NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results

Core Insights - NewAmsterdam Pharma is advancing its clinical development of obicetrapib, an oral, low-dose CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [4][14] - The company reported a cash position of $808.5 million as of March 31, 2025, indicating strong financial backing for ongoing and future projects [11][3] - NewAmsterdam plans to submit for EMA approval in the second half of 2025 through its partner Menarini, highlighting its regulatory progress [3][4] Financial Performance - For the first quarter of 2025, NewAmsterdam recognized $3.0 million in revenue, up from $1.4 million in the same period in 2024, primarily due to increased transaction prices related to R&D contributions from Menarini [11] - Research and Development (R&D) expenses increased to $44.8 million in Q1 2025 from $42.4 million in Q1 2024, driven by higher personnel costs and investments in pipeline expansion [11] - Selling, General and Administrative (SG&A) expenses rose significantly to $27.2 million in Q1 2025 from $14.5 million in Q1 2024, reflecting increased costs associated with the planned commercial launch of obicetrapib [11] Clinical Development Updates - NewAmsterdam is conducting several pivotal Phase 3 trials, including PREVAIL, which has enrolled over 9,500 patients to evaluate obicetrapib's impact on major adverse cardiac events (MACE) [5][10] - The company is also progressing with the VINCENT Phase 2 trial, assessing the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) [5] - The REMBRANDT Phase 3 trial will evaluate the effect of obicetrapib plus ezetimibe on coronary plaque in high-risk ASCVD patients [6] Corporate Updates - NewAmsterdam appointed Adele Gulfo to its Board of Directors in April 2025, bringing over three decades of pharmaceutical experience [7] - The company will host an R&D Day on June 11, 2025, to discuss its research and development initiatives [8] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals with current treatments [13][14] - The company aims to address the needs of the approximately 30 million under-treated U.S. adults who are not at their risk-based LDL-C goal [13]