Celcuity Inc (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, stock fell 2.62% (As on April 1, 11:26:59 AM UTC-4, Source: Google Finance) after the company missed the earning expectations for the fourth quarter of FY24. The company expects 2025 to be a transformational year for Celcuity as it anticipate reporting several clinical data readouts, including primary analysis for the PIK3CA wild-type cohort of the VIKTORIA-1 trial. The company expects to share topline data in Q2 2025. In addition, the company anticipates reporting topline data for the Phase 1b/2 trial in metastatic castration resistant prostate cancer in late Q2 2025, and topline data for the PIK3CA mutant-type cohort of the VIKTORIA-1 trial in Q4 2025. The company also remain on track to enroll the first patient for our VIKTORIA-2 Phase 3 trial in Q2 2025.

CELC in the fourth quarter of FY24 has reported the adjusted loss per share of 85 cents, missing the analysts’ estimates for the adjusted loss per share of 71 cents. Net loss for the fourth quarter of 2024 was $36.7 million, or $0.85 loss per share, compared to a net loss of $18.8 million, or $0.65 loss per share, for the fourth quarter of 2023. Research and development (“R&D”) expenses were $33.5 million for the fourth quarter of 2024, compared to $18.1 million for the prior-year period. Of the approximately $15.4 million increase in R&D expenses, $9.9 million primarily related to costs supporting ongoing activities for the VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial, along with the commencement of the VIKTORIA-2 Phase 3 trial. The remaining $5.5 million primarily relates to increased employee and consulting expenses. In December 2024, Celcuity presented overall survival data from a Phase 1b trial, which evaluated gedatolisib in combination with palbociclib and either letrozole or fulvestrant, in patients with HR+, HER2- advanced or metastatic breast cancer during a poster session at the 2024 San Antonio Breast Cancer Symposium (SABCS).

Moreover, general and administrative (“G&A”) expenses were $3.0 million for the fourth quarter of 2024, compared to $1.6 million for the prior year period. Of the approximately $1.4 million increase, $1.1 million was related to increased employee-related expenses, and $0.3 million was related to professional fees, expanding infrastructure costs and other administrative expenses. Total operating expenses were $36.4 million for the fourth quarter of 2024, compared to $19.7 million for the fourth quarter of 2023.