Correcting & Replacing – Y-mAbs Provides Strategic Business Update and 2025 Priorities

Core Insights - Y-mAbs Therapeutics, Inc. has announced the establishment of two business units aimed at accelerating the clinical development of its Radiopharmaceuticals Platform and optimizing the commercial potential of DANYELZA [2][3][4] - Preliminary data from the GD2-SADA Phase 1 trial indicates the tolerability and validity of the SADA PRIT platform's pre-targeting approach, with data presentation expected in Q2 2025 [8][9] - The company reported preliminary estimated unaudited total net revenue of approximately $88 million for the year ended December 31, 2024, aligning with its guidance range [10] - As of December 31, 2024, the company has approximately$67 million in cash, cash equivalents, and marketable securities, which is expected to support operations into 2027 [10] Business Update - The company is realigning operations by creating two business units: Radiopharmaceuticals and DANYELZA, to enhance resource optimization and clinical development agility [3][4] - The realignment is expected to lead to a workforce reduction of up to approximately 13%, with some roles being moved from Denmark to the U.S. for better coordination [7] Radiopharmaceuticals - The SADA PRIT platform aims to improve traditional radioimmunotherapy by delivering high therapeutic doses while minimizing off-target exposure and reducing costs [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 patients aged one year and older with high-risk relapsed/refractory neuroblastoma, commercially launched in 2021 [6] 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 anticipates dosing the first patient in the CD38-SADA Phase 1 trial in the first quarter of 2025 [9] Financial Overview - Preliminary estimated total cash investment for FY 2024 is approximately $11 million, below the guidance range of$15 million to $20 million [10] - The company plans to provide full-year 2025 guidance alongside the FY 2024 earnings report in Q1 2025 [13] Upcoming Events - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [12]