NewAmsterdam Pharma Company (NAMS) investor relations material

Clinical trial progress and outcomes

• All pivotal lipid-lowering registration studies (BROADWAY, BROOKLYN, TANDEM) are completed and published in leading journals.

• PREVAIL, the major outcomes trial, is fully enrolled with baseline characteristics mirroring BROADWAY and event rates tracking as expected.

• PREVAIL requires a minimum 2.5-year participation per patient, resulting in a longer median follow-up than recent trials.

• PREVAIL is four times larger and longer than BROADWAY, aiming to confirm the 21% MACE reduction seen previously.

• Additional studies, including REMBRANDT (CT angio trial with Harvard) and an Alzheimer’s biomarker sub-study, are ongoing.

Regulatory and commercial strategy

• European filings for both monotherapy and fixed-dose combination have been accepted, with potential approvals expected in the second half of next year.

• U.S. launch is planned to coincide with PREVAIL outcomes data; final readout timing will be clearer next year as event rates are monitored.

• Discussions with the FDA regarding data readout and approval process are scheduled for next year.

Scientific insights and data interpretation

• BROADWAY showed a 21% reduction in MACE, supported by Kaplan-Meier curves and mediation analysis linking LDL, LDL particles, and Lp(a) to outcomes.

• LDL particles, especially small ones, are considered better predictors of cardiovascular risk than LDL-C alone, with CETP inhibition dramatically reducing these particles.

• Ongoing analyses in large databases and clinical trials aim to further validate the predictive value of LDL particles and ApoB.