Ezetimibe

LEQVIO marks a significant advancement in hypercholesterolemia management, particularly for patients not achieving target LDL-C levels despite maximally tolerated statin therapy. As the first FDA-approved siRNA therapy for LDL-C reduction, it introduces a novel mechanism of action with sustained efficacy and biannual dosing, enhancing patient adherence. LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's " LEQVIO Market Size, Forecast, and Market Insight Report" highlights the details around LEQVIO, which is a PCSK9 Inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LEQVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Novartis/Alnylam Pharmaceuticals' LEQVIO (inclisiran) Overview LEQVIO (inclisiran) is a first-of-its-kind therapy developed by Novartis based on small interfering RNA (siRNA) technology. It targets the mRNA of PCSK9 (proprotein convertase subtilisin/kexin type 9), reducing the production of this protein in the liver. Unlike traditional treatments, LEQVIO lowers LDL-C levels by enhancing the liver's ability to absorb and eliminate it from the bloodstream. In the US, LEQVIO is approved for use alongside diet and statin therapy in adults with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia (HeFH), to help reduce low-density lipoprotein cholesterol (LDL-C). The recommended LEQVIO dosage is 284 mg, given via subcutaneous injection initially, followed by a dose at 3 months, and then every 6 months thereafter, in combination with statins. In 2034, the market size of inclisiran is expected to be USD 2.2 billion in the US. Learn more about LEQVIO projected market size for PCSK9 inhibitors @ LEQVIO Market Potential Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a serine protease essential to cholesterol metabolism, primarily by controlling the breakdown of low-density lipoprotein (LDL) receptors. This mechanism decreases the removal of LDL particles from the blood, thereby influencing LDL cholesterol (LDL-C) levels. There is an inverse relationship between PCSK9 activity and LDL-C levels: gain-of-function mutations in the PCSK9 gene lead to increased LDL-C and a higher cardiovascular risk, as seen in familial hypercholesterolemia, while loss-of-function mutations are associated with lower LDL-C levels and reduced atherosclerotic cardiovascular disease (ASCVD) risk. In 2023, approximately 640,000 cases of familial hypercholesterolemia were diagnosed across the 7MM, with homozygous forms being extremely rare. PCSK9 inhibitors have emerged as a vital therapeutic option for hypercholesterolemia management, especially for patients at elevated cardiovascular risk or those unresponsive to standard treatments like statins. These drugs inhibit PCSK9, a protein that promotes LDL receptor degradation. By blocking PCSK9, these therapies enhance the presence of LDL receptors on liver cells, improving LDL-C clearance from the bloodstream. According to DelveInsight, the PCSK9 inhibitor market in the 7MM was valued at USD 2 billion in 2023. In summary, the PCSK9 inhibitor market is projected to witness substantial growth, driven by their use in statin-intolerant patients, expanding applications of PCSK9 inhibition, potential in broader therapeutic areas, and their role in preventive strategies to help reduce the overall cardiovascular disease burden. Discover more about the PCSK9 inhibitors market in detail @ PCSK9 Inhibitors Market Report Emerging Competitors of LEQVIO Several drugs are currently under development in the PCSK9 inhibitor pipeline, including Lerodalcibep (LIB Therapeutics), MK-0616 (Merck), VERVE-101 and VERVE-102 (Verve Therapeutics), and CiVi 008 (CiVi Biopharma), among others. Lerodalcibep is a third-generation PCSK9 inhibitor designed to overcome the limitations of traditional LDL-C-lowering therapies like statins and ezetimibe. It aims to help patients reach the more aggressive LDL-C targets recommended by recent cardiovascular guidelines. The drug is being developed as a once-monthly, low-volume injection with long shelf stability at room temperature. Currently in Phase III clinical trials, LIB Therapeutics intends to file a Biologics License Application (BLA) by year-end, with a potential PDUFA decision expected in the latter half of 2025. MK-0616, an oral PCSK9 inhibitor from Merck, is a novel macrocyclic peptide that blocks the interaction between PCSK9 and LDL receptors, thus reducing LDL cholesterol. It is currently in Phase III trials and could become the first oral treatment in its class. Verve Therapeutics is advancing two gene-editing candidates— VERVE-101 and VERVE-102—targeting PCSK9. These one-time treatments are designed to permanently switch off the PCSK9 gene in the liver, thereby lowering LDL-C levels. VERVE-102 is being evaluated in the Heart-2 Phase Ib trial for patients with heterozygous familial hypercholesterolemia (HeFH) or early-onset coronary artery disease. Meanwhile, enrollment in the Heart-1 trial for VERVE-101 has been paused due to lab abnormalities, and an investigation is ongoing. Based on the results, Verve will work with regulators to decide the next steps for VERVE-101. The company plans to initiate a randomized, placebo-controlled Phase II trial based on data from both the Heart-1 and Heart-2 studies. As these next-generation therapies move closer to approval, they have the potential to significantly disrupt and redefine the PCSK9 inhibitor market, ultimately giving fierce competition to LEQVIO. To know more about the number of competing drugs in development, visit @ LEQVIO Market Positioning Compared to Other Drugs Key Milestones of LEQVIO In July 2023, the US FDA approved an expanded indication for Novartis LEQVIO to include treatment of adults with high LDL-C and who are at increased risk of heart disease. The updated indication for primary hyperlipidemia allows for the expanded use of LEQVIO as an adjunct to diet and statin therapy beyond the previously approved ASCVD and HeFH patient populations. In 2023, LEQVIO (inclisiran) was approved by MHLW for familial and non-familial hypercholesterolemia and for patients who are at a high risk of developing cardiovascular events. In August 2022, Novartis selected Soleo Health as a Limited Drug Distribution Partner for the Administration of LEQVIO. Under this partnership, Soleo Health will administer the drug to patients in their homes or at one of the Company's Ambulatory Infusion Centers (AICs) in the US. In 2021, Novartis reached an agreement with the National Health Service (NHS) in England to implement a first-of-its-kind population health management approach designed to provide faster and broader access to LEQVIO for certain high-risk patients with ASCVD. In December 2020, Novartis announced that the European Commission (EC) approved LEQVIO to treat adults with hypercholesterolemia or mixed dyslipidemia, two common forms of elevated cholesterol. Discover how LEQVIO is shaping the PCSK9 inhibitors treatment landscape @ LEQVIO Injection LEQVIO Market Dynamics LEQVIO, as a first-in-class small interfering RNA (siRNA) that helps maintain bad cholesterol levels and improve mortality rates, strengthens its market position with a value-based price per dose and promising market access and reimbursement. Ongoing trials for CVRR and Pediatric Hyperlipidemia expansion pave the way for label expansion, addressing diverse medical needs. The escalating patient population presents a favorable trend for expanding LEQVIO's market reach and driving growth. However, its market is currently constrained by its specific indication for HeFH in adults, potentially limiting its reach compared to competitors like REPATHA and PRALUENT, which are approved for both HoHF and HeHF in adults and pediatrics. The market is expected to face heightened competition post-2027, which may impact LEQVIO's market share, and similar annual treatment costs across PCSK9 inhibitors may pose a challenge, affecting LEQVIO's competitive edge despite better reimbursement policies. Dive deeper to get more insight into LEQVIO's strengths & weaknesses relative to competitors @ LEQVIO Market Drug Report Table of Contents Related Reports PCSK9 Inhibitor Market PCSK9 Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PCSK9 inhibitor companies, including LIB Therapeutics, Merck, Verve Therapeutics, CiVi Biopharma, among others. PCSK9 Inhibitors Pipeline PCSK9 Inhibitors Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PCSK9 inhibitors companies, including Ionis Pharmaceuticals, Akeso Biopharma, Amgen, Novo Nordisk, Civi BioPharma, among others. Hypercholesterolemia Market Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hypercholesterolemia companies, including Novartis Pharmaceuticals, Merck Sharp & Dohme LLC, Esperion Therapeutics, Inc., Arrowhead Pharmaceuticals, LIB Therapeutics LLC, Medpace, Inc., AstraZeneca, NewAmsterdam Pharma, among others. Homozygous Familial Hypercholesterolemia Market Homozygous Familial Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key homozygous familial hypercholesterolemia companies, including Arrowhead Pharmaceuticals, Novartis, Alnylam Pharmaceuticals, LIB Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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– EMA submission expected in 2H25 by partner Menarini – – PREVAIL Phase 3 CVOT remains on track – -- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively -- -- Company to host R&D day on June 11th, 2025 in New York City -- –$808.5 million in cash, cash equivalents and marketable securities at March 31, 2025 – NAARDEN, The Netherlands and MIAMI, May 08, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam,” “we,” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the quarter ended March 31, 2025 and provided a corporate update. "Our first quarter was marked by continued clinical execution and investment in our commercial organization to support the potential launch of obicetrapib,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “With over $800 million in cash, cash equivalents and marketable securities on our balance sheet, we believe we are well positioned to drive near- and long-term value for our stakeholders, as we move closer to delivering novel, once-daily, low dose, oral therapies to address the significant global unmet need for safe and effective LDL-C lowering therapies.” Dr. Davidson continued, “In addition, the data recently presented at EAS and published in the New England Journal of Medicine and The Lancet highlight obicetrapib’s differentiated product profile for the potential treatment of lipid management, and we are eager to continue to share additional data from our three pivotal Phase 3 trials, particularly regarding obicetrapib’s impact on major adverse cardiac events (“MACE”), at prominent medical conferences and journal publications. We are also progressing with regulatory interactions, including an expected EMA submission in the second half of the year by our partner Menarini. This commercial and clinical progress, combined with our financial strength provides a foundation for future growth as we look to address the needs of many more patients living with dyslipidemia.” Clinical Development Updates NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated. Additional data from BROADWAY, TANDEM, and BROOKLYN is expected to be presented and published over the next several months, highlighting what we believe to be obicetrapib’s differentiated product profile to lipid management. Ongoing Trials: Following the successful completion of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials NewAmsterdam plans to announce additional data over the course of 2025 relating to obicetrapib and the fixed-dose combination (“FDC”) of obicetrapib plus ezetimibe. The following trials are currently ongoing: PREVAIL Phase 3 trial. PREVAIL is a cardiovascular outcomes trial (“CVOT”) evaluating obicetrapib in patients with a history of atherosclerotic cardiovascular disease (“ASCVD”), whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 9,500 patients in April 2024.VINCENT Phase 2 trial. The trial will evaluate the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) (“Lp(a)”) in patients with mild dyslipidemia. The single arm study will treat patients with obicetrapib 10 mg daily for 8 weeks followed by obicetrapib 10 mg daily plus evolocumab 140 mg/dL every other week for 8 weeks. There will be two cohorts in the study. The first cohort will include 39 participants with Lp(a) levels greater than 125 nmol/L, and the second cohort will include 30 participants with Lp(a) levels greater than 50 nmol/L but less than 125 nmol/L.REMBRANDT Phase 3 trial. The trial will utilize coronary computed tomography angiography imaging to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque. The 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, to assess the impact of the obicetrapib 10 mg plus ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics. The study is expected to enroll 300 patients. Corporate Updates In April 2025, NewAmsterdam appointed Adele Gulfo to the Company’s Board of Directors. Ms. Gulfo is an established pharmaceutical executive with over three decades of experience in the healthcare industry, distinguished by her expertise in global strategy, operations leadership, and commercialization of multiple blockbuster medicines. Upcoming Investor Event NewAmsterdam will host an R&D Day event on Wednesday, June 11, 2025, beginning at 9 a.m. ET in New York City. A live webcast of the event will be available through the investor relations section of the NewAmsterdam website at ir.newamsterdampharma.com. Following the live webcast, an archived replay will be available on the Company’s website. First Quarter Financial Results Cash Position: As of March 31, 2025, NewAmsterdam recorded cash, cash equivalents and marketable securities of $808.5 million, compared to $834.2 million as of December 31, 2024. The decrease is primarily driven by ongoing operating expenditures, partially offset by the first of two development cost contributions from our partner Menarini and cash received from interest and the exercise of options.Revenue: NewAmsterdam recognized $3.0 million in revenue for the quarter ended March 31, 2025, compared to $1.4 million in the same period in 2024. The increase is primarily attributable to the increase in transaction price attributable to the R&D performance obligation as a result of the recognition in 2024 of the first of two annual development cost contributions pursuant to the terms of the license agreement with Menarini.Research and Development (“R&D”) Expenses: R&D expenses were $44.8 million in the quarter ended March 31, 2025, compared to $42.4 million for the same period in 2024. This increase was primarily due to an increase in personnel costs, including share-based compensation, non-clinical costs related to pipeline expansion and product lifecycle management and investments in commercial manufacturing capabilities, partially offset by a decrease in clinical expenses.Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses were $27.2 million in the quarter ended March 31, 2025, compared to $14.5 million for the same period in 2024. This increase was primarily due to an increase in personnel costs, including share-based compensation, and investments in capabilities to support the Company's planned commercial launch of obicetrapib, if approved and an increase in costs related to the Company's intellectual property primarily driven by worldwide patent filings.Net loss: Net loss for the quarter ended March 31, 2025 was $39.5 million, compared to net loss of $93.8 million for the same period in 2024. The individual components of the change are described above in addition to non-cash losses related to changes in the fair value of our derivative liabilities. About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL CVOT in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. About Cardiovascular Disease Cardiovascular disease remains the leading cause of death globally, despite the availability of lipid-lowering therapies (“LLTs”). By 2050 more than 184 million U.S. adults are expected to be affected by CVD and hypertension, including 27 million with coronary heart disease and 19 million with stroke. In the United States from 2019 through 2022, CVD age-adjusted mortality rates increased by 9%, reversing the trend observed since 2010 and undoing nearly a decade of progress. Despite the availability of high-intensity statins and non-statin LLTs, LDL-C target level attainment remains low, contributing to residual cardiovascular risk, and underscoring a significant clinical need for improved therapeutic regimens. Even with 269 million LLT prescriptions written over the last 12 months, 30 million under-treated US adults are not at their risk-based LDL-C goal, of which 13 million have ASCVD. Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70 mg/dL and only 10% of very high risk ASCVD patients achieve the goal below 55 mg/dL. In addition to the 30 million under-treated U.S. adults, there are 10 million patients diagnosed with elevated LDL-C who are not taking any LLTs including statins. Beyond LDL-C, additional factors are at play, such as lifestyle choices, tobacco use, and obesity, as well as inflammation, thrombosis, triglyceride levels, elevated Lp(a) levels, and type 2 diabetes. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage, clinical biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily 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 CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Forward-Looking Statements Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company’s business and strategic plans, the Company’s commercial opportunity, the therapeutic and curative potential of the Company’s product candidate, the Company’s clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; whether topline, initial or preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, or whether projections regarding clinical outcomes will reflect actual results in future clinical trials or clinical use of our product candidate, if approved; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflicts; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the Securities and Exchange Commission. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; and ability to continue to source the raw materials for the Company’s product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com Media ContactSpectrum Science on behalf of NewAmsterdamJaryd LeadyP: 1-856-803-7855jleady@spectrumscience.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696austin.murtagh@precisionaq.com NewAmsterdam Pharma Company N.V.Condensed Consolidated Balance Sheet(Unaudited) March 31,2025 December 31,2024 (In thousands of USD) Assets Current assets: Cash and cash equivalents 748,420 771,743 Prepayments and other receivables 8,827 24,272 Employee receivables — 4,951 Marketable securities 60,057 62,447 Total current assets 817,304 863,413 Property, plant and equipment, net 238 242 Operating right of use asset 369 431 Intangible assets 502 534 Total assets 818,413 864,620 Liabilities and Shareholders' Equity Current liabilities: Accounts payable 6,087 4,744 Accrued expenses and other current liabilities 8,021 13,608 Deferred revenue, current 3,030 6,008 Lease liability, current 252 246 Derivative earnout liability, current — 44,798 Derivative warrant liabilities 23,523 37,514 Total current liabilities 40,913 106,918 Lease liability, net of current portion 137 202 Total liabilities 41,050 107,120 Commitments and contingencies (Note 10) Shareholders' Equity: Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 112,169,291 and 108,064,340 shares issued and outstanding as at March 31, 2024 and December 31, 2023, respectively 13,968 13,444 Additional paid-in capital 1,357,059 1,298,160 Accumulated loss (598,098) (558,571)Accumulated other comprehensive income 4,434 4,467 Total shareholders' equity 777,363 757,500 Total liabilities and shareholders' equity 818,413 864,620 NewAmsterdam Pharma Company N.V.Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)(Unaudited) For the three months ended March 31, 2025 2024 (In thousands of USD, except per share amounts) Revenue 2,978 1,401 Operating expenses: Research and development expenses 44,751 42,430 Selling, general and administrative expenses 27,152 14,453 Total operating expenses 71,903 56,883 Operating loss (68,925) (55,482)Other income (expense): Interest income 7,351 3,083 Fair value change – earnout 3,992 (8,702)Fair value change – warrants 13,762 (30,248)Foreign exchange gains/(losses) 4,293 (2,418)Loss before tax (39,527) (93,767)Income tax expense — — Loss for the year (39,527) (93,767)Other comprehensive income/(loss) Unrealized gain/(loss) on available-for-sale securities, net of tax (33) — Total comprehensive loss for the year, net of tax (39,560) (93,767) NewAmsterdam Pharma Company N.V.Condensed Consolidated Statements of Mezzanine Equity and Shareholders' Equity (Deficit)(Unaudited) (In thousands of USD, except share amounts)Shares Amount Additional Paid-In Capital Accumulated Loss Accumulated Other Comprehensive Income Total Shareholders' Equity Balance at December 31, 2023 82,469,768 10,173 590,771 (316,973) 4,422 288,393 Issuance of Ordinary Shares and Pre-Funded Warrants, net of issuance costs 5,871,909 759 189,207 — — 189,966 Exercise of warrants 926,698 121 19,674 — — 19,795 Exercise of stock options 452,461 60 (609) — — (549)Share-based compensation — — 7,965 — — 7,965 Total loss and comprehensive loss for the period — — — (93,767) — (93,767)As at March 31, 2024 89,720,836 11,113 807,008 (410,740) 4,422 411,803 Balance at December 31, 2024 108,064,340 13,444 1,298,160 (558,571) 4,467 757,500 Issuance of Earnout Shares 1,743,136 226 40,581 — — 40,807 Exercise of Pre-Funded Warrants 1,293,938 162 (162) — — — Exercise of warrants 15,942 2 410 — — 412 Exercise of stock options 909,140 116 2,875 — — 2,991 Vesting of RSUs 142,795 18 (18) — — — Share-based compensation — — 15,213 — — 15,213 Total loss and comprehensive loss for the period — — — (39,527) (33) (39,560)As at March 31, 2025 112,169,291 13,968 1,357,059 (598,098) 4,434 777,363 NewAmsterdam Pharma Company N.V.Condensed Consolidated Statements of Cash Flows(Unaudited) For the three months ended March 31, 2025 2024 (In thousands of USD) Operating activities: Loss for the period (39,527) (93,767)Non-cash adjustments to reconcile loss for the period to net cash flows: Depreciation and amortization 52 15 Non-cash rent expense 3 1 Fair value change - derivative earnout and warrants (17,754) 38,950 Foreign exchange (gains)/losses (4,293) 2,418 Amortization of premium/discount on available-for-sale debt securities (513) — Share-based compensation 15,213 7,918 Changes in working capital: Changes in prepayments (current and non-current) and other receivables 16,031 956 Changes in accounts payable 2,251 (8,311)Changes in accrued expenses and other current liabilities (4,953) (1,381)Changes in deferred revenue (2,978) (1,401)Net cash used in operating activities (36,468) (54,602)Investing activities: Purchase of property, plant and equipment, including internal use software (16) (385)Maturity of available-for-sale debt securities 12,500 — Purchase of available-for-sale debt securities (9,629) — Net cash (used in)/provided by investing activities 2,855 (385)Financing activities: Proceeds from February 2024 offering of Ordinary Shares and Pre-Funded Warrants — 190,481 Transaction costs on February 2024 issue of Ordinary Shares and Pre-Funded Warrants — (515)Transaction costs on December 2024 issue of Ordinary Shares and Pre-Funded Warrants (1,586) — Proceeds from exercise of warrants 183 8,763 Proceeds from exercise of options 7,922 440 Payment of withholding taxes related to net share settlement of exercised options — (989)Net cash provided by financing activities 6,519 198,180 Net change in cash (27,094) 143,193 Foreign exchange differences 3,771 (2,496)Cash and cash equivalents at the beginning of the year 771,743 340,450 Cash and cash equivalents at the end of the year 748,420 481,147 Noncash financing and investing activities Receivable related to exercise of warrants — 1,271 Issuance of earnout shares 40,807 —