NewAmsterdam Pharma Reports Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - NewAmsterdam Pharma Company is advancing its development of obicetrapib, an oral, non-statin medicine aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [1][2][4] - The company reported significant financial results for 2024, including a net loss of $241.6 million, but also highlighted a strong cash position of$834.2 million as of December 31, 2024 [1][9][19] Clinical Development Updates - NewAmsterdam has completed three pivotal Phase 3 trials: BROADWAY, TANDEM, and BROOKLYN, all demonstrating significant LDL-C reduction [2][5][7] - The BROADWAY trial showed a 33% reduction in LDL-C with obicetrapib compared to placebo, while the TANDEM trial achieved a 49% reduction in a fixed-dose combination with ezetimibe [7][10] - The PREVAIL cardiovascular outcomes trial is ongoing, with over 9,500 patients enrolled, aimed at evaluating the impact of obicetrapib on major adverse cardiac events (MACE) [6][10] Financial Performance - For the year ended December 31, 2024, NewAmsterdam reported revenue of $45.6 million, a significant increase from$14.1 million in 2023, primarily due to clinical success milestones [9][19] - Research and development expenses decreased to $151.4 million from$159.4 million in the previous year, while selling, general, and administrative expenses rose to $70.4 million from$37.6 million [9][19] - The company’s cash and cash equivalents increased to $771.7 million from$340.5 million in 2023, driven by successful financing efforts [9][26] Regulatory and Market Outlook - An EMA submission for obicetrapib is anticipated in the second half of 2025, with plans to build inventory and commercial capabilities in preparation for potential U.S. and European launches [1][3][2] - The company aims to address the significant unmet need in the LDL-lowering therapy market, particularly for patients who are not adequately treated with existing therapies [12][11]