NewAmsterdam Pharma Co N.V.
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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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, 2025 · Filed Nov 5, 2025
NAMS$18.90+0.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0000950170-25-103521
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001193125-25-265796
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 120 previous paragraphs and 122 current paragraphs.
63 unchanged; 44 reworded; 15 added; 10 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 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 (15)
Current report
Third Quarter Highlights
Current report
Acceptance of Marketing Authorization Applications for Review by European Medicines Agency for Obicetrapib
Current report
On August 18, 2025 we announced that the European Medicines Agency (“EMA”) validated the Marketing Authorization Applications (“MAAs”) for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (“FDC”) for patients with primary hypercholesterolemia, both HeFH and non-familial or mixed dyslipidemia. The MAAs were submitted by our partner, Menarini, who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive license agreement with us (the "Menarini License").
Current report
Menarini Supply Agreement
Current report
On August 12, 2025, we entered into a Supply Agreement with Menarini as contemplated by the Menarini License. Under the terms of the Supply Agreement, we agreed to supply Menarini with obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination finished products in bulk tablet form (the “Drug Products”). We will initially be Menarini’s exclusive supplier of the Drug Products. 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 report
The Supply Agreement also provides for the initiation of a process to transfer manufacturing of the Drug Products to Menarini or to a designated third-party contract manufacturer. In connection with the manufacturing transfer, we granted Menarini a non-exclusive, non-transferable license under our patents and know-how to manufacture finished Drug Products.
Current report
In addition, we entered into the Menarini Supply Agreement to provide commercial supply of Drug Products for distribution by Menarini in specified European territories.
Current report
We recognize revenue from the sale of obicetrapib tablets, as a monotherapy and as a FDC therapy with ezetimibe, 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 report
Revenue was $0.3 million for the three months ended September 30, 2025 compared to $29.1 million for the three months ended September 30, 2024, a decrease of $28.8 million, or 99%. This decrease is largely due to the recognition of $27.3 million of revenue from the Menarini License related to a clinical development milestone which was earned in the three months ended September 30, 2024 while there were no clinical milestones earned in the three months ended September 30, 2025.
Current report
Research and development expenses were $31.0 million for the three months ended September 30, 2025 compared to $35.7 million for the three months ended September 30, 2024, a decrease of $4.7 million, or 13%. This was primarily driven by:
Current report
a $1.4 million decrease in manufacturing costs mainly driven by the completion of certain investments in commercial manufacturing capabilities during the current period;
Current report
partially offset by:
Current report
Comparison of the nine months ended September 30, 2025 and 2024
Current report
partially offset by:
Current report
Selling, general and administrative expenses were $78.9 million for the nine months ended September 30, 2025 compared to $49.3 million for the nine months ended September 30, 2024, an increase of $29.6 million or 60%. This was primarily driven by:
Removed paragraphs (10)
Previous report
Recent Developments
Previous report
Positive Alzheimer's Disease Biomarker Data from BROADWAY Clinical Trial
Previous report
On July 30, 2025, we announced data from the prespecified AD biomarker analysis in our BROADWAY clinical trial. The BROADWAY trial was primarily designed as a pivotal Phase 3 trial to evaluate LDL-C lowering efficacy of obicetrapib in adult patients with established ASCVD and/or HeFH, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. In connection with this trial, a prespecified analysis evaluated the effect of obicetrapib on plasma biomarkers of AD in 1,515 patients with established ASCVD and/or HeFH whose ApoE status was able to be determined based on phenotypic testing, including 367 ApoE4 carriers. ApoE4 is both a risk factor for cardiovascular disease and AD where ApoE4 carriers generally exhibit higher levels of LDL-C, Lp(a), and reduced cholesterol transport and clearance. Safety in this population was not evaluated independently from the overall BROADWAY study population, where obicetrapib was observed to be well-tolerated, with safety results comparable to placebo. Because this analysis was based on a subset of patients from BROADWAY (which was designed to evaluate LDL-C reductions in an ASCVD and/or HeFH population), it was not controlled for baseline differences between the treatment and placebo population.
Previous report
In this analysis, treatment with obicetrapib 10 mg daily for 12 months resulted in statistically significant lower absolute changes in plasma p-tau217, a key biomarker of AD pathology, in both the analysis set of patients with baseline and end of study datapoints above the lower limit of quantification and excluding ApoE2/ApoE4 carriers (p=0.0019; n=1,515) and in the ApoE4 carriers (p=0.0215; n=367). Favorable trends were also observed across additional biomarkers, including neurofilament light chain (“NFL”), glial fibrillary acidic protein (“GFAP”), p-tau181, and the Aβ42/40 ratio, in the full analysis set and in ApoE4 carriers, with the greatest effect generally observed in carriers of two E4 proteins.
Previous report
p-tau217 is one of the first biomarkers to provide evidence of neurodegeneration and can begin to increase more than 20 years before onset of cognitive impairment. In addition, p-tau217 has been reported to have significantly higher accuracy in assessing AD than alternative plasma- or MRI-based analyses, and its performance has been reported to not significantly differ from key CSF- or PET-based measures. NFL and GFAP biomarkers are also considered predictive of neurodegeneration, and elevated levels in the blood have been associated with AD progression and pathology. These results build on the Company’s Phase 2a proof of concept trial and preclinical data, which showed reductions in brain cholesterol metabolites and stabilization of AD biomarkers in ApoE4 carriers.
Previous report
Research and development expenses were $27.5 million for the three months ended June 30, 2025 compared to $38.4 million for the three months ended June 30, 2024, a decrease of $10.9 million, or 28%. This was primarily driven by:
Previous report
Selling, general and administrative expenses were $27.3 million for the three months ended June 30, 2025 compared to $16.5 million for the three months ended June 30, 2024, an increase of $10.8 million or 65%. This was primarily driven by:
Previous report
Comparison of the six months ended June 30, 2025 and 2024
Previous report
Revenue was $22.1 million for the six months ended June 30, 2025 compared to $3.7 million for the six months ended June 30, 2024, an increase of $18.4 million, or 501%. This increase 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 current period. The remaining increase was due to the 2024 increase in transaction price attributable to the R&D performance obligation.
Previous report
Selling, general and administrative expenses were $54.4 million for the six months ended June 30, 2025 compared to $30.9 million for the six months ended June 30, 2024, an increase of $23.5 million or 76%. This was primarily driven by:
Reworded paragraphs (44)
Previous wording
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 year ended December 31, 2024, 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 26, 2025, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations. 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.
Current wording
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, 2024, 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 26, 2025, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations. 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.
Previous wording
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.
Current wording
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. We completed enrollment in PREVAIL in April 2024. PREVAIL will continue until the last participant has been followed for a minimum of 2.5 years and the target number of MACE events have occurred. As a result, the earliest the trial could conclude based on the minimum follow-up period is the end of 2026. However, we will continue the trial until the target number of MACE events occur, which could likely require the trial to continue beyond this point.
Previous wording
We have partnered with Menarini, providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a fixed-dose combination with ezetimibe, in the majority of European countries, if approved. Subject to receipt of marketing approval, our current plan is to pursue development and commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and the European Union (the “EU”), 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 continually evaluating the potential acquisition or license of new product candidates.
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 or in a fixed-dose combination with ezetimibe, in the majority of European countries, if approved. Subject to receipt of marketing approval, our current plan is to pursue development and commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and the European Union (the “EU”), 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 continually evaluating the potential acquisition or license of new product candidates.
Previous wording
To date, we have not generated any revenue from the sale of pharmaceutical products. Our revenue has been solely derived from our license agreement with Menarini. 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. As of June 30, 2025, the R&D performance obligation had been deemed to be completely 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 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. As of September 30, 2025, the R&D performance obligation had been deemed to be completely satisfied and all deferred revenue related to such performance obligation was recognized.
Previous wording
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.
Current wording
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 (as defined in the Menarini License). 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.
Previous wording
We do not expect to generate any revenue from product sales for the foreseeable future. Any revenue generated from potential future collaborations may vary due to the many uncertainties in the development of obicetrapib and other factors.
Current wording
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.
Previous wording
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 due to increased efforts to drug patent development and protection globally, and general overhead costs.
Current wording
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 related to drug patent development and protection globally, and general overhead costs.
Previous wording
Interest income is recognized using the effective interest rate method. Interest income for the three and six months ended June 30, 2025 and 2024 is related to interest earned on cash, cash equivalents 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, 2025 and 2024 is related to interest earned on cash, cash equivalents and marketable securities.
Previous wording
Our exchange gain 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, 2025, our net exposure to foreign currency risk was $124.3 million, as compared to $108.6 million as of December 31, 2024.
Current wording
Our exchange gain 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, 2025, our net exposure to foreign currency risk was $112.8 million, as compared to $108.6 million as of December 31, 2024.
Previous wording
a $23.1 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials;
Current wording
a $6.6 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials; and
Previous wording
partially offset by a $2.4 million increase in personnel expenses related to research and development activities primarily driven by our share-based compensation arrangements which account for $2.1 million of the increase;
Current wording
a $2.2 million increase in personnel expenses related to research and development activities primarily driven by our share-based compensation arrangements which account for $1.9 million of the increase; and
Previous wording
a $1.3 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management; and
Current wording
a $0.7 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management.
Previous wording
a $7.8 million increase in personnel expenses related to selling, general and administrative activities primarily driven by our share-based compensation arrangements which account for $4.8 million of the increase. The remainder was largely due to 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;
Current wording
Selling, general and administrative expenses were $24.5 million for the three months ended September 30, 2025 compared to $18.4 million for the three months ended September 30, 2024, an increase of $6.1 million or 33%. This was primarily driven by a $6.3 million increase in personnel expenses related to selling, general and administrative activities primarily driven by our share-based compensation arrangements which account for $5.1 million of the increase. The remainder was largely due to 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.
Previous wording
Interest income was $7.1 million for the three months ended June 30, 2025 compared to $4.9 million for the three months ended June 30, 2024, an increase of $2.2 million or 45%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable debt securities on which interest was earned.
Current wording
Interest income was $6.7 million for the three months ended September 30, 2025 compared to $4.4 million for the three months ended September 30, 2024, an increase of $2.3 million or 52%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable securities on which interest was earned.
Previous wording
Fair value change - earnout was nil for the three months ended June 30, 2025 compared to a gain of $3.1 million for the three months ended June 30, 2024. The earnout liability was settled in full in March 2025.
Current wording
Fair value change - earnout was nil for the three months ended September 30, 2025 compared to a loss of $5.4 million for the three months ended September 30, 2024. The earnout liability was settled in full in March 2025.
Previous wording
Fair value change - warrants was a gain of $2.6 million for the three months ended June 30, 2025 compared to a gain of $6.6 million for the three months ended June 30, 2024. The change is driven by changes in the market price of the warrants trading under the symbol “NAMSW” (the “Warrants”) during the period.
Current wording
Fair value change - warrants was a loss of $23.8 million for the three months ended September 30, 2025 compared to a gain of $4.6 million for the three months ended September 30, 2024. The change is driven by changes in the market price of the warrants trading under the symbol “NAMSW” (the “Warrants”) during the period.
Previous wording
Net foreign exchange gains/(losses) were a gain of $8.6 million for the three months ended June 30, 2025 compared to a loss of $1.0 million for the three months ended June 30, 2024. 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 gain of $0.2 million for the three months ended September 30, 2025 compared to a gain of $4.7 million for the three months ended September 30, 2024. 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 $17.4 million for the three months ended June 30, 2025 compared to $39.0 million for the three months ended June 30, 2024, a decrease of $21.6 million. The individual components of the change are described above.
Current wording
Loss for the period was $72.0 million for the three months ended September 30, 2025 compared to $16.6 million for the three months ended September 30, 2024, an increase of $55.4 million. The individual components of the change are described above.
Previous wording
Revenue was $19.1 million for the three months ended June 30, 2025 compared to $2.3 million for the three months ended June 30, 2024, an increase of $16.8 million, or 740%. This increase is largely due to the recognition of $16.1 million of revenue in the current period related to the second installment of development cost contributions under the Menarini License.
Current wording
Revenue was $22.5 million for the nine months ended September 30, 2025 compared to $32.8 million for the nine months ended September 30, 2024, a decrease of $10.3 million, or 31%. This decrease was largely due to the recognition of $27.3 million of revenue from the Menarini License related to a clinical development milestone which was earned in the nine months ended September 30, 2024 while there were no clinical milestones earned in the three months ended September 30, 2025. The decrease in revenue related to clinical development milestones pursuant to the Menarini License was partially offset by the recognition of $16.1 million of revenue in the current period related to the second installment of development cost contributions under the Menarini License.
Previous wording
Research and development expenses were $72.3 million for the six months ended June 30, 2025 compared to $80.8 million for the six months ended June 30, 2024, a decrease of $8.5 million, or 11%. This was primarily driven by a:
Current wording
Research and development expenses were $103.2 million for the nine months ended September 30, 2025 compared to $116.5 million for the nine months ended September 30, 2024, a decrease of $13.3 million, or 11%. This was primarily driven by:
Previous wording
a $15.0 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials;
Current wording
a $29.7 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials;
Previous wording
a $5.3 million increase in personnel expenses related to research and development activities primarily driven by our share-based compensation arrangements which accounted for $3.9 million of the increase;
Current wording
a $7.5 million increase in personnel expenses related to research and development activities primarily driven by our share-based compensation arrangements which accounted for $5.8 million of the increase;
Previous wording
partially offset by a $6.1 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;
Current wording
a $6.8 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;
Previous wording
a $0.6 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib.
Current wording
a $1.4 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib; and
Previous wording
a $2.2 million increase in manufacturing expenses driven by investments in commercial manufacturing capabilities; and
Current wording
a $0.8 million increase in manufacturing expenses driven by investments in commercial manufacturing capabilities.
Previous wording
a $17.3 million increase in personnel expenses related to selling, general and administrative activities primarily driven by our share-based compensation arrangements which accounted for $10.3 million of the increase. The remainder was largely due to 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;
Current wording
a $22.9 million increase in personnel expenses related to selling, general and administrative activities primarily driven by our share-based compensation arrangements which accounted for $15.4 million of the increase. The remainder was largely due to 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;
Previous wording
a $2.1 million increase in marketing and communication expenses related to startup costs as we began to build capabilities to support our planned commercial launch of obicetrapib, if approved; and
Current wording
a $4.6 million increase in marketing and communication expenses related to startup costs as we began to build capabilities to support our planned commercial launch of obicetrapib, if approved; and
Previous wording
Interest income was $14.4 million for the six months ended June 30, 2025 compared to $8.0 million for the six months ended June 30, 2024, an increase of $6.4 million or 80%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable debt securities on which interest was earned.
Current wording
Interest income was $21.1 million for the nine months ended September 30, 2025 compared to $12.4 million for the nine months ended September 30, 2024, an increase of $8.7 million or 70%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable securities on which interest was earned.
Previous wording
Fair value change - earnout was a gain of $4.0 million for the six months ended June 30, 2025 compared to a loss of $5.6 million for the six months ended June 30, 2024. The change was driven by changes in the market price for ordinary shares which trade under the symbol “NAMS” (the “Ordinary Shares”) prior to the settlement of the earnout liability, which occurred in March 2025.
Current wording
Fair value change - earnout was a gain of $4.0 million for the nine months ended September 30, 2025 compared to a loss of $11 million for the nine months ended September 30, 2024. The change was driven by changes in the market price for ordinary shares which trade under the symbol “NAMS” (the “Ordinary Shares”) prior to the settlement of the earnout liability, which occurred in March 2025.
Previous wording
Fair value change - warrants was a gain of $16.4 million for the six months ended June 30, 2025 compared to a loss of $23.7 million for the six months ended June 30, 2024. The change was driven by changes in the market price of the Warrants during the period.
Current wording
Fair value change - warrants was a loss of $7.4 million for the nine months ended September 30, 2025 compared to a loss of $19 million for the nine months ended September 30, 2024. The change was driven by changes in the market price of the Warrants during the period.
Previous wording
Net foreign exchange gains/(losses) were a gain of $12.9 million for the six months ended June 30, 2025 compared to a loss of $3.4 million for the three months ended June 30, 2024. 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 gain of $13.1 million for the nine months ended September 30, 2025 compared to a gain of $1.3 million for the three months ended September 30, 2024. 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 $56.9 million for the six months ended June 30, 2025 compared to $132.8 million for the six months ended June 30, 2024, a decrease of $75.9 million. The individual components of the change are described above.
Current wording
Loss for the period was $128.9 million for the nine months ended September 30, 2025 compared to $149.4 million for the nine months ended September 30, 2024, a decrease of $20.5 million. The individual components of the change are described above.
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, 2025, we had an accumulated loss of $615.5 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, 2025, we had an accumulated loss of $687.5 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, 2025, we had cash, cash equivalents and marketable securities of $783.3 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, 2025, we had cash, cash equivalents and marketable securities of $756.0 million.
Previous wording
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, 2025, we did not sell any Ordinary Shares pursuant to the Sales Agreement.
Current wording
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 nine months ended September 30, 2025, we did not sell any Ordinary Shares pursuant to the Sales Agreement.
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, for any use in the Menarini Territory. 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, 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. 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.
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, 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. 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, 2025, we have received a total of €30 million and €13.8 million in milestone payments and R&D cost reimbursements, respectively, from Menarini, including €13.8 million which was received in the six months ended June 30, 2025.
Current wording
As of September 30, 2025, we have received a total of €30.0 million and €13.8 million in milestone payments and R&D cost reimbursements, respectively, from Menarini, including €13.8 million which was received in the nine months ended September 30, 2025.
Previous wording
In the six months ended June 30, 2025, 16,042 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $0.2 million. As of June 30, 2025, we had another 2,616,539 outstanding Warrants to purchase 2,616,539 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 $30.1 million assuming the exercise of all Warrants outstanding as of June 30, 2025. 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.
Current wording
In the nine months ended September 30, 2025, 39,868 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $0.5 million. As of September 30, 2025, we had another 2,592,713 outstanding Warrants to purchase 2,592,713 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 $29.8 million assuming the exercise of all Warrants outstanding as of September 30, 2025. 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.
Previous wording
The following is a summary of cash flows for the six months ended June 30, 2025 and 2024:
Current wording
The following is a summary of cash flows for the nine months ended September 30, 2025 and 2024:
Previous wording
Net cash flows used in operating activities was $74.1 million in the six months ended June 30, 2025 compared to $108.6 million in the six months ended June 30, 2024, a decrease of $34.5 million. This change was primarily due to an increase in interest income and the receipt of the first of two annual development cost contributions due under the Menarini License.
Current wording
Net cash flows used in operating activities was $106.9 million in the nine months ended September 30, 2025 compared to $121.1 million in the nine months ended September 30, 2024, a decrease of $14.2 million. This change was primarily due to an increase in interest income and the receipt of the first of two annual development cost contributions due under the Menarini License, partially offset by an increase in operating expenditures.
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Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
a $0.6 million increase in costs related to our intellectual property primarily driven by worldwide patent filings.
Previous report — wording carried elsewhere
a $1.1 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib.
Previous report — wording carried elsewhere
a $4.1 million increase in marketing and communication expenses related to startup costs as we began to build capabilities to support our planned commercial launch of obicetrapib, if approved; and