NewAmsterdam Pharma Company (NAMS) investor relations material

Strategic and scientific updates

• PREVAIL, the pivotal CVOT for obicetrapib, is designed for high statistical power, with interim analysis expected in early 2025 and final readout in 2027, aiming for at least a 15% relative risk reduction in MACE events, leveraging learnings from prior trials and robust event adjudication processes.

• BROADWAY and BROOKLYN phase III trials demonstrated a 21% relative risk reduction in four-point MACE, supporting optimism for PREVAIL's interim and final outcomes, with event rates in PREVAIL closely tracking those in BROADWAY.

• The company is advancing REMBRANDT (plaque regression), RUBENS (diabetes/metabolic syndrome), and SPINOZA (Alzheimer’s biomarkers) studies, all designed to support label expansion and differentiation, with REMBRANDT using advanced imaging and RUBENS targeting diabetes risk reduction.

• SPINOZA, a prevention trial in APOE4 carriers at risk for Alzheimer's, is set to launch, leveraging promising biomarker data (p-tau217) and strong patient advocacy support, with FDA protocol review completed.

• Obicetrapib's mechanism offers broad lipid benefits, including significant LDL and Lp(a) lowering, HDL raising, and potential diabetes and Alzheimer's risk reduction, differentiating it from other therapies.

Commercial and market outlook

• The lipid management market is experiencing robust growth, with over 60 million undertreated patients in the U.S. and similar trends in Europe, driven by new guidelines advocating lower LDL targets and earlier intervention.

• Obicetrapib and its FDC are positioned as post-statin, oral, once-daily options with efficacy comparable to PCSK9 inhibitors and unique benefits on residual lipid risk, diabetes, and tolerability.

• The company is preparing for imminent European launch with Menarini and U.S. launch readiness, supported by a seasoned commercial team and strong KOL engagement.

• Recent regulatory milestones include positive CHMP opinion and anticipated EMA approval in Q4, with launches in the UK and Germany expected by year-end.

• Early demand studies show strong physician intent to prescribe obicetrapib and its FDC, with 2 out of 3 HCPs indicating likely use within 6 months of launch.

Financial and operational highlights

• Cash reserves of $678 million provide ample runway for global launch and ongoing R&D.

• Clinical operations are outperforming industry benchmarks in patient retention and event capture, supporting confidence in trial integrity and timelines.

• Over 100 employees and new offices in Philadelphia, Miami, and Amsterdam reflect rapid organizational growth.

• The company is committed to data-driven publication strategy, with over 26 peer-reviewed papers and a strong presence at major scientific congresses.

• Upcoming catalysts include RUBENS data by year-end, PREVAIL interim in early 2025, and REMBRANDT readout in 2027.