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

Core Insights - CG Oncology is advancing cretostimogene as a potential backbone therapy for non-muscle invasive bladder cancer (NMIBC), with plans to submit a Biologics License Application (BLA) in the second half of 2025 [2][4] - The company reported a net loss of $34.5 million for Q1 2025, an increase from $16.9 million in Q1 2024, primarily due to rising research and development expenses [11][15] - Cash and cash equivalents as of March 31, 2025, were $688.4 million, down from $742.0 million at the end of 2024, with sufficient funds projected to last into the first half of 2028 [5] Clinical Development Updates - The BOND-003 trial showed a 24-month complete response rate of 42.3% for Cohort C, with a 75.5% complete response at any time [6][7] - Cohort P demonstrated a promising 90.5% high-grade recurrence-free survival at 3 and 9 months [6][7] - The CORE-008 trial has been initiated to evaluate the combination of cretostimogene and gemcitabine in high-risk BCG-exposed NMIBC patients [6][7] Financial Performance - Research and development expenses for Q1 2025 were $27.5 million, up from $17.2 million in Q1 2024, driven by increased clinical trial costs and headcount [11] - General and administrative expenses rose to $14.8 million in Q1 2025 from $5.8 million in Q1 2024, attributed to higher personnel-related costs and professional fees [11] - License and collaboration revenue decreased to $52,000 in Q1 2025 from $529,000 in Q1 2024 [15] Future Milestones - The company anticipates completing enrollment for the Phase 3 PIVOT-006 trial in the second half of 2025 [6][4] - The initiation of the BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC is expected [6][7] - Topline data from ongoing clinical trials, including CORE-008 and BOND-003, are anticipated in the near future [6][7]