Business Description

1. Description of Business and Basis of Presentation Description of Business CG Oncology, Inc. (the Company) is a late-stage clinical biopharmaceutical company focused on developing and commercializing its product candidate, cretostimogene grenadenorepvec, for patients with bladder cancer. The Company is at a clinical stage and does not project to generate significant revenues if and until the U.S. FDA approves its product candidate, cretostimogene, and the Company is able to commercialize this product candidate. On January 11, 2024, the Company’s board of directors approved a 1-for- 9.535 reverse stock split of its issued and outstanding common stock and stock option awards which was effected on January 16, 2024. All issued and outstanding shares of common stock, stock option awards and per share data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented. The par value of the common stock and preferred stock was not adjusted as a result of the reverse stock split. The conversion ratios for each series of the Company's redeemable convertible preferred stock and the shares of common stock underlying outstanding stock options and other equity instruments were all proportionately adjusted, as needed. On January 29, 2024, the Company completed the closing of its initial public offering of 23,000,000 common shares at a price of $ 19.00 per share, including the exercise in full by the underwriters of their option to purchase an additional 3,000,000 shares of common stock. The common shares began trading on the Nasdaq Global Market on January 25, 2024, under the symbol “CGON”. The Company received net proceeds of $ 399.6 million , after deducting discounts and commissions and other offering expenses. In addition, as a result of its initial public offering, the Company’s redeemable convertible preferred stock converted into common stock concurrently with the initial public offering. In December 2024, the Company completed a follow-on offering of 8,500,000 common shares at a price of $ 28.00 per share, including the exercise in full by the underwriters of their option to purchase an additional 1,200,000 shares of common stock. The Company received net proceeds of $ 223.1 million , after deducting discounts, commissions and other offering expenses. On March 28, 2025, the Company entered into an Open Market Sale Agreement SM (Jefferies Sales Agreement) with Jefferies LLC, as agent, pursuant to which the Company may offer and sell, from time to time through Jefferies, shares of the Company's common stock. Through December 31, 2025, the Company received net proceeds of $ 147.1 million under the Jefferies Sales Agreement, after deducting discounts and commissions and other offering expenses. In February 2025, SafeGuard Healthcare, LLC (Safeguard), a wholly owned subsidiary of the Company, purchased a $ 26.8 million convertible note, including accrued interest, from SP Healthcare SPV I, LLC (the SPV). The SPV used the proceeds from the Note to invest and acquire substantially all of the assets of Biovire, Inc. (Biovire), a contract manufacturing organization that produces cretostimogene for the Company. In July 2025, Safeguard converted the Note (the Conversion Event) and obtained control of both the SPV and Biovire. Refer to Note 17 for additional details on the Conversion Event. Basis of Presentation The accompanying consolidated financial statements are prepared in conformity with U.S. generally accepted accounting principles (GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB). Liquidity As of December 31, 2025, the Company had approximately $ 742.2 million of cash, cash equivalents and marketable securities and working capital of approximately $ 728.6 million . The revenue and income potential of the Company’s business and market are unproven. The Company has experienced net losses and negative cash flows from operations since its inception and, as of December 31, 2025, the Company had an accumulated deficit of $ 379.0 million . During the year ended December 31, 2025, the Company incurred a net loss of $ 161.0 million and negative cash flows from operations of $ 132.3 million .…