Core Insights - CG Oncology, Inc. announced a robust 24-month complete response (CR) rate of 41.8% for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment [1][2] - The study showed that 90% of 12-month responders remained disease-free at 24 months, indicating strong durability of response [2] - The safety profile of cretostimogene remains consistent, with no grade 3 or greater treatment-related adverse events (TRAEs) reported [1][3] Study Details - The Phase 3 BOND-003 Cohort C study involved 110 highly pretreated patients, making it the largest study in this patient population to date [3] - The study reported a complete response rate of 75.5% at any time and a 24-month CR rate of 41.8%, with 46 confirmed CRs as of June 23, 2025 [2][3] - The estimated duration of response (DOR) rates at 12 and 24 months were 64.1% and 58.3%, respectively, with a median DOR of 28 months [2] Patient Tolerance and Compliance - Patients tolerated cretostimogene treatment well, with a median resolution time of one day for any grade TRAEs [3] - No treatment-related discontinuation was observed, and 97.3% of patients completed all expected treatments, indicating favorable patient adherence [3] Cretostimogene Overview - Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy studied in over 400 patients with NMIBC [4] - The clinical development program includes two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [4] Company Vision - CG Oncology aims to develop and commercialize innovative immunotherapies for bladder cancer patients, enhancing their quality of life [6]

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]

Core Insights - CG Oncology announced promising results from the Phase 3 BOND-003 study of cretostimogene, showing that 75.5% of patients achieved a complete response at any time [1] - The median duration of response exceeds 28 months, indicating long-lasting efficacy [1] - No close contact precautions are necessary post-treatment, enhancing the treatment's practicality [2] Study Results - In the BOND-003 study, 83 out of 110 patients (75.5%) achieved a complete response, with 46% remaining in complete response at 12 months and 30 confirmed responses at 24 months [1] - The data presented at the EAU Congress indicates that cretostimogene levels peaked immediately after instillation and were sustained locally for 4-5 days, with no systemic exposure [2] - The most common treatment-related adverse events (TRAEs) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria, with a median resolution time of one day for any grade of TRAEs [3] Safety and Efficacy - No Grade 3 or greater treatment-related adverse events or deaths were reported, and 97.3% of patients completed all expected treatments, demonstrating high adherence [3] - Cretostimogene is an investigational oncolytic immunotherapy being evaluated for high-risk non-muscle invasive bladder cancer (NMIBC) patients unresponsive to BCG therapy [4][5] Company Overview - CG Oncology is focused on developing and commercializing innovative therapies for bladder cancer, aiming to improve patient quality of life [6]