Celcuity Q3 net loss $43.8M; gedatolisib NDA on track for Q4 2025

Celcuity Inc.

2025-Q3 EPS reported -$2.81

Q3 net loss $43.8M ($0.92 loss per share) vs $29.8M ($0.70 loss) in prior year.
Operating expenses $42.8M (R&D $34.9M, G&A $7.9M), up from $30.1M.
PIK3CA WT cohort: gedatolisib triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 vs 2.0 months.
FDA accepted NDA under RTOR program; submission for gedatolisib on track for Q4 2025.
PIK3CA mutant cohort fully enrolled; topline data expected late Q1 2026 or Q2 2026.

item 2.02item 9.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.