Business
Celcuity Inc. Reports First Quarter 2025 Financial Results and Provides Corporate Update
The primary completion date of the PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial is expected in June 2025 and a topline data readout is anticipated
About this update from Celcuity Inc.
[{"type":"text","content":"The primary completion date of the PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial is expected in June 2025 and a topline data readout is anticipated in the third quarter of 2025 Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 Phase 3 trial and a topline data readout is anticipated in the fourth quarter of 2025 VIKTORIA-2 Phase 3 trial remains on track to dose its first patient in the second quarter of 2025Initiating a clinical trial collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancerApproximately $206 million in cash, cash equivalents and investments at March 31, 2025 is expected to fund current clinical development program activities through 2026 Management to host webcast and conference call today, May 14, 2025, at 4:30 p.m. ET MINNEAPOLIS, May 14, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the first quarter ended March 31, 2025 and other recent business developments. “We continue to make steady progress across our pipeline with several critical data catalysts anticipated this year,” said Brian Sullivan, CEO and co-founder of Celcuity. “We now expect to report topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 trial in the third quarter of this year and to report topline data for the PIK3CA mutant cohort in the fourth quarter of 2025. If our topline data from the WT cohort is positive, we expect the data will support the filing of our first new drug application and, if approved, our transition to a commercial stage company.” First Quarter 2025 Business Highlights and Other Recent Developments Based on evaluation of blinded event rates in the ongoing VIKTORIA-1 Phase 3 clinical trial, the primary completion date for the PIK3CA wild-type patient cohort is projected to occur in June 2025 with topline data now anticipated to be available in the third quarter of 2025. Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial and remains on track to report topline data in the fourth quarter of 2025.VIKTORIA-1 is a global Phase 3 study evaluating gedatolisib in combination with fulvestrant with a...