Celcuity Inc. announced its financial results for the second quarter ended June 30, 2025, reporting increased operating expenses and net loss, alongside significant clinical and financial advancements. Total operating expenses for Q2 2025 were $44.0 million, up from $24.3 million in Q2 2024.
Research and development (R&D) expenses increased to $40.2 million, an increase of $17.7 million from the prior-year period, partly due to a $5.0 million anticipated development milestone payment under the license agreement with Pfizer. The net loss for Q2 2025 was $45.3 million, or $1.04 loss per share.
As of June 30, 2025, Celcuity reported cash, cash equivalents, and short-term investments of $168.4 million. However, on a proforma basis, including net proceeds from third-quarter financing activities, this figure rose to $455 million, which is expected to fund operations through 2027.
The company highlighted the positive topline data from the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 clinical trial, which showed an unprecedented reduction in the risk of disease progression or death. Celcuity remains on track to submit a New Drug Application (NDA) for gedatolisib later this year based on this data and expects to report topline data from the PIK3CA mutant cohort in Q4 2025.
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