NewAmsterdam Pharma Co N.V. (NAMS) SEC Filings & Earnings Calls

Clinical trial risk; obicetrapib is in early-stage development for Alzheimer's.

“SPINOZA is a Phase 2b clinical trial evaluating obicetrapib in individuals with preclinical Alzheimer’s disease.”

Post-authorization efficacy study required; PREVAIL trial results must be submitted.

“EC specified that the Company must submit final results from PREVAIL cardiovascular outcomes trial.”

Clinical trial risk: PREVAIL CVOT interim analysis expected 4Q2026, result 1Q2027; RUBENS topline by year-end 2026

“PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027; Topline data from RUBENS Phase 3 expected by year-end 2026” · word for word

PREVAIL CVOT interim analysis risk

“If, as a result of the interim analysis, the DSMB recommends that PREVAIL is discontinued for futility, our business prospects may be substantially harmed.” · word for word

Drug pricing and reimbursement risk

“The IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.”

Tariff risk on supply chain

“In April 2025, the Administration imposed a baseline ten percent tariff on imports from all nations importing goods to the United States, with that baseline supplemented in certain cases by additional tariffs that vary by nation, product or industry.” · word for word

Reliance on Menarini partnership

“Pursuant to the Menarini License, Menarini has sole discretion to set the price of the products in the European markets covered by its license.” · word for word

Loss of COO could impact operational execution, though transition support planned.

“COO resignation; advisor agreement expected for transition support”

Major insider selling / loss of key institutional support

“Following the sale of Ordinary Shares on May 12, 2026 described in Item 5(c) above, the Reporting Persons ceased to beneficially own 5% or more of the Issuer's outstanding Ordinary Shares.” · word for word

Major insider selling / loss of key institutional support

“Following the sale of Ordinary Shares on May 12, 2026 described in Item 5(c) above, the Reporting Persons ceased to beneficially own 5% or more of the Issuer's outstanding Ordinary Shares.” · word for word

Clinical trial outcome risk: PREVAIL interim analysis may not meet efficacy endpoints, delaying or derailing regulatory approval.

“Should the trial not stop for efficacy at that time, we anticipate completion by the end of 2027.” · word for word

Regulatory approval uncertainty: Decisions from EMA, UK, and Switzerland expected in 2H26, with potential delays or rejections.

“Decisions on regulatory approval from EMA, UK, and Switzerland for obicetrapib and obicetrapib/ezetimibe fixed-dose combination expected in 2H26.”

Clinical Trial Failure Risk

“If, as a result of the interim analysis, the DSMB recommends that PREVAIL is discontinued for futility, our business prospects may be substantially harmed.” · word for word

Regulatory Approval Uncertainty

“We anticipate that Menarini will receive decisions on the MAAs from each of the regulators in the second half of 2026.” · word for word

Drug Pricing and Reimbursement Risk

“The IRA permits HHS to engage in price-capped negotiation to set the price of certain drugs and biologics reimbursed under Medicare Part B and Part D.” · word for word

Tariff and Trade Policy Risk

“Increased tariffs on critical raw materials, components, and finished goods could raise our production costs and disrupt our supply chain.” · word for word

Clinical and regulatory risk: obicetrapib not yet approved; regulatory decisions expected 2H26; PREVAIL CVOT readout timing uncertain; potential for negative outcomes.

“Approval decisions expected 2H26; PREVAIL CVOT ongoing; RUBENS topline data YE2026.”

No revenue or profitability disclosed; pre-commercial stage with significant cash burn.

“No revenue mentioned; cash $728.9M but no profitability timeline.”

Pre-revenue clinical-stage company with no approved product

“We are a clinical-stage biopharmaceutical company and, since inception, we have incurred significant operating losses and expect to continue to do so for the foreseeable future.” · word for word

Regulatory and clinical execution risk; EMA decision expected 2H26; PREVAIL CVOT results pending.

“EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26” · word for word

Clinical trial and regulatory risk

“PREVAIL will continue until the last participant has been followed for a minimum of 2.5 years and the target number of MACE events have occurred. As a result, the earliest the trial could conclude based on the minimum follow-up period is the end of 2026.” · word for word

Commercialization risk

“If we obtain marketing approval, we intend to commercialize obicetrapib for patients with ASCVD and/or HeFH and elevated levels of LDL-C despite being treated with currently available optimal lipid lowering therapy.” · word for word

Financing risk

“We expect to continue to incur significant losses for the foreseeable future.” · word for word

No revenue; pre-commercial stage; cash burn continues.

“No revenue reported; cash decreased from $834.2M to $756M.”

Clinical trial risk: PREVAIL CVOT and REMBRANDT imaging trial outcomes uncertain.

“PREVAIL ongoing; REMBRANDT enrolling 300 patients.”