Durable bladder cancer responses in CG Oncology (NASDAQ: CGON) BOND-003

Rhea-AI Filing Summary

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.

Insights

Oncology clinical-trial analyst

BOND-003 shows durable bladder cancer responses with clean safety.

The updated BOND-003 Cohort C data for cretostimogene in high-risk BCG-unresponsive NMIBC show a 24-month complete response rate of 41.8%, with 46 of 110 patients in sustained complete response. Overall, 75.5% of patients achieved complete response at any time, and the median duration of response of 28 months is ongoing, which supports the company’s claim of strong durability.

From a risk-benefit perspective, the safety profile appears favorable in this dataset. As of the June 23, 2025 cutoff, there were no Grade 3 or higher treatment-related adverse events or deaths, most treatment-related events resolved in a median of one day, and 97.3% of patients completed all expected treatments. Additionally, 96.6% of patients remained free from progression to muscle invasive disease at 24 months, which is important in a high-risk population.

Future interpretation will depend on full Phase 3 outcomes and regulatory interactions, but these results, including estimated 12- and 24-month duration-of-response rates of 64.1% and 58.3%, respectively, help frame cretostimogene’s potential role in BCG-unresponsive NMIBC as more data and analyses are disclosed in subsequent company communications.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

0001991792false00019917922025-09-052025-09-05

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 05, 2025

CG Oncology, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-41925	37-1611499
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
400 Spectrum Center Drive Suite 2040
Irvine, California				92618
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (949) 409-3700

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		CGON		The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

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 new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On September 5, 2025, CG Oncology, Inc. (the “Company”) issued a press release entitled “CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months”. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

On September 5, 2025, the Company posted an updated corporate presentation on the Company’s website. Investors may access the presentation by visiting the “Investor Relations” section of the Company’s website at www.cgoncology.com. The Company plans to use its website to disseminate future updates to its corporate presentation and does not intend to file or furnish a Form 8-K alerting investors each time the presentation is updated.

The information furnished under this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filing.

By furnishing the information in this Item 7.01, the Company makes no admission as to the materiality of Item 7.01 in this report or the presentation available on the Company’s website. The information contained in the corporate presentation is summary information that is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Item 7.01, although it may do so from time to time as its management believes is appropriate or as required by applicable law. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases, by updating its website or through other public disclosure.

Item 8.01 Other Events.

On September 5, 2025, the Company reported updated data from Cohort C of the BOND-003 Phase 3 clinical trial evaluating the efficacy and safety of cretostimogene as monotherapy in patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). These updated data showed 12 additional patients with NMIBC were in complete response (CR) at 24 months. The 24-month complete response landmark rate of 41.8% (CR rate observed in 46 out of 110 patients) for cretostimogene monotherapy reaffirms the best-in-disease durability that the Company announced at the American Urological Association Annual Meeting in April 2025. The study reported 75.5% CR at any time and 41.8% at 24 months with 46 confirmed CRs as of the cutoff date of June 23, 2025. The estimated 12- and 24-month duration of response (DOR) rates are 64.1% and 58.3%, respectively. Median DOR is 28 months and is ongoing. Notably, 96.6% of patients were free from progression to muscle invasive disease at 24 months. Cretostimogene has been generally well-tolerated in the trial as of the cutoff date of June 23, 2025. There were no Grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. Patients who experienced TRAEs of any grade had a median resolution time of one day. No treatment-related discontinuation of cretostimogene was observed, and 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance. The most common TRAEs (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

Forward Looking Statements

The Company cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients and its potential to have best-in-disease durability and tolerability and to meaningfully improve patient outcomes, and the importance of the data as they relate to addressing bladder cancer. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in our business, including, without limitation: additional patient data related to cretostimogene that continues to become available may be inconsistent with the data produced as of the data cutoff, and further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; potential delays in the commencement, enrollment and completion of clinical trials; competitive developments with respect to current and other investigational NMIBC treatments may adversely affect the commercial opportunity of cretostimogene; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, as supplemented in Part II, Item 1A, “Risk Factors” of our quarterly report on Form 10-Q for the quarter ended June 30, 2025, and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release, dated September 5, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CG Oncology, Inc.
Date: September 5, 2025	By: /s/ Josh Patterson
	Name: Josh Patterson
	Title: General Counsel and Chief Compliance Officer

FAQ

What did CG Oncology (CGON) announce in this 8-K filing?

CG Oncology announced updated data from Cohort C of its BOND-003 Phase 3 trial of cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer, highlighting long-term complete response durability and safety.

What are the key efficacy results from CGON's BOND-003 Cohort C data?

The 24-month complete response rate was 41.8%, with 46 of 110 patients in complete response. The study reported 75.5% complete response at any time and a median duration of response of 28 months, which is ongoing.

How durable were responses to cretostimogene in CG Oncology's trial?

The estimated duration-of-response rates were 64.1% at 12 months and 58.3% at 24 months, and the median duration of response was 28 months and ongoing as of the June 23, 2025 cutoff.

What did CGON report about progression to muscle invasive disease?

CG Oncology reported that 96.6% of patients in BOND-003 Cohort C were free from progression to muscle invasive bladder cancer at 24 months, indicating strong disease control in this high-risk setting.

How was cretostimogene tolerated in the BOND-003 trial?

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.

What were the most common treatment-related adverse events reported by CG Oncology?

The most common treatment-related adverse events (occurring in at least 10% of patients) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

Where can investors find CG Oncology's updated corporate presentation?

Investors can access CG Oncology’s updated corporate presentation in the Investor Relations section of its website at www.cgoncology.com, where the company plans to post future updates.