CG oncology Inc 2026年季度报告

CG Oncology, Inc. 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 submit 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 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.ExhibitsSignatures PART I—FINANCIAL INFORMATION 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) CG ONCOLOGY, INC.Condensed Consolidated Statements of Cash Flows(In thousands) CG ONCOLOGY, INC. 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, 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 and In February 2025, SafeGuard Healthcare, LLC (SafeGuard), a wholly owned subsidiary of the Company, purchased a $26.8 millionconvertible note, including accrued interest, from SP Healthcare SPV I, LLC (the SPV). The SPV used the proceeds from the Note toinvest and acquire substantially all of the assets of Biovire, Inc. (Biovire), a contract manufacturing organization that producescretostimogene for the Company. In July 2025, SafeGuard converted the Note (the Conversion Event) and obtained control of both the Basis of Presentation The accompanying unaudited condensed consolidated financial statements as of March 31, 2026 and for the three months endedMarch 31, 2026 and 2025 have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interimfinancial 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 thedisclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed consolidatedfinancial statements and the notes accompanying them should be read in conjunction with the Company’s audited financial statements for The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptionsthat affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial Liquidity and Management’s Plans As of March 31, 2026, the Company had approximately $1,076.2 million of cash, cash equivalents and marketable securities andworking capital of approximately $1,066.9 million. The Company has a relatively limited operating history, and the revenue and incomepotential of the Company’s business and market are unproven. The Company has experienced net losses and negative cash flows fromoperations since its inception and, as of March 31, 2026, the Company had an accumulated deficit of $439.2 million. During the threemonths ended March 31, 2026, the Company incurred a net loss of $60.2 million and had negative cash flows fr