CG Oncology (CGON) Investor presentation summary

Market opportunity and disease landscape

• Non-muscle invasive bladder cancer (NMIBC) represents about 75% of newly diagnosed bladder cancer cases, with a multi-billion dollar market potential in the U.S. alone.

• More than 70% of NMIBC market potential is addressed by cretostimogene programs across high- and intermediate-risk patient segments.

• Annualized wholesale acquisition cost (WAC) of approved therapies in high-risk NMIBC ranges from $200K to $690K, with over 150,000 addressable patients.

Clinical program overview and milestones

• Cretostimogene is being evaluated in multiple Phase 2 and 3 trials for high-risk and intermediate-risk NMIBC, including BOND-003, PIVOT-006, and CORE-008.

• Key upcoming milestones include long-term data from BOND-003 Cohort C in 2026, topline data from PIVOT-006 in 1H'26, and BLA submission initiation in 2025.

• Enrollment for PIVOT-006, the first Phase 3 randomized trial in broad intermediate-risk NMIBC, was completed ahead of schedule.

Efficacy and safety highlights

• BOND-003 Cohort C showed a 75.5% overall complete response (CR) rate, with 46.4% at 12 months and 41.8% at 24 months; 96.4% of treated patients were progression-free to muscle-invasive disease at 24 months.

• Cretostimogene demonstrated best-in-disease long-term duration of response and safety, with 0% grade 3 or higher treatment-related adverse events (TRAEs).

• In BOND-003 Cohort P, high-grade event-free survival (EFS) was 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months, with no serious TRAEs or discontinuations.

• CORE-008 Cohort A reported an 88% CR rate with optimized instillation and no grade ≥3 TRAEs, serious adverse events, or deaths.