NewAmsterdam Pharma Company (NAMS) Wells Fargo 21st Annual Healthcare Conference summary

Company overview and drug profile

• Developing obicetrapib, a CETP inhibitor with potent LDL-lowering and HDL-raising effects, plus benefits for diabetes, Lp(a), and Alzheimer's biomarkers.

• Completed phase III for LDL lowering, approved in Europe, and nearing completion of PREVAIL, a large cardiovascular outcomes trial.

• RUBIN phase III trial for diabetes patients will finish this year, focusing on lipid parameters for labeling.

• Plans to file and launch obicetrapib within 12–18 months after PREVAIL completion.

Clinical trial strategy and interim analysis

• PREVAIL was designed to provide outcome data at launch, starting alongside phase III trials and using similar sites and criteria.

• Adjusted PREVAIL powering from 20% to 15% relative risk reduction, extended trial duration, and broadened event capture to increase statistical power.

• Interim analysis will occur after reaching event targets in Q4 this year, with DSMB decision expected in Q1 next year.

• If interim is not successful, trial will continue to final analysis, allowing more events and higher power for detecting benefits.

Differentiation and market positioning

• Obicetrapib offers oral dosing, no food effect, and is well tolerated, differentiating it from PCSK9 inhibitors.

• Unique in lowering Lp(a), reducing diabetes risk, and potentially benefiting Alzheimer's, unlike statins or PCSK9s.

• Market research indicates strong adoption potential, especially as the only CETP inhibitor, with growing demand for LDL-lowering therapies.

• Market expansion is expected as more therapies increase awareness and patient uptake, with CETP and PCSK9s seen as complementary options.