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

Company overview and lead asset

• Focuses on bladder-sparing therapeutics for bladder cancer, with lead asset Cretostimogene in phase III trials for BCG-unresponsive and intermediate-risk NMIBC patients.

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

Clinical efficacy and safety

• 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 or higher adverse events and 0% treatment-related discontinuation.

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

Regulatory and trial design insights

• Monitoring requirements post-administration are not expected to be included in the label due to strong safety data.

• Reinduction at 3 months for persistent disease shows over 50% conversion to CR between 3-6 months, supporting delayed immune response.

• Final BOND-003 results will extend survival data beyond 12 months, focusing on long-term bladder preservation and safety.