What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-02-26 compared with 2024-02-28 · 140 added, 208 removed, 175 unchanged (67% of the section changed)

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Factors that could cause or contribute to these differences include those under “Risk Factors” included in Part I, Item 1A and under “Special Note Regarding Forward-Looking Statements” or in other parts of this Annual Report on Form 10-K.

As of January 1, 2024, we no longer qualified as a foreign private issuer under the rules and regulations of the SEC and as a result, are no longer entitled to rely on the foreign private issuer exemptions.

We are required to report as a domestic U.S.

filer, including filing Annual Reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and proxy statements under Section 14 of the Exchange Act.

In addition, since January 1, 2024, our “insiders” have been subject to the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act.

We are no longer exempt from the requirements of Regulation FD promulgated by the SEC under the Exchange Act.

Moreover, as a domestic filer, we are no longer permitted to follow our home country rules in lieu of the corporate governance obligations imposed by Nasdaq and are required to comply with the governance practices required of U.S.

domestic issuers.

In prior periods, we prepared our financial information in accordance with the International Financial Reporting Standards as issued by the International Accounting Standard Board ("IFRS") and presented our financial results in Euros.

As a consequence of becoming a domestic issuer as of January 1, 2024, we are required to present our financial information in accordance with U.S.

The below financial information has been prepared in accordance with U.S.

GAAP and expressed in U.S.

dollars for all periods presented.

The financial information should not be expected to correspond to figures we have previously presented under IFRS.

The functional currency of the Company and its subsidiaries has historically been EUR.

The Company reassessed its functional currency and determined the U.S.

Dollar to be the functional currency of the Company and its subsidiaries beginning January 1, 2023.

Significant elements involved in the determination of the functional currency change include a shift in the Company’s sources of financing from EUR to USD given its access to the U.S.

public market and an increase of operating costs incurred in USD due to Phase III trials taking place predominantly in the United States, among other factors.

In the Company’s previously reported financial statements as at December 2022 and 2021 and for each of the three years in the period ended December 31, 2022, prepared in accordance with IFRS, the weighted average ordinary shares outstanding used to calculate net loss per ordinary share, basic and diluted, contained an error.

The reported amounts in the IFRS financial statements for the weighted average ordinary share outstanding, basic and diluted, were 81,559,780, 24,131,427 and 10,653,636 for the years ended December 31, 2022, 2021 and 2020 respectively.

If corrected, those amounts would have been 39,628,088 , 23,636,341 and 9,238,016 for the years ending December 31, 2022, 2021 and 2020 respectively.

As a result, the reported amounts in IFRS financial statements for net loss per ordinary share, basic and diluted, were (€.96), (€1.19) and (€.54) for the years ending December 31, 2022, 2021 and 2020 respectively.

If corrected those amounts would have been (€.1.97), (€1.21) and (€.62) for the years ending December 31 2022, 2021 and 2020 respectively.

GAAP financial statements correctly reflect the weighted average ordinary share outstanding, basic and diluted, and net loss per ordinary share, basic and diluted.

GAAP financial statements are not restated as this is their first time being presented.

We are a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic 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 LDL-lowering therapy.

In multiple phase 3 studies, we are investigating obicetrapib, an oral, low-dose and once-daily 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.

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 or Type 2 diabetes.

Our product candidate, obicetrapib, is a next-generation, oral, low-dose CETP inhibitor that we are developing to potentially overcome the limitations of current LDL-C lowering treatments.

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 LDL-C lowering therapy.

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.

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.

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.

In our Phase 2 ROSE2 clinical trial evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, obicetrapib met its primary and secondary endpoints, with statistically significant reductions in LDL-C and ApoB observed.

In five of our Phase 2 trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b 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.

We have observed a favorable tolerability profile for obicetrapib in an aggregate of over 800 patients with dyslipidemia in our clinical trials to date.

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 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.

Furthermore, we believe that obicetrapib’s oral delivery, demonstrated activity at low doses, chemical properties and tolerability make it well-suited for combination approaches.

developing a fixed dose combination of obicetrapib 10 mg and ezetimibe 10 mg, which has been observed to demonstrate even greater LDL-C reduction in our Phase 2b ROSE2 clinical trial.

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.

We are performing a cardiovascular outcomes trial (“CVOT”) to reconfirm this relationship.

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.

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, ApoB, and sdLDL-P.

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 LDL particles and more specifically small LDL particles, which are believed to be more atherogenic particles.

CVD is a leading cause of death worldwide.

ASCVD is primarily caused by atherosclerosis, which involves the build-up of fatty material within the inner walls of the arteries.

Atherosclerosis is the primary cause of heart attacks, strokes and peripheral vascular disease.

One of the most important risk factors for ASCVD is hypercholesterolemia, which refers to elevated LDL-C levels within the body, commonly known as high cholesterol.

A significant proportion of patients with high cholesterol do not achieve acceptable LDL-C levels using statin therapy alone.

We estimate that in the United States there are approximately 30 million patients that are not at their risk-based LDL-C goals despite treatment with lipid lowering therapy, including approximately 13 million with ASCVD.

Existing non-statin treatment options have been largely unable to address the needs of patients with high cholesterol due to limited efficacy, an inconvenient injectable administration route and, in the past, market access restrictions.

It is estimated that over 75% of ASCVD and HeFH outpatients prefer oral drugs to injectable therapies.

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.

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.

We have partnered with A.

Menarini International Licensing S.A., part of Menarini Group (“Menarini”), providing them with the exclusive rights to commercialize obicetrapib 10 mg either as a sole active ingredient product or in a fixed dose combination with ezetimibe in the majority of European countries, if approved.

Subject to receipt of marketing approval, our current plan is to pursue development and commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and the European Union (the “EU”), including in Japan and China.

In addition to our partnership with Menarini, we may in the future utilize a variety of types of collaboration, license, monetization, distribution and other arrangements with other third parties relating to the development or commercialization, once approved, of obicetrapib or future product candidates or indications.

We 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.

In addition to our partnership with Menarini, we may in the future utilize a variety of types of collaboration, license, monetization, distribution and other

arrangements with other third parties relating to the development or commercialization, once approved, of obicetrapib or future product candidates or indications.

We are also continually evaluating the potential acquisition or license of new product candidates.

As of December 31, 2023 we had cash of $340.5 million as compared to $467.7 million as of December 31, 2022.

The reduction in cash is primarily driven by research and development costs as we continue development of obicetrapib and increased spending on selling, general and administrative expenses to support our growing organization, partially offset by cash receipts related to the achievement of a clinical development milestone under the Menarini License and the exercise of Warrants.

Based on our current operating plan, we believe that our existing cash will be sufficient to fund our anticipated level of operations through the anticipated readouts from our BROADWAY, BROOKLYN, TANDEM and PREVAIL trials.

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.

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..

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.

Recent Developments

On February 16, 2024, we completed an underwritten public offering (the “Offering”) of 5,871,909 Ordinary Shares at a public offering price of $19.00 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, pre-funded warrants (“Pre-Funded Warrants”) to purchase 4,736,841 Ordinary Shares at a public offering price of $18.9999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares less the $0.0001 per share exercise price for each such Pre-Funded Warrant.

December 2024 Follow-On Offering

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.

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.

The Ordinary Shares and Pre-Funded Warrants were issued and sold pursuant to an underwriting agreement among the Company and Jefferies LLC, Leerink Partners LLC, Piper Sandler & Co.

and RBC Capital Markets, LLC, as representatives of the several underwriters listed on Schedule A thereto.

The net proceeds to the Company from the Offering were $189.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

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.

Positive Topline Data from Pivotal Phase 3 BROADWAY Clinical Trial

On December 10, 2024, we announced positive topline data from our Phase 3 BROADWAY clinical trial.

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.

The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001).

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.

In addition, a 21% reduction in MACE favoring obicetrapib was observed.

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.

As part of the safety analysis, key AEs of special interests were monitored.

Among these AEs, glycemic control and renal function were monitored and each of the events favored obicetrapib.

Overall, obicetrapib was also observed to be well-tolerated, with safety results, including blood pressure, comparable to placebo.

Positive Topline Data from Pivotal Phase 3 TANDEM Clinical Trial

On November 20, 2024, we announced positive topline data from our Phase 3 TANDEM clinical trial.

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.

Secondary endpoints incorporated percent changes from baseline in other biomarkers, including Lp(a), non-HDL-C and ApoB.

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.

In the trial, the fixed-dose combination of obicetrapib and ezetimibe was observed to be well tolerated, with safety results comparable to placebo.

Positive Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial

On November 18, 2024, we announced additional positive data from our Phase 3 BROOKLYN clinical trial.

The trial met its primary endpoint of percent change from baseline in LDL-C of obicetrapib 10 mg compared to placebo after 84 days.

The trial also met several of its prespecified secondary endpoints with statistical significance and observed results consistent with our prior clinical trials.

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.

The p-value for the LS mean for all secondary endpoints compared to placebo was <0.0001 following 84 days of treatment with obicetrapib.

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.

Components of our Results of Operations

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Our revenue has been solely derived from our license agreement with Menarini.

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 recognized as revenue upon the execution of the Menarini License on June 23, 2022 and $4.1 million (€4.0 million) was subsequently recognized as revenue in 2022.

In the year ended December 31, 2023, $14.1 million of revenue was recognized, partially related to the achievement of a clinical milestone and partially related to the recognition of additional amounts of the deferred portion of the upfront payment received from 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").

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.

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, out of our control, the fixed €27.5 million is considered constrained at contract execution and is 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 fixed consideration associated with these payments within the transaction price.

Under the Menarini License, we are also entitled to receive fixed reimbursement payments for our continued development costs, certain cost sharing payments, sales-based royalties, as well as payments based upon the achievement of defined development, regulatory and commercial milestones.

These milestones are contingent payments and represent variable considerations that are not initially recognized within the transaction price.

Due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials, 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.

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.

Under the Menarini License, we are also entitled to receive certain cost sharing payments, sales-based royalties and payments based upon the achievement of defined development, regulatory and commercial milestones linked to the enhanced value of the license performance obligation.

These milestones are contingent payments and represent variable considerations that are not initially recognized within the transaction price, due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials.

Our ability to receive and generate revenue from these payments is dependent upon a number of factors, including our ability to successfully complete the development of and obtain regulatory approval for obicetrapib within the Menarini Territory.

The uncertainty of achieving these milestones significantly impacts our ability to generate revenue.

We achieved a milestone pursuant to the Menarini License in January 2023 in connection with the announcement of topline data from our ROSE2 trial.

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.

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.

We do not expect to generate any revenue from product sales for the foreseeable future.

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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.

We commenced a Phase 3 CVOT and two other Phase 3 trials in 2022.

Much of our current focus in the Phase 3 trials is on patient recruitment and retention and data cleaning.

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:

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• contracted personnel and employment costs attributed to research and development efforts, which includes management fees, salaries, share-based compensation expenses, bonus plans and payments to contractors who work for us for a fixed number of hours per week or per month;

• preclinical and nonclinical research and development expenses of the product candidate, primarily for costs incurred by CROs assisting with an ongoing two-year rat and hamster carcinogenicity study;

• preclinical and nonclinical research and development expenses of the product candidate;

• other clinical costs such as clinical trial insurance and other consultancy fees.

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Interest income is recognized using the effective interest rate method.

Finance income for the year ended December 31, 2023 is related to interest earned on cash balances.

Finance income for the year ended December 31, 2024 is related to interest earned on cash, cash equivalents and marketable securities.

Net Foreign Exchange Gain/Loss

Our exchange gain relates mainly to cash balances denominated in foreign currencies, but also to transactions denominated in foreign currencies.

We determined the United States Dollar to be the functional currency of the Company and its subsidiaries beginning January 1, 2023.

Prior to January 1, 2023, the functional currency of the Company and its subsidiaries was the Euro.

As such, the Company's foreign currency exposure at December 31, 2023 is mainly related to the Euro while the Company’s foreign currency exposure at December 31, 2022 is mainly related to the U.S.

As of December 31, 2023, our net exposure to foreign currency risk was $114.3 million, mainly related to the Euro, as compared to €268.2 million ($286.1 million) as of December 31, 2022, mainly related to the U.S.

Our exchange gain/loss relates mainly to cash balances denominated in foreign currencies, but also to transactions denominated in foreign currencies.

Our foreign currency exposure is mainly related to the Euro.

As of December 31, 2024, our net exposure to foreign currency risk was $108.6 million compared to $114.3 million as of December 31, 2023, mainly related to the Euro.

We have a history of losses and therefore have de minimis amounts of corporate tax.

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Interest income

Interest Expense

Fair value change - earnout and warrants

Fair value change - profit rights

Fair value change - tranche rights

Fair value change - earnout

Fair value change - warrants

Foreign exchange gains/(losses)

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Loss for the year

Revenue decreased by $88.6 million, or 86%, from $102.7 million for the year ended December 31, 2022 to $14.1 million for the year ended December 31, 2023.

This decrease is largely due to the one-time recognition in 2022 of $98.6 million of revenue allocated to the license performance obligation out of the $120.9 million upfront payment received pursuant to the Menarini License on June 23, 2022.

This was partially offset by $5.4 million of revenue related to a clinical development milestone achieved in 2023 and the recognition of $8.7 million of deferred revenue related to the research and development performance obligation in 2023 as compared to $4.1 million recognized in 2022.

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.

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.

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.

This increase in revenue related to the R&D performance obligation is composed of the following:

• 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;

• 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.

Research and Development Expenses

Research and development expenses increased by $72.7 million, or 84%, from $86.7 million for the year ended December 31, 2022 to $159.4 million for the year ended December 31, 2023.

This was primarily driven by a:

• $45.4 million increase in clinical expenses which related to our ongoing clinical trials.

Costs related to our Phase 3 clinical trials increased by $47.9 million in 2023 as compared to 2022, The increase related to Phase 3 clinical trials is slightly offset by a reduction of $2.5 million in costs related to Phase 1 and 2 clinical trials and other clinical expenses;

• $15.3 million increase in personnel expenses related to research and development expenses, primarily driven by our share-based compensation arrangements which account for $12.1 million of the increase.

In addition to expenses related to new awards granted in 2023, our financial results for the year ended December 31, 2022 only reflected less than two months of expense related to the 2022 awards as compared to 12 months of such expense recognized in 2023.

The remaining increase is largely due to the growth of the organization to support clinical trial management and regulatory affairs;

• $11.6 million increase in manufacturing costs related to the ongoing operation of larger Phase 3 clinical trials

The following table summarizes our selling, general and administrative expenses for the periods indicated:

Research and development expenses decreased by $8.0 million, or 5.0%, to $151.4 million for the year ended December 31, 2024 compared to $159.4 million for the year ended December 31, 2023.

This was primarily driven by:

• a $10.2 million decrease in manufacturing costs;

• a $1.1 million decrease in non-clinical expenses related to preclinical studies;

• a $0.9 million decrease in clinical expenses due to clinical trial which are complete or nearing completion;

• a partially offsetting $0.9 million increase in regulatory expenses;

• a partially offsetting $3.1 million increase in personnel expenses.

The following table summarizes our research and development expenses for the periods indicated:

For the year ended December 31,

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Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by $18.1 million, or 93%, from $19.5 million for the year ended December 31, 2022 to $37.6 million for the year ended December 31, 2023.

This was primarily driven by a:

• $11.9 million increase in personnel expenses related to selling, general and administrative expenses primarily driven by our share-based compensation arrangements which account for $8.3 million of the increase.

The remainder is largely due to increased fees and hiring of individuals involved with administrative activities to support the growth of the organization and operation as a public company;

• $2.4 million increase in finance and administration expenses largely due to costs incurred in relation to the secondary offering and increased costs associated with operating as a public company for the entirety of 2023;

• $2.3 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;

• $3.0 million increase in facility related and other costs primarily due to increased insurance costs incurred as a public company as well as increased travel expenses in support of the overall growth of the organization;

• $2.0 million decrease in commission expense due to the largest portion of the commission expense being recognized in 2022 related to the upfront payment received pursuant to the Menarini License.

The following table summarizes our research and development expenses for the periods indicated:

ended December 31,

(In thousands of USD)

Personnel expense

Intellectual property

Finance and administration

Marketing and communication

Commission expense

Facility-related and other costs

Total selling, general and administrative expenses

Selling, general and administrative expenses increased by $32.8 million, or 87.2%, to $70.4 million for the year ended December 31, 2024 compared to $37.6 million for the year ended December 31, 2023.

This was primarily driven by:

• a $25.9 million increase in personnel expenses related to selling, general and administrative expenses, of which our share-based compensation arrangements account for $10.3 million.

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;

• 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;

• 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.

We did not sell any Ordinary Shares in the offering and did not receive any proceeds from the offering.

Interest Income

Interest income increased by $11.3 million, from nil for the year ended December 31, 2022 to $11.3 million for the year ended December 31, 2023.

This increase was driven by interest earned on cash balances.

Fair Value Change - Earnout and Warrants

Fair value change - earnout and warrants was a loss of $10.3 million for the year ended December 31, 2023 compared to a loss of $1.0 million for the year ended December 31, 2022.

The change is driven by changes in the market price during the period for Ordinary Shares and Warrants which trade under the symbols "NAMS" and "NAMSW," respectively.

Interest income increased by $5.6 million, to $16.9 million for the year ended December 31, 2024 compared to $11.3 million for the year ended December 31, 2023.

This increase was primarily driven by greater cash balances and investments in marketable securities during the year ended December 31, 2024 as compared to cash balances during the year ended December 31, 2023.

Fair Value Change - Earnout

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.

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.

Fair Value Change - Warrants

Fair value change - warrants was a loss of $38.6 million for the year ended December 31, 2024 compared to a loss of $10.0 million for the year ended December 31, 2023.

The change is driven by changes in the market price during the period for the Warrants, which trade under the symbol "NAMSW."

Foreign Exchange Gains/(Losses)

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.

This change was largely driven by a strengthening of the Euro against the U.S.

Dollar, which was determined to be our functional currency as of January 1, 2023.

This change was largely driven by a weakening of the Euro against the U.S.

Loss for the Year

Loss for the year increased by $154.3 million, from $22.6 million for the year ended December 31, 2022 to $176.9 million for the year ended December 31, 2023.

This increase was largely driven by a decrease in revenue recognized in 2023 as compared to 2022 in conjunction with an increase in both research and development expenses and selling, general and administrative expenses.

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.

The individual components of the change are described above.

Comparison of the Years Ended December 31, 2023 and December 31, 2022

The following table summarizes our consolidated statements of operations for the periods indicated:

For the year ended December 31,

(In thousands of USD)

Operating Expenses:

Research and development expenses

Selling, general and administrative expenses

Total operating expenses

Operating Loss

Other income (expense):

Interest Expense

Loss on debt extinguishment

Fair value change - earnout and warrants

Fair value change - profit rights

Fair value change - tranche rights

Foreign exchange gains/(losses)

Loss before tax

Income tax expense

Loss for the year

Revenue increased by $102.7 million from nil for the year ended December 31, 2021 to $102.7 million for the year ended December 31, 2022.

This was driven by the revenue allocated to the license performance obligation out of the $120.9 million upfront payment received pursuant to the Menarini License on June 23, 2022.

$22.3 million was allocated to the research and development performance obligation and recorded as deferred revenue.

Of this amount, $4.1 million was recognized in respect of the research and development performance obligation for the period ended December 31, 2022.

Research and Development Expenses

Research and development expenses increased by $57.8 million, or 199%, from $29.0 million for the year ended December 31, 2021 to $86.7 million for the year ended December 31, 2022.

This was primarily driven by a:

• $48.7 million increase in clinical research and development cost which related to costs incurred in connection with our larger Phase 3 clinical trials in 2022 compared to our smaller Phase 2 clinical trials which were mostly conducted in 2021;

• $1.7 million increase in non-clinical expenses primarily as a result of costs incurred by the rat and hamster carcinogenicity study which is being conducted over two years and commenced at the end of 2021;

• $2.1 million increase in personnel expenses related to research and development expenses, primarily driven by our share-based compensation arrangements due to new grants awarded in 2022 as well as growth of the organization related to clinical trial management;

• $6.1 million increase in manufacturing costs as a result of our Phase 2 clinical trials that continued in 2022 in addition to startup API campaign, process optimization and kit, labeling and distribution costs for our Phase 3 clinical trials.

The following table summarizes our research and development expenses for the periods indicated:

For the year ended December 31,

(In thousands of USD)

Clinical expenses

Non-clinical expenses

Personnel expenses

Manufacturing costs

Regulatory expenses

Other research and development costs

Total research and development expenses

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by $13.5 million, or 225%, from $6.0 million for the year ended December 31, 2021 to $19.5 million for the year ended December 31, 2022.

This was primarily driven by a:

• $2.8 increase in personnel expenses related to increased fees, hiring of individuals involved with administrative and quality control activities and share-based payments due to new grants awarded in 2022;

• $1.9 million increase in intellectual property and other legal costs due to increased efforts related to drug patent development and global patent protection efforts, legal services rendered with respect to due diligence and the Business Combination;

• $5.2 million increase in finance and administration costs due to increased audit fees and accounting and advisory fees in support of the Menarini License and Business Combination;

• $2.2 million of commission expense recognized in relation to the Menarini License.

The following table summarizes our selling, general and administrative expenses for the periods indicated:

ended December 31,

(In thousands of USD)

Personnel expense

Intellectual property

Finance and administration

Marketing and communication

Commission expense

Facility-related and other costs

Total selling, general and administrative expenses

Fair Value Change - Earnout and Warrants

Fair value change - earnout and warrants was a loss of $1.0 million for the year ended December 31, 2022.

The derivative earnout and warrant liabilities were recognized as part of the accounting for the Business Combination which occurred on November 22, 2022.

As such, in the year ended December 31, 2021 there is no fair value change recognized for the earnout and warrants.

Foreign Exchange Gains/(Losses)

Net foreign exchange gains/(losses) were a gain of $1.7 million for the year ended December 31, 2021 compared to a loss of $9.7 million for the year ended December 31, 2022.

This change was largely driven by the effect of the appreciation of the U.S.

Dollar on cash balances held in U.S.

Dollars at the end of the year and the increased research and development expenditures denominated in U.S.

Loss for the Period

Loss for the period decreased by $19.2 million, from $41.8 million for the year ended December 31, 2021 to $22.6 million for the year ended December 31, 2022.

This decrease was largely driven by the increase in research and development expenses and selling, general and administrative expenses, offset by revenue that was recognized pursuant to the Menarini License.

Please refer to the section titled “Management Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 for a comparative discussion of our fiscal years ended December 31, 2023 and December 31, 2022.

Liquidity and Capital Resources

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• the costs of preparing for launch and commercialization of our product candidate;

• losing our status as a foreign private issuer;

• losing our status as an emerging growth company;

• the costs of operating as a public company in the United States.

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Our prior losses and expected future losses have had and will continue to have an adverse effect on our shareholders’ equity and working capital unless and until eliminated by revenue generation and growth.

We have historically funded our operations primarily through private placements of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the Business Combination.

As of December 31, 2023, we had cash of $340.5 million.

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.

As of December 31, 2024, we had cash and cash equivalents of $771.7 million.

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.

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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.

To the extent that we raise additional funds by issuing and selling equity or equity-linked securities, shareholders will experience dilution.

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.

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Sources of Liquidity

Follow-on Offering

On February 16, 2024, we completed the Offering of 5,871,909 Ordinary Shares at a public offering price of $19.00 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,736,841 Ordinary Shares at a public offering price of $18.9999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares less the $0.0001 per share exercise price for each such Pre-Funded Warrant.

Of the 5,871,909 Ordinary Shares issued and sold in the Offering, 1,383,750 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share.

The Ordinary Shares and Pre-Funded Warrants were issued and sold pursuant to the Underwriting Agreement, among the Company and Jefferies LLC, Leerink Partners LLC, Piper Sandler & Co.

and RBC Capital Markets, LLC, as representatives of the several underwriters listed on Schedule A thereto.

The net proceeds to the Company from the Offering were $189.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

At-the-Market Offering

On December 7, 2023, we entered into a 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 $150 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 December 31, 2023, we did not sell any Ordinary Shares pursuant to the Sales Agreement.

December 2024 Follow-on Offering

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.

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.

The net proceeds to the Company from the December 2024 Offering were $453.4 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.

February 2024 Follow-on Offering

On February 16, 2024, we completed an underwritten public offering (the “February 2024 Offering”) of 5,871,909 Ordinary Shares at a public offering price of $19.00 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,736,841 Ordinary Shares at a public offering price of $18.9999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares less the $0.0001 per share exercise price for each such Pre-Funded Warrant.

Of the 5,871,909 Ordinary Shares issued and sold in the February 2024 Offering, 1,383,750 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share.

The net proceeds to the Company from the February 2024 Offering were $190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Menarini License

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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.

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.

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 ” for a full description of the Menarini License.

As of December 31, 2023, we have received €5 million in milestone payments from Menarini.

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.

In the year ended December 31, 2024, 1,384,640 Warrants were exercised at an exercise price of $11.50 per Ordinary Share, generating gross proceeds of $13.8 million.

As of December 31, 2023, we had another 4,017,221 outstanding Warrants to purchase 4,017,221 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.

As of December 31, 2024, we had another 2,632,581 outstanding Warrants to purchase 2,632,581 Ordinary Shares, exercisable at an exercise price of $11.50 per share, which will 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 $30.3 million, assuming the exercise of all Warrants outstanding as of December 31, 2024.

From January 1, 2024 through February 16, 2024 a total of 663,011 additional Warrants were exercised generating gross proceeds of $7.6 million.

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.

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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.

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.

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Foreign exchange differences

Cash at the beginning of the year

Cash at the end of the year

Cash and cash equivalents at the beginning of the year

Cash and cash equivalents at the end of the year

Net Cash Flows Provided By/Used In Operating Activities

Net cash flows from operating activities decreased by $151.9 million from $10.7 million provided by operating activities in 2022 compared to $141.2 million used in operating activities in 2023.

This change was primarily due to an increase in research and development and selling general administrative expenditures in addition to the non-recurring nature of the upfront fee received in 2022 pursuant to the Menarini License.

Net cash flows from operating activities were $29.5 million used in operating activities in 2021 as compared to $10.7 million provided by operating activities in 2022.

This change was primarily due to the upfront fee received pursuant to the Menarini License, offset by an increase in research and development and selling, general and administrative expenditures.

Net cash used in operating activities increased by $17.4 million from $141.2 million in 2023 to $158.6 million in 2024.

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.

Net Cash Flows Provided By/Used In Investing Activities

The $0.2 million decrease in net cash used in investing activities in 2023 as compared to 2022 and the $0.2 million increase in net cash used in investing activities in 2022 as compared to 2021 are primarily due to costs paid in 2022 related to capitalized software.

Net cash flows used in investing activities increased by $62.8 million from $0.0 million in 2023 to $62.8 million in 2024.

This change was primarily due to investments in marketable securities.

Net Cash Flows Provided By Financing Activities

The $383.0 million decrease in net cash provided by financing activities in 2023 as compared to 2022 was primarily due to the closing of the Business Combination and second tranche of series A financing which occurred in 2022 with no similar financing events occurring in 2023.

The decrease of cash flows from these sources was partially offset by the cash proceeds received from the exercise of Warrants and options.

The $307.2 million increase in net cash provided by financing activities in 2022 as compared to 2021 was primarily due to the closing of the Business Combination.

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.

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.

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.

Operating Capital and Capital Expenditure Requirements

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However, some of our service providers also charge cancellation fees upon cancellation.

The amount and timing of such payments are not known, but at December 31, 2023 they are estimated to be a maximum of $12.6 million due within one year and $3.0 million due in more than a year.

As of December 31, 2023, we had cash of $340.5 million which is sufficient to fund these obligations.

We are party to two lease agreements, the Naarden Lease and the office lease agreement with Renaissance Aventura LLC, dated May 24, 2021 (the “Miami Lease”).

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

one year and $2.4 million due in more than a year.

As of December 31, 2024, we had cash and cash equivalents of $771.7 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”);

and an 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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The Miami Lease will expire by its terms on October 31, 2027, unless terminated earlier by either party pursuant to the terms of the Miami Lease.

Pursuant to the Yardley Lease, we are required to pay annual rent ranging from $189 thousand to $194 thousand, increasing from the low end of the range to the higher end of the range for each year of the lease.

The Yardley Lease will expire by its terms on April 3, 2026, unless terminated earlier by either party pursuant to the terms of the Yardley Lease.

Menarini License

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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.

What changed 10-K

Item 7. Management’s Discussion and Analysis