NAMS Filings — Newamsterdam Pharma Company N.v. - FilingSpy
NAMS
Newamsterdam Pharma Company N.v.
A biotech company developing a once-daily oral pill to lower "bad" LDL cholesterol in people at risk of heart disease. Its lead drug, obicetrapib, met its goals in three late-stage trials and is also being studied for Alzheimer's disease. Founded in 2019 by Dutch lipidologist John Kastelein and investor Forbion, the company's name bridges its Dutch roots and US ambitions. The drug itself was famously rescued from the scrap heap after drug giant Amgen shelved it, reviving a treatment rivals had abandoned.
R&D costs rose 52% and prior-year license revenue did not recur, widening the net loss to $64.1M ahead of the pivotal PREVAIL interim analysis.
The story shifted from commercial build-up back to clinical spending. fell 81% to $3.7 million as a $16.1 million partner contribution from a year ago did not repeat, while R&D expense rose 52% to $41.7 million, pushing the net loss to $64.1 million. The company enters the second half of 2026 with $678.3 million in cash and and a PREVAIL cardiovascular outcomes trial interim analysis that will define obicetrapib's future.
Key takeaways
fell 81% to $3.7 million, because the prior-year quarter included a $16.1 million non-recurring development cost contribution from Menarini under the obicetrapib license agreement.
R&D expense rose 52% to $41.7 million, driven by an $11.1 million increase in clinical trial costs and a $3.3 million rise in personnel expenses, partially offset by lower manufacturing costs.
SG&A expense was nearly flat at $26.9 million, as a $3.0 million decline in marketing spend was largely offset by a $2.7 million increase in and employment costs.
Section summaries
Management's Discussion and Analysis
Net loss widened to $64.1M in Q2 FY2026 as R&D costs surged 52% and prior-year Menarini license revenue did not recur.
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fell 81% to $3.7M, primarily because the prior-year period included a $16.1M non-recurring development cost contribution from Menarini.
R&D expenses rose 52% to $41.7M, driven by an $11.1M increase in clinical trial costs and a $3.3M rise in personnel expenses, partly offset by lower manufacturing costs.
The net loss widened to $64.1 million from $17.4 million a year ago, reflecting the decline, the R&D increase, and a swing to a non-cash .
Cash, cash equivalents, and totaled $678.3 million at quarter-end, down from $707.3 million at the end of Q1 2026, with of $39.2 million for the quarter.
A Data Safety Monitoring Board interim analysis of the PREVAIL cardiovascular outcomes trial is expected in Q4 2026, with a recommendation anticipated in Q1 2027.
What changed
The $16.1 million Menarini development cost contribution that drove Q2 2025 to $19.1 million did not recur, causing revenue to drop back to $3.7 million — a level consistent with the $3.0 million recorded in Q1 2026 and Q1 2025.
R&D expense reversed its post-Phase 3 decline, rising 52% to $41.7 million after falling 28% in Q2 2025 and 15% in Q1 2026, as new clinical trial costs ramped up.
The operating cash burn of $39.2 million was higher than the $30.6 million in Q1 2026 and the $37.7 million in Q2 2025, reflecting the increase in R&D spending.
The company's cash and balance of $678.3 million is down from $728.9 million at year-end 2025 and $783.3 million a year ago, as operating cash outflows continue with no new financing events.
What to watch
The DSMB interim analysis of the PREVAIL cardiovascular outcomes trial in Q4 2026, and the subsequent recommendation in Q1 2027 — a futility stop would substantially harm obicetrapib's prospects.
Quarterly R&D expense trajectory, to confirm whether the Q2 2026 increase to $41.7 million represents a new run-rate or a one-time step-up tied to specific trial activity.
Cash consumption against the $678.3 million balance, to confirm the runway remains sufficient through the PREVAIL readout without additional financing.
Any update on the planned Alzheimer's disease clinical trial for obicetrapib, which the company said in its FY 2025 annual report it would initiate in 2026.
SG&A expenses were nearly flat at $26.9M, as a $3.0M drop in marketing spend was largely offset by a $2.7M increase in and employment costs.
Operating loss deepened to $64.9M from $35.6M, while a swing in foreign exchange and a fair value loss on warrants further increased the net loss.
Cash, equivalents, and marketable securities totaled $678.3M at quarter-end, with operating cash outflow of $69.8M for the first half of FY2026.
The company expects a DSMB interim analysis of the PREVAIL cardiovascular outcomes trial in Q4 2026, with a recommendation anticipated in Q1 2027.
Quantitative and Qualitative Disclosures About Market Risk
The company faces limited interest rate risk, $72.6M net foreign currency exposure (mainly Euro), and $54.5M derivative warrant liability tied to its share price.
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Interest rate risk from cash and short-term investments is considered immaterial; a 100 change would not materially affect financial condition.
Net foreign currency exposure was $72.6 million as of June 30, 2026, primarily in Euros, with a hypothetical 1% rate change impacting earnings by ~$0.7 million.
The company partly manages currency risk by holding foreign cash to offset and plans to use it for future foreign-currency expenses.
, a result of the Business Combination, were valued at $54.5 million and are now priced using a Black-Scholes model due to low Public Warrant trading volume.
A 1% change in the company's Ordinary Share price would change the derivative warrant liability by approximately 1%, or $0.5 million.
Credit risk is limited to treasury deposits with investment-grade banks and recoverable VAT from tax authorities; no significant sales-related credit exposure exists.
We are not party to any material pending legal proceedings. From time to time, we may be involved in legal proceedings arising in the ordinary course of business.
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We are not party to any material pending legal proceedings. From time to time, we may be involved in legal proceedings arising in the ordinary course of business.
Topline/interim trial data may not predict final results, and evolving U.S. and EU drug-pricing reforms could materially reduce obicetrapib’s commercial value.
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Preliminary blinded PREVAIL CVOT data show a Year 1 rate consistent with BROADWAY and a larger-than-expected Year 1-to-2 decline, but these trends may not reflect a treatment effect and could change as events are adjudicated.
An interim analysis of PREVAIL is planned for Q4 2026; if the recommends stopping for , obicetrapib’s prospects would be substantially harmed.
The Inflation Reduction Act’s Medicare price negotiation and inflation rebates could cap obicetrapib’s U.S. pricing and returns, especially after seven years on the market.
Trump administration MFN pricing models and executive orders may force Medicaid/Medicare rebates tied to lower international prices, and Menarini’s EU pricing discretion could set an unfavorable benchmark.
New EU pharmaceutical legislation and the EU Health Technology Assessment Regulation are expected to increase pricing pressure, limit market protection, and allow member states to compel earlier launches.
U.S. tariff actions, including a potential tariff on imported pharmaceuticals, could raise production costs and disrupt supply chains.