CG Oncology(US:CGON)2025-11-14 13:15Clinical Development - CG Oncology initiated a rolling Biologics License Application (BLA) submission for cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with complete submission expected in 2026[4] - The 24-month complete response (CR) rate for cretostimogene monotherapy in patients with HR NMIBC was 41.8%, with 90% of 12-month responders remaining disease-free at 24 months[6] - Enrollment for the PIVOT-006 clinical trial was completed approximately 10 months ahead of schedule, highlighting significant interest in cretostimogene[6] - The company expects to present additional data from BOND-003 Cohort P and CORE-008 Cohort A before year-end 2025[5] Financial Performance - Cash and cash equivalents as of September 30, 2025, were $680.3 million, sufficient to fund operations into the first half of 2028[8] - Research and Development (R&D) expenses for Q3 2025 were $27.9 million, an increase from $19.6 million in Q3 2024[8] - General and Administrative (G&A) expenses for Q3 2025 were $23.3 million, up from $8.7 million in Q3 2024, primarily due to increased legal and personnel-related expenses[8] - The net loss for Q3 2025 was $43.8 million, or ($0.57) per share, compared to a net loss of $20.4 million, or ($0.30) per share, in Q3 2024[8] - Total revenues for Q3 2025 were $1.666 million, compared to $43,000 in Q3 2024[15] - Total stockholders' equity as of September 30, 2025, was $687.6 million, down from $733.4 million as of December 31, 2024[17]