Core Insights - The investment represents a multi-million-dollar upgrade in equipment to enhance production capabilities for fixed dose combination (FDC) products [1][4] - The new manufacturing suite at the Sellersville facility will support the production of NewAmsterdam Pharma's investigational non-statin cholesterol medication aimed at reducing LDL-C [2][4] - The partnership between Piramal Pharma Solutions and NewAmsterdam Pharma is crucial for the development and production of the FDC, with significant contributions from Piramal's facilities in India [2][4] Company Developments - The new suite is expected to create over 20 new jobs at the Sellersville site over the next five years, contributing positively to the local economy [3] - The investment reflects a commitment to continuous improvement and operational efficiency, enabling both companies to meet future commercial demands for the FDC product [4] - NewAmsterdam Pharma is focused on developing obicetrapib, a low-dose CETP inhibitor, to address unmet needs in LDL-lowering therapies [5][6] Industry Context - NewAmsterdam Pharma operates in the late-stage clinical biopharmaceutical sector, targeting metabolic diseases with inadequate existing therapies [6] - Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) providing comprehensive services across the drug life cycle, enhancing its capabilities through this investment [7][8]

Core Viewpoint - NewAmsterdam Pharma has submitted Marketing Authorization Applications (MAAs) for obicetrapib monotherapy and its fixed-dose combination with ezetimibe to the European Medicines Agency (EMA) for treating primary hypercholesterolemia and mixed dyslipidemia, marking a significant step in providing new LDL-C lowering therapies for patients at risk of cardiovascular disease [1][2][3] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients with elevated low-density lipoprotein cholesterol (LDL-C) who are at risk of cardiovascular disease [1][6] - The company aims to address unmet needs in LDL-lowering therapies that are safe, well-tolerated, and convenient for patients [6] Product Development - Obicetrapib is a novel, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor, which has shown statistically significant LDL-C reductions in multiple Phase 3 trials, including BROADWAY, BROOKLYN, and TANDEM [2][5] - The BROADWAY trial reported a 33% reduction in LDL-C compared to placebo, while the TANDEM trial achieved a 49% reduction, demonstrating the efficacy of obicetrapib both as a monotherapy and in combination with ezetimibe [7] Partnership and Financials - NewAmsterdam has an exclusive licensing agreement with Menarini for the commercialization of obicetrapib in Europe, which includes an upfront payment of €115 million and potential milestone payments totaling up to €863 million [3][4] - The company is entitled to tiered double-digit percentage royalties on net sales in the Menarini territory, ranging from low double-digits to mid-twenties [1][3] Market Context - Cardiovascular disease remains the leading cause of death globally, with an estimated 17.9 million deaths annually, highlighting the need for effective LDL-lowering therapies [3] - Despite the availability of lipid-lowering therapies, many patients do not achieve their LDL-C targets, indicating a significant market opportunity for new treatments like obicetrapib [3][6]

Core Insights - NewAmsterdam Pharma Company N.V. reported a quarterly loss of $0.15 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.52, representing an earnings surprise of +71.15% [1] - The company achieved revenues of $19.15 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 486.19%, compared to revenues of $2.28 million in the same quarter last year [2] - The stock has underperformed the market, losing about 15.5% since the beginning of the year, while the S&P 500 has gained 7.1% [3] Financial Performance - Over the last four quarters, NewAmsterdam Pharma has surpassed consensus EPS estimates two times and topped consensus revenue estimates four times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.50 on revenues of $3.5 million, and for the current fiscal year, it is -$1.81 on revenues of $13.73 million [7] Market Outlook - The company's earnings outlook will be crucial for future stock performance, with management's commentary on the earnings call expected to influence investor sentiment [3][4] - The Zacks Rank for NewAmsterdam Pharma is currently 4 (Sell), indicating expectations of underperformance in the near future [6] - The Medical - Drugs industry, to which NewAmsterdam belongs, is currently in the top 34% of Zacks industries, suggesting a favorable industry outlook [8]

[Corporate Overview & Highlights](index=1&type=section&id=Corporate%20Overview%20%26%20Highlights) [Q2 2025 Financial & Corporate Highlights](index=1&type=section&id=Q2%202025%20Financial%20%26%20Corporate%20Highlights) NewAmsterdam Pharma announced Q2 2025 financial results and provided a corporate update, highlighting progress in clinical trials, regulatory submissions, and a strong cash position - European marketing authorization application for obicetrapib is on track for 2H25[1](index=1&type=chunk) - PREVAIL Phase 3 Cardiovascular Outcomes Trial (CVOT) remains on track[1](index=1&type=chunk) - BROADWAY Alzheimer's disease analysis showed obicetrapib significantly reduced plasma p-tau217 levels versus placebo in both the full analysis set and in ApoE4 carriers over 12 months[1](index=1&type=chunk) Cash, Cash Equivalents and Marketable Securities | Date | Amount (USD millions) | | :--- | :--- | | June 30, 2025 | 783.3 | | December 31, 2024 | 834.2 | [CEO Statement](index=1&type=section&id=CEO%20Statement) CEO Michael Davidson emphasized obicetrapib's rapid advancement, compelling Phase 3 data showing robust LDL-C reduction and potential in neurodegenerative risk, and the expansion of the clinical program with the planned RUBENS trial - Obicetrapib is rapidly advancing towards patients worldwide, potentially addressing the urgent need for additional cardiovascular disease treatment options[2](index=2&type=chunk) - Phase 3 studies reinforce obicetrapib's lipoprotein modifying properties, including robust LDL-C reduction, and suggest a potential role in reducing neurodegenerative risk[2](index=2&type=chunk) - Launch of the Phase 3 RUBENS trial is planned for later this year to evaluate obicetrapib in combination with ezetimibe in patients with type 2 diabetes and metabolic syndrome[2](index=2&type=chunk) - The company is focused on building out commercial capabilities to support the potential launch of obicetrapib, if approved[2](index=2&type=chunk) [Clinical Development & Pipeline](index=1&type=section&id=Clinical%20Development%20%26%20Pipeline) [Obicetrapib Overview](index=1&type=section&id=Obicetrapib%20Overview) Obicetrapib is an oral, low-dose, once-daily CETP inhibitor being developed as a preferred LDL-C lowering therapy for patients at risk of CVD where existing therapies are insufficient or not well-tolerated - Obicetrapib is an oral, low-dose and once-daily cholesteryl ester transfer protein ("CETP") inhibitor[3](index=3&type=chunk) - It is being developed as the preferred LDL-C lowering therapy for patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated[3](index=3&type=chunk) [Key Clinical Trial Updates](index=1&type=section&id=Key%20Clinical%20Trial%20Updates) NewAmsterdam presented late-breaking data from BROADWAY and TANDEM trials, and announced positive topline data from a prespecified Alzheimer's disease biomarker analysis in BROADWAY, showing significant reductions in p-tau217 [BROADWAY & TANDEM Data Presentation](index=1&type=section&id=BROADWAY%20%26%20TANDEM%20Data%20Presentation) Late-breaking data from BROADWAY and TANDEM pivotal trials were presented at the European Atherosclerosis Society Congress and published in NEJM and The Lancet - In May 2025, late-breaking data from the BROADWAY and TANDEM pivotal trials were presented at the European Atherosclerosis Society Congress[3](index=3&type=chunk) - Data were simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet (TANDEM)[3](index=3&type=chunk) [Alzheimer's Disease Biomarker Analysis](index=1&type=section&id=Alzheimer's%20Disease%20Biomarker%20Analysis) Positive topline data from the prespecified AD biomarker analysis in BROADWAY showed statistically significant reductions in p-tau217 - In June 2025, positive topline data from the prespecified AD biomarker analysis in the BROADWAY clinical trial were announced[3](index=3&type=chunk) - Statistically significant reductions in p-tau217, a key biomarker of AD pathology, were observed in both the full analysis set (**p<0.002**, n=1,515) and in ApoE4 carriers (**p=0.0215**, n=367)[3](index=3&type=chunk) - In July 2025, additional results presented at AAIC 2025 showed obicetrapib reduced p-tau217 levels by **20.5%** over 12 months in ApoE4/E4 carriers (**p=0.010**, n=29)[6](index=6&type=chunk) [Upcoming Milestones & Ongoing Trials](index=2&type=section&id=Upcoming%20Milestones%20%26%20Ongoing%20Trials) Following successful completion of Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, additional data will be announced in 2025, while PREVAIL and REMBRANDT Phase 3 trials are ongoing - NewAmsterdam plans to announce additional data from the BROADWAY, TANDEM, and BROOKLYN trials over the course of 2025[5](index=5&type=chunk) [PREVAIL Phase 3 Trial](index=2&type=section&id=PREVAIL%20Phase%203%20Trial) The PREVAIL cardiovascular outcomes trial, evaluating obicetrapib in ASCVD patients, completed enrollment of over 9,500 patients - PREVAIL is a cardiovascular outcomes trial (CVOT) evaluating obicetrapib in patients with a history of ASCVD whose LDL-C is not adequately controlled[7](index=7&type=chunk) - Enrollment of over **9,500 patients** was completed in April 2024[7](index=7&type=chunk) [REMBRANDT Phase 3 Trial](index=2&type=section&id=REMBRANDT%20Phase%203%20Trial) The REMBRANDT trial will evaluate obicetrapib plus ezetimibe FDC on coronary plaque in 300 high-risk ASCVD patients - The REMBRANDT trial will utilize coronary computed tomography angiography imaging to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque[7](index=7&type=chunk) - The study is expected to enroll **300 adult participants** with high-risk ASCVD[7](index=7&type=chunk) [RUBENS Phase 3 Trial (Planned)](index=1&type=section&id=RUBENS%20Phase%203%20Trial%20%28Planned%29) The Phase 3 RUBENS trial is planned to evaluate obicetrapib with ezetimibe in patients with type 2 diabetes and metabolic syndrome - The Phase 3 RUBENS trial is planned for later this year to evaluate obicetrapib in combination with ezetimibe in patients with type 2 diabetes and metabolic syndrome[2](index=2&type=chunk) [Corporate Activities](index=2&type=section&id=Corporate%20Activities) [R&D Day & Conference Calls](index=2&type=section&id=R%26D%20Day%20%26%20Conference%20Calls) NewAmsterdam hosted an R&D Day in June 2025 to discuss obicetrapib's clinical development and commercial readiness, and a conference call at AAIC 2025 in July 2025 to discuss BROADWAY AD biomarker analysis results - In June 2025, NewAmsterdam hosted an R&D Day event to discuss obicetrapib's clinical development path and commercial readiness and strategy[7](index=7&type=chunk) - In July 2025, a conference call was hosted at AAIC 2025 to discuss the results from the prespecified AD biomarker analysis in the BROADWAY trial[7](index=7&type=chunk) [Commercial Readiness](index=1&type=section&id=Commercial%20Readiness) The company is actively building out its commercial capabilities to support the potential launch of obicetrapib, if approved, and its EMA application through partner Menarini remains on track - The company is focused on building out commercial capabilities to support the potential launch of obicetrapib, if approved[2](index=2&type=chunk) - The EMA application through partner Menarini remains on track[2](index=2&type=chunk) [Financial Performance (Q2 2025)](index=2&type=section&id=Financial%20Performance%20%28Q2%202025%29) [Key Financial Highlights](index=2&type=section&id=Key%20Financial%20Highlights) NewAmsterdam Pharma reported a significant increase in revenue for Q2 2025, primarily due to a development cost contribution from Menarini, while reducing R&D expenses and increasing SG&A expenses for commercial readiness, leading to a decreased net loss [Revenue](index=2&type=section&id=Revenue) Revenue for Q2 2025 increased substantially year-over-year, driven by a development cost contribution from the Menarini license agreement Revenue (USD thousands) | Period | 2025 Q2 | 2024 Q2 | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue | 19,145 | 2,279 | +16,866 (+740.0%) | - The increase was primarily attributable to the recognition of **$16.1 million** of revenue related to the second installment of development cost contributions under the license agreement with Menarini[7](index=7&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) R&D expenses decreased due to lower clinical expenses, partially offset by increased personnel and regulatory costs, while SG&A expenses increased significantly due to higher personnel costs, investments in marketing, and intellectual property filings [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20Development%20%28R%26D%29%20Expenses) R&D expenses decreased due to lower clinical expenses, partially offset by increased personnel and regulatory costs R&D Expenses (USD thousands) | Period | 2025 Q2 | 2024 Q2 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | 27,516 | 38,379 | -10,863 (-28.3%) | - Decrease primarily due to a decrease in clinical expenses, partially offset by an increase in personnel expenses (including share-based compensation), non-clinical expenses, and regulatory expenses[7](index=7&type=chunk) - Share-based payment expenses included with R&D expenses totaled **$5.1 million** in Q2 2025, compared to **$3.0 million** for the same period in 2024[7](index=7&type=chunk) [Selling, General and Administrative (SG&A) Expenses](index=2&type=section&id=Selling%2C%20General%20and%20Administrative%20%28SG%26A%29%20Expenses) SG&A expenses increased significantly due to higher personnel costs, marketing investments, and intellectual property filings SG&A Expenses (USD thousands) | Period | 2025 Q2 | 2024 Q2 | Change (YoY) | | :--- | :--- | :--- | :--- | | SG&A Expenses | 27,264 | 16,475 | +10,789 (+65.5%) | - Increase primarily due to an increase in personnel costs (including share-based compensation), investments in marketing and communications capabilities, and increased intellectual property costs[7](index=7&type=chunk)[8](index=8&type=chunk) - Share-based payment expenses included with SG&A expenses totaled **$10.1 million** in Q2 2025, compared to **$5.3 million** for the same period in 2024[8](index=8&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) The net loss for Q2 2025 significantly decreased compared to the same period in 2024, influenced by the revenue increase, R&D expense decrease, and non-cash losses related to derivative liabilities Net Loss (USD thousands) | Period | 2025 Q2 | 2024 Q2 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net Loss | (17,364) | (39,007) | +21,643 (+55.5%) | - The change in net loss is attributed to the individual components of revenue and operating expenses, in addition to non-cash losses related to changes in the fair value of derivative liabilities[8](index=8&type=chunk) [Cash Position](index=2&type=section&id=Cash%20Position) The company's cash, cash equivalents, and marketable securities decreased from December 31, 2024, to June 30, 2025, primarily due to ongoing operating expenditures Cash, Cash Equivalents and Marketable Securities | Date | Amount (USD millions) | | :--- | :--- | | June 30, 2025 | 783.3 | | December 31, 2024 | 834.2 | - The decrease was primarily driven by ongoing operating expenditures[7](index=7&type=chunk) [Disease Background & Product Information](index=3&type=section&id=Disease%20Background%20%26%20Product%20Information) [About Obicetrapib](index=3&type=section&id=About%20Obicetrapib) Obicetrapib is a novel, oral, low-dose CETP inhibitor designed to overcome limitations of current LDL-lowering treatments, showing statistically significant LDL-lowering with a placebo-like side effect profile in multiple trials, with commercialization rights in Europe exclusively granted to Menarini Group - Obicetrapib is a novel, oral, low-dose CETP inhibitor developed to overcome the limitations of current LDL-lowering treatments[9](index=9&type=chunk) - Statistically significant LDL-lowering combined with a side effect profile similar to placebo was observed in Phase 2 (ROSE2, TULIP, ROSE, OCEAN) and Phase 3 (BROOKLYN, BROADWAY, TANDEM) trials[9](index=9&type=chunk) - Commercialization rights of obicetrapib in Europe have been exclusively granted to the Menarini Group[9](index=9&type=chunk) [About Cardiovascular Disease](index=3&type=section&id=About%20Cardiovascular%20Disease) Cardiovascular disease remains the leading cause of death globally, with increasing mortality rates in the U.S. despite available lipid-lowering therapies, highlighting a significant unmet clinical need for improved therapeutic regimens - Cardiovascular disease remains the leading cause of death globally, with U.S. age-adjusted mortality rates increasing by **9%** from 2019 through 2022[10](index=10&type=chunk) - Despite **269 million** lipid-lowering therapy (LLT) prescriptions, **30 million** under-treated U.S. adults are not at their risk-based LDL-C goal, including **13 million** with ASCVD[10](index=10&type=chunk) - 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**[10](index=10&type=chunk) [Detailed Alzheimer's Analysis](index=3&type=section&id=Detailed%20Alzheimer's%20Analysis) A pre-specified analysis in the BROADWAY trial assessed plasma biomarkers of Alzheimer's disease over 12 months, particularly in ApoE3/4 or 4/4 carriers, showing statistically significant lower absolute changes in p-tau217 compared to placebo, with favorable trends in other AD biomarkers, and obicetrapib was well-tolerated - A pre-specified analysis in the BROADWAY trial assessed plasma biomarkers of Alzheimer's disease (AD) over 12 months in **1,727 patients**, including **367 ApoE4 carriers**[11](index=11&type=chunk) - Statistically significant lower absolute changes in p-tau217 were observed compared to placebo over 12 months in both the full analysis set (**p=0.0019**; n=1,515) and in ApoE4 carriers (**p=0.0215**; n=367)[11](index=11&type=chunk) - Favorable trends were observed in additional AD biomarkers including NFL, GFAP, p-tau181, and Aβ42/40 ratio[11](index=11&type=chunk) - Obicetrapib was observed to be well-tolerated in BROADWAY, with safety results comparable to placebo[11](index=11&type=chunk) [About NewAmsterdam Pharma](index=3&type=section&id=About%20NewAmsterdam%20Pharma) [Company Mission & Product Focus](index=3&type=section&id=Company%20Mission%20%26%20Product%20Focus) NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on improving patient care in metabolic diseases where current therapies are inadequate or poorly tolerated, investigating obicetrapib, alone or in combination with ezetimibe, as an LDL-C lowering therapy for CVD patients - NewAmsterdam Pharma 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[12](index=12&type=chunk)[13](index=13&type=chunk) - The company 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[13](index=13&type=chunk) - These therapies are intended 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[13](index=13&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) [Risks and Uncertainties](index=4&type=section&id=Risks%20and%20Uncertainties) This section contains forward-looking statements regarding the company's business plans, commercial opportunities, therapeutic potential of product candidates, clinical trial timings, regulatory filings, and commercialization plans, which are subject to various risks and uncertainties - Forward-looking statements cover the Company's business and strategic plans, commercial opportunity, therapeutic potential of product candidates, clinical trial timings, regulatory filings and approvals, and commercialization plans[14](index=14&type=chunk) - These statements are subject to a number of risks and uncertainties, including changes in business conditions, risks related to regulatory approval, clinical trial outcomes, competitive product candidates, and intellectual property[14](index=14&type=chunk) - The Company does not undertake any obligation to update these forward-looking statements, except as may be required by law[14](index=14&type=chunk) [Contacts](index=4&type=section&id=Contacts) [Company, Media & Investor Relations](index=4&type=section&id=Company%2C%20Media%20%26%20Investor%20Relations) Provides contact information for Company, Media, and Investor relations - Contact information is provided for Matthew Philippe (Company Contact), Christian Edgington (Media Contact), and Austin Murtagh (Investor Contact)[15](index=15&type=chunk)[16](index=16&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Condensed Consolidated Balance Sheet](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) The balance sheet shows a decrease in total assets from **$864.6 million** at December 31, 2024, to **$815.1 million** at June 30, 2025, primarily driven by a decrease in cash and cash equivalents, while total liabilities also decreased significantly Balance Sheet Highlights (USD thousands) | Item | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Total Assets | 815,112 | 864,620 | (49,508) | | Cash and cash equivalents | 563,864 | 771,743 | (207,879) | | Marketable securities, current | 175,298 | 62,447 | 112,851 | | Total Liabilities | 36,615 | 107,120 | (70,505) | | Derivative warrant liabilities | 20,932 | 37,514 | (16,582) | | Total Shareholders' Equity | 778,497 | 757,500 | 20,997 | - The decrease in total assets was primarily due to a reduction in cash and cash equivalents, partially offset by an increase in current marketable securities[18](index=18&type=chunk) - Total liabilities decreased significantly, mainly due to a reduction in derivative earnout liability and derivative warrant liabilities[18](index=18&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended June 30, 2025, revenue increased significantly, operating loss decreased, and net loss improved compared to the prior year, with similar trends for the six-month period Statements of Operations (USD thousands) | Item | Q2 2025 | Q2 2024 | Change (YoY) | 6M 2025 | 6M 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 19,145 | 2,279 | +16,866 | 22,123 | 3,680 | +18,443 | | Operating loss | (35,635) | (52,575) | +16,940 | (104,560) | (108,057) | +3,497 | | Loss for the period | (17,364) | (39,007) | +21,643 | (56,891) | (132,774) | +75,883 | - Interest income increased for both the three and six months ended June 30, 2025, compared to the prior year periods[20](index=20&type=chunk) - Fair value changes in earnout and warrants significantly impacted other income (expense) for both periods[20](index=20&type=chunk) [Condensed Consolidated Statements of Mezzanine Equity and Shareholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Mezzanine%20Equity%20and%20Shareholders'%20Equity) Total shareholders' equity increased from **$757.5 million** at December 31, 2024, to **$778.5 million** at June 30, 2025, primarily due to issuance of earnout shares, exercise of stock options, and share-based compensation, partially offset by the accumulated loss for the period Total Shareholders' Equity (USD thousands) | Date | Amount | | :--- | :--- | | June 30, 2025 | 778,497 | | December 31, 2024 | 757,500 | - The increase in equity was driven by the issuance of earnout shares (**$40.8 million**), exercise of stock options (**$2.99 million**), and share-based compensation (**$15.18 million**), partially offset by the accumulated loss for the period (**$17.36 million**)[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities decreased compared to the prior year, while net cash used in investing activities significantly increased, and net cash provided by financing activities decreased substantially, resulting in an overall decrease in cash at period-end Cash Flow Highlights (Six Months Ended June 30, USD thousands) | Item | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | (74,139) | (108,581) | +34,442 | | Net cash used in investing activities | (156,281) | (594) | (155,687) | | Net cash provided by financing activities | 9,944 | 202,838 | (192,894) | | Net change in cash | (220,476) | 93,663 | (314,139) | | Cash at the end of the period | 563,864 | 430,708 | +133,156 | - Net cash used in investing activities significantly increased in 2025 due to purchases of available-for-sale debt securities (**$193.3 million**)[23](index=23&type=chunk) - Net cash provided by financing activities decreased substantially in 2025 compared to 2024, which included significant proceeds from the February 2024 offering of Ordinary Shares and Pre-Funded Warrants[23](index=23&type=chunk)

[SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) Cautions readers about forward-looking statements, noting inherent risks and uncertainties that may cause actual results to differ materially - This Quarterly Report contains forward-looking statements regarding the Company's future operations, cash flows, financial position, dividend policy, prospects, strategies, objectives, and other future events. These statements are subject to known and unknown risks and uncertainties, and actual results could differ materially from expectations[8](index=8&type=chunk)[9](index=9&type=chunk) - Readers are cautioned not to place undue reliance on these statements, which speak only as of the report date, and to review risk factors described in this report and the annual report on Form 10-K[9](index=9&type=chunk)[10](index=10&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents unaudited condensed consolidated financial statements, including Balance Sheets, Statements of Operations, Equity, and Cash Flows [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (USD thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :-------------------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | 563,864 | 771,743 | (207,879) | -26.9% | | Marketable securities, current | 175,298 | 62,447 | 112,851 | 180.7% | | Total current assets | 769,850 | 863,413 | (93,563) | -10.8% | | Total assets | 815,112 | 864,620 | (49,508) | -5.7% | | Total current liabilities | 36,512 | 106,918 | (70,406) | -65.8% | | Total liabilities | 36,615 | 107,120 | (70,505) | -65.8% | | Total shareholders' equity | 778,497 | 757,500 | 20,997 | 2.8% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (USD thousands, except per share) | Metric (3 months ended June 30) | 2025 | 2024 | Change | % Change | | :------------------------------ | :-------- | :-------- | :-------- | :------- | | Revenue | 19,145 | 2,279 | 16,866 | 740.1% | | Research and development expenses | 27,516 | 38,379 | (10,863) | -28.3% | | Selling, general and administrative expenses | 27,264 | 16,475 | 10,789 | 65.5% | | Operating loss | (35,635) | (52,575) | 16,940 | -32.2% | | Loss for the period | (17,364) | (39,007) | 21,643 | -55.5% | | Basic and diluted net loss per ordinary share | (0.15) | (0.41) | 0.26 | -63.4% | | Metric (6 months ended June 30) | 2025 | 2024 | Change | % Change | | :------------------------------ | :-------- | :-------- | :-------- | :------- | | Revenue | 22,123 | 3,680 | 18,443 | 501.2% | | Research and development expenses | 72,267 | 80,809 | (8,542) | -10.6% | | Selling, general and administrative expenses | 54,416 | 30,928 | 23,488 | 75.9% | | Operating loss | (104,560) | (108,057) | 3,497 | -3.2% | | Loss for the period | (56,891) | (132,774) | 75,883 | -57.1% | | Basic and diluted net loss per ordinary share | (0.48) | (1.45) | 0.97 | -66.9% | [Condensed Consolidated Statements of Shareholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity) - Total shareholders' equity increased from **$757.5 million** at December 31, 2024, to **$778.5 million** at June 30, 2025. Key changes include the issuance of **1,743,136** Ordinary Shares for earnout settlement, exercise of pre-funded warrants, warrants, and stock options, and share-based compensation, partially offset by the total comprehensive loss for the period[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (USD thousands) | Cash Flow Activity (6 months ended June 30) | 2025 | 2024 | Change | | :---------------------------------------- | :-------- | :-------- | :-------- | | Net cash used in operating activities | (74,139) | (108,581) | 34,442 | | Net cash used in investing activities | (156,281) | (594) | (155,687) | | Net cash provided by financing activities | 9,944 | 202,838 | (192,894) | | Net change in cash | (220,476) | 93,663 | (314,139) | | Cash at the end of the period | 563,864 | 430,708 | 133,156 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The Company is a late-stage biopharmaceutical company focused on metabolic diseases, developing obicetrapib. It faces risks common to early-stage biopharmaceutical companies, including dependence on intellectual property, regulatory approvals, and securing additional capital[27](index=27&type=chunk) - Revenue for the six months ended June 30, 2025, was **$22.1 million**, primarily from the Menarini License R&D performance obligation, including **$16.1 million** from the second development cost reimbursement installment[30](index=30&type=chunk)[31](index=31&type=chunk) Cash, Cash Equivalents, and Marketable Securities (USD thousands) | Category | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :----------------------------------- | :------------------------- | :----------------------------- | | Cash and cash equivalents | 563,864 | 771,743 | | Marketable securities | 219,470 | 62,447 | | **Total** | **783,334** | **834,190** | - The derivative earnout liability was settled in full in March 2025, resulting in the issuance of **1,743,136** Ordinary Shares, with a change in fair value recognized through profit and loss of **$(3.992) million**[35](index=35&type=chunk) Share-Based Compensation Expense (USD thousands) | Expense Type (3 months ended June 30) | 2025 | 2024 | | :------------------------------------ | :----- | :---- | | Share options | 12,518 | 8,290 | | Restricted stock units | 2,661 | — | | **Total** | **15,179** | **8,290** | | Expense Type (6 months ended June 30) | 2025 | 2024 | | :------------------------------------ | :----- | :---- | | Share options | 25,090 | 16,208 | | Restricted stock units | 5,302 | — | | **Total** | **30,392** | **16,208** | - The Company operates as a single segment focused on cardio-metabolic diseases, with revenue primarily from the Menarini License in Italy[54](index=54&type=chunk) Net Loss Per Ordinary Share (USD, except share amounts) | Metric (3 months ended June 30) | 2025 | 2024 | | :------------------------------ | :------------ | :----------- | | Net loss | (17,364) | (39,007) | | Weighted average Ordinary Shares outstanding | 118,556,492 | 94,711,604 | | Net loss per Ordinary Share | (0.15) | (0.41) | | Metric (6 months ended June 30) | 2025 | 2024 | | :------------------------------ | :------------ | :----------- | | Net loss | (56,891) | (132,774) | | Weighted average Ordinary Shares outstanding | 117,347,434 | 91,611,785 | | Net loss per Ordinary Share | (0.48) | (1.45) | - As of June 30, 2025, the Company had estimated maximum cancellation payments for third-party service agreements of **$20.5 million**[59](index=59&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analyzes the company's financial condition, operational results, liquidity, and critical accounting policies for the period [Overview](index=20&type=section&id=Overview) - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on improving patient care in cardiometabolic diseases, particularly by developing obicetrapib, a highly selective CETP inhibitor, for LDL-C lowering[64](index=64&type=chunk)[65](index=65&type=chunk) - Obicetrapib has shown significant reductions in LDL-C, lipoprotein (a), and small LDL particles in multiple Phase 3 and Phase 2 clinical trials (BROADWAY, BROOKLYN, TANDEM, TULIP, ROSE, OCEAN, ROSE2, Japan Phase 2b), with a safety profile comparable to placebo[65](index=65&type=chunk)[67](index=67&type=chunk) - The company aims to commercialize obicetrapib as a monotherapy and fixed-dose combination therapy in the U.S. and has partnered with Menarini for exclusive commercialization rights in most European countries[71](index=71&type=chunk)[72](index=72&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) - On July 30, 2025, the company announced positive Alzheimer's Disease (AD) biomarker data from the prespecified analysis of its BROADWAY clinical trial[73](index=73&type=chunk) - Treatment with obicetrapib 10 mg daily for 12 months resulted in **statistically significant** lower absolute changes in plasma p-tau217, a key AD biomarker, in both the full analysis set (**p=0.0019**) and ApoE4 carriers (**p=0.0215**)[74](index=74&type=chunk) Percent Change in AD Biomarkers Among E4/E4 Carriers vs. Placebo (n=29) | Biomarker | Mean % Change | p-value | | :-------- | :------------ | :------ | | p-tau217 | -20.48% | 0.010 | | NFL | -17.31% | 0.020 | | GFAP | -15.24% | 0.006 | | p-tau181 | -13.67% | 0.06 | | Aβ42/40 | -7.96% | 0.013 | | p-tau217/(Aβ42/40) | -22.65% | 0.032 | [Components of our Results of Operations](index=22&type=section&id=Components%20of%20our%20Results%20of%20Operations) - Revenue is solely derived from the Menarini License, with **$98.6 million** recognized upfront for the license performance obligation and **$22.3 million** initially deferred for the R&D performance obligation, which has now been fully recognized[78](index=78&type=chunk) - Research and development expenses are recognized as incurred, covering clinical and preclinical activities, drug development, manufacturing, and CRO costs. These are expected to remain significant as product candidates advance[82](index=82&type=chunk)[83](index=83&type=chunk) - Selling, general and administrative expenses, including consultant fees, employee costs, legal, marketing, and intellectual property costs, are expected to increase due to organizational growth and commercial preparedness as a public company[84](index=84&type=chunk)[85](index=85&type=chunk) - Interest income is earned on cash, cash equivalents, and marketable securities. Foreign exchange gains/losses are primarily driven by Euro-denominated cash balances and transactions[87](index=87&type=chunk)[88](index=88&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Revenue Comparison (USD thousands) | Period | 2025 | 2024 | Change | % Change | | :----- | :----- | :---- | :----- | :------- | | Q2 | 19,145 | 2,279 | 16,866 | 740.1% | | H1 | 22,123 | 3,680 | 18,443 | 501.2% | - The significant increase in revenue was largely due to the recognition of **$16.1 million** from the second installment of development cost contributions under the Menarini License in Q2 2025[91](index=91&type=chunk)[103](index=103&type=chunk) Research and Development Expenses Comparison (USD thousands) | Period | 2025 | 2024 | Change | % Change | | :----- | :----- | :----- | :------- | :------- | | Q2 | 27,516 | 38,379 | (10,863) | -28.3% | | H1 | 72,267 | 80,809 | (8,542) | -10.6% | - The decrease in R&D expenses was primarily driven by a **$15.0 million** (Q2) / **$23.1 million** (H1) decrease in clinical expenses due to the completion of several Phase 3 trials and cost phasing, partially offset by increases in personnel, non-clinical, manufacturing, and regulatory expenses[92](index=92&type=chunk)[99](index=99&type=chunk)[104](index=104&type=chunk) Selling, General and Administrative Expenses Comparison (USD thousands) | Period | 2025 | 2024 | Change | % Change | | :----- | :----- | :----- | :----- | :------- | | Q2 | 27,264 | 16,475 | 10,789 | 65.5% | | H1 | 54,416 | 30,928 | 23,488 | 75.9% | - The increase in SG&A expenses was mainly due to higher personnel expenses (including share-based compensation), increased marketing and communication expenses for commercial launch preparation, and intellectual property costs[94](index=94&type=chunk)[100](index=100&type=chunk)[106](index=106&type=chunk)[111](index=111&type=chunk) Loss for the Period Comparison (USD thousands) | Period | 2025 | 2024 | Change | % Change | | :----- | :------ | :------- | :----- | :------- | | Q2 | (17,364) | (39,007) | 21,643 | -55.5% | | H1 | (56,891) | (132,774)| 75,883 | -57.1% | [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the Company had cash, cash equivalents, and marketable securities totaling **$783.3 million**, with an accumulated loss of **$615.5 million**[112](index=112&type=chunk)[113](index=113&type=chunk) - Historical funding sources include private and public share placements, convertible notes, and proceeds from the Menarini License and Business Combination Agreement[113](index=113&type=chunk) - The Company completed a December 2024 Offering, raising **$453.4 million** net, and a February 2024 Offering, raising **$190.0 million** net, through the issuance of Ordinary Shares and Pre-Funded Warrants[114](index=114&type=chunk)[115](index=115&type=chunk) - An At-the-Market Offering agreement allows for the sale of up to **$250 million** of Ordinary Shares, though no sales occurred in the six months ended June 30, 2025[116](index=116&type=chunk) - The Menarini License provides for an upfront payment, R&D funding (**€27.5 million** over two years, with **€13.8 million** received in H1 2025), and potential milestone payments up to **€863 million**, plus tiered royalties[117](index=117&type=chunk)[119](index=119&type=chunk) - As of June 30, 2025, **2,616,539** outstanding Warrants could generate up to **$30.1 million** if exercised, but the Company does not include these potential proceeds in liquidity projections due to price dependency[120](index=120&type=chunk) - Net cash used in operating activities decreased by **$34.5 million** in H1 2025 compared to H1 2024, primarily due to increased interest income and Menarini License contributions[122](index=122&type=chunk) - Net cash used in investing activities increased significantly by **$155.7 million** in H1 2025, mainly due to **$193.3 million** in purchases of available-for-sale debt securities[123](index=123&type=chunk)[124](index=124&type=chunk) - Net cash provided by financing activities decreased by **$192.9 million** in H1 2025, primarily due to the proceeds from the February 2024 Offering in the prior year[125](index=125&type=chunk) [Critical Accounting Policies and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - The preparation of consolidated financial statements requires management to make estimates and assumptions affecting reported amounts, based on historical experience, known trends, and market-specific factors. These estimates are continuously evaluated, and changes are recorded in the period they become known[129](index=129&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Outlines the Company's exposure to interest rate, foreign currency, and other market risks, along with credit and liquidity risks - The Company is exposed to interest rate risk through its cash, cash equivalents, and marketable securities, investing primarily in high-quality financial instruments with maturities of less than one year. A hypothetical **100 basis point** change in interest rates is not expected to have a material effect[134](index=134&type=chunk) - Foreign currency risk primarily relates to cash and payables denominated in currencies other than the U.S. Dollar, mainly the Euro. As of June 30, 2025, net exposure was **$124.3 million**, with a hypothetical **1%** change in exchange rates potentially impacting future earnings by approximately **$1.2 million**[135](index=135&type=chunk) - Other market price risk stems from derivative warrant liabilities, valued at **$20.9 million** as of June 30, 2025. A **1%** change in the market price of the publicly traded Warrants (NAMSW) would alter the liability's value by **$0.2 million**[137](index=137&type=chunk) - Credit risk is mainly from treasury activities, with cash held in investment-grade bank accounts. Management periodically reviews bank creditworthiness and believes value-added tax receivables are fully recoverable[138](index=138&type=chunk)[140](index=140&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Details management's evaluation of disclosure controls and procedures and reports on internal control changes - Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were **effective** at the reasonable assurance level as of June 30, 2025[142](index=142&type=chunk) - No **material changes** in internal control over financial reporting occurred during the three months ended June 30, 2025[143](index=143&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) Confirms the Company is not currently involved in any material pending legal proceedings - The Company is **not a party to any material pending legal proceedings**[146](index=146&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Updates previously disclosed risk factors, highlighting new risks related to changes in U.S. government policies and tariffs - There have been **no material changes** to previously disclosed risk factors, except for new risks related to government regulation[147](index=147&type=chunk) - Changes in U.S. government policies, including increased tariffs (e.g., a baseline **ten percent** tariff imposed in April 2025), could adversely affect the Company's business by raising production costs, disrupting supply chains, and negatively impacting global economic conditions[148](index=148&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered sales of equity securities or use of proceeds during the period - **No unregistered sales** of equity securities or use of proceeds occurred during the period[151](index=151&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Confirms no defaults upon senior securities occurred during the reporting period - There were **no defaults** upon senior securities during the period[152](index=152&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that this item is not applicable to the Company - This item is **not applicable**[153](index=153&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) Provides details on changes to Rule 10b5-1 trading arrangements for company officers - On April 4, 2025, CFO Ian Somaiya terminated a Rule 10b5-1 trading arrangement for the potential sale of up to **200,000** Ordinary Shares[155](index=155&type=chunk) - On June 30, 2025, CEO Michael Davidson modified his Rule 10b5-1 trading arrangement, allowing for the potential sale of up to **750,000** Ordinary Shares, subject to conditions, expiring October 30, 2026[156](index=156&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed as part of this Quarterly Report on Form 10-Q - Exhibits include the English translation of the Deed of Conversion and Articles of Association, Form of Restricted Stock Unit Award Agreement, Employment Agreement for Dr. John Kastelein, and various certifications (302 and 906 certifications)[158](index=158&type=chunk) [SIGNATURES](index=37&type=section&id=SIGNATURES) - The report was signed on August 6, 2025, by Michael Davidson, M.D., Chief Executive Officer and Director, and Ian Somaiya, Chief Financial Officer[161](index=161&type=chunk)

Core Insights - NewAmsterdam Pharma is advancing its oral, low-dose CETP inhibitor obicetrapib, targeting cardiovascular disease and Alzheimer's pathology, with significant clinical data supporting its efficacy [3][4][10] - The company reported a substantial increase in revenue for Q2 2025, recognizing $19.1 million compared to $2.3 million in Q2 2024, primarily due to development cost contributions from Menarini [7][19] - NewAmsterdam's cash position as of June 30, 2025, was $783.3 million, down from $834.2 million at the end of 2024, reflecting ongoing operating expenditures [7][19] Clinical Development Updates - The PREVAIL Phase 3 cardiovascular outcomes trial has completed enrollment of over 9,500 patients, focusing on those with a history of ASCVD [9][10] - Positive topline data from the BROADWAY trial indicated a statistically significant reduction in p-tau217 levels, a key Alzheimer's biomarker, in patients treated with obicetrapib [4][12] - The company plans to launch the Phase 3 RUBENS trial later in 2025, evaluating obicetrapib in combination with ezetimibe for patients with type 2 diabetes and metabolic syndrome [3][4] Financial Performance - NewAmsterdam reported a net loss of $17.4 million for Q2 2025, an improvement from a net loss of $39.0 million in Q2 2024 [7][19] - Research and development expenses decreased to $27.5 million in Q2 2025 from $38.4 million in the same period in 2024, attributed to reduced clinical expenses [7][19] - Selling, general, and administrative expenses rose to $27.3 million in Q2 2025, up from $16.5 million in Q2 2024, driven by increased personnel costs and marketing investments [7][19] Market Context - Cardiovascular disease remains a leading global health issue, with a projected increase in affected U.S. adults to over 184 million by 2050, highlighting the need for effective LDL-C lowering therapies [11] - Despite the availability of lipid-lowering therapies, many patients remain undertreated, with only 10% of very high-risk ASCVD patients achieving LDL-C goals below 55 mg/dL [11] - The company aims to address this unmet need with obicetrapib, which has shown promising LDL-C reduction and a favorable safety profile in clinical trials [10][11]

Summary of New Amsterdam Pharma Company (NAMS) Conference Call - July 30, 2025 Company Overview - **Company**: New Amsterdam Pharma Company (NAMS) - **Focus**: Development of obacetropib for Alzheimer's disease and its potential as a disease-modifying therapy Key Industry Insights - **Alzheimer's Disease**: The conference highlighted the significance of obacetropib in potentially slowing or preventing Alzheimer's disease progression, particularly in APOE4 carriers, a high-risk genetic group for both Alzheimer's and cardiovascular diseases [6][7][9] - **Biomarkers**: The presentation emphasized the importance of pTau217 as a biomarker for Alzheimer's disease progression, showing that obacetropib significantly reduced pTau217 levels compared to placebo [12][13][14][18] Core Findings and Data - **Clinical Trial Results**: - In the Broadway trial, obacetropib resulted in a statistically significant reduction in pTau217 progression over 12 months, with a 1.99% increase in the treatment group versus nearly 5% in the placebo group (p=0.019) [12] - In APOE4 carriers, the increase was 1.45% with obacetropib compared to 7.19% with placebo (p=0.022) [12] - In APOE4 homozygotes, a 20.5% absolute difference in pTau217 progression was observed (p=0.01) [13] - **Comprehensive Biomarker Improvement**: The trial showed favorable trends across multiple Alzheimer's biomarkers, including GFAP and neurofilament light (NfL), indicating a potential for disease modification [15][22][24] Potential Market Impact - **Differentiation from Existing Therapies**: Obacetropib is positioned as a first-in-class oral therapy that not only lowers LDL cholesterol but also addresses Alzheimer's pathology, which is not achieved by current anti-amyloid therapies [22][25] - **Target Population**: Approximately 25% of the general population are APOE4 carriers, representing a significant market opportunity for obacetropib as a preventive treatment [23][36] Regulatory and Development Considerations - **Future Studies**: The company plans to engage with the FDA regarding the potential for obacetropib to be used in primary prevention of Alzheimer's disease, with ongoing trials like PREVAIL involving 9,500 patients [54][59] - **Biomarker as Endpoint**: There is ongoing discussion about the potential for pTau217 to be accepted as a registrational endpoint, although current FDA stance may require cognitive outcome data [63][70] Expert Panel Insights - **Panelists' Perspectives**: Experts highlighted the significance of the findings, particularly the safety profile of obacetropib and its potential for early intervention in high-risk populations [26][31][41] - **Preventive Neurology**: The need for a precision medicine approach in Alzheimer's treatment was emphasized, advocating for the use of biomarkers to personalize care [34][38] Conclusion - **Strategic Positioning**: New Amsterdam Pharma is positioned to lead in the development of innovative therapies for Alzheimer's disease, with obacetropib showing promise as a unique oral treatment that addresses both cardiovascular and neurodegenerative risks [22][25][54]

Core Insights - NewAmsterdam Pharma's obicetrapib significantly reduced plasma p-tau217 levels, a key Alzheimer's disease biomarker, in both the full analysis set and in ApoE4 carriers, indicating its potential as a novel approach to Alzheimer's prevention [1][3][13] - In ApoE4/E4 carriers, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo [1][4][5] - The results support obicetrapib's cardiometabolic profile, showing reductions in LDL-C and other cardiovascular risk factors [1][2][15] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C [1][16] - The company aims to address unmet needs in populations where current therapies are inadequate or poorly tolerated [16] - Obicetrapib is being evaluated in multiple clinical trials, including the pivotal Phase 3 BROADWAY trial, which assesses its efficacy and safety in patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia [2][10][15] Clinical Trial Insights - The BROADWAY trial included 2,530 patients and was designed to evaluate the LDL-C lowering efficacy of obicetrapib [2][10] - A prespecified analysis of the trial assessed the effects of obicetrapib on plasma biomarkers of Alzheimer's disease in 1,515 patients, including 367 ApoE4 carriers [2][13] - The primary outcome measure was the absolute and percent change in p-tau217 over 12 months, with significant reductions observed [3][13] Biomarker Analysis - Statistically significant reductions in p-tau217 levels were observed in both the full analysis set and ApoE4 carriers, with p-values of 0.0019 and 0.0215, respectively [1][3][13] - Additional favorable trends were noted across other biomarkers, including NFL, GFAP, and p-tau181 [3][4][6] - The analysis highlights the potential of obicetrapib to influence Alzheimer's disease risk through lipid modulation, particularly in high-risk ApoE4 carriers [7][13] Future Directions - NewAmsterdam plans to discuss the results with regulatory authorities to determine potential next steps for obicetrapib [7][18] - The company is also exploring the commercialization rights of obicetrapib in Europe, which have been granted to the Menarini Group [15][16]

Core Insights - Obicetrapib significantly reduced plasma p-tau217 levels, a key Alzheimer's disease biomarker, in both the full analysis set and in ApoE4 carriers, indicating its potential as a novel approach to Alzheimer's prevention [1][3][12] - In ApoE4/E4 carriers, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo [1][4] - The results support obicetrapib's cardiometabolic profile, showing reductions in LDL-C and other cardiovascular risk factors [1][2] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C [1][15] - The company aims to address unmet needs in populations where existing therapies are not sufficiently effective or well-tolerated [15] Clinical Trial Details - The BROADWAY trial was a pivotal Phase 3 study designed to evaluate the LDL-C lowering efficacy of obicetrapib in patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia [2][10] - A total of 2,530 patients were randomized to receive either 10 mg obicetrapib or placebo for 52 weeks, with the primary endpoint being the percent change in LDL-C [10][11] Biomarker Analysis - The prespecified analysis evaluated the effect of obicetrapib on plasma biomarkers of Alzheimer's disease in 1,515 patients, including 367 ApoE4 carriers [2][12] - Statistically significant reductions in p-tau217 were observed, with additional favorable trends in other biomarkers such as NFL and GFAP [3][4][12] Implications for Alzheimer's Disease - The findings suggest that upstream lipid modulation may influence Alzheimer's disease risk, particularly in ApoE4 carriers, who represent over 25% of the population [7] - Obicetrapib's ability to reduce multiple important AD biomarkers alongside its LDL-C lowering effects highlights its potential to address both neurodegenerative and cardiovascular disease risks [7][14]

Core Insights - NewAmsterdam Pharma is set to present full data from the Alzheimer's Disease biomarker analyses in the BROADWAY clinical trial at the Alzheimer's Association International Conference on July 30, 2025 [1][2] Company Overview - 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][6] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [6] Product Information - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [5] - The company has observed statistically significant LDL-lowering effects in multiple Phase 2 trials, with a side effect profile similar to that of placebo [5] - NewAmsterdam commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, enrolling over 9,500 patients [5] Upcoming Events - The presentation titled "Effects of Obicetrapib, a Potent Oral CETP Inhibitor, on Alzheimer's Disease Biomarkers in 1727 Patients with Cardiovascular Disease" will take place on July 30, 2025, at 8:21 AM ET [2] - A live webcast and conference call will be hosted by NewAmsterdam at 10:00 AM ET on the same day to review the full AD biomarker data [2][3]