NAARDEN, The Netherlands and MIAMI, Nov. 25, 2025 (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 company management will participate in the following up ...

NewAmsterdam Pharma Company (NasdaqGM:NAMS) 2025 Conference November 19, 2025 07:00 AM ET Company ParticipantsJohn Kastelein - CSOIan Somaiya - CFOConference Call ParticipantsDennis Ding - Biotech AnalystDennis DingHi, good afternoon. Welcome to the Jefferies London Healthcare Conference. My name is Dennis Ding, biotech analyst here at Jefferies. I have the wonderful pleasure of having NewAmsterdam Pharma here. We have the CSO, John Kastelein, and CFO, Ian Somaiya, here with us. Welcome.Ian SomaiyaThank you ...

Summary of NewAmsterdam Pharma Company Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Event**: 2025 Conference on November 12, 2025 - **Key Speakers**: CEO Michael Davidson, CFO Ian Somaiya Industry Insights - **Industry**: Lipid management and cardiovascular health - **Recent Event**: Discussion of the Freselius trial presented at the American Heart Association (AHA) conference, highlighting significant advancements in lipid treatment guidelines Core Points and Arguments 1. **Freselius Trial Results**: - Reported a 25% reduction in three-point MACE and a mortality benefit, which is a significant improvement over the previous FOURIER trial that showed only a 15% relative risk reduction without mortality benefit [2][3] - The trial's findings are expected to broaden the population guidelines for LDL cholesterol management, suggesting targets below 55 mg/dL, potentially even 40 mg/dL [3][4] 2. **PREVAIL Trial Design**: - The PREVAIL trial is designed to run longer (4.6 years) to capture adequate event data, similar to the successful approach of the Freselius trial [4][5] - The trial aims to validate the LDL-lowering benefits and their correlation with reduced myocardial infarction rates [5] 3. **Market Expansion**: - The new guidelines will effectively double the market for LDL-lowering treatments, as they will include patients with atherosclerotic disease regardless of prior heart attacks or strokes [9] 4. **Oral PCSK9 Developments**: - Merck's oral PCSK9 treatment shows promise but has limitations similar to Rybelsus, which may affect patient adherence [11][12] - NewAmsterdam believes its fixed-dose combination (FDC) will achieve better LDL lowering with easier administration [12] 5. **BROADWAY Trial Outcomes**: - NewAmsterdam's BROADWAY trial demonstrated a 21% MACE benefit, suggesting that their drug offers additional benefits beyond LDL lowering [14][24] - The company is optimistic about matching or exceeding this benefit in the PREVAIL trial [24] 6. **Regulatory Strategy**: - NewAmsterdam plans to engage with the FDA regarding the timing of filing for PREVAIL outcomes data, which could be included in the product label [19] - The European filing by partner Menarini has been accepted, with expected approval in the second half of next year [19] 7. **LPL-A and Alzheimer's Research**: - The company is exploring the potential of obicetrapib in treating Alzheimer's, particularly in high-risk populations [47][48] - There is significant interest from the Alzheimer's community regarding the drug's potential benefits [48] 8. **Market Opportunity**: - The lipid market is substantial, with 30 million individuals in the U.S. diagnosed with hypercholesterolemia, many not at treatment goals [42] - NewAmsterdam estimates an $8 billion market opportunity for its drug, supported by the ability to treat a wide range of patients with elevated LDL and LPL-A [42][43] 9. **Competitive Landscape**: - The company acknowledges the presence of other PCSK9 therapies but believes its product offers superior benefits and ease of use [16][45] - The evolving landscape of lipid treatments, including oral options, is expected to expand the overall market rather than cannibalize existing products [45] Additional Important Insights - **Patient Compliance**: NewAmsterdam is actively monitoring trial execution metrics and ensuring high patient compliance through site visits and support [37][39] - **Future Directions**: The company is committed to launching obicetrapib independently to maximize value and is optimistic about its strategic position in the lipid space [51]

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Event**: FY Conference on November 11, 2025 Key Industry Insights - **Lipid Management**: The conference highlighted significant advancements in lipid management, particularly in the context of cardiovascular disease prevention. The recent American Heart Association (AHA) meeting emphasized the importance of LDL lowering and its correlation with mortality benefits, which is expected to shift treatment guidelines towards more aggressive LDL targets [6][54]. Core Points Discussed 1. **Mortality Benefit Evidence**: New studies have shown that aggressive LDL lowering can lead to mortality benefits, particularly in broader high-risk populations, which opens up new market opportunities for NewAmsterdam's products [6][54]. 2. **Prevail Study Design**: The Prevail study is designed to track event rates similar to previous successful studies, with a focus on achieving a significant reduction in cardiovascular events. The company is confident in the study's design and its potential outcomes [20][21][12]. 3. **Market Competition**: The competitive landscape includes Merck's oral PCSK9 inhibitor, which has shown promising LDL lowering results. However, NewAmsterdam believes its product, Obsettra, offers unique benefits, including Lp(a) lowering and potential Alzheimer's disease benefits, which could differentiate it in the market [13][15][47]. 4. **Regulatory Strategy**: NewAmsterdam plans to align its NDA submission with the completion of the Prevail study to ensure that the most relevant data is available at launch. The timing of the NDA submission is contingent on event tracking and FDA feedback [41][42][43]. 5. **Future Studies**: Additional studies, including Rubin and Rembrandt, are planned to further explore the drug's benefits in specific populations, particularly those with high Lp(a) levels and diabetes [44][45]. Additional Important Insights - **Market Growth Potential**: Analysts predict a significant market growth for lipid-lowering therapies, estimating a market size of $4 billion to $5 billion for both Merck and AstraZeneca, which NewAmsterdam aims to capture with its innovative approach [15][16]. - **Patient Compliance Concerns**: The discussion highlighted the challenges of patient compliance in real-world settings compared to clinical trials, which may affect the uptake of new therapies [13][14]. - **Emerging Technologies**: The future of lipid management is expected to be transformed by new technologies and therapies, including gene editing approaches, which could significantly impact cardiovascular disease prevention [54]. Conclusion NewAmsterdam Pharma is positioned to capitalize on the evolving landscape of lipid management with its upcoming product, Obsettra. The company is focused on leveraging new evidence supporting aggressive LDL lowering, maintaining a strategic approach to regulatory submissions, and preparing for a competitive market environment. The insights from the AHA meeting and ongoing studies will play a crucial role in shaping the company's future trajectory in the healthcare sector.

Core Insights - NewAmsterdam Pharma is focused on advancing obicetrapib, a novel oral therapy for lowering LDL-C in patients at risk of cardiovascular disease, with recent regulatory milestones achieved in Europe [2][7][11] Clinical Development Updates - The European Medicines Agency has accepted marketing authorization applications for obicetrapib and its fixed-dose combination with ezetimibe, marking a significant regulatory milestone [2][7] - Ongoing clinical trials include PREVAIL, a cardiovascular outcomes trial with over 9,500 patients enrolled, and REMBRANDT, a Phase 3 imaging trial [9][11] - Recent data from the BROADWAY trial indicates obicetrapib's potential to modify Alzheimer's disease biomarkers, particularly in high-risk patients [5][13] Financial Performance - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities totaling $756.0 million, a decrease from $834.2 million at the end of 2024 [10][21] - Revenue for the third quarter of 2025 was $0.3 million, down from $29.1 million in the same period in 2024, primarily due to the absence of clinical milestone revenue [10][23] - Research and development expenses decreased to $31.0 million from $35.7 million year-over-year, while selling, general, and administrative expenses increased to $24.5 million from $18.4 million [10][23] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals despite existing treatments [12][14] - The company aims to address this gap with obicetrapib, which has shown promising results in clinical trials, indicating its potential as a differentiated therapy in a growing market [2][11]

Core Insights - NewAmsterdam Pharma Company N.V. (NAMS) shares increased by 5.9% to $32.48, with a notable trading volume, reflecting a 13.6% gain over the past four weeks [1][2] Company Overview - The rise in NAMS stock price is linked to investor optimism surrounding its investigational candidate, obicetrapib, which is being evaluated for lowering LDL-C in patients with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia across three pivotal late-stage studies [2] Financial Expectations - The company is projected to report a quarterly loss of $0.41 per share, marking a year-over-year decline of 127.8%, with expected revenues of $2.35 million, down 91.9% from the previous year [3] - The consensus EPS estimate for NAMS has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - NAMS operates within the Zacks Medical - Drugs industry, where another company, Stevanato Group (STVN), experienced a 5.6% decline in stock price, closing at $24.53, despite a 7.6% return over the past month [4] - Stevanato's consensus EPS estimate has remained stable at $0.15, reflecting a year-over-year increase of 15.4%, and it holds a Zacks Rank of 2 (Buy) [5]

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Key Personnel**: Founder and Chief Scientific Officer John Kastelein, Head of Investor Relations and Executive Vice President Matthew Philippe - **Focus**: Development of lipid-lowering therapies, particularly obicetrapib Core Points and Arguments - **Clinical Trials**: - Completed pivotal lipid-lowering registration studies: BROADWAY, BROOKLYN, and TANDEM, all published in reputable journals [2][3] - Current focus on PREVAIL trial, which is fully enrolled and aims to translate findings from BROADWAY, showing a 21% reduction in major adverse cardiovascular events (MACE) [2][3] - PREVAIL has four times the number of patients and a longer duration than BROADWAY, enhancing confidence in MACE reduction outcomes [3] - **Regulatory Filings**: - Applications filed in Europe for both monotherapy and fixed-dose combination, with expected approvals in the second half of next year [6] - U.S. filing timelines are contingent on PREVAIL outcomes data, with hopes for data availability by early 2026 [7][8] - **Efficacy Data**: - The 21% MACE reduction observed in BROADWAY is supported by Kaplan-Meier curves, indicating biological plausibility [10][11] - Analysis of previous trials suggests that MACE reductions in phase three trials typically translate to outcomes in larger trials [12] - **Lipid Dynamics**: - Focus on small LDL particles and lipoprotein(a) as significant contributors to cardiovascular risk, with obicetrapib showing a 90% reduction in small LDL particles [16][18] - Ongoing studies to establish the predictive value of LDL particles over traditional LDL cholesterol measurements [17] - **Lipoprotein(a) Insights**: - Anticipation of positive outcomes from the HORIZON trial, which will assess the impact of lipoprotein(a) lowering on MACE [20][21] - The relationship between lipoprotein(a) reduction and MACE is expected to be established, aiding in the understanding of obicetrapib's effects [21][22] - **Competitive Landscape**: - NewAmsterdam Pharma positions obicetrapib as the only CETP inhibitor, differentiating it from existing PCSK9 inhibitors [36][37] - Emphasis on the safety profile of obicetrapib as a key factor for broad market access [38] Other Important Content - **Alzheimer's Disease Biomarker Study**: Recent findings suggest obicetrapib may also impact Alzheimer's disease biomarkers, presenting a unique selling point [4][41] - **Patient Compliance and Trial Integrity**: The company has established robust tracking mechanisms for patient compliance in the PREVAIL trial, ensuring data integrity [31][34] - **Market Potential**: The lipid management market is expected to accommodate multiple successful therapies, with NewAmsterdam Pharma aiming for a significant share due to its differentiated product profile [36][38] This summary encapsulates the key discussions and insights from the NewAmsterdam Pharma conference call, highlighting the company's strategic direction, clinical trial progress, and competitive positioning in the lipid-lowering market.

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][3] Company Overview - NewAmsterdam Pharma aims to address unmet needs in metabolic diseases where current 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 [3] - Obicetrapib is being studied as an LDL-C lowering therapy, either alone or in combination with ezetimibe, to be used alongside statin therapy for patients with elevated LDL-C [3] Upcoming Events - John Kastelein and Matthew Philippe will participate in a virtual fireside chat at the Stifel 2025 Virtual Cardiometabolic Forum on September 30, 2025 [1] - A live webcast of the event will be available on the investor relations section of the NewAmsterdam Pharma website, with an archived replay to follow [2]

Core Insights - Several healthcare and biotech stocks saw significant price movements in after-hours trading on September 12, with notable gains in companies like Penumbra, Check-Cap, Adaptimmune Therapeutics, and NewAmsterdam Pharma, indicating a volatile session for the sector [1] Company Summaries Penumbra Inc. (PEN) - Penumbra's stock closed at $272.73 during regular trading, down by $3.67 or 1.33%, but rebounded to $289.86 in after-hours, gaining 6.28% [2] - The trading range for the day was $271.83 to $280.14, with a volume of 454,478 shares, slightly below its average of 472,087 [3] - The company has a market capitalization of approximately $10.64 billion and a trailing price-to-earnings ratio of 71.96 based on earnings per share of $3.79 [3] - Penumbra raised its full-year 2025 revenue guidance to $1.355 billion - $1.370 billion, reflecting a growth of 13% - 15% over 2024 revenue of $1.195 billion, and projects a 20% - 21% growth in its U.S. thrombectomy segment [5] - The company appointed Shruthi Narayan as its new president, indicating potential strategic shifts [6] Check-Cap Ltd. (CHEK) - Check-Cap's stock surged from $0.7459 to $2.1600 in after-hours trading, marking a gain of 191.22%, driven by a strategic merger announcement [6] - During regular trading, the stock gained 8.09%, closing at $0.7459, with a trading range of $0.6860 to $0.7602 and a volume of 67,178 shares [7] - The merger with MBody AI aims to enhance Check-Cap's colorectal cancer screening capabilities through AI integration [8] Adaptimmune Therapeutics plc (ADAP) - Adaptimmune's stock rose from $0.0560 to $0.0651 in after-hours trading, a gain of 16.25%, following a 10.89% increase during regular hours [8] - For Q2 2025, the company reported a net loss of $30.3 million, or $0.02 per share, with total revenue of $13.7 million, primarily from product sales of TECELRA [9] - Adaptimmune entered a definitive agreement to sell certain cell therapies for $55 million upfront, with potential future milestone payments of up to $30 million, allowing it to repay debt and restructure for value maximization [10] NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam's shares rose from $24.19 to $26.18 in after-hours trading, an 8.23% gain, following a 9.06% decline during the day [11] - The stock's recovery is attributed to optimism surrounding its lead candidate, obicetrapib, which has received regulatory review acceptance from the EMA [11] - The company reported Q2 2025 revenue of $16.45 million and a net loss of $14.92 million, improving from a $0.41 loss per share in the same quarter of 2024 [13]

Financial Data and Key Metrics Changes - The company has achieved significant milestones in its LDL studies, with positive data released last year supporting its European filing accepted by the EMA [3][4] - The expected approval in Europe is anticipated within the next 12 months, with a projected 33% to 36% reduction in LDL-C for monotherapy and approximately 49% for the fixed-dose combination [8][10] Business Line Data and Key Metrics Changes - The company is focusing on redefining hyperlipidemia treatment through its drug obicetrapib, which not only reduces LDL but also Lp(a) by 40% to 50% in targeted patient populations [4][5] - The BROADWAY trial demonstrated a 21% MACE benefit at one year, indicating the drug's potential effectiveness [34] Market Data and Key Metrics Changes - The global opportunity for the drug is projected to exceed $8 billion, with potential revenue splits favoring the U.S. market [16][17] - The company expects a slower launch pace in Europe compared to the U.S. due to country-by-country approval processes [18] Company Strategy and Development Direction - The company aims to leverage its unique drug profile to gain a competitive edge in the lipid-lowering market, particularly against PCSK9 inhibitors and other therapies [44][45] - The strategy includes a focus on broad access and pricing negotiations in Europe, with a collaborative relationship with its partner Menarini [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's potential to address residual risks associated with small LDL particles, which are not effectively targeted by existing therapies [5][46] - The company is optimistic about the upcoming PREVAIL study results, which are expected to support its U.S. filing strategy [25][34] Other Important Information - The company has secured a new composition of matter patent valid until 2043, enhancing its intellectual property position [60] - The management highlighted the importance of outcomes data in shaping the drug's market access and pricing strategies [20][23] Q&A Session Summary Question: Can you provide an overview of the company and upcoming investor focus areas? - The company was founded to redefine hyperlipidemia treatment, with significant progress in LDL studies and an upcoming outcome study [3][4] Question: What are the expectations for the European regulatory submission? - The submission is based on the BROADWAY and BROOKLYN studies, with expected LDL-C reductions of 33% to 36% for monotherapy [8][10] Question: How does the company plan to approach U.S. filing strategies? - The company aims to launch with the broadest possible label, leveraging outcomes data to enhance market access [20][21] Question: What is the competitive landscape for obicetrapib? - The drug is positioned to outperform existing therapies by addressing both LDL and Lp(a) levels effectively [44][45] Question: What is the company's confidence in its intellectual property position? - The company has a strong IP estate, including a new patent valid until 2043, which supports its market position [60]