NewAmsterdam Pharma Co N.V.
For the period ended Jun 30, 2025. Filed Aug 6, 2025.
View on SEC.govAbout this filing
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.
Jun 30, 2025 · Filed Aug 6, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0000950170-25-066413
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 101 previous paragraphs and 120 current paragraphs.
53 unchanged; 35 reworded; 24 added; 13 removed; 0 previous and 8 current paragraphs rearranged.
Tables are not compared: 3 previous and 8 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 (24)
Current report
Positive Alzheimer's Disease Biomarker Data from BROADWAY Clinical Trial
Current 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.
Current 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.
Current 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.
Current report
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 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:
Current report
a $0.6 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib.
Current 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:
Current report
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 report
Comparison of the six months ended June 30, 2025 and 2024
Current report
Revenue
Current 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.
Current report
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 report
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 report
a $1.1 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib.
Current 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:
Current report
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 report
Fair Value Change - Earnout
Current report
Fair Value Change - Warrants
Current report
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 report
Foreign Exchange Gains/(Losses)
Current report
Loss for the Period
Current report
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 report
Net Cash Flows Used In Investing Activities
Removed paragraphs (13)
Previous report
As of March 31, 2025 we had cash and cash equivalents of $748.4 million as compared to $771.7 million as of December 31, 2024. The reduction in cash and cash equivalents is primarily driven by ongoing operating expenditures, partially offset by the first of two development cost contributions from our partner Menarini and cash received from interest and the exercise of options.
Previous report
Late-Breaking Data from BROADWAY and TANDEM Pivotal Phase 3
Previous report
On May 7, 2025, we announced additional data from the BROADWAY and TANDEM pivotal Phase 3 studies were presented as late-breaking oral presentations at the European Atherosclerosis Society Congress 2025 and simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet (TANDEM).
Previous report
Research and Development Expenses
Previous report
Selling, General and Administrative Expenses
Previous report
Interest Income
Previous report
Revenue was $3.0 million for the three months ended March 31, 2025 compared to $1.4 million for the three months ended March 31, 2024, an increase of $1.6 million or 113%. In both periods all revenues were recognized from the opening balance of deferred revenue in the period. The increase in revenue for the three months ended March 31, 2025 as compared to the same period in 2024 is primarily attributable to the increase in transaction price attributable to the R&D performance obligation as a result of the recognition in 2024 of the first of two annual development cost contributions pursuant to the terms of the Menarini License.
Previous report
Research and Development Expenses
Previous report
Research and development expenses were $44.8 million for the three months ended March 31, 2025 compared to $42.4 million for the three months ended March 31, 2024, an increase of $2.4 million or 5%. This was primarily driven by:
Previous report
Selling, General and Administrative Expenses
Previous report
Selling, general and administrative expenses were $27.2 million for the three months ended March 31, 2025 compared to $14.5 million for the three months ended March 31, 2024, an increase of $12.7 million or 88%. This was primarily driven by:
Previous report
Interest Income
Previous report
Net Cash Flows (Used In)/Provided By Investing Activities
Reworded paragraphs (35)
Previous wording
We are a late-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well tolerated and convenient low-density lipoprotein cholesterol (“LDL-C”) lowering therapy. In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease (“CVD”) with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. We believe that CETP inhibition may also play a role in other indications by potentially mitigating the risk of developing diseases such as Alzheimer’s disease.
Current wording
We are a late-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well tolerated and convenient low-density lipoprotein cholesterol (“LDL-C”) lowering therapy. In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease (“CVD”) with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. We believe that CETP inhibition may also play a role in other indications by potentially mitigating the risk of developing diseases such as Alzheimer’s disease (“AD”).
Previous wording
Obicetrapib is a next-generation, oral, low-dose, highly selective CETP inhibitor that we are developing to potentially overcome the limitations of current LDL-C lowering treatments. In addition to LDL-C, obicetrapib has shown significant reductions in lipoprotein (a) (“Lp(a)”) and small LDL particles, all with safety comparable to placebo. We believe that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In each of our Phase 3 clinical trials, BROADWAY and BROOKLYN, evaluating obicetrapib as an adjunct to high-intensity statin therapy, obicetrapib met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In our Phase 3 TANDEM clinical trial, evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, obicetrapib in combination with ezetimibe met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In five of our Phase 2 clinical trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b clinical trial, evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C lowering with side effects similar in frequency and severity to placebo including muscle-related side effects and drug-related treatment emergent serious adverse events. We have observed obicetrapib to be well tolerated in an aggregate of over 3,500 patients with low or moderately elevated LDL-C levels (“dyslipidemia”) in our clinical trials to date. Furthermore, we believe that obicetrapib’s oral delivery, demonstrated activity at low doses, chemical properties and tolerability make it well-suited for combination approaches.
Current wording
Obicetrapib is a next-generation, oral, low-dose, highly selective CETP inhibitor that we are developing to potentially overcome the limitations of current LDL-C lowering treatments. In addition to LDL-C, in clinical trials obicetrapib has shown significant reductions in lipoprotein (a) (“Lp(a)”) and small LDL particles, all with safety comparable to placebo. We believe that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In each of our Phase 3 clinical trials, BROADWAY and BROOKLYN, evaluating obicetrapib as an adjunct to high-intensity statin therapy, obicetrapib met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In our Phase 3 TANDEM clinical trial, evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, obicetrapib in combination with ezetimibe met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In five of our Phase 2 clinical trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b clinical trial, evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C lowering with side effects similar in frequency and severity to placebo including muscle-related side effects and drug-related treatment emergent serious adverse events. We have observed obicetrapib to be well tolerated in an aggregate of over 3,500 patients with low or moderately elevated LDL-C levels (“dyslipidemia”) in our clinical trials to date. Furthermore, we believe that obicetrapib’s oral delivery, demonstrated activity at low doses, chemical properties and tolerability make it well-suited for combination approaches.
Previous wording
Obicetrapib has shown to not only reduce LDL-C but also several additional biomarkers associated with MACE. To date, obicetrapib has shown reductions in non-HDL-C, apolipoprotein B, and small dense lipoprotein particles. In our clinical trials, we have also observed reductions in Lp(a), which is believed to be an independent MACE risk factor, along with reductions in total lipoprotein (“LDL”) particles and more specifically small LDL particles, which are believed to be more atherogenic particles.
Current wording
In our clinical trials, obicetrapib has not only reduced LDL-C but also several additional biomarkers associated with MACE including non-HDL-C, apolipoprotein B, and small dense lipoprotein particles. We have also observed reductions in Lp(a), which is believed to be an independent MACE risk factor, along with reductions in total lipoprotein (“LDL”) particles and more specifically small LDL particles, which are believed to be more atherogenic particles.
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 the Company's 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.
Current 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.
Previous wording
Additionally, in partial contribution to our costs of development of the licensed products, Menarini may pay us €27.5 million, payable in two equal annual installments and attributed entirely to the R&D performance obligation. Due to the scientific uncertainties around the commercialization of the licensed products based on the success of clinical trials, which is out of our control, the fixed €27.5 million was considered constrained at contract execution and was not initially recognized within the transaction price until it becomes highly probable of no significant revenue reversal. 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 constrained amounts associated with these payments within the transaction price. The first of the two annual installments has been received and recognized as either revenue or deferred revenue based on the same methodology as the portion of the upfront payment which was allocated to the R&D performance obligation. The second of the two installments remains constrained as of March 31, 2025 for the reasons discussed above.
Current wording
Additionally, in partial contribution to our costs of development of the licensed products, Menarini may pay us €27.5 million, payable in two equal annual installments and attributed entirely to the R&D performance obligation. Due to the scientific uncertainties around the commercialization of the licensed products based on the success of clinical trials, which is out of our control, the fixed €27.5 million was considered constrained at contract execution and was not initially recognized within the transaction price until it becomes highly probable of no significant revenue reversal. As of June 30, 2025, both annual development cost contributions had been recognized within the transaction price.
Previous wording
All such costs are for the purpose of advancing our product candidate to successfully complete clinical development, attain regulatory approval and, if approved, commercialize our product candidate. Much of our current focus in our ongoing trials is on patient recruitment and retention and data cleaning. Research and development expenses consist of the following:
Current wording
All such costs are for the purpose of advancing our product candidates to successfully complete clinical development, attain regulatory approval and, if approved, commercialize our product candidates. Much of our current focus in our ongoing trials is on patient recruitment and retention and data cleaning. Research and development expenses consist of the following:
Previous wording
manufacturing expenses arising from investments in commercial manufacturing capabilities and active pharmaceutical ingredient and drug product development as performed by our contract manufacturing organizations (“CMOs”), which are used in our clinical trials and research and development activities;
Current wording
manufacturing expenses arising from investments in commercial manufacturing capabilities and active pharmaceutical ingredient and drug product development as performed by our contract manufacturing organizations (“CMOs”);
Previous wording
costs associated with obtaining potential regulatory approval of our product candidate, including preparation and submission of filings, ongoing monitoring and compliance with comments and recommendations provided by regulatory authorities, and regulatory-related advisory fees;
Current wording
costs associated with obtaining potential regulatory approval of our product candidates, including preparation and submission of filings, ongoing monitoring and compliance with comments and recommendations provided by regulatory authorities, and regulatory-related advisory fees;
Previous wording
preclinical and nonclinical research and development expenses of the product candidate, primarily for costs incurred by CROs assisting with an ongoing two-year rat and hamster carcinogenicity study; and
Current wording
preclinical and nonclinical research and development expenses of our product candidates; and
Previous wording
We expect our research and development expenses to be significant as we advance obicetrapib through clinical trials and pursue regulatory approval. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming. Clinical trials generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical trial expenses. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of obicetrapib. See the section entitled “Risk Factors—Risks Related to Our Product Development, Regulatory Approval and Commercialization” for more information regarding the risks associated with clinical development.
Current wording
We expect our research and development expenses to be significant as we advance our product candidates through clinical trials and pursue regulatory approval. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming. Clinical trials generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical trial expenses. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of obicetrapib as a monotherapy and as a fixed-dose combination with ezetimibe. See the section entitled “Risk Factors—Risks Related to Our Product Development, Regulatory Approval and Commercialization” contained in the Annual Report for more information regarding the risks associated with clinical development.
Previous wording
Interest income is recognized using the effective interest rate method. Interest income for the three months ended March 31, 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 six months ended June 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. The Company's foreign currency exposure is mainly related to the Euro. As of March 31, 2025, our net exposure to foreign currency risk was $106.0 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 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.
Previous wording
a partially offsetting $8.1 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024.
Current 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;
Previous wording
a $2.9 million increase in personnel expenses related to research and development expenses primarily driven by our share-based compensation arrangements which account for $1.7 million of the increase;
Current 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;
Previous wording
a $4.8 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;
Current wording
a $1.3 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management; and
Previous wording
a $9.4 million increase in personnel expenses related to selling, general and administrative expenses primarily driven by our share-based compensation arrangements which account for $5.6 million of the increase. The remainder is 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 $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;
Previous wording
a $2.0 million increase in marketing and communication expenses related to startup costs as we begin to build capabilities to support our planned commercial launch of obicetrapib, if approved; and
Current 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
Previous wording
a $0.8 million increase in costs related to our intellectual property primarily driven by worldwide patent filings.
Current wording
a $0.6 million increase in costs related to our intellectual property primarily driven by worldwide patent filings.
Previous wording
Interest income was $7.4 million for the three months ended March 31, 2025 compared to $3.1 million for the three months ended March 31, 2024, an increase of $4.3 million or 138%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable debt securities on which interest is earned.
Current 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.
Previous wording
Fair value change - warrants was a gain of $13.8 million for the three months ended March 31, 2025 compared to a loss of $30.2 million for the three months ended March 31, 2024. The change is driven by changes in the market price during the period for Warrants which trade under the symbol "NAMSW."
Current 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.
Previous wording
Net foreign exchange gains/(losses) were a gain of $4.3 million for the three months ended March 31, 2025 compared to a loss of $2.4 million for the three months ended March 31, 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 $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.
Previous wording
Loss for the period was $39.5 million for the three months ended March 31, 2025 compared to $93.8 million for the three months ended March 31, 2024. The individual components of the change are described above.
Current 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.
Previous wording
Fair value change - earnout was a gain of $4.0 million for the three months ended March 31, 2025 compared to a loss of $8.7 million for the three months ended March 31, 2024. The change is driven by changes in the market price during the period for Ordinary Shares which trade under the symbol "NAMS."
Current 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.
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 March 31, 2025, we had an accumulated loss of $598.1 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 June 30, 2025, we had an accumulated loss of $615.5 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 March 31, 2025, we had cash, cash equivalents and marketable securities of $808.5 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 June 30, 2025, we had cash, cash equivalents and marketable securities of $783.3 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 three months ended March 31, 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 six months ended June 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 IP 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, 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.
Previous wording
As of March 31, 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 three months ended March 31, 2025.
Current 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.
Previous wording
In the three months ended March 31, 2025, 15,942 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $0.2 million. As of March 31, 2025, we had another 2,616,639 outstanding Warrants to purchase 2,616,639 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 March 31, 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 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.
Previous wording
The following is a summary of cash flows for the three months ended March 31, 2025 and 2024:
Current wording
The following is a summary of cash flows for the six months ended June 30, 2025 and 2024:
Previous wording
Net cash flows used in operating activities was $36.5 million in the three months ended March 31, 2025 compared to $54.6 million in the three months ended March 31, 2024, a decrease of $18.1 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 $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.
Previous wording
Net cash flows (used in)/provided by investing activities was $2.9 million in the three months ended March 31, 2025 compared to $(0.4 million) in the three months ended March 31, 2024, a change of $3.3 million. The change is primarily due to our investments in available-for-sale debt securities of which we had none in the three months ended March 31, 2024. During the three months ended March 31, 2025 maturities of debt securities totaled $12.5 million, partially offset by purchases of debt securities totaling $9.6 million.
Current wording
Net cash flows used in investing activities was $156.3 million in the six months ended June 30, 2025 compared to $0.6 million in the six months ended June 30, 2024, a change of $155.7 million. The change was primarily due to our investments in available-for-sale debt securities of which we had none in the six months ended June 30, 2024. During the six months ended June 30, 2025, purchases of debt securities totaled $193.3 million, partially offset by maturities of debt securities totaling $37.2 million.
Previous wording
Net cash flows provided by financing activities was $6.5 million in the three months ended March 31, 2025 compared to $198.2 million in the three months ended March 31, 2024, a decrease of $191.7 million. This decrease was primarily related to the receipt of proceeds from the February 2024 offering in the prior year.
Current wording
Net cash flows provided by financing activities was $9.9 million in the six months ended June 30, 2025 compared to $202.8 million in the six months ended June 30, 2024, a decrease of $192.9 million. This decrease was primarily related to the receipt of proceeds from the February 2024 Offering in the prior year.
Previous wording
We have entered into a variety of agreements and financial commitments in the normal course of business with CROs, CMOs, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at March 31, 2025 they are estimated to be a maximum of $18.8 million due within one year and $1.3 million due in more than a year. As at March 31, 2025, we had cash and cash equivalents of $748.4 million which is sufficient to fund these obligations.
Current wording
We have entered into a variety of agreements and financial commitments in the normal course of business with CROs, CMOs, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at June 30, 2025 they are estimated to be a maximum of $18.3 million due within one year and $2.2 million due in more than a year. As at June 30, 2025, we had cash and cash equivalents of $563.9 million which is sufficient to fund these obligations.
Previous wording
We will be responsible for the development and commercialization costs related to Licensed Products other than those in the Menarini Territory. In addition, under specified conditions of the agreement, we agreed to bear 50% of certain development costs incurred by the other party in the development of the Licensed Products in the Menarini Territory. Please see the section “Business—Marketing and Sales” contained in the Annual Report for a description of the Menarini License.
Current wording
We will be responsible for the development and commercialization costs related to Licensed Products other than those in the Menarini Territory. In addition, under specified conditions of the agreement, we agreed to bear 50% of certain development costs incurred by the other party in the development of the Licensed Products in the Menarini Territory. See the section entitled “Business—Marketing and Sales” contained in the Annual Report for a description of the Menarini License.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
The following table summarizes our consolidated statements of operations for the periods indicated:
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
The following table summarizes our research and development expenses for the periods indicated:
Current report — wording carried from elsewhere
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 report — wording carried from 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
Current report — wording carried from elsewhere
a $1.4 million increase in costs related to our intellectual property primarily driven by worldwide patent filings.
Current report — wording carried from elsewhere
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.