Business
Celcuity Inc. Reports First Quarter 2023 Financial Results and Provides Corporate Updates
Presented updated results for treatment-naïve patients from Phase 1b study of gedatolisib at the ESMO Breast Cancer Annual Congress - median progression free
About this update from Celcuity Inc.
[{"type":"text","content":"Presented updated results for treatment-naïve patients from Phase 1b study of gedatolisib at the ESMO Breast Cancer Annual Congress - median progression free survival (PFS) was 48.6 monthsPresented nonclinical prostate cancer data at ASCO GU Cancers Symposium demonstrating the superior therapeutic effect of gedatolisib compared to other PI3K, AKT, and mTOR inhibitors regardless of PTEN or P13K mutational statusPresented nonclinical gynecological cancer data at AACR demonstrating the superior therapeutic effect of gedatolisib compared to other PI3K, AKT, and mTOR inhibitors regardless of PTEN, P13K, or AKT mutational statusManagement to host webcast and conference call today, May 15, 2023, at 4:30 p.m. ETMINNEAPOLIS, MN / ACCESSWIRE / May 15, 2023 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today reported financial results for the first quarter ended March 31, 2023 and provided other recent corporate updates.\"I am very pleased with the execution to date of our VIKTORIA-1 Phase 3 clinical trial enrollment activities at our trial sites. Our team is relentlessly focused and keeping us on track to deliver initial data in the second half of 2024,\" said Brian Sullivan, CEO and Co-Founder of Celcuity.\"The updated median progression free survival (mPFS) data for treatment-naïve HR+/HER2- advanced breast cancer patients we presented last week at the ESMO Breast Cancer Congress is very encouraging. The reported mPFS of 48.6 months compares very favorably to published data for available standards of care in this setting. In addition, the findings from the various nonclinical studies we presented at ASCO-GU and AACR further highlight the benefit of inhibiting all Class I PI3K isoforms and MTOR1/MTORC2 and provide important input as we prioritize our clinical development plans.\"First Quarter 2023 Business Highlights and Other Recent DevelopmentsSite activation and patient enrollment activities for the VIKTORIA-1 Phase 3 clinical trial remained on track to enable primary analysis of the PIK3CA WT sub-group in the second half of 2024. VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant, an endocrine therapy, with and without palbociclib, a CDK4/6 inhibitor, in adults with HR+/HER2- advanced breast cancer.In February 2023, the Company presen...