Significant Milestones Achieved
Celcuity reported positive top line data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 clinical trial, showing significant improvements in progression-free survival (PFS) for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer patients. Median PFS for the gedatolisib triplet was 9.3 months with a hazard ratio of 0.24, and 7.4 months for the gedatolisib doublet with a hazard ratio of 0.33.
Phase III VIKTORIA-2 Clinical Trial Progress
The first patient was dosed in the Phase III VIKTORIA-2 trial, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR-positive, HER2-negative advanced breast cancer.
Favorable Preliminary Results from Early-Phase Trials
Preliminary top line results from trials evaluating gedatolisib with darolutamide in prostate cancer and with trastuzumab biosimilar in HER2-positive breast cancer were favorable. The prostate cancer trial showed a 66% 6-month radiographic PFS rate.
Patent Extension for Gedatolisib
Celcuity extended patent exclusivity for gedatolisib into 2042 with a new dosing regimen patent.
Strong Financial Position
Celcuity raised approximately $287 million through public offerings, bringing cash, cash equivalents, and investments to $455 million on a pro forma basis, ensuring funding through 2027.