Summary of CG Oncology (CGON) Conference Call - April 28, 2025 Company Overview - **Company**: CG Oncology - **Focus**: Development of bladder-sparing therapeutics for bladder cancer, targeting over 70% of the non-muscle invasive bladder cancer market in intermediate and high-risk categories [5][6] Key Points Discussed Clinical Development and Trials - **Programs**: Multiple programs in development, including: - **PIVOT006**: Phase III trial for intermediate risk non-muscle invasive bladder cancer, ahead of enrollment schedule, expected completion in H2 2025 [6][32] - **BORN-three**: Pivotal Phase III study for high-risk BCG unresponsive non-muscle invasive bladder cancer, showing a 75.5% complete response rate [9][13] - **CORE-eight**: Expanding potential applicability of creatostimogene in both naïve and exposed high-risk settings [6][32] Efficacy and Safety Data - **Efficacy**: - 75.5% complete response rate at any time, with ongoing complete responses at 12 months in 46% of patients [13] - 24-month complete response rate of 33.7%, with 97.3% free from progression to muscle invasive bladder cancer [14][15] - Median duration of response is 27.9 months, with 91% projected to remain in complete response at 24 months [16] - **Safety**: - Zero percent grade three or greater treatment-related adverse events, with a median time to resolution of one day [22] - High patient adherence with 97.3% completing all protocol-defined treatments [23] Competitive Landscape - **Positioning**: Creatostimogene is positioned as a backbone therapy in non-muscle invasive bladder cancer with best-in-class durability and safety [24] - **Comparative Data**: - Creatostimogene shows superior complete response rates compared to pembrolizumab (9%), nadoliterine (19%), and ANCTIVA (16%) at 24 months [14][24] Commercial Strategy - **BLA Submission**: Planned initiation in H2 2025, with breakthrough therapy designation allowing for rolling submission [39][40] - **Prelaunch Activities**: Ongoing engagement with future commercial customers and scientific exchange around clinical data [41][42] Combination Therapies - **Gemcitabine**: Selected as a combination partner for its potential to enhance efficacy and maintain a good safety profile [45] - **CORE-eight Study**: Evaluating the combination of creatostimogene and gemcitabine in high-risk BCG exposed non-muscle invasive bladder cancer [35] Future Outlook - **Expansion Potential**: Plans to expand into frontline settings for both intermediate and high-risk disease [36] - **Cash Position**: Strong balance sheet with a cash runway expected into the first half of 2028 [37] Additional Insights - **Patient Demographics**: Majority of patients in BORN-three were elderly, white, and male, with a high proportion of comorbidities [11][12] - **Regulatory Interactions**: Stable interactions with the FDA, with ongoing communication regarding the review process [62][63] - **Delivery Mechanism**: Creatostimogene can be administered by various healthcare professionals without the need for a urologist, fitting into existing workflows [25][66] This summary encapsulates the critical aspects of CG Oncology's conference call, highlighting the company's strategic direction, clinical advancements, and market positioning in the bladder cancer therapeutic landscape.