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 strategy covers about 70% of NMIBC, with most opportunity in the U.S. (80% of market, 83,000 new patients/year).

• High unmet need due to recurrence, BCG shortages, and limited alternatives, with radical cystectomy as an option most patients want to avoid.

• Programs are solely focused on intermediate and high-risk NMIBC, with multiple ongoing and completed trials.

• Addressable patient population for BCG-exposed and unresponsive is well over 10,000 annually.

Clinical Development and Trial Results

• BOND-003 pivotal trial includes two cohorts (CIS and papillary), with data readouts expected later this year.

• 75% complete response rate in BOND-003, with 97.3% progression-free survival and 90% cystectomy-free survival at 12 months.

• Durable responses: 63% maintain CR at 12 months, 50% at two years; median DoR exceeds 27 months and is ongoing.

• No grade 3 or higher treatment-related adverse events and no treatment-related discontinuations; most adverse events were grade 1-2.

• Ongoing phase III (PIVOT-006) and phase II trials target both intermediate and high-risk NMIBC, including BCG-naive and exposed populations.

Regulatory and Commercialization Strategy

• Preparing a robust BLA submission for the second half of the year, leveraging Breakthrough Therapy and Fast Track designations for potential rolling submission.

• Label strategy focuses on including CR duration and median DOR as differentiators.

• Addressable market estimated at 15,000+ patients/year, with pricing of approved agents at $200K–$240K, and a total BCG demand of 450,000–500,000 doses annually.

• High patient concentration at key centers supports focused launch strategy; pre-launch activities and customer engagement are well underway.

• 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.