Summary of Celcuity FY Conference Call (December 03, 2025) Company Overview - **Company**: Celcuity (NasdaqCM:CELC) - **Lead Asset**: Gedatolisib, a pan-PI3K/mTOR inhibitor - **Focus**: Breast cancer treatment, specifically HR-positive, HER2-negative breast cancer Key Points Clinical Trials and Drug Development - **Ongoing Trials**: Three Phase III programs in HR-positive, HER2-negative breast cancer, with one initiated in the first-line setting and two in the second-line setting [3][4] - **Promising Data**: Reported encouraging results for gedatolisib in metastatic castration-resistant prostate cancer and unprecedented data in second-line breast cancer trials [3] - **Victoria Trials**: - **Victoria I**: Focused on post-CDK4/6 treatment in women who are endocrine therapy resistant [6][10] - **Victoria II**: Targets treatment-naive women who did not respond well to adjuvant therapy [6][10] - **Expected Data Releases**: Additional data for mutation patients anticipated by end of Q1 or Q2 2026 [8][17] Mechanism of Action - **Complex Pathway**: Gedatolisib targets the interconnected estrogen receptor, CDK4/6, and PAM (PI3K/AKT/mTOR) pathways, which are crucial for tumor control [5][12] - **Potency**: Gedatolisib is reported to be 300 times more potent than existing single-target inhibitors, demonstrating cytotoxic effects rather than just cytostasis [12][13] Efficacy and Safety - **Hazard Ratios**: The triplet therapy (gedatolisib + fulvestrant + CDK4/6) showed a hazard ratio of 0.24, indicating a significant improvement over historical data [18][20] - **Median PFS**: - Wild-type cohort reported over 9 months median PFS, compared to 7 months for alpelisib in mutation settings [22][23] - Anticipated that a 10% improvement in the triplet therapy could double the current standard of care [23] - **Tolerability**: Reported low levels of hyperglycemia (10% all-grade, 2% grade 3) compared to other drugs, suggesting a better safety profile [27] Market Potential - **Market Size**: The overall market potential for the second-line setting is estimated at around $6 billion, with 40% of patients having mutations [25] - **Patient Population**: Approximately 37,000 patients in the second-line setting, with 60% wild-type and 40% mutant [25] Commercial Strategy - **Launch Preparations**: The company is preparing for the drug launch in Q1 2024, having built most of the necessary team [35] - **Sales Force**: Anticipated sales team size is between 80 and 90 representatives, which is standard for breast cancer drugs [35] - **Pricing Strategy**: Current PI3K inhibitors are priced around $25,000 per cycle, which will serve as a benchmark for gedatolisib's pricing [36] Future Outlook - **OS Updates**: Further updates on overall survival (OS) data expected in Q1 2027, with additional data related to safety and subgroup analyses to be presented on December 11, 2025 [28][29] Additional Insights - **Treatment Paradigm Shift**: The evolving treatment landscape for breast cancer is moving beyond traditional therapies, with a focus on comprehensive pathway inhibition [4][5] - **Regulatory Environment**: The company is adhering to regulatory standards, with no interim analyses planned for ongoing trials [17]