CG Oncology (CGON) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Program overview and clinical development

• Cretostimogene is being developed as an oncolytic immunotherapy for non-muscle invasive bladder cancer, with evidence supporting its use across high-risk, BCG-unresponsive, BCG-exposed, BCG-naive, and intermediate-risk settings.

• A third phase III trial is planned in BCG-exposed high-risk patients, comparing cretostimogene plus gemcitabine to gemcitabine monotherapy, with positive FDA alignment on the trial concept.

• Sequential administration of cretostimogene and gemcitabine is favored for tolerability, with induction and maintenance regimens tailored for high-risk disease.

• PIVOT-006, an event-driven phase III study in intermediate-risk patients, has nearly reached its target events, with top-line results anticipated soon.

• The trial aims for a clinically meaningful 30% relative risk reduction, and will analyze FGFR3 alterations to inform efficacy in different tumor subtypes.

Manufacturing, regulatory, and filing updates

• All BLA-enabling manufacturing studies, including process characterization and validation, are complete, with robust and scalable production processes in place.

• The remaining work focuses on compiling documentation for Module 3 of the BLA, which will support multiple future filings.

• No scale changes are planned for the initial commercial launch, ensuring sufficient inventory.

• The company has invested in inspection readiness for its fill and finish facility, anticipating FDA inspection post-BLA submission.

• Internal discussions considered aligning BLA submission with J-code cycles, but priority is on timely market entry for BCG-unresponsive disease.

Market dynamics and adoption strategies

• Market adoption for high-risk NMIBC therapies is influenced by J-code assignment, with revenue ramping post-J-code and early adoption often seen in academic centers.

• The company leverages Medicare claims data to identify early adopters and tailors outreach to both academic and community providers.

• Workflow compatibility is a key selling point, as cretostimogene administration aligns with established BCG procedures, minimizing disruption for practices.

• The prevalence of BCG-exposed patients is larger than BCG-unresponsive, with community settings housing more BCG-exposed and intermediate-risk patients.

• The company is monitoring competitor launches and learning from their adoption curves to optimize its own strategy.