NewAmsterdam Pharma Company (NAMS) investor relations material

Strategic and scientific updates

• Obicetrapib is a differentiated CETP inhibitor with robust LDL, Lp(a), and HDL effects, significant diabetes and Alzheimer's prevention potential, and strong clinical/genetic support.

• PREVAIL, the pivotal CVOT, is powered for both 15% and 20% relative risk reduction in MACE, with interim analysis expected in early 2027.

• BROADWAY and BROOKLYN phase III trials showed a 21% relative risk reduction in MACE, with event rates and populations mirroring PREVAIL.

• REMBRANDT and RUBENS trials target plaque regression and diabetes/metabolic syndrome, aiming to expand label claims and address unmet needs.

• SPINOZA trial focuses on Alzheimer's prevention in APOE4 carriers, leveraging p-tau217 as a biomarker, with FDA-reviewed protocol.

Commercial and market outlook

• The lipid management market is growing rapidly, with over 84 million diagnosed patients and significant unmet need, especially among those not at LDL goal despite statin use.

• Obicetrapib and its FDC are expected to launch in Europe (pending EMA approval) and the US, with Menarini as the EU partner and a strong commercial team.

• The product is positioned as an oral, once-daily, well-tolerated therapy with broad efficacy, targeting LDL, Lp(a), ApoB, and HDL, and is expected to be first in class with outcomes data at launch.

• Market research and early demand studies show strong physician and patient interest, with 2 out of 3 HCPs likely to prescribe within 6 months of launch.

• The company leverages AI and a publication-driven strategy to maximize clinical adoption and inform prescriber decision-making.

Financial and operational highlights

• Cash balance of $678 million supports global launch plans and ongoing R&D.

• Clinical operations and trial execution are best-in-class, with low dropout/drop-in rates and high data quality.

• Key milestones include RUBENS data by year-end, PREVAIL interim analysis in Q1 2027, REMBRANDT readout in 2027, and SPINOZA trial initiation.

• Positive outcomes from PREVAIL and RUBENS could significantly expand label indications and market uptake.

• The leadership team is experienced and expanding, with a focus on operational excellence and launch readiness.