Celcuity (CELC)

Executive Summary

Celcuity is a clinical-stage biotechnology company advancing targeted therapies for cancers driven by the PI3K/AKT/mTOR (PAM) pathway, a key oncogenic signaling network. Its lead candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor designed to comprehensively block this pathway. The company is initially focused on developing gedatolisib for HR+/HER2- breast cancer and metastatic castration-resistant prostate cancer (mCRPC), areas with high unmet need. Celcuity aims to improve patient outcomes by addressing resistance mechanisms that limit current therapies.

Upcoming Catalysts (preview)

• Q3 2026Phase 3 data readout for gedatolisib in HR+/HER2- breast cancer60% success
• Q4 2026Phase 2 interim data for gedatolisib in mCRPC50% success
• TBDPotential partnership or licensing deal for gedatolisib outside the US40% success