CELC·Celcuity Inc.

Most important lines

1. 1

   Gedatolisib regimens demonstrated robust and durable responses: 49% objective response rate (“ORR”) and median duration of response (“DoR”) of 15.7 months for the gedatolisib-triplet and 36% ORR and median DoR of 24.2 months for the gedatolisib-doublet.

   New this quarter
2. 2

   Following the unprecedented results from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, on July 14, 2026 Celcuity announced that the U.S. Food and Drug Administration (“FDA”) had approved REVTORPYK, the company’s pan-PI3K, mTORC1/2 inhibitor, for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor 2 receptor negative (”HER2-“), locally advanced or metastatic breast cancer (“ABC”) without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

   New this quarter
3. 3

   The Phase 3 PIK3CA mutant cohort of the VIKTORIA-1 trial achieved its primary endpoint by doubling the likelihood of survival without disease progression or death compared to alpelisib plus fulvestrant; a supplemental New Drug Application (“sNDA”) is planned for submission in the third quarter of 2026

   New this quarter