Celcuity (CELC) Q1 FY26 earnings call

Celcuity reported strong progress for gedatolisib, driven by positive Phase III VIKTORIA-1 data in both wild-type and mutant PIK3CA cohorts, positioning it as a potential new standard of care in second-line HR-positive/HER2-negative advanced breast cancer. The company expanded its VIKTORIA-2 study into the first-line setting and advanced a subcutaneous formulation, while also building out its commercial team ahead of a potential Q3 FDA approval. Despite increased operating expenses due to launch preparations, Celcuity maintains a cash runway through 2027.