NewAmsterdam Pharma pany N.V.(NAMS) - 2025 Q3 - Quarterly Results

Financial Performance - Revenue for the quarter ended September 30, 2025, was $0.3 million, a significant decrease from $29.1 million in the same period in 2024, mainly due to the absence of clinical milestone revenue[8] - Revenue for Q3 2025 was $348,000, a significant decrease from $29,111,000 in Q3 2024, representing a decline of approximately 98.8%[23] - The net loss for the quarter ended September 30, 2025, was $72.0 million, compared to a net loss of $16.6 million for the same period in 2024[9] - The operating loss for Q3 2025 was $55,143,000, compared to an operating loss of $25,003,000 in Q3 2024, reflecting a deterioration of 120.5%[23] - The company reported a loss for the nine months ended September 30, 2025, of $128,896,000, an improvement compared to a loss of $149,421,000 for the same period in 2024, showing a reduction of approximately 13.7%[26] Cash and Assets - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities of $756.0 million, down from $834.2 million as of December 31, 2024, primarily due to ongoing operating expenditures[8] - Cash and cash equivalents as of September 30, 2025, were $538,407,000, down from $771,743,000 at the end of 2024, a decrease of approximately 30.1%[21] - Total assets decreased to $786,427,000 as of September 30, 2025, from $864,620,000 at the end of 2024, a decline of about 9.0%[21] - The company had a total shareholders' equity of $728,070,000 as of September 30, 2025, compared to $757,500,000 at the end of 2024, a decrease of approximately 3.9%[21] Expenses - Research and Development (R&D) expenses were $31.0 million for the quarter ended September 30, 2025, compared to $35.7 million for the same period in 2024, reflecting a decrease in clinical and manufacturing expenses[8] - Selling, General and Administrative (SG&A) expenses increased to $24.5 million in the quarter ended September 30, 2025, from $18.4 million in the same period in 2024, driven by higher personnel costs[8] - Total operating expenses for Q3 2025 were $55,491,000, slightly up from $54,114,000 in Q3 2024, indicating an increase of about 2.5%[23] - Research and development expenses for Q3 2025 were $30,971,000, down from $35,702,000 in Q3 2024, a decrease of about 13.5%[23] Clinical Development - The European Medicines Agency accepted for review marketing authorization applications for obicetrapib monotherapy and the fixed-dose combination with ezetimibe in August 2025, marking a significant regulatory milestone[5] - NewAmsterdam plans to initiate the RUBENS Phase 3 clinical trial in Q4 2025 to evaluate obicetrapib in combination with ezetimibe for patients with type 2 diabetes or metabolic syndrome[4] - In the BROADWAY trial, obicetrapib was shown to reduce p-tau217 levels by 20.5% over 12 months in ApoE4/E4 carriers, indicating potential benefits for Alzheimer's disease[3] - The company completed enrollment of over 9,500 patients in the PREVAIL Phase 3 cardiovascular outcomes trial in April 2024[7] - NewAmsterdam continues to advance its clinical development strategy, including ongoing trials such as PREVAIL and REMBRANDT, to support the potential launch of obicetrapib[2] Interest Income - Interest income for the nine months ended September 30, 2025, was $21,119,000, an increase from $12,396,000 in the same period of 2024, representing a growth of about 70.5%[23] Cash Flow - The company experienced a net cash used in operating activities of $106,908,000 for the nine months ended September 30, 2025, compared to $121,083,000 for the same period in 2024, indicating a decrease of approximately 11.7%[26]