NewAmsterdam Pharma Company N.V.

What they do

NewAmsterdam Pharma is a clinical-stage company focused on developing obicetrapib, an oral, low-dose, once-daily CETP inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe for lowering LDL-C in patients with cardiometabolic diseases. The company has completed multiple Phase 3 trials (BROADWAY, BROOKLYN, TANDEM) that met primary and secondary endpoints, and it is preparing for regulatory submissions and a cardiovascular outcomes trial (PREVAIL). It has no approved products and no significant product revenue, relying on funding from investors and partnerships.

Revenue drivers

• Obicetrapib monotherapy — No approved product yet; potential revenue would come from sales of obicetrapib 10 mg if approved, targeting patients with primary hypercholesterolemia or mixed dyslipidemia.
• Obicetrapib/ezetimibe FDC — Fixed-dose combination with ezetimibe is being developed as a second product; positive CHMP opinion received in July 2026 recommending marketing authorization.
• Licensing and partnerships — Potential future revenue from collaborations, but no current licensing agreements are mentioned in the provided excerpts; current revenue is minimal (e.g., $3.7M in Q2 2026).

Recent performance

For the quarter ended June 30, 2026, the company reported revenue of $3.7 million, up from $32,000 in Q4 2025 and $348,000 in Q3 2025, but still minimal. Net losses have been consistent, with 2025 net loss of $203.0 million and cash, cash equivalents, and marketable securities of $678.3 million at June 30, 2026. Operating cash flow was negative $147.8 million in 2025. The company incurred a net loss of $242.0 million in 2024 and $177.0 million in 2023, reflecting heavy R&D spending.

Strategy

The company's stated direction is to develop and commercialize obicetrapib as a preferred LDL-C lowering therapy, leveraging its oral delivery and tolerability profile. It is pursuing regulatory approval in Europe (positive CHMP opinion) and conducting the PREVAIL cardiovascular outcomes trial to confirm MACE benefit, with an interim analysis planned for Q4 2026. It is also exploring the potential of CETP inhibition in Alzheimer's disease, based on exploratory analyses from the BROADWAY trial. The company aims to address the significant unmet need among patients not achieving LDL-C goals on statins, and plans to host investor days to update on strategy and pipeline.

Risks

• Clinical-stage, no approved products — The company has no approved products and no significant product revenue, making it dependent on successful regulatory approval and commercialization.
• Regulatory uncertainty — Positive CHMP opinion is not a guarantee of final European Commission approval, and U.S. approval is not yet filed; failure to obtain approvals would materially harm the business.
• Cash burn and capital needs — With operating cash flow of -$147.8 million in 2025 and -$158.6 million in 2024, the company has limited cash runway and will need to raise additional capital.
• Clinical trial failure — The PREVAIL CVOT may not confirm the exploratory MACE benefit seen in BROADWAY, and any safety or efficacy issues could delay or prevent approval.

Outlook

Management expects a European Commission decision later this year following the positive CHMP opinion. Topline data from the RUBENS Phase 3 trial are expected by year-end 2026, and the PREVAIL interim analysis is planned for Q4 2026 with results in Q1 2027. The company is focused on regulatory and clinical milestones, including the CVOT, and continues to build evidence for obicetrapib across cardiovascular and Alzheimer's disease indications.