Core Insights - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York on February 11-12, 2026 [1] - Brian Sullivan, CEO and Co-founder of Celcuity, is scheduled for a fireside chat on February 11, 2026, at 9:30 a.m. ET, with a live webcast available [2] Company Overview - Celcuity's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor that targets the PI3K/AKT/mTOR pathway [3] - The company has completed enrollment for the Phase 3 clinical trial VIKTORIA-1, which evaluates gedatolisib in combination with fulvestrant in patients with HR+/HER2- ABC, and has reported results for the PIK3CA wild-type cohort [3] - The ongoing Phase 3 clinical trial VIKTORIA-2 is assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- ABC patients [3] - A Phase 1/2 clinical trial, CELC-G-201, is evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3]

Core Insights - Celcuity Inc. announced the acceptance of an abstract for an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), highlighting its ongoing research in targeted therapies for oncology [1][2]. Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for multiple solid tumor indications, with its lead candidate being gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor [3]. - Gedatolisib targets the PI3K/AKT/mTOR pathway, differentiating its mechanism of action and pharmacokinetic properties from other therapies that target PI3Kα, AKT, or mTORC1 alone or in combination [3]. Clinical Trials - The VIKTORIA-1 trial, a Phase 3 clinical study, has completed enrollment and is evaluating gedatolisib in combination with fulvestrant with or without palbociclib for patients with HR+/HER2- advanced breast cancer [3]. - The company has reported detailed results for the PIK3CA wild-type cohort and has also completed enrollment for the PIK3CA mutant cohort [3]. - A second Phase 3 trial, VIKTORIA-2, is currently enrolling patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer [3]. - Additionally, a Phase 1/2 trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3].

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]