NAARDEN, The Netherlands and MIAMI, March 23, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” 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 that it will present data highlighting the potential for obi ...

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Lead Asset**: Obicetrapib Key Updates and Core Points - **Clinical Trials Progress**: - Completed Phase 3 trials: BROOKLYN, BROADWAY, and TANDEM, demonstrating obicetrapib's efficacy as a potent oral LDL-lowering drug [4][5] - Achieved LDL lowering in the 50% range when combined with ezetimibe, comparable to injectable therapies [4] - BROADWAY data showed a 21% MACE (Major Adverse Cardiac Events) benefit in a mini outcome study with 2,500 patients over one year [5] - PREVAIL trial designed with 9,500 patients to maximize success, focusing on high baseline LDL levels [5][6] - **Regulatory and Market Opportunities**: - Filed for approval in Europe, with potential launch in late 2026, starting in Germany and the U.K. [10] - Projected market potential for obicetrapib is $8 billion or higher, with 40%-50% of sales expected from outside the U.S. [10] - Expected royalties from the partnership with Menarini in the low double-digit to mid-20% range, with €800 million in milestones contingent on European approvals [11] - **Diabetes and Expanded Indications**: - RUBENS study focuses on diabetic patients, aiming to expand the label to include those without heart disease, potentially increasing the patient population by $20 million [6][61] - The drug shows significant efficacy in diabetic patients, with a focus on improving glycemic indices [61] - **Market Competition**: - Acknowledgment of Merck's upcoming oral PCSK9 therapy, with expectations of launching ahead in the U.S. but with different mechanisms and benefits [33][34] - Emphasis on the unique characteristics of obicetrapib, including Lp(a) lowering and diabetes benefits, which may differentiate it in the market [34][35] - **Alzheimer's Initiative**: - Plans for a Phase IIb trial targeting Alzheimer's, leveraging findings related to lipid metabolism and APOE4 gene associations [70][74] - Previous studies indicated obicetrapib's potential to stabilize biomarkers related to cognitive decline, with a focus on prevention rather than treatment [77][78] Additional Important Insights - **Imaging Studies**: - The REMBRANDT study aims to show plaque reduction, which could influence prescriber mindsets and drive uptake of obicetrapib [62][68] - The study is expected to be one of the first to demonstrate plaque reduction with a drug, enhancing its promotional potential [63] - **Market Dynamics**: - The potential for treatment guidelines to evolve, possibly doubling the patient population eligible for lipid therapies [36] - The importance of achieving LDL goals and the role of obicetrapib in achieving these goals, especially in high-risk populations [36][37] - **Regulatory Landscape**: - Discussion on the FDA's evolving approach to MACE studies and how it may benefit obicetrapib's labeling [15][16] This summary encapsulates the key points discussed during the conference call, highlighting NewAmsterdam Pharma's strategic direction, clinical advancements, and market positioning.

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Event**: FY Conference on March 03, 2026 Key Industry Insights - **Market Size**: The unmet need for LDL-lowering therapies is significant, with an estimated 30 million patients requiring treatment. The latest data indicates that achieving LDL levels below 55 is crucial for reducing total mortality, expanding the target population for combination therapies [4][5] - **Lipid Market Growth**: The lipid market is experiencing substantial growth, particularly in the branded segment, driven by more aggressive treatment targets and guidelines. The introduction of oral therapies is expected to further accelerate this growth [10][11] Core Product Insights - **Obicetrapib**: NewAmsterdam's lead drug, obicetrapib, is positioned as a differentiated LDL-lowering therapy with several key benefits: - **LDL Reduction**: Comparable LDL reductions to injectable therapies, with a significant reduction in small LDL particles by 90% [6][14][45] - **HDL Increase**: A 150% increase in HDL levels, which is associated with a lower risk of diabetes and potential benefits in Alzheimer's disease prevention [6][14][19] - **Lp(a) Lowering**: A 50% reduction in Lp(a) levels, targeting a population that may not qualify for existing injectable therapies [7][36] Clinical Trial Highlights - **BROADWAY Trial**: Demonstrated a 21% MACE benefit at 12 months, with a consistent LDL-lowering effect. The trial's design aligns closely with the upcoming PREVAIL trial, which is expected to validate these findings [3][12][15][23] - **Future Trials**: The PREVAIL trial is anticipated to provide further evidence of obicetrapib's efficacy, with a focus on achieving a positive MACE benefit to ensure broad uptake among clinicians [21][30] Regulatory and Commercial Strategy - **European Launch**: NewAmsterdam plans to launch obicetrapib in Europe, with regulatory approval expected by the end of 2026. The partnership with Menarini is seen as advantageous for market entry and reimbursement strategies [21][61][63] - **Market Differentiation**: The company aims to position obicetrapib as the first Lp(a)-lowering therapy in Europe, which could enhance its competitive edge [60][61] Financial Insights - **Funding and Milestones**: NewAmsterdam has secured $730 million in financing, with expectations to achieve significant sales milestones through its partnership with Menarini [4][61] - **Market Potential**: The potential market for obicetrapib is vast, with estimates suggesting it could serve tens of millions of patients, especially as treatment guidelines evolve [79] Additional Considerations - **Alzheimer's Disease Focus**: The potential for obicetrapib to impact Alzheimer's disease is highlighted as a significant opportunity, with market research indicating strong motivation among patients for effective treatments [18][78] - **Diabetes Risk**: Unlike statins, obicetrapib has shown a reduction in the risk of new-onset diabetes, which is a critical differentiator in the LDL-lowering market [14][30] Conclusion NewAmsterdam Pharma is positioned to capitalize on the growing demand for effective LDL-lowering therapies through its innovative product, obicetrapib. The company's strategic focus on clinical validation, regulatory approval, and market differentiation is expected to drive its success in the competitive landscape of lipid management.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number 001-41562 NewAmsterdam Pharma Company N.V. (Exact Name of Registrant as Specified in Its Charter) The Netherlands N/A (State or Other Jurisdiction ...

Financial Position - As of December 31, 2025, NewAmsterdam Pharma Company reported a cash, cash equivalents, and marketable securities balance of approximately $729 million[8] - The report does not include any financial statements or exhibits beyond the press release[11] Company Overview - The company is registered under the Commission File Number 001-41562 and trades on The Nasdaq Stock Market LLC under the symbol NAMS[5] - NewAmsterdam Pharma is classified as an emerging growth company under the Securities Act of 1933[5] - The company has not indicated any changes in its name or address since the last report[2] Strategic Priorities - The company highlighted its achievements for 2025 and outlined strategic priorities for 2026 in a press release issued on January 9, 2026[8] Compliance and Reporting - The company has not elected to use the extended transition period for complying with new or revised financial accounting standards[6] - The information provided in the report is not deemed "filed" for purposes of the Securities Exchange Act of 1934[10] - The Chief Financial Officer, Ian Somaiya, signed the report on January 9, 2026[15] - The press release is furnished as Exhibit 99.1 to the Current Report on Form 8-K[8]

Core Insights - NewAmsterdam Pharma is advancing its clinical and regulatory efforts for obicetrapib, with expected approval decisions from EMA, UK, and Switzerland regulators in the second half of 2026 [1][2] - The company reported a cash position of $728.9 million as of December 31, 2025, indicating financial strength to support ongoing operations and potential commercial launch [1][2] Clinical Development and Regulatory Updates - NewAmsterdam is developing obicetrapib as a low-dose, oral CETP inhibitor for patients at risk of cardiovascular disease (CVD) [3][10] - Marketing Authorization Applications (MAAs) for obicetrapib and its fixed-dose combination with ezetimibe have been accepted for review by EMA, UK, and Switzerland [2][3] - The company is preparing for a potential commercial launch in Europe alongside its partner Menarini [2][3] - Ongoing Phase 3 trials include PREVAIL, REMBRANDT, and RUBENS, with topline data from RUBENS expected by year-end 2026 [2][8] Financial Performance - NewAmsterdam reported a revenue of $22.5 million for the year ended December 31, 2025, a decrease from $45.6 million in 2024 [6][21] - Research and Development (R&D) expenses were $141.8 million in 2025, down from $151.4 million in 2024, primarily due to the completion of several Phase 3 trials [9][21] - Selling, General and Administrative (SG&A) expenses increased to $106.4 million in 2025 from $70.4 million in 2024, driven by higher personnel and marketing costs [13][21] Alzheimer's Disease Analysis - Positive data from the BROADWAY trial indicated significant reductions in p-tau217, a key Alzheimer's disease biomarker, supporting a link between CETP inhibition and neurodegeneration [7][12] - The analysis included 1,535 patients, with notable results in ApoE4 carriers, showing a 20.5% reduction in p-tau217 levels over 12 months compared to placebo [7][12][14] Upcoming Milestones - NewAmsterdam plans to announce additional data from its ongoing Phase 3 trials in 2026, including the potential initiation of a new clinical trial for obicetrapib in early Alzheimer's disease patients [5][8]

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM: NAMS) - **Event**: 2026 Emerging Outlook Biotech Summit - **Date**: February 11, 2026 Key Points Industry and Product Focus - NewAmsterdam Pharma is focused on the development of obicetrapib, a CETP inhibitor aimed at treating hyperlipidemia and associated cardiovascular risks [1][2] Clinical Trials and Study Updates - **PREVAIL Study**: Expected mid-year update on the study's readout timelines, with a commitment to provide updates based on event adjudication over two years [7][8] - **BROADWAY Study**: Demonstrated a 21% MACE (Major Adverse Cardiac Events) benefit, with event rates tracking in line with PREVAIL [7][8] - **Compliance Tracking**: Emphasis on patient compliance due to the long duration of outcome studies, with strategies in place to maintain patient engagement [16][17] Drug Efficacy and Safety - Obicetrapib shows the ability to achieve risk-based goals in 70%-80% of patients, with a convenient dosing regimen of a 10-mg oral pill [22] - The drug has demonstrated a reduction in Lp(a) levels by upwards of 50% and has potential implications for diabetes and Alzheimer's disease [23][52] - The safety profile is favorable, with lower adverse events compared to placebo, enhancing patient retention in studies [17][18] Market Opportunity - There are approximately 30 million patients in the U.S. not achieving risk-based goals despite being on treatment for hyperlipidemia, indicating a significant market opportunity [24][52] - The commercial landscape is expected to evolve positively, with NewAmsterdam positioned to leverage its differentiated drug profile against competitors [51][72] Competitive Landscape - NewAmsterdam is the only company with a CETP inhibitor in development, with expectations for regulatory approval in Europe and the U.S. [51][76] - The company plans to differentiate obicetrapib by emphasizing its broader benefits beyond LDL-C reduction, targeting various patient populations including those with diabetes and elevated Lp(a) levels [52][76] Regulatory and Launch Strategy - The U.S. filing is contingent on having outcomes data available at launch, while the European filing has already occurred [76] - The company is confident in its ability to launch successfully, drawing on the experience of its commercial team [70][72] Future Studies and Insights - Ongoing studies (VINCENT, RUBENS, REMBRANDT) will further explore the drug's efficacy, particularly regarding small LDL particle elimination [31][34] - The HORIZON study will provide insights into the contribution of Lp(a) to MACE benefits observed in BROADWAY, which may inform expectations for PREVAIL [79] Additional Insights - The design of the PREVAIL study is intended to avoid the pitfalls of previous CETP inhibitors, focusing on LDL reduction rather than HDL elevation [43][44] - The company has a strong leadership team with extensive experience in cardiology and lipidology, which is expected to enhance the study's execution and outcomes [42][43] This summary encapsulates the critical aspects of NewAmsterdam Pharma's conference call, highlighting the company's strategic focus, clinical developments, market opportunities, and competitive positioning within the biotech industry.

Core Insights - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1] Company Overview - NewAmsterdam Pharma aims to improve patient care in populations with metabolic diseases where existing therapies are inadequate or poorly tolerated [3] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, in multiple phase 3 trials as a LDL-C lowering therapy [3] - Obicetrapib is being studied both alone and in fixed-dose combinations with ezetimibe, intended as an adjunct to statin therapy for patients with elevated LDL-C [3]

Core Insights - NewAmsterdam Pharma is advancing its clinical development program for obicetrapib, an oral CETP inhibitor, with EMA approval expected in the second half of 2026 [1][3][5] - The company is conducting multiple Phase 3 trials, including PREVAIL, REMBRANDT, and RUBENS, to evaluate the efficacy of obicetrapib in various patient populations [3][6] - NewAmsterdam reported a year-end cash balance of approximately $729 million, which is expected to support operations through anticipated clinical milestones [7] Clinical Development - Obicetrapib is being developed as a low-dose, once-daily therapy for patients with elevated LDL-C who are at risk of cardiovascular disease [2][12] - The PREVAIL trial is tracking overall MACE event rates in line with the BROADWAY trial, indicating promising results for cardiovascular outcomes [3][4] - The RUBENS trial has enrolled its first patients and aims to evaluate obicetrapib in patients with metabolic syndrome [1][3] Regulatory and Commercialization Plans - NewAmsterdam is preparing for a potential commercial launch in Europe, contingent upon EMA approval for obicetrapib and its fixed-dose combination with ezetimibe [3][5] - The company has submitted marketing authorization applications (MAAs) for both obicetrapib monotherapy and the fixed-dose combination [5] Financial Position - As of December 31, 2025, NewAmsterdam's cash, cash equivalents, and marketable securities balance is approximately $729 million, which is projected to be sufficient for ongoing operations and potential commercialization [7] Alzheimer's Disease Research - Positive data from the BROADWAY trial indicated significant reductions in p-tau217, a key biomarker for Alzheimer's disease, suggesting a link between CETP inhibition and neurodegeneration [4][11] - NewAmsterdam plans to initiate a dedicated Alzheimer's trial in 2026 based on encouraging biomarker analysis results [3][6]

Core Insights - TimesSquare Capital Management's "U.S. Small Cap Growth Strategy" reported a gross return of 2.26% and a net return of 2.01% for Q3 2025, significantly underperforming the Russell 2000 Growth Index, which returned 12.19% [1] - The fund's top five holdings were highlighted, indicating its best investment picks for 2025 [1] Company Analysis - NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS) is a late-stage biopharmaceutical firm focused on cholesterol inhibitors for cardiovascular diseases [3] - The stock of NewAmsterdam Pharma experienced a one-month decline of 3.79% but has gained 28.57% over the past 52 weeks, closing at $33.48 per share with a market capitalization of $3.796 billion as of January 5, 2026 [2] - NewAmsterdam's lead candidate, a CETP inhibitor, demonstrated significant LDL level reductions without adverse side effects, contributing to a 57% increase in its share price [3] Investment Sentiment - NewAmsterdam Pharma was held by 28 hedge fund portfolios at the end of Q3 2025, a decrease from 31 in the previous quarter, indicating a slight decline in popularity among hedge funds [4] - Despite the potential of NewAmsterdam as an investment, the company is viewed as having less upside compared to certain AI stocks, which are considered to carry less downside risk [4]