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Dec 31, 2021
Celcuity Q4 2021 Earnings Report
Reported financial results for Q4 and full year 2021, pivotal Phase 3 trial design for Gedatolisib, and business updates.
Key Takeaways
Celcuity Inc. reported its Q4 and full year 2021 financial results, along with the design for its pivotal Phase 3 trial for gedatolisib and other business updates. The company's operating expenses and net loss increased compared to the same period in 2020, driven by increased R&D expenses related to the Pfizer license agreement and gedatolisib development.
Finalized the trial design for the pivotal Phase 3 study following productive meetings with the FDA.
Phase 3 clinical trial, named VIKTORIA-1, will evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib.
The company expects to initiate the clinical trial in the first half of 2022.
At December 31, 2021, Celcuity had cash and cash equivalents of $84.3 million.
Forward Guidance
Celcuity expects to achieve potential milestones over the next twelve months.
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