CG Oncology (CGON) Investor presentation summary

BOND-003 cohort C: CIS-containing disease

• Phase 3, single-arm study enrolled 112 patients with high-risk BCG-unresponsive NMIBC and CIS, with or without Ta/T1 disease; efficacy cutoff June 23, 2025.

• Cretostimogene achieved a 75.5% complete response rate at any time (83/110; 95% CI 66.3%–83.2%); 24-month landmark CR rate was 41.8% (95% CI 32.5%–51.6%).

• Median duration of response was 27.9 months (95% CI 14.3–NE), ongoing; estimated response probability at 24 months was 60.1% (95% CI 48.2%–70.0%).

• 90% of patients in CR at 12 months were projected to remain in CR at 24 months; 96.4% (106/110) were free from progression to ≥T2 disease.

• Most treatment-related AEs were Grade 1–2; no Grade ≥3 treatment-related AEs or deaths, 1.8% had serious Grade 2 treatment-related AEs, and 97.3% received all protocol-defined treatments.

BOND-003 cohort P: papillary-only disease

• Cohort enrolled 56 patients with high-risk BCG-unresponsive high-grade Ta/T1 NMIBC without CIS; 33.9% had T1 disease and median follow-up was 6.0 months.

• Kaplan-Meier estimated high-grade event-free survival was 95.7% at 3 months, 84.6% at 6 months and 80.4% at 9 months; data cutoff was September 1, 2025.

• At 9 months, high-grade event-free survival was 75.9% for high-grade Ta and 87.5% for high-grade T1; one patient progressed to metastatic urothelial carcinoma despite clinical CR in the bladder.

• No Grade ≥3 treatment-related AEs, serious treatment-related AEs or deaths; no treatment-related discontinuations, and 98.2% received all protocol-defined treatments.

Treatment rationale and development

• Cretostimogene selectively replicates in and lyses bladder cancer cells while cytokine and antigen release activates T and B cells and may induce immunologic memory.

• Cohort P conclusions highlighted consistent responses across high-grade Ta and T1 populations, a well-tolerated profile, and ongoing longer-term treatment and follow-up.