NewAmsterdam Pharma: A Year of Triumphs and 2025 Strategic Visions

NewAmsterdam Pharma Company N.V. (NAMS) concluded 2024 on a high note, announcing significant achievements in its obicetrapib clinical development program and outlining strategic priorities for 2025. The company's strong performance was underscored by exceptional clinical and operational execution, setting the stage for a transformative year in cardiovascular disease (CVD) care.



Key 2024 Achievements:

1. Positive Topline Results for Phase 3 Trials:
- BROADWAY: 33% LDL-C reduction and 21% MACE reduction in ASCVD and HeFH patients.
- TANDEM: 49% LDL-C reduction with fixed-dose combination of obicetrapib and ezetimibe.
- BROOKLYN: 36% LDL-C reduction in HeFH patients.

2. Enrollment Completion for PREVAIL Cardiovascular Outcomes Trial:
- Over 9,500 patients enrolled in the PREVAIL trial, supporting global regulatory filings, including EMA submission in 2H25.

3. Financial Strength:
- Unaudited cash balance of $835 million following an oversubscribed public offering, providing runway through critical milestones.

4. Patent Protection:
- Secured patent protection for obicetrapib's solid form until July 2043, enhancing intellectual property portfolio and long-term revenue potential.

2025 Strategic Priorities:

1. Present Additional Scientific Findings:
- Share data from BROADWAY, BROOKLYN, and TANDEM trials at leading medical meetings and high-impact journals.

2. Advance PREVAIL Cardiovascular Outcomes Trial:
- Progress toward a successful data readout, supporting global regulatory filings.

3. Focus on Commercial Readiness:
- Establish manufacturing capacity and inventory build-out to meet potential commercial demand.

4. Strengthen Partnerships:
- Leverage Menarini's distribution networks and local market expertise for accelerated market uptake upon approval.

NewAmsterdam Pharma's 2024 achievements and 2025 strategic priorities position the company strongly for upcoming milestones, including the PREVAIL cardiovascular outcomes trial readout and potential commercial launch of obicetrapib. With a substantial war chest and a robust pipeline, NAMS is well-equipped to unlock the full potential of obicetrapib for millions of people living with dyslipidemia and at heightened risk for CVD.