Celcuity Reports $177M Net Loss for Fiscal Year 2025 Amid Clinical Trials for Gedatolisib

Celcuity Inc., a clinical-stage biotechnology company, reported a net loss of $177.0 million for the fiscal year ending December 31, 2025, compared to a net loss of $111.8 million in 2024, marking a 58% increase in losses. The company's total operating expenses rose to $172.2 million, a 52% increase from $113.3 million in the previous year. This increase was primarily driven by a 39% rise in research and development expenses, which reached $145.0 million, largely due to higher employee-related costs and clinical trial activities. General and administrative expenses also surged by 200% to $27.2 million, reflecting increased staffing and professional fees associated with the company's growth and public company obligations.

Celcuity's lead product candidate, gedatolisib, is currently undergoing pivotal clinical trials, including the Phase 3 VIKTORIA-1 trial, which has completed enrollment and is evaluating the drug's efficacy in combination with fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer. The company announced significant results from the PIK3CA wild-type cohort of this trial, demonstrating a 76% reduction in the risk of disease progression or death compared to fulvestrant alone, with a median progression-free survival of 9.3 months. The results from the PIK3CA mutant cohort are expected in the second quarter of 2026.

In terms of financial resources, Celcuity had $441.5 million in cash, cash equivalents, and short-term investments as of December 31, 2025. The company has raised substantial capital through various financing activities, including a $201.3 million convertible notes offering and a $91.6 million equity offering in 2025. These funds are intended to support ongoing clinical trials and prepare for the potential commercialization of gedatolisib, which has received both Fast Track and Breakthrough Therapy designations from the FDA. The company anticipates that its current capital will be sufficient to fund operations through at least 2027.

Celcuity's operational strategy includes expanding its clinical development and regulatory capabilities while preparing for the commercialization of gedatolisib. The company has also entered into a license agreement with Pfizer for gedatolisib, which includes milestone payments and royalties on future sales. As of December 31, 2025, the company had 155 full-time employees, reflecting its growth in anticipation of a potential product launch. The company’s outlook remains contingent on the successful completion of clinical trials and obtaining regulatory approvals, with the FDA's target review date for the New Drug Application set for July 17, 2026.