CG Oncology(US:CGON)2025-04-28 13:02Summary 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.