NewAmsterdam Pharma Co N.V.
For the period ended Mar 31, 2026. Filed May 7, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 7, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001193125-25-265796
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001193125-26-210272
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 122 previous paragraphs and 110 current paragraphs.
46 unchanged; 40 reworded; 24 added; 32 removed; 4 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (24)
Current report
We have partnered with A. Menarini International Licensing S.A. (“Menarini”), providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a FDC with ezetimibe (the “Licensed Products”), in the majority of European countries (the Menarini Territory), if approved. In August 2025, the European Medicines Agency (the “EMA”) accepted for review the Marketing Authorization Applications (“MAAs”) submitted by Menarini for obicetrapib 10 mg monotherapy and the FDC of 10 mg obicetrapib plus 10 mg ezetimibe for the treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. Subsequently, MAAs were also submitted to regulators in the United Kingdom (“UK”) and Switzerland and accepted for review. The submissions are supported by data from the BROADWAY, BROOKLYN, and TANDEM pivotal Phase 3 trials. We anticipate that Menarini will receive decisions on the MAAs from each of the regulators in the second half of 2026. If the MAAs are approved by the regulators, Menarini will be required to use commercially reasonable efforts to commercialize obicetrapib in the Menarini Territory and could potentially launch these products in the fourth quarter of 2026 in Germany and the UK.
Current report
We conducted two Phase 3 pivotal clinical trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to potentially enhance LDL-C lowering in patients with ASCVD and/or HeFH. In March 2022, we commenced our Phase 3 PREVAIL CVOT, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE, including cardiovascular death, non-fatal myocardial infarction, total stroke and total coronary revascularization, in at least 9,000 patients. We completed enrollment in PREVAIL in April 2024. We expect the minimum 2.5 year follow-up period for the last participant in PREVAIL to be satisfied at the end of the 2026, but the PREVAIL trial protocol requires PREVAIL to continue until the target number of MACE events have occurred. Based on our review of preliminary blinded PREVAIL data following the second anniversary of the completion of enrollment, including a Year 1 event rate consistent with that we observed in BROADWAY and a Year 1-to-Year 2 overall MACE event rate lower than expected, we have decided to conduct an interim analysis of PREVAIL data in the fourth quarter of 2026 coinciding with reaching the minimum 2.5-year follow-up period for the trial. The blinded PREVAIL data available to us is preliminary and subject to change as additional MACE events continue to be identified and adjudicated (including with respect to the Year 1-to-Year 2 period discussed above). Additionally, the Year 1 and Year 1-to-Year 2 MACE event trends observed to date may not be indicative of future trends.
Current report
The interim analysis will be conducted by the Independent Data Safety Monitoring Board (“DSMB”) for the trial, and will remain blinded to us. Based on the analysis, we will receive a recommendation from the DSMB based on certain pre-specified criteria that we have set to end the trial early for efficacy or futility, as well as other considerations for which the DSMB has discretion, or if such criteria are not achieved, to continue the trial until the target number of MACE events has occurred. Only the DSMB will have access to unblinded data in connection with the interim analysis. We expect to receive the DSMB’s recommendation based on the interim analysis in the first quarter of 2027. If the interim analysis results in the trial being stopped early for efficacy or futility, then we will initiate activities to wind-down the study over the next few months including, among other things, final patient study visits and data collection procedures, to enable database lock and unblinding of the study. If the interim analysis results in the trial continuing, we expect to complete PREVAIL by the end of 2027.
Current report
In March 2026, we completed enrollment of 323 patients in REMBRANDT, a placebo-controlled, double-blind, randomized, Phase 3 trial is being conducted in adult participants with high-risk ASCVD with evidence of coronary plaque who are not adequately controlled by their maximally tolerated lipid-modifying therapy, with the aim to assess the impact of the obicetrapib 10 mg plus ezetimibe 10 mg FDC daily on lipid-rich coronary plaque and arterial wall inflammation characteristics. We are also conducting the RUBENS Phase 3 trial. Initiated in December 2025, this trial is evaluating obicetrapib alone or in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome that require additional lowering of LDL-C despite treatment with available therapy. The trial is expected to enroll approximately 300 patients, with topline data expected by year end 2026.
Current report
In addition to our cardiometabolic program, we are exploring the potential application of CETP inhibition in other indications, including AD and diabetes. Based on the lipid-modifying effects of CETP inhibition observed in our clinical trials for obicetrapib to date, we have conducted preclinical and early clinical evaluations of obicetrapib in AD. We initiated a Phase 2a clinical trial in patients with early AD to evaluate the pharmacodynamic and pharmacokinetic effects, safety and tolerability of obicetrapib, and announced initial data from this trial in September 2023. In July 2025, we announced data from the prespecified AD biomarker analysis in our BROADWAY clinical trial. Based on these results, we expect to initiate a new clinical trial evaluating obicetrapib in patients with early AD in 2026. Clinically demonstrated anti-diabetic benefits have also been observed with CETP inhibition in Phase 3 CVOTs that, if seen in obicetrapib, would differentiate it from current treatment alternatives, especially statin therapy. We are planning preclinical studies to examine the potential of obicetrapib for patients suffering from diabetes and have included new onset of Type 2 diabetes as an endpoint in our PREVAIL CVOT, as measured by adverse events (“AEs”) indicating Type 2 diabetes, initiation of anti-diabetes medication after confirmed diabetes diagnosis or high levels of hemoglobin A1c and fasting plasma glucose. In the Phase 3 BROADWAY trial, we observed a statistically significant improvement in these prespecified AEs of special interest after one year of treatment that we hope to reconfirm in the PREVAIL CVOT trial.
Current report
Research and Development Expenses
Current report
Selling, General and Administrative Expenses
Current report
Interest Income
Current report
Explanatory Note to Aid Comparison
Current report
In prior periods, including the three months ended March 31, 2025, costs related to medical affairs activities and personnel were classified within selling, general and administrative expenses. Due to changes in the nature of activities performed by our medical affairs function, certain such costs, including personnel costs, are classified in accordance with U.S. GAAP as research and development expenses in the three months ended March 31, 2026. Costs associated with our medical affairs function totaled $5.1 million in the three months ended March 31, 2025, of which $3.0 million were personnel costs, compared to total costs of $4.5 million in the three months ended March 31, 2026, of which $3.2 million were personnel costs.
Current report
Revenue was $3.0 million for the three months ended March 31, 2026 compared to $3.0 million for the three months ended March 31, 2025. Revenue for the three months ended March 31, 2025 was due to recognition of deferred revenue related to the R&D performance obligation. Revenue for the three months ended March 31, 2026 was related to the Menarini Supply Agreement.
Current report
Research and Development Expenses
Current report
Research and development expenses were $38.0 million for the three months ended March 31, 2026 compared to $44.8 million for the three months ended March 31, 2025, a decrease of $6.8 million or 15%. This was primarily driven by:
Current report
a $2.7 million increase in personnel expenses related to research and development activities, including the impact of including medical affairs related personnel costs in the current period, as discussed above. The remainder of the change is primarily driven by increased recruitment and employment costs for individuals involved within the research and development activities to support the growth of the organization, together with an offsetting $3.3 million decrease related to a payroll tax relief grant received in the Netherlands; and
Current report
Selling, General and Administrative Expenses
Current report
Selling, general and administrative expenses were $23.5 million for the three months ended March 31, 2026 compared to $27.2 million for the three months ended March 31, 2025, a decrease of $3.7 million or 14%. This was primarily driven by:
Current report
a $3.8 million decrease in marketing and communication expenses. The decrease is primarily driven by the change in the nature of medical affairs related costs, as described above, together with a $1.4 million reduction driven by lower market research spending;
Current report
a $0.8 million decrease in legal expenses primarily due to the transition of legal advisory services in-house;
Current report
a $0.7 million decrease in intellectual property costs primarily driven by worldwide patent filings incurred in the comparative period, which did not recur in the current period; and
Current report
Interest Income
Current report
Fair value change - warrants was a gain of $5.9 million for the three months ended March 31, 2026 compared to a gain of $13.8 million for the three months ended March 31, 2025. Prior to 2026, the fair value of the Warrants was determined using the last reported trading price of the Public Warrants, which trade under the symbol “NAMSW.” Beginning in 2026, due to a decrease in the trading volume of the Public Warrants, the fair value of the Warrants is determined by utilizing the Black-Scholes option pricing model. The primary driver of the change in fair value of the Warrants derived by such pricing method is the change in the trading price of the Company's Ordinary Shares, which trade under the symbol “NAMS.”
Current report
Menarini License and Menarini Supply Agreement
Current report
Net Cash Flows (Used In)/Provided By Investing Activities
Current report
Net cash flows (used in)/provided by investing activities was $11.5 million in the three months ended March 31, 2026 compared to $2.9 million in the three months ended March 31, 2025, a change of $14.4 million. The change is primarily attributable to the purchases and maturities of marketable securities.
Removed paragraphs (32)
Previous report
Third Quarter Highlights
Previous report
Acceptance of Marketing Authorization Applications for Review by European Medicines Agency for Obicetrapib
Previous report
On August 18, 2025 we announced that the European Medicines Agency (“EMA”) validated the Marketing Authorization Applications (“MAAs”) for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (“FDC”) for patients with primary hypercholesterolemia, both HeFH and non-familial or mixed dyslipidemia. The MAAs were submitted by our partner, Menarini, who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive license agreement with us (the "Menarini License").
Previous report
Menarini Supply Agreement
Previous report
The Supply Agreement also provides for the initiation of a process to transfer manufacturing of the Drug Products to Menarini or to a designated third-party contract manufacturer. In connection with the manufacturing transfer, we granted Menarini a non-exclusive, non-transferable license under our patents and know-how to manufacture finished Drug Products.
Previous report
Revenue was $0.3 million for the three months ended September 30, 2025 compared to $29.1 million for the three months ended September 30, 2024, a decrease of $28.8 million, or 99%. This decrease is largely due to the recognition of $27.3 million of revenue from the Menarini License related to a clinical development milestone which was earned in the three months ended September 30, 2024 while there were no clinical milestones earned in the three months ended September 30, 2025.
Previous report
Research and development expenses were $31.0 million for the three months ended September 30, 2025 compared to $35.7 million for the three months ended September 30, 2024, a decrease of $4.7 million, or 13%. This was primarily driven by:
Previous report
a $6.6 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials; and
Previous report
a $1.4 million decrease in manufacturing costs mainly driven by the completion of certain investments in commercial manufacturing capabilities during the current period;
Previous report
a $2.2 million increase in personnel expenses related to research and development activities primarily driven by our share-based compensation arrangements which account for $1.9 million of the increase; and
Previous report
Selling, general and administrative expenses were $24.5 million for the three months ended September 30, 2025 compared to $18.4 million for the three months ended September 30, 2024, an increase of $6.1 million or 33%. This was primarily driven by a $6.3 million increase in personnel expenses related to selling, general and administrative activities primarily driven by our share-based compensation arrangements which account for $5.1 million of the increase. The remainder was largely due to increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company.
Previous report
Fair value change - warrants was a loss of $23.8 million for the three months ended September 30, 2025 compared to a gain of $4.6 million for the three months ended September 30, 2024. The change is driven by changes in the market price of the warrants trading under the symbol “NAMSW” (the “Warrants”) during the period.
Previous report
Comparison of the nine months ended September 30, 2025 and 2024
Previous report
Revenue
Previous report
Revenue was $22.5 million for the nine months ended September 30, 2025 compared to $32.8 million for the nine months ended September 30, 2024, a decrease of $10.3 million, or 31%. This decrease was largely due to the recognition of $27.3 million of revenue from the Menarini License related to a clinical development milestone which was earned in the nine months ended September 30, 2024 while there were no clinical milestones earned in the three months ended September 30, 2025. The decrease in revenue related to clinical development milestones pursuant to the Menarini License was partially offset by the recognition of $16.1 million of revenue in the current period related to the second installment of development cost contributions under the Menarini License.
Previous report
Research and development expenses were $103.2 million for the nine months ended September 30, 2025 compared to $116.5 million for the nine months ended September 30, 2024, a decrease of $13.3 million, or 11%. This was primarily driven by:
Previous report
a $7.5 million increase in personnel expenses related to research and development activities primarily driven by our share-based compensation arrangements which accounted for $5.8 million of the increase;
Previous report
a $1.4 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib; and
Previous report
Selling, general and administrative expenses were $78.9 million for the nine months ended September 30, 2025 compared to $49.3 million for the nine months ended September 30, 2024, an increase of $29.6 million or 60%. This was primarily driven by:
Previous report
a $4.6 million increase in marketing and communication expenses related to startup costs as we began to build capabilities to support our planned commercial launch of obicetrapib, if approved; and
Previous report
a $1.4 million increase in costs related to our intellectual property primarily driven by worldwide patent filings.
Previous report
Interest income was $21.1 million for the nine months ended September 30, 2025 compared to $12.4 million for the nine months ended September 30, 2024, an increase of $8.7 million or 70%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable securities on which interest was earned.
Previous report
Fair Value Change - Earnout
Previous report
Fair value change - earnout was a gain of $4.0 million for the nine months ended September 30, 2025 compared to a loss of $11 million for the nine months ended September 30, 2024. The change was driven by changes in the market price for ordinary shares which trade under the symbol “NAMS” (the “Ordinary Shares”) prior to the settlement of the earnout liability, which occurred in March 2025.
Previous report
Fair Value Change - Warrants
Previous report
Fair value change - warrants was a loss of $7.4 million for the nine months ended September 30, 2025 compared to a loss of $19 million for the nine months ended September 30, 2024. The change was driven by changes in the market price of the Warrants during the period.
Previous report
Foreign Exchange Gains/(Losses)
Previous report
Loss for the Period
Previous report
Loss for the period was $128.9 million for the nine months ended September 30, 2025 compared to $149.4 million for the nine months ended September 30, 2024, a decrease of $20.5 million. The individual components of the change are described above.
Previous report
Net Cash Flows Used In Investing Activities
Previous report
Net cash flows used in investing activities was $153.8 million in the nine months ended September 30, 2025 compared to $0.7 million in the nine months ended September 30, 2024, a change of $153.1 million. The change was primarily due to our investments in marketable securities of which we had none in the nine months ended September 30, 2024. During the nine months ended September 30, 2025, purchases of debt securities totaled $225.2 million, partially offset by maturities of debt securities totaling $71.6 million.
Previous report
Menarini License
Reworded paragraphs (40)
Previous wording
The unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report, and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read together with our audited financial statements and accompanying notes for the year ended December 31, 2024, included in our Annual Report on Form 10-K (the "Annual Report"), filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2025, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those contained in or implied by any forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the sections titled “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in the Annual Report and this Quarterly Report. Our operating results are not necessarily indicative of results that may occur for the full fiscal year or any other future period.
Current wording
The unaudited condensed consolidated financial statements, included elsewhere in this Quarterly Report, and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read together with our audited financial statements and accompanying notes for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K (the “Annual Report”), filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 18, 2026. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those contained in or implied by any forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the sections titled “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in the Annual Report and this Quarterly Report. Our operating results are not necessarily indicative of results that may occur for the full fiscal year or any other future period.
Previous wording
We are a late-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well tolerated and convenient low-density lipoprotein cholesterol (“LDL-C”) lowering therapy. In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease (“CVD”) with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. We believe that CETP inhibition may also play a role in other indications by potentially mitigating the risk of developing diseases such as Alzheimer’s disease (“AD”).
Current wording
We are a late-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well tolerated and convenient low-density lipoprotein cholesterol (“LDL-C”) lowering therapy. In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination ("FDC") with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease (“CVD”) with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. We believe that CETP inhibition may also play a role in other indications by potentially mitigating the risk of developing diseases such as Alzheimer’s disease (“AD”).
Previous wording
Obicetrapib is a next-generation, oral, low-dose, highly selective CETP inhibitor that we are developing to potentially overcome the limitations of current LDL-C lowering treatments. In addition to LDL-C, in clinical trials obicetrapib has shown significant reductions in lipoprotein (a) (“Lp(a)”) and small LDL particles, all with safety comparable to placebo. We believe that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In each of our Phase 3 clinical trials, BROADWAY and BROOKLYN, evaluating obicetrapib as an adjunct to high-intensity statin therapy, obicetrapib met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In our Phase 3 TANDEM clinical trial, evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, obicetrapib in combination with ezetimibe met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In five of our Phase 2 clinical trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b clinical trial, evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C lowering with side effects similar in frequency and severity to placebo including muscle-related side effects and drug-related treatment emergent serious adverse events. We have observed obicetrapib to be well tolerated in an aggregate of over 3,500 patients with low or moderately elevated LDL-C levels (“dyslipidemia”) in our clinical trials to date. Furthermore, we believe that obicetrapib’s oral delivery, demonstrated activity at low doses, chemical properties and tolerability make it well-suited for combination approaches.
Current wording
Obicetrapib is a next-generation, oral, low-dose, highly selective CETP inhibitor that we are developing to potentially overcome the limitations of current LDL-C lowering treatments. We believe that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In each of our Phase 3 clinical trials, BROADWAY and BROOKLYN, evaluating obicetrapib as an adjunct to high-intensity statin therapy, obicetrapib met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In our Phase 3 TANDEM clinical trial, evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, obicetrapib in combination with ezetimibe met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. Following the successful completion and positive topline results of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, we plan to announce additional clinical data from these trials relating to obicetrapib and the FDC of obicetrapib plus ezetimibe during 2026. 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. In each of these trials, side effects were similar in frequency and severity to placebo including muscle-related side effects and drug-related treatment emergent serious adverse events. We have observed obicetrapib to be well tolerated in an aggregate of over 3,500 patients with low or moderately elevated LDL-C levels (“dyslipidemia”) in our clinical trials to date. Furthermore, we believe that obicetrapib’s oral delivery, demonstrated activity at low doses, chemical properties and tolerability make it well-suited for combination approaches.
Previous wording
Lowering of LDL-C, has been associated with major adverse cardiovascular events (“MACE”) benefit in trials of LDL-C lowering drugs, including the REVEAL trial with the CETP inhibitor, anacetrapib. In our Phase 3 BROADWAY clinical trial we observed a 21% reduction in the exploratory MACE endpoint (coronary heart disease death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization) and we are performing a Phase 3 cardiovascular outcomes trial (“CVOT”), PREVAIL, to reconfirm this relationship. We completed enrollment in PREVAIL in April 2024. PREVAIL will continue until the last participant has been followed for a minimum of 2.5 years and the target number of MACE events have occurred. As a result, the earliest the trial could conclude based on the minimum follow-up period is the end of 2026. However, we will continue the trial until the target number of MACE events occur, which could likely require the trial to continue beyond this point.
Current wording
Lowering of LDL-C has been associated with major adverse cardiovascular events (“MACE”) benefit in trials of LDL-C lowering drugs, including the REVEAL trial with the CETP inhibitor anacetrapib. In our Phase 3 BROADWAY clinical trial, we observed a 21% reduction in the exploratory MACE endpoint (coronary heart disease death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization) and we are performing a Phase 3 cardiovascular outcomes trial (“CVOT”), PREVAIL, to reconfirm this relationship.
Previous wording
In our clinical trials, obicetrapib has not only reduced LDL-C but also several additional biomarkers associated with MACE including non-HDL-C, apolipoprotein B, and small dense lipoprotein particles. We have also observed reductions in Lp(a), which is believed to be an independent MACE risk factor, along with reductions in total lipoprotein (“LDL”) particles and more specifically small LDL particles, which are believed to be more atherogenic particles.
Current wording
Obicetrapib has shown to not only reduce LDL-C but also several additional biomarkers associated with MACE. To date, obicetrapib has shown reductions in non-HDL-C, apolipoprotein B, and small dense lipoprotein particles. In our clinical trials, we have also observed reductions in Lp(a), which is believed to be an independent MACE risk factor, along with reductions in total lipoprotein (“LDL”) particles and more specifically small LDL particles, which are believed to be more atherogenic particles.
Previous wording
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.
Current wording
Our goal is to develop and commercialize an LDL-C lowering monotherapy and an FDC therapy, which offers the advantage of a single, low dose, once-daily oral pill, and fulfills the significant unmet need for an effective and convenient LDL-C lowering therapy. If we obtain marketing approval, we intend to commercialize obicetrapib for patients with ASCVD and/or HeFH and elevated levels of LDL-C despite being treated with currently available optimal lipid lowering therapy. Our goal is to submit a New Drug Application (“NDA”) in the U.S. for the FDC shortly after submitting an NDA for obicetrapib as a monotherapy. We expect that efficacy and safety data from BROADWAY and BROOKLYN will be described in the FDC product label, if approved.
Previous wording
We have partnered with A. Menarini International Licensing S.A. ("Menarini"), providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a fixed-dose combination with ezetimibe, in the majority of European countries, if approved. Subject to receipt of marketing approval, our current plan is to pursue development and commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and the European Union (the “EU”), including in Japan and China. In addition to our partnership with Menarini, we may in the future utilize a variety of types of collaboration, license, monetization, distribution and other arrangements with other third parties relating to the development or commercialization, once approved, of obicetrapib or future product candidates or indications. We are also continually evaluating the potential acquisition or license of new product candidates.
Current wording
Our current plan is to pursue development and, subject to the receipt of marketing approval, commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and Europe, including in Japan and China. 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 regularly evaluating the potential acquisition or license of new product candidates.
Previous wording
To date, we have not generated significant revenue from the sale of pharmaceutical products. Our revenue has been primarily derived from the Menarini License. Two performance obligations for the Menarini License were identified at contract inception, comprising a license to use our intellectual property (the “license performance obligation”) and a promise to continue the development activities for the licensed compound (the “R&D performance obligation”). Pursuant to the Menarini License, we received a non-refundable, non-creditable upfront amount of $120.9 million (€115.0 million) from Menarini on July 7, 2022, of which $98.6 million (€93.5 million) was attributed to the license performance obligation and recognized as revenue upon the execution of the Menarini License on June 23, 2022. The remaining $22.3 million (€21.5 million) was attributed to the R&D performance obligation and initially recognized as deferred revenue. As of September 30, 2025, the R&D performance obligation had been deemed to be completely satisfied and all deferred revenue related to such performance obligation was recognized.
Current wording
To date, we have not generated significant revenue from the sale of pharmaceutical products. Our revenue has been primarily derived from our license agreement with Menarini (the “Menarini License”). Two performance obligations for the Menarini License were identified at contract inception, comprising a license to use our intellectual property (the “license performance obligation”) and a promise to continue the development activities for the licensed compound (the “R&D performance obligation”). Pursuant to the Menarini License, we received a non-refundable, non-creditable upfront amount of $120.9 million (€115.0 million) from Menarini on July 7, 2022, of which $98.6 million (€93.5 million) was attributed to the license performance obligation and recognized as revenue upon the execution of the Menarini License on June 23, 2022. The remaining $22.3 million (€21.5 million) was attributed to the R&D performance obligation and initially recognized as deferred revenue. During the year ending December 31, 2025 the R&D performance obligation was satisfied and all deferred revenue related to such performance obligation was recognized.
Previous wording
Additionally, in partial contribution to our costs of development of the licensed products, Menarini may pay us €27.5 million, payable in two equal annual installments and attributed entirely to the R&D performance obligation. Due to the scientific uncertainties around the commercialization of the licensed products based on the success of clinical trials, which is out of our control, the fixed €27.5 million was considered constrained at contract execution and was not initially recognized within the transaction price until it becomes highly probable of no significant revenue reversal. As of September 30, 2025, both annual development cost contributions had been recognized within the transaction price.
Current wording
Additionally, in partial contribution to our costs of development of the Licensed Products, Menarini paid us €27.5 million, in two equal annual installments. Due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials, which is out of our control, the fixed €27.5 million was considered constrained at contract execution and was not initially recognized within the transaction price until it became highly probable of no significant revenue reversal. Both annual development cost contributions have since been recognized within the transaction price.
Previous wording
Under the Menarini License, we are also entitled to receive certain cost sharing payments, sales-based royalties and payments based upon the achievement of defined development, regulatory and commercial milestones linked to the enhanced value of the license performance obligation. These milestones are contingent payments and represent variable considerations that are not initially recognized within the transaction price, due to the scientific uncertainties around the commercialization of the licensed products based on the success of clinical trials. Our ability to receive and generate revenue from these payments is dependent upon a number of factors, including our ability to successfully complete the development of and obtain regulatory approval for obicetrapib within the Menarini Territory (as defined in the Menarini License). The uncertainty of achieving these milestones significantly impacts our ability to generate revenue. At the end of each reporting period, we assess the probability of significant reversals for any amounts that become likely to be realized prior to recognizing the variable consideration associated with these payments within the transaction price.
Current wording
Under the Menarini License, we are also entitled to receive certain cost sharing payments, sales-based royalties and payments based upon the achievement of defined development, regulatory and commercial milestones linked to the enhanced value of the license performance obligation. These milestones are contingent payments and represent variable considerations that are not initially recognized within the transaction price, due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials. Our ability to receive and generate revenue from these payments is dependent upon a number of factors, including our ability to successfully complete the development of and obtain regulatory approval for obicetrapib within the Menarini Territory. 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
In addition, we entered into the Menarini Supply Agreement to provide commercial supply of Drug Products for distribution by Menarini in specified European territories.
Current wording
In addition, we entered into a supply agreement with Menarini (the “Menarini Supply Agreement”) to provide commercial supply of obicetrapib monotherapy and obicetrapib and ezetimibe fixed-dose combination finished products in bulk tablet form (the “Drug Products”) for distribution by Menarini in specified European territories.
Previous wording
We recognize revenue from the sale of obicetrapib tablets, as a monotherapy and as a FDC therapy with ezetimibe, and from the sale of active pharmaceutical ingredients to Menarini for the manufacturer of such tablets. Our product supply revenue is recognized at a point in time when the performance obligation is satisfied by transferring control of the promised goods or services to the customer and it is probable that we will collect the consideration to which we are entitled. In accordance with the terms of the Menarini Supply Agreement, control of the product is transferred upon the conveyance of title, which occurs when the product is made available to Menarini. The transaction price is contractually fixed at a markup of the actual cost of goods sold. Due to the cost-based nature of the agreement, the pricing structure includes a variable component which is measured using the expected value method. At each reporting period end, we update our estimate of the transaction price using actual cost data and forecasted expenses. We state revenues net of any taxes collected from customers that are required to be remitted to various government agencies.
Current wording
We recognize revenue from the sale of Drug Products, and from the sale of active pharmaceutical ingredients to Menarini for the manufacturer of such tablets. Our product supply revenue is recognized at a point in time when the performance obligation is satisfied by transferring control of the promised goods or services to the customer and it is probable that we will collect the consideration to which we are entitled. In accordance with the terms of the Menarini Supply Agreement, control of the product is transferred upon the conveyance of title, which occurs when the product is made available to Menarini. The transaction price is contractually fixed at a markup of the actual cost of goods sold. Due to the cost-based nature of the agreement, the pricing structure includes a variable component which is measured using the expected value method. At each reporting period end, we update our estimate of the transaction price using actual cost data and forecasted expenses. We state revenues net of any taxes collected from customers that are required to be remitted to various government agencies.
Previous wording
We expect our research and development expenses to be significant as we advance our product candidates through clinical trials and pursue regulatory approval. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming. Clinical trials generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical trial expenses. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of obicetrapib as a monotherapy and as a fixed-dose combination with ezetimibe. See the section entitled “Risk Factors—Risks Related to Our Product Development, Regulatory Approval and Commercialization” contained in the Annual Report for more information regarding the risks associated with clinical development.
Current wording
We expect our research and development expenses to be significant as we advance our product candidates through clinical trials and pursue regulatory approval. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming. Clinical trials generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical trial expenses. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. See the section titled “Risk Factors—Risks Related to Our Product Development, Regulatory Approval and Commercialization” contained in the Annual Report and Part II, Item 1A Risk Factors of this Quarterly Report on Form 10-Q for more information regarding the risks associated with clinical development.
Previous wording
We recognize selling, general and administrative expenses on the accrual basis when incurred. These expenses mainly relate to consultant fees, employee costs, legal costs, marketing and communication, intellectual property costs related to drug patent development and protection globally, and general overhead costs.
Current wording
We recognize selling, general and administrative expenses on the accrual basis when incurred. These expenses mainly relate to consultant fees, employee costs, legal costs, marketing and communication, intellectual property costs and general overhead costs.
Previous wording
Due to the general growth of the organization associated with administering ongoing and planned clinical trials and our focus on commercial preparedness, we expect that our selling, general and administrative expenses may increase. We will incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance costs as well as investor and public relations expenses associated with being a public company. Additionally, if and when a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and expenses as a result of our preparation for commercial operations.
Current wording
Due to the general growth of the organization associated with administering ongoing and planned clinical trials and our focus on commercial preparedness, we expect that our selling, general and administrative expenses will increase. We may incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses associated with being a public company. Additionally, if and when a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and expenses as a result of our preparation for commercial operations.
Previous wording
Interest income is recognized using the effective interest rate method. Interest income for the three and nine months ended September 30, 2025 and 2024 is related to interest earned on cash, cash equivalents and marketable securities.
Current wording
Interest income is recognized using the effective interest rate method. Interest income for the three months ended March 31, 2026 and 2025 is related to interest earned on cash, cash equivalents, restricted cash and marketable securities.
Previous wording
Our exchange gain relates mainly to cash balances denominated in foreign currencies, but also to transactions denominated in foreign currencies. Our foreign currency exposure is mainly related to the Euro. As of September 30, 2025, our net exposure to foreign currency risk was $112.8 million, as compared to $108.6 million as of December 31, 2024.
Current wording
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 March 31, 2026, our net exposure to foreign currency risk was $ 80.9 million, as compared to $95.6 million as of December 31, 2025.
Previous wording
We have a history of losses and therefore have de minimis amounts of corporate tax. We expect to continue incurring losses as we continue to invest in our clinical and preclinical development programs. Consequently, any deferred tax assets are fully offset by a valuation allowance on our balance sheet.
Current wording
We have a history of losses and therefore have incurred de minimis amounts of corporate tax. We expect to continue incurring losses as we continue to invest in our clinical and preclinical development programs. Consequently, any deferred tax assets are fully offset by a valuation allowance on our balance sheet.
Previous wording
a $29.7 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials;
Current wording
a $8.3 million decrease in clinical expenses primarily due to the completion of Phase 3 clinical trials in the first half of 2025;
Previous wording
a $0.7 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management.
Current wording
a $2.9 million decrease in non-clinical expenses primarily due to reduced activity related to pipeline expansion and product lifecycle management;
Previous wording
a $0.8 million increase in manufacturing expenses driven by investments in commercial manufacturing capabilities.
Current wording
a $1.7 million increase in manufacturing expenses driven by a $4.9 million increase related to initial supply activities, partially offset by a $3.2 million decrease associated with commercial manufacturing capability investments made in the comparative period.
Previous wording
a $22.9 million increase in personnel expenses related to selling, general and administrative activities primarily driven by our share-based compensation arrangements which accounted for $15.4 million of the increase. The remainder was largely due to increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company;
Current wording
a $1.7 million increase in personnel expenses related to selling, general and administrative activities, including the impact of excluding medical affairs related personnel costs in the current period, as discussed above. The remainder of the change is primarily driven by increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company.
Previous wording
Interest income was $6.7 million for the three months ended September 30, 2025 compared to $4.4 million for the three months ended September 30, 2024, an increase of $2.3 million or 52%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable securities on which interest was earned.
Current wording
Interest income was $5.7 million for the three months ended March 31, 2026 compared to $7.4 million for the three months ended March 31, 2025, a decrease of $1.7 million or 23%. This was largely driven by a decrease in the amount of cash, cash equivalents and marketable debt securities on which interest is earned.
Previous wording
Fair value change - earnout was nil for the three months ended September 30, 2025 compared to a loss of $5.4 million for the three months ended September 30, 2024. The earnout liability was settled in full in March 2025.
Current wording
Fair value change - earnout was nil for the three months ended March 31, 2026 compared to a gain of $4.0 million for the three months ended March 31, 2025. The earnout liability was settled in full in March 2025.
Previous wording
Net foreign exchange gains/(losses) were a gain of $0.2 million for the three months ended September 30, 2025 compared to a gain of $4.7 million for the three months ended September 30, 2024. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.
Current wording
Net foreign exchange gains/(losses) were a loss of $1.6 million for the three months ended March 31, 2026 compared to a gain of $4.3 million for the three months ended March 31, 2025. 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 $72.0 million for the three months ended September 30, 2025 compared to $16.6 million for the three months ended September 30, 2024, an increase of $55.4 million. The individual components of the change are described above.
Current wording
Loss for the period was $48.4 million for the three months ended March 31, 2026 compared to $39.5 million for the three months ended March 31, 2025. The individual components of the change are described above.
Previous wording
To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of obicetrapib. As a result, we are not yet profitable and have incurred losses in each annual period since our inception. As of September 30, 2025, we had an accumulated loss of $687.5 million. We expect to continue to incur significant losses for the foreseeable future.
Current wording
To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of obicetrapib. As a result, we are not yet profitable and have incurred losses in each annual period since our inception. As of March 31, 2026, we had an accumulated loss of $810.8 million. We expect to continue to incur significant losses for the foreseeable future.
Previous wording
We have historically funded our operations primarily through private and public placements of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the closing of the transactions contemplated by the Business Combination Agreement. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $756.0 million.
Current wording
We have historically funded our operations primarily through private and public placements of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the closing of the transactions contemplated by the Business Combination Agreement. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $707.3 million.
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 (as defined in the Menarini License), for any use in the Menarini Territory (as defined in the Menarini License). Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million. Menarini has also committed to providing us €27.5 million in funding for the research and development activities related to the Licensed Products over two years, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory. We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones. If obicetrapib is approved, and successfully commercialized by Menarini, we will be entitled to tiered royalties ranging from the low double-digits to the mid-twenties as a percentage of net sales in the Menarini Territory, with royalty step-downs in the event of generic entrance or in respect of required third-party intellectual property payments. See the section entitled “Business—Commercial” contained in our Annual Report for a full description of the Menarini License.
Current wording
On June 23, 2022, we entered into the Menarini License, pursuant to which we granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property and our regulatory documentation to undertake post approval development activities and commercialize the Licensed Products (as defined in the Menarini License), for any use in the Menarini Territory (as defined in the Menarini License). Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million. Menarini has also committed to providing us €27.5 million in funding for the research and development activities related to the Licensed Products over two years, all of which has been received to date, 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, of which €30 million 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 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 September 30, 2025, we have received a total of €30.0 million and €13.8 million in milestone payments and R&D cost reimbursements, respectively, from Menarini, including €13.8 million which was received in the nine months ended September 30, 2025.
Current wording
As of March 31, 2026, we have received a total of €30 million in milestone payments from Menarini, none of which was received in the three months ended March 31, 2026.
Previous wording
On August 12, 2025, we entered into a Supply Agreement with Menarini as contemplated by the Menarini License. Under the terms of the Supply Agreement, we agreed to supply Menarini with obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination finished products in bulk tablet form (the “Drug Products”). We will initially be Menarini’s exclusive supplier of the Drug Products. The price to be paid by Menarini will be based on a specified mark-up to our “cost of goods sold” for the supplied Drug Products as determined in accordance with the Supply Agreement, subject to periodic adjustments.
Current wording
On August 12, 2025, we entered into the Menarini Supply Agreement, pursuant to which we will supply Menarini with the Drug Products. We will initially be Menarini’s exclusive supplier of the Drug Products and fulfill purchase orders based on periodic volume forecasts that Menarini is required to provide, a portion of which will be binding. The price to be paid by Menarini will be based on a specified mark-up to our “cost of goods sold” for the supplied Drug Products (as determined in accordance with the supply agreement), subject to periodic adjustments.
Previous wording
On August 9, 2024, we entered into an amended and restated sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may issue and sell from time to time up to $250 million of our Ordinary Shares through or to TD Cowen as our sales agent or acting as principal in any method deemed to be an “at the market offering.” TD Cowen will receive a commission of up to 3.0% of the gross proceeds of any Ordinary Shares sold pursuant to the Sales Agreement. During the nine months ended September 30, 2025, we did not sell any Ordinary Shares pursuant to the Sales Agreement.
Current wording
On August 9, 2024, we entered into an amended and restated sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may issue and sell from time to time up to $250 million of our Ordinary Shares through or to TD Cowen as our sales agent or acting as principal in any method deemed to be an “at the market offering.” TD Cowen will receive a commission of up to 3.0% of the gross proceeds of any Ordinary Shares sold pursuant to the Sales Agreement. During the three months ended March 31, 2026, we did not sell any Ordinary Shares pursuant to the Sales Agreement.
Previous wording
In the nine months ended September 30, 2025, 39,868 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $0.5 million. As of September 30, 2025, we had another 2,592,713 outstanding Warrants to purchase 2,592,713 Ordinary Shares, exercisable at an exercise price of $11.50 per share, which expire on November 23, 2027, at 5:00 p.m., Eastern Standard Time. Based on the exercise price of the Warrants, we may receive up to $29.8 million assuming the exercise of all Warrants outstanding as of September 30, 2025. The exercise of the Warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our Ordinary Shares and the spread between the exercise price of the Warrant and the price of an Ordinary Share at the time of exercise. For example, to the extent that the trading price of the Ordinary Shares exceeds $11.50 per share, it is more likely that holders of our Warrants will exercise their Warrants. If the trading price of the Ordinary Shares is less than $11.50 per share, it is unlikely that such holders will exercise their Warrants. The exercise price of the Warrants has at times exceeded the market price of the Ordinary Shares. To the extent that the price of our Ordinary Shares is below $11.50, we believe that the Warrant holders will be unlikely to cash exercise their warrants, resulting in little to no cash proceeds to us. There can be no assurance that our Warrants will be in the money prior to their expiration and, as such, certain unexercised Warrants may expire worthless. As such, it is possible that we may never generate any additional cash proceeds from the exercise of our Warrants. We have not included, and do not intend to include, any potential cash proceeds from the exercise of our Warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability that the Warrants are exercised over the life of our Warrants and the merit of including potential cash proceeds from the exercise thereof in our liquidity projections.
Current wording
In the three months ended March 31, 2026, 56,619 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $0.7 million. As of March 31, 2026, we had another 2,433,485 outstanding Warrants to purchase 2,433,485 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 $28.0 million assuming the exercise of all Warrants outstanding as of March 31, 2026. 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 nine months ended September 30, 2025 and 2024:
Current wording
The following is a summary of cash flows for the three months ended March 31, 2026 and 2025:
Previous wording
Net cash flows used in operating activities was $106.9 million in the nine months ended September 30, 2025 compared to $121.1 million in the nine months ended September 30, 2024, a decrease of $14.2 million. This change was primarily due to an increase in interest income and the receipt of the first of two annual development cost contributions due under the Menarini License, partially offset by an increase in operating expenditures.
Current wording
Net cash flows used in operating activities was $30.6 million in the three months ended March 31, 2026 compared to $36.5 million in the three months ended March 31, 2025, a decrease of $5.9 million. This change was primarily due to a reduction in operating expenses for the period partially offset by a change in working capital resulting from a decrease in accrued expenses.
Previous wording
Net cash flows provided by financing activities was $15.8 million in the nine months ended September 30, 2025 compared to $202.9 million in the nine months ended September 30, 2024, a decrease of $187.1 million. This decrease was primarily related to the receipt of proceeds from the February 2024 Offering in the prior year.
Current wording
Net cash flows provided by financing activities was $11.1 million in the three months ended March 31, 2026 compared to $6.5 million in the three months ended March 31, 2025, an increase of $4.6 million. The increase primarily reflects an increase in proceeds received upon the exercise of options.
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 September 30, 2025 they are estimated to be a maximum of $27.9 million due within one year and $11.4 million due in more than a year. As at September 30, 2025, we had cash and cash equivalents of $538.4 million which is sufficient to fund these obligations.
Current wording
We have entered into a variety of agreements and financial commitments in the normal course of business with CROs, CMOs, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at March 31, 2026 they are estimated to be a maximum of $29.5 million due within one year and $8.9 million due in more than a year. As at March 31, 2026, we had cash, cash equivalents and marketable securities of $707.3 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, 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. 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.
Current wording
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 and March 11, 2026 (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. The Naarden Lease will continue until terminated by either us or the landlord. Pursuant to the Miami Lease, we were 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 expired by its terms on April 30, 2026. Pursuant to the Yardley Lease, we were 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 expired by its terms on April 30, 2026.
Previous wording
We will be responsible for the development and commercialization costs related to Licensed Products (as defined in the Menarini License) other than those in the Menarini Territory (as defined in the Menarini License). In addition, under specified conditions of the agreement, we agreed to bear 50% of certain development costs incurred by the other party in the development of the Licensed Products in the Menarini Territory. See the section entitled “Business—Marketing and Sales” contained in the Annual Report for a description of the Menarini License.
Current wording
We will be responsible for the development and commercialization costs related to Licensed Products (as defined in the Menarini License) other than those in the Menarini Territory (as defined in the Menarini License). In addition, under specified conditions of the agreement, we agreed to bear 50% of certain development costs incurred by the other party in the development of the Licensed Products in the Menarini Territory. See the section entitled “Business—Marketing and Sales” contained in the Annual Report on Form 10-K for a description of the Menarini License.
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 on Form 10-K 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.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
The following table summarizes our consolidated statements of operations for the periods indicated:
Previous report — wording carried elsewhere
a $6.8 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses for the periods indicated:
Previous report — wording carried elsewhere
Net foreign exchange gains/(losses) were a gain of $13.1 million for the nine months ended September 30, 2025 compared to a gain of $1.3 million for the three months ended September 30, 2024. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.