Results of Operations and Financial Condition · Other Events
Item 2.02 Results of Operations and Financial Condition. On August 6, 2026, CG Oncology, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.…
Filed Aug 6, 2026Accepted Aug 6, 2026, 8:30 AM EDTCIK 1991792Accession 0001193125-26-336886
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
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Item 2.02Item 2.02 - Results of Operations
Item 2.02
Results of Operations and Financial Condition.
On August 6, 2026, CG Oncology, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On August 6, 2026, the Company filed Amendment No. 2 to Prospectus (the “Amendment No. 2”) with the Securities and Exchange Commission (the “SEC”) for the offer and sale of shares of its common stock, par value $0.0001 per share (the “Shares”), pursuant to that certain Open Market Sale Agreement, dated March 28, 2025, by and between the Company and Jefferies LLC (the “Sale Agreement”), to increase the Shares available to be sold pursuant to the terms of the Sale Agreement by an additional $500.0 million (the “Additional Shares”). The Amendment amends and supplements the information in the prospectus dated March 28, 2025 (the “Prospectus”) filed with the SEC as part of the Company’s Registration Statement on Form S-3ASR (File No. 333-286230) and Amendment No. 1 to Prospectus dated January 13, 2026 (the “Amendment No. 1”), pursuant to which the Company previously registered and sold approximately $550.0 million of shares of the Company’s common stock pursuant to the Sale Agreement.
The Amendment should be read in conjunction with the Prospectus and Amendment No. 1, and is qualified by reference thereto, except to the extent that the information therein amends or supersedes the information contained in the Prospectus and Amendment No. 1. The Amendment is not complete without, and may only be delivered or utilized in connection with, the Prospectus, Amendment No. 1 to Prospectus and any future amendments or supplements thereto.
A copy of the opinion of Cooley LLP relating to the validity of the Additional Shares is attached as Exhibit 5.1 hereto.
Filed exhibits (1)
EX-99.1 (by filename) ck0001991792-ex99_1.htm
EX-99.1
3
ck0001991792-ex99_1.htm
EX-99.1
EX-99.1
Exhibit 99.1
CG Oncology Reports Second Quarter 2026 Financial Results and Provides Business Updates
• PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC anticipated in the near-term
• BLA completion for HR BCG-unresponsive NMIBC expected fourth quarter 2026
• Phase 3 BOND-003 Cohort C Study Results published in The Lancet Oncology, further validating the strength of the clinical evidence supporting cretostimogene
• Well-positioned to deliver on key milestones with approximately $1.0 billion cash, cash equivalents and marketable securities sufficient to fund operations through 2029
DALLAS, Texas, August 6, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the second quarter ended June 30, 2026, and provided business updates.
“This quarter we have made significant progress across our clinical, regulatory, manufacturing and commercial-readiness initiatives, positioning the Company for long-term success. PIVOT-006 has accrued the vast majority of the target events, and we look forward to sharing topline results s…