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Sep 30, 2025
Celcuity Q3 2025 Earnings Report
Celcuity reported a wider net loss in Q3 2025 compared to the prior year, driven by increased R&D and administrative expenses.
Key Takeaways
Celcuity's Q3 2025 results reflected higher operating expenses, particularly in research and development and administrative functions, contributing to a larger net loss. Despite no revenue, the company made key progress in its clinical trials and regulatory pipeline.
Forward Guidance
Celcuity plans to submit an NDA for gedatolisib in Q4 2025 and expects topline data from another key trial in early to mid-2026.
Positive Outlook
- NDA submission for gedatolisib on track for Q4 2025
- Completed enrollment for Phase 3 PIK3CA mutant cohort
- Strong clinical results for gedatolisib in PIK3CA WT cohort
- RTOR program acceptance by FDA
- Cash runway expected through 2027
Challenges Ahead
- No revenue generated in the quarter
- Net loss widened to $43.8 million
- R&D and G&A expenses significantly increased
- No new product approvals yet
- Dependence on trial results and regulatory outcomes
Historical Earnings Impact
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Avg. Return Before/After Earnings
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