CG Oncology is a clinical-stage biopharmaceutical company developing a single drug candidate, cretostimogene grenadenorepvec (cretostimogene), for bladder cancer. Cretostimogene is an oncolytic immunotherapy — a modified adenovirus engineered to selectively replicate inside and destroy cancer cells while also triggering a broader anti-tumor immune response. The drug is delivered directly into the bladder via catheter (intravesically), the same route used for BCG, the current standard-of-care, meaning urologists can administer it in-office without anesthesia or an operating room. CG Oncology's initial target is patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) — patients whose cancer persisted despite BCG therapy — for whom the main alternative is full bladder removal, a surgery most patients avoid. CG Oncology initiated a BLA submission in Q4 2025, supported by Phase 3 data showing a 75.5% complete response rate and median response duration of 28 months. Beyond this lead indication, CG Oncology is running trials in intermediate-risk NMIBC, BCG-naïve NMIBC, and combination regimens, targeting a total addressable U.S. population of up to 150,000 patients. CG Oncology has no approved products and generates no product revenue today. If approved, CG Oncology plans to commercialize directly in the U.S. through a lean in-house salesforce targeting high-volume urology practices. Outside the U.S., CG Oncology has licensed rights to Kissei Pharmaceutical for most of Asia and to Lepu Biotech for mainland China. For manufacturing, CG Oncology relies on third-party contract manufacturers, including Biovire, in which CG Oncology acquired a majority stake in 2025.