CG Oncology (CGON) 44th Annual J.P. Morgan Healthcare Conference summary

Market opportunity and strategy

• Focused on developing a bladder-sparing therapy for non-muscle invasive bladder cancer (NMIBC), targeting a 150,000 patient-per-year market in the US.

• Strategy centers on intermediate and high-risk NMIBC, with pivotal phase 3 trials in both segments.

• Initial addressable market is 25,000 BCG-unresponsive patients, with expansion to 50,000 intermediate-risk patients expected after PIVOT-006 data.

• Near-term data catalysts include PIVOT-006 and CORE-008, both expected to read out in the first half of the year.

• BLA submission for the first BCG-unresponsive indication is set for completion in 2026, with intermediate-risk submission targeted for 2027.

Clinical development and efficacy

• Cretostimogene grenadenorepvec (Creto) is an oncolytic immunotherapy with a dual mechanism: selective cancer cell lysis and immune activation.

• Phase 3 BOND-003 trial in BCG-unresponsive CIS showed a 75.5% complete response rate, with 46.4% at 12 months and 42% at 24 months.

• 96.4% of patients remained progression-free from muscle-invasive disease at 24 months, the highest PFS rate in this category.

• Safety profile is favorable, with no significant grade 3 adverse events and high event-free survival in Ta/T1 adjuvant setting.

• PIVOT-006 phase 3 trial in intermediate-risk NMIBC completed enrollment nine months ahead of schedule due to strong physician and patient interest.

Competitive positioning and differentiation

• Creto demonstrates superior long-term response rates compared to approved agents, including Keytruda.

• Positioned as the first-line adjuvant therapy for intermediate-risk NMIBC, covering a broader patient spectrum than competitors.

• Differentiation based on efficacy, duration of response, and best-in-disease safety profile.

• Survey of 100 US HCPs identified duration of response, safety, and prevention of radical cystectomy as top prescribing criteria.

• Granted breakthrough therapy and fast track designations, with manufacturing capacity up to 50,000 vials/year and plans to scale 10x.