Business
Celcuity Inc. Reports Second Quarter Financial Results and Provides Corporate Update
Announced plan to initiate Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor as first-line treatment for
About this update from Celcuity Inc.
[{"type":"text","content":"Announced plan to initiate Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+, HER2- advanced breast cancer; expect to enroll first patient in Q2 2025Expect to reach enrollment target for VIKTORIA-1 PIK3CA WT cohort in Q4 2024 and report topline data for this cohort in late Q4 2024 or Q1 2025Raised $129 million in gross proceeds from equity and debt financings; extending runway of current operational activities through 2026Management to host webcast and conference call today, August 14, 2024, at 4:30 p.m. ET MINNEAPOLIS, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the second quarter ended June 30, 2024 and other recent business developments. “We made significant strides advancing the clinical development of gedatolisib this quarter. Overall enrollment in VIKTORIA-1 remains robust and on-track relative to our previous projections,” said Brian Sullivan, CEO and co-founder of Celcuity. “We also initiated efforts to launch VIKTORIA-2, a Phase 3 study to evaluate gedatolisib as a first-line treatment option for patients with HR+, HER2- advanced breast cancer.” “In our VIKTORIA-1 study, while overall enrollment is on track, the proportion of patients who have PIK3CA wild-type tumors, versus those with PIK3CA mutations, has recently shifted lower than our original estimates. As a result, we expect to reach the enrollment target for the PIK3CA wild-type cohort in the fourth quarter, rather than the third quarter, as we originally forecasted. In light of this, we expect topline data for the PIK3CA WT cohort to shift to sometime between late Q4 2024 and Q1 2025.” Second Quarter 2024 Business Highlights and Other Recent Developments The VIKTORIA-1 Phase 3 trial expects to provide topline data for the PIK3CA wild-type cohort in late Q4 2024 or Q1 2025 and for the PIK3CA mutant cohort in the first half of 2025. VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.Enrollment of the PIK3CA wild-type cohort is more than 80% complete and expected to reac...