Celcuity Inc. ( (CELC) ) has released its Q3 earnings. Here is a breakdown of the information Celcuity Inc. presented to its investors.
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Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, with its lead therapeutic candidate, gedatolisib, undergoing multiple clinical trials for various cancer indications.
In its third quarter of 2025 financial report, Celcuity Inc. highlighted significant clinical and regulatory advancements, including the presentation of promising efficacy and safety results from its Phase 3 VIKTORIA-1 trial at the European Society for Medical Oncology Congress, and the progress towards submitting a New Drug Application for gedatolisib to the FDA.
Key financial metrics revealed an increase in total operating expenses to $42.8 million, driven by higher research and development costs and general administrative expenses, leading to a net loss of $43.8 million for the quarter. The company also reported a strengthened balance sheet with cash, cash equivalents, and short-term investments totaling $455.0 million, expected to fund operations through 2027.
Strategic developments included the completion of patient enrollment for the PIK3CA mutant cohort of the VIKTORIA-1 trial, with topline data anticipated in early to mid-2026, and the initiation of the VIKTORIA-2 trial. Additionally, Celcuity secured significant financial backing through convertible senior notes and an expanded term loan facility.
Looking ahead, Celcuity remains focused on advancing its clinical trials and preparing for the potential commercial launch of gedatolisib, pending FDA approval, with a robust financial position supporting its strategic initiatives.