CG Oncology (CGON) Study Update summary

Study design and patient population

• BOND-003 is a pivotal phase 3, single-arm, open-label trial evaluating cretostimogene in 112 high-risk BCG-unresponsive NMIBC patients, with induction and maintenance cycles and eligibility for re-induction at month three.

• The study population was predominantly elderly, white, and male, with a high proportion of prior BCG and chemotherapy exposure, and included more Asian and Black patients than typical for this indication.

• Patients underwent mandatory bladder mapping at 12 months and regular cystoscopy and cytology.

Efficacy and durability results

• The complete response (CR) rate at any time was 75.5% (95% CI: 66.3%-83.2%), with 46% maintaining CR at 12 months and 33.7% at 24 months; nine patients are pending 24-month assessment.

• Median duration of response exceeded 28 months, with 91% of 12-month CRs projected to remain in CR at 24 months; 58.3% maintained CR at 24 months per KM analysis.

• 97.3% of patients were free from progression to muscle-invasive disease at 24 months, and 84% avoided radical cystectomy.

• Re-induction therapy converted half of eligible patients to CR, with 64.3% of these maintaining durable response.

• High CR rates were consistent across subgroups, including those with prior chemotherapy and high-risk phenotypes.

Safety and tolerability

• No grade 3 or higher treatment-related adverse events or deaths were observed; most AEs were grade 1 or 2 and resolved within one day.

• Most common AEs included bladder spasm (25%), pollakiuria (21.4%), urgency (20.5%), dysuria (16.1%), and hematuria (13.4%).

• 97.3% of patients completed all protocol-defined treatments, with no treatment-related discontinuations.