CG Oncology Inc 2026年季度报告

OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from_____________________to_____________________Commission File Number: 001-41925 CG Oncology, Inc.(Exact Name of Registrant as Specified in its Charter) Registrant’s telephone number, including area code: (949) 409-3700 Title of each classTradingSymbol(s)Name of each exchange on which registeredCommon Stock, par value $0.0001 per shareCGONThe Nasdaq Global Select Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Actof 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to suchfiling requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submitsuch files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growthcompany” in Rule 12b-2 of the Exchange Act. Accelerated filer☐Smaller reporting company☐Emerging growth company☐ Large accelerated filer☒Non-accelerated filer☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying withany 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 6, 2026, the registrant had 88,202,473 shares 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 SheetsCondensed Consolidated Statements of Operations and Comprehensive LossCondensed Consolidated Statements of Stockholders’ EquityCondensed Consolidated Statements of Cash FlowsNotes 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 Proceedings29Item 1A.Risk Factors29Item 2.Unregistered Sales of Equity Securities and Use of Proceeds30Item 3.Defaults Upon Senior Securities30Item 4.Mine Safety Disclosures30Item 5.Other Information30Item 6.Exhibits31Signatures32 CG ONCOLOGY, INC. Condensed Consolidated Balance Sheets(In thousands, except share and per share amounts) CG ONCOLOGY, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share amounts)(unaudited) CG ONCOLOGY, INC. Condensed Consolidated Statements of Stockholders’ Equity(In thousands, except share amounts)(unaudited) CG ONCOLOGY, INC. Condensed Consolidated Statements of Cash Flows(In thousands)(unaudited) CG ONCOLOGY, INC. Notes to Condensed Financial Statements(Unaudited) 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 commercializingits product candidate, cretostimogene grenadenorepvec, for patients with bladder cancer. The Company is at a clinical stage and does notproject to generate significant revenues if and until the U.S. Food and Drug Administration (FDA) approves its product candidate,cretostimogene, and the Company is able to commercialize this product candidate. On March 28, 2025, the Company entered into an Open Market Sale AgreementSM(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.As of March 31, 2026, the Company has completed the Jefferies Sales Agreement, having received gross proceeds of $550.0 million andnet aggregate proceeds of $538.5 million under the Jefferies Sales Agreement, after deducting discounts and commissions and otheroffering expenses.During the three months ended March 31, 2026, 6,941,407 shares were sold under the Jefferies Sales Agreement, at aweighted-average price of $57.56 per share, and the Company received net proceeds of $391.4 million, after deducting discounts andcommissions and other offering expenses. In February 2025, SafeGuard Healthcare, LLC (SafeGuard), a wholly owned subsidiary of the Company, purchased a $26.8 millionconvert