Celcuity Inc. is a cancer-focused biotech company with one pipeline candidate, gedatolisib, showing promise in breast and prostate cancer. Gedatolisib is a differentiated PI3K inhibitor with a favorable tolerability profile, but faces risks associated with the history of PI3K inhibition in cancer medicine. CELC has a strong cash position to fund key data-related catalysts, but the jump from phase 1 to phase 3 trials carries inherent risks.