MINNEAPOLIS, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S. Food and Drug Administration (“FDA”) agreed to accept its New Drug Application (“NDA”) for gedatolisib in HR+/HER2- advanced breast cancer (“ABC”) for review under the Real-Time Oncology Review (“RTOR”) program, which facilitates earlier submission of topline efficacy and safety results, prior to the submission o ...

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 PAM pathway comprehensively [3] - Celcuity is headquartered in Minneapolis and provides further information on its website [3] 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 [3] - A Phase 1/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3] - Another Phase 3 clinical trial, VIKTORIA-2, is enrolling patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Upcoming Financial Results - Celcuity will release its financial results for the second quarter of 2025 after the market closes on August 14, 2025 [1] - Management will host a webcast/teleconference on the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update [1]

Group 1 - Celcuity (NASDAQ: CELC) recently announced positive results from its phase 3 VIKTORIA-1 trial, which tested its drug gedatolisib in combination with other therapies for treating patients with PIK3CA wildtype HR+/HER2- advanced breast cancer [2] - The trial involved a triplet therapy approach, indicating a potential advancement in treatment options for this specific type of breast cancer [2] Group 2 - The Biotech Analysis Central service offers in-depth analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] - The service is available for $49 per month, with a discounted yearly plan at $399, providing a 33.50% savings for subscribers [1]

Core Viewpoint - Celcuity Inc. has announced the pricing of its public offerings, including $175 million in convertible senior notes and approximately 1.84 million shares of common stock at $38.00 per share, aiming to raise a total of approximately $248.7 million for various corporate purposes [1][6]. Offering Details - The company is offering $175 million in 2.750% convertible senior notes due 2031, with an option for underwriters to purchase an additional $26.25 million to cover over-allotments [1][2]. - The common stock offering includes 1,836,842 shares priced at $38.00 each, with pre-funded warrants available at $37.999 per warrant [1][2]. Financial Terms - The convertible notes will accrue interest at 2.750% per year, payable semiannually, and will mature on August 1, 2031 [3]. - The initial conversion rate for the convertible notes is set at 19.4932 shares of common stock per $1,000 principal amount, equating to a conversion price of approximately $51.30 per share, representing a 35% premium over the common stock offering price [4]. Closing Timeline - The expected closing date for the convertible notes offering is August 1, 2025, while the common stock offering is anticipated to close on July 31, 2025, subject to customary closing conditions [5]. Use of Proceeds - The net proceeds from both offerings are estimated to be approximately $248.7 million, which will be used for working capital, clinical trial expenditures, and other general corporate purposes [6]. Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, with its lead candidate, gedatolisib, currently undergoing multiple clinical trials for various cancer indications [11].

Core Viewpoint - Celcuity Inc. is conducting public offerings of $150 million in convertible senior notes and $75 million in common stock to support its oncology-focused development efforts [1][4]. Group 1: Offerings Details - The company plans to offer $150 million in convertible senior notes due in 2031 and $75 million in common stock, with options for underwriters to purchase additional amounts [1][2]. - The convertible notes will be unsecured, with interest payable semi-annually, maturing on August 1, 2031, unless converted or redeemed earlier [3]. - The net proceeds from both offerings will be used for capped call transactions, working capital, and general corporate purposes, including clinical trials and business development [4]. Group 2: Capped Call Transactions - The company expects to enter capped call transactions to mitigate potential dilution from the convertible notes, which will cover shares of common stock underlying the notes [6]. - These transactions are designed to offset cash payments exceeding the principal amount of converted notes, subject to a cap [6]. - The option counterparties may engage in derivative transactions that could influence the market price of the common stock and convertible notes [7][8]. Group 3: Management and Underwriters - Jefferies, TD Cowen, and Leerink Partners are the joint book-running managers for the offerings, with LifeSci Capital acting as lead manager for the convertible notes [9]. - The company has filed a registration statement with the SEC regarding these offerings, providing necessary documentation for potential investors [10]. Group 4: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors, with its lead candidate being gedatolisib, a pan-PI3K and mTORC1/2 inhibitor [12]. - Ongoing clinical trials include VIKTORIA-1 for advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [12].

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]

Core Insights - Celcuity Inc. has been granted U.S. Patent No. 12,350,276 for the clinical dosing regimen of its lead drug candidate, gedatolisib, in ER+/HER2- breast cancer patients, extending patent exclusivity until 2042 [1][2] - The company has a robust patent portfolio for gedatolisib, including 13 granted patents in the U.S. and 290 patents in foreign jurisdictions [2] - Celcuity plans to announce topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial in Q3 2025 and for the PIK3CA mutant cohort in Q4 2025 [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 [4] - Gedatolisib is a potent pan-PI3K and mTORC1/2 inhibitor that targets the PI3K/AKT/mTOR pathway, differentiating it from other therapies [4] - The company is currently conducting multiple clinical trials, including the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer and the Phase 1/2 CELC-G-201 trial for metastatic castration-resistant prostate cancer [4]

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]