NAMS 8-K
NewAmsterdam Pharma Co N.V. (NAMS)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). |
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Item 2.02 Results of Operations and Financial Condition.
On January 9, 2026, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release highlighting its 2025 achievements and outlining 2026 strategic priorities. In this press release, the Company announced that its unaudited cash, cash equivalents and marketable securities balance as of December 31, 2025 was approximately $729 million.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01 Regulation FD Disclosure.
The information contained in Item 2.02 of this Current Report on Form 8-K is incorporated herein by reference.
The information contained in Item 2.02 and Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in Item 2.02 and Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
Item 9.01 Financial Statements and Exhibits.
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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NewAmsterdam Pharma Company N.V. |
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January 9, 2026 |
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/s/ Ian Somaiya |
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Ian Somaiya |
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Chief Financial Officer |
NewAmsterdam Pharma Highlights 2025 Achievements and Outlines 2026 Strategic Priorities
-- EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26 --
-- Phase 3 PREVAIL CVOT overall event rate tracking in line with observed rate in BROADWAY --
-- First patient enrolled in RUBENS Phase 3 trial of obicetrapib and obicetrapib/ezetimibe fixed dose combo (FDC) in patients with metabolic syndrome --
-- Year-end cash, cash equivalents and marketable securities balance of approximately $729 million (unaudited) --
Naarden, the Netherlands and Miami, USA; January 9, 2026 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided an update on the obicetrapib clinical development program and outlined its strategic priorities for 2026.
NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, and highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
"2025 was an important year for NewAmsterdam, as we continued to further the regulatory process for obicetrapib and the fixed-dose combo. In partnership with Menarini, the company is preparing for a potential commercial launch in Europe, contingent upon an EMA approval decision that is expected in 2H26. In PREVAIL, we are encouraged by the rate of overall MACE events (blinded) in this cardiovascular outcomes trial (“CVOT”), which suggest that the initial 12 month rate is tracking in line with the overall rate observed in the Phase 3 BROADWAY trial,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We are also excited to announce the RUBENS trial enrolled its first few patients in December and could allow for additional label enhancements, if approved, for patients with Type 2 Diabetes and/or Metabolic Syndrome that are not at their LDL-C risk-based goals. We expect topline results from the trial by the end of 2026.”
“As we look to 2026, we remain committed to advancing our broader clinical development strategy, which includes three Phase 3 trials, PREVAIL, REMBRANDT, and RUBENS. In addition and based on the positive data from our Alzheimer’s disease (“AD’”) biomarker analysis from the BROADWAY trial, we are planning to start our first dedicated Alzheimer’s trial in 2026. This study could further demonstrate the potential of obicetrapib to modify key biomarkers and clinical pathology of AD. Lastly, we continue to make progress towards building out a portfolio of obicetrapib based combinations, conducting studies that could guide the development of proprietary fixed-dosed combinations in the future,” continued Dr. Davidson.
Key 2025 Achievements:
Key Expected 2026 Milestones and Ongoing Trials:
Following the successful completion and positive topline results of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, NewAmsterdam plans to announce additional data from these trials relating to obicetrapib and the FDC of obicetrapib plus ezetimibe.
The following Phase 3 trials are currently ongoing:
Additionally, NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib in early Alzheimer’s disease patients in 2026.
Financial Guidance: Based on its current operating and development plans, NewAmsterdam believes that its unaudited cash, cash equivalents and marketable securities balance of approximately $729 million, as of December 31st, 2025, will be sufficient to fund the Company’s operations through the anticipated readout of its PREVAIL CVOT and support the subsequent US commercial launch, if approved.
About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.
About Cardiovascular Disease
Cardiovascular disease remains the leading cause of death globally, despite the availability of lipid-lowering therapies (“LLTs”). By 2050 more than 184 million U.S. adults are expected to be affected by CVD and hypertension, including 27 million with coronary heart disease and 19 million with stroke. In the United States from 2019 through 2022, CVD age-adjusted mortality rates increased by 9%, reversing the trend observed since 2010 and undoing nearly a decade of progress. Despite the availability of high-intensity statins and non-statin LLTs, LDL-C target level attainment remains low, contributing to residual cardiovascular risk, and underscoring a significant clinical need for improved therapeutic regimens. Even with 269 million LLT prescriptions written over the last 12 months, 30 million under-treated US adults are not at their risk-based LDL-C goal, of which 13 million have ASCVD. Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70 mg/dL and only 10% of very high risk ASCVD patients achieve the goal below 55 mg/dL. In addition to the 30 million under-treated U.S. adults, there are 10 million patients diagnosed with elevated LDL-C who are not taking any LLTs including statins. Beyond LDL-C, additional factors are at play, such as lifestyle choices, tobacco use, and obesity, as well as inflammation, thrombosis, triglyceride levels, elevated Lp(a) levels, and type 2 diabetes.
Alzheimer’s Analysis
In BROADWAY, a pre-specified analysis was designed to assess plasma biomarkers of Alzheimer’s disease (“AD”) in patients enrolled in the BROADWAY trial and evaluated the effects of longer duration of therapy (12 months) with a prespecified ApoE population, based on phenotypic analysis. The analysis included 1,535 patients, including 367 ApoE4 carriers (ApoE3/E4 or ApoE4/E4), whose ApoE status was able to be determined. Because this analysis was based on a subset of patients from BROADWAY (which was designed to evaluate LDL-C reductions in an ASCVD and/or HeFH population), the AD analysis was not controlled for baseline differences between the treatment and placebo populations, but statistical analyses were adjusted for baseline biomarker values and age. The absolute and percent change over 12 months in p-tau217, a key biomarker of AD pathology, was measured among patients with baseline and end of study datapoints above the lower limit of quantitation. Additional outcome measures included NFL, GFAP, p-tau181, and Aβ42/40 ratio absolute and percent change over 12 months. NewAmsterdam observed statistically significant lower absolute changes in p-tau217 compared to placebo over 12 months in both the full analysis set (p=0.002; n= 1,535) and in ApoE4 carriers (p=0.02; n=367) as well as favorable trends in the other AD biomarkers. Although a safety analysis was not performed in the AD analysis population, in BROADWAY obicetrapib was observed to be well-tolerated, with safety results comparable to placebo.
1. Michael H Davidson et al JPAD 2025. Effect of obicetrapib, a potent cholesteryl ester transfer protein inhibitor, on p-tau217 levels in patients with cardiovascular disease. The Journal of Prevention of Alzheimer’s Disease
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and are subject to the “safe harbor” provisions created thereunder. All statements that are not historical facts are hereby identified as forwarding-looking statements for this purposes and include, among others, statements relating to: expectations regarding the timing of a potential EMA approval decision with respect to MAAs for obicetrapib and the FDC of obicetrapib plus ezetimibe, and, if approved, preparations for commercial launch; the encouraging nature of the rate of overall MACE events (blinded) in PREVAIL which suggest that the initial 12 month rate is tracking in line with the overall rate observed in the Phase 3 BROADWAY trial; the potential for data from the RUBENS trial to result in additional label enhancements for patients with Type 2 Diabetes and/or Metabolic Syndrome that are not at their LDL-C risk-based goals; strategic priorities, milestones and business plans for 2026 and beyond; the
Company’s plans to start its first dedicated Alzheimer’s trial in 2026; progress towards building out a portfolio of obicetrapib based combinations; the therapeutic potential of the Company’s product candidates; the timing for commencing trials, enrolling patients and completing trials, and the timing and forums for announcing data; expected milestones in 2026; Company’s belief that, based on its current operating and development plans, its cash, cash equivalents and marketable securities balance as of December 31, 2025, will be sufficient to fund its operations through the anticipated readout of its PREVAIL CVOT and support the subsequent US commercial launch, if approved; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives, strategies and other future events
These forward-looking statements are based upon management’s current expectations and assumptions, and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: uncertainties and delays regarding the initiation, enrollment and completion of the Company’s clinical trials;
uncertainties regarding the outcome of the Company’s clinical trials, and whether such outcomes will be adequate to support regulatory review and approval of its product candidates; whether topline, initial or preliminary results or analyses from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, or whether projections regarding clinical outcomes will reflect actual results in future clinical trials or clinical use of the Company’s product candidates; the potential for varying interpretation of the results of clinical trials and analyses; risks related to the Company’s ability to achieve its business plans, objectives and milestones, including approval of the Company’s product candidates and potential commercialization; unanticipated costs and expenses impacting the Company’s cash runway; the Company’s ability to continue to source the raw materials for its product candidates and ensure adequate supply of product for clinical trials and, if approved, commercialization; the impact of competing product candidates on the Company’s business; risks and uncertainties relating to intellectual property and regulatory exclusivities; changes in domestic and foreign business, market, financial, political, and legal conditions; and those risks, uncertainties and other factors discussed under the caption “Item 1A. Risk Factors” and elsewhere in the Company’s most recent Form 10-K, Form 10-Q and other public filings with the Securities and Exchange Commission, which are available at www.sec.gov.
As a result, you should not place undue reliance on any forward-looking statements. The forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Company Contact
Matthew Philippe
P: 1-917-882-7512
Media Contact
Real Chemistry on behalf of NewAmsterdam
Christian Edgington
P: 1-513-310-6410
Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696