Y-mAbs(YMAB) Newsfilter·2025-01-10 14:26Core Insights - Y-mAbs Therapeutics, Inc. has established two business units focused on Radiopharmaceuticals and DANYELZA to enhance clinical development and commercial potential [3][4][5] - Preliminary data from the GD2-SADA Phase 1 trial indicates the tolerability and validity of the SADA PRIT platform, with data presentation expected in Q2 2025 [8][9] - The company reported an estimated unaudited total net revenue of approximately 67 million in cash and marketable securities, expected to support operations until 2027 [10] Business Update - The company is realigning operations by creating two business units: Radiopharmaceuticals and DANYELZA, aimed at optimizing resources and enhancing clinical execution [3][4] - The realignment is expected to improve capital efficiencies and align strategic priorities [5] Radiopharmaceuticals - The SADA PRIT platform aims to enhance traditional radioimmunotherapy by delivering high therapeutic doses while minimizing off-target exposure [6] - The platform is currently being evaluated in two clinical trials in the U.S. [6] DANYELZA - DANYELZA is the only FDA-approved treatment for high-risk relapsed/refractory neuroblastoma in patients aged one year and older, launched commercially in 2021 [6] Workforce Adjustment - The company anticipates a workforce reduction of up to approximately 13%, with some roles being relocated from Denmark to the U.S. [7] Pipeline Advancement - In the GD2-SADA Phase 1 trial, 21 patients have been dosed, showing no dose-limiting toxicities or treatment-related adverse events [8][9] - The company plans to dose the first patient in the CD38-SADA Phase 1 trial in Q1 2025 [9] Financial Results - Preliminary estimated unaudited total net revenue for FY 2024 is approximately 87 million to 11 million, below the guidance range of 20 million [10] Upcoming Events - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [12]