CG Oncology (CGON) RBC Capital Markets Global Healthcare Conference 2026 summary

Key clinical data and trial updates

• Recent Cohort CX data showed higher efficacy for the cretostimogene and gemcitabine combination, with a 15-point higher CR rate compared to previous datasets, and similar efficacy between concurrent and sequential dosing schedules.

• Both regimens demonstrated a favorable safety profile, with no grade 3 or higher side effects observed, and the combination maintained the chemo-sparing advantage of cretostimogene.

• The positive signal from Cohort CX will inform the design of a randomized phase III trial in BCG-exposed patients, targeting a population of about 50,000.

• PIVOT-006, a trial comparing cretostimogene to TURBT in intermediate-risk NMIBC, is event-driven and expected to report data in the coming months, with a broad label anticipated.

• The expected effect size for PIVOT-006 is a hazard ratio of 0.7, with reference to the ATLAS trial's 50% at 12 months as a benchmark.

Market positioning and competitive landscape

• Cretostimogene aims to become backbone therapy across NMIBC, with data supporting use in unresponsive, high-risk, exposed, and soon intermediate-risk settings.

• The NMIBC market is segmented, with distinct competitors in high-risk, BCG-unresponsive, and BCG-naive populations; cretostimogene is 18+ months ahead in intermediate-risk.

• The addressable market includes 150,000 patients across intermediate-risk, BCG-unresponsive, BCG-exposed, and naive populations.

• Launch strategy focuses on establishing a presence in unresponsive patients, then expanding to intermediate-risk and exposed populations.

Manufacturing, regulatory, and launch readiness

• Manufacturing capacity is set at 50,000 vials, with clinical and commercial scales aligned to avoid scale-up issues; future scale-up planned for additional indications.

• Clinical and non-clinical BLA modules are complete; CMC module and facility upgrades are underway, with full BLA submission targeted for Q4 this year.

• Sequential filings are planned: high-risk BLA by year-end, intermediate-risk filing in 2027, both sharing CMC and non-pharm packages.

• Launch readiness includes a field team of 75, ongoing engagement with clinicians, payers, and health systems, and established reimbursement support services.