Celcuity reports Phase 3 gedatolisib milestone; NDA filing on track for Q4 2025

Celcuity Inc.

2025-Q2 EPS reported -$1.90

Phase 3 VIKTORIA-1: gedatolisib triplet reduced risk of progression/death by 76% (HR=0.24); median PFS 9.3 mo vs 2.0 mo.
NDA for gedatolisib based on PIK3CA wild-type cohort expected Q4 2025; PIK3CA mutant topline data also in Q4 2025.
Q2 2025 net loss $45.3M ($1.04/sh) vs $23.7M ($0.62/sh) in Q2 2024; operating expenses $44.0M.
Completed concurrent offerings of notes, stock, warrants with net proceeds $286.5M; proforma cash $455M funding through 2027.
New patent extends gedatolisib dosing regimen exclusivity into 2042; first patient dosed in Phase 3 VIKTORIA-2 first-line trial.

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