CG Oncology (NasdaqGS:CGON) FY Conference Transcript

Summary of CG Oncology FY Conference Call Company Overview - Company: CG Oncology (NasdaqGS:CGON) - Focus: Developing a bladder-sparing therapeutic for bladder cancer patients, specifically targeting the non-muscle invasive bladder cancer (NMIBC) segment, which includes approximately 150,000 patients per year in the U.S. [2][3] Industry Insights - Bladder Cancer Statistics: - Incidence: Approximately 85,000 new cases annually in the U.S. - Prevalence: Over 700,000 patients, with 75% being non-muscle invasive [2] - Recurrence rates are high, often leading to progression and metastatic disease [2] Core Strategies and Trials - Target Market: Focus on intermediate-risk and high-risk populations within NMIBC [2][3] - Pivotal Trials: - PIVOT-006: Expected data readout in the first half of 2026, targeting 25,000 patients in the BCG-unresponsive segment [3][4] - BOND-003: Phase 3 monotherapy trial already read out, currently under BLA process [3] - CORE-008, Cohort CX: Combination trial of Credo plus gemcitabine, with data expected in the first half of 2026 [4][5] Product Profile - Credo: An oncolytic immunotherapy with a dual mechanism of action, selectively killing cancer cells and triggering a potent anti-tumor immune response [7][8] - Clinical Data: - 75.5% complete response rate in over 110 patients with BCG-unresponsive disease [10] - 46.4% observed complete response rate at 12 months and 42% at 24 months [10] - 96.4% progression-free survival from muscle-invasive disease at 24 months [10] - 90% of patients who achieve a complete response at 12 months remain in response at 24 months [11] Competitive Positioning - Differentiation: Credo shows superior efficacy and safety compared to existing therapies, with no significant grade three side effects reported [12][22] - Market Opportunity: The intermediate-risk population represents a potential 50,000 patients per year opportunity for CG Oncology [14] Commercial Strategy - Pre-launch Activities: Engaging with key accounts and conducting clinical research to prepare for market entry [20][21] - Field Force: Plans to deploy a lean field force of 75 to cover 300 network sites that account for 70% of BCG and TURBT volume [20] - Manufacturing Capacity: Current capacity of 50,000 vials per year, with plans to scale up to meet anticipated demand [22] Financial Outlook - Cash Position: As of Q3, CG Oncology reported $680 million, providing a runway into the first half of 2028 without revenue projections [41] Pricing Strategy - Market Pricing: Competitors' pricing ranges from $200,000 to $690,000 per year for BCG-unresponsive disease [43] - Pricing Considerations: Factors include efficacy, safety, treatment length, and access for physicians and patients [43][45] Future Directions - Regulatory Submissions: Ongoing BLA submission for high-risk BCG-unresponsive indication, with a focus on de-risking the submission process [33][34] - Expansion Plans: Interest in conducting randomized trials for the BCG-exposed population, which has been underserved due to the BCG shortage [48] Conclusion - CG Oncology is positioned to make a significant impact in the bladder cancer treatment landscape with its innovative therapy, Credo, and is preparing for a strategic market entry backed by strong clinical data and a solid financial foundation [22][41]