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 US market of 150,000 patients annually.

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

• Near-term expansion opportunities include BCG-exposed populations and additional patient cohorts.

• Stepwise TAM expansion: initial 25,000 BCG-unresponsive patients, with PIVOT-006 data potentially adding 50,000 more.

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

Clinical development and data highlights

• Two pivotal phase 3 trials: BOND-003 (monotherapy, already read out) and PIVOT-006 (intermediate risk, data expected 1H this year).

• CORE-008 Cohort CX (Creto + gemcitabine) data expected 1H this year for BCG-exposed patients.

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

• 96.4% progression-free from muscle-invasive disease at 24 months, highest in category.

• Safety profile notable for absence of significant grade 3 side effects and high tolerability.

Product differentiation and physician perception

• Creto is an oncolytic immunotherapy with dual MOA: selective cancer cell lysis and potent anti-tumor immune response.

• Administered intravesically, fitting standard practice and can be performed by medical assistants.

• Outperforms competitors in duration of response and safety, with 90% of 12-month CR patients maintaining CR at 24 months.

• Survey of 100 HCPs identified duration of response, efficacy, safety, and cystectomy avoidance as top prescribing criteria.

• Strong physician interest and rapid trial enrollment attributed to compelling clinical data.