CG Oncology (NASDAQ:CGON) executives said the company remains on track to complete a rolling biologics license application for cretostimogene in BCG-unresponsive high-risk non-muscle invasive bladder cancer by the fourth quarter, while reiterating expectations for top-line data from a separate Phase 3 trial in the first half of the year.
Speaking at the 2026 Bank of America Healthcare Conference, Chairman and Chief Executive Officer Arthur Kuan said the company had narrowed its guidance for completing the first BLA submission after recent communications with the U.S. Food and Drug Administration. The submission is for the company’s first indication in BCG-unresponsive high-risk non-muscle invasive bladder cancer, or NMIBC.
Kuan said cretostimogene’s breakthrough therapy designation allows for more frequent interaction with the FDA, and that recent discussions provided “alignment and clarity” specific to the program. He said facility inspection readiness, particularly around a fill-and-finish facility acquired last year, remains a major focus.
“We believe everything is going on track and according to plan,” Kuan said.
BLA Timing and PIVOT-006 Plans
Kuan said CG Oncology still expects top-line data from the PIVOT-006 trial, a Phase 3 study in intermediate-risk NMIBC, could be available in the first half of the year. He cautioned that the trial is event-based, making the exact timing difficult to pinpoint.
For PIVOT-006, Kuan said the company plans to file a second BLA after completing the first submission in BCG-unresponsive disease. He said the two applications will share some modules, including manufacturing, but the company needs to wait for the 12-month response rate for all patients in PIVOT-006, followed by data cleanup and preparation of the submission package. CG Oncology currently anticipates completing the PIVOT-006 BLA in 2027.
Kuan said there is currently no FDA-approved adjuvant therapy for intermediate-risk NMIBC in the United States. Based on physician conversations, he said CG Oncology has consistently described a 30% relative risk reduction as the minimum clinically meaningful bar for the trial.
He added that the company expects the control arm to be in the roughly 50% recurrence-free survival range at around 12 to 15 months, while noting caveats around historical comparisons. Kuan pointed to UroGen’s ATLAS trial as one proxy, but said no trial has perfectly matched the AUA/SUO definition of intermediate-risk NMIBC used in PIVOT-006.
Competitive Positioning and Commercial Preparation
Kuan said CG Oncology hopes to secure a differentiated label that emphasizes durability of response, noting that management believes durability will matter to physicians and patients. He said anything beyond a 12-month durability label seen in a competing product would represent upside for the company.
President and Chief Operating Officer Ambaw Bellete said CG Oncology has been preparing for a potential commercial launch by studying other launches in the bladder cancer market. He said the company’s field medical team has been engaging in scientific exchange with future commercial customers for about 18 months, while health system directors have been profiling accounts and working to understand buying processes.
Bellete said the company sees potential eligible patients across several categories, including patients following BCG and those who may have failed other therapies such as TAR-200, gemcitabine or pembrolizumab.
Management also highlighted what it views as a practical advantage for cretostimogene’s administration. Bellete contrasted cretostimogene, which he described as intravesically delivered by a nurse or medical assistant using a catheter, with TAR-200, which he said requires cystoscopic procedures for placement and removal every three months.
Bellete said CG Oncology intends to supply cretostimogene to centers on a just-in-time basis, while also offering storage flexibility. He said the product can be kept in a normal refrigerator for more than four weeks after receipt and can remain in the box until the patient arrives for up to five days. He said preparation and administration take about 15 to 20 minutes.
He also said the company aims to have a two-step process in the label, noting that patients in Cohort CX and PIVOT-006 underwent the two-step process rather than a five-step process.
CORE-008 Cohort CX Data Expected at AUA
Kuan said CG Oncology will present additional data from CORE-008 Cohort CX at the American Urological Association meeting. The study evaluates cretostimogene plus gemcitabine in BCG-exposed and BCG-unresponsive patients.
The trial enrolled slightly more than 50 patients, Kuan said. While the company initially intended to enroll BCG-exposed patients, it also enrolled some BCG-unresponsive patients. Kuan said the company may not break out the groups separately but will comment on responses in both categories.
He said one goal of the study is to determine whether cretostimogene plus gemcitabine should be given concurrently or sequentially. He also said investors should watch complete response data in carcinoma in situ at early time points.
Kuan described the BCG-exposed market as about 50,000 patients, roughly twice the size of the company’s initial label opportunity, and said the population currently has no labeled therapy.
Manufacturing Capacity and Pricing Comments
Kuan said CG Oncology can currently supply up to 50,000 vials of cretostimogene per year and has been investing in manufacturing capacity since its initial public offering. He said the company’s long-term goal is to increase capacity tenfold.
On pricing, Kuan said the BCG-unresponsive regimen involves about 30 doses over three years, while the intermediate-risk setting involves 14 doses over one year. He said pricing will be considered on a per-dose basis and by indication, rather than only by total treatment cost.
Kuan said the company remains focused on intravesical combinations that can be administered in the urology clinic. Discussing prior data with pembrolizumab, he said the combination showed an approximately 50% two-year complete response rate in a 35-patient study, but noted that cretostimogene monotherapy later showed a 42% rate at two years, while pembrolizumab carries systemic side effects.
“The bar is definitely high when it comes to a checkpoint,” Kuan said.
About CG Oncology (NASDAQ:CGON)
CG Oncology, Inc (NASDAQ: CGON) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibody-based immunotherapies for the treatment of solid tumor cancers. The company leverages a platform-driven approach to identify and optimize antibody candidates that engage key immune checkpoints and co-stimulatory pathways within the tumor microenvironment. Its pipeline encompasses multiple preclinical programs alongside early-phase clinical trials designed to assess safety, dosing and preliminary anti-tumor activity.
Headquartered in South San Francisco, California, CG Oncology conducts clinical research primarily in the United States, collaborating with leading academic medical centers and contract research organizations to advance its lead candidates.
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