Celcuity Reports $45.3 Million Net Loss in Q2 2025, Increases Investment in Clinical Trials

Celcuity Inc. reported significant financial results for the second quarter of 2025, revealing a net loss of approximately $45.3 million, compared to a loss of $23.7 million in the same period of 2024. For the first half of 2025, the company recorded a net loss of $82.3 million, up from $45.3 million in the prior year. The increase in losses is attributed to a substantial rise in operating expenses, which totaled $44.0 million for the quarter, an 81% increase from $24.3 million in Q2 2024. Research and development expenses surged by 79% to $40.2 million, driven by increased clinical trial activities and anticipated milestone payments under a licensing agreement with Pfizer.

As of June 30, 2025, Celcuity's total assets amounted to $183.6 million, a decrease from $245.1 million at the end of 2024. The decline in assets was primarily due to a reduction in cash and cash equivalents, which increased to $46.4 million from $22.5 million, while investments decreased significantly from $212.6 million to $122.0 million. The company's accumulated deficit also grew to approximately $354.1 million, reflecting its ongoing investment in research and development without generating revenue.

Strategically, Celcuity is advancing its lead therapeutic candidate, gedatolisib, through multiple clinical trials. The company is currently enrolling patients in the Phase 3 VIKTORIA-1 trial and has initiated the VIKTORIA-2 trial, both targeting advanced breast cancer. The first patient in the VIKTORIA-2 trial was dosed in July 2025. Additionally, Celcuity announced the achievement of a milestone that allows it to draw an additional $30 million under its loan agreement, which is expected to support ongoing clinical trials.

Operationally, the company has seen an increase in its employee headcount, reflecting its expansion in clinical and administrative functions. As of June 30, 2025, Celcuity had approximately 492 patients enrolled across various clinical trials, with a focus on the efficacy and safety of gedatolisib. The company has also made significant strides in its intellectual property portfolio, with recent patent issuances extending exclusivity for gedatolisib into 2042.

Looking ahead, Celcuity plans to submit a New Drug Application (NDA) for gedatolisib to the FDA in the fourth quarter of 2025. The company anticipates that its current cash reserves, combined with the proceeds from recent equity and convertible note offerings, will be sufficient to fund operations through 2027. However, it acknowledges the potential need for additional capital to support ongoing research, development, and commercialization efforts.