Highlights

  • Second quarter net loss widened to $64.1 million, or $0.52 per share, with research and development expenses up 52%.
  • Revenue fell to $3.7 million from $19.1 million, which included a $16.1 million Menarini development cost contribution a year earlier.
  • A European committee adopted a positive opinion in July 2026 on obicetrapib monotherapy and its fixed-dose combination with ezetimibe.
  • Cash, cash equivalents and marketable securities totaled $678.3 million, against an accumulated loss of $875.0 million.

NewAmsterdam Pharma Company (NASDAQ:NAMS) shares were trading near their 52-week low at USD 21.50 on October 21, 2026, down 0.02%. The late-stage biopharmaceutical company announced a positive CHMP opinion for obicetrapib in July, reported a second quarter 2026 net loss of $64.1 million in a quarterly report filed on August 5, and said it plans an interim analysis of its PREVAIL outcomes trial in the fourth quarter.

Based in Naarden, the Netherlands, NewAmsterdam Pharma is incorporated in the Netherlands and focuses on cardiometabolic disease. Its lead candidate, obicetrapib, is an oral, low-dose, once-daily CETP inhibitor being developed to lower LDL cholesterol, alone or as a fixed-dose combination with ezetimibe, as an add-on to statin therapy. The company has licensed commercial rights in most European countries to Menarini and plans to pursue U.S. development and commercialization itself, subject to approval. It has not generated significant revenue from product sales to date.

Net Loss Widens as Trial Spending Rises

For the three months ended June 30, 2026, revenue was $3.7 million, down 81% from $19.1 million. The company said the decline largely reflected $16.1 million recognized a year earlier for the second installment of development cost contributions under the Menarini license, which did not recur. Research and development expenses rose to $41.7 million from $27.5 million, with clinical expenses up $11.1 million as trials started and others progressed,.

Selling, general and administrative expenses were nearly flat at $26.9 million. The operating loss was $64.9 million against $35.6 million. A $4.6 million warrant fair value expense also affected the result. Net loss was $64.1 million, or $0.52 per basic and diluted share, versus $17.4 million, or $0.15. For the six months, the net loss was $113.5 million, or $0.92 per share, compared with $57.0 million.

Regulatory Progress and Pipeline

In July 2026, the company announced that the CHMP of the European Medicines Agency adopted a positive opinion recommending marketing authorization for obicetrapib 10 mg monotherapy and the 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination for primary hypercholesterolemia. Applications were also accepted for review in the United Kingdom and Switzerland. The company anticipates that Menarini will receive regulator decisions later this year, and if approved, products could launch in parts of the Menarini territory in the fourth quarter of 2026.

In the U.S., the company's goal is to submit a New Drug Application for obicetrapib monotherapy and then, shortly afterward, one for the fixed-dose combination. The BROADWAY, BROOKLYN and TANDEM Phase 3 trials met their primary and secondary endpoints.

The Phase 3 PREVAIL cardiovascular outcomes trial, which enrolled at least 9,000 patients, remains the key open study. After reviewing preliminary blinded data, including a Year 1 event rate consistent with BROADWAY and a lower than expected Year 1 to Year 2 rate, management decided to run an interim analysis. The filing cautions that the blinded data are preliminary, may change and may not reflect a treatment effect. REMBRANDT completed enrollment of 323 patients in March.

Liquidity and Funding

Cash, cash equivalents and marketable securities were $678.3 million at June 30, 2026. Operating activities used $69.8 million in the six months, versus $74.1 million a year earlier, and financing provided $22.1 million, mainly from option exercises. It expects significant losses to continue for the foreseeable future. It maintains a $250 million at-the-market sales agreement but sold no shares under it in the six months, and 2,420,733 warrants at an $11.50 exercise price remained outstanding.

Outlook and Upcoming Milestones

The filing does not provide financial guidance. It lists the PREVAIL interim analysis in the fourth quarter of 2026, with the independent data monitoring board's recommendation expected in the first quarter of 2027. If the trial continues, the company expects to complete it by the end of 2027. RUBENS topline data are expected by year end 2026, and a new Alzheimer's disease trial is expected to start in 2026.