Core Insights - Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials, demonstrating promising efficacy and safety profiles in treating metastatic cancers [1][4][5] Phase 1 Clinical Trial in mCRPC - In the Phase 1 trial evaluating gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (mCRPC), the six-month radiographic progression-free survival (rPFS) rate was reported at 66% [1][4] - The trial involved 38 patients, with two arms receiving different doses of gedatolisib (120 mg and 180 mg) alongside darolutamide [2] - No patients discontinued treatment due to treatment-related adverse events (AEs), and less than 3% experienced Grade 3 stomatitis [4][5] Phase 2 Clinical Trial in HER2+ Metastatic Breast Cancer - In the Phase 2 trial for HER2+ metastatic breast cancer (mBC), the objective response rate (ORR) was 43% among 44 patients treated with gedatolisib plus trastuzumab-pkrb [1][6] - The median number of prior anti-HER2 therapies for enrolled patients was four or more, with 86% having received at least three prior treatments [6] - No patients discontinued treatment due to treatment-related AEs, and no Grade 3 hyperglycemia was reported [5][6] Future Directions - The company plans to amend the clinical trial protocol to explore additional dosing options for gedatolisib in the ongoing Phase 1/1b trial [4] - Up to six patients will be enrolled in each of three arms to determine the recommended Phase 2 dose (RP2D), with a total of approximately 30 subjects expected to be treated with the RP2D in the Phase 2 dose expansion study [4][5] - Celcuity is also conducting other clinical trials, including a Phase 3 trial evaluating gedatolisib in combination with fulvestrant for HR+/HER2- advanced breast cancer [7]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [2] - The company's lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [2] - Celcuity is headquartered in Minneapolis and provides further information on its website [2] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, is currently enrolling patients to evaluate gedatolisib in combination with fulvestrant with or without palbociclib for HR+/HER2- advanced breast cancer [2] - A Phase 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [2] - Another Phase 3 clinical trial, VIKTORIA-2, is recruiting patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [2] Investor Engagement - Brian Sullivan, CEO and Co-founder of Celcuity, will present at investor conferences and be available for one-on-one meetings [1] - Live webcasts of the presentations will be accessible on the company's website, with replays available shortly after the events [1] - Upcoming events include a fireside chat at the TD Cowen: 6th Annual Oncology Innovation Summit on May 28, 2025, and at the Jefferies Global Healthcare Conference on June 5, 2025 [3]