Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial

• PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled
  
• Additional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival (“PFS”) of 14.6 months in patients with HR+/HER2-/PIK3CA-mutated advanced breast cancer (“ABC”)
  

MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutant (“MT”) tumors, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Analysis of data from a Phase 1b clinical trial that evaluated gedatolisib combined with palbociclib and fulvestrant in the same population was also provided.

“We are pleased to announce that the PIK3CA mutant cohort of the VIKTORIA-1 study is 100% enrolled,” said Brian Sullivan, CEO and co-founder of Celcuity. “Based on our current forecast of reaching the event threshold that will trigger primary analysis in the PIK3CA mutant cohort, we expect to report topline data sometime in late Q1 2026 or during Q2 2026.”

Updated Analysis of Data from the Phase 1b Trial

In a presentation of results from the PIK3CA wild-type (“WT”) cohort of the VIKTORIA-1 study at the European Society for Medical Oncology (“ESMO”) Congress, additional data from a Phase 1b clinical trial that evaluated gedatolisib in patients with HR+/HER2- ABC was included. The analyses reported efficacy data from patients who were treated with the same drug regimen evaluated in the VIKTORIA-1 study, gedatolisib combined with fulvestrant and palbociclib.¹ This included patients from Escalation Arm B and Expansion Arms B, C and D of the Phase 1b study.