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NewAmsterdam Pharma Co NV

For the period ended Jun 30, 2024. Filed Aug 7, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 7, 2024

NAMS$18.90+0.1%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-08.

0000950170-24-055767

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-07.

0000950170-24-092281

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 95 previous paragraphs and 115 current paragraphs.

54 unchanged; 28 reworded; 22 added; 12 removed; 1 previous and 11 current paragraphs rearranged.

Tables are not compared: 4 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (22)

Current report

On June 11, 2024, we announced that the United States Patent and Trademark Office (“USPTO”) has issued U.S. Patent No. 12,006,305, titled “Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof.” The newly issued patent contains claims covering amorphous obicetrapib hemicalcium, the solid form that will be used in the Company’s products and will be listed in the FDA’s “Orange Book” as a drug substance patent, if any such products are approved. The issuance of this composition of matter patent is expected to provide patent protection for obicetrapib until July 2043.

Current report

On July 8, 2024, we announced the completion of patient enrollment in the pivotal Phase 3 TANDEM clinical trial evaluating the fixed-dose combination (“FDC”) of obicetrapib plus ezetimibe in adult patients with HeFH and/or ASCVD or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies. The primary endpoint of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10 mg obicetrapib and 10 mg ezetimibe FDC on the change in LDL-C levels from baseline, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo. Secondary endpoints include evaluating the percent change from baseline of the FDC on lipoprotein(a) , apolipoprotein B and non-high-density lipoprotein cholesterol. The trial will also evaluate the safety and tolerability profile of the FDC. We expect to report topline data in the first quarter of 2025.

Current report

Positive Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial

Current report

On July 29, 2024, we announced positive topline data from our Phase 3 BROOKLYN clinical trial (NCT05425745). The BROOKLYN trial met its primary endpoint, with the obicetrapib arm achieving a statistically significant reduction of LDL-C versus placebo at day 84. An LS mean reduction of 36.3% (p < 0.0001) was observed compared to placebo at day 84, which was sustained at day 365 with an LS mean LDL-C reduction of 41.5% (p < 0.0001). The observed reductions in other biomarkers, including high-density lipoprotein cholesterol (“HDL-C”), non-HDL-C, lipoprotein(a) (“Lp(a)”), and apolipoprotein B (“ApoB”), met statistical significance.

Current report

Revenue was $2.3 million for the three months ended June 30, 2024 compared to $1.7 million for the three months ended June 30, 2023, an increase of $0.6 million or 33%. This increase is largely due to an increase in the amount of previously deferred revenue which was recognized as revenue in the current period.

Current report

Research and development expenses were $38.4 million for the three months ended June 30, 2024 compared to $34.3 million for the three months ended June 30, 2023, an increase of $4.1 million or 12%. This was primarily driven by a:

Current report

$0.9 million decrease in non-clinical expenses related to pre-clinical studies.

Current report

Selling, general and administrative expenses were $16.5 million for the three months ended June 30, 2024 compared to $9.9 million for the three months ended June 30, 2023, an increase of $6.6 million or 67%. This was primarily driven by a:

Current report

$2.3 million decrease in finance and administration expenses which is primarily due to costs incurred in June 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.

Current report

Research and development expenses were $80.8 million for the six months ended June 30, 2024 compared to $74.8 million for the six months ended June 30, 2023, an increase of $6.0 million or 8%. This was primarily driven by a:

Current report

$1.2 million decrease in non-clinical expenses related to pre-clinical studies.

Current report

Selling, general and administrative expenses were $30.9 million for the six months ended June 30, 2024 compared to $17.9 million for the six months ended June 30, 2023, an increase of $13.0 million or 73%. This was primarily driven by a:

Current report

$2.6 million decrease in finance and administration expenses which is primarily due to costs incurred in June 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.

Current report

Interest income was $8.0 million for the six months ended June 30, 2024 compared to $5.6 million for the six months ended June 30, 2023, an increase of $2.4 million or 43%. This increase was driven by interest earned on cash balances.

Current report

Loss for the period was $132.8 million for the six months ended June 30, 2024 compared to $80.3 million for the six months ended June 30, 2023, an increase of $52.5 million. The individual components of the change are described above.
Removed paragraphs (12)

Previous report

On March 12, 2024, we announced the dosing of the first patient in TANDEM, a Phase 3 pivotal trial, to evaluate 10 mg obicetrapib and 10 mg ezetimibe as a fixed-dose combination used as an adjunct to diet and maximally tolerated lipid-lowering therapies to potentially enhance LDL-lowering in patients with HeFH, ASCVD or ASCVD risk equivalents. We anticipate enrolling approximately 400 patients in the United States who have a baseline LDL-C of ≥ 70 mg/dL.

Previous report

Research and development expenses were $42.4 million for the three months ended March 31, 2024 compared to $40.4 million for the three months ended March 31, 2023, an increase of $2.0 million or 5%. This was primarily driven by a:

Previous report

Selling, general and administrative expenses were $14.5 million for the three months ended March 31, 2024 compared to $8.1 million for the three months ended March 31, 2023, an increase of $6.4 million or 79%. This was primarily driven by a:
Reworded paragraphs (28)

Previous wording

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 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 apolipoprotein 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 treatment-emergent serious adverse events. We have observed a favorable tolerability profile for obicetrapib in an aggregate of over 800 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. We are 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.

Current wording

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 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 apolipoprotein observed. In our Phase 2 and Phase 3 trials, TULIP, ROSE, OCEAN, ROSE2, our Japan Phase 2b trial and BROOKLYN evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C lowering with side effects similar in frequency and severity to placebo including muscle related side effects and drug-related treatment-emergent serious adverse events. We have observed a favorable tolerability profile for obicetrapib in an aggregate of over 800 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. We are 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.

Previous wording

As of March 31, 2024 we had cash of $481.1 million as compared to $340.5 million as of December 31, 2023. The increase in cash is primarily driven by the proceeds of the Offering (as defined below) and Warrant (as defined below) exercises 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.

Current wording

As of June 30, 2024 we had cash of $430.7 million as compared to $340.5 million as of December 31, 2023. The increase in cash is primarily driven by the proceeds of the Offering (as defined below) and Warrant (as defined below) exercises 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. While we currently qualify as an “emerging growth company,” we will no longer qualify as such as of December 31, 2024 and, as a result, we will no longer be able to avail ourselves of certain reduced reporting requirements applicable to emerging growth companies and expect to incur increased expenses as a result.

Previous wording

To date, we have not generated any revenue from the sale of pharmaceutical products. Our revenue has been solely derived from our license agreement with Menarini. 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 three months ended March 31, 2024, $1.4 million of revenue was recognized related to the recognition of additional amounts of the deferred portion of the upfront payment received from Menarini. 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.

Current wording

To date, we have not generated any revenue from the sale of pharmaceutical products. Our revenue has been solely derived from our license agreement with Menarini. 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 three and six months ended June 30, 2024, $2.3 million and $3.7 million of revenue was recognized, respectively, related to the recognition of additional amounts of the deferred portion of the upfront payment received from Menarini. 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.

Previous wording

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. 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.

Current wording

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. Our ability to receive and generate revenue from these payments is dependent upon a number of factors, including our ability to successfully complete the development of and obtain regulatory approval for obicetrapib within the Menarini Territory. The uncertainty of achieving these milestones significantly impacts our ability to generate revenue. At the end of each reporting period, we assess the probability of significant reversals for any amounts that become likely to be realized prior to recognizing the variable consideration associated with these payments within the transaction price.

Previous wording

Interest income is recognized using the effective interest rate method. Finance income for the three months ended March 31, 2024 and 2023 is related to interest earned on cash balances.

Current wording

Interest income is recognized using the effective interest rate method. Finance income for the three and six months ended June 30, 2024 and 2023 is related to interest earned on cash balances.

Previous wording

Our exchange gain relates mainly to cash balances denominated in foreign currencies, but also to transactions denominated in foreign currencies. The Company's foreign currency exposure is mainly related to the Euro. As of March 31, 2024, our net exposure to foreign currency risk was $98.3 million, as compared to $114.3 million as of December 31, 2023.

Current wording

Our exchange gain relates mainly to cash balances denominated in foreign currencies, but also to transactions denominated in foreign currencies. The Company's foreign currency exposure is mainly related to the Euro. As of June 30, 2024, our net exposure to foreign currency risk was $89.6 million, as compared to $114.3 million as of December 31, 2023.

Previous wording

$7.0 million increase in clinical expenses which related to our ongoing clinical trials. Costs related to our Phase 3 clinical trials increased by $7.3 million in the three months ended March 31, 2024 as compared to three months ended March 31, 2023. The increase related to Phase 3 clinical trials is slightly offset by a reduction of $0.3 million in costs related to Phase 1 and 2 clinical trials and other clinical expenses; and

Current wording

$5.2 million increase in clinical expenses which related to our ongoing clinical trials. Costs related to our Phase 3 clinical trials increased by $4.7 million in the three months ended June 30, 2024 as compared to three months ended June 30, 2023. The remaining increase of $0.5 million is related to Phase 1 and 2 clinical trials and other clinical expenses; offset by

Previous wording

$4.5 million decrease in manufacturing costs due to a $5 million decrease in costs related to drug substance validation which is partially offset by increased costs for clinical supply as we continue to plan and execute Phase 3 clinical trials.

Previous wording

$3.0 million increase in personnel expenses related to selling, general and administrative expenses primarily driven by our share-based compensation arrangements which account for $1.3 million of the increase. The remainder is largely due to increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company; and

Current wording

$5.8 million increase in personnel expenses related to selling, general and administrative expenses primarily driven by our share-based compensation arrangements which account for $3.5 million of the increase. The remainder is largely due to increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization;

Previous wording

$3.5 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.

Current wording

$3.0 million increase in marketing and communication expenses related to startup costs as we begin to build capabilities to support our planned commercial launch of obicetrapib, if approved; and

Previous wording

Interest income was $3.1 million for the three months ended March 31, 2024 compared to $0.9 million for the three months ended March 31, 2023, an increase of $2.2 million or 227%. This increase was driven by interest earned on cash balances.

Current wording

Interest income was $4.9 million for the three months ended June 30, 2024 compared to $4.6 million for the three months ended June 30, 2023, an increase of $0.3 million or 6%. This increase was driven by interest earned on cash balances.

Previous wording

Fair value change - earnout and warrants was a loss of $39.0 million for the three months ended March 31, 2024 compared to a loss of $6.2 million for the three months ended March 31, 2023. 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.

Current wording

Fair value change - earnout and warrants was a gain of $9.7 million for the three months ended June 30, 2024 compared to a loss of $0.4 million for the three months ended June 30, 2023. 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.

Previous wording

Net foreign exchange gains/(losses) were a loss of $2.4 million for the three months ended March 31, 2024 compared to a gain of $3.1 million for the three months ended March 31, 2023. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.

Current wording

Net foreign exchange gains/(losses) were a loss of $1.0 million for the three months ended June 30, 2024 compared to a loss of $0.1 million for the three months ended June 30, 2023. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.

Previous wording

Loss for the period was $93.8 million for the three months ended March 31, 2024 compared to $42.0 million for the three months ended March 31, 2023, an increase of $51.8 million. The individual components of the change are described above.

Current wording

Loss for the period was $39.0 million for the three months ended June 30, 2024 compared to $38.3 million for the three months ended June 30, 2023, an increase of $0.7 million. The individual components of the change are described above.

Previous wording

Revenue was $1.4 million for the three months ended March 31, 2024 compared to $8.6 million three months ended March 31, 2023, a decrease of $7.2 million or 84%. This decrease is largely due to the recognition of $5.4 million of revenue from the Menarini License related to a clinical development milestone achieved in the three months ended March 31, 2023 while no milestones were achieved during the three months ended March 31, 2024. The remaining decrease is due to recognition of $1.4 million of deferred revenue from the Menarini License related to the research and development performance obligation in the three months ended March 31, 2024 as compared to $3.2 million recognized in the three months ended March 31, 2023.

Current wording

Revenue was $3.7 million for the six months ended June 30, 2024 compared to $10.3 million for the six months ended June 30, 2023, a decrease of $6.6 million or 64%. This decrease is largely due to the recognition of $5.4 million of revenue from the Menarini License related to a clinical development milestone achieved in the six months ended June 30, 2023 while no milestones were achieved during the six months ended June 30, 2024. The remaining decrease is due to recognition as revenue of $3.7 million of previously deferred revenue from the Menarini License related to the research and development performance obligation in the six months ended June 30, 2024 as compared to $5.0 million recognized in the six months ended June 30, 2023.

Previous wording

To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of obicetrapib. As a result, we are not yet profitable and have incurred losses in each annual period since our inception. As of March 31, 2024, we had an accumulated loss of $410.7 million. We expect to continue to incur significant losses for the foreseeable future.

Current wording

To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of obicetrapib. As a result, we are not yet profitable and have incurred losses in each annual period since our inception. As of June 30, 2024, we had an accumulated loss of $449.7 million. We expect to continue to incur significant losses for the foreseeable future.

Previous wording

We have historically funded our operations primarily through private and public placements of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the closing of the transactions contemplated by the Business Combination Agreement, dated July 25, 2022 (the "Business Combination Agreement"), by and among the Company, NewAmsterdam Pharma Holding B.V., Frazier Lifesciences Acquisition Corporation ("FLAC"), and NewAmsterdam Pharma Investment Corporation (the “Business Combination”). As of March 31, 2024, we had cash of $481.1 million.

Current wording

We have historically funded our operations primarily through private and public placements of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the closing of the transactions contemplated by the Business Combination Agreement, dated July 25, 2022 (the "Business Combination Agreement"), by and among the Company, NewAmsterdam Pharma Holding B.V., Frazier Lifesciences Acquisition Corporation ("FLAC"), and NewAmsterdam Pharma Investment Corporation (the “Business Combination”). As of June 30, 2024, we had cash of $430.7 million.

Previous wording

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 March 31, 2024, we did not sell any Ordinary Shares pursuant to the Sales Agreement.

Current wording

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 six months ended June 30, 2024, we did not sell any Ordinary Shares pursuant to the Sales Agreement.

Previous wording

On June 23, 2022, we entered into the Menarini License, pursuant to which we granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property and our regulatory documentation to undertake post approval development activities and commercialize the Licensed Products, for any use in the Menarini Territory. Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million. Menarini has also committed to providing us €27.5 million in funding for the research and development activities related to the Licensed Products over two years, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory. We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones. If obicetrapib is approved, and successfully commercialized by Menarini, we will be entitled to tiered royalties ranging from the low double-digits to the mid-twenties as a percentage of net sales in the Menarini Territory, with royalty step-downs in the event of generic entrance or in respect of required third-party IP payments. See the section titled “Business—Commercial” contained in our Annual Report for a full description of the Menarini License.

Current wording

On June 23, 2022, we entered into the Menarini License, pursuant to which we granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property and our regulatory documentation to undertake post approval development activities and commercialize the Licensed Products, for any use in the Menarini Territory. Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million. Menarini has also committed to providing us €27.5 million in funding for the research and development activities related to the Licensed Products over two years, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory. We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones. If obicetrapib is approved, and successfully commercialized by Menarini, we will be entitled to tiered royalties ranging from the low double-digits to the mid-twenties as a percentage of net sales in the Menarini Territory, with royalty step-downs in the event of generic entrance or in respect of required third-party intellectual property payments. See the section titled “Business—Commercial” contained in our Annual Report for a full description of the Menarini License.

Previous wording

As of March 31, 2024, we have received a total of €5 million in milestone payments from Menarini none of which was received in the three months ended March 31, 2024.

Current wording

As of June 30, 2024, we have received a total of €5 million in milestone payments from Menarini none of which was received in the six months ended June 30, 2024.

Previous wording

In the three months ended March 31, 2024, 1,022,548 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $10.0 million. As of March 31, 2024, we had another 2,994,673 outstanding Warrants to purchase 2,994,673 Ordinary Shares, exercisable at an exercise price of $11.50 per share, which expire on November 23, 2027, at 5:00 p.m., Eastern Standard Time. Based on the exercise price of the Warrants, we may receive up to $34.4 million assuming the exercise of all Warrants outstanding as of March 31, 2024. From April 1, 2024 through May 3, 2024 a total of 255,702 additional Warrants were exercised generating gross proceeds of $2.9 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. For example, to the extent that the trading price of the Ordinary Shares exceeds $11.50 per share, it is more likely that holders of our Warrants will exercise their Warrants. If the trading price of the Ordinary Shares is less than $11.50 per share, it is unlikely that such holders will exercise their Warrants. The exercise price of the Warrants has at times exceeded the market price of the Ordinary Shares. To the extent that the price of our Ordinary Shares is below $11.50, we believe that the Warrant holders will be unlikely to cash exercise their warrants, resulting in little to no cash proceeds to us. There can be no assurance that our Warrants will be in the money prior to their expiration and, as such, certain unexercised Warrants may expire worthless. As such, it is possible that we may never generate any additional cash proceeds from the exercise of our Warrants. We have not included, and do not intend to include, any potential cash proceeds from the exercise of our Warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability that the Warrants are exercised over the life of our Warrants and the merit of including potential cash proceeds from the exercise thereof in our liquidity projections.

Current wording

In the six months ended June 30, 2024, 1,317,069 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $13.4 million. As of June 30, 2024, we had another 2,700,152 outstanding Warrants to purchase 2,700,152 Ordinary Shares, exercisable at an exercise price of $11.50 per share, which expire on November 23, 2027, at 5:00 p.m., Eastern Standard Time. Based on the exercise price of the Warrants, we may receive up to $31.1 million assuming the exercise of all Warrants outstanding as of June 30, 2024. The exercise of the Warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our Ordinary Shares and the spread between the exercise price of the Warrant and the price of an Ordinary Share at the time of exercise. For example, to the extent that the trading price of the Ordinary Shares exceeds $11.50 per share, it is more likely that holders of our Warrants will exercise their Warrants. If the trading price of the Ordinary Shares is less than $11.50 per share, it is unlikely that such holders will exercise their Warrants. The exercise price of the Warrants has at times exceeded the market price of the Ordinary Shares. To the extent that the price of our Ordinary Shares is below $11.50, we believe that the Warrant holders will be unlikely to cash exercise their warrants, resulting in little to no cash proceeds to us. There can be no assurance that our Warrants will be in the money prior to their expiration and, as such, certain unexercised Warrants may expire worthless. As such, it is possible that we may never generate any additional cash proceeds from the exercise of our Warrants. We have not included, and do not intend to include, any potential cash proceeds from the exercise of our Warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability that the Warrants are exercised over the life of our Warrants and the merit of including potential cash proceeds from the exercise thereof in our liquidity projections.

Previous wording

The following is a summary of cash flows for the three months ended March 31, 2024 and 2023:

Current wording

The following is a summary of cash flows for the six months ended June 30, 2024 and 2023:

Previous wording

Net cash flows used in operating activities was $54.6 million in the three months ended March 31, 2024 compared to $31.9 million in the three months ended March 31, 2023, an increase of $22.7 million. This change was primarily due to an increase in research and development and selling general administrative expenditures, the underlying reasons for which are described above.

Current wording

Net cash flows used in operating activities was $108.6 million in the six months ended June 30, 2024 compared to $61.2 million in the six months ended June 30, 2023, an increase of $47.4 million. This change was primarily due to an increase in research and development and selling, general and administrative expenditures, the underlying reasons for which are described above.

Previous wording

Net cash flows used in investing activities was $0.4 million in the three months ended March 31, 2024 compared to $0.0 million in the three months ended March 31, 2023, an increase of $0.4 million. The change is primarily due to investments in the three months ended March 31, 2024 in software for internal use.

Current wording

Net cash flows used in investing activities was $0.6 million in the six months ended June 30, 2024 compared to $0.0 million in the six months ended June 30, 2023, an increase of $0.6 million. This change was primarily due to investments in internal use software and computer equipment to support our growing organization.

Previous wording

Net cash flows provided by financing activities was $198.2 million in the three months ended March 31, 2024 compared to $2.4 million in the three months ended March 31, 2023, an increase of $195.8 million. This change was primarily related to the Offering which generated net proceeds of $190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company. The remaining change is due to an $8.6 million increase in the proceeds received from the exercise of Warrants, offset by a $0.5 million net outflow upon the exercise of options after taking into account the payment of related withholding taxes.

Current wording

Net cash flows provided by financing activities was $202.8 million in the six months ended June 30, 2024 compared to $8.7 million in the six months ended June 30, 2023, an increase of $194.1 million. This change was primarily related to the Offering which generated net proceeds of $190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company. The remaining change is due to a $4.8 million increase in the proceeds received from the exercise of Warrants, offset by a $0.5 million net outflow upon the exercise of options after taking into account the payment of related withholding taxes.

Previous wording

We have entered into a variety of agreements and financial commitments in the normal course of business with CROs, CMOs, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at March 31, 2024 they are estimated to be a maximum of $14.9 million due within one year and $4.3 million due in more than a year. As at March 31, 2024, we had cash of $481.1 million which is sufficient to fund these obligations.

Current wording

We have entered into a variety of agreements and financial commitments in the normal course of business with CROs, CMOs, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at June 30, 2024 they are estimated to be a maximum of $15.1 million due within one year and $3.0 million due in more than a year. As at June 30, 2024, we had cash of $430.7 million which is sufficient to fund these obligations.

Previous wording

We are party to a services agreement (the "Naarden Lease") pursuant to which an affiliate of Forbion leased us office space and the office lease agreement with Renaissance Aventura LLC, dated May 24, 2021 (the “Miami Lease”). Under the Naarden Lease, we are obligated to pay €40 thousand per year in rent. The Naarden Lease will continue until terminated by either us or the landlord. Pursuant to the Miami Lease, we are required to pay annual rent ranging from $69 thousand to $75 thousand, increasing from the low end of the range to the higher end of the range for each year of the lease. The Miami Lease will expire by its terms on October 31, 2024, unless terminated earlier by either party pursuant to the terms of the Miami Lease.

Current wording

(the “Yardley Lease”). Under the Naarden Lease, we are obligated to pay €40 thousand per year in rent. The Naarden Lease will continue until terminated by either us or the landlord. Pursuant to the Miami Lease, we are required to pay annual rent ranging from $75 thousand to $82 thousand, increasing from the low end of the range to the higher end of the range for each year of the lease. 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.

Previous wording

See Note 2 to our consolidated financial statements in the Annual Report and Note 2 to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report for a summary of significant accounting policies and the effect on our consolidated financial statements.

Current wording

See Note 2 to our consolidated financial statements in the Annual Report for a summary of significant accounting policies and the effect on our consolidated financial statements.
Rearranged current paragraphs (11)

Current report — wording carried from elsewhere

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

Current report — wording carried from elsewhere

$12.1 million increase in clinical expenses which related to our ongoing clinical trials. Costs related to our Phase 3 clinical trials increased by $12.0 million in the six months ended June 30, 2024 as compared to six months ended June 30, 2023. The remaining increase of $0.4 million is related to Phase 1 and 2 clinical trials and other clinical expenses; offset by

Current report — wording carried from elsewhere

$5.8 million decrease in manufacturing costs; and

Current report — wording carried from elsewhere

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

Current report — wording carried from elsewhere

$8.8 million increase in personnel expenses related to selling, general and administrative expenses primarily driven by our share-based compensation arrangements which account for $4.8 million of the increase. The remainder is largely due to increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization;

Current report — wording carried from elsewhere

$6.5 million increase in marketing and communication expenses related to startup costs as we begin to build capabilities to support our planned commercial launch of obicetrapib, if approved; and

Current report — wording carried from elsewhere

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

Current report — wording carried from elsewhere

Fair Value Change - Earnout and Warrants

Current report — wording carried from elsewhere

Fair value change - earnout and warrants was a loss of $29.3 million for the six months ended June 30, 2024 compared to a loss of $6.5 million for the six months ended June 30, 2023. 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.

Current report — wording carried from elsewhere

Net foreign exchange gains/(losses) were a loss of $3.4 million for the six months ended June 30, 2024 compared to a gain of $3.0 million for the three months ended June 30, 2023. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.

Current report — wording carried from elsewhere

We are party to a services agreement (the "Naarden Lease") pursuant to which an affiliate of Forbion leased us office space, the 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
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

On February 16, 2024, we completed an underwritten public offering (the “Offering”) of 5,871,909 of the Company's ordinary shares, nominal value €0.12 per share (the “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. 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 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 $190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.