CG Oncology (CGON) TD Cowen 45th Annual Healthcare Conference summary

Mission and Market Focus

• Focused on developing bladder-sparing therapeutics for bladder cancer, targeting the largest market opportunity in NMIBC, especially intermediate and high-risk patients.

• Clinical development covers about 70% of NMIBC, with a strong emphasis on efficacy, durability, and safety of cretostimogene, an oncolytic immunotherapy.

• U.S. market represents about 80% of the opportunity, with 83,000 new bladder cancer patients annually and a high prevalence due to recurrence.

• Addressable patient population includes BCG-naive, BCG-exposed, and BCG-unresponsive patients, with ongoing expansion into intermediate risk.

• BCG shortage and high recurrence rates create significant unmet needs and market potential.

Key Clinical Insights and Data

• Cretostimogene, an oncolytic immunotherapy, targets bladder cancer with selective tumor killing and durable immune response.

• BOND-003 pivotal trial in high-risk NMIBC shows a 75% complete response rate and 97.3% progression-free survival at 12 months.

• Median duration of response at 12 months is 63%, with about 50% maintaining CR at two years; median DoR exceeds 27 months and is ongoing.

• Safety profile is strong, with no grade 3 or higher treatment-related adverse events and high compliance rates; most adverse events were grade 1-2.

• 97.3% of patients were free from progression to muscle-invasive bladder cancer at 12 months, and 90% cystectomy-free survival at 12 months.

Development Pipeline and Milestones

• Multiple ongoing and planned studies: BOND-003 (high-risk BCG-unresponsive), PIVOT-006 (intermediate-risk, enrollment completion expected 1H'26), and CORE-008 (high-risk BCG-naïve and BCG-exposed, topline data expected 2H'25 and 2026).

• Anticipated milestones include BOND-003 Cohort C topline and durability data in 4Q'24 and 1H'25, BLA submission in 2H'25, and potential commercial launch in 2026.

• Combination trial with Keytruda (CORE-001) completed, supporting cretostimogene as a backbone therapy.

• Ongoing phase III (PIVOT-006) and phase II trials target both intermediate and high-risk populations, with multiple data readouts and a BLA submission planned for the second half of the year.

• Strong balance sheet with cash runway expected into the first half of 2028 to support commercialization and indication expansion.