Quarterly ResultMay 14, 2026, 05:22 PM
Celcuity Q1 Net Loss $(52.8)M; FDA PDUFA Date July 17, 2026
AI Summary
Celcuity Inc. reported a net loss of $(52.8) million for the first quarter of 2026, an increase from $(37.0) million in the same period last year, driven by higher R&D and SG&A expenses. Despite the increased loss and cash burn, the company highlighted the FDA's acceptance of its New Drug Application (NDA) for gedatolisib in HR+/HER2- PIK3CA WT Advanced Breast Cancer, with a PDUFA goal date of July 17, 2026. Celcuity maintains $387.1 million in cash, cash equivalents, and investments, which it believes is sufficient to fund operations for at least one year.
Key Highlights
- Net loss for Q1 2026 was $(52.8) million, compared to $(37.0) million in Q1 2025.
- Research and development expenses increased to $33.1 million in Q1 2026 from $29.8 million in Q1 2025.
- Selling, general and administrative expenses rose to $17.4 million in Q1 2026 from $6.4 million in Q1 2025.
- Cash, cash equivalents, and investments totaled $387.1 million as of March 31, 2026.
- The FDA PDUFA goal date for gedatolisib NDA in HR+/HER2- PIK3CA WT ABC is July 17, 2026.
- Net cash used in operating activities was $(55.1) million in Q1 2026, up from $(35.9) million in Q1 2025.
- Total liabilities decreased to $356.6 million as of March 31, 2026, from $366.0 million at Dec 31, 2025.
- Total stockholders' equity was $53.5 million as of March 31, 2026, down from $100.6 million at Dec 31, 2025.