NewAmsterdam Pharma Co N.V.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 4, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0001193125-26-333824
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001193125-26-446228
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 124 previous paragraphs and 122 current paragraphs.
63 unchanged; 48 reworded; 10 added; 11 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
Revenue was $19.2 million for the three months ended September 30, 2026 compared to $0.3 million for the three months ended September 30, 2025, an increase of $18.9 million, or 6300%. This increase is largely due to the achievement of regulatory milestones under the Menarini License agreement, which resulted in the recognition of $18.3 million license revenue in the current period.
Current report
Research and development expenses were $39.4 million for the three months ended September 30, 2026 compared to $31.0 million for the three months ended September 30, 2025, an increase of $8.4 million, or 27%. This was primarily driven by:
Current report
a $0.8 million decrease in regulatory expenses primarily due to non-recurring consultant expenses incurred in a comparative period; and
Current report
Selling, general and administrative expenses were $24.0 million for the three months ended September 30, 2026 compared to $24.5 million for the three months ended September 30, 2025, a decrease of $0.5 million or 2%. This was primarily driven by:
Current report
a $1.3 million increase primarily driven by increased tax consulting costs and organizational commercial readiness.
Current report
Comparison of the nine months ended September 30, 2026 and 2025
Current report
Revenue was $25.9 million for the nine months ended September 30, 2026 compared to $22.5 million for the nine months ended September 30, 2025, an increase of $3.4 million, or 15%. Revenue recognized during the nine months ended September 30, 2026 included $18.3 million of license revenue related to the achievement of regulatory milestones under the Menarini License, and $7.6 million of supply revenue under the Menarini Supply Agreements. Revenue recognized during the nine months ended September 30, 2025 included $22.1 million related to the R&D performance obligation under the Menarini License agreement, and $0.3 million of supply revenue under the Menarini Supply Agreements.
Current report
Research and development expenses were $119.0 million for the nine months ended September 30, 2026 compared to $103.2 million for the nine months ended September 30, 2025, an increase of $15.8 million, or 15%. This was primarily driven by:
Current report
Selling, general and administrative expenses were $74.3 million for the nine months ended September 30, 2026 compared to $78.9 million for the nine months ended September 30, 2025, a decrease of $4.6 million or 6%. This was primarily driven by:
Current report
Net cash flows used in operating activities was $109.6 million in the nine months ended September 30, 2026 compared to $106.9 million in the nine months ended September 30, 2025, an increase of $2.7 million. This increase was primarily driven by an increase in loss for the period, net of non-cash items, partially offset by favorable changes in working capital.
Removed paragraphs (11)
Previous report
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.
Previous report
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:
Previous report
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:
Previous report
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;
Previous report
Comparison of the six months ended June 30, 2026 and 2025
Previous report
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.
Previous report
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:
Previous report
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:
Previous report
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
Previous report
a $0.9 million decrease in legal expenses primarily due to the transition of legal advisory services in-house;
Previous report
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 .
Reworded paragraphs (48)
Previous wording
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 important risk factors for ASCVD is hypercholesterolemia, which refers to elevated LDL-C levels within the body, commonly known as high cholesterol.
Current wording
Atherosclerosis is the primary cause of heart attacks, strokes and peripheral vascular disease. One of the most important risk factors for ASCVD is hypercholesterolemia, which refers to elevated LDL-C levels within the body, commonly known as high cholesterol.
Previous wording
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.
Current wording
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 40 million patients that are not at their risk-based LDL-C goals despite treatment with lipid lowering therapy, including approximately 17 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.
Previous wording
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.
Current wording
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 in the United States, 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 United States 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.
Previous wording
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.
Current wording
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 (Ubeslo®) or in a FDC with ezetimibe (Evlarco® and, with Ubeslo®, 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 Evlarco® and Ubeslo® 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 had adopted a positive opinion recommending marketing authorization for Evlarco® and Ubeslo® for patients with primary hypercholesterolemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia. In September 2026, we and Menarini announced that the European Commission had granted marketing authorization for Ubeslo® and Evlarco.® We expect Menarini to launch Evlarco® and Ubeslo® in Germany by the end of 2026. We anticipate that Menarini will receive decisions from regulators in Switzerland and the UK later this year. Menarini is required to use commercially reasonable efforts to commercialize Evlarco® and Ubeslo® in the Menarini Territory as relevant regulatory approvals are received.
Previous wording
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 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.
Current wording
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 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 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.
Previous wording
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.
Current wording
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. In August 2026, the trial completed enrollment of 347 patients, and we expect to report topline data from RUBENS around year end 2026.
Previous wording
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.
Current wording
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 initiated the Phase 2b SPINOZA clinical trial evaluating obicetrapib in patients with pre-clinical AD in September 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.
Previous wording
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.
Current wording
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 ended December 31, 2025, the R&D performance obligation was satisfied and all deferred revenue related to such performance obligation was recognized.
Previous wording
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.
Current wording
In addition, we entered into two separate supply agreements with Menarini (the “Menarini Supply Agreements”) to provide commercial supply of obicetrapib monotherapy and obicetrapib and ezetimibe fixed-dose combination finished products in bulk tablet form under the first agreement, and active pharmaceutical ingredients under the second agreement, in each case for distribution by Menarini in specified European territories.
Previous wording
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.
Current wording
We recognize revenue from the sale of obicetrapib tablets, as a monotherapy and as a fixed-dose combination therapy with ezetimibe, or from the sale of active pharmaceutical ingredients (collectively, “Products”). 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 Agreements, control of the Products is transferred upon the conveyance of title, which occurs upon delivery in accordance with the applicable shipping terms. The transaction price is contractually fixed at a markup of the actual cost of goods sold. Due to the cost-based nature of the agreements, 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.
Previous wording
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.
Current wording
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 U.S. 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.
Previous wording
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.
Current wording
Interest income is recognized using the effective interest rate method. Interest income for the three and nine months ended September 30, 2026 and 2025 is related to interest earned on cash, cash equivalents, restricted cash and marketable securities.
Previous wording
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.
Current wording
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 September 30, 2026, our net exposure to foreign currency risk was $82.2 million, as compared to $95.6 million as of December 31, 2025.
Previous wording
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.
Current wording
We have a history of losses and have generally not incurred significant 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.
Previous wording
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.
Current wording
In prior periods, including the three months ended September 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 months ended September 30, 2026. Costs associated with our medical affairs function totaled $4.1 million in the three months ended September 30, 2025, of which $2.8 million were personnel costs, compared to total costs of $3.9 million in the three months ended September 30, 2026, of which $3.2 million were personnel costs.
Previous wording
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;
Current wording
a $6.1 million increase in clinical expenses mainly due to the initiation of clinical trials and increased costs associated with the progression of ongoing trials; and
Previous wording
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;
Current wording
a $3.5 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;
Previous wording
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.
Current wording
a $0.5 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.
Previous wording
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.
Current wording
a $1.8 million decrease in personnel expense related to the impact of the reclassification of medical affairs costs, as discussed above. The decrease is partially offset by increased recruitment and employment costs for individuals involved with administrative and commercial preparation activities to support the growth of the organization;
Previous wording
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.
Current wording
Interest income was $5.2 million for the three months ended September 30, 2026 compared to $6.7 million for the three months ended September 30, 2025, a decrease of $1.5 million or 22%. This decrease was largely driven by a decrease in the amount of cash, cash equivalents and marketable debt securities on which interest was earned.
Previous wording
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.”
Current wording
Fair value change - warrants was a gain of $23.1 million for the three months ended September 30, 2026 compared to a loss of $23.8 million for the three months ended September 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.”
Previous wording
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.
Current wording
Net foreign exchange gains/(losses) were a loss of $0.3 million for the three months ended September 30, 2026 compared to a gain of $0.2 million for the three months ended September 30, 2025. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.
Previous wording
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.
Current wording
Loss for the period was $17.4 million for the three months ended September 30, 2026 compared to $72.0 million for the three months ended September 30, 2025, a decrease of $54.6 million. The individual components of the change are described above. In addition, net loss for the current period included income tax expense related to an assessment on a tax year currently under review.
Previous wording
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.
Current wording
In prior periods, including the nine months ended September 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 nine months ended September 30, 2026. Costs associated with our medical affairs function totaled $13.8 million in the nine months ended September 30, 2025, of which $8.9 million were personnel costs, compared to total costs of $12.7 million in the nine months ended September 30, 2026, of which $9.3 million were personnel costs.
Previous wording
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
Current wording
a $9.5 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 $4.8 million decrease related to a payroll tax relief grant received in the Netherlands; and
Previous wording
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
Current wording
an $8.9 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;
Previous wording
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.
Current wording
a $2.1 million decrease in non-clinical expenses due to reduced activity related to pipeline expansion and product lifecycle management.
Previous wording
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;
Current wording
a $7.4 million decrease in marketing and communication expenses, primarily driven by the change in the nature of medical affairs related costs, as described above, together with a $2.0 million reduction driven by lower market research spending;
Previous wording
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.
Current wording
a $2.6 million increase in personnel expenses related to share-based compensation costs and increased recruitment and employment costs for individuals involved with administrative and commercial preparation activities to support the growth of the organization. These increases are partially offset by the reclassification of medical affairs costs, as discussed above.
Previous wording
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.
Current wording
Interest income was $16.6 million for the nine months ended September 30, 2026 compared to $21.1 million for the nine months ended September 30, 2025, a decrease of $4.5 million or 21%. This decrease was largely driven by a decrease in the amount of cash, cash equivalents and marketable debt securities on which interest was earned.
Previous wording
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.
Current wording
Fair value change - earnout was nil for the nine months ended September 30, 2026 compared to a gain of $4.0 million for the nine months ended September 30, 2025. The earnout liability was settled in full in March 2025.
Previous wording
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.”
Current wording
Fair value change - warrants was a gain of $24.5 million for the nine months ended September 30, 2026 compared to a loss of $7.4 million for the nine months ended September 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.”
Previous wording
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.
Current wording
Net foreign exchange gains/(losses) were a loss of $2.4 million for the nine months ended September 30, 2026 compared to a gain of $13.1 million for the nine months ended September 30, 2025. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.
Previous wording
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.
Current wording
Loss for the period was $130.0 million for the nine months ended September 30, 2026 compared to $128.9 million for the nine months ended September 30, 2025, an increase of $1.1 million. The individual components of the change are described above. In addition, net loss for the current period included income tax expense related to an assessment on a tax year currently under review.
Previous wording
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.
Current wording
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 September 30, 2026, we had an accumulated loss of $892.4 million. We expect to continue to incur significant losses for the foreseeable future.
Previous wording
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.
Current wording
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 September 30, 2026, we had cash, cash equivalents and marketable securities of $643.1 million.
Previous wording
Menarini License and Menarini Supply Agreement
Current wording
Menarini License and Menarini Supply Agreements
Previous wording
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.
Current wording
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 €46 million has been earned 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 entitled “Business—Commercial” contained in our Annual Report for a full description of the Menarini License.
Previous wording
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.
Current wording
As of September 30, 2026, we have earned a total of €46 million in milestone payments from Menarini, €16 million of which was earned in the nine months ended September 30, 2026.
Previous wording
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.
Current wording
On August 12, 2025, and August 7, 2026, we entered into the Menarini Supply Agreements, pursuant to which we will supply Menarini with Products. We will initially be Menarini’s exclusive supplier of the 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 Products (as determined in accordance with the supply agreements), subject to periodic adjustments.
Showing the first 40 of 48 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
a $0.7 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;
Previous report — wording carried elsewhere
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