cretostimogene - (PIVOT-006) (EAP)

May 8, 2026: CG Oncology, Inc. (NASDAQ: CGON) reported Q1 2026 results and outlined 2026 development/regulatory catalysts for cretostimogene grenadenorepvec (intravesical oncolytic immunotherapy) in non-muscle invasive bladder cancer (NMIBC). Following FDA alignment discussions, the company expects to complete its rolling BLA submission in 4Q 2026 for an initial indication of high-risk (HR) BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without Ta/T1 disease; the remaining CMC module is in progress and manufacturing inspection-readiness activities are ongoing.

Key upcoming clinical milestones:

• PIVOT-006 (Phase 3; intermediate-risk NMIBC): topline data anticipated in 1H 2026.
• CORE-008 Cohort CX (Phase 2; cretostimogene + gemcitabine in HR BCG-exposed and BCG-unresponsive NMIBC): first results expected in 1H 2026 and scheduled for podium/poster presentation at AUA 2026 (SUO session) on May 16, 2026.
• BOND-003 Cohorts C and P and CORE-008 Cohort A: durability data expected in 2026.

Financially, cash/cash equivalents/marketable securities were ~$1.1B as of March 31, 2026, with runway expected through 2029; net loss was $60.2M for Q1 2026.