NewAmsterdam Pharma Company (NAMS) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Clinical program updates and data insights

• Obicetrapib reduces LDL by 35%-40% as monotherapy and over 50% in fixed-dose combination, with a manageable safety profile and once-daily dosing.

• BROADWAY and BROOKLYN studies showed reduced incidence of new-onset diabetes, improved kidney function, and significant Lp(a) reduction.

• Blinded PREVAIL data tracks closely with BROADWAY, showing lower-than-expected event rates, with final unblinded results expected next year.

• PREVAIL interim analysis is powered for a 20% MACE benefit, with a p-value threshold of 0.01 for statistical significance, aligning with FDA expectations.

• Additional studies, RUBENS and REMBRANDT, are ongoing, with REMBRANDT providing imaging-based evidence of plaque reduction.

Competitive landscape and strategic positioning

• Obicetrapib is the only CETP inhibitor among branded and in-development therapies, offering broader benefits beyond LDL reduction.

• Contemporary studies like VESALIUS-CV, ZEUS, and HORIZON are referenced to contextualize evolving treatment paradigms and event rates.

• Combination therapy is emphasized as the future of LDL management, with ongoing evaluation of additional combinations beyond ezetimibe.

• Launches of oral PCSK9s by other companies are being closely monitored for pricing and payer access strategies.

Commercialization and organizational planning

• European approval is imminent, with launches expected to begin in Germany and the UK, followed by other EU countries.

• U.S. pricing strategy will be informed by European dynamics but is expected to have limited direct impact.

• Commercial team build-out is planned to be gradual, with a focus on enabling functions and minimal increase in spending as R&D winds down by 2027.

• The company maintains a disciplined, resource-efficient approach to scaling for launch.