Summary of Celcuity (CELC) Investor Call - July 28, 2025 Company Overview - **Company**: Celcuity (CELC) - **Focus**: Development of geditalisib for HR positive, HER2 negative advanced breast cancer Key Industry Insights - **Clinical Trial**: Phase III VICTORIA-one trial results presented - **Target Population**: Patients with HR positive, HER2 negative advanced breast cancer, specifically those with PIK3CA wild type tumors Core Findings and Results - **Progression-Free Survival (PFS)**: - **Triplet Regimen (geditalisib + fulvestrant + palbociclib)**: Median PFS of 9.3 months vs. 2 months for fulvestrant alone, with a hazard ratio of 0.24, indicating a 4.2 times higher likelihood of survival without disease progression [10][25] - **Doublet Regimen (geditalisib + fulvestrant)**: Median PFS of 7.4 months vs. 2 months for fulvestrant alone, with a hazard ratio of 0.33, indicating a 3 times higher likelihood of survival without disease progression [11][26] - **Significance**: These results are unprecedented in the treatment of this patient population, establishing new milestones in drug development [11][12] Mechanism of Action - **PAM Pathway**: Geditalisib targets the PAM pathway, which is crucial in cancer progression. The drug provides comprehensive blockade of the pathway, reducing the potential for adaptive resistance [8][19] - **Efficacy Across Mutation Status**: Preliminary data shows objective response rates over 50% in patients with or without PIK3CA mutations [20] Safety and Tolerability - **Adverse Events**: Both triplet and doublet regimens were well tolerated, with lower discontinuation rates due to treatment-related adverse events compared to previous studies [28][44] - **Overall Survival Trends**: Positive trends observed, although data is still immature due to crossover from the control arm [29][60] Market Opportunity - **Patient Population**: Estimated 34,000 patients transitioning to second-line treatment after CDK4/6 inhibitors, with approximately 60% being PIK3CA wild type [46] - **Market Size**: Projected market opportunity of $5 billion for geditalisib [46] - **Reimbursement Dynamics**: IV administered drugs like geditalisib typically face smoother reimbursement processes compared to oral drugs [46] Future Plans - **NDA Submission**: Anticipated submission for geditalisib in Q4 2025 [52] - **Upcoming Data Presentations**: Full results from the VICTORIA-one trial to be presented at major medical conferences [30][52] - **Continued Research**: Ongoing studies to explore the efficacy of geditalisib in combination with other therapies, including oral SERDs [74] Conclusion - **Strategic Positioning**: Celcuity is well-positioned to address significant unmet needs in the treatment of HR positive, HER2 negative advanced breast cancer, with geditalisib showing promising clinical results and a strong market opportunity ahead [48][49]