Business
CG Oncology Reports 2024 Year End Financial Results and Provides Business Updates
- Cretostimogene Monotherapy Demonstrated Sustained, Durable Complete Responses in High-Risk Bacillus Calmette Guérin (BCG)-Unresponsive Non-Muscle Invasive
About this update from Cg Oncology, Inc.
[{"type":"text","content":"- Cretostimogene Monotherapy Demonstrated Sustained, Durable Complete Responses in High-Risk Bacillus Calmette Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) - - Initiated CORE-008 Clinical Trial of Cretostimogene Monotherapy in High-Risk BCG-Naïve (Cohort A) and BCG-Exposed (Cohort B) NMIBC - - Late-Breaking Clinical and First Translational Data from BOND-003 Cohort C Presented at the 40th Annual European Association of Urology Congress - - Completed Oversubscribed $238 Million Follow-on Public Equity Offering that Extends Expected Runway into the First Half of 2028 - IRVINE, Calif., March 28, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today reported financial results for the fourth quarter and year ended December 31, 2024, and provided business updates. “We made substantial progress in the fourth quarter of 2024, with our announcement at SUO of topline data from the Phase 3 BOND-003 Cohort C trial, as well as a successful follow-on equity offering to expand our clinical development programs and support our commercial readiness activities,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “Looking ahead, further readouts are expected from our BOND-003 trial and the anticipated initiation of our Biologics License Application (BLA) submission, as well as the announcement of topline data from CORE-008 Cohort A expected before year-end.” Corporate Highlights Cretostimogene Monotherapy Demonstrated 74.5% Complete Response Rate at Any Time in High-Risk (HR) BCG-Unresponsive NMIBC with carcinoma in situ (CIS) with or without Ta/T1 disease. On December 5th at the Society of Urologic Oncology (SUO) 25th Annual Meeting, the Company presented groundbreaking data from Cohort C of the Phase 3 BOND-003 clinical trial that showed 74.5% of patients (82 out of 110, 95% confidence interval (CI), 65.4-82.4%) with HR-NMIBC unresponsive to BCG 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, 2024.Updated Clinical Results from BOND-003 Cohort ...