CG Oncology, Inc.

The company is a late-stage clinical biopharmaceutical company that develops and commercializes cretostimogene grenadenorepvec (cretostimogene). Cretostimogene is an investigational oncolytic immunotherapy designed to eliminate cancer cells directly through selective replication and indirectly by activating an anti-tumor immune response. It is being developed as a potential backbone therapy for patients with bladder cancer. Cretostimogene is currently in clinical development for treating high-risk and intermediate-risk non-muscle invasive bladder cancer (NMIBC), which could address up to 150,000 patients. The company is evaluating cretostimogene as a monotherapy in BOND-003 Cohort C, an ongoing Phase 3 clinical trial for high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS), with or without Ta/T1 disease. Enrollment for this cohort is complete, and data was reported in September 2025. This trial formed the basis for the Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for the initial indication, which began in the fourth quarter of 2025 and is expected to be completed in 2026. 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. In April 2024, the company also started BOND-003 Cohort P, an exploratory study of cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC with only Ta/T1 disease. Initial data from Cohort P was reported at the 2025 AUA Annual Meeting, with further data reported at the Society of Urologic Oncology (SUO) 26th Annual Meeting in December 2025.