In This Article:
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Net Loss: $37 million or $0.86 per share for Q1 2025, compared to $21.6 million or $0.6 per share for Q1 2024.
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Non-GAAP Adjusted Net Loss: $34.7 million or $0.81 per share for Q1 2025, compared to $19.9 million or $0.59 per share for Q1 2024.
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Research and Development Expenses: $32.2 million for Q1 2025, up from $20.6 million for Q1 2024.
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General and Administrative Expenses: $3.9 million for Q1 2025, compared to $1.8 million for Q1 2024.
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Net Cash Used in Operating Activities: $35.9 million for Q1 2025, compared to $17.1 million for Q1 2024.
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Cash, Cash Equivalents, and Short-term Investments: Approximately $205.7 million at the end of Q1 2025.
Release Date: May 14, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Celcuity Inc (NASDAQ: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.
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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.
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Celcuity Inc (NASDAQ:CELC) has a strong cash position, ending the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments.
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The company is collaborating with prestigious institutions like Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in endometrial cancer.
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Celcuity Inc (NASDAQ:CELC) expects their cash reserves and debt facility to fund current clinical development program activities through 2026.
Negative Points
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Celcuity Inc (NASDAQ: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.
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Research and development expenses increased by $11.6 million compared to the previous year, primarily due to increased employee and consulting expenses.
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General and administrative expenses more than doubled compared to the first quarter of 2024, rising to $3.9 million.
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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.
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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.
Q & A Highlights
Q: Can you provide more perspective on the timeline for the VIKTORIA-1 trial data analysis and results? A: Brian Sullivan, CEO, explained that the primary completion date refers to the data cutoff when data collection stops, triggered by reaching the event threshold. The data cleaning process follows, leading to database lock. They expect to have the data available in Q3 2025, with no further risk of delay.