Core Insights - NewAmsterdam Pharma will 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] - The presentation will focus on the effects of Obicetrapib, a potent oral CETP inhibitor, on Alzheimer's Disease biomarkers in 1,727 patients with cardiovascular disease [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 LDL-C [1][6] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [6][7] Product Information - Obicetrapib is a novel, oral, low-dose CETP inhibitor developed by NewAmsterdam to improve LDL-lowering treatment outcomes [5] - The company has conducted multiple Phase 2 and Phase 3 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [5][7] - The Phase 3 PREVAIL cardiovascular outcomes trial, which began in March 2022, has enrolled over 9,500 patients to assess the potential of obicetrapib in reducing major adverse cardiovascular events (MACE) [5] Conference Details - The live webcast and conference call to review the full AD biomarker data will take place on July 30, 2025, at 10:00 a.m. ET [1][4] - The presentation will be led by Philip Scheltens, M.D., Ph.D., and will occur from 8:21 to 8:28 AM ET [2]

Obicetrapib Clinical Development and Market Opportunity - Obicetrapib is designed to address the significant unmet need for oral LDL-C lowering therapy as an adjunct to statins, targeting over 30 million patients in the US who are not achieving LDL-C lowering goals[7, 11] - Obicetrapib demonstrated a 43% mean LDL-C lowering as monotherapy and a 59% mean LDL-C lowering in combination with ezetimibe, observed on top of high-intensity statins[8] - The lipid-lowering therapy market is a growing opportunity, with over 250 million prescriptions written in the past 12 months and a market growth of over 4% in the last 2 years[16] - Approximately 75% of ASCVD patients are not at their risk-based LDL-C goal, highlighting the need for more effective treatments[23] PREVAIL CVOT Trial Design and Potential Benefits - The PREVAIL CVOT is designed to apply lessons learned from previous CVOTs to reduce risk and demonstrate Obicetrapib's full benefit, targeting higher baseline LDL-C patients and a longer duration of follow-up[32] - Phase 2 efficacy data applied to PREVAIL baseline data predicts at least a 20% MACE benefit projection across multiple biomarkers[34, 35, 37, 40] - The PREVAIL study inclusion criteria requires high baseline LDL-C (also translates to high ApoB) and risk enhancers will increase high-risk patient populations[62] Upcoming Milestones and Data Readouts - Multiple potential pivotal data readouts are expected in the next 12 months from Phase 3 BROADWAY, BROOKLYN, and Phase 2b Japan trials[42, 43] - Enrollment is complete for the BROOKLYN Phase 3 trial, and topline results are expected in Q4 2024, while BROADWAY Phase 3 topline results are expected in Q3 2024[65] Addressing Limitations of Existing Therapies - Obicetrapib program is designed to overcome limitations of prior CETP inhibitors, with a 97% CETP inhibition at a 10mg dose, and demonstrated Lp(a) lowering of 47-57%[28]

Clinical Program and Trial Results - NewAmsterdam Pharma completed enrollment for BROOKLYN, BROADWAY and PREVAIL Phase 3 studies[5] - The BROOKLYN Phase 3 trial, involving 354 participants with HeFH and LDL-C ≥70 mg/dL, has primary endpoint of LDL-C reduction at 12 weeks[46, 49] - The BROADWAY Phase 3 trial, involving 2,532 participants with ASCVD or HeFH and LDL-C ≥55 mg/dL, also has primary endpoint of LDL-C reduction at 12 weeks[46, 53] - The PREVAIL CVOT, involving 9,541 participants with ASCVD and LDL-C ≥55 mg/dL, has primary endpoint of 4-Point MACE+ with a minimum 30-month follow-up[46, 61] - Initial data from an Alzheimer's Disease sub-study showed that obicetrapib 10mg decreased 24s- & 27s-hydroxycholesterol in both plasma and cerebrospinal fluid in a phase 2a study (n=13)[55] Obicetrapib's Potential Benefits - Obicetrapib observed to lower small LDL-P by 90%+ and total particles by over 70% in combination with ezetimibe[24] - Obicetrapib 10 mg on top of high-intensity statins significantly lowered Lp(a) by 57% vs placebo, in ROSE[80] - Obicetrapib monotherapy observed a 43% mean LDL-C lowering[30] - Obicetrapib in combination with ezetimibe observed a 59% mean LDL-C lowering on top of high-intensity statins[31] Commercial Opportunity - Approximately 30 million+ patients in the US are not achieving LDL-C lowering goals despite standard-of-care[30] - The lipid-lowering therapy market has over 250 million prescriptions annually[164] - The market is growing at over 4% over the last 2 years, with the non-statin market growing at high double digits[164] Financial Position - NewAmsterdam Pharma had $481 million in cash as of 1Q24[225]

Summary of NewAmsterdam Pharma Company (NAMS) 2025 Update Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Event**: R&D Day held on June 11, 2025 - **Focus**: Updates on Alzheimer's research and drug development, particularly obacetropib Key Points Discussed 1. Corporate and Clinical Updates - 2024 was a successful year with the completion of three Phase III trials: Brooklyn, Tandem, and Broadway [5] - The company has expanded its commercial team to nearly 100 people across the U.S. and Amsterdam [5] - New Composition of Matter IP secured exclusivity until February 1943 [6] - Data from Broadway and Tandem trials published in reputable journals, enhancing credibility [6] 2. Alzheimer's Disease Research - The company is focusing on HDL raising as a potential treatment pathway for Alzheimer's disease [9] - Obacetropib is being studied for its LDL lowering effects, which may also benefit Alzheimer's patients [10] - The brain's cholesterol metabolism is distinct, with HDL being crucial for brain health [11][12] - The company is exploring the relationship between HDL levels and amyloid beta plaque formation, which is linked to Alzheimer's [13][14] 3. APOE4 Gene and Alzheimer's Risk - APOE4 carriers have a significantly increased risk of cardiovascular disease and Alzheimer's [15] - The company aims to determine if obacetropib can effectively prevent Alzheimer's in APOE4 patients [16] - The urgency for treatment is heightened in APOE4 patients due to their family history of Alzheimer's [28] 4. Clinical Trial Insights - The Broadway trial included 3,000 patients and showed promising results in reducing Alzheimer's biomarkers [22] - The pTal217 biomarker is highlighted as a significant predictor for Alzheimer's progression [20] - The company plans to present further data at the AIC conference on July 30 [7] 5. Drug Mechanism and Benefits - Obacetropib targets the CETP protein, inhibiting its activity by 97%, which may influence both heart and brain health [44] - The drug has shown a reduction in small LDL particles, which are more harmful to arterial health [73] - The reduction in small particles is believed to contribute to the observed MACE (major adverse cardiovascular events) reduction in trials [78] 6. Future Directions - The PREVAIL study is ongoing, designed to evaluate the long-term benefits of obacetropib [35] - The company is considering expanding the MACE endpoint to include ischemic stroke and other cardiovascular events [43] - There is a focus on the potential of obacetropib to replace existing therapies like PCSK9 inhibitors due to its broader benefits [31] 7. Market Positioning - Obacetropib is positioned as a complementary therapy to statins, addressing limitations such as increased Lp(a) levels and diabetes risk associated with statins [29][30] - The company is optimistic about the drug's market potential, especially among high-risk populations [32] Additional Important Insights - The company has received positive feedback from the medical community regarding the efficacy and safety profile of obacetropib [30] - The integration of new biomarkers into patient care is expected to enhance diagnosis and treatment monitoring for Alzheimer's [21] - The company emphasizes the importance of understanding lipid metabolism in developing effective therapies for both cardiovascular and neurodegenerative diseases [63][64] This summary encapsulates the critical updates and insights shared during the NewAmsterdam Pharma Company R&D Day, highlighting the company's strategic focus on Alzheimer's research and the development of obacetropib as a potential therapeutic option.

Alzheimer's Disease Update - Emerging evidence suggests a vascular component in multi-infarct dementia, implying LDL-lowering could reduce atherosclerosis in the brain [15] - Alzheimer's disease affects over 50 million people worldwide, with an economic burden exceeding $1 trillion [15] - ApoE4 carriers exhibit a 22-45% elevated risk for CVD [28] - In a proof-of-concept study in 13 ApoE4 carriers with MCI and biomarker-proven AD, obicetrapib showed significant reductions in plasma and CSF levels of 24S- and 27-hydroxycholeterol [41, 43] PREVAIL and MACE Reduction - BROADWAY study showed a 21% observed MACE reduction [98, 99] - In BROADWAY, patients on Obicetrapib had a 42% first 4-point MACE compared to 52% in the placebo group [90] - BROADWAY + BROOKLYN pooled data showed a 75% first 4-point MACE in the Obicetrapib group compared to 49% in the placebo group [91] - Mediation analysis predicts 26% of MACE reduction from Lp(a) in BROADWAY [132, 133] Market Opportunity and Commercial Launch - The lipid-lowering therapy market has shown growth each year for the last 5 years [172] - Repatha® experienced a +47% Rx growth in the last 12 months [172] - The company estimates an $8 billion+ potential worldwide market opportunity for Obicetrapib [247]

Summary of NewAmsterdam Pharma Company (NAMS) FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Focus**: Development of LDL lowering therapies, specifically elbocetropib Market Opportunity - The LDL lowering market has evolved significantly over the past 15 years, with guidelines shifting to recommend lower LDL targets for high-risk patients, specifically a target of 55 mg/dL [2][5] - The market for LDL lowering drugs is growing, with branded drugs like Repatha increasing by 40% and generic Ezetimibe by 20% [5] - Elbocetropib is positioned to lower LDL by 35% to 50%, making it a competitive option in the market [17] Product Differentiation - Elbocetropib is an LDL plus drug, offering additional benefits beyond LDL lowering, such as potential diabetes protection and Alzheimer's disease implications [6][14] - The drug is well tolerated, with adverse events comparable to placebo, making it appealing for primary care prescriptions [17] - Elbocetropib targets a patient population that does not qualify for injectable therapies, addressing a significant unmet need [18][19] Clinical Trials and FDA Interaction - NAMS has conducted three phase three trials (Brooklyn, Broadway, and Tandem) demonstrating significant LDL lowering efficacy [25][26] - The FDA has requested a dedicated blood pressure trial and an outcome study during the review period, which is expected to read out by the end of 2026 [27][28] - The Broadway trial showed a 21% MACE benefit, indicating potential cardiovascular advantages [29] Financial Position - NAMS has over $800 million in cash, providing a strong financial position for upcoming launches and trials [39][40] - The company is preparing for a structured commercial rollout, with a focus on timing regulatory filings and launch strategies [42] Partnerships and Market Strategy - NAMS has a partnership with Metarini in Europe, which provided significant upfront payments to support the company’s financial needs [43][44] - The company is exploring options for a potential partnership in the U.S. but is currently focused on a go-alone strategy to maximize shareholder value [46] Regulatory Environment - The company is monitoring drug pricing policy dynamics, particularly in relation to its European partner, which may provide some advantages regarding pricing control [49][50] Upcoming Catalysts - Key upcoming events include an R&D Day where further data on MACE benefits and atherosclerosis will be presented, as well as a presentation at the AIC meeting on July 30 [51][53] - The company plans to file for approval in Europe in the second half of the year and is working on a study combining elbocetropib with PCSK9 inhibitors [57] Conclusion - NewAmsterdam Pharma is positioned to capitalize on the growing LDL lowering market with its innovative product, elbocetropib, which offers unique benefits and a strong clinical profile. The company is well-financed and strategically planning for future growth and regulatory approvals.

Core Insights - NewAmsterdam Pharma announced positive topline data from the Phase 3 BROADWAY clinical trial, indicating that obicetrapib treatment leads to significant reductions in Alzheimer's disease biomarkers in both the full population and ApoE4 carriers [1][2][3] Group 1: Clinical Trial Details - The BROADWAY study was designed to evaluate the LDL-C lowering efficacy of obicetrapib in patients with established atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) [2][4] - The trial involved 2,530 patients randomized to receive either 10 mg obicetrapib or placebo for 52 weeks, with a mean baseline LDL-C of approximately 100 mg/dL [4][5] - The primary endpoint showed a 33% reduction in LDL-C after 84 days for the obicetrapib group compared to placebo [6] Group 2: Alzheimer's Disease Sub-Study - A pre-specified sub-study assessed the effects of obicetrapib on plasma biomarkers of Alzheimer's disease, including p-tau217, in 1,727 patients, with significant results in both the full population (p<0.002) and ApoE4 carriers (p=0.0215) [7] - The sub-study aimed to evaluate the impact of a 12-month therapy duration on AD biomarkers, indicating a potential to alter disease trajectory in ApoE4 carriers [3][7] Group 3: Implications and Future Plans - The findings suggest a potential preventive strategy for Alzheimer's disease, particularly for the 25% of the population carrying ApoE4 risk alleles [3] - NewAmsterdam plans to present full results from the AD sub-study at the Alzheimer's Association International Conference in July 2025 [1][3] Group 4: About Obicetrapib - Obicetrapib is a novel, oral, low-dose CETP inhibitor developed to address limitations of current LDL-lowering treatments, showing significant LDL-lowering effects in multiple trials [9][10] - The company has also initiated the Phase 3 PREVAIL cardiovascular outcomes trial, which has enrolled over 9,500 patients [9]

Company Overview - NewAmsterdam Pharma Company N.V. is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) [1][5] - The company aims to address the unmet need for safe, well-tolerated, and convenient LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [5] R&D Day Announcement - NewAmsterdam will host an R&D Day event for analysts and investors on June 11, 2025, at 9:00 a.m. ET in New York City [1] - The event will feature key members of the management team, including the CEO and Chief Scientific Officer [2] Obicetrapib Development - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [4] - The company has conducted multiple Phase 2 and Phase 3 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [4] - The Phase 3 PREVAIL CVOT trial, which commenced in March 2022, has enrolled over 9,500 patients to assess obicetrapib's potential in reducing major adverse cardiovascular events (MACE) [4] Commercialization Rights - The commercialization rights for obicetrapib in Europe have been exclusively granted to the Menarini Group, a leading international pharmaceutical and diagnostics company [4]

Summary of NewAmsterdam Pharma Company (NAMS) Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Event**: Jefferies Healthcare Conference - **Date**: June 04, 2025 Key Points Industry and Market Context - The focus is on redefining the treatment of Atherosclerotic Cardiovascular Disease (ASCVD) beyond just LDL reduction to include other risk factors such as LpLA and diabetes [3][6][24] - There are approximately **70 million patients in the U.S.** with elevated LDL under treatment, indicating a vast market opportunity for NAMS's drug, obisetropib [10] Drug Development and Clinical Trials - NAMS has had **three positive Phase III trial readouts** last year, boosting confidence in regulatory approval and market entry [3] - The company is targeting additional conferences to present data that differentiates obisetropib from existing and developing drugs [4] - Obisetropib has shown an **average of 45% reduction in LpLA** in Phase III studies, addressing a significant patient population that does not qualify for existing LpLA-targeted therapies [13] Competitive Advantages - Obisetropib aims to address multiple cardiometabolic risk factors, including LDL, LpLA, and diabetes, making it a comprehensive treatment option [6][29] - The drug is positioned to potentially outperform existing therapies by significantly reducing small LDL particles, which are not effectively targeted by current treatments [37][38] Regulatory and Commercial Strategy - NAMS plans to engage with regulatory agencies to include LpLA in clinical trial sections, which could enhance the drug's marketability [15][16] - The company has raised approximately **$700 million** in financing, providing a strong balance sheet of about **$810 million** to support clinical trials and a planned U.S. launch around **2027** [52][53][54] Future Outlook - The ASCVD market is expected to evolve towards combination therapies and fixed-dose approaches, with obisetropib positioned as a preferred option due to its comprehensive risk factor management [24][28] - The company anticipates a **21% MACE benefit** based on recent data, which could significantly enhance its competitive position in the market [34][49] Additional Insights - NAMS is conducting a Phase II trial (Vinson study) to evaluate the combination of obisetropib with Amgen's Repatha, focusing on both LDL and LpLA reduction [14][19] - The company emphasizes the importance of safety and convenience in treatment options, aiming to provide a low-dose, once-daily pill for patients [32] Conclusion NewAmsterdam Pharma is strategically positioned to redefine ASCVD treatment with obisetropib, leveraging positive clinical trial results and a robust financial foundation to capture a significant share of the market. The focus on comprehensive risk factor management and engagement with regulatory bodies will be crucial for its future success.

Summary of NewAmsterdam Pharma Company (NAMS) FY Conference Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Focus**: Development of novel LDL lowering therapies, specifically obacetropib, targeting high-risk patients with elevated LDL levels [1][2] Key Industry Insights - **Market Dynamics**: The LDL lowering therapy market is experiencing robust growth, with drugs growing over 40% annually, and even generic ezetimibe growing over 20% per year [7][8] - **Patient Need**: Over 30 million patients are above the LDL target of 55, indicating a significant need for new therapies [5][9] Core Product Insights - **Obacetropib**: - Achieves LDL lowering of 35% to over 50% [5] - Demonstrated a 21% reduction in cardiovascular events in Phase III trials [5][15] - Well tolerated with no significant side effects compared to placebo [21] - Can be combined with ezetimibe to enhance efficacy, achieving over 90% of patients reaching LDL targets [14][15] Clinical Data Highlights - **Phase III Trials**: - Broadway and Brooklyn trials showed significant cardiovascular benefits and LDL lowering efficacy [22][15] - MACE (major adverse cardiac events) benefit observed at 21% reduction within 12 months [15] - Small particle reduction by 90%, which is associated with cardiovascular events [17][18] Safety and Efficacy - **Safety Profile**: - No increase in liver or muscle enzymes, and a decrease in diabetes risk [21] - Extremely safe based on Phase III data, addressing patient concerns about side effects [21] Future Developments - **Ongoing Trials**: - PREVAIL cardiovascular outcome trial fully enrolled, results expected by the end of 2026 [25] - Research into Alzheimer's disease due to HDL raising properties of obacetropib [23][24] - Imaging trial (Rembrandt) for plaque reduction also underway [24] Commercial Strategy - **Market Positioning**: - Plans to leverage patient demand and unique drug profile to navigate insurance coverage challenges [46][47] - Focus on cardiometabolic patients, who represent a significant portion of the target market [50][51] Additional Considerations - **Guideline Changes**: The shift in guidelines in 2013 led to an increase in cardiovascular deaths, highlighting the need for effective LDL lowering therapies [9] - **Patient Education**: Emphasis on educating patients about the benefits of obacetropib, particularly regarding its diabetes risk profile [33][34] Conclusion - NewAmsterdam Pharma is positioned to address a significant unmet need in the LDL lowering therapy market with obacetropib, supported by strong clinical data and a robust safety profile. The company is focused on upcoming trials and commercial strategies to maximize patient access and market penetration [26][52]