STOCK TITAN

NewAmsterdam Pharma (Nasdaq: NAMS) June-quarter loss widens; cash $678M

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

NewAmsterdam Pharma Company N.V. reported results for the quarter ended June 30, 2026 and highlighted regulatory and clinical developments. The Committee for Medicinal Products for Human Use issued a positive opinion recommending EU marketing authorization for obicetrapib (Ubeslo) and the obicetrapib/ezetimibe fixed-dose combination (Evlarco), with a European Commission decision expected later this year.

The company is running multiple Phase 3 programs, including the PREVAIL cardiovascular outcomes trial with over 9,500 patients enrolled and an interim analysis planned for the fourth quarter of 2026, the REMBRANDT imaging trial with 323 patients enrolled, and the RUBENS diabetes/metabolic syndrome trial targeting about 300 patients and topline data by year-end 2026. Cash, cash equivalents and marketable securities were $678.3 million at June 30, 2026. Revenue for the three months ended June 30, 2026 was $3.7 million versus $19.1 million a year earlier, reflecting lower contributions under the Menarini license and supply arrangements. R&D expenses rose to $41.7 million, SG&A expenses were $26.9 million, and net loss widened to $64.1 million compared with $17.4 million in the prior-year period.

Positive

  • The Committee for Medicinal Products for Human Use adopted a positive opinion recommending EU marketing authorization for obicetrapib and the obicetrapib/ezetimibe fixed-dose combination, advancing NewAmsterdam’s first potential products toward approval.
  • Enrollment in the PREVAIL cardiovascular outcomes trial is complete with over 9,500 patients, and an interim analysis is planned for the fourth quarter of 2026.
  • NewAmsterdam held $678.3 million in cash, cash equivalents and marketable securities at June 30, 2026, supporting its late-stage development programs and planned studies.

Negative

  • Revenue for the three months ended June 30, 2026 fell to $3.7 million from $19.1 million in the same period of 2025, as the prior year included a $16.1 million Menarini development contribution.
  • Net loss for the three months ended June 30, 2026 widened to $64.1 million from $17.4 million a year earlier, driven by higher R&D spending and fair value and foreign exchange effects.

Filing Explained

At June 30, 2026, the company had 117,651,697 shares outstanding, up from 114,399,326 at year-end, reducing existing holders’ percentage ownership absent offsets.

This Form 8-K furnishes the company's June 30, 2026 quarterly results and corporate update; the information is not deemed filed for Section 18 purposes and is not incorporated by reference unless expressly stated.

The balance sheet shows 117,651,697 ordinary shares issued and outstanding at June 30, 2026, versus 114,399,326 at December 31, 2025; the equity statement identifies warrant and option exercises and RSU vesting during 2026.

Because additional shares increase the total share count, the disclosed issuance reduces an existing holder's percentage ownership absent offsetting changes.

The company also reports $678.3 million in cash, cash equivalents and marketable securities at June 30, 2026, alongside 69,818 thousand dollars of net cash used in operating activities during the six months ended that date.

These figures describe the reported liquidity position and recent cash use; they do not establish a committed future funding amount.

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.
Cash, cash equivalents and marketable securities $678.3 million Balance as of June 30, 2026
Revenue (three months ended June 30, 2026) $3.7 million Revenue for the three months ended June 30, 2026
Revenue (three months ended June 30, 2025) $19.1 million Revenue for the three months ended June 30, 2025, including $16.1 million Menarini contribution
Net loss (three months ended June 30, 2026) $64.1 million Loss for the three months ended June 30, 2026
R&D expenses (three months ended June 30, 2026) $41.7 million Research and development expenses for the three months ended June 30, 2026
SG&A expenses (three months ended June 30, 2026) $26.9 million Selling, general and administrative expenses for the three months ended June 30, 2026
PREVAIL trial enrollment over 9,500 patients Patients enrolled in the PREVAIL cardiovascular outcomes trial as of completion in April 2024
Ordinary shares outstanding 117,651,697 shares Ordinary shares issued and outstanding as of June 30, 2026
cholesteryl ester transfer protein medical
"an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor"
A cholesteryl ester transfer protein (CETP) is a naturally occurring protein in blood that moves cholesterol molecules between the particles that carry “good” and “bad” cholesterol, acting like a courier redistributing packages. It matters to investors because modifying CETP’s activity is a common drug strategy to change cholesterol levels and reduce heart disease risk, so clinical trial results, regulatory decisions, or new therapies targeting CETP can materially affect pharmaceutical and healthcare company valuations.
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.
major adverse cardiovascular events medical
"obicetrapib was observed to reduce major adverse cardiovascular events (“MACE”) by 23%"
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.
p-tau217 medical
"Prespecified analyses from the Phase 3 BROADWAY trial demonstrated statistically significant reductions in plasma p-tau217 versus placebo"
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.
Revenue $3.7 million compared with $19.1 million for the three months ended June 30, 2025
Net loss $64.1 million compared with $17.4 million for the three months ended June 30, 2025
R&D expenses $41.7 million compared with $27.5 million for the three months ended June 30, 2025
SG&A expenses $26.9 million compared with $27.3 million for the three months ended June 30, 2025

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What were NewAmsterdam Pharma (NAMS) revenues and net loss for the quarter ended June 30, 2026?

NewAmsterdam reported $3.7 million in revenue and a net loss of $64.1 million for the three months ended June 30, 2026, compared with $19.1 million in revenue and a $17.4 million net loss in the same period of 2025.

How much cash and marketable securities did NewAmsterdam Pharma (NAMS) have at June 30, 2026?

As of June 30, 2026, NewAmsterdam held $678.3 million in cash, cash equivalents and marketable securities. This compares with $728.9 million at December 31, 2025 and reflects funding of ongoing clinical development and operating expenses.

What key regulatory milestone did NewAmsterdam Pharma (NAMS) recently achieve for obicetrapib?

In July 2026, the CHMP issued a positive opinion recommending EU marketing authorization for obicetrapib 10 mg monotherapy and the 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination for primary hypercholesterolemia and mixed dyslipidemia, with a European Commission decision expected later in 2026.

Which Phase 3 trials of obicetrapib are ongoing at NewAmsterdam Pharma (NAMS)?

NewAmsterdam is conducting three Phase 3 trials: PREVAIL, a cardiovascular outcomes trial with over 9,500 patients; REMBRANDT, an imaging study with 323 patients; and RUBENS, evaluating obicetrapib ± ezetimibe in about 300 patients with type 2 diabetes or metabolic syndrome.

What did NewAmsterdam Pharma (NAMS) report about obicetrapib’s impact on major adverse cardiovascular events (MACE)?

A pooled mediation analysis of Phase 3 BROADWAY and BROOKLYN data found obicetrapib was observed to reduce major adverse cardiovascular events by 23%, with LDL-C and lipoprotein(a) reductions jointly mediating 84.5% of this observed benefit, primarily attributable to LDL-C lowering.

What Alzheimer’s disease biomarker results did NewAmsterdam Pharma (NAMS) observe in the BROADWAY analysis?

In a prespecified BROADWAY analysis of 1,535 patients, NewAmsterdam observed statistically significant lower absolute changes in p-tau217 versus placebo over 12 months in both the full analysis set (p=0.002) and in ApoE4 carriers (p=0.02), with favorable trends in other Alzheimer’s biomarkers.
0001936258false00-00000000001936258us-gaap:CommonStockMember2026-08-052026-08-050001936258us-gaap:WarrantMember2026-08-052026-08-0500019362582026-08-052026-08-05

 

 

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): August 5, 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 August 5, 2026, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing corporate updates and its financial results for the quarter ended June 30, 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 August 5, 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:

August 5, 2026

By:

/s/ Ian Somaiya

 

 

Name:

Ian Somaiya

 

 

Title:

Chief Financial Officer

 

 


NewAmsterdam Pharma Provides Corporate Update and Reports Second Quarter Financial Results

 

– Announced positive CHMP opinion recommending marketing authorization for obicetrapib and obicetrapib/ezetimibe –

 

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

 

– Topline data from RUBENS Phase 3 expected by year-end 2026 –

 

– $678.3 million in cash, cash equivalents and marketable securities at June 30, 2026 –

 

– Company to host investor day today at 9:00 AM ET in New York City –

 

 

Naarden, the Netherlands and Miami, USA; August 5, 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 June 30, 2026 and provided a corporate update.

 

“During the second quarter, we continued to build momentum across our regulatory, clinical, and scientific priorities,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “Our quarterly update is headlined by the positive opinion for Europe from CHMP, recommending the granting of a marketing authorization for Ubeslo and Evlarco, intended for the treatment of primary hypercholesterolemia or mixed dyslipidemia. Additionally, supportive analyses presented at NLA and AAIC continue to expand the growing body of evidence supporting the potential of obicetrapib across multiple diseases. As we continue to advance our late-stage development program and prepare for several important regulatory and clinical milestones in the months ahead, we remain focused on disciplined execution and look forward to sharing additional updates on our strategy, pipeline, and priorities during today’s Investor Day.”

 

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 July 2026, NewAmsterdam announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (“EMA”) has adopted a positive opinion recommending marketing authorization for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (“FDC”) for patients with primary hypercholesterolemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia. A final decision from the European Commission is expected later this year.

 

In July 2026, NewAmsterdam presented four analyses from its Phase 3 BROADWAY program at the Alzheimer's Association International Conference (AAIC) 2026, further characterizing the potential role of CETP inhibition in the prevention of early Alzheimer’s disease. Highlights include:

 

Prespecified analyses from the Phase 3 BROADWAY trial demonstrated statistically significant reductions in plasma p-tau217 versus placebo.
Additional analyses provided further insights into Alzheimer’s disease biology and potential approaches to optimize future clinical development.

 

In June 2026, NewAmsterdam presented four analyses at the National Lipid Association (“NLA”) Scientific Sessions further characterizing obicetrapib’s differentiated profile across atherosclerotic cardiovascular disease (“ASCVD”) and heterozygous familial hypercholesterolemia (“HeFH”). The analyses included pooled Phase 3 BROADWAY and BROOKLYN data, real-world evidence from a large U.S. claims database and a cross-class review of contemporary cholesterol-lowering development programs. Highlights included:

 


Two real-world analyses using the Komodo Claims and Research Dataset highlighted persistent gaps in LDL-C goal attainment, treatment adherence, and tolerability among high-risk patients receiving high-intensity statins, reinforcing the need for additional well-tolerated LDL-C lowering therapies.
A pooled mediation analysis of the Phase 3 BROADWAY and BROOKLYN trials found that obicetrapib was observed to reduce major adverse cardiovascular events (“MACE”) by 23%, with reductions in LDL-C and lipoprotein(a) jointly mediating 84.5% of this observed benefits. This analysis further found that the observed MACE benefit was primarily attributable to LDL-C lowering, with Lp(a) as an important additional mediator.
A cross-class review of contemporary cholesterol-lowering development programs suggest suggested non-CVOT MACE assessments may provide meaningful insight into subsequent cardiovascular outcomes.

 

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.

 

Investor Day

 

NewAmsterdam will host an Investor Day event for analysts and investors, today, August 5, 2026, beginning at 9:00 a.m. ET in New York City.

 

A live webcast of the R&D event will be available and those who intend to join virtually can pre-register for the webcast through the link here. The live webcast and supporting presentation materials will be available on the Events section of the Investor Relations page of the NewAmsterdam website at ir.newamsterdampharma.com at the time of the live event. An archived replay will be available on the NewAmsterdam website. Please note advanced registration is required for in-person attendance.

First Quarter Financial Results

 

 

Cash Position: As of June 30, 2026, NewAmsterdam recorded cash, cash equivalents and marketable securities of $678.3 million, compared to $728.9 million as of December 31, 2025. 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 $3.7 million in revenue for the quarter ended June 30, 2026, compared to $19.1 million in the same period in 2025. Revenue for the three months ended June 30, 2025 was primarily attributable to the recognition of $16.1 million of revenue related to the second installment of development cost contributions under the license agreement with Menarini. Revenue for the three months ended June 30, 2026 was related to Company's supply agreement with Menarini.

 

Research and Development (“R&D”) Expenses: R&D expenses were $41.7 million in the quarter ended June 30, 2026, compared to $27.5 million for the same period in 2025. This increase was primarily due to increases in clinical expenses driven by the initiation of clinical trials and increased costs associated with the progression of ongoing trials, and an increase in personnel expenses. Share-based payment expenses included within R&D expenses totaled $5.9 million in the quarter ended June 30, 2026, compared to $5.1 million in the same period in 2025.

 

Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses were $26.9 million in the quarter ended June 30, 2026, compared to $27.3 million for the same period in 2025. This decrease was primarily due to decreases in marketing and communication and intellectual property expenses, partially offset by an increase in personnel expenses. Share-based payment expenses included within SG&A expenses totaled $12.5 million in the quarter ended June 30, 2026, compared to $10.1 million in the same period in 2025.

 

Net loss: Net loss for the quarter ended June 30, 2026, was $64.1 million, compared to net loss of $17.4 million for the same period in 2025. The individual components of the change are described above in addition to interest income, a non-cash loss related to changes in the fair value of our derivative warrant liabilities and foreign exchange 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, 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 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 therapy that lowers LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. 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: the Company’s intention to conduct the PREVAIL interim analysis and its expectations regarding the timing of the interim analysis and when the result of the interim analysis may be announced; expectations regarding the timing of potential approval decisions from the European Commission for obicetrapib and the FDC of obicetrapib plus ezetimibe; the Company’s 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; 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; 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 Quarterly Report on Form 10-Q filed with the SEC on August 5, 2026, 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)

 

June 30,
2026

 

 

December 31,
2025

 

(In thousands of USD)

 

 

 

 

 

Assets

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

424,151

 

 

 

490,002

 

Prepayments and other receivables

 

23,996

 

 

 

38,138

 

Marketable securities, current

 

209,703

 

 

 

146,239

 

Restricted cash

 

1,357

 

 

 

1,321

 

Total current assets

 

659,207

 

 

 

675,700

 

Marketable securities, net of current portion

 

44,409

 

 

 

92,609

 

Property, plant and equipment, net

 

411

 

 

 

383

 

Operating right of use asset

 

82

 

 

 

185

 

Intangible assets

 

343

 

 

 

407

 

Total assets

 

704,452

 

 

 

769,284

 

Liabilities and Shareholders' Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

5,422

 

 

 

8,970

 

Accrued expenses and other current liabilities

 

10,277

 

 

 

15,422

 

Deferred revenue, current

 

2,797

 

 

 

3,987

 

Lease liability, current

 

26

 

 

 

136

 

Derivative warrant liabilities

 

54,452

 

 

 

57,272

 

Total current liabilities

 

72,974

 

 

 

85,787

 

Lease liability, net of current portion

 

56

 

 

 

66

 

Total liabilities

 

73,030

 

 

 

85,853

 

Commitments and contingencies (Note 12)

 

 

 

 

 

Shareholders' Equity:

 

 

 

 

 

Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 117,651,697 and 114,399,326 shares issued and outstanding as at June 30, 2026 and December 31, 2025, respectively

 

14,735

 

 

 

14,278

 

Additional paid-in capital

 

1,487,792

 

 

 

1,426,750

 

Accumulated loss

 

(874,966

)

 

 

(762,390

)

Accumulated other comprehensive income

 

3,861

 

 

 

4,793

 

Total shareholders' equity

 

631,422

 

 

 

683,431

 

Total liabilities and shareholders' equity

 

704,452

 

 

 

769,284

 

 

 


 

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

For the three months ended June 30,

 

 

For the six months ended June 30,

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

(In thousands of USD, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

3,701

 

 

 

19,145

 

 

 

6,741

 

 

 

22,123

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

41,673

 

 

 

27,516

 

 

 

79,682

 

 

 

72,267

 

Selling, general and administrative expenses

 

26,892

 

 

 

27,264

 

 

 

50,343

 

 

 

54,416

 

Total operating expenses

 

68,565

 

 

 

54,780

 

 

 

130,025

 

 

 

126,683

 

Operating loss

 

(64,864

)

 

 

(35,635

)

 

 

(123,284

)

 

 

(104,560

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

5,810

 

 

 

7,055

 

 

 

11,460

 

 

 

14,406

 

Fair value change – earnout

 

 

 

 

 

 

 

 

 

 

3,992

 

Fair value change – warrants

 

(4,555

)

 

 

2,590

 

 

 

1,387

 

 

 

16,352

 

Foreign exchange gains/(losses)

 

(526

)

 

 

8,626

 

 

 

(2,139

)

 

 

12,919

 

Loss before tax

 

(64,135

)

 

 

(17,364

)

 

 

(112,576

)

 

 

(56,891

)

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

(64,135

)

 

 

(17,364

)

 

 

(112,576

)

 

 

(56,891

)

Other comprehensive income/(loss)

 

 

 

 

 

 

 

 

 

 

 

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

 

(360

)

 

 

(107

)

 

 

(932

)

 

 

(140

)

Total comprehensive loss for the period, net of tax

 

(64,495

)

 

 

(17,471

)

 

 

(113,508

)

 

 

(57,031

)

 

 


 

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

 

Exercise of warrants

 

100

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

2

 

Exercise of stock options

 

340,317

 

 

 

46

 

 

 

3,378

 

 

 

 

 

 

 

 

 

3,424

 

Vesting of RSUs

 

206

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

15,179

 

 

 

 

 

 

 

 

 

15,179

 

Total loss and comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

(17,364

)

 

 

(107

)

 

 

(17,471

)

As at June 30, 2025

 

112,509,914

 

 

 

14,014

 

 

 

1,375,618

 

 

 

(615,462

)

 

 

4,327

 

 

 

778,497

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

Exercise of warrants

 

12,752

 

 

 

2

 

 

 

476

 

 

 

 

 

 

 

 

 

478

 

Exercise of stock options

 

971,668

 

 

 

135

 

 

 

11,701

 

 

 

 

 

 

 

 

 

11,836

 

Vesting of RSUs

 

25,621

 

 

 

4

 

 

 

(4

)

 

 

 

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

18,381

 

 

 

 

 

 

 

 

 

18,381

 

Total loss and comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

(64,135

)

 

 

(360

)

 

 

(64,495

)

As at June 30, 2026

 

117,651,697

 

 

 

14,735

 

 

 

1,487,792

 

 

 

(874,966

)

 

 

3,861

 

 

 

631,422

 

 

 


 

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

For the six months ended June 30,

 

 

2026

 

 

2025

 

(In thousands of USD)

 

 

 

 

 

Operating activities:

 

 

 

 

 

Loss for the period

 

(112,576

)

 

 

(56,891

)

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

 

 

 

 

 

Depreciation and amortization

 

121

 

 

 

97

 

Non-cash rent expense

 

(13

)

 

 

3

 

Fair value change - derivative earnout and warrants

 

(1,387

)

 

 

(20,344

)

Loss on disposal of property, plant and equipment

 

18

 

 

 

 

Foreign exchange (gains)/losses

 

2,139

 

 

 

(12,919

)

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

 

(42

)

 

 

(985

)

Share-based compensation

 

36,383

 

 

 

30,392

 

Changes in working capital:

 

 

 

 

 

Changes in prepayments and other receivables

 

15,354

 

 

 

(5,830

)

Changes in accounts payable

 

(3,480

)

 

 

1,860

 

Changes in accrued expenses and other current liabilities

 

(5,145

)

 

 

(3,514

)

Changes in deferred revenue

 

(1,190

)

 

 

(6,008

)

Net cash used in operating activities

 

(69,818

)

 

 

(74,139

)

Investing activities:

 

 

 

 

 

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

 

(118

)

 

 

(104

)

Maturities of marketable securities

 

97,500

 

 

 

37,163

 

Purchases of marketable securities

 

(113,653

)

 

 

(193,340

)

Net cash used in investing activities

 

(16,271

)

 

 

(156,281

)

Financing activities:

 

 

 

 

 

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

 

 

 

 

(1,586

)

Proceeds from exercise of warrants

 

798

 

 

 

184

 

Proceeds from exercise of options

 

21,308

 

 

 

11,346

 

Net cash provided by financing activities

 

22,106

 

 

 

9,944

 

Net change in cash, cash equivalents and restricted cash

 

(63,983

)

 

 

(220,476

)

Foreign exchange differences

 

(1,832

)

 

 

12,597

 

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

 

425,508

 

 

 

563,864

 

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

 

424,151

 

 

 

563,864

 

Restricted cash

 

1,357

 

 

 

 

 

 

425,508

 

 

 

563,864

 

 

 


Filing Exhibits & Attachments

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