CG Oncology (CGON) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Company overview and clinical pipeline

• Focuses on bladder-sparing therapeutics for bladder cancer, with lead asset Cretostimogene in phase III for BCG-unresponsive NMIBC and a second pivotal trial (PIVOT-006) in intermediate-risk, BCG-naive patients.

• BOND-003 study has FDA Fast Track and breakthrough therapy designations, with additional data expected by year-end.

Clinical data and efficacy

• Reported 75% complete response (CR) rate at AUA, with 43% durable CR at 12 months, the highest monotherapy response in this space.

• Over 200 patients treated with no grade 3+ adverse events and 0% treatment-related discontinuation.

• Unique oncolytic immunotherapy mechanism provides direct tumor cell lysis and potent antitumor immune response.

Safety, monitoring, and reinduction

• No unforeseen safety events observed; post-treatment monitoring not expected in the label.

• Reinduction allowed for persistent disease at 3 months, with over 50% conversion to CR from 3 to 6 months.

• Reinduction is MOA-driven, reflecting delayed immune response typical of immunotherapy.