Celcuity Inc. has released its financial results for the first quarter of 2025, along with updates on its clinical development programs and other recent business developments. The company reported approximately $206 million in cash, cash equivalents, and investments at the end of March 31, 2025, which is expected to fund its current clinical development program activities through 2026.
In terms of financial performance, total operating expenses for the first quarter of 2025 were $36.1 million, compared to $22.5 million for the same period in 2024. Research and development expenses were $32.2 million for the first quarter of 2025, up from $20.6 million in the prior-year period. General and administrative expenses also increased to $3.9 million for the first quarter of 2025, compared to $1.8 million for the same period in 2024. The net loss for the first quarter of 2025 was $37.0 million, or $0.86 loss per share, compared to a net loss of $21.6 million, or $0.64 loss per share, for the first quarter of 2024. The non-GAAP adjusted net loss for the first quarter of 2025 was $34.7 million, or $0.81 loss per share, compared to $19.9 million, or $0.59 loss per share, for the first quarter of 2024.
The company's cash used in operating activities for the first quarter of 2025 was $35.9 million, compared to $17.1 million for the first quarter of 2024. As of March 31, 2025, Celcuity reported cash, cash equivalents, and short-term investments of $205.7 million.
On the clinical development front, Celcuity provided updates on its ongoing phase 3 clinical trials, including the VIKTORIA-1 and VIKTORIA-2 studies, evaluating gedatolisib in combination with other therapies for the treatment of advanced breast cancer. The company also highlighted the progress of the CELC-G-201 study, a phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration-resistant prostate cancer.
Furthermore, Celcuity announced the initiation of a clinical trial collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.
The press release also mentioned upcoming milestones, including the expected topline data readouts for the VIKTORIA-1 trial cohorts, with the pik3ca wild-type cohort anticipated in the third quarter of 2025 and the pik3ca mutant cohort expected in the fourth quarter of 2025. Additionally, the VIKTORIA-2 trial is on track to dose its first patient in the second quarter of 2025.
As a result of these announcements, the company's shares have moved 1.36% on the market, and are now trading at a price of $10.82. For the full picture, make sure to review Celcuity's 8-K report.
