (b) (Amendment No. )* CG Oncology, Inc. (Name of Issuer) Common Stock, par value $0.0001 (Title of Class of Securities) 156944100 (CUSIP Number) January 24, 2024 (Date of Event Wh

CGON / CG Oncology, Inc. / Longitude Capital Partners IV, LLC - SC 13G Passive Investment

SC 13G 1 d719787dsc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* CG Oncology, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 156944100 (CUSIP Number) January 29, 2024 (Date of Event which Requires Filing of this Statement) Check the appro

Amended and Restated Bylaws of CG Oncology, Inc.

EX-3.2 Exhibit 3.2 Amended and Restated Bylaws of CG Oncology, Inc. (a Delaware corporation) Table of Contents    Page Article I - Corporate Offices 1 1.1 Registered Office 1 1.2 Other Offices 1 Article II - Meetings of Stockholders 1 2.1 Place of Meetings 1 2.2 Annual Meeting 1 2.3 Special Meeting 1 2.4 Notice of Business to be Brought before a Meeting. 2 2.5 Notice of Nominations for Election to

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported) January 29, 2024 CG Oncology, Inc. (

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported) January 29, 2024 CG Oncology, Inc.

Amended and Restated Certificate of Incorporation of CG Oncology, Inc.

EX-3.1 Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CG ONCOLOGY, INC. CG Oncology, Inc. (the “Corporation”), a corporation organized and existing under the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify as follows: 1. The name of the Corporation is CG Oncology, Inc. The Corporation was incorporated under the name Cold Genesys, Inc. by the fil

CG Oncology, Inc. 2022 Incentive Award Plan and form of stock option agreement, form of stock option agreement (early exercise) and form of restricted stock unit agreement thereunder

Exhibit 10.2 CG ONCOLOGY, INC. 2022 INCENTIVE AWARD PLAN ARTICLE I. PURPOSE The Plan’s purpose is to enhance the Company’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities. Capitalized terms used in the Plan are

Calculation of Filing Fee Table

Exhibit 107 CALCULATION OF FILING FEE TABLE Form S-8 (Form Type) CG Oncology, Inc.

CG Oncology, Inc. 2024 Employee Stock Purchase Plan

Exhibit 10.4 CG ONCOLOGY, INC. 2024 EMPLOYEE STOCK PURCHASE PLAN ARTICLE I. PURPOSE The purpose of this Plan is to assist Eligible Participants of the Company and its Designated Subsidiaries in acquiring a stock ownership interest in the Company. The Plan consists of two components: (i) the Section 423 Component and (ii) the Non-Section 423 Component. The Section 423 Component is intended to quali

CG Oncology, Inc. 2015 Equity Incentive Plan, as amended, and form of stock grant agreement and form of stock option agreement thereunder

Exhibit 10.1 CG ONCOLOGY, INC. 2015 EQUITY INCENTIVE PLAN 1. Purposes of the Plan. The purposes of this Plan are: • to attract and retain the best available personnel for positions of substantial responsibility, • to provide additional incentive to Employees, Directors and Consultants, and • to promote the success of the Company’s business. The Plan permits the grant of Incentive Stock Options, No

As filed with the Securities and Exchange Commission on January 26, 2024

As filed with the Securities and Exchange Commission on January 26, 2024 Registration No.

CG Oncology, Inc. 2024 Incentive Award Plan and form of stock option agreement and form of restricted stock unit agreement thereunder

Exhibit 10.3 CG ONCOLOGY, INC. 2024 INCENTIVE AWARD PLAN ARTICLE I. PURPOSE The Plan’s purpose is to enhance the Company’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities. Capitalized terms used in the Plan are

20,000,000 Shares Common Stock

424B4 Table of Contents Filed Pursuant to Rule 424(b)(4) Registration Nos. 333-276350 and 333-276685 20,000,000 Shares Common Stock This is an initial public offering of shares of common stock of CG Oncology, Inc. We are offering 20,000,000 shares of our common stock. Prior to this offering, there has been no public market for our common stock. The initial public offering price is $19.00 per share

As filed with the Securities and Exchange Commission on January 24, 2024

As filed with the Securities and Exchange Commission on January 24, 2024 Registration No.

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Table Form S-1 CG Oncology, Inc. Table 1 - Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1)(2) Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price(3) Fee Rate Amount of Registration Fee(2)  Equity  Common Stock, par value $0.0001 per share  Rule 457(a)   3,450,000   $19.00  $65,550,

Exhibit 107

Exhibit 107 Calculation of Filing Fee Table Form S-1 CG Oncology, Inc. Table 1 - Newly Registered Securities Security Type Security Class Title Fee  Calculation  Rule Amount Registered(1) Proposed  Maximum  Offering Price Per Share Maximum Aggregate Offering Price(2) Fee Rate Amount of Registration Fee(2) Equity Common Stock, par value $0.0001 per share Rule 457(a) 19,550,000 $18.00 $351,900,000 0

As filed with the Securities and Exchange Commission on January 23, 2024

Table of Contents As filed with the Securities and Exchange Commission on January 23, 2024 Registration No.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-A FOR REGISTRATION OF CERTAIN CLASSES OF SECURITIES PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 CG ONCOLOGY, INC. (Exact name of registrant as

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-A FOR REGISTRATION OF CERTAIN CLASSES OF SECURITIES PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 CG ONCOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 37-1611499 (State of incorporation or organization) (I.R.S. Employer Identification No.) 400 Spectrum Drive, Suite

CG Oncology, Inc. 400 Spectrum Center Drive, Suite 2040 Irvine, CA 92618

CG Oncology, Inc. 400 Spectrum Center Drive, Suite 2040 Irvine, CA 92618 January 22, 2024 VIA EDGAR Mr. Jimmy McNamara Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549 Re: CG Oncology, Inc. Registration Statement on Form S-1, as amended File No. 333-276350 Ladies and Gentlemen: Pursuant to Rule 461 of Regulatio

[signature page follows]

January 22, 2024 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.

As filed with the Securities and Exchange Commission on January 18, 2024

Table of Contents As filed with the Securities and Exchange Commission on January 18, 2024 Registration No.

Amended and Restated Certificate of Incorporation, as amended (currently in effect)

Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CG ONCOLOGY, INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware) CG Oncology, Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), DOES HEREBY CERTIFY: FIRST: That the name o

CG Oncology, Inc. 2024 Incentive Award Plan and form of stock option agreement and form of restricted stock unit agreement thereunder

Exhibit 10.3 CG ONCOLOGY, INC. 2024 INCENTIVE AWARD PLAN ARTICLE I. PURPOSE The Plan’s purpose is to enhance the Company’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities. Capitalized terms used in the Plan are

CG Oncology, Inc. 2024 Employee Stock Purchase Plan

Exhibit 10.4 CG ONCOLOGY, INC. 2024 EMPLOYEE STOCK PURCHASE PLAN ARTICLE I. PURPOSE The purpose of this Plan is to assist Eligible Participants of the Company and its Designated Subsidiaries in acquiring a stock ownership interest in the Company. The Plan consists of two components: (i) the Section 423 Component and (ii) the Non-Section 423 Component. The Section 423 Component is intended to quali

Employment Agreement, effective January 16, 2024, between Corleen Roche and the Registrant

Exhibit 10.18 EMPLOYMENT AGREEMENT This Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Corleen Roche (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of January 16, 2024 (the “Effective Date”). RECITALS WHEREAS, the Company seeks to employ Executive as its Chief Financial O

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Table Form S-1 CG Oncology, Inc. Table 1 - Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price(2) Fee Rate Amount of Registration Fee(2) Equity Common Stock, par value $0.0001 per share Rule 457(a) 13,570,000 $18.00 $244,260,000 0.000

Specimen stock certificate evidencing the shares of common stock

Exhibit 4.1 NUMBER SHARES COUNTERSIGNED: BROADRIDGE CORPORATE ISSUER SOLUTIONS, LLC TRANSFER AGENT BY: AUTHORIZED SIGNATURE DATED: INCORPORATED UNDER THE LAWS OF THE STATE OF DELAWARE CUSIP 156944 10 0 SEE REVERSE FOR CERTAIN DEFINITIONS This Certifies That: is the owner of C O M M ON S T O C K CHIEF FINANCIAL OFFICER CHIEF EXECUTIVE OFFICER FULLY PAID AND NON-ASSESSABLE SHARES OF COMMON STOCK OF

Amended and Restated Investors’ Rights Agreement, dated July 28, 2023, as amended, by and among the Registrant and certain of its stockholders

Exhibit 4.2 CG ONCOLOGY, INC. AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (AS AMENDED) DATED: July 28, 2023 CG ONCOLOGY, INC. AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT THIS AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (this “Agreement”) is made as of July 28, 2023 by and among CG ONCOLOGY, INC., a Delaware corporation (the “Company”), as amended, and the investors listed on Schedul

Form of Underwriting Agreement

Exhibit 1.1 [•] Shares CG ONCOLOGY, INC. COMMON STOCK, PAR VALUE $0.0001 PER SHARE UNDERWRITING AGREEMENT [•], 2024 [•], 2024 Morgan Stanley & Co. LLC Goldman Sachs & Co. LLC Cantor Fitzgerald & Co. c/o Morgan Stanley & Co. LLC 1585 Broadway New York, New York 10036 c/o Goldman Sachs & Co. LLC 200 West Street New York, New York 10282 c/o Cantor Fitzgerald & Co. 110 East 59th Street New York, New Y

Non-Employee Director Compensation Program

Exhibit 10.5 CG ONCOLOGY, INC. NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM Non-employee members of the board of directors (the “Board”) of CG Oncology, Inc. (the “Company”) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this “Program”). The cash and equity compensation described in this Program shall be paid or be made, as applicable, aut

Amended and Restated Certificate of Incorporation

Exhibit 3.3 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CG ONCOLOGY, INC. CG Oncology, Inc. (the “Corporation”), a corporation organized and existing under the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify as follows: 1. The name of the Corporation is CG Oncology, Inc. The Corporation was incorporated under the name Cold Genesys, Inc. by the filing of

12670 High Bluff Drive

12670 High Bluff Drive San Diego, California 92130 Tel: +1.858.523.5400 Fax: +1.858.523.5450 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh FOIA CONFIDENTIAL TREATMENT REQUEST Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul The entity requesting confidential treatment is: Hamburg Silicon Valley Hong

Amended and Restated Certificate of Incorporation, as amended (currently in effect)

Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CG ONCOLOGY, INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware) CG Oncology, Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), DOES HEREBY CERTIFY: FIRST: That the name o

Amended and Restated Employment Agreement, effective December 13, 2023, between Vijay Kasturi and the Registrant

Exhibit 10.17 AMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Vijay Kasturi, M.D. (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of December 13, 2023 (the “Effective Date”). RECITALS WHEREAS, the Company c

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12670 High Bluff Drive San Diego, California 92130 Tel: +1.858.523.5400 Fax: +1.858.523.5450 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh January 2, 2024 Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul VIA EDGAR Hamburg Silicon Valley Hong Kong Singapore Jimmy McNamara Office of Life Sciences Divis

Form of Amended and Restated Certificate of Incorporation (to be effective immediately prior to the closing of this offering)

Exhibit 3.3 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CG ONCOLOGY, INC. CG Oncology, Inc. (the “Corporation”), a corporation organized and existing under the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify as follows: 1. The name of the Corporation is CG Oncology, Inc. The Corporation was incorporated under the name Cold Genesys, Inc. by the filing of

Amended and Restated Bylaws

Exhibit 3.4 Amended and Restated Bylaws of CG Oncology, Inc. (a Delaware corporation) Table of Contents Page Article I - Corporate Offices 1 1.1 Registered Office 1 1.2 Other Offices 1 Article II - Meetings of Stockholders 1 2.1 Place of Meetings 1 2.2 Annual Meeting 1 2.3 Special Meeting 1 2.4 Notice of Business to be Brought before a Meeting 2 2.5 Notice of Nominations for Election to the Board

Annual Bonus Plan

Exhibit 10.11 CG ONCOLOGY, INC. ANNUAL BONUS PLAN 1. PURPOSE This Annual Bonus Plan (the “Plan”) is adopted under the CG Oncology, Inc. 2024 Incentive Award Plan (the “2024 Plan”) and is intended to provide an incentive for eligible employees of CG Oncology, Inc. (the “Company”) as part of the company’s “Total Rewards” approach that is competitive and flexible enough to attract, retain and motivat

Bylaws (currently in effect)

Exhibit 3.2 AMENDED AND RESTATED BYLAWS OF COLD GENESYS, INC. (A DELAWARE CORPORATION) TABLE OF CONTENTS Page ARTICLE I OFFICES 1    1.1 Registered Office 1 1.2 Offices 1 ARTICLE II MEETINGS OF STOCKHOLDERS 1 2.1 Location 1 2.2 Timing 1 2.3 Notice of Meeting 1 2.4 Stockholders’ Records 1 2.5 Special Meetings 2 2.6 Notice of Meeting 2 2.7 Business Transacted at Special Meeting 2 2.8 Quorum; Meeting

Amended and Restated Investors’ Rights Agreement, dated July 28, 2023, by and among the Registrant and certain of its stockholders

Exhibit 4.2 CG ONCOLOGY, INC. AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT DATED: July 28, 2023 CG ONCOLOGY, INC. AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT THIS AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (this “Agreement”) is made as of July 28, 2023 by and among CG ONCOLOGY, INC., a Delaware corporation (the “Company”), and the investors listed on Schedule A hereto (each an “Inve

Policy for the Recovery of Erroneously Awarded Compensation

Exhibit 10.10 CG ONCOLOGY, INC. POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION CG Oncology, Inc. (the “Company”) has adopted this Policy for Recovery of Erroneously Awarded Compensation (the “Policy”), effective as of the date on which the Company’s securities are listed on the Nasdaq Stock Market (the “Effective Date”). Capitalized terms used in this Policy but not otherwise defined in t

CG Oncology, Inc. 2024 Incentive Award Plan and form of stock option agreement and form of restricted stock unit agreement thereunder

Exhibit 10.3 CG ONCOLOGY, INC. 2024 INCENTIVE AWARD PLAN ARTICLE I. PURPOSE The Plan’s purpose is to enhance the Company’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities. Capitalized terms used in the Plan are

CG Oncology, Inc. 2022 Incentive Award Plan and form of stock option agreement, form of stock option agreement (early exercise) and form of restricted stock unit agreement thereunder

Exhibit 10.2 CG ONCOLOGY, INC. 2022 INCENTIVE AWARD PLAN ARTICLE I. PURPOSE The Plan’s purpose is to enhance the Company’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities. Capitalized terms used in the Plan are

Amended and Restated Employment Agreement, effective December 13, 2023, between Ambaw Bellete and the Registrant

Exhibit 10.15 AMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Ambaw Bellete (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of December 13, 2023 (the “Effective Date”). RECITALS WHEREAS, the Company current

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Table Form S-1 CG Oncology, Inc. Table 1 - Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price(1)(2) Fee Rate Amount of Registration Fee(2) Equity Common Stock, par value $0.0001 per share Rule 457(o) — — $100,000,000 0.00014760 $14,760

CG Oncology, Inc. 2015 Equity Incentive Plan, as amended, and form of stock grant agreement and form of stock option agreement thereunder

Exhibit 10.1 CG ONCOLOGY, INC. 2015 EQUITY INCENTIVE PLAN 1. Purposes of the Plan. The purposes of this Plan are: • to attract and retain the best available personnel for positions of substantial responsibility, • to provide additional incentive to Employees, Directors and Consultants, and • to promote the success of the Company’s business. The Plan permits the grant of Incentive Stock Options, No

Amended and Restated Employment Agreement, effective December 13, 2023, between Arthur Kuan and the Registrant

Exhibit 10.13 AMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Arthur Kuan (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of December 13, 2023 (the “Effective Date”). RECITALS WHEREAS, the Company currently

Employment Agreement, effective August 14, 2023, between Vijay Kasturi and the Registrant

Exhibit 10.16 EMPLOYMENT AGREEMENT This Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Vijay Kasturi, M.D. (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of August 14, 2023 (the “Effective Date”). RECITALS WHEREAS, the Company seeks to employ Executive as its Chief Medica

First Amendment to the License and Collaboration Agreement, dated September 15, 2022, between Kissei Pharmaceutical Co., Ltd. and the Registrant

Exhibit 10.8 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CG ONCOLOGY, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CG ONCOLOGY, INC. IF PUBLICLY DISCLOSED. FIRST AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT This FIRST AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT (“F

Development and License Agreement, dated March 11, 2019, between the Lepu Biotech Co., Ltd. and the Registrant

Exhibit 10.6 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CG ONCOLOGY, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CG ONCOLOGY, INC. IF PUBLICLY DISCLOSED. DEVELOPMENT AND LICENSE AGREEMENT This DEVELOPMENT AND LICENSE AGREEMENT (“Agreement”) effective as of March 11, 2019 (“Effect

Form of Indemnification Agreement for Directors and Officers

Exhibit 10.9 INDEMNIFICATION AND ADVANCEMENT AGREEMENT This Indemnification and Advancement Agreement (“Agreement”) is made as of , 20 by and between CG Oncology, Inc. a Delaware corporation (the “Company”), and , [a member of the Board of Directors/an officer/an employee/an agent] of the Company (“Indemnitee”). This Agreement supersedes and replaces any and all previous Agreements between the Com

License and Collaboration Agreement, dated March 26, 2020, between Kissei Pharmaceutical Co., Ltd. and the Registrant

Exhibit 10.7 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CG ONCOLOGY, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CG ONCOLOGY, INC. IF PUBLICLY DISCLOSED. LICENSE AND COLLABORATION AGREEMENT BETWEEN CG ONCOLOGY, INC. AND KISSEI PHARMACEUTICAL CO., LTD. TABLE OF CONTENTS Page ARTIC

As filed with the Securities and Exchange Commission on January 2, 2024

S-1 Table of Contents As filed with the Securities and Exchange Commission on January 2, 2024 Registration No.

Amended and Restated Employment Agreement, effective March 15, 2023, between Arthur Kuan and the Registrant

Exhibit 10.12 AMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Arthur Kuan (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of March 15, 2023 (the “Effective Date”). RECITALS WHEREAS, the Company currently em

Employment Agreement, effective July 9, 2023, between Ambaw Bellete and the Registrant

Exhibit 10.14 EMPLOYMENT AGREEMENT This Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Ambaw Bellete (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of 09-Jul-2023 (the “Effective Date”). RECITALS WHEREAS, the Company seeks to employ Executive as its President and Chief Op

Non-Employee Director Compensation Program

Exhibit 10.5 CG ONCOLOGY, INC. NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM Non-employee members of the board of directors (the “Board”) of CG Oncology, Inc. (the “Company”) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this “Program”). The cash and equity compensation described in this Program shall be paid or be made, as applicable, aut

CG Oncology, Inc. 2024 Employee Stock Purchase Plan

Exhibit 10.4 CG ONCOLOGY, INC. 2024 EMPLOYEE STOCK PURCHASE PLAN ARTICLE I. PURPOSE The purpose of this Plan is to assist Eligible Participants of the Company and its Designated Subsidiaries in acquiring a stock ownership interest in the Company. The Plan consists of two components: (i) the Section 423 Component and (ii) the Non-Section 423 Component. The Section 423 Component is intended to quali

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12670 High Bluff Drive San Diego, California 92130 Tel: +1.858.523.5400 Fax: +1.858.523.5450 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego December 4, 2023 Düsseldorf San Francisco Frankfurt Seoul VIA EDGAR Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Jimmy McNamar

CG ONCOLOGY, INC. POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION

Exhibit 10.13 CG ONCOLOGY, INC. POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION CG Oncology, Inc. (the “Company”) has adopted this Policy for Recovery of Erroneously Awarded Compensation (the “Policy”), effective as of the date on which the Company’s securities are listed on the Nasdaq Stock Market (the “Effective Date”). Capitalized terms used in this Policy but not otherwise defined in t

CG ONCOLOGY, INC. ANNUAL BONUS PLAN

Exhibit 10.14 CG ONCOLOGY, INC. ANNUAL BONUS PLAN 1. PURPOSE This Annual Bonus Plan (the “Plan”) is adopted under the CG Oncology, Inc. 2024 Incentive Award Plan (the “2024 Plan”) and is intended to provide an incentive for eligible employees of CG Oncology, Inc. (the “Company”) as part of the company’s “Total Rewards” approach that is competitive and flexible enough to attract, retain and motivat

As confidentially submitted to the Securities and Exchange Commission on December 4, 2023 as Amendment No. 1 to the draft Registration Statement

DRS/A 1 filename1.htm Table of Contents As confidentially submitted to the Securities and Exchange Commission on December 4, 2023 as Amendment No. 1 to the draft Registration Statement Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CG ONCOLOGY, INC. (Exact name of registrant as specified

As confidentially submitted to the Securities and Exchange Commission on October 27, 2023

Table of Contents As confidentially submitted to the Securities and Exchange Commission on October 27, 2023 Registration No.

CG ONCOLOGY, INC. 2015 EQUITY INCENTIVE PLAN

Exhibit 10.1 CG ONCOLOGY, INC. 2015 EQUITY INCENTIVE PLAN 1. Purposes of the Plan. The purposes of this Plan are: • to attract and retain the best available personnel for positions of substantial responsibility, • to provide additional incentive to Employees, Directors and Consultants, and • to promote the success of the Company’s business. The Plan permits the grant of Incentive Stock Options, No

EMPLOYMENT AGREEMENT

Exhibit 10.10 EMPLOYMENT AGREEMENT This Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Ambaw Bellete (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of 09-Jul-2023 (the “Effective Date”). RECITALS WHEREAS, the Company seeks to employ Executive as its President and Chief Op

EMPLOYMENT AGREEMENT

Exhibit 10.11 EMPLOYMENT AGREEMENT This Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Vijay Kasturi, M.D. (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of August 14, 2023 (the “Effective Date”). RECITALS WHEREAS, the Company seeks to employ Executive as its Chief Medica

CG ONCOLOGY, INC. AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT DATED: July 28, 2023

Exhibit 4.2 CG ONCOLOGY, INC. AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT DATED: July 28, 2023 CG ONCOLOGY, INC. AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT THIS AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (this “Agreement”) is made as of July 28, 2023 by and among CG ONCOLOGY, INC., a Delaware corporation (the “Company”), and the investors listed on Schedule A hereto (each an “Inve

AMENDED AND RESTATED CERTIFICATE OF INCORPORATION CG ONCOLOGY, INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware)

Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CG ONCOLOGY, INC. (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware) CG Oncology, Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), DOES HEREBY CERTIFY: FIRST: That the name o

FIRST AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT

Exhibit 10.8 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CG ONCOLOGY, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CG ONCOLOGY, INC. IF PUBLICLY DISCLOSED. FIRST AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT This FIRST AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT (“F

LICENSE AND COLLABORATION AGREEMENT CG ONCOLOGY, INC. KISSEI PHARMACEUTICAL CO., LTD.

Exhibit 10.7 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CG ONCOLOGY, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CG ONCOLOGY, INC. IF PUBLICLY DISCLOSED. LICENSE AND COLLABORATION AGREEMENT BETWEEN CG ONCOLOGY, INC. AND KISSEI PHARMACEUTICAL CO., LTD. TABLE OF CONTENTS Page ARTIC

AMENDED AND RESTATED BYLAWS OF COLD GENESYS, INC. (A DELAWARE CORPORATION)

Exhibit 3.2 AMENDED AND RESTATED BYLAWS OF COLD GENESYS, INC. (A DELAWARE CORPORATION) TABLE OF CONTENTS Page ARTICLE I OFFICES 1    1.1 Registered Office 1 1.2 Offices 1 ARTICLE II MEETINGS OF STOCKHOLDERS 1 2.1 Location 1 2.2 Timing 1 2.3 Notice of Meeting 1 2.4 Stockholders’ Records 1 2.5 Special Meetings 2 2.6 Notice of Meeting 2 2.7 Business Transacted at Special Meeting 2 2.8 Quorum; Meeting

DEVELOPMENT AND LICENSE AGREEMENT

Exhibit 10.6 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CG ONCOLOGY, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CG ONCOLOGY, INC. IF PUBLICLY DISCLOSED. DEVELOPMENT AND LICENSE AGREEMENT This DEVELOPMENT AND LICENSE AGREEMENT (“Agreement”) effective as of March 11, 2019 (“Effect

CG ONCOLOGY, INC. 2022 INCENTIVE AWARD PLAN ARTICLE I.

Exhibit 10.2 CG ONCOLOGY, INC. 2022 INCENTIVE AWARD PLAN ARTICLE I. PURPOSE The Plan’s purpose is to enhance the Company’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities. Capitalized terms used in the Plan are

AMENDED AND RESTATED EMPLOYMENT AGREEMENT

Exhibit 10.9 AMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement (this “Agreement”) is made by and between CG Oncology, Inc. (the “Company”), and Arthur Kuan (“Executive”) (collectively referred to herein as the “Parties” or individually referred to as a “Party”), effective as of March 15, 2023 (the “Effective Date”). RECITALS WHEREAS, the Company currently emp