Celcuity Inc.

Celcuity Inc. (Nasdaq Capital Market: CELC) is a clinical-stage biotechnology company focused on developing targeted therapies for the treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a kinase inhibitor targeting the phosphatidylinositol 3-kinase, serine/threonine-protein kinase protein kinase B, and mechanistic target of rapamycin pathway. Gedatolisib binds to all class I PI3K isoforms and mTOR complexes mTORC1 and mTORC2, inducing comprehensive inhibition of the PI3K/AKT/mTOR pathway. The company's mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies targeting single components of this pathway.

Celcuity's clinical development programs focus on two primary cancer indications. In breast cancer, the company is advancing gedatolisib in combination with fulvestrant, with or without palbociclib, for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. The Phase 3 VIKTORIA-1 trial has completed enrollment of 754 subjects and reported positive results from the PIK3CA wild-type cohort, demonstrating statistically significant improvements in progression-free survival compared to fulvestrant monotherapy. A Phase 3 VIKTORIA-2 trial evaluating gedatolisib as first-line treatment for endocrine treatment resistant advanced breast cancer commenced patient dosing in July 2025. In prostate cancer, the company is conducting a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for patients with metastatic castration-resistant prostate cancer.

Gedatolisib received Fast Track designation from the FDA in January 2022 and Breakthrough Therapy designation in July 2022 for the treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer after progression on CDK4/6 therapy. In August 2025, the FDA granted the company's request to submit a New Drug Application under the Real-Time Oncology Review program, with the application accepted in January 2026 and designated for Priority Review with a target user fee goal date of July 17, 2026. As of December 31, 2025, approximately 1,127 patients and healthy volunteers have received gedatolisib across completed and ongoing clinical trials. The company operates through exclusive global development and commercialization rights obtained from a license agreement with Pfizer Inc. More information is available at www.celcuity.com.