CG Oncology is a late-stage clinical biopharmaceutical company focused on developing cretostimogene grenadenorepvec, an oncolytic immunotherapy for bladder cancer. The company initiated its Biologics License Application (BLA) submission to the FDA in Q4 2025 for high-risk Bacillus Calmette-Gurin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS), with or without Ta/T1 disease, based on positive Phase 3 BOND-003 Cohort C data. Cretostimogene has received both Fast Track and Breakthrough Therapy designations from the FDA for high-risk BCG-unresponsive NMIBC with CIS with or without Ta or T1 papillary tumors. Phase 3 BOND-003 Cohort C showed a 75.5% complete response (CR) at any time, with 41.8% of evaluable responders maintaining CR at 24 months, and 96.6% of patients free from progression to muscle invasive disease at 24 months. The company completed enrollment for its Phase 3 PIVOT-006 trial in intermediate-risk NMIBC in Q3 2025, with topline data expected in H1 2026. Initial data from Phase 2 CORE-008 Cohort A in high-risk BCG-nave NMIBC showed an 83.7% overall CR rate at any time. Net loss for the year ended December 31, 2025, was $161.0 million, compared to $88.0 million in 2024. Research and development expenses increased to $116.6 million in 2025 from $82.1 million in 2024, driven by higher clinical trial costs and personnel expenses. General and administrative expenses rose to $73.5 million in 2025 from $33.7 million in 2024, primarily due to increased compensation, professional fees, and marketing costs. As of December 31, 2025, the company held $742.2 million in cash, cash equivalents, and marketable securities. The company acquired a controlling interest in Biovire, a contract manufacturing organization, in July 2025, to strengthen its manufacturing supply continuity. A legal proceeding with ANI Pharmaceuticals, Inc. regarding royalty payments was resolved in the company's favor by a jury verdict in July 2025, rejecting ANI's claims for unjust enrichment damages.