CELC · Celcuity Inc.

Celcuity’s Q1 2026 financial results reflect a deliberate ramp-up in commercial readiness and clinical development execution. The $15.8 million year-over-year increase in net loss was primarily driven by a $11.1 million surge in SG&A expenses—$6.6 million of which directly funded commercial headcount additions and launch-related activities—underscoring the company’s transition toward pre-commercialization for gedatolisib. R&D expenses rose $3.3 million, with increases in employee-related and consulting costs ($3.0 million) and manufacturing/other costs ($5.4 million), partially offset by a $5.1 million decline in clinical trial costs tied to reduced VIKTORIA-1 spending. This cost profile aligns with management’s stated intent to prepare for potential FDA approval and commercial launch in Q3 2026. Critically, the filing anchors its financial narrative to two pivotal clinical developments: the positive topline results from the PIK3CA mutant cohort of VIKTORIA-1—which demonstrated statistically significant and clinically meaningful PFS improvements for both gedatolisib regimens—and the strategic expansion of VIKTORIA-2 to include a large first-line endocrine-sensitive cohort, broadening the potential addressable population to ~60,000 newly diagnosed US patients annually. These data form the basis for the planned sNDA submission in Q3 2026 and reinforce the therapeutic differentiation and lifecycle extension strategy, including the first USPTO patent filing for a subcutaneous formulation. With $387.1 million in cash and short-term investments at quarter-end and explicit guidance that capital will fund operations through 2027, Celcuity maintains strong financial flexibility to execute on near-term regulatory milestones and longer-term development goals without immediate dilution risk.