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NewAmsterdam Pharma (NAMS) posts Q1 2026 loss with $707M cash and key trial milestones

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

Rhea-AI Filing Summary

NewAmsterdam Pharma reported first quarter 2026 results and a broad clinical update. Revenue was $3.0 million, while net loss widened to $48.4 million from $39.5 million a year earlier. Cash, cash equivalents and marketable securities totaled $707.3 million as of March 31, 2026.

The company highlighted ongoing Phase 3 programs for obicetrapib, including the PREVAIL cardiovascular outcomes trial with over 9,500 patients enrolled, REMBRANDT with 323 patients enrolled, and RUBENS targeting about 300 patients. Interim PREVAIL analysis is planned for 4Q 2026 with results expected in 1Q 2027.

Regulatory decisions in Europe, the UK and Switzerland for obicetrapib and the obicetrapib/ezetimibe fixed‑dose combination are expected in 2H 2026, with potential launches by Menarini in 4Q 2026 in Germany and the UK. The company also described Alzheimer’s biomarker findings from the BROADWAY trial and plans a new trial in early Alzheimer’s disease in 2026.

Positive

  • None.

Negative

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Insights

Late-stage pipeline advances while net losses grow but remain well-funded.

NewAmsterdam combines expanding late-stage data with solid liquidity. Cash, cash equivalents and marketable securities of $707.3 million at March 31, 2026 support multiple Phase 3 trials and planned regulatory and commercial steps with partner Menarini in Europe.

Operating expenses declined year over year, with R&D at $38.0 million and SG&A at $23.5 million, yet net loss increased to $48.4 million due to lower other income and foreign exchange impacts. Revenue was modest at $3.0 million, mainly from Menarini agreements.

Key upcoming events include regulatory decisions in 2H 2026, potential launches in 4Q 2026, and PREVAIL interim analysis in 4Q 2026 with result expected in 1Q 2027. Actual impact will depend on regulatory outcomes and PREVAIL data quality.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Revenue $3.0M Quarter ended March 31, 2026; versus $3.0M in 2025
Net loss $48.4M Quarter ended March 31, 2026; versus $39.5M in 2025
Cash and securities $707.3M Cash, cash equivalents and marketable securities as of March 31, 2026
R&D expenses $38.0M Research and development expenses in Q1 2026; $44.8M in Q1 2025
SG&A expenses $23.5M Selling, general and administrative expenses in Q1 2026; $27.2M in Q1 2025
PREVAIL enrollment Over 9,500 patients Enrollment completed in April 2024 for cardiovascular outcomes trial
REMBRANDT enrollment 323 patients Phase 3 plaque-imaging trial completed enrollment in March 2026
PREVAIL interim timing 4Q 2026 / 1Q 2027 Interim analysis planned 4Q 2026 with result expected 1Q 2027
cardiovascular outcomes trial medical
"PREVAIL is a cardiovascular outcomes trial (“CVOT”) evaluating obicetrapib in patients with a history of ASCVD"
A cardiovascular outcomes trial is a large clinical study designed to see whether a medicine or intervention affects major heart-related events such as heart attacks, strokes, hospitalization for heart failure, or death. Think of it as a long road-test that measures real-world safety and benefit for the heart rather than just short-term lab results. Investors watch these trials because their results can change a product’s approval, labeling, sales potential, and legal risk, and thus a company’s valuation.
CETP inhibitor medical
"obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor"
A CETP inhibitor is a medicine that blocks a blood protein responsible for moving cholesterol between different carriers, which typically raises “good” HDL cholesterol and can lower “bad” LDL cholesterol. For investors, these drugs matter because if clinical trials and regulators confirm they reduce heart disease, they can create large new revenue streams for developers; conversely, trial failures or safety concerns can sharply reduce a company’s value, like a promising new tool that must still prove it fixes the problem.
major adverse cardiovascular events medical
"designed to assess the potential of obicetrapib to reduce occurrences of MACE"
Major adverse cardiovascular events (often abbreviated MACE) are a grouped set of serious heart- and blood-vessel problems—commonly heart attack, stroke, and death from cardiovascular causes—used as a single “scorecard” in clinical studies. Investors watch MACE results because they directly affect whether a treatment or device is seen as safe and effective, which in turn shapes regulatory approval, market access, potential sales, and legal or reputational risk.
fixed-dose combination medical
"developing obicetrapib ... in fixed-dose combination with ezetimibe"
A fixed-dose combination is a single medication that contains two or more active drugs combined in set proportions, like a combo meal that packages complementary items into one order. For investors it matters because such products can improve patient convenience and adherence, streamline manufacturing and marketing, and create distinct regulatory and patent opportunities or risks that affect a drug’s market size, pricing power, and long-term revenue potential.
p-tau217 medical
"The absolute and percent change over 12 months in p-tau217, a key biomarker of AD pathology, were measured"
p-tau217 is a specific form of the tau protein that has a phosphate tag at position 217 and is measured in blood or spinal fluid as a biomarker for Alzheimer’s disease. It matters to investors because changes in p-tau217 can signal whether a drug is affecting the underlying disease or whether a diagnostic test can detect Alzheimer’s earlier, which can drive regulatory approvals, market demand for tests, and the commercial success of therapies.
derivative warrant liabilities financial
"a non-cash gain related to changes in the fair value of our derivative warrant liabilities"
Derivative warrant liabilities are the obligation a company records for outstanding warrants—contracts that give holders the right to receive cash or shares based on the company’s stock price. They matter to investors because these liabilities signal potential future cash outflows or share dilution that can reduce earnings per share, change available cash, and increase stock volatility; think of them as outstanding IOUs that may force a company to pay money or issue more shares.
Revenue $3.0M
Net loss $48.4M
R&D expenses $38.0M
SG&A expenses $23.5M
Cash and securities $707.3M
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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): May 7, 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 May 7, 2026, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing corporate updates and its financial results for the quarter ended March 31, 2026. 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 May 7, 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:

May 7, 2026

By:

/s/ Ian Somaiya

 

 

Name:

Ian Somaiya

 

 

Title:

Chief Financial Officer

 

 


NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results

 

– Decisions on regulatory approval from EMA, UK, and Switzerland for obicetrapib and obicetrapib/ezetimibe fixeddose combination expected in 2H26, and based on the outcomes, with potential launches by Menarini in 4Q26 in Germany and the UK –

 

– PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027 –

 

– Completed enrollment in REMBRANDT; Topline data from RUBENS Phase 3 expected by year-end 2026 –

 

– Presented new analyses of Phase 3 BROOKLYN and BROADWAY studies at the American College of Cardiology Annual Scientific Session (ACC) and simultaneously published in the American Journal of Preventative Cardiology–

 

– $707.3 million in cash, cash equivalents and marketable securities at March 31, 2026 –

 

– Management to host PREVAIL update call today at 8:00 AM ET –

 

Naarden, the Netherlands and Miami, USA; May 7, 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 quarter ended March 31, 2026 and provided a corporate update.

 

“Our clinical execution remains strong. We have completed enrollment in REMBRANDT and continue to advance PREVAIL and RUBENS — three Phase 3 trials that underscore the breadth and maturity of our development program,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “We are excited following an initial blinded review of PREVAIL data after the two-year anniversary of enrollment completion — which showed a Year 1 overall MACE event rate consistent with BROADWAY and a Year 1-to-Year 2 overall MACE event rate lower than expected — and we have decided to conduct an interim analysis in the fourth quarter of 2026. This timing coincides with the minimum 2.5-year follow-up for the trial. We are optimistic about the interim analysis and expect to report the result of the analysis in the first quarter of 2027. Should the trial not stop for efficacy at that time, we anticipate completion by the end of 2027. We will provide further details at our annual Investor Day on August 5, 2026.”

 

Clinical Development 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 March 2026, NewAmsterdam presented results from additional analyses of its pivotal Phase 3 BROADWAY and BROOKLYN trials evaluating obicetrapib in patients with established atherosclerotic cardiovascular disease (“ASCVD”) and/or heterozygous familial hypercholesterolemia (“HeFH”) at ACC, which were simultaneously published in the American Journal of Preventative Cardiology. The new analyses explored the potential effects of obicetrapib beyond LDL-C lowering, including signals related to new-onset diabetes mellitus and kidney function, and further evaluated the investigational therapy’s safety profile. Data presented include:

 

Pooled analysis of the BROADWAY and BROOKLYN trials showed that CETP inhibition with obicetrapib 10 mg was associated with a slower annualized decline in estimated glomerular filtration rate (eGFR) (-0.41 vs. -1.08 with placebo; difference of 0.67 mL/min/1.73 m²) in patients with high cardiovascular risk.

 

Patients treated with obicetrapib had nominally fewer composite renal events over 12 months, consisting of death due to cardiovascular or renal causes, eGFR <15 mL/min/1.73 m² post- baseline, ≥40 % decline in eGFR from baseline, kidney transplant, or dialysis initiation. The analysis of time weighted achieved HDL-C versus

renal event indicated a strong association between higher achieved HDL-C and lower renal event risk (spline nominal P < 0.0001), independent of baseline HDL-C and eGFR.

 

Pooled Phase 3 safety analysis from BROOKLYN and BROADWAY continued to reinforce the safety and tolerability profile of obicetrapib.

 

Findings that higher small/medium LDL particle (“LDL-P”) discordance was observed to be independently associated with incident major adverse cardiovascular events (“MACE”), specifically in patients with high cardiometabolic burden.

 

Datasets from the analyses were published in the American Journal of Preventive Cardiology. The full posters presented at ACC are available on the Scientific Publications and Presentations page of the NewAmsterdam Pharma website at www.newamsterdampharma.com/publications/.

 

NewAmsterdam plans to present additional analyses from the BROOKLYN and BROADWAY studies throughout 2026.

 

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 clinical data from these trials relating to obicetrapib and the fixed-dose combination (“FDC”) of obicetrapib plus ezetimibe during 2026.

 

The following Phase 3 trials are currently ongoing:

 

PREVAIL Phase 3 trial: PREVAIL is a cardiovascular outcomes trial (“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, with the aim to assess the impact of the obicetrapib 10 mg plus ezetimibe 10 mg FDC daily on lipid-rich coronary plaque and arterial wall inflammation characteristics. In March 2026, the trial completed enrollment of 323 patients.

 

RUBENS Phase 3 trial: Initiated in December 2025, the RUBENS trial is evaluating 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 for the prevention of early Alzheimer’s disease in 2026.

 

First Quarter Financial Results

 

Cash Position: As of March 31, 2026, NewAmsterdam recorded cash, cash equivalents and marketable securities of $707.3 million, compared to $728.9 million as of December 31, 2025. The increase/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 $3.0 million in revenue for the quarter ended March 31, 2026, compared to $3.0 million in the same period in 2025. Revenue for the three months ended March 31, 2025 was due to recognition of deferred revenue related to the R&D performance obligation under the Company’s license

agreement with the Menarini Group. Revenue for the three months ended March 31, 2026 was related to the Company’s supply agreement with Menarini.

 

Research and Development (“R&D”) Expenses: R&D expenses were $38.0 million in the quarter ended March 31, 2026, compared to $44.8 million for the same period in 2025. This decrease was primarily due to decreases in clinical expenses driven by the completion of Phase 3 clinical trials in the first half of 2025 and non-clinical expenses, partially offset by increases in personnel and manufacturing expenses. Share-based payment expenses included within R&D expenses totaled $6.8 million in the quarter ended March 31, 2026, compared to $5.2 million in the same period in 2025.

 

Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses were $23.5 million in the quarter ended March 31, 2026, compared to $27.2 million for the same period in 2025. This decrease was primarily due to decreases in marketing and communication, legal and intellectual property expenses, partially offset by an increase in personnel expenses. Share-based payment expenses included within SG&A expenses totaled $11.2 million in the quarter ended March 31, 2026, compared to $10.0 million in the same period in 2025.

 

Net loss: Net loss for the quarter ended March 31, 2026, was $48.4 million, compared to net loss of $39.5 million for the same period in 2025. The individual components of the change are described above in addition to interest income, a non-cash gain related to changes in the fair value of our derivative warrant liabilities and foreign exchange losses.

 

Conference Call and Webcast Information

 

NewAmsterdam will host a live webcast and conference call at 8:00 a.m. ET today. To access the live call, participants may register here. The live webcast will be available under the "Events” section of the Investor Relations page of the NewAmsterdam website at ir.newamsterdampharma.com.

 

While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archived replay of the webcast will be available on NewAmsterdam’s website.

 

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, were 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. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” “expects” and variations of these words or similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, 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, as well as the potential launch by Menarini in Germany and the United Kingdom; the Company’s intention to conduct the PREVAIL interim analysis; the Company’s expectations regarding the timing of the interim analysis, when the result of the interim analysis may be announced and the potential of PREVAIL being stopped early for efficacy as a result of the interim analysis; the Company’s expectation regarding the timing of the completion of the PREVAIL trial if it is not stopped for efficacy following the interim analysis; expectations for total enrollment figures for and topline data from the RUBENS trial by year-end 2026; the initiation of a new clinical trial evaluating obicetrapib in early Alzheimer’s disease in 2026; the therapeutic potential of the Company’s product candidates; the Company’s other plans regarding and the timing for commencing trials, enrolling patients and completing trials, and the timing and forums for announcing data; expected milestones and anticipated progress toward such milestones; the Company’s anticipated update regarding the PREVAIL trial at its Investor Day; and other statements regarding the Company's future operations, prospects, objectives, strategies and other future events.

 

The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon management’s current expectations and assumptions. Actual results or events could differ materially and adversely from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various risks, uncertainties and other factors, including, among others: uncertainties and delays regarding the initiation, enrollment and completion of the Company’s clinical trials; uncertainties regarding the result of the PREVAIL


interim analysis; risk that the trends observed in the blinded data in PREVAIL are not being driven by a treatment effect of obicetrapib; the potential for unknown or unadjudicated events to impact the trends observed in the preliminary blinded data in PREVAIL; 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, trends 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; challenges inherent to the launch of new drug products, if approved; risks related to the Company’s reliance on third parties; 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 other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 18, 2026 and in its most recent Quarterly Report Form 10-Q, as well as in other filings the Company may make with the SEC in the future, which are available at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date of this press release, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of new information, future events, changed circumstances or otherwise, except as otherwise required by law.

 

 

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.

Condensed Consolidated Balance Sheet

(Unaudited)

 

March 31,
2026

 

 

December 31,
2025

 

(In thousands of USD)

 

 

 

 

 

Assets

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

457,607

 

 

 

490,002

 

Prepayments and other receivables

 

20,603

 

 

 

38,138

 

Marketable securities, current

 

178,498

 

 

 

146,239

 

Restricted cash

 

1,336

 

 

 

1,321

 

Total current assets

 

658,044

 

 

 

675,700

 

Marketable securities, net of current portion

 

71,239

 

 

 

92,609

 

Property, plant and equipment, net

 

379

 

 

 

383

 

Operating right of use asset

 

21

 

 

 

185

 

Intangible assets

 

375

 

 

 

407

 

Long term prepaid expenses

 

2,585

 

 

 

 

Total assets

 

732,643

 

 

 

769,284

 

Liabilities and Shareholders' Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

8,090

 

 

 

8,970

 

Accrued expenses and other current liabilities

 

5,092

 

 

 

15,422

 

Deferred revenue, current

 

3,987

 

 

 

3,987

 

Lease liability, current

 

23

 

 

 

136

 

Derivative warrant liabilities

 

50,229

 

 

 

57,272

 

Total current liabilities

 

67,421

 

 

 

85,787

 

Lease liability, net of current portion

 

 

 

 

66

 

Total liabilities

 

67,421

 

 

 

85,853

 

Commitments and contingencies (Note 12)

 

 

 

 

 

Shareholders' Equity:

 

 

 

 

 

Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 116,641,656 and 114,399,326 shares issued and outstanding at March 31, 2026 and December 31, 2025 respectively

 

14,594

 

 

 

14,278

 

Additional paid-in capital

 

1,457,238

 

 

 

1,426,750

 

Accumulated loss

 

(810,831

)

 

 

(762,390

)

Accumulated other comprehensive income

 

4,221

 

 

 

4,793

 

Total shareholders' equity

 

665,222

 

 

 

683,431

 

Total liabilities and shareholders' equity

 

732,643

 

 

 

769,284

 

 

 


 

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

For the three months ended March 31,

 

 

2026

 

 

2025

 

(In thousands of USD, except per share amounts)

 

 

 

 

 

Revenue

 

3,040

 

 

 

2,978

 

Operating expenses:

 

 

 

 

 

Research and development expenses

 

38,009

 

 

 

44,751

 

Selling, general and administrative expenses

 

23,451

 

 

 

27,152

 

Total operating expenses

 

61,460

 

 

 

71,903

 

Operating loss

 

(58,420

)

 

 

(68,925

)

Other income (expense):

 

 

 

 

 

Interest income

 

5,650

 

 

 

7,351

 

Fair value change – earnout

 

 

 

 

3,992

 

Fair value change – warrants

 

5,942

 

 

 

13,762

 

Foreign exchange gains/(losses)

 

(1,613

)

 

 

4,293

 

Loss before tax

 

(48,441

)

 

 

(39,527

)

Income tax expense

 

 

 

 

 

Loss for the year

 

(48,441

)

 

 

(39,527

)

Other comprehensive income/(loss)

 

 

 

 

 

Unrealized gain/(loss) on available-for-sale securities, net of tax

 

(572

)

 

 

(33

)

Total comprehensive loss for the year, net of tax

 

(49,013

)

 

 

(39,560

)

 

 


 

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Shareholders' Equity

(Unaudited)

(In thousands of USD, except share amounts)

Shares

 

 

Amount

 

 

Additional Paid-In Capital

 

 

Accumulated Loss

 

 

Accumulated Other Comprehensive Income

 

 

Total Shareholders' Equity

 

Balance 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

 

15,942

 

 

 

2

 

 

 

410

 

 

 

 

 

 

 

 

 

412

 

Exercise of stock options

 

909,140

 

 

 

116

 

 

 

2,875

 

 

 

 

 

 

 

 

 

2,991

 

Vesting of RSUs

 

142,795

 

 

 

18

 

 

 

(18

)

 

 

 

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

15,213

 

 

 

 

 

 

 

 

 

15,213

 

Total loss and comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

(39,527

)

 

 

(33

)

 

 

(39,560

)

As at March 31, 2025

 

112,169,291

 

 

 

13,968

 

 

 

1,357,059

 

 

 

(598,098

)

 

 

4,434

 

 

 

777,363

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2025

 

114,399,326

 

 

 

14,278

 

 

 

1,426,750

 

 

 

(762,390

)

 

 

4,793

 

 

 

683,431

 

Exercise of warrants

 

56,619

 

 

 

8

 

 

 

1,745

 

 

 

 

 

 

 

 

 

1,753

 

Exercise of stock options

 

1,971,548

 

 

 

278

 

 

 

10,771

 

 

 

 

 

 

 

 

 

11,049

 

Vesting of RSUs

 

214,163

 

 

 

30

 

 

 

(30

)

 

 

 

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

18,002

 

 

 

 

 

 

 

 

 

18,002

 

Total loss and comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

(48,441

)

 

 

(572

)

 

 

(49,013

)

As at March 31, 2026

 

116,641,656

 

 

 

14,594

 

 

 

1,457,238

 

 

 

(810,831

)

 

 

4,221

 

 

 

665,222

 

 

 


 

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 


 

 

For the three months ended March 31,

 

 

2026

 

 

2025

 

(In thousands of USD)

 

 

 

 

 

Operating activities:

 

 

 

 

 

Loss for the period

 

(48,441

)

 

 

(39,527

)

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

 

 

 

 

 

Depreciation and amortization

 

62

 

 

 

52

 

Non-cash rent expense

 

(16

)

 

 

3

 

Fair value change - derivative earnout and warrants

 

(5,942

)

 

 

(17,754

)

Loss on disposal of property, plant and equipment

 

12

 

 

 

 

Foreign exchange (gains)/losses

 

1,613

 

 

 

(4,293

)

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

 

10

 

 

 

(513

)

Share-based compensation

 

18,002

 

 

 

15,213

 

Changes in working capital:

 

 

 

 

 

Changes in prepayments and other receivables

 

15,219

 

 

 

16,031

 

Changes in accounts payable

 

(793

)

 

 

2,251

 

Changes in accrued expenses and other current liabilities

 

(10,330

)

 

 

(4,953

)

Changes in deferred revenue

 

-

 

 

 

(2,978

)

Net cash used in operating activities

 

(30,604

)

 

 

(36,468

)

Investing activities:

 

 

 

 

 

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

 

(38

)

 

 

(16

)

Maturities of marketable securities

 

51,000

 

 

 

12,500

 

Purchases of marketable securities

 

(62,471

)

 

 

(9,629

)

Net cash (used in)/provided by investing activities

 

(11,509

)

 

 

2,855

 

Financing activities:

 

 

 

 

 

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

 

 

 

 

(1,586

)

Proceeds from exercise of warrants

 

651

 

 

 

183

 

Proceeds from exercise of options

 

10,414

 

 

 

7,922

 

Net cash provided by financing activities

 

11,065

 

 

 

6,519

 

Net change in cash, cash equivalents and restricted cash

 

(31,048

)

 

 

(27,094

)

Foreign exchange differences

 

(1,332

)

 

 

3,771

 

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

 

491,323

 

 

 

771,743

 

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

 

458,943

 

 

 

748,420

 

Noncash financing and investing activities

 

 

 

 

 

Issuance of earnout shares

 

 

 

 

40,807

 

 

 

 

 

 

 

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

 

 

 

 

 

Cash and cash equivalents

 

457,607

 

 

 

748,420

 

Restricted cash

 

1,336

 

 

 

 

 

 

458,943

 

 

 

748,420

 

 

 


Filing Exhibits & Attachments

2 documents