Celcuity reports Q1 net loss $52.8M; VIKTORIA-1 hits primary endpoint in PIK3CA mutant

Celcuity Inc.

Net loss $52.8M ($0.97/share) vs $37.0M ($0.86/share) in Q1 2025; non-GAAP adjusted net loss $46.8M ($0.86).
VIKTORIA-1 PIK3CA mutant cohort: gedatolisib triplet and doublet both achieved statistically significant PFS improvement vs alpelisib+fulvestrant.
Detailed VIKTORIA-1 data to be presented at ASCO LBA oral session on June 2, 2026; sNDA submission planned for Q3 2026.
NDA for gedatolisib in PIK3CA wild-type accepted with Priority Review; PDUFA date July 17, 2026.
VIKTORIA-2 expanded: Study 2 (~740 patients) evaluating gedatolisib as first-line in endocrine-sensitive HR+/HER2- advanced breast cancer.

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