Celcuity Reports $37M Net Loss in Q1 2025, Increases R&D Spending Amid Clinical Trials

Celcuity Inc. reported a net loss of approximately $37.0 million for the first quarter of 2025, a significant increase from the $21.6 million loss recorded in the same period of 2024. The company's total operating expenses rose to $36.1 million, up 61% from $22.5 million year-over-year. This increase was primarily driven by a 56% rise in research and development expenses, which reached $32.2 million, reflecting heightened activity in ongoing clinical trials. General and administrative expenses also surged by 112% to $3.9 million, attributed to increased employee costs and professional fees.

In terms of financial position, Celcuity's total assets decreased to $218.1 million as of March 31, 2025, down from $245.1 million at the end of 2024. The decline was largely due to a reduction in cash and cash equivalents, which fell to $16.5 million from $22.5 million. The company’s accumulated deficit increased to approximately $308.9 million, highlighting its ongoing investment in research and development without generating revenue to date. The company continues to rely on external financing, having raised approximately $374.6 million since its inception.

Strategically, Celcuity is advancing its lead therapeutic candidate, gedatolisib, which is currently undergoing multiple clinical trials. The VIKTORIA-1 Phase 3 trial is evaluating gedatolisib in combination with fulvestrant and palbociclib for patients with HR+/HER2- advanced breast cancer, with topline data expected in the third quarter of 2025. Additionally, the VIKTORIA-2 trial is set to begin dosing patients in the second quarter of 2025. The company has also initiated a Phase 1b/2 trial, CELC-G-201, for metastatic castration-resistant prostate cancer, with results anticipated later this year.

Operationally, Celcuity has seen an increase in its employee headcount and clinical trial activities, with 492 patients having received gedatolisib across various studies. The company is also expanding its geographic reach, with clinical sites activated in North America, Europe, Latin America, and Asia-Pacific. Despite the current financial losses, Celcuity's management remains optimistic about the potential for gedatolisib, projecting that successful clinical outcomes could lead to significant market opportunities, with peak revenue potential exceeding $2 billion if the drug receives FDA approval. The company plans to continue its focus on research and development, anticipating increased expenses as it progresses through its clinical trials.