Celcuity Inc.

Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology company founded in 2011 and headquartered in Minneapolis, Minnesota. The company went public in September 2017 and focuses on developing molecularly targeted cancer therapies. Celcuity operates through two main platforms: its lead drug candidate gedatolisib, which targets multiple cancer pathways simultaneously, and its proprietary CELsignia diagnostic platform that uses living tumor cells to identify specific cellular processes driving individual patients' cancers. The company is currently in late-stage clinical trials with potential regulatory approval on the horizon for 2025-2026.

Over the past few years, Celcuity has made significant strategic progress transitioning from early-stage development to late-stage clinical trials. The company achieved a major milestone by receiving Breakthrough Therapy Designation from the FDA for gedatolisib, which expedites the regulatory review process. The company's primary focus has been advancing the VIKTORIA-1 Phase 3 trial, which completed enrollment of the PIK3CA wild-type patient cohort and is expected to deliver topline data in Q3 2025 for this group and Q4 2025 for the PIK3CA mutant cohort. This represents the company's most critical value inflection point. Celcuity has also expanded its clinical development with the VIKTORIA-2 Phase 3 trial targeting first-line treatment, which began dosing patients in Q2 2025. This trial addresses a potentially larger market opportunity worth an estimated additional $3 billion. The company has activated approximately 200 clinical sites globally to support enrollment. Strategic partnerships have expanded beyond the core breast cancer program. The company initiated a Phase 1b/2 trial in metastatic castration-resistant prostate cancer and began a collaboration with Dana Farber and Massachusetts General Hospital to evaluate gedatolisib in endometrial cancer, demonstrating efforts to broaden the therapeutic application. On the commercial preparation front, Celcuity hired Eldon Mayer as Chief Commercial Officer to build the infrastructure needed for potential drug launch. The company has also strengthened its balance sheet significantly, raising $129 million in equity and debt offerings to fund operations through the critical data readout period.