After the closure of the market yesterday, Celcuity Inc. (NASDAQ: CELC) witnessed a significant uptick in its shares during the extended trading session. As per the latest update, CELC stock experienced a 4.70% increase, reaching $18.04 on the US stock market charts, following a 2.01% rise in the regular session, closing at $17.23.
Strategic Milestones And Clinical Advancements
During this quarter, Celcuity (CELC) demonstrated commendable progress. The VIKTORIA-1 study maintained its trajectory, and CELC successfully administered the initial dose to the first patient in its Phase 1b/2 trial targeting metastatic castration-resistant prostate cancer.
Bolstering its leadership team, Celcuity appointed a Chief Commercial Officer, marking the initiation of essential groundwork for the potential commercial introduction of gedatolisib. Furthermore, Celcuity anticipates presenting crucial topline data from the PIK3CA wild-type patient subgroup later this year.
Financial Insights And Operational Highlights
Celcuity reported $22.5 million in total operating costs for the first quarter of 2024, of which $20.7 million was allocated to research and development (R&D). Significantly, R&D spending increased by around $9.4 million, mostly because of work related to the VIKTORIA-1 Phase 3 study and the start of the CELC-G-201 Phase 1b/2 clinical trial.
An additional $1.5 million of this increase came from higher personnel and consultant costs. The net loss, which came to $21.6 million, or $0.64 loss per share, in spite of these investments was less than the $11.9 million, or $0.55 loss per share, reported in the same period of the prior year. Celcuity reported having $177.7 million in liquid assets as of March 31, 2024.
Forward-looking Strategies And Clinical Trials Progress
Topline findings for the PIK3CA mutant patient cohort are anticipated to be released in the first half of 2025 by Celcuity’s VIKTORIA-1 Phase 3 investigation, and for the PIK3CA wild-type patient subgroup in the second half of 2024. There is still room for more volunteers in the Phase 3 VIKTORIA-1 clinical investigation, which is being carried out at more than 220 sites throughout 23 countries in North and South America, Europe, and Asia.”
In the meanwhile, a Phase 1b/2 clinical investigation for metastatic castration-resistant prostate cancer (mCRPC) is making good progress with the evaluation of gedatolisib in combination with darolutamide. Eldon Mayer’s appointment as Chief Commercial Officer, a calculated strategic move, fits with Celcuity’s goal of being ready for gedatolisib’s possible commercial debut.
