Business
Celcuity Inc. Reports Third Quarter 2022 Financial Results and Provides Corporate Update
Completed selection of 200 clinical trial sites for the Phase 3 VIKTORIA-1 breast cancer study; activated first clinical trial site in the third quarter;
About this update from Celcuity Inc.
[{"type":"text","content":"Completed selection of 200 clinical trial sites for the Phase 3 VIKTORIA-1 breast cancer study; activated first clinical trial site in the third quarter; expect dosing of first patient by year-endUpdated Phase 1b data will be reviewed during a Spotlight Poster Discussion Session at the 2022 San Antonio Breast Cancer Symposium in December 2022Expanded Board of Directors with appointment of Polly Murphy, D.V.M., Ph.D., a seasoned pharmaceutical executive with significant business development and commercialization experienceManagement to host webcast and conference call today, November 10, 2022, at 4:30 p.m. ETMINNEAPOLIS, MN / ACCESSWIRE / November 10, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, today announced financial results for the third quarter ended September 30, 2022 and other recent business developments.\"We are encouraged by the significant interest from clinical sites across the world to participate in our Phase 3 VIKTORIA-1 study for gedatolisib,\" said Brian Sullivan, CEO and Co-Founder of Celcuity. \"We completed selection of sites for the study in the third quarter, and we are now focused on activating these selected sites. We are pleased that updated data from our Phase 1b study in advanced breast cancer will be reviewed during a Spotlight Poster Discussion Session at the 2022 San Antonio Breast Cancer Symposium in December 2022. Finally, I am excited that Dr. Polly Murphy has joined our Board of Directors. Her business development and commercial experience will provide a very helpful perspective to our board.\"Third Quarter 2022 Business Highlights and Other Recent DevelopmentsIn July, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Celcuity's lead drug product candidate gedatolisib, an investigational pan-PI3K/mTOR inhibitor, for the treatment of HR+/HER2- locally advanced, inoperable or metastatic breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with a nonsteroidal aromatase inhibitor. This designation allows for more intensive guidance from the FDA and a potentially accelerated review time if relevant criteria are met. Gedatolisib previously received Fast Track designation from the FDA in January 2022.In August, Celcuity a...