Celcuity, Inc. is a clinical-stage biotechnology company. The Company is seeking to extend the lives of cancer patients by pursuing an integrated therapeutic (Rx) and companion diagnostic (CDx) strategy. Its therapeutic efforts are focused on developing molecularly targeted therapies that address the same cancer driver a CELsignia companion diagnostic can identify. The Company’s lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that selectively targets all Class I isoforms of PI3K and mammalian target of rapamycin (mTOR). Its mechanism of action and pharmacokinetic properties are highly differentiated from other investigational therapies that target PI3K or mTOR alone or together. Its initial clinical development program for gedatolisib focus on the treatment of patients with hormone receptor positive (HR+), HER2-negative, advanced, or metastatic breast cancer. The Company’s additional clinical development programs focus on various other tumor types.