Cretostimogene Clinical Development and Efficacy - CG Oncology's clinical development strategy targets approximately 70% of the Non-Muscle Invasive Bladder Cancer (NMIBC) market, representing a multi-billion dollar opportunity[10, 49] - In a Phase 3 registrational study for High-Risk BCG-unresponsive NMIBC, cretostimogene demonstrated a potential best-in-class efficacy with a 75% Complete Response (CR) rate at any time[10] - The 12-month Duration of Response (DoR) was 63.5%, and the 24-month DoR was 56.6%, with the median DoR exceeding 27 months and ongoing in the Phase 3 study[10] - In the BOND-003 Cohort C trial, 97.3% of patients were free from progression to MIBC at 12 months[23] - Cystectomy-Free Survival in BOND-003 Cohort C was 90% at 12 months[23] - In BOND-003 Cohort C, 50% of patients reinduced with oncolytic immunotherapy converted to CR, and 64.3% remained in durable response after conversion[28] Safety and Tolerability - Cretostimogene has a favorable safety profile with 0% Grade 3 or higher treatment-related adverse events observed in clinical trials[10, 30] - In the cretostimogene arm, 64.3% of patients experienced any grade of Treatment-Related Adverse Events (TRAEs)[31] Financial and Strategic Outlook - CG Oncology has a strong balance sheet with a cash runway expected into the first half of 2028 to drive commercialization and indication expansion[10] Market and Treatment Landscape - Physicians in top key accounts treat more than 70% of NMIBC patients by volume[46]

Company Overview - CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [6] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [6] Clinical Trials and Developments - CG Oncology will host a conference call on April 28, 2025, to discuss results from the Phase 3 BOND-003 trial of cretostimogene monotherapy for high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [1] - Cretostimogene is an investigational oncolytic immunotherapy being evaluated in the BOND-003 trial and is also part of another Phase 3 trial (PIVOT-006) for intermediate-risk NMIBC [4][5] - The safety and efficacy of cretostimogene have not yet been established by the FDA or any other health authority [5] Bladder Cancer Statistics - An estimated 85,000 people are expected to be diagnosed with bladder cancer in 2025, with NMIBC representing approximately 75% of newly diagnosed cases [3] - Bladder cancer is the sixth most common cancer in the United States, with men accounting for three-quarters of new diagnoses [3]