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Item 2 — Management's Discussion and Analysis
Newamsterdam Pharma Company N.v. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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The unaudited condensed consolidated financial statements, included elsewhere in this Quarterly Report, and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read together with our audited financial statements and accompanying notes for the year ended December 31, 2025, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K (the “Annual Report”), filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 18, 2026. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those contained in or implied by any forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the sections titled “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in the Annual Report and this Quarterly Report. Our operating results are not necessarily indicative of results that may occur for the full fiscal year or any other future period.
Overview
We are a late-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic 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 low-density lipoprotein cholesterol (“LDL-C”) lowering therapy. In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination ("FDC") with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease (“CVD”) with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. We believe that CETP inhibition may also play a role in other indications by potentially mitigating the risk of developing diseases such as Alzheimer’s disease (“AD”).
Obicetrapib is a next-generation, oral, low-dose, highly selective CETP inhibitor that we are developing to potentially overcome the limitations of current LDL-C lowering treatments. We believe that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In each of our Phase 3 clinical trials, BROADWAY and BROOKLYN, evaluating obicetrapib as an adjunct to high-intensity statin therapy, obicetrapib met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In our Phase 3 TANDEM clinical trial, evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, obicetrapib in combination with ezetimibe met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. Following the successful completion and positive topline results of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, we plan to announce additional clinical data from these trials relating to obicetrapib and the FDC of obicetrapib plus ezetimibe during 2026. In five of our Phase 2 clinical trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b clinical trial, evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C lowering. In each of these trials, side effects were similar in frequency and severity to placebo including muscle-related side effects and drug-related treatment emergent serious adverse events. We have observed obicetrapib to be well tolerated in an aggregate of over 3,500 patients with low or moderately elevated LDL-C levels (“dyslipidemia”) in our clinical trials to date. Furthermore, we believe that obicetrapib’s oral delivery, demonstrated activity at low doses, chemical properties and tolerability make it well-suited for combination approaches.
Lowering of LDL-C has been associated with major adverse cardiovascular events (“MACE”) benefit in trials of LDL-C lowering drugs, including the REVEAL trial with the CETP inhibitor anacetrapib. In our Phase 3 BROADWAY clinical trial, we observed a 21% reduction in the exploratory MACE endpoint (coronary heart disease death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization) and we are performing a Phase 3 cardiovascular outcomes trial (“CVOT”), PREVAIL, to reconfirm this relationship.
Obicetrapib has shown to not only reduce LDL-C but also several additional biomarkers associated with MACE. To date, obicetrapib has shown reductions in non-HDL-C, apolipoprotein B, and small dense lipoprotein particles. In our clinical trials, we have also observed reductions in Lp(a), which is believed to be an independent MACE risk factor, along with reductions in total lipoprotein (“LDL”) particles and more specifically small LDL particles, which are believed to be more atherogenic particles.
CVD is a leading cause of death worldwide. Atherosclerotic cardiovascular disease (“ASCVD”) is primarily caused by atherosclerosis, which involves the build-up of fatty material within the inner walls of the arteries. Atherosclerosis is the primary cause of heart attacks, strokes and peripheral vascular disease. One of the most
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important risk factors for ASCVD is hypercholesterolemia, which refers to elevated LDL-C levels within the body, commonly known as high cholesterol.
A significant proportion of patients with high cholesterol do not achieve acceptable LDL-C levels using statin therapy alone. We estimate that in the United States there are approximately 30 million patients that are not at their risk-based LDL-C goals despite treatment with lipid lowering therapy, including approximately 13 million with ASCVD. Existing non-statin treatment options have been largely unable to address the needs of patients with high cholesterol due to limited efficacy, an inconvenient injectable administration route and, in the past, market access restrictions. It is estimated that over 75% of ASCVD and heterozygous familial hypercholesterolemia (“HeFH”) outpatients prefer oral drugs to injectable therapies.
Our goal is to develop and commercialize an LDL-C lowering monotherapy and an FDC therapy, which offers the advantage of a single, low dose, once-daily oral pill, and fulfills the significant unmet need for an effective and convenient LDL-C lowering therapy. If we obtain marketing approval, we intend to commercialize obicetrapib for patients with ASCVD and/or HeFH and elevated levels of LDL-C despite being treated with currently available optimal lipid lowering therapy. Our goal is to submit a New Drug Application (“NDA”) in the U.S. for the FDC shortly after submitting an NDA for obicetrapib as a monotherapy. We expect that efficacy and safety data from BROADWAY and BROOKLYN will be described in the FDC product label, if approved.
We have partnered with A. Menarini International Licensing S.A. (“Menarini”), providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a FDC with ezetimibe (the “Licensed Products”), in the majority of European countries (the Menarini Territory), if approved. In August 2025, the European Medicines Agency (the “EMA”) accepted for review the Marketing Authorization Applications (“MAAs”) submitted by Menarini for obicetrapib 10 mg monotherapy and the FDC of 10 mg obicetrapib plus 10 mg ezetimibe for the treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. Subsequently, MAAs were also submitted to regulators in the United Kingdom (“UK”) and Switzerland and accepted for review. The submissions are supported by data from the BROADWAY, BROOKLYN, and TANDEM pivotal Phase 3 trials. In July 2026, we announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the 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. We anticipate that Menarini will receive decisions on the MAAs from each of the regulators later this year. If the MAAs are approved by the regulators, Menarini will be required to use commercially reasonable efforts to commercialize obicetrapib in the Menarini Territory and could potentially launch these products in the fourth quarter of 2026 in Germany and the UK.
Our current plan is to pursue development and, subject to the receipt of marketing approval, commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and Europe, including in Japan and China. In addition to our partnership with Menarini, we may in the future utilize a variety of types of collaboration, license, monetization, distribution and other arrangements with other third parties relating to the development or commercialization, once approved, of obicetrapib or future product candidates or indications. We are also regularly evaluating the potential acquisition or license of new product candidates.
We conducted two Phase 3 pivotal clinical trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to potentially enhance LDL-C lowering in patients with ASCVD and/or HeFH. In March 2022, we commenced our Phase 3 PREVAIL CVOT, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE, including cardiovascular death, non-fatal myocardial infarction, total stroke and total coronary revascularization, in at least 9,000 patients. We completed enrollment in PREVAIL in April 2024. We expect the minimum 2.5 year follow-up period for the last participant in PREVAIL to be satisfied at the end of the 2026, but the PREVAIL trial protocol requires PREVAIL to continue until the target number of MACE events have occurred. Based on our review of preliminary blinded PREVAIL data following the second anniversary of the completion of enrollment, including a Year 1 event rate consistent with that we observed in BROADWAY and a Year 1-to-Year 2 overall MACE event rate lower than expected, we have decided to conduct an interim analysis of PREVAIL data in the fourth quarter of 2026 coinciding with reaching the minimum 2.5-year follow-up period for the trial. The blinded PREVAIL data available to us is preliminary and subject to change as additional MACE events continue to be identified and adjudicated (including
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with respect to the Year 1-to-Year 2 period discussed above). Additionally, the Year 1 and Year 1-to-Year 2 MACE event trends observed to date may not be indicative of future trends.
The interim analysis will be conducted by the Independent Data Safety Monitoring Board (“DSMB”) for the trial, and will remain blinded to us. Based on the analysis, we will receive a recommendation from the DSMB based on certain pre-specified criteria that we have set to end the trial early for efficacy or futility, as well as other considerations for which the DSMB has discretion, or if such criteria are not achieved, to continue the trial until the target number of MACE events has occurred. Only the DSMB will have access to unblinded data in connection with the interim analysis. We expect to receive the DSMB’s recommendation based on the interim analysis in the first quarter of 2027. If the interim analysis results in the trial being stopped early for efficacy or futility, then we will initiate activities to wind-down the study over the next few months including, among other things, final patient study visits and data collection procedures, to enable database lock and unblinding of the study. If the interim analysis results in the trial continuing, we expect to complete PREVAIL by the end of 2027.
In March 2026, we completed enrollment of 323 patients in REMBRANDT, a 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. We are also conducting the RUBENS Phase 3 trial. Initiated in December 2025, this 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.
In addition to our cardiometabolic program, we are exploring the potential application of CETP inhibition in other indications, including AD and diabetes. Based on the lipid-modifying effects of CETP inhibition observed in our clinical trials for obicetrapib to date, we have conducted preclinical and early clinical evaluations of obicetrapib in AD. We initiated a Phase 2a clinical trial in patients with early AD to evaluate the pharmacodynamic and pharmacokinetic effects, safety and tolerability of obicetrapib, and announced initial data from this trial in September 2023. In July 2025, we announced data from the prespecified AD biomarker analysis in our BROADWAY clinical trial. Based on these results, we expect to initiate a new clinical trial evaluating obicetrapib in patients with early AD in 2026. Clinically demonstrated anti-diabetic benefits have also been observed with CETP inhibition in Phase 3 CVOTs that, if seen in obicetrapib, would differentiate it from current treatment alternatives, especially statin therapy. We are planning preclinical studies to examine the potential of obicetrapib for patients suffering from diabetes and have included new onset of Type 2 diabetes as an endpoint in our PREVAIL CVOT, as measured by adverse events (“AEs”) indicating Type 2 diabetes, initiation of anti-diabetes medication after confirmed diabetes diagnosis or high levels of hemoglobin A1c and fasting plasma glucose. In the Phase 3 BROADWAY trial, we observed a statistically significant improvement in these prespecified AEs of special interest after one year of treatment that we hope to reconfirm in the PREVAIL CVOT trial.
Components of our Results of Operations
Revenue
To date, we have not generated significant revenue from the sale of pharmaceutical products. Our revenue has been primarily derived from our license agreement with Menarini (the “Menarini License”). Two performance obligations for the Menarini License were identified at contract inception, comprising a license to use our intellectual property (the “license performance obligation”) and a promise to continue the development activities for the licensed compound (the “R&D performance obligation”). Pursuant to the Menarini License, we received a non-refundable, non-creditable upfront amount of $120.9 million (€115.0 million) from Menarini on July 7, 2022, of which $98.6 million (€93.5 million) was attributed to the license performance obligation and recognized as revenue upon the execution of the Menarini License on June 23, 2022. The remaining $22.3 million (€21.5 million) was attributed to the R&D performance obligation and initially recognized as deferred revenue. During the year ending December 31, 2025 the R&D performance obligation was satisfied and all deferred revenue related to such performance obligation was recognized.
Additionally, in partial contribution to our costs of development of the Licensed Products, Menarini paid us €27.5 million, in two equal annual installments. Due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials, which is out of our control, the fixed €27.5 million was
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considered constrained at contract execution and was not initially recognized within the transaction price until it became highly probable of no significant revenue reversal. Both annual development cost contributions have since been recognized within the transaction price.
Under the Menarini License, we are also entitled to receive certain cost sharing payments, sales-based royalties and payments based upon the achievement of defined development, regulatory and commercial milestones linked to the enhanced value of the license performance obligation. These milestones are contingent payments and represent variable considerations that are not initially recognized within the transaction price, due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials. Our ability to receive and generate revenue from these payments is dependent upon a number of factors, including our ability to successfully complete the development of and obtain regulatory approval for obicetrapib within the Menarini Territory. The uncertainty of achieving these milestones significantly impacts our ability to generate revenue. At the end of each reporting period, we assess the probability of significant reversals for any amounts that become likely to be realized prior to recognizing the variable consideration associated with these payments within the transaction price.
In addition, we entered into a supply agreement with Menarini (the “Menarini Supply Agreement”) to provide commercial supply of obicetrapib monotherapy and obicetrapib and ezetimibe fixed-dose combination finished products in bulk tablet form (the “Drug Products”) for distribution by Menarini in specified European territories.
We recognize revenue from the sale of Drug Products, and from the sale of active pharmaceutical ingredients to Menarini for the manufacturer of such tablets. Our product supply revenue is recognized at a point in time when the performance obligation is satisfied by transferring control of the promised goods or services to the customer and it is probable that we will collect the consideration to which we are entitled. In accordance with the terms of the Menarini Supply Agreement, control of the product is transferred upon the conveyance of title, which occurs when the product is made available to Menarini. The transaction price is contractually fixed at a markup of the actual cost of goods sold. Due to the cost-based nature of the agreement, the pricing structure includes a variable component which is measured using the expected value method. At each reporting period end, we update our estimate of the transaction price using actual cost data and forecasted expenses. We state revenues net of any taxes collected from customers that are required to be remitted to various government agencies.
Any revenue generated from potential future collaborations or product sales may vary due to the many uncertainties in the development of obicetrapib and other factors.
Research and Development Expenses
Research and development expenses are recognized as an expense when incurred and are typically made up of costs from our clinical and preclinical activities, drug development and manufacturing costs, and costs for contract research organizations (“CROs”) and investigative sites. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data provided by vendors of their actual costs incurred. At each balance sheet date, we estimate the level of services provided by vendors and the associated expenditure incurred for the services performed.
All such costs are for the purpose of advancing our product candidates to successfully complete clinical development, attain regulatory approval and, if approved, commercialize our product candidates. Much of our current focus in our ongoing trials is on patient recruitment and retention and data cleaning. Research and development expenses consist of the following:
•clinical expenses primarily incurred by CROs assisting with our sponsored clinical trials and including clinical investigator costs, patient enrollments and costs of clinical sites;
•manufacturing expenses arising from investments in commercial manufacturing capabilities and active pharmaceutical ingredient and drug product development as performed by our contract manufacturing organizations (“CMOs”);
•costs associated with obtaining potential regulatory approval of our product candidates, including preparation and submission of filings, ongoing monitoring and compliance with comments and recommendations provided by regulatory authorities, and regulatory-related advisory fees;
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•contracted personnel and employment costs attributed to research and development efforts, which includes management fees, salaries, share-based compensation expenses, bonus plans and payments to contractors who work for us for a fixed number of hours per week or per month;
•preclinical and nonclinical research and development expenses of our product candidates; and
•other clinical costs such as clinical trial insurance and other consultancy fees.
We expect our research and development expenses to be significant as we advance our product candidates through clinical trials and pursue regulatory approval. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming. Clinical trials generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical trial expenses. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. See the section titled “Risk Factors—Risks Related to Our Product Development, Regulatory Approval and Commercialization” contained in the Annual Report and Part II, Item 1A Risk Factors of this Quarterly Report on Form 10-Q for more information regarding the risks associated with clinical development.
Selling, General and Administrative Expenses
We recognize selling, general and administrative expenses on the accrual basis when incurred. These expenses mainly relate to consultant fees, employee costs, legal costs, marketing and communication, intellectual property costs and general overhead costs.
Due to the general growth of the organization associated with administering ongoing and planned clinical trials and our focus on commercial preparedness, we expect that our selling, general and administrative expenses will increase. We may incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses associated with being a public company. Additionally, if and when a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and expenses as a result of our preparation for commercial operations.
Interest Income
Interest income is recognized using the effective interest rate method. Interest income for the three and six months ended June 30, 2026 and 2025 is related to interest earned on cash, cash equivalents, restricted cash and marketable securities.
Net Foreign Exchange Gain/Loss
Our exchange gain/loss relates mainly to cash balances denominated in foreign currencies, but also to transactions denominated in foreign currencies. Our foreign currency exposure is mainly related to the Euro. As of June 30, 2026, our net exposure to foreign currency risk was $72.6 million, as compared to $95.6 million as of December 31, 2025.
Income Tax
We have a history of losses and therefore have incurred de minimis amounts of corporate tax. We expect to continue incurring losses as we continue to invest in our clinical and preclinical development programs. Consequently, any deferred tax assets are fully offset by a valuation allowance on our balance sheet.
Results of Operations
Comparison of the three months ended June 30, 2026 and 2025
The following table summarizes our consolidated statements of operations for the periods indicated:
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For the three months ended June 30,
(In thousands of USD) 2026 2025 Change
Revenue 3,701 19,145 (15,444 )
Operating Expenses:
Research and development expenses 41,673 27,516 14,157
Selling, general and administrative expenses 26,892 27,264 (372 )
Total operating expenses 68,565 54,780 13,785
Operating Loss (64,864 ) (35,635 ) (29,229 )
Other income (expense):
Interest Income 5,810 7,055 (1,245 )
Fair value change - warrants (4,555 ) 2,590 (7,145 )
Foreign exchange gains/(losses) (526 ) 8,626 (9,152 )
Loss before tax (64,135 ) (17,364 ) (46,771 )
Income tax expense — — —
Loss for the period (64,135 ) (17,364 ) (46,771 )
Explanatory Note to Aid Comparison
In prior periods, including the three months ended June 30, 2025, costs related to medical affairs activities and personnel were classified within selling, general and administrative expenses. Due to changes in the nature of activities performed by our medical affairs function, certain such costs, including personnel costs, are classified in accordance with U.S. GAAP as research and development expenses in the three and six months ended June 30, 2026. Costs associated with our medical affairs function totaled $4.6 million in the three months ended June 30, 2025, of which $3.1 million were personnel costs, compared to total costs of $4.3 million in the three months ended June 30, 2026, of which $2.9 million were personnel costs.
Revenue
Revenue was $3.7 million for the three months ended June 30, 2026 compared to $19.1 million for the three months ended June 30, 2025, a decrease of $15.4 million, or 81%. This decrease is largely due to the recognition of $16.1 million of revenue in the comparative period related to the second installment of development cost contributions under the Menarini License, which did not recur in the current period.
Research and Development Expenses
Research and development expenses were $41.7 million for the three months ended June 30, 2026 compared to $27.5 million for the three months ended June 30, 2025, an increase of $14.2 million, or 52%. This was primarily driven by:
•an $11.1 million increase in clinical expenses mainly due to the initiation of clinical trials and increased costs associated with the progression of ongoing trials, as well as credits received upon the close-out of trials in the comparative period that did not recur in the current period;
•a $3.3 million increase in personnel expenses related to research and development activities, including the impact of including medical affairs related personnel costs in the current period, as discussed above. The remainder of the change is primarily driven by increased recruitment and employment costs for individuals involved within the research and development activities to support the growth of the organization, together with an offsetting $2.5 million decrease related to a payroll tax relief grant received in the Netherlands; and
•a $0.7 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;
partially offset by:
•a $1.5 million decrease in manufacturing expenses primarily attributable to commercial manufacturing capability investments made in the comparative period, which did not recur in the current period.
The following table summarizes our research and development expenses for the periods indicated:
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For the three months ended June 30,
(In thousands of USD) 2026 2025 Change
Clinical expenses 24,047 12,969 11,078
Non-clinical expenses 2,300 1,580 720
Personnel expenses 10,910 7,625 3,285
Manufacturing costs 2,776 4,289 (1,513 )
Regulatory expenses 1,294 1,025 269
Other research and development costs 346 28 318
Total research and development expenses 41,673 27,516 14,157
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $26.9 million for the three months ended June 30, 2026 compared to $27.3 million for the three months ended June 30, 2025, a decrease of $0.4 million or 1%. This was primarily driven by:
•a $3.0 million decrease in marketing and communication expenses. The decrease is primarily driven by the change in the nature of medical affairs related costs, as described above; and
•a $0.5 million decrease in intellectual property expenses primarily driven by costs related to worldwide patent filings incurred in the comparative period, which did not recur in the current period;
partially offset by:
•a $2.7 million increase in share-based compensation costs and increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company. These increases are partially offset by the reclassification of medical affairs costs, as discussed above.
Interest Income
Interest income was $5.8 million for the three months ended June 30, 2026 compared to $7.1 million for the three months ended June 30, 2025, a decrease of $1.3 million or 18%. This decrease was largely driven by a decrease in the amount of cash, cash equivalents and marketable debt securities on which interest was earned.
Fair Value Change - Warrants
Fair value change - warrants was a loss of $4.6 million for the three months ended June 30, 2026 compared to a gain of $2.6 million for the three months ended June 30, 2025. Prior to 2026, the fair value of the Warrants was determined using the last reported trading price of the Public Warrants, which trade under the symbol “NAMSW.” Beginning in 2026, due to a decrease in the trading volume of the Public Warrants, the fair value of the Warrants is determined by utilizing the Black-Scholes option pricing model. The primary driver of the change in fair value of the Warrants derived by such pricing method is the change in the trading price of the Company's Ordinary Shares, which trade under the symbol “NAMS.”
Foreign Exchange Gains/(Losses)
Net foreign exchange gains/(losses) were a loss of $0.5 million for the three months ended June 30, 2026 compared to a gain of $8.6 million for the three months ended June 30, 2025. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.
Loss for the Period
Loss for the period was $64.1 million for the three months ended June 30, 2026 compared to $17.4 million for the three months ended June 30, 2025, an increase of $46.7 million. The individual components of the change are described above.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our consolidated statements of operations for the periods indicated:
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For the six months ended June 30,
(In thousands of USD) 2026 2025 Change
Revenue 6,741 22,123 (15,382 )
Operating Expenses:
Research and development expenses 79,682 72,267 7,415
Selling, general and administrative expenses 50,343 54,416 (4,073 )
Total operating expenses 130,025 126,683 3,342
Operating Loss (123,284 ) (104,560 ) (18,724 )
Other income (expense):
Interest Income 11,460 14,406 (2,946 )
Fair value change - earnout — 3,992 (3,992 )
Fair value change - warrants 1,387 16,352 (14,965 )
Foreign exchange gains/(losses) (2,139 ) 12,919 (15,058 )
Loss before tax (112,576 ) (56,891 ) (55,685 )
Income tax expense — — —
Loss for the period (112,576 ) (56,891 ) (55,685 )
Explanatory Note to Aid Comparison
In prior periods, including the six months ended June 30, 2025, costs related to medical affairs activities and personnel were classified within selling, general and administrative expenses. Due to changes in the nature of activities performed by our medical affairs function, certain such costs, including personnel costs, are classified in accordance with U.S. GAAP as research and development expenses in the six months ended June 30, 2026. Costs associated with our medical affairs function totaled $9.7 million in the six months ended June 30, 2025, of which $6.1 million were personnel costs, compared to total costs of $8.8 million in the six months ended June 30, 2026, of which $6.1 million were personnel costs.
Revenue
Revenue was $6.7 million for the six months ended June 30, 2026 compared to $22.1 million for the six months ended June 30, 2025, a decrease of $15.4 million, or 70%. This decrease was largely due to the recognition of $16.1 million of revenue related to the second installment of development cost contributions under the Menarini License in the comparative period.
Research and Development Expenses
Research and development expenses were $79.7 million for the six months ended June 30, 2026 compared to $72.3 million for the six months ended June 30, 2025, an increase of $7.4 million, or 10%. This was primarily driven by a:
•a $2.7 million increase in clinical expenses mainly due to the initiation of clinical trials and increased costs associated with the progression of ongoing trials, partially offset by the completion of Phase 3 clinical trials in the first half of 2025; and
•a $6.0 million increase in personnel expenses related to research and development activities, including the impact of including medical affairs related personnel costs in the current period, as discussed above. The remainder of the change is primarily driven by increased recruitment and employment costs for individuals involved within the research and development activities to support the growth of the organization, together with an offsetting $5.7 million decrease related to a payroll tax relief grant received in the Netherlands;
partially offset by:
•a $2.1 million decrease in non-clinical expenses due to reduced activity in the first quarter related to pipeline expansion and product lifecycle management.
The following table summarizes our research and development expenses for the periods indicated:
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For the six months ended June 30,
(In thousands of USD) 2026 2025 Change
Clinical expenses 39,727 36,979 2,748
Non-clinical expenses 4,723 6,863 (2,140 )
Personnel expenses 22,219 16,191 6,028
Manufacturing costs 10,348 10,130 218
Regulatory expenses 1,995 2,042 (47 )
Other research and development costs 670 62 608
Total research and development expenses 79,682 72,267 7,415
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $50.3 million for the six months ended June 30, 2026 compared to $54.4 million for the six months ended June 30, 2025, a decrease of $4.1 million or 8%. This was primarily driven by:
•a $6.7 million decrease in marketing and communication expenses. The decrease is primarily driven by the change in the nature of medical affairs related costs, as described above, together with a $1.4 million reduction driven by lower market research spending;
•a $1.2 million decrease in costs related to our intellectual property primarily driven by worldwide patent filings incurred in the comparative period, which did not recur in the current period; and
•a $0.9 million decrease in legal expenses primarily due to the transition of legal advisory services in-house;
partially offset by:
•a $4.3 million increase in share-based compensation costs and increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company. These increases are partially offset by the reclassification of medical affairs costs, as discussed above.
Interest Income
Interest income was $11.5 million for the six months ended June 30, 2026 compared to $14.4 million for the six months ended June 30, 2025, a decrease of $2.9 million or 20%. This decrease was largely driven by a decrease in the amount of cash, cash equivalents and marketable debt securities on which interest was earned.
Fair Value Change - Earnout
Fair value change - earnout was a nil for the six months ended June 30, 2026 compared to a gain of $4.0 million for the six months ended June 30, 2025. The earnout liability was settled in full in March 2025.
Fair Value Change - Warrants
Fair value change - warrants was a gain of $1.4 million for the six months ended June 30, 2026 compared to a gain of $16.4 million for the six months ended June 30, 2025. Prior to 2026, the fair value of the Warrants was determined using the last reported trading price of the Public Warrants, which trade under the symbol “NAMSW.” Beginning in 2026, due to a decrease in the trading volume of the Public Warrants, the fair value of the Warrants is determined by utilizing the Black-Scholes option pricing model. The primary driver of the change in fair value of the Warrants derived by such pricing method is the change in the trading price of the Company's Ordinary Shares, which trade under the symbol “NAMS.”
Foreign Exchange Gains/(Losses)
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Net foreign exchange gains/(losses) were a loss of $2.1 million for the six months ended June 30, 2026 compared to a gain of $12.9 million for the three months ended June 30, 2025. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.
Loss for the Period
Loss for the period was $112.6 million for the six months ended June 30, 2026 compared to $56.9 million for the six months ended June 30, 2025, an increase of $55.7 million. The individual components of the change are described above.
Liquidity and Capital Resources
Overview
To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of obicetrapib. As a result, we are not yet profitable and have incurred losses in each annual period since our inception. As of June 30, 2026, we had an accumulated loss of $875.0 million. We expect to continue to incur significant losses for the foreseeable future.
We have historically funded our operations primarily through private and public placements of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the closing of the transactions contemplated by the Business Combination Agreement. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $678.3 million.
Sources of Liquidity
Menarini License and Menarini Supply Agreement
On June 23, 2022, we entered into the Menarini License, pursuant to which we granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property and our regulatory documentation to undertake post approval development activities and commercialize the Licensed Products (as defined in the Menarini License), for any use in the Menarini Territory (as defined in the Menarini License). Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million. Menarini has also committed to providing us €27.5 million in funding for the research and development activities related to the Licensed Products over two years, all of which has been received to date, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory. We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones, of which €30 million has been received to date. If obicetrapib is approved, and successfully commercialized by Menarini, we will be entitled to tiered royalties ranging from the low double-digits to the mid-twenties as a percentage of net sales in the Menarini Territory, with royalty step-downs in the event of generic entrance or in respect of required third-party intellectual property payments. See the section titled “Business—Commercial” contained in our Annual Report for a full description of the Menarini License.
As of June 30, 2026, we have received a total of €30 million in milestone payments from Menarini, none of which was received in the six months ended June 30, 2026.
On August 12, 2025, we entered into the Menarini Supply Agreement, pursuant to which we will supply Menarini with the Drug Products. We will initially be Menarini’s exclusive supplier of the Drug Products and fulfill purchase orders based on periodic volume forecasts that Menarini is required to provide, a portion of which will be binding. The price to be paid by Menarini will be based on a specified mark-up to our “cost of goods sold” for the supplied Drug Products (as determined in accordance with the supply agreement), subject to periodic adjustments.
December 2024 Follow-on Offering
On December 13, 2024, we completed an underwritten public offering (the “December 2024 Offering”) of 14,667,347 Ordinary Shares at a public offering price of $24.50 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares, less the $0.0001 per share exercise price for each such Pre-Funded Warrant. Of the 14,667,347 Ordinary Shares issued
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and sold in the December 2024 Offering, 2,550,000 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share. The net proceeds to the Company from the December 2024 Offering were $453.4 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.
February 2024 Follow-on Offering
On February 16, 2024, we completed an underwritten public offering (the “February 2024 Offering”) of 5,871,909 Ordinary Shares at a public offering price of $19.00 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,736,841 Ordinary Shares at a public offering price of $18.9999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares less the $0.0001 per share exercise price for each such Pre-Funded Warrant. Of the 5,871,909 Ordinary Shares issued and sold in the February 2024 Offering, 1,383,750 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share. The net proceeds to the Company from the February 2024 Offering were $190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.
At-the-Market Offering
On August 9, 2024, we entered into an amended and restated sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may issue and sell from time to time up to $250 million of our Ordinary Shares through or to TD Cowen as our sales agent or acting as principal in any method deemed to be an “at the market offering.” TD Cowen will receive a commission of up to 3.0% of the gross proceeds of any Ordinary Shares sold pursuant to the Sales Agreement. During the six months ended June 30, 2026, we did not sell any Ordinary Shares pursuant to the Sales Agreement.
Warrants
In the six months ended June 30, 2026, 69,371 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $0.8 million. As of June 30, 2026, we had another 2,420,733 outstanding Warrants to purchase 2,420,733 Ordinary Shares, exercisable at an exercise price of $11.50 per share, which expire on November 23, 2027, at 5:00 p.m., Eastern Standard Time. Based on the exercise price of the Warrants, we may receive up to $27.8 million assuming the exercise of all Warrants outstanding as of June 30, 2026. The exercise of the Warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our Ordinary Shares and the spread between the exercise price of the Warrant and the price of an Ordinary Share at the time of exercise. For example, to the extent that the trading price of the Ordinary Shares exceeds $11.50 per share, it is more likely that holders of our Warrants will exercise their Warrants. If the trading price of the Ordinary Shares is less than $11.50 per share, it is unlikely that such holders will exercise their Warrants. The exercise price of the Warrants has at times exceeded the market price of the Ordinary Shares. To the extent that the price of our Ordinary Shares is below $11.50, we believe that the Warrant holders will be unlikely to cash exercise their warrants, resulting in little to no cash proceeds to us. There can be no assurance that our Warrants will be in the money prior to their expiration and, as such, certain unexercised Warrants may expire worthless. As such, it is possible that we may never generate any additional cash proceeds from the exercise of our Warrants. We have not included, and do not intend to include, any potential cash proceeds from the exercise of our Warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability that the Warrants are exercised over the life of our Warrants and the merit of including potential cash proceeds from the exercise thereof in our liquidity projections.
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Cash Flows
The following is a summary of cash flows for the six months ended June 30, 2026 and 2025:
For the six months ended June 30,
(In thousands of USD) 2026 2025
Net cash used in operating activities (69,818 ) (74,139 )
Net cash used in investing activities (16,271 ) (156,281 )
Net cash provided by financing activities 22,106 9,944
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
Net Cash Flows Used In Operating Activities
Net cash flows used in operating activities was $69.8 million in the six months ended June 30, 2026 compared to $74.1 million in the six months ended June 30, 2025, a decrease of $4.3 million. This change was primarily driven by favorable working capital changes, including a decrease in prepayments and other receivables and an increase in accounts payable, partially offset by an increase in operating expenses for the period .
Net Cash Flows Used In Investing Activities
Net cash flows used in investing activities was $16.3 million in the six months ended June 30, 2026 compared to $156.3 million in the six months ended June 30, 2025, a change of $140.0 million. The change is primarily attributable to the purchases and maturities of marketable securities.
Net Cash Flows Provided By Financing Activities
Net cash flows provided by financing activities was $22.1 million in the six months ended June 30, 2026 compared to $9.9 million in the six months ended June 30, 2025, an increase of $12.2 million. The increase primarily reflects an increase in proceeds received upon the exercise of options.
Operating Capital and Capital Expenditure Requirements
Third-Party Service Agreements
We have entered into a variety of agreements and financial commitments in the normal course of business with CROs, CMOs, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at June 30, 2026 they are estimated to be a maximum of $50.6 million due within one year and $11.4 million due in more than a year. As at June 30, 2026, we had cash, cash equivalents and marketable securities of $678.3 million which is sufficient to fund these obligations.
Leases
We are party to a services agreement (the "Naarden Lease") pursuant to which an affiliate of Forbion leased us office space, and an office lease agreement with Weston Common Area LLC, dated April 16, 2026, (the “Weston Lease”). Under the Naarden Lease, we are obligated to pay €40 thousand per year in rent. The Naarden Lease will continue until terminated by either us or the landlord. Pursuant to the Weston Lease, we are required to pay annual rent ranging from $31 thousand to $34 thousand, increasing from the low end of the range to the higher end of the range for each year of the lease. The Weston Lease will expire by its terms on April 30, 2029, unless terminated earlier by either party pursuant to the terms of the Weston Lease.
Menarini License
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We will be responsible for the development and commercialization costs related to Licensed Products (as defined in the Menarini License) other than those in the Menarini Territory (as defined in the Menarini License). In addition, under specified conditions of the agreement, we agreed to bear 50% of certain development costs incurred by the other party in the development of the Licensed Products in the Menarini Territory. See the section entitled “Business—Marketing and Sales” contained in the Annual Report on Form 10-K for a description of the Menarini License.
Critical Accounting Policies and Estimates
The preparation of our consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. We based our estimates on historical experience, known trends and other market-specific or other relevant factors that we believe to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. If actual results differ from our estimates, or to the extent these estimates are adjusted in future periods, our results of operations could either benefit from, or be adversely affected by, any such change in estimate.
See Note 2 to our consolidated financial statements in the Annual Report on Form 10-K and Note 2 to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report for a summary of significant accounting policies and the effect on our consolidated financial statements.