Business
Celcuity Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
Dosing of first patient in VIKTORIA-1 in the fourth quarter triggered closing of $100 million PIPE financing and drawdown of $20 million term loan tranche,
About this update from Celcuity Inc.
[{"type":"text","content":"Dosing of first patient in VIKTORIA-1 in the fourth quarter triggered closing of $100 million PIPE financing and drawdown of $20 million term loan tranche, which extends cash runway through 2025Updated clinical data from the Phase 1b advanced breast cancer trial with gedatolisib was presented at SABCS in December - median PFS was 42.3 months in treatment naïve advanced breast cancer patientsPreclinical data reporting therapeutic effects of gedatolisib and other PI3K/AKT/mTOR inhibitors in prostate cancer cell lines was presented at ASCO-GU in FebruaryAn abstract was published in advance of the AACR Annual Meeting 2023 reporting therapeutic effects of gedatolisib and other PI3K/AKT/mTOR inhibitors in gynecological cell linesManagement to host webcast and conference call today, March 23, 2023, at 4:30 p.m. ETMINNEAPOLIS, MN / ACCESSWIRE / March 23, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced financial results for the fourth quarter and full year ended December 31, 2022 and other recent business developments.\"We achieved a number of critical milestones in the fourth quarter. Most importantly, we dosed the first patient in our Phase 3 VIKTORIA-1 trial of gedatolisib in advanced breast cancer. This milestone, in turn, triggered the closing of our $100 million PIPE financing and a $20 million drawdown on our term loan,\" said Brian Sullivan, CEO and Co-Founder of Celcuity. \"These financings significantly strengthen our balance sheet and are expected to provide the capital we need to fund operations through 2025.\"Fourth Quarter 2022 Business Highlights and Other Recent DevelopmentsIn December, the first patient was dosed in the Phase 3 VIKTORIA-1 clinical trial. VIKTORIA-1 is evaluating the safety and efficacy of Celcuity's lead drug product candidate, gedatolisib, an investigational pan-PI3K/mTOR inhibitor, in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease progressed while receiving prior CDK4/6 therapy. Patient enrollment is currently in progress. Gedatolisib was previously granted Breakthrough Therapy designation in July 2022 from the U.S. Food and Drug Administration for the treatment of patients with HR+/HER2- advanced breast cancer whose disease progre...