CG Oncology Inc 2025年度报告

Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YESշNOն 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 Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days. YESշNOն Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).YESշNOն Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or anemerging 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 filerնSmaller reporting companyնEmerging growth companyն Large accelerated filerշNon-accelerated filerն If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any newor revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.նIndicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared orissued its audit report.շ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in thefiling reflect the correction of an error to previously issued financial statements.ն Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation receivedby any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).ն Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YESնNOշ As of June 30, 2025 (the last trading day of the registrant’s most recently completed second quarter), the aggregate market value of the registrant’scommon stock held by non-affiliates of the registrant was approximately $1.7 billion, based on the closing price of the registrant’s common stock on theNasdaq Global Select Market of 26.00 per share.As of February 25, 2026, the registrant had 84,435,200 shares of common stock ($0.0001 par value) outstanding. Portions of the registrant’s Proxy Statement for its 2026 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Reporton Form 10-K to the extent stated herein. Such Proxy Statement will be filed with the Securities and Exchange Commission within 120 days of theregistrant’s fiscal year ended December 31, 2025. Table of Contents Forward-Looking Statements and Market DataRisk Factors Summary PART I Item 1.Business4Item 1A.Risk Factors38Item 1B.Unresolved Staff Comments101Item 1C.Cybersecurity101Item 2.Properties102Item 3.Legal Proceedings102Item 4.Mine Safety Disclosures103 Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases ofEquity Securities104Item 6.[Reserved]106Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations107Item 7A.Quantitative and Qualitative Disclosures About Market Risk120Item 8.Financial Statements and Supplementary Data121Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure156Item 9A.Controls and Procedures156Item 9B.Other Information159Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections159 PART III Item 10.Directors, Executive Officers and Corporate Governance160Item 11.Executive Compensation160Item 12.Security Ownership of Certain Beneficial Owners and Management and Related StockholderMatters160Item 13.Certain Relationships and Related Transactions, and Director Independence160Item 14.Principal Accounting Fees and Services160 PART IV Item 15.Exhibits and Financial Statement Schedules161Item 16.Form 10-K Summary161 This Annual Report on Form 10-K (Annual Report) contains forward-looking statements within the meaningof Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the SecuritiesExchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical factscontained in this Annual Report