NewAmsterdam Pharma Company (NAMS) R&D Day 2025 summary

Corporate and R&D Progress

• Completed and published results for BROOKLYN, BROADWAY, and TANDEM Phase 3 studies, with BROADWAY published in NEJM and TANDEM in The Lancet.

• Expanded commercial team to nearly 100 employees across the US and Amsterdam, doubled company size, and expanded offices.

• Secured $810M in cash by 1Q25, ensuring capital for US commercial launch and ongoing R&D milestones.

• Secured new composition of matter IP, granting exclusivity through 2043.

• EMA submission and completion of VINCENT Phase 2 trial expected in 2025.

Clinical and Scientific Insights

• Obicetrapib demonstrates broad benefits: effective LDL-C, Lp(a), and small particle reduction, with favorable diabetes risk profile.

• Phase 3 data show strong tolerability and safety, with significant reductions in LDL-C, Lp(a), and small LDL particles, especially in high-risk populations.

• Early MACE reduction in BROADWAY exceeded expectations, attributed to combined effects on LDL-C, small particles, and Lp(a).

• Obicetrapib’s mechanism extends beyond LDL-C lowering, with unique efficacy in patients with elevated Lp(a), small particles, and ApoE4 genotype.

• Obicetrapib preferentially reduces small LDL particles and Lp(a) by up to 45% in key populations.

Alzheimer's Disease and Neuroprotection

• Obicetrapib, a CETP inhibitor, is being studied for its potential to delay or prevent Alzheimer's in ApoE4 carriers, targeting upstream lipid dysregulation.

• Proof-of-concept study in ApoE4 carriers showed reductions in plasma and CSF oxysterols, increased antioxidants, and stabilization of AD biomarkers.

• BROADWAY trial included biomarker analysis (p-tau-217), showing stabilization and potential reduction in Alzheimer’s progression.

• Mendelian randomization and preclinical studies support CETP inhibition as protective against Alzheimer’s, particularly in ApoE4 populations.

• Full Alzheimer's biomarker sub-study data for obicetrapib to be presented at AAIC 2025.