CG Oncology, Inc.

Cretostimogene is a late-stage clinical biopharmaceutical company focused on developing and commercializing cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy designed to treat bladder cancer. The company operates under the ticker symbol on the Nasdaq Global Select Market and maintains its corporate presence at www.aytusbio.com.

The company's core business centers on the development of cretostimogene, an oncolytic immunotherapy with a dual mechanism of action that works both to eliminate cancer cells directly through selective viral replication and indirectly by activating anti-tumor immune responses. Cretostimogene is currently in clinical development for treating patients with high-risk and intermediate-risk non-muscle invasive bladder cancer, potentially addressing up to 150,000 patients in the United States.

Cretostimogene has received both Fast Track and Breakthrough Therapy designations from the FDA. The company is conducting multiple clinical trials including BOND-003 Cohort C, a Phase 3 trial in high-risk BCG-unresponsive NMIBC with carcinoma in situ, which has completed enrollment and generated potentially best-in-disease data. The company initiated a Biologics License Application submission to the FDA in the fourth quarter of 2025. Additionally, the company is conducting PIVOT-006, a Phase 3 randomized trial evaluating adjuvant cretostimogene in intermediate-risk NMIBC following transurethral resection, with enrollment completed in the third quarter of 2025. The company also operates multiple Phase 2 cohorts through the CORE-008 trial evaluating cretostimogene in high-risk BCG-exposed and BCG-naïve patients, as well as in combination with gemcitabine.

As of January 30, 2026, cretostimogene had been administered to over 740 patients across multiple clinical trials with generally favorable tolerability. The company is building internal marketing, sales, and market access capabilities in preparation for potential FDA regulatory approval. The company leverages third-party manufacturing relationships while maintaining in-house chemistry, manufacturing and controls expertise supported by an advisory board with former senior pharmaceutical and FDA leadership experience.