CG Oncology Reports Third Quarter 2025 Financial Results and Provides Business Updates

Core Insights - CG Oncology, Inc. is advancing its lead therapeutic candidate, cretostimogene, for bladder cancer, with a focus on high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [2][6][10] - The company has initiated a rolling Biologics License Application (BLA) submission to the U.S. FDA, with complete submission expected in 2026 [6][7] - Financial results for Q3 2025 show a net loss of $43.8 million, an increase from $20.4 million in Q3 2024, attributed to rising R&D and G&A expenses [12][14] Corporate Highlights - The company reported a cash position of $680.3 million as of September 30, 2025, an increase from $661.1 million as of June 30, 2025, providing sufficient funds to support operations into the first half of 2028 [5][8] - Cretostimogene has received Fast Track and Breakthrough Therapy Designations, aimed at expediting its regulatory review process [7] Anticipated Upcoming Milestones - Topline data from the BOND-003 Cohort P trial is expected in Q4 2025, focusing on HR BCG-unresponsive NMIBC without CIS [7] - Initial results from the CORE-008 Cohort A trial are also anticipated in Q4 2025, targeting HR BCG-naïve NMIBC [7] Financial Highlights - Total revenues for Q3 2025 were $1.666 million, compared to $43,000 in Q3 2024, with commercial and development revenue of $1.508 million [14] - R&D expenses increased to $27.9 million in Q3 2025 from $19.6 million in Q3 2024, primarily due to higher clinical trial costs [12][14] - G&A expenses rose to $23.3 million in Q3 2025 from $8.7 million in Q3 2024, driven by increased legal and professional fees [12][14]