Celcuity Inc. is a clinical-stage biotechnology company, which develops targeted therapies for the treatment of multiple solid tumor indications. Its lead therapeutic candidate is gedatolisib, a potent, small molecule reversible inhibitor, that selectively targets all Class I isoforms of phosphatidylinositol-3-kinase (PI3K) and the two mechanistic target of rapamycin (mTOR) sub-complexes, mTORC1 and mTORC2. Its initial clinical development programs for gedatolisib are focusing on the treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), or HR+/HER2-, advanced or metastatic breast cancer and patients with metastatic castration resistant prostate cancer. Its VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast. Its CELsignia companion diagnostic platform is able to analyze live patient tumor cells to identify new groups of cancer patients.