Celcuity Stock Earnings Reports

Celcuity reported significant clinical and corporate progress in Q1 2026 as it prepares for a potential FDA approval of gedatolisib with a PDUFA target date of July 17, 2026. Top-line positive Phase III results were announced for the PIK3CA mutant cohort of VIKTORIA-1 (detailed data to be presented at ASCO on June 2), where both the gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) and doublet (gedatolisib + fulvestrant) showed statistically significant and clinically meaningful improvements in progression-free survival versus alpelisib-containing regimens and were generally well tolerated. Based on combined mutant and previously reported wild-type data, Celcuity believes gedatolisib can improve the second-line standard of care regardless of PIK3CA status. The company expanded its Phase III VIKTORIA-2 program to add a first-line study for endocrine-sensitive HR+/HER2- advanced breast cancer, now running two parallel studies (endocrine-resistant Study 1 and endocrine-sensitive Study 2) with topline expectations of end-2028 for Study 1 and 2030 for Study 2. Celcuity is also developing a subcutaneous (subQ) formulation of gedatolisib (first U.S. patent application submitted) aimed at long-duration indications; clinical equivalence and regulatory bridging studies will be required. Commercial preparations are well advanced: the oncology sales specialists team is fully hired (average 24 years pharma experience, 16 years in oncology), payer and strategic account outreach is extensive, and market research suggests strong physician willingness to prescribe. Financially, Q1 net loss was $52.8M ($0.97/share) and non-GAAP adjusted net loss was $46.8M ($0.86/share); R&D and SG&A increased due to launch-related hires and manufacturing costs. Cash, cash equivalents and short-term investments were $387.1M at quarter end, and management expects existing cash plus drawdowns on its debt facility to fund operations through 2027. Management emphasized readiness for launch activities while deferring detailed discussion of the mutant cohort until the ASCO presentation.