CG Oncology, a late-stage clinical biopharmaceutical company focused on developing and commercialising a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced updated data on BOND-003 Cohort C showing 12 additional patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) were in complete response (CR) at 24 months. The robust 24-month complete response landmark rate of 41.8 per cent (CR rate observed in 46 out of 110 patients) for cretostimogene monotherapy reaffirms the best-in-disease durability that the Company announced at the American Urological Association Annual Meeting in April 2025. Cretostimogene’s safety profile also remains consistent with no grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. Trinity J. Bivalacqua, MD, PhD, Urologic Oncology at Penn Medicine, and Co-Director, Genitourinary Cancer Service Line, Abramson Cancer Centre, will present these updated data tomorrow, September 6, 2025, at the New England Section of the American Urological Association’s 94th annual meeting in Boston, Massachusetts.

“Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high-risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG,” said Trinity J. Bivalacqua, MD, PhD. “In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and sustained results. The latest data from the BOND-003 Cohort C study demonstrates that if a patient is a responder at 12 months, there is a 90 per cent chance they will remain in response at 24 months. This is unprecedented in the high-risk, heavily pretreated NMIBC patient population and very meaningful for those battling this difficult disease.”

“The data from our Phase 3 BOND-003 Cohort C registrational trial underscores cretostimogene’s potential to become a breakthrough backbone treatment for bladder cancer patients,” said Ambaw Bellete, President & Chief Operating Officer at CG Oncology. “We are eager to bring this innovative treatment to a broad range of NMIBC patients, and we are making great strides towards that goal as we prepare to initiate our BLA submission for cretostimogene in our initial indication for the treatment of patients with HR NMIBC unresponsive to BCG in the fourth quarter of this year.”