Celcuity(US:CELC)2026-03-25 20:10Financial Performance - Celcuity reported a net loss of $51.0 million, or $0.97 per share, for Q4 2025, compared to a net loss of $36.7 million, or $0.85 per share, in Q4 2024[15]. - The net loss for the year ended December 31, 2025, was $177,042,000, which is a 58% increase from the net loss of $111,779,000 in 2024[24]. - The GAAP net loss per share for the year ended December 31, 2025, was $3.79, compared to $2.83 in 2024, reflecting a 34% increase[27]. - Non-GAAP adjusted net loss for the year ended December 31, 2025, was $150,788,000, up from $101,946,000 in 2024, indicating a 48% increase[27]. Operating Expenses - Total operating expenses for Q4 2025 were $49.2 million, up from $36.4 million in Q4 2024, while full year operating expenses increased to $172.2 million from $113.3 million in 2024[10]. - For the three months ended December 31, 2025, the total operating expenses were $49,201,000, compared to $36,430,000 for the same period in 2024, representing an increase of 35%[24]. - General and administrative (G&A) expenses for Q4 2025 were $11.6 million, up from $3.0 million in the prior year, with full year G&A expenses reaching $27.2 million compared to $9.1 million in 2024[13][14]. - General and administrative expenses for the year ended December 31, 2025, totaled $27,197,000, compared to $9,064,000 in 2024, marking an increase of 200%[24]. - Research and development (R&D) expenses for Q4 2025 were $37.6 million, compared to $33.5 million in the prior year, with a full year total of $145.0 million versus $104.2 million in 2024[11][12]. - Research and development expenses for the year ended December 31, 2025, were $144,995,000, a significant increase of 39% from $104,203,000 in 2024[24]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $441.5 million at the end of 2025, expected to finance operations through 2027[16]. Drug Development and Regulatory Updates - The FDA accepted Celcuity's New Drug Application for gedatolisib with a PDUFA goal date of July 17, 2026, indicating a priority review status[6]. - Median progression-free survival (PFS) for patients treated with the gedatolisib triplet was 16.6 months, significantly better than 1.9 months for fulvestrant, with a hazard ratio of 0.14[7]. - The gedatolisib triplet demonstrated a median duration of response of 17.5 months and an objective response rate improvement of 31% compared to control[9]. - Celcuity plans to release topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study in Q2 2026, which could impact treatment standards for advanced breast cancer[4]. - The company is on track to commercially launch gedatolisib in anticipation of FDA approval in Q3 2026[4]. Shareholder Information - The weighted average common shares outstanding for the year ended December 31, 2025, were 46,757,691, compared to 39,449,393 in 2024, reflecting an increase of 18%[27]. Interest and Non-Cash Income - Interest expense for the year ended December 31, 2025, was $17,148,000, up from $10,280,000 in 2024, representing a 67% increase[24]. - The company reported a non-cash interest income of $12,298,000 for the year ended December 31, 2025, compared to $11,768,000 in 2024, which is an increase of 4%[24]. - The adjustments to net loss included stock-based compensation of $12,974,000 for general and administrative expenses for the year ended December 31, 2025, compared to $2,583,000 in 2024, indicating a significant increase of 401%[27].