On Thursday, CG Oncology, Inc. ( CGON ) revealed topline data from the Phase 3 BOND-003 trial in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG).

The trial demonstrated that 74.5% of patients (82 out of 110) achieved a complete response (CR) at any time after receiving treatment with cretostimogene as a single agent.

The median duration of response (DOR) has not been reached but exceeds 27 months as of the data cutoff of September 30.

The data will be presented at the Society of Urologic Oncology Annual Meeting.

Gary Steinberg, Professor, Department of Urology at Rush University Medical Center, said, “I am very encouraged by the latest data from the BOND-003 study, which demonstrates cretostimogene’s compelling efficacy as well as its potential to induce a best-in-class durable response in NMIBC patients, with 63.5% of patients remaining in response at 12 months or greater and 56.6% of patients remaining in response at 24 months or greater, by K-M estimate. Additionally, 97.3% of patients were free from progression to Muscle Invasive Bladder Cancer (MIBC) at 12 months.”

No Grade 3 or greater treatment-related adverse events (TRAEs) or deaths were reported. No treatment-related discontinuation of cretostimogene was observed.

97.3% of patients completed all expected treatments.

As of September 30, 2024, cash and cash equivalents and marketable securities were $540.7 million, which is expected to be sufficient to fund operations through 2027.

Price Action: CGON stock is down 5.67% at $33.88 at the last check on Thursday.

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