6 unchanged sentences
We seek to fill a significant unmet need for a safe, well tolerated and convenient LDL-C lowering therapy.
−Removed: In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective 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 CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
−Removed: 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.
+Added: In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective CETP inhibitor, alone or as an FDC with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
+Added: Additionally, 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.
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.
−Removed: In addition to LDL-C, obicetrapib has shown significant reductions in 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.
1 unchanged sentence
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.
−Removed: 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 TESAEs.
+Added: 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.
+Added: In each of these trials, side effects were similar in frequency and severity to placebo including muscle-related side effects and drug-related TESAEs.
We have observed obicetrapib to be well tolerated in an aggregate of over 3,500 patients with dyslipidemia in our clinical trials to date.
1 unchanged sentence
Lowering of LDL-C, has been associated with MACE benefit in trials of LDL-C lowering drugs, including the REVEAL trial with the CETP inhibitor, anacetrapib.
−Removed: In our Phase 3 BROADWAY clinical trial we observed a positive trend in the exploratory MACE endpoint and we are performing a Phase 3 CVOT PREVAIL trial to reconfirm this relationship.
+Added: 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 CVOT, PREVAIL, to reconfirm this relationship.
Obicetrapib has shown to not only reduce LDL-C but also several additional biomarkers associated with MACE.
9 unchanged sentences
It is estimated that over 75% of ASCVD and HeFH outpatients prefer oral drugs to injectable therapies.
−Removed: Our goal is to develop and commercialize an LDL-C lowering monotherapy and a fixed-dose combination therapy, which offers the advantage of a single, low dose, once-daily oral pill, and fulfills the significant unmet need for an effective and convenient LDL-C lowering therapy.
+Added: Our goal is to develop and commercialize an LDL-C lowering monotherapy and an FDC therapy, which offers the advantage of a single, low dose, once-daily oral pill, and fulfills the significant unmet need for an effective and convenient LDL-C lowering therapy.
If we obtain marketing approval, we intend to commercialize obicetrapib for patients with ASCVD and/or HeFH and elevated levels of LDL-C despite being treated with currently available optimal lipid lowering therapy.
−Removed: 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.
−Removed: 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 EU, including in Japan and China.
−Removed: In addition to our partnership with Menarini, we may in the future utilize a variety of types of collaboration, license, monetization, distribution and other
−Removed: arrangements with other third parties relating to the development or commercialization, once approved, of obicetrapib or future product candidates or indications.
−Removed: We are also continually evaluating the potential acquisition or license of new product candidates.
−Removed: As of December 31, 2024, we had cash and cash equivalents of $771.7 million as compared to $340.5 million as of December 31, 2023.
−Removed: The increase in cash is primarily driven by the proceeds of the February 2024 Offering (as defined below), the December 2024 Offering (as defined below), Warrant exercises, exercises of options and the achievement of a clinical development milestone, partially offset by cash outflows related to research and development costs as we continue development of obicetrapib and increased spending on selling, general and administrative expenses to support our growing organization..
−Removed: As of December 31, 2024, we no longer qualify as an “emerging growth company,” and, as a result, we are no longer able to avail ourselves of certain reduced reporting requirements applicable to emerging growth companies, and we expect to incur increased expenses as a result.
−Removed: Recent Developments
−Removed: December 2024 Follow-On Offering
−Removed: On December 13, 2024, the Company completed an underwritten public offering (the “December 2024 Offering”) of 14,667,347 Ordinary Shares at a public offering price of $24.50 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares, less the $0.0001 per share exercise price for each such Pre-Funded Warrant.
−Removed: Of the 14,667,347 Ordinary Shares issued and sold in the offering, 2,550,000 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share.
−Removed: The net proceeds to the Company from the December 2024 Offering were $453.4 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.
−Removed: Positive Topline Data from Pivotal Phase 3 BROADWAY Clinical Trial
−Removed: On December 10, 2024, we announced positive topline data from our Phase 3 BROADWAY clinical trial.
−Removed: The primary endpoint was the least-squares mean of the percent change in LDL-C from baseline to day 84 for obicetrapib 10 mg compared to placebo, using imputation for missing data.
−Removed: The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001).
−Removed: As part of the safety analysis, the trial adjudicated MACE as an exploratory endpoint, including death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization.
−Removed: In addition, a 21% reduction in MACE favoring obicetrapib was observed.
−Removed: The observed changes in other biomarkers, including HDL-C, non-HDL-C, Lp(a), ApoB, and Apolipoprotein A1 (ApoA1) were consistent with data reported in our prior clinical trials.
−Removed: As part of the safety analysis, key AEs of special interests were monitored.
−Removed: Among these AEs, glycemic control and renal function were monitored and each of the events favored obicetrapib.
−Removed: Overall, obicetrapib was also observed to be well-tolerated, with safety results, including blood pressure, comparable to placebo.
−Removed: Positive Topline Data from Pivotal Phase 3 TANDEM Clinical Trial
−Removed: On November 20, 2024, we announced positive topline data from our Phase 3 TANDEM clinical trial.
−Removed: The co-primary endpoints were percent change from baseline in LDL-C of the fixed-dose combination compared to each monotherapy arm after 84 days and obicetrapib 10 mg compared to placebo after day 84.
−Removed: Secondary endpoints incorporated percent changes from baseline in other biomarkers, including Lp(a), non-HDL-C and ApoB.
−Removed: The TANDEM trial met all co-primary endpoints, including the obicetrapib-ezetimibe fixed dose combination achieving an LS mean reduction of 48.6% (p < 0.0001) compared to placebo at day 84.
−Removed: In the trial, the fixed-dose combination of obicetrapib and ezetimibe was observed to be well tolerated, with safety results comparable to placebo.
−Removed: Positive Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial
−Removed: On November 18, 2024, we announced additional positive data from our Phase 3 BROOKLYN clinical trial.
−Removed: The trial met its primary endpoint of percent change from baseline in LDL-C of obicetrapib 10 mg compared to placebo after 84 days.
−Removed: The trial also met several of its prespecified secondary endpoints with statistical significance and observed results consistent with our prior clinical trials.
−Removed: Key secondary endpoints included percent changes from baseline of obicetrapib 10 mg compared to placebo after 84 days in Lp(a), ApoB, HDL-C and non-HDL-C.
−Removed: The p-value for the LS mean for all secondary endpoints compared to placebo was <0.0001 following 84 days of treatment with obicetrapib.
−Removed: Obicetrapib was also observed to be well tolerated, with safety results in the treatment arm comparable to placebo and no observed increase in blood pressure.
+Added: 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 an FDC with ezetimibe, in the Menarini Territory, if approved.
+Added: In August 2025, the EMA accepted for review the MAAs submitted by Menarini for obicetrapib 10 mg monotherapy and the FDC of 10 mg obicetrapib plus 10 mg ezetimibe for the treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia.
+Added: Subsequently, MAAs were also submitted to regulators in the UK and Switzerland and accepted for review.
+Added: The submissions are supported by data from the BROADWAY,
+Added: BROOKLYN, and TANDEM pivotal Phase 3 trials.
+Added: We anticipate that Menarini will receive decisions on the MAAs from each of the regulators in the second half of 2026.
+Added: If the MAAs are approved, Menarini will be required to use commercially reasonable efforts to commercialize obicetrapib in the Menarini Territory.
+Added: Our current plan is to pursue development and, subject to the receipt of marketing approval, commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and Europe, including in Japan and China.
+Added: 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.
+Added: We are also regularly evaluating the potential acquisition or license of new product candidates.
+Added: In addition to our cardiometabolic program, we are exploring the potential application of CETP inhibition in other indications, including Alzheimer’s disease.
+Added: Based on the lipid-modifying effects of CETP inhibition observed in our clinical trials for obicetrapib to date, we have conducted preclinical and early clinical evaluations of obicetrapib in this area.
+Added: We initiated a Phase 2a clinical trial in patients with early Alzheimer’s disease to evaluate the pharmacodynamic and pharmacokinetic effects, safety and tolerability of obicetrapib, and announced initial data from this trial in September 2023.
+Added: In July 2025, we announced data from the prespecified Alzheimer’s disease biomarker analysis in our BROADWAY clinical trial.
+Added: Based on these results, we expect to initiate a new clinical trial evaluating obicetrapib in patients with early Alzheimer’s disease in 2026.
+Added: As of December 31, 2025, we had cash, cash equivalents and marketable securities of $728.9 million as compared to $834.2 million as of December 31, 2024.
Components of our Results of Operations
−Removed: To date, we have not generated any revenue from the sale of pharmaceutical products.
−Removed: Our revenue has been solely derived from our license agreement with Menarini.
+Added: To date, we have not generated significant revenue from the sale of pharmaceutical products.
+Added: Our revenue has been primarily 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").
−Removed: 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
−Removed: attributed to the license performance obligation and recognized as revenue upon the execution of the Menarini License on June 23, 2022.
+Added: 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.
+Added: As of December 31, 2025, the R&D performance obligation had been deemed to be completely satisfied and all deferred revenue related to such performance obligation was recognized.
Additionally, in partial contribution to our costs of development of the Licensed Products, Menarini may pay us €27.5 million, payable in two equal annual installments.
Due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials, which is out of our control, the fixed €27.5 million was considered constrained at contract execution and is not initially recognized within the transaction price until it becomes highly probable of no significant revenue reversal.
−Removed: 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.
+Added: As of December 31, 2025, both annual development cost contributions had been recognized within the transaction price.
Under the Menarini License, we are also entitled to receive certain cost sharing payments, sales-based royalties and payments based upon the achievement of defined development, regulatory and commercial milestones linked to the enhanced value of the license performance obligation.
3 unchanged sentences
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.
−Removed: We do not expect to generate any revenue from product sales for the foreseeable future.
−Removed: Any revenue generated from potential future collaborations may vary due to the many uncertainties in the development of obicetrapib and other factors.
+Added: In addition, we entered into the Menarini Supply Agreement to provide commercial supply of obicetrapib monotherapy and obicetrapib and ezetimibe fixed-dose combination finished products in bulk tablet form (the “Drug Products”) for distribution by Menarini in specified European territories.
+Added: We recognize revenue from the sale of Drug Products, and from the sale of active pharmaceutical ingredients to Menarini for the manufacturer of such tablets.
+Added: 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.
+Added: 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.
+Added: The transaction price is contractually fixed at a markup of the actual cost of goods sold.
+Added: Due to the cost-based nature of the agreement, the pricing structure includes a variable component which is measured using the expected value method.
+Added: At each reporting period end, we update our estimate of the transaction price using actual cost data and forecasted expenses.
+Added: We state revenues net of any taxes collected from customers that are required to be remitted to various government agencies.
+Added: Any revenue generated from potential future collaborations or product sales may vary due to the many uncertainties in the development of obicetrapib and other factors.
Research and Development Expenses
2 unchanged sentences
At each balance sheet date, we estimate the level of services provided by vendors and the associated expenditure incurred for the services performed.
−Removed: 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.
+Added: 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.
1 unchanged sentence
• clinical expenses primarily incurred by CROs assisting with our sponsored clinical trials and including clinical investigator costs, patient enrollments and costs of clinical sites;
−Removed: • manufacturing expenses arising from API and drug product development as performed by our CMOs, which are used in our clinical trials and research and development activities;
−Removed: • 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;
+Added: • manufacturing expenses arising from investments in commercial manufacturing capabilities and API and drug product development as performed by our CMOs;
+Added: • 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;
• contracted personnel and employment costs attributed to research and development efforts, which includes management fees, salaries, share-based compensation expenses, bonus plans and payments to contractors who work for us for a fixed number of hours per week or per month;
−Removed: • preclinical and nonclinical research and development expenses of the product candidate;
+Added: • preclinical and nonclinical research and development expenses of our product candidates;
• other clinical costs such as clinical trial insurance and other consultancy fees.
−Removed: We expect our research and development expenses to be significant as we advance obicetrapib through clinical trials and pursue regulatory approval.
+Added: 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.
−Removed: 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.
−Removed: 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.
+Added: At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates.
+Added: See the section titled “ Risk Factors—Risks Related to Our Product Development, Regulatory Approval and Commercialization ” for more information regarding the risks associated with clinical development.
Selling, General and Administrative Expenses
6 unchanged sentences
Interest income is recognized using the effective interest rate method.
−Removed: Finance income for the year ended December 31, 2024 is related to interest earned on cash, cash equivalents and marketable securities.
+Added: Interest income for the year ended December 31, 2025 is related to interest earned on cash, cash equivalents and marketable securities.
Net Foreign Exchange Gain/Loss
21 unchanged sentences
Loss before tax
−Removed: Income tax expense
+Added: Income tax expense (benefit)
Loss for the year
−Removed: Revenue increased by $31.5 million, or 223.4%, to $45.6 million for the year ended December 31, 2024 compared to $14.1 million for the year ended December 31, 2023.
−Removed: This change is largely due to $27.3 million of revenue recognized in the year ended December 31, 2024 related to the license performance obligation under the Menarini License for a clinical success milestone compared to $5.4 million of such revenue recognized in the year ended December 31, 2023.
−Removed: The remainder of the change is due to an increase of $9.5 million in the revenue recognized related to the R&D performance obligation in the year ended December 31, 2024 as compared to the year ended December 31, 2023.
−Removed: This increase in revenue related to the R&D performance obligation is composed of the following:
−Removed: • recognition of $11.9 million of revenue for a general development cost reimbursement in the year ended December 31, 2024 while no such cost reimbursement was recognized in the year ended December 31, 2023;
−Removed: • an offsetting decrease of $2.3 million in recognition of deferred revenues in the year ended December 31, 2024 as compared to the year ended December 31, 2023 due to differences in the percentage of completion achieved in each respective year related to the performance obligation.
+Added: Revenue decreased by $23.1 million, or 50.6%, to $22.5 million for the year ended December 31, 2025 compared to $45.6 million for the year ended December 31, 2024.
+Added: 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 year ended December 31, 2024 while there were no clinical milestones earned in the year ended December 31, 2025.
+Added: The decrease in revenue related to clinical development milestones pursuant to the Menarini License was partially offset by an increase in the amount of revenue recognized in the current period related to the development cost contributions under the Menarini License.
Research and Development Expenses
1 unchanged sentence
This was primarily driven by:
−Removed: • a $10.2 million decrease in manufacturing costs;
−Removed: • a $1.1 million decrease in non-clinical expenses related to preclinical studies;
−Removed: • a $0.9 million decrease in clinical expenses due to clinical trial which are complete or nearing completion;
−Removed: • a partially offsetting $0.9 million increase in regulatory expenses;
−Removed: • a partially offsetting $3.1 million increase in personnel expenses.
+Added: • a $30.5 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;
+Added: partially offset by:
+Added: • an $8.3 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;
+Added: • a $6.1 million increase in manufacturing expense driven by investments in commercial manufacturing capabilities;
+Added: • a $5.0 million increase in personnel expenses primarily driven by an increase in share-based compensation expense;
+Added: • a $1.5 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib.
The following table summarizes our research and development expenses for the periods indicated:
13 unchanged sentences
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;
−Removed: • a $10.9 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;
−Removed: • a partially offsetting $3.5 million decrease in finance and administration expenses primarily due to costs incurred in 2023 in connection with an underwritten public offering of Ordinary Shares by certain of our shareholders.
−Removed: We did not sell any Ordinary Shares in the offering and did not receive any proceeds from the offering.
+Added: • a $5.1 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;
+Added: • a $1.5 million increase in costs related to our intellectual property primarily driven by worldwide patent filings.
Interest Income
2 unchanged sentences
Fair Value Change - Earnout
−Removed: Fair value change - earnout was a loss of $37.0 million for the year ended December 31, 2024 compared to a loss of $0.3 million for the year ended December 31, 2023.
−Removed: The change is driven by changes in the market price during the period for Ordinary Shares and an increase in the estimated probability of achieving the earnout milestone from 40% as of December 31, 2023 to 100% as of December 31, 2024.
+Added: Fair value change - earnout was a gain of $4.0 million for the year ended December 31, 2025 compared to a loss of $37.0 million for the year ended December 31, 2024.
+Added: The earnout liability was settled in March 2025.
Fair Value Change - Warrants
Fair value change - warrants was a loss of $22.8 million for the year ended December 31, 2025 compared to a loss of $38.6 million for the year ended December 31, 2024.
−Removed: The change is driven by changes in the market price during the period for the Warrants, which trade under the symbol "NAMSW."
+Added: The change is primarily driven by changes in the market price during the period for the Warrants, which trade under the symbol "NAMSW."
Foreign Exchange Gains/(Losses)
−Removed: Net foreign exchange gains/(losses) were a loss of $6.6 million for the year ended December 31, 2024 compared to a gain of $5.1 million for the year ended December 31, 2023.
−Removed: This change was largely driven by a weakening of the Euro against the U.S.
+Added: Net foreign exchange gains/(losses) were a gain of $13.1 million for the year ended December 31, 2025 compared to a loss of $6.6 million for the year ended December 31, 2024.
+Added: This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.
Loss for the Year
−Removed: Loss for the year increased by $64.7 million, to $241.6 million for the year ended December 31, 2024 compared to $176.9 million for the year ended December 31, 2023.
+Added: Loss for the year decreased by $37.8 million, to $203.8 million for the year ended December 31, 2025 compared to $241.6 million for the year ended December 31, 2024.
The individual components of the change are described above.
3 unchanged sentences
We are a clinical-stage biopharmaceutical company and, since inception, we have incurred significant operating losses and expect to continue to do so for the foreseeable future.
−Removed: Since inception, we have not generated any product revenues or net positive cash flows from operating activities.
−Removed: We will not receive any product revenues or net positive cash flows from operating activities until we successfully develop a product candidate, obtain regulatory approval, and successfully commercialize it.
+Added: Since inception, we have not generated significant product revenues or net positive cash flows from operating activities.
+Added: We do not expect to receive significant product revenues or achieve net positive cash flows from operating activities until we successfully develop a product candidate, obtain regulatory approval, and successfully commercialize it.
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.
8 unchanged sentences
• the costs of filing, prosecuting, defending and enforcing any patent applications, claims, patents and other intellectual property rights;
−Removed: • the costs and timing of obtaining sufficient quantities of our product candidate for clinical trials by establishing production capacities through contracts with CMOs;
+Added: • the costs and timing of obtaining sufficient quantities of our product candidates for clinical trials by establishing production capacities through contracts with CMOs;
• the terms and timing of any collaborative, licensing and other arrangements that we may establish;
• compensation expenses associated with increased headcount;
−Removed: • the costs of preparing for launch and commercialization of our product candidate;
−Removed: • losing our status as an emerging growth company;
+Added: • the costs of preparing for launch and commercialization of our product candidates;
• the costs of operating as a public company in the United States.
3 unchanged sentences
We have historically funded our operations primarily through private placements and public offerings of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the Business Combination.
−Removed: As of December 31, 2024, we had cash and cash equivalents of $771.7 million.
+Added: As of December 31, 2025, we had cash, cash equivalents and marketable securities of $728.9 million which management believes is sufficient to fund operating activities for at least the twelve-month period following the issuance of the consolidated financial statements accompanying this Annual Report.
Until we can generate substantial revenue, if ever, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, convertible loans, warrants, collaborations, or other means.
3 unchanged sentences
If we raise additional capital through public or privately placed equity offerings of securities, the terms of these securities or offerings may include liquidation or other preferences that adversely affect our other shareholders’ rights.
−Removed: To the extent that we raise additional funds by issuing and selling equity or
−Removed: equity-linked securities, shareholders will experience dilution.
+Added: To the extent that we raise additional funds by issuing and selling equity or equity-linked securities, shareholders will experience dilution.
If we raise additional capital through debt financing, we would likely be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, licensing or selling assets, making capital expenditures or declaring dividends.
8 unchanged sentences
Sources of Liquidity
+Added: Menarini License and Menarini Supply Agreement
+Added: 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.
+Added: Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million.
+Added: 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, of which €13.8 million has been received to date, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory.
+Added: We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones, €30 million of which has been received to date.
+Added: 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.
+Added: See the section titled “ Business—Commercial ” for a full description of the Menarini License.
+Added: As of December 31, 2025, we have received a total of €30 million in milestone payments from Menarini, none of which was received in the year ended December 31, 2025.
+Added: On August 12, 2025, we entered into a supply agreement with Menarini pursuant to which we will supply Menarini with the Drug Products.
+Added: We will initially be Menarini’s exclusive supplier of the Drug Products and fulfill purchase orders based on periodic volume forecasts that Menarini is required to provide, a portion of which will be binding.
+Added: The price to be paid by Menarini will be based on a specified mark-up to our “cost of goods sold” for the supplied Drug Products (as determined in accordance with the supply agreement), subject to periodic adjustments.
December 2024 Follow-on Offering
−Removed: On December 13, 2024, we completed the December 2024 Offering of 14,667,347 Ordinary Shares at a public offering price of $24.50 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares, less the $0.0001 per share exercise price for each such Pre-Funded Warrant.
+Added: On December 13, 2024, we completed an underwritten public offering (the “December 2024 Offering”) of 14,667,347 Ordinary Shares at a public offering price of $24.50 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares, less the $0.0001 per share exercise price for each such Pre-Funded Warrant.
Of the 14,667,347 Ordinary Shares issued and sold in the December 2024 Offering, 2,550,000 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share.
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The net proceeds to the Company from the February 2024 Offering were $190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.
−Removed: Menarini License
−Removed: 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.
−Removed: Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million.
−Removed: 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.
−Removed: We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones, €30 million of which has been received to date.
−Removed: 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.
−Removed: See the section titled “ Business—Commercial ” for a full description of the Menarini License.
−Removed: As of December 31, 2024, we have received a total of €30 million in milestone payments from Menarini, €25 million of which was received in the year ended December 31, 2024.
+Added: At-the-Market Offering
+Added: 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.
+Added: During the year ended December 31, 2025, we did not sell any Ordinary Shares pursuant to the Sales Agreement.
In the year ended December 31, 2025, 142,477 Warrants were exercised at an exercise price of $11.50 per Ordinary Share, generating gross proceeds of $1.6 million.
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The exercise price of the Warrants has at times exceeded the market price of the Ordinary Shares.
−Removed: 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
−Removed: no cash proceeds to us.
−Removed: 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.
+Added: 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.
+Added: There can be no assurance that our Warrants will be in the money prior to their expiration and, as such, certain
+Added: 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.
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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.
−Removed: Business Combination and PIPE Financing
−Removed: In July 2022, we entered into a Business Combination Agreement with FLAC, NewAmsterdam Pharma and Merger Sub, which closed on November 22, 2022.
−Removed: Concurrently with the execution of the Business Combination Agreement, we and FLAC also entered into subscription agreements with certain investors (the "PIPE Investors"), pursuant to which the PIPE Investors agreed to subscribe for and purchase from us, and we agreed to issue and sell to such PIPE Investors in a private placement, an aggregate of 23,460,000 Ordinary Shares at $10.00 per share for gross proceeds of $234.6 million (the "PIPE Financing").
−Removed: The PIPE Financing closed substantially concurrently with the Business Combination.
−Removed: We received an aggregate of $306.3 million from the Business Combination and associated PIPE Financing at the closing of the Business Combination, prior to deducting the $2.6 million of transaction costs directly attributable to these financing activities.
The following is a summary of cash flows for the years ended December 31, 2025, 2024 and 2023:
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(In thousands of USD)
−Removed: Net cash (used in)/provided by operating activities
+Added: Net cash used in operating activities
Net cash used in investing activities
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Foreign exchange differences
−Removed: Cash and cash equivalents at the beginning of the year
−Removed: Cash and cash equivalents at the end of the year
−Removed: Net Cash Flows Provided By/Used In Operating Activities
−Removed: Net cash used in operating activities increased by $17.4 million from $141.2 million in 2023 to $158.6 million in 2024.
−Removed: This change was primarily due to an increase in operating expenditures, the underlying reasons for which are described above, partially offset by an increase in the amount of cash received related to the achievement of clinical development milestones in the current period as compared to the same period in the prior year.
−Removed: Net Cash Flows Provided By/Used In Investing Activities
+Added: Cash, cash equivalents and restricted cash at the beginning of the year
+Added: Cash, cash equivalents and restricted cash at the end of the year
+Added: Net Cash Flows Used In Operating Activities
+Added: Net cash used in operating activities decreased by $10.8 million from $158.6 million in 2024 to $147.8 million in 2025.
+Added: This change was primarily driven by:
+Added: • a $24.8 million favorable change in total adjustments for changes in working capital from a net unfavorable adjustment of $32.7 million in 2024 to a net unfavorable adjustment of $7.9 million in 2025;
+Added: • a $37.8 million decrease in net loss for the year;
+Added: partially offset by:
+Added: • a $51.7 million unfavorable change in total non-cash adjustments to reconcile loss for the year to net cash flows from a net favorable adjustment of $115.7 million in 2024 to a net favorable adjustment of $64.0 million in 2025.
+Added: Net Cash Flows Used In Investing Activities
Net cash flows used in investing activities increased by $112.1 million from $62.8 million in 2024 to $174.9 million in 2025.
−Removed: This change was primarily due to investments in marketable securities.
+Added: This change was primarily due to cash flows related to investments in marketable securities.
+Added: In 2024, purchases of marketable securities totaled $62.2 million, compared to purchases of marketable securities of $296.7 million, partially offset by $122.1 million of maturities of marketable securities during 2025.
Net Cash Flows Provided By Financing Activities
−Removed: Net cash flows provided by financing activities was $659.5 million in 2024 compared to $8.9 million in 2023, an increase of $650.6 million.
−Removed: This change was primarily related to the February 2024 Offering and the December 2024 Offering, which together generated net proceeds of $645.0 million after deducting underwriting discounts and commissions and offering expenses paid by the Company.
−Removed: The remaining change is due to a $5.1 million increase in the proceeds received from the exercise of Warrants and a $0.5 increase in net proceeds from the exercise of options.
+Added: Net cash flows provided by financing activities decreased by $630.0 million from $659.5 million in 2024 to $29.5 million in 2025.
+Added: This change was primarily related to the receipt of net proceeds totaling $645.0 million from the February 2024 Offering and the December 2024 Offering in the prior year and a $12.1 million decrease in proceeds from the exercise of warrants, partially offset by a $27.7 million increase in proceeds received from the exercise of options.
Operating Capital and Capital Expenditure Requirements
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However, some of our service providers also charge cancellation fees upon cancellation.
−Removed: The amount and timing of such payments are not known, but at December 31, 2024 they are estimated to be a maximum of $11.8 million due within
−Removed: one year and $2.4 million due in more than a year.
−Removed: As of December 31, 2024, we had cash and cash equivalents of $771.7 million, which is sufficient to fund these obligations.
+Added: The amount and timing of such payments are not known, but at December 31, 2025 they are estimated to be a maximum of $25.2 million due within one year and $13.9 million due in more than one year.
+Added: As of December 31, 2025, we had cash, cash equivalents and marketable securities of $728.9 million, which is sufficient to fund these obligations.
We are party to a services agreement (the "Naarden Lease") pursuant to which an affiliate of Forbion leased us office space;
an office lease agreement with Renaissance Aventura LLC, dated May 24, 2021, as amended April 9, 2024 (as amended, the “Miami Lease”);
−Removed: and an office sublease agreement with GR8 People, Inc., dated April 2, 2024 (the “Yardley Lease”).
+Added: office sublease agreement with GR8 People, Inc., dated April 2, 2024 (the “Yardley Lease”).
Under the Naarden Lease, we are obligated to pay €40 thousand per year in rent.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.