Celcuity Reports $52.8 Million Net Loss in Q1 2026, Increases R&D and Operating Expenses

Celcuity Inc. reported a net loss of $52.8 million for the first quarter of 2026, a 43% increase from the $37.0 million loss recorded in the same period of 2025. The company's total operating expenses rose to $50.5 million, up 40% from $36.1 million year-over-year. This increase was primarily driven by a significant rise in selling, general, and administrative expenses, which surged to $17.4 million from $6.4 million, reflecting heightened costs associated with commercial preparations and personnel expansion. Research and development expenses also increased by 11% to $33.1 million, attributed to higher employee-related costs and manufacturing expenses.

In terms of financial position, Celcuity's cash and cash equivalents decreased to $145.2 million as of March 31, 2026, down from $165.7 million at the end of 2025. The company’s accumulated deficit reached $501.7 million, underscoring its ongoing investment in clinical trials and product development without generating revenue from product sales. The company has not yet commercialized its lead candidate, gedatolisib, which is currently undergoing multiple clinical trials, including the Phase 3 VIKTORIA-1 trial, with a New Drug Application (NDA) submission accepted by the FDA and a target review date set for July 17, 2026.

Operationally, Celcuity has made significant strides in its clinical development programs. The VIKTORIA-1 trial has reported promising results, demonstrating a statistically significant improvement in progression-free survival (PFS) for patients treated with gedatolisib compared to standard therapies. The company is also advancing its VIKTORIA-2 trial, which aims to evaluate gedatolisib in combination with other treatments for patients with hormone receptor-positive breast cancer. As of March 31, 2026, a total of 1,127 patients and healthy volunteers have participated in trials involving gedatolisib, indicating a robust engagement in clinical research.

Looking ahead, Celcuity anticipates continued increases in both research and development and administrative expenses as it prepares for the potential commercialization of gedatolisib. The company plans to utilize its existing cash reserves and proceeds from recent financing activities to support ongoing clinical trials and operational needs. Celcuity's management believes that its current financial resources will be sufficient to fund operations through at least 2027, although they may seek additional capital to support future growth and development initiatives.