NewAmsterdam Pharma Company (NAMS) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Clinical program and timelines

• PREVAIL interim analysis remains on schedule to trigger by end-2026; DSMB feedback expected in Q1 2027, with the trial otherwise expected to conclude by end-2027.

• RUBENS studies obicetrapib in patients with type 2 diabetes or metabolic syndrome without ASCVD; remaining cardiovascular studies, including RUBENS, are expected to complete by end-2027.

• REMBRANDT is an imaging study of the fixed-dose obicetrapib/ezetimibe combination; data are expected toward end-2027 and may inform commercial use.

• Menarini plans to launch obicetrapib in Germany by end-2026, making treatment available to patients in Europe.

• If PREVAIL succeeds at interim, filing would follow as soon as possible after DSMB confirmation; if it continues to final, filing timing will be discussed with FDA.

Differentiated treatment profile

• BROADWAY showed ~15% lower rate of new-onset diabetes; management cited this as a potential differentiator beyond LDL reduction.

• Management said high-intensity statins can increase prediabetes-to-diabetes conversion risk by up to 36%; most BROADWAY participants were on high-intensity statins.

• RUBENS targets an estimated 20–30 million people with elevated LDL and diabetes or metabolic syndrome but no prior ASCVD event.

• Management cited AHA discussion as reinforcing aggressive LDL-C lowering; it also noted higher baseline LDL among patients with higher Lp(a) in prior obicetrapib analyses.

PREVAIL interim and blinded data

• PREVAIL is well-powered at interim; management said a BROADWAY-like effect on both MACE-3 and MACE-4 could support stopping, while a continue decision may reflect mixed endpoint results.

• Management described the blinded data as encouraging and said analyses against BROADWAY and modeled placebo curves showed lower event rates; it cautioned against over-interpreting blinded comparisons.

• Reported drop-in rate is ~1% annually; management said GLP-1 use was balanced between arms in comparable studies and argued baseline LDL-C explains much of the variation in event rates across studies.

• Management contrasted PREVAIL with ACCELERATE, citing use of direct LDL measurement rather than beta quantification and the two-year study duration as important limitations to that comparison.