Core Insights - Celcuity Inc. is positioned for a transformative year in 2026, with anticipated topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study, which could enhance treatment standards for HR+/HER2- advanced breast cancer patients [2] - The FDA has accepted Celcuity's New Drug Application for gedatolisib, granting Priority Review with a PDUFA goal date of July 17, 2026 [4] Business Highlights - The Phase 3 VIKTORIA-1 study has shown promising results, with a median progression-free survival of 16.6 months for the gedatolisib triplet compared to 1.9 months for fulvestrant, indicating a significant improvement in patient outcomes [5] - The gedatolisib triplet demonstrated a median time to definitive deterioration of 23.7 months, significantly better than the 4.0 months for fulvestrant [5] - The triplet therapy was generally well tolerated, with low-grade treatment-related adverse events reported [5] Financial Results - Total operating expenses for Q4 2025 were $49.2 million, up from $36.4 million in Q4 2024, while full-year operating expenses reached $172.2 million compared to $113.3 million in 2024 [7] - Research and development expenses for Q4 2025 were $37.6 million, an increase from $33.5 million in the prior year, driven by higher employee and consulting costs [8] - The net loss for Q4 2025 was $51.0 million, or $0.97 per share, compared to a net loss of $36.7 million, or $0.85 per share, in Q4 2024 [12] Cash Position - Cash, cash equivalents, and short-term investments totaled $441.5 million at the end of 2025, expected to finance operations through 2027 [14]

Core Insights - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [2] Company Overview - The lead therapeutic candidate of Celcuity is gedatolisib, which is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR ("PAM") pathway comprehensively [2] - Gedatolisib's mechanism of action and pharmacokinetic properties are distinct from other therapies that target PI3Kα, AKT, or mTORC1 alone or in combination [2] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, has completed enrollment, evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, for patients with HR+/HER2- advanced breast cancer [2] - The company has reported detailed results for the PIK3CA wild-type cohort from the VIKTORIA-1 trial [2] - A second Phase 3 trial, VIKTORIA-2, is ongoing, assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [2] - A Phase 1/2 clinical trial, CELC-G-201, is also ongoing, evaluating gedatolisib in combination with darolutamide for patients with metastatic castration-resistant prostate cancer [2] Investor Engagement - Brian Sullivan, CEO and Co-founder of Celcuity, will present at various investor conferences and is available for one-on-one meetings [1][3] - Live webcasts of the presentations will be accessible on the company's website, with replays available shortly after the events [1]

Core Insights - Celcuity Inc. announced updated results from the Phase 3 VIKTORIA-1 trial for gedatolisib, a multi-target PI3K/AKT/mTOR inhibitor, in patients with advanced breast cancer [1] Efficacy Results - For patients with time to progression on prior therapy >18 months, median progression-free survival (PFS) was 12.4 months for the gedatolisib triplet and 10.0 months for the gedatolisib doublet, compared to 1.9 months for fulvestrant [2][6] - In patients from the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months for the gedatolisib triplet and 7.1 months for the gedatolisib doublet, versus 1.9 months for fulvestrant [2][6] Safety Analysis - Stomatitis was effectively managed, with median time to improvement for Grade 2 or 3 stomatitis being 12 and 14 days for the triplet, and 8 and 9 days for the doublet [3][6] - Gedatolisib did not cause clinically relevant hyperglycemia, and glucose levels remained stable over time [3][6] Patient-Reported Outcomes - Both gedatolisib regimens delayed time to definitive deterioration in well-being measures compared to fulvestrant, with median time to deterioration being 23.7 months for the triplet and not reached for the doublet, versus 4.0 months for fulvestrant [4][6] Company Perspective - The Chief Medical Officer of Celcuity expressed excitement over the results, highlighting nearly two years of delay in definitive deterioration of well-being for patients and the differentiated safety profile of gedatolisib regimens [5][6] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors, with gedatolisib as its lead candidate [6][7] - The company is conducting multiple clinical trials, including VIKTORIA-2 for first-line treatment in HR+/HER2- advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [7]

Core Insights - Celcuity Inc. is set to release its financial results for Q3 2025 on November 12, 2025, after market close, followed by a webcast and teleconference at 4:30 p.m. Eastern Time [1] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications [3] - The lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [3] - Celcuity's clinical trials include: - VIKTORIA-1: A Phase 3 trial evaluating gedatolisib with fulvestrant in HR+/HER2- ABC, which has completed enrollment and reported results for the PIK3CA Wild-Type cohort [3] - VIKTORIA-2: A Phase 3 trial currently enrolling patients, assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- ABC [3] - CELC-G-201: A Phase 1/2 trial ongoing, evaluating gedatolisib with darolutamide in metastatic castration-resistant prostate cancer patients [3]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR ("PAM") pathway comprehensively [3] - Celcuity is headquartered in Minneapolis and provides further information on its website [3] Clinical Trials - The Phase 3 clinical trial VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, has completed enrollment and reported results for the PIK3CA Wild-Type cohort [3] - Enrollment for the PIK3CA mutant cohort in the VIKTORIA-1 trial has also been completed [3] - The ongoing Phase 3 clinical trial VIKTORIA-2 is evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC [3] - A Phase 1/2 clinical trial, CELC-G-201, is currently evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer [3] Upcoming Events - Brian Sullivan, CEO and Co-founder of Celcuity, is scheduled for a fireside chat at the Stifel 2025 Healthcare Conference on November 11, 2025, at 10:00 a.m. ET [2] - A live webcast of the event will be available on the company's website [2]

Core Insights - Celcuity Inc. is set to disclose topline results from the Phase 3 VIKTORIA-1 trial on July 28, 2025 [1][2] - The company focuses on developing targeted therapies for oncology, particularly for solid tumors [3] Company Overview - Celcuity is a clinical-stage biotechnology company headquartered in Minneapolis [3] - The lead therapeutic candidate is gedatolisib, a pan-PI3K and mTORC1/2 inhibitor, which targets the PAM pathway [3] - Ongoing clinical trials include VIKTORIA-1 for HR+/HER2- advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [3]

Core Insights - Celcuity Inc. has initiated the Phase 3 clinical trial VIKTORIA-2 to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant for HR+/HER2- advanced breast cancer patients who are resistant to endocrine therapy [1][2][3] Group 1: Clinical Trial Details - The VIKTORIA-2 trial is an open-label, randomized study comparing the efficacy and safety of gedatolisib combined with fulvestrant and a CDK4/6 inhibitor against the standard treatment of fulvestrant and a CDK4/6 inhibitor [3][4] - Approximately 638 subjects will be enrolled, with random assignment to either the experimental group (gedatolisib, fulvestrant, and a CDK4/6 inhibitor) or the control group (fulvestrant and a CDK4/6 inhibitor) [4] - The trial will assess primary endpoints of progression-free survival (PFS) based on RECIST 1.1 criteria, evaluated separately for PI3KCA wild type and mutant subjects [4] Group 2: Efficacy and Safety - Previous Phase 1b trial results indicated that patients receiving gedatolisib with palbociclib and letrozole had a median progression-free survival of 48.6 months and median overall survival of 77.3 months, with an objective response rate of 79% [2] - The trial aims to provide robust data to support the potential of gedatolisib as a first-line treatment option for patients with endocrine-resistant advanced breast cancer [2][3] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [5][6] - The company is headquartered in Minneapolis and is also conducting other clinical trials, including VIKTORIA-1 and CELC-G-201, targeting different cancer types [5][6]