Item 7.01 Regulation FD Disclosure.
On January 9, 2026, CG Oncology, Inc. (the “Company”) issued a press release entitled “CG Oncology Provides Updated Timeline for PIVOT-006 Phase 3 Topline Data in Intermediate-Risk NMIBC.” The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
On January 9, 2026, the Company posted an updated corporate presentation on the Company’s website. A copy of this presentation is being furnished as Exhibit 99.2 to this Current Report on Form 8-K. Investors may also 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, including Exhibits 99.1 and 99.2, 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 (the “SEC”) made by the Company, regardless of any general incorporation language in such filing.
By furnishing the information in this Item 7.01, including Exhibits 99.1 and 99.2, the Company makes no admission as to the materiality of Item 7.01 in this report. 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 SEC 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, including Exhibits 99.1 and 99.2, 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 SEC, through press releases, by updating its website or through other public disclosure.
Item 8.01 Other Events.
On January 9, 2026, the Company announced an expedited timeline for the topline data readout now expected in the first half of 2026 for the Phase 3 PIVOT-006 clinical trial comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer (“IR NMIBC”). PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines including HG Ta solitary lesions less than 3cm. The intermediate risk population in the United States is estimated to be greater than 50,000 patients.
Additionally, in December 2025, the Company announced the below topline data from BOND-003 Cohort P and first results from CORE-008 Cohort A.
Topline Bond-003 Cohort P Results
Results from the BOND-003 Cohort P clinical trial of cretostimogene monotherapy in patients with BCG-UR papillary-only NMIBC demonstrate encouraging HG-EFS and a consistent, well-tolerated safety profile. The study’s primary endpoint is High-Grade Event-Free Survival (“HG-EFS”). As of the September 1, 2025, data cut-off, in 51 efficacy evaluable patients, Kaplan-Meier estimates of HG-EFS at 3- 6- and 9-months are 95.7% (95% CI 83.8 – 98.9), 84.6% (95% CI 68.6 – 92.9%) and 80.4% (95% CI 62.3-90.4%), respectively.
A favorable safety and tolerability profile was observed with no Grade 3 or greater treatment-related adverse events (“TRAEs”) and no deaths reported. To date, no patients have undergone a radical cystectomy or progressed to MIBC. No treatment-related discontinuation of cretostimogene was observed. There were no missed doses, or dose delays due to TRAE. The most common TRAEs (≥10%) were bladder spasms, dysuria, pollakiuria, and hematuria.
The study has completed enrollment with 56 patients receiving cretostimogene across 35 clinical sites in the United States and Japan.
CORE-008 Cohort A Results
The first results from CORE-008 Cohort A demonstrate that cretostimogene monotherapy has promising clinical efficacy, tolerability, and safety in patients with high-risk, BCG-naïve NMIBC with CIS, compared with outcomes observed in historical BCG-naive trials. The primary endpoint is Complete Response (“CR”) at any time. As of the September 1, 2025, data cut off, the overall CR rate at any time in evaluable patients is 83.7% (41/49) (95% CI 70.3-92.7%) with the original administration achieving a 79.2% CR rate (57.8, 92.9) in 19 out of 24 patients as compared with the optimized administration which resulted in an 88.0% CR rate (68.8, 97.5) in 22 out of 25 patients.
The safety and tolerability profile is consistent with prior clinical trials of cretostimogene. The most common adverse events are low grade and localized to the bladder. There are no related serious adverse events, Grade 3+ adverse events or treatment-related discontinuations. No patients progressed to MIBC or metastatic disease.