Q1 2025 Celcuity Inc Earnings Call Transcript
Key Points
- Celcuity Inc (CELC) anticipates multiple upcoming clinical data readouts, including top line data from the PIK3CA wild-type patient cohort of their Phase III VIKTORIA-1 trial in Q3 2025.
- The company has made significant progress in activating trial sites for their Phase III first-line VIKTORIA-2 trial, with nearly 200 sites qualified across multiple regions.
- Celcuity Inc (CELC) has a strong cash position, ending the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments.
- The company is collaborating with prestigious institutions like Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in endometrial cancer.
- Celcuity Inc (CELC) expects their cash reserves and debt facility to fund current clinical development program activities through 2026.
- Celcuity Inc (CELC) reported a net loss of $37 million for the first quarter of 2025, a significant increase from the $21.6 million net loss in the first quarter of 2024.
- Research and development expenses increased by $11.6 million compared to the previous year, primarily due to increased employee and consulting expenses.
- General and administrative expenses more than doubled compared to the first quarter of 2024, rising to $3.9 million.
- The company used $35.9 million in net cash for operating activities in the first quarter of 2025, more than double the amount used in the same period in 2024.
- There is uncertainty regarding the timing of data readouts, with potential delays in reporting results from the VIKTORIA-1 trial due to the complexity of the trial design.
Good afternoon, ladies and gentlemen, and welcome to the Celcuity first-quarter 2025 financial results webcast conference call. (Operator Instructions)
I would now like to turn the conference over to Apoorva Chiluri with ICR Healthcare. Please go ahead.
Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity's First Quarter 2025 Financial Results and Business Update. Earlier today, Celcuity Inc. released financial results for the first quarter ended March 31, 2025. The press release can be found on the Investors section of Celcuity's website.
Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer, who will be available during Q&A. Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties,
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