Celcuity Inc. Reports Promising Q2 2025 Results

Celcuity Inc. ( (CELC) ) has released its Q2 earnings. Here is a breakdown of the information Celcuity Inc. presented to its investors.

Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, particularly in the treatment of solid tumors. The company is headquartered in Minneapolis and is known for its lead therapeutic candidate, gedatolisib, which targets the PAM pathway in cancer treatment.

In its second quarter 2025 earnings report, Celcuity Inc. highlighted significant advancements in its clinical trials and financial activities. The company reported positive results from its Phase 3 VIKTORIA-1 trial, showing unprecedented improvements in progression-free survival for HR+/HER2- advanced breast cancer patients. Additionally, Celcuity plans to submit a New Drug Application for gedatolisib to the FDA by the end of 2025.

Key financial metrics revealed an increase in operating expenses, primarily driven by research and development costs. The company reported a net loss of $45.3 million for the quarter, compared to $23.7 million in the same period last year. Despite the losses, Celcuity successfully raised $286.5 million through public offerings, resulting in a proforma cash position of $455 million, expected to fund operations through 2027.

Strategically, Celcuity is advancing multiple clinical trials, including the ongoing enrollment for the PIK3CA mutant cohort in the VIKTORIA-1 trial and the initiation of the VIKTORIA-2 trial. The issuance of a new patent for gedatolisib’s dosing regimen further strengthens its intellectual property portfolio, extending exclusivity into 2042.

Looking forward, Celcuity’s management remains optimistic about the potential of gedatolisib to become a practice-changing therapy in oncology. With a strong financial position and promising clinical data, the company is poised to continue its progress in developing innovative cancer treatments.