Celcuity (CELC) Q4 2025 earnings summary

Executive summary

• Achieved major clinical and regulatory milestones in 2025, including FDA acceptance and priority review of the NDA for gedatolisib, with a PDUFA goal date of July 17, 2026.

• Completed enrollment of the PIK3CA mutant cohort in the phase III VIKTORIA-1 trial; top-line results expected in Q2 2026.

• Presented and published unprecedented efficacy data for the PIK3CA wild-type cohort, setting new benchmarks in HR-positive, HER2-negative advanced breast cancer.

• Advanced commercial preparations for a potential 2026 launch, including sales force buildout and payer engagement.

Financial highlights

• Q4 2025 net loss was $51 million ($0.97/share), up from $36.7 million ($0.85/share) in Q4 2024; full year 2025 net loss was $177 million ($3.79/share), compared to $111.8 million ($2.83/share) in 2024.

• Non-GAAP adjusted net loss for Q4 2025 was $38.4 million ($0.73/share), and $150.8 million ($3.22/share) for the year.

• R&D expenses rose to $37.6 million in Q4 and $145 million for the year, driven by increased headcount and launch activities.

• G&A expenses increased to $11.6 million in Q4 and $27.2 million for the year, mainly due to higher employee and stock-based compensation.

• Cash, cash equivalents, and short-term investments totaled $441.5 million at year-end, expected to fund operations through 2027.

Outlook and guidance

• Anticipates FDA decision on gedatolisib in July 2026.

• Top-line results from the PIK3CA mutant cohort of VIKTORIA-1 expected in Q2 2026, with full results at a medical conference.

• Commercial launch of gedatolisib planned for Q3 2026, pending FDA approval.

• Update on VIKTORIA-2 phase III study design expected in Q2 2026, with enrollment to follow.

• Current cash position expected to finance operations through 2027.