This segment focuses on the development and commercialization of targeted therapies for various types of cancer, with a primary emphasis on breast cancer. The lead drug candidate, Gedatolisib, a pan-PI3K/mTOR inhibitor, is being evaluated in Phase 3 clinical trials for HR+/HER2- advanced breast cancer. Research and development activities include preclinical studies, clinical trial design and execution, and biomarker discovery to identify patient populations most likely to benefit from Gedatolisib. The segment leverages the CELsignia diagnostic platform to personalize treatment strategies and improve patient outcomes. Future opportunities include expanding the application of Gedatolisib to other cancer types and developing novel combination therapies. Celcuity collaborates with pharmaceutical companies like Pfizer and Bayer to advance its clinical programs.

This segment is dedicated to the development and commercialization of the CELsignia diagnostic platform, which uses a patient's living tumor cells to identify the specific abnormal cellular processes driving their cancer and predict response to targeted therapies. Research and development efforts focus on expanding the platform's capabilities to analyze additional signaling pathways and cancer types. The CELsignia MP test measures HER2, c-Met, and PI3K signaling activity in breast and ovarian tumor cells. The platform aims to improve patient outcomes by enabling personalized treatment decisions and identifying patients who are most likely to benefit from specific therapies. Future opportunities include expanding the platform's use in clinical trials and developing companion diagnostics for novel cancer therapies. The segment's market positioning is based on its ability to provide unique insights into cancer biology and personalize treatment strategies.