0001493152-26-012801
SEC filingCelcuity 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.
Celcuity reported FY2025 net loss of $177.0M, widening 58% YoY from $111.8M, primarily due to R&D expenses rising 39% to $145.0M from $104.2M amid Phase 3 trials (VIKTORIA-1 topline data, VIKTORIA-2 dosing, CELC-G-201 updates). G&A increased nearly 3x to $27.2M from $9.1M for commercial buildup. Total opEx hit $172.2M vs $113.3M prior. Other expense net $4.8M reflected $17.1M interest expense on debt. Shares outstanding averaged 46.8M basic/diluted, EPS -$3.79 vs -$2.83. No revenue as pre-commercial. Liquidity robust at $441.5M cash/investments, funding ops past 1 year.
No revenue generated in FY2025 or 2024, as Celcuity remains clinical-stage with no approved products. Focus on gedatolisib development for HR+/HER2- ABC and mCRPC. Estimated $5B+ U.S. addressable market in 2L setting post-CDK4/6, with peak sales potential $2.5B annually if approved.
N/A - No revenue, gross margins inapplicable. Op loss $172.2M vs $113.3M prior, driven by R&D scale-up (clinical milestones: VIKTORIA-1 WT cohort PFS 9.3/7.4 months triplet/doublet vs 2.0 months control). Stock comp $21.4M (up from prior). Interest expense $17.1M on $195.3M convertible debt, $126.5M notes.
Op cash use $153.3M (vs $83.5M 2024), reflecting trial acceleration. Investing outflow $64.1M (investments net -$63.8M). Financing inflow $360.6M: $195.0M convertible debt net, $91.6M equity offering, $27.7M note, $42.1M warrants exercise. Net cash +$143.2M to $165.7M. Total assets $466.6M (current $465.7M), liabilities $366.0M (debt dominant), equity $100.6M (accum deficit -$448.9M). Current ratio strong ~10.5x.
NDA submitted Nov2025 via RTOR for gedatolisib (PIK3CA WT cohort), accepted Jan2026 Priority Review, PDUFA Jul17 2026. VIKTORIA-1 MT cohort topline Q2 2026. VIKTORIA-2 safety run-in complete Q1 2026, Phase3 ~638 pts. CELC-G-201 Phase1b rPFS 9.1 months. Cash funds ops >1yr; additional debt available ($220M Term E/F). Risks: trial delays, approval uncertainty, debt covenants, competition.