Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒As of May 9, 2025, the registrant had76,225,308shares of common stock, $0.0001 par value per share, outstanding. Table of Contents PART I.FINANCIAL INFORMATION Item 1.Condensed Consolidated Financial Statements (unaudited) Condensed Consolidated Balance Sheets Condensed Consolidated Statements of Operations and Comprehensive Loss Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity(Deficit) Condensed Consolidated Statements of Cash Flows Notes to Condensed Consolidated Financial StatementsItem 2.Management’s Discussion and Analysis of Financial Condition and Results of OperationsItem 3.Quantitative and Qualitative Disclosures About Market RiskItem 4.Controls and Procedures PART II.OTHER INFORMATION Item 1.Legal ProceedingsItem 1A.Risk FactorsItem 2.Unregistered Sales of Equity Securities and Use of ProceedsItem 3.Defaults Upon Senior SecuritiesItem 4.Mine Safety DisclosuresItem 5.Other InformationItem 6.Exhibits PART I—FINANCIAL INFORMATION CondensedConsolidated Balance Sheets(In thousands, except share and per share amounts) CG ONCOLOGY, INC. Condensed Consolidated Statements ofOperations and Comprehensive Loss(In thousands, except share and per share amounts) CG ONCOLOGY, INC. CG ONCOLOGY, INC. 1. Description of Business and Basis of Presentation Description of Business CGOncology,Inc.(the Company)is a late-stage clinical biopharmaceutical company focused on developing andcommercializing its product candidate, cretostimogene grenadenorepvec, for patients with bladder cancer. The Company is at aclinical stage and does not project to generate significant revenues if and until the U.S. Food and Drug Administration (FDA) On January 11, 2024, the Company’s board of directors approved a 1-for-9.535reverse stock split of its issued andoutstanding common stock and stock option awards which was effected on January 16, 2024.All issued and outstanding shares ofcommon stock, stock option awards and per share data have been adjusted in these condensed consolidated financial statements, on On January 29, 2024, the Company completed the closing of its initial public offering (IPO) of23,000,000shares of commonstock, which included the exercise in full by the underwriters of their option to purchase3,000,000additional shares, at a price of$19.00per share. The common stock began trading on the Nasdaq Global Market on January 25, 2024, under the symbol "CGON".The Company received net proceeds of $399.6million, after deducting discounts and commissions and other offering expenses. Inaddition, as a result of its IPO, the Company’s redeemable convertible preferred stock converted into common stock concurrently In February 2025, the Company's wholly owned subsidiary, SafeGuard Healthcare, LLC, established a note receivable in theprincipal amount of $25.0million through a convertible promissory note (Note) from SP Healthcare SPV I, LLC (SPV). The SPVused the proceeds from the Note to make an investment in Biovire, Inc. for the purpose of Biovire acquiring substantially all of the Basis of Presentation The accompanying unaudited condensed consolidated financial statements as of March 31, 2025 and for the three monthsended March 31, 2025 and 2024 have been prepared in accordance with U.S. generally accepted accounting principles (U.S.GAAP) for interim financial information and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission(SEC). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements.Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unauditedcondensed consolidated financial statements and the notes accompanying them should be read in conjunction with the Company’s The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date CG ONCOLOGY, INC. Liquidity and Management’s Plans As of March 31, 2025, the Company had approximately$688.4millionof cash, cash equivalents and marketable securitiesand working capital of approximately$678.6million. The Company has a relative