CG Oncology, Inc. filings document the public-company record of a late-stage clinical biopharmaceutical issuer focused on cretostimogene grenadenorepvec for non-muscle invasive bladder cancer. Recent Form 8-K reports disclose financial results, Regulation FD materials, clinical-program updates, FDA-related communications, executive appointments, board changes and other material events.
The company's SEC record also includes proxy disclosures on board structure, compensation and stockholder matters, along with registration and prospectus materials related to common-stock offerings under an open market sale agreement. These filings describe CG Oncology's Nasdaq-listed common stock, capital-raising activity, governance framework, clinical development priorities and risk-related disclosure context.
CG Oncology, Inc. filed a current report to let investors know it plans to discuss an updated corporate presentation at the 23rd Annual Morgan Stanley Global Healthcare Conference on September 9, 2025. The presentation, dated the same day, is provided as Exhibit 99.1 and is incorporated by reference in the report.
The company emphasizes that the information in the presentation is being furnished under Regulation FD and is not considered "filed" for purposes of certain liability provisions under U.S. securities laws, unless specifically incorporated into other documents. CG Oncology also notes it has no obligation to update the presentation, though future updates may be made through additional SEC filings or other public disclosures.
James J. Mulay, a director of CG Oncology, Inc. (CGON), exercised a fully vested director stock option to buy 27,015 shares at an exercise price of $0.60 on 09/05/2025. The same day he sold a total of 27,015 common shares under a Rule 10b5-1 trading plan adopted June 6, 2025, at weighted-average prices ranging across four blocks: $30.47, $31.42, $32.64, and $33.22. Following these transactions the reporting person reports 0 shares beneficially owned. Sales were effected pursuant to the 10b5-1 plan and the option was fully vested.
CG Oncology, Inc. (CGON) filing a Form 144 to report a proposed sale of common stock. The notice shows 27,015 shares to be sold through Morgan Stanley Smith Barney LLC on 09/05/2025 on NASDAQ with an aggregate market value of $835,844.10 and 76,247,581 shares outstanding. The securities were acquired on 09/05/2025 by exercise of stock options from the issuer, paid in cash. The filer reports no securities sold in the past three months and includes the standard representation that the seller is not aware of undisclosed material adverse information.
CG Oncology, Inc. reported updated efficacy and safety data from Cohort C of its BOND-003 Phase 3 trial of cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer. The 24-month complete response rate was 41.8%, with 46 of 110 patients in complete response, including 12 additional patients maintaining response at 24 months. Overall, 75.5% of patients achieved a complete response at any time, and the estimated 12- and 24-month duration-of-response rates were 64.1% and 58.3%, respectively, with a median duration of response of 28 months that is still ongoing.
Progression control and tolerability were notable, with 96.6% of patients free from progression to muscle invasive disease at 24 months. Cretostimogene was generally well-tolerated, with no Grade 3 or higher treatment-related adverse events or deaths, a median resolution time of one day for treatment-related side effects, and 97.3% of patients completing all expected treatments, supporting favorable adherence. Common treatment-related events included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.
CG Oncology director Hong Fang Song (filing signed by attorney-in-fact) reported multiple sales of common stock on 09/03/2025 under a written plan. The Form 4 shows discrete dispositions of 69,695, 30,105, 100, 100 and 613,928 shares, totaling 713,928 shares sold. Two groups are identified as record holders: Charming Jade Limited and Unique Diamond Investments Limited, and Ms. Song discloses indirect beneficial ownership through a chain of entities she ultimately owns. The filing notes weighted average price ranges for portions of the sales and indicates the transactions were made pursuant to a Rule 10b5-1 plan.
Leonard E. Post, a director of CG Oncology, Inc. (CGON), reported transactions on Form 4 dated 09/04/2025 reflecting activity on 09/03/2025. The filing shows purchase and sale activity plus option holdings. Mr. Post acquired 1,000 shares of common stock at $0.60 per share and simultaneously sold 1,000 shares under a Rule 10b5-1 plan at $28.00 per share. The director holds a fully vested stock option exercisable at $0.60 covering 1,000 shares and, following the reported transactions, beneficially owns 125,077 shares directly. The sale was executed pursuant to a 10b5-1 trading plan adopted on September 6, 2024.
CG Oncology (CGON) Form 144: The filer notifies a proposed sale of 100,000 shares of common stock through Merrill Lynch on NASDAQ with an approximate sale date of 09/03/2025. The aggregate market value is reported as $2,746,000.00 and the company reports 76,247,581 shares outstanding, implying the filing relates to a transaction representing a known, disclosed portion of outstanding equity.
The securities were acquired on 01/25/2024 in a private placement from the Company and paid in cash the same day. No securities were reported sold by the person in the past three months. The filing includes the standard signature representation that the seller is not aware of undisclosed material adverse information.
CG Oncology, Inc. (CGON) reported a Form 144 notice indicating a proposed sale of 1,000 common shares by a person exercising stock options on 09/03/2025. The shares were acquired and paid for in cash on the same date through exercise of stock options from the issuer. The proposed sale lists Morgan Stanley Smith Barney LLC as the broker and an aggregate market value of $27,460 based on the filing. The filer also disclosed two prior 10b5-1 plan sales on 07/17/2025 totaling 2,000 shares with gross proceeds of $56,000. The form includes the standard representation that the seller is unaware of undisclosed material adverse information.
CG Oncology, Inc. reported consolidated cash, cash equivalents and marketable securities of approximately $661.1 million and working capital of approximately $642.6 million, giving the company an explicit runway the company says extends into the first half of 2028. The company recorded a net loss of $75.9 million for the six months ended June 30, 2025, compared with a $35.8 million loss in the prior-year period, driven by higher research and development spending of $58.8 million and increased general and administrative costs of $32.2 million during the six months.
The balance sheet shows marketable securities of $646.4 million and a $26.0 million note receivable. Significant corporate developments disclosed include an Open Market Sale Agreement for up to $250.0 million (no sales as of June 30, 2025), a July 20, 2025 conversion and consolidation of an SPV, and a July 29, 2025 jury verdict unanimously rejecting ANI Pharmaceuticals' unjust enrichment claims so no royalty or damages are due under the disputed agreement.
CG Oncology, Inc. filed a current report to note that it issued a press release on August 8, 2025 announcing its financial results for the quarter ended June 30, 2025. The press release is furnished as Exhibit 99.1, meaning it is provided for informational purposes and is not treated as filed for liability purposes under the Exchange Act. The company’s common stock continues to trade on the Nasdaq Global Select Market under the symbol CGON.