Core Insights - CG Oncology, Inc. reported positive results from the Phase 3 BOND-003 trial, highlighting the durability and tolerability of cretostimogene for bladder cancer treatment [2][6] - The company plans to submit a Biologics License Application (BLA) for cretostimogene in Q4 2025, targeting high-risk non-muscle invasive bladder cancer (NMIBC) patients unresponsive to BCG [2][11] - A recent legal victory against ANI Pharmaceuticals allows CG Oncology to focus resources on developing cretostimogene without future royalty obligations [2][5] Financial Highlights - For Q2 2025, CG Oncology reported a net loss of $41.4 million, or $0.54 per share, compared to a net loss of $18.9 million, or $0.28 per share in Q2 2024 [11][14] - Research and development expenses increased to $31.3 million in Q2 2025 from $18.5 million in Q2 2024, primarily due to higher clinical trial costs and increased headcount [11][14] - General and administrative expenses rose to $17.4 million in Q2 2025 from $7.5 million in Q2 2024, attributed to personnel-related costs and legal expenses [11][14] Cash Position - As of June 30, 2025, CG Oncology had cash and cash equivalents of $661.1 million, down from $688.4 million as of March 31, 2025 [11][16] - The company expects its current cash position to fund operations into the first half of 2028 [11] Clinical Development Updates - The company presented best-in-disease durability data from the BOND-003 trial, showing a 75.5% complete response rate at any time and a median duration of response of 28 months [6] - The CORE-008 trial was initiated to evaluate the combination of cretostimogene and gemcitabine in high-risk BCG-exposed NMIBC patients [5][6] - Anticipated milestones include the completion of Phase 3 enrollment for PIVOT-006 in Q3 2025 and topline data from various trials expected in Q4 2025 and 1H 2026 [4][11]