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NewAmsterdam Pharma (Nasdaq: NAMS) narrows 2025 loss and pushes obicetrapib toward key 2026 catalysts

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

NewAmsterdam Pharma reported full year 2025 results and highlighted progress advancing its cholesterol drug obicetrapib. Revenue was $22.5 million, down from $45.6 million in 2024, while the net loss narrowed to $203.8 million from $241.6 million as R&D expenses declined.

Cash, cash equivalents and marketable securities totaled $728.9 million at December 31, 2025, which the company expects will fund operations through the PREVAIL cardiovascular outcomes readout and, if approved, support a potential U.S. launch. Marketing applications for obicetrapib and a fixed-dose combination with ezetimibe have been accepted in Europe, the UK and Switzerland, with decisions anticipated in the second half of 2026.

The company is running three Phase 3 trials—PREVAIL, REMBRANDT and RUBENS—and plans to start a trial of obicetrapib in early Alzheimer’s disease in 2026 following positive Alzheimer’s biomarker data from the BROADWAY study.

Positive

  • None.

Negative

  • None.

Insights

Late-stage pipeline advances and strong cash are offset by ongoing operating losses.

NewAmsterdam remains a clinical-stage story. In 2025 it advanced obicetrapib with three ongoing Phase 3 trials and MAAs accepted in Europe, the UK and Switzerland, with regulatory decisions anticipated in the second half of 2026.

Financially, revenue of $22.5 million fell versus 2024 milestone revenue, but the net loss improved to $203.8 million as R&D spending eased after several Phase 3 completions. Cash and marketable securities of $728.9 million give a runway through the PREVAIL cardiovascular outcomes readout and potential U.S. launch, according to management.

Key value inflection points now depend on regulatory outcomes in Europe, PREVAIL cardiovascular results after enrollment of over 9,500 patients, RUBENS and REMBRANDT data, and the planned early Alzheimer’s trial initiated in 2026 following encouraging biomarker signals.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 18, 2026

 

 

NewAmsterdam Pharma Company N.V.

(Exact name of Registrant as Specified in Its Charter)

 

 

The Netherlands

001-41562

N/A

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

Goomieer 2-35

 

Naarden

 

 

The Netherlands

 

1411 DC

(Address of Principal Executive Offices)

 

(Zip Code)

 

+31 (0) 35 206 2971

 

(Registrant’s Telephone Number, Including Area Code)

 

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Ordinary shares, nominal value €0.12 per share

 

NAMS

 

The Nasdaq Stock Market LLC

Warrants to purchase ordinary shares

 

NAMSW

 

The Nasdaq Stock Market LLC

 

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).

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On February 18, 2026, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing corporate updates and its financial results for the year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 hereto.

 

**The information contained in Item 2.02, 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”). Additionally, the information contained in Item 2.02, 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.

(d)

Exhibits.

Exhibit No.

 

Description

 

 

99.1

 

NewAmsterdam Pharma Company N.V. Press Release, dated February 18, 2026

104

 

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.

 

 

 

NewAmsterdam Pharma Company N.V.

 

 

 

 

Date:

February 18, 2026

By:

/s/ Ian Somaiya

 

 

Name:

Ian Somaiya

 

 

Title:

Chief Financial Officer

 

 


NewAmsterdam Pharma Reports Full Year 2025 Financial Results and Provides Corporate Update

 

-- Approval decisions from EMA, UK and Switzerland regulators for obicetrapib and obicetrapib/ezetimibe fixed dose combination expected in 2H26 --

 

-- Phase 3 PREVAIL CVOT blinded event rate during the initial 12-months tracking in line with observed event rate in BROADWAY--

-- Topline data from RUBENS Phase 3 trial in patients with type 2 diabetes and metabolic syndrome expected by year-end 2026 --

 

-- $728.9 million in cash, cash equivalents and marketable securities at December 31, 2025 --

 

Naarden, the Netherlands and Miami, USA; February 18, 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 announced financial results for the full year ended December 31, 2025 and provided a corporate update.

 

“2025 marked a year of meaningful clinical and regulatory progress for NewAmsterdam, as we advanced our mission to bring a potentially transformative therapy with obicetrapib to cardiometabolic disease patients who continue to struggle to reach their LDL-C goals,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Marketing Authorization Applications for obicetrapib and the fixed dose combination were accepted for review by the European Medicines Agency (“EMA”), Switzerland, and United Kingdom regulators, and we anticipate a decision from each in the second half of 2026. In parallel, together with our partner Menarini, we are actively preparing for a potential commercial launch in Europe. In the United States, we continue to expand our commercial capabilities with several notable hires that will lead our market access and public affairs efforts, expanding the already established team.”

 

“At the same time, we remain focused and well positioned to execute our clinical development strategy, including the advancement of obicetrapib in our three ongoing Phase 3 trials: PREVAIL, REMBRANT and RUBENS. In December 2025, we initiated the RUBENS trial, which will evaluate obicetrapib alone and in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome that require additional lowering of LDL-C despite treatment with available therapy, with topline data expected by year-end 2026. Our PREVAIL cardiovascular outcomes trial continues to progress well, where the overall blinded MACE event rate in PREVAIL through the initial 12-months was in line with what we observed in BROADWAY. NewAmsterdam continues to operate from a position of financial strength, with cash runway expected to be sufficient to fund operations through the PREVAIL readout and, if approved, support the subsequent U.S. commercial launch. Additionally, following positive biomarker results from the Alzheimer’s disease analysis in the BROADWAY trial, we plan to initiate a new clinical trial evaluating obicetrapib in early Alzheimer’s disease patients this year.”

 

Clinical Development and Regulatory Updates

 

NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated.

 

In August 2025, NewAmsterdam announced acceptance of MAAs for review by the EMA for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe FDC for patients with primary hypercholesterolemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia. Subsequently, MAAs were also submitted to regulators in UK and Switzerland and accepted for review. The MAAs were submitted by NewAmsterdam’s partner, A. Menarini International Licensing S.A. (“Menarini”), who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive License Agreement (the “Menarini License”). NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the European countries covered by the Menarini License and

up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones.
In August 2025, NewAmsterdam presented pooled data from its pivotal Phase 3 BROADWAY and BROOKLYN trials on the impact of obicetrapib on major adverse cardiovascular events at the European Society of Cardiology Congress (“ESC”) 2025, along with the simultaneous publication in the Journal of the American College of Cardiology, highlighting obicetrapib’s performance across diverse lipid-lowering backgrounds observed in these trials. The presentation and publication underscore the Company’s continued momentum in advancing obicetrapib as a differentiated oral therapy for patients with elevated LDL-C.
In June and July 2025, NewAmsterdam announced positive data from the prespecified AD biomarker analysis in the BROADWAY clinical trial and presented at the 2025 Alzheimer’s Association International Conference (“AAIC”). The pre-specified analysis was conducted to assess the effect of obicetrapib on plasma biomarkers of AD in both the full analysis set and in patients carrying the apolipoprotein E4 (“ApoE4”) gene, based on phenotypic analysis.
o
NewAmsterdam observed statistically significant reductions in p-tau217, a key biomarker of AD pathology, in both the full analysis set (p<0.002, n=1,515) and in ApoE4 carriers (p=0.0215, n=367), which NewAmsterdam believes support an emerging link between CETP-inhibition and neurodegeneration.
o
In ApoE4/E4 carriers, the highest risk category for Alzheimer’s disease, obicetrapib was observed to reduce p-tau217 levels by 20.5%, over 12 months, compared to placebo (p=0.010, n=29).
o
In October 2025, the data was published in the Journal of Prevention of Alzheimer's Disease.

 

Upcoming 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 during 2026.

 

The following Phase 3 trials are currently ongoing:

 

PREVAIL Phase 3 trial: PREVAIL is a CVOT evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 9,500 patients in April 2024.
REMBRANDT Phase 3 trial: The REMBRANDT trial utilizes coronary computed tomography angiography imaging to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque burden. The placebo-controlled, double-blind, randomized, Phase 3 trial is being conducted in adult participants with high-risk ASCVD with evidence of coronary plaque who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg plus ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics. The trial is expected to complete enrollment of approximately 300 patients in 2026.
RUBENS Phase 3 trial: Initiated in December 2025, the RUBENS trial will evaluate obicetrapib alone or in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome that require additional lowering of LDL-C despite treatment with available therapy. The trial is expected to enroll approximately 300 patients, with topline data expected by year end 2026.

 

Additionally, NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib in early Alzheimer’s disease patients in 2026.

 

Full Year 2025 Financial Results

 

Cash Position: As of December 31, 2025, NewAmsterdam reported cash, cash equivalents and marketable securities of $728.9 million, compared to $834.2 million as of December 31, 2024. The decrease was primarily driven by cash outflows related to research and development costs as the Company continues development of obicetrapib and spending on selling, general and administrative expenses to support the Company’s ongoing operations, partially offset by cash inflows from the exercise of options and warrants.

Revenue: NewAmsterdam recognized $22.5 million in revenue for the year ended December 31, 2025, compared to $45.6 million in the year ended December 31, 2024. The decrease in revenue related to clinical development milestones pursuant to the Menarini License was partially offset by an increase in the amount of revenue recognized in the current period related to the development cost contributions under the Menarini License.
Research and Development (“R&D”) Expenses: R&D expenses were $141.8 million for the year ended December 31, 2025, compared to $151.4 million in the year ended December 31, 2024. The decrease was primarily driven by a decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials, partially offset by increases in non-clinical expenses, manufacturing expenses, personnel expenses and regulatory expenses. Share-based payment expenses included within R&D expenses totaled $19.6 million in the year ended December 31, 2025, compared to $13.3 million in the year ended December 31, 2024.
Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses were $106.4 million for the year ended December 31, 2025, compared to $70.4 million in the year ended December 31, 2024. This increase was primarily due to increases in personnel expenses, marketing and communication expenses and costs related to our intellectual property. Share-based payment expenses included within SG&A expenses totaled $39.9 million in the year ended December 31, 2025, compared to $20.3 million in the year ended December 31, 2024.
Net loss: Net loss for the year ended December 31, 2025, was $203.8 million, compared to net loss of $241.6 million in the year ended December 31, 2024. The individual components of the change are described above in addition to non-cash losses related to changes in the fair value of our derivative liabilities and foreign exchange gains/(losses).

 

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.

 

About NewAmsterdam

 

NewAmsterdam (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 potential approval decisions from the EMA, UK and Switzerland regulators with respect to MAAs for obicetrapib and the FDC of obicetrapib plus ezetimibe, and preparations for commercial launch, if approved; the initiation of a new clinical trial evaluating obicetrapib in early Alzheimer disease in 2026; 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 and business objectives for 2026 and beyond; the Company’s expectation that its cash runway will be sufficient to fund operations through the PREVAIL readout and, if approved, support the subsequent U.S. commercial launch; 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 and analyses will be indicative of the results of later clinical trials and analyses, 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

matthew.philippe@newamsterdampharma.com

 

Media Contact

Real Chemistry on behalf of NewAmsterdam

Christian Edgington

P: 1-513-310-6410

cedgington@realchemistry.com

 

Investor Contact

Precision AQ on behalf of NewAmsterdam

Austin Murtagh

P: 1-212-698-8696

austin.murtagh@precisionaq.com

 

 


 

NewAmsterdam Pharma Company N.V.

Consolidated Balance Sheet

 

As at December 31,

 

 

2025

 

 

2024

 

(In thousands of USD)

 

 

 

 

 

Assets

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

490,002

 

 

 

771,743

 

Prepayments and other receivables

 

38,138

 

 

 

24,272

 

Employee receivables

 

 

 

 

4,951

 

Marketable securities, current

 

146,239

 

 

 

62,447

 

Restricted cash

 

1,321

 

 

 

 

Total current assets

 

675,700

 

 

 

863,413

 

Marketable securities, net of current portion

 

92,609

 

 

 

 

Property, plant and equipment, net

 

383

 

 

 

242

 

Operating right of use asset

 

185

 

 

 

431

 

Intangible assets

 

407

 

 

 

534

 

Total assets

 

769,284

 

 

 

864,620

 

Liabilities and Shareholders' Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

8,970

 

 

 

4,744

 

Accrued expenses and other current liabilities

 

15,422

 

 

 

13,608

 

Deferred revenue, current

 

3,987

 

 

 

6,008

 

Lease liability, current

 

136

 

 

 

246

 

Derivative earnout liability, current

 

 

 

 

44,798

 

Derivative warrant liabilities

 

57,272

 

 

 

37,514

 

Total current liabilities

 

85,787

 

 

 

106,918

 

Lease liability, net of current portion

 

66

 

 

 

202

 

Total liabilities

 

85,853

 

 

 

107,120

 

Commitments and contingencies (Note 13)

 

 

 

 

 

Shareholders' Equity:

 

 

 

 

 

Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 114,399,326 and 108,064,340 shares issued and outstanding at December 31, 2025 and 2024, respectively

 

14,278

 

 

 

13,444

 

Additional paid-in capital

 

1,426,750

 

 

 

1,298,160

 

Accumulated loss

 

(762,390

)

 

 

(558,571

)

Accumulated other comprehensive income

 

4,793

 

 

 

4,467

 

Total shareholders' equity

 

683,431

 

 

 

757,500

 

Total liabilities and shareholders' equity

 

769,284

 

 

 

864,620

 

 

 


 

NewAmsterdam Pharma Company N.V.

Consolidated Statements of Operations and Comprehensive Loss

 

For the year ended December 31,

 

 

2025

 

 

2024

 

 

2023

 

(In thousands of USD, except per share amounts)

 

 

 

 

 

 

 

 

Revenue

 

22,503

 

 

 

45,563

 

 

 

14,090

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development expenses

 

141,832

 

 

 

151,406

 

 

 

159,424

 

Selling, general and administrative expenses

 

106,354

 

 

 

70,446

 

 

 

37,633

 

Total operating expenses

 

248,186

 

 

 

221,852

 

 

 

197,057

 

Operating loss

 

(225,683

)

 

 

(176,289

)

 

 

(182,967

)

Other income (expense):

 

 

 

 

 

 

 

 

Interest income

 

27,592

 

 

 

16,881

 

 

 

11,283

 

Fair value change – earnout

 

3,992

 

 

 

(37,010

)

 

 

(266

)

Fair value change – warrants

 

(22,775

)

 

 

(38,583

)

 

 

(10,018

)

Foreign exchange gains/(losses)

 

13,055

 

 

 

(6,598

)

 

 

5,058

 

Loss before tax

 

(203,819

)

 

 

(241,599

)

 

 

(176,910

)

Income tax expense (benefit)

 

 

 

 

(1

)

 

 

27

 

Loss for the year

 

(203,819

)

 

 

(241,598

)

 

 

(176,937

)

Other comprehensive income/(loss)

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities, net of tax

 

326

 

 

 

45

 

 

 

 

Total comprehensive loss for the year, net of tax

 

(203,493

)

 

 

(241,553

)

 

 

(176,937

)

 

 


 

NewAmsterdam Pharma Company N.V.

Consolidated Statements of Shareholders' Equity

(In thousands of USD, except share amounts)

Shares

 

 

Amount

 

 

Additional Paid-In Capital

 

 

Accumulated Loss

 

 

Accumulated other comprehensive income (loss)

 

 

Total Shareholders' Equity

 

Opening balance at January 1, 2023

 

81,559,780

 

 

 

10,055

 

 

 

555,625

 

 

 

(140,036

)

 

 

4,422

 

 

 

430,066

 

Exercise of warrants

 

749,741

 

 

 

97

 

 

 

10,116

 

 

 

 

 

 

 

 

 

10,213

 

Exercise of stock options

 

160,247

 

 

 

21

 

 

 

269

 

 

 

 

 

 

 

 

 

290

 

Share-based compensation

 

-

 

 

 

-

 

 

 

24,761

 

 

 

 

 

 

 

 

 

24,761

 

Total loss and comprehensive loss for the year

 

-

 

 

 

 

 

 

 

 

 

(176,937

)

 

 

 

 

 

(176,937

)

As at December 31, 2023

 

82,469,768

 

 

 

10,173

 

 

 

590,771

 

 

 

(316,973

)

 

 

4,422

 

 

 

288,393

 

February 2024 Issuance of Ordinary Shares and Pre-Funded Warrants, net of issuance costs

 

5,871,909

 

 

 

759

 

 

 

189,206

 

 

 

 

 

 

 

 

 

189,965

 

December 2024 Issuance of Ordinary Shares and Pre-Funded Warrants, net of issuance costs

 

14,667,347

 

 

 

1,851

 

 

 

451,564

 

 

 

 

 

 

 

 

 

453,415

 

Exercise of Pre-Funded Warrants

 

2,105,248

 

 

 

279

 

 

 

(279

)

 

 

 

 

 

 

 

 

 

Exercise of warrants

 

1,288,790

 

 

 

168

 

 

 

27,673

 

 

 

 

 

 

 

 

 

27,841

 

Exercise of stock options

 

1,661,278

 

 

 

214

 

 

 

5,496

 

 

 

 

 

 

 

 

 

5,710

 

Share-based compensation

 

 

 

 

 

 

 

33,729

 

 

 

 

 

 

 

 

 

33,729

 

Total loss and comprehensive loss for the year

 

 

 

 

 

 

 

 

 

 

(241,598

)

 

 

45

 

 

 

(241,553

)

As at December 31, 2024

 

108,064,340

 

 

 

13,444

 

 

 

1,298,160

 

 

 

(558,571

)

 

 

4,467

 

 

 

757,500

 

Issuance of Earnout Shares

 

1,743,136

 

 

 

226

 

 

 

40,581

 

 

 

 

 

 

 

 

 

40,807

 

Exercise of Pre-Funded Warrants

 

1,293,938

 

 

 

162

 

 

 

(162

)

 

 

 

 

 

 

 

 

-

 

Exercise of warrants

 

142,477

 

 

 

19

 

 

 

4,636

 

 

 

 

 

 

 

 

 

4,655

 

Exercise of stock options

 

3,012,434

 

 

 

408

 

 

 

24,129

 

 

 

 

 

 

 

 

 

24,537

 

Vesting of RSUs

 

143,001

 

 

 

19

 

 

 

(19

)

 

 

 

 

 

 

 

 

-

 

Share-based compensation

 

 

 

 

 

 

 

59,425

 

 

 

 

 

 

 

 

 

59,425

 

Total loss and comprehensive loss for the year

 

 

 

 

 

 

 

 

 

 

(203,819

)

 

 

326

 

 

 

(203,493

)

As at December 31, 2025

 

114,399,326

 

 

 

14,278

 

 

 

1,426,750

 

 

 

(762,390

)

 

 

4,793

 

 

 

683,431

 

 

 


 

NewAmsterdam Pharma Company N.V.

Consolidated Statements of Cash Flows

 

For the year ended December 31,

 

 

2025

 

 

2024

 

 

2023

 

(In thousands of USD)

 

 

 

 

 

 

 

 

Operating activities:

 

 

 

 

 

 

 

 

Loss for the year

 

(203,819

)

 

 

(241,598

)

 

 

(176,937

)

Non-cash adjustments to reconcile loss for the year to net cash flows:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

220

 

 

 

113

 

 

 

49

 

Non-cash rent expense

 

 

 

 

12

 

 

 

6

 

Fair value change - derivative earnout and warrants

 

18,783

 

 

 

75,593

 

 

 

10,284

 

Loss on disposal of property, plant and equipment

 

12

 

 

 

 

 

 

 

Foreign exchange (gains)/losses

 

(13,055

)

 

 

6,598

 

 

 

(5,058

)

Amortization of premium/discount on available-for-sale debt securities

 

(1,405

)

 

 

(227

)

 

 

 

Share-based compensation

 

59,425

 

 

 

33,619

 

 

 

24,572

 

Changes in working capital:

 

 

 

 

 

 

 

 

Changes in prepayments (current and non-current) and other receivables

 

(13,280

)

 

 

(17,459

)

 

 

4,031

 

Changes in accounts payable

 

4,909

 

 

 

(12,948

)

 

 

5,070

 

Changes in accrued expenses and other current liabilities

 

2,448

 

 

 

1,686

 

 

 

5,470

 

Changes in deferred revenue

 

(2,021

)

 

 

(3,953

)

 

 

(8,705

)

Net cash used in operating activities

 

(147,783

)

 

 

(158,564

)

 

 

(141,218

)

Investing activities:

 

 

 

 

 

 

 

 

Purchase of property, plant and equipment, including internal use software

 

(246

)

 

 

(672

)

 

 

(24

)

Maturities of marketable securities

 

122,063

 

 

 

 

 

 

 

Purchases of marketable securities

 

(296,733

)

 

 

(62,176

)

 

 

 

Net cash used in investing activities

 

(174,916

)

 

 

(62,848

)

 

 

(24

)

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from February 2024 offering of Ordinary Shares and Pre-Funded Warrants

 

 

 

 

190,481

 

 

 

 

Transaction costs on February 2024 issue of Ordinary Shares and Pre-Funded Warrants

 

 

 

 

(515

)

 

 

 

Proceeds from December 2024 offering of Ordinary Shares and Pre-Funded Warrants

 

 

 

 

455,026

 

 

 

 

Transaction costs on December 2024 issue of Ordinary Shares and Pre-Funded Warrants

 

(1,586

)

 

 

(25

)

 

 

 

Proceeds from exercise of warrants

 

1,638

 

 

 

13,761

 

 

 

8,622

 

Proceeds from exercise of options

 

29,468

 

 

 

1,768

 

 

 

290

 

Payment of withholding taxes related to net share settlement of exercised options

 

 

 

 

(989

)

 

 

 

Net cash provided by financing activities

 

29,520

 

 

 

659,507

 

 

 

8,912

 

Net change in cash, cash equivalents and restricted cash

 

(293,179

)

 

 

438,095

 

 

 

(132,330

)

Foreign exchange differences

 

12,759

 

 

 

(6,802

)

 

 

5,052

 

Cash, cash equivalents and restricted cash at the beginning of the year

 

771,743

 

 

 

340,450

 

 

 

467,728

 

Cash, cash equivalents and restricted cash at the end of the year

 

491,323

 

 

 

771,743

 

 

 

340,450

 

Noncash financing and investing activities

 

 

 

 

 

 

 

 

Recognition of ROU asset

 

 

 

 

562

 

 

 

 

Issuance of earnout shares

 

40,807

 

 

 

 

 

 

 

Supplemental cash flow disclosures

 

 

 

 

 

 

 

 

Cash paid for income taxes

 

 

 

 

1

 

 

 

27

 

 

 

 

 

 

 

 

 

 

Reconciliation of cash, cash equivalents and restricted cash to the Consolidated Balance Sheets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

490,002

 

 

 

771,743

 

 

 

340,450

 

Restricted cash

 

1,321

 

 

 

 

 

 

 

 

 

491,323

 

 

 

771,743

 

 

 

340,450

 

 

 


FAQ

How did NewAmsterdam Pharma (NAMS) perform financially in full year 2025?

NewAmsterdam Pharma reported a 2025 net loss of $203.8 million, improving from a $241.6 million loss in 2024. Revenue was $22.5 million, down from $45.6 million, mainly reflecting lower Menarini milestone revenue while the company continued investing heavily in late-stage clinical development.

What is NewAmsterdam Pharma’s cash position and runway after 2025?

As of December 31, 2025, NewAmsterdam held $728.9 million in cash, cash equivalents and marketable securities. Management states this cash runway is expected to fund operations through the PREVAIL cardiovascular outcomes readout and, if obicetrapib is approved, support a subsequent U.S. commercial launch.

What late-stage clinical trials is NewAmsterdam Pharma (NAMS) running for obicetrapib?

NewAmsterdam is conducting three Phase 3 trials: PREVAIL, a cardiovascular outcomes study with over 9,500 patients enrolled; REMBRANDT, assessing coronary plaque via CT angiography; and RUBENS, evaluating obicetrapib with or without ezetimibe in type 2 diabetes and metabolic syndrome patients.

What regulatory milestones are upcoming for NewAmsterdam Pharma’s obicetrapib?

Marketing Authorization Applications for obicetrapib and its fixed-dose combination with ezetimibe have been accepted for review by the EMA, UK and Swiss regulators. The company expects approval decisions from each of these authorities in the second half of 2026, subject to regulatory review.

How is NewAmsterdam Pharma involved in Alzheimer’s disease research?

NewAmsterdam reported statistically significant reductions in p‑tau217, a key Alzheimer’s biomarker, in the BROADWAY analysis. Based on these results, the company plans to initiate a new clinical trial in early Alzheimer’s disease patients in 2026 to further evaluate obicetrapib’s potential neurological effects.

What drove changes in NewAmsterdam Pharma’s R&D and SG&A expenses in 2025?

R&D expenses fell to $141.8 million from $151.4 million as several Phase 3 trials completed, partly offset by higher manufacturing and regulatory costs. SG&A rose to $106.4 million from $70.4 million, driven by additional personnel, marketing, communication and intellectual property-related expenses.

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