Celcuity Inc.

Celcuity Inc., a clinical-stage biotech, reported a net loss of $177.0 million for FY 2025, up from $111.8 million in FY 2024, driven by elevated operating expenses of $172.2 million versus $113.3 million prior year. Research and development costs surged to $145.0 million from $104.2 million, reflecting accelerated clinical trials including VIKTORIA-1 (completed enrollment, topline data reported for PIK3CA WT cohort), ongoing VIKTORIA-2, and CELC-G-201. General and administrative expenses rose to $27.2 million from $9.1 million amid commercial preparations. No revenue was generated, consistent with pre-commercial status. Balance sheet strengthened with $466.6 million total assets, including $165.7 million cash equivalents and $275.8 million investments, up from $245.1 million assets end-2024. Stockholders' equity stood at $100.6 million. Cash burn intensified with $153.3 million used in operations (vs. $83.5 million prior), offset by $360.6 million financing inflows from $195.0 million convertible debt, $91.6 million equity offering, and note proceeds. NDA for gedatolisib accepted by FDA in Jan 2026 under Priority Review (PDUFA July 17, 2026), positioning for potential approval in HR+/HER2- ABC post-CDK4/6 progression, with $5B+ addressable market estimated.

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