Cretostimogene

May 08, 2026 — CG Oncology, Inc. (NASDAQ: CGON) reported Q1 2026 financial results (quarter ended March 31, 2026) and provided development/regulatory updates for cretostimogene grenadenorepvec (investigational intravesical oncolytic immunotherapy) in non-muscle invasive bladder cancer (NMIBC). Following FDA alignment discussions, the company expects to complete its rolling BLA for high-risk (HR) BCG-unresponsive NMIBC (CIS with or without Ta/T1 disease) in 4Q 2026; CMC module work and manufacturing inspection readiness are ongoing. Key 2026 milestones include Phase 3 PIVOT-006 topline data in intermediate-risk NMIBC in 1H 2026 and first Phase 2 CORE-008 Cohort CX results (cretostimogene + gemcitabine in HR BCG-exposed/BCG-unresponsive NMIBC) in 1H 2026, with presentation at AUA 2026 (May 16).

Financially, cash/cash equivalents/marketable securities were $1.1B at March 31, 2026 (vs $742.2M at Dec 31, 2025), including ~$391.4M net ATM proceeds; runway is projected through 2029. Q1 R&D expense was $43.7M (vs $27.5M in Q1 2025), G&A $20.8M (vs $14.8M), and net loss $60.2M or $(0.71)/share (vs $34.5M or $(0.45)/share). The company also appointed Jim DeTore as CFO (April 2026).