- Celcuity published a press release reporting Q4 and full-year 2025 financial results and a corporate update.
- Q4 operating expenses rose 35.1% to USD 49.2 million, including R&D expense up 12.2% to USD 37.6 million driven by higher employee and consulting costs (including commercial headcount additions and launch-related activities), partially offset by lower VIKTORIA-1 trial support costs.
- G&A expense more than doubled to USD 11.6 million, primarily due to higher employee-related and consulting expenses, including USD 5.4 million of non-cash stock-based compensation.
- Net loss was USD 51.0 million (USD 0.97 per share) in Q4 and USD 177.0 million (USD 3.79 per share) for the full year; cash, cash equivalents and short-term investments were USD 441.5 million at year-end and are expected to fund operations through 2027.
- On the pipeline, the FDA accepted the gedatolisib NDA for HR+/HER2-/PIK3CA wild-type advanced breast cancer with Priority Review and a PDUFA goal date of July 17, 2026, while management said it expects topline results from the PIK3CA mutant VIKTORIA-1 cohort in Q2 2026 and is preparing for a potential commercial launch in Q3 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603251601PRIMZONEFULLFEED9678621) on March 25, 2026, and is solely responsible for the information contained therein.
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