Progress in Clinical Development Programs
Celcuity completed enrollment of the PIK3CA wild-type cohort in the VIKTORIA-1 Phase III study and selection of approximately 200 sites for the VIKTORIA-2 Phase III study. The Phase Ib dose escalation study for prostate cancer is ongoing and on track for preliminary data by mid-2025.
Potential Blockbuster Revenue
Celcuity estimates that nearly 200,000 late-stage cancer patients globally could be eligible for treatment with gedatolisib, potentially generating blockbuster revenue if regulatory approvals are obtained.
Encouraging Overall Survival Data
Preliminary overall survival data from the Phase Ib study showed promising results, with median overall survival of 77 months for first-line patients and 34 months for second-line patients, compared favorably to published data.
Strong Financial Position
Celcuity ended fiscal 2024 with $235.1 million in cash, cash equivalents, and short-term investments, an increase of $54.5 million from the previous year.