Financial Performance - Revenue for the quarter ended September 30, 2025, was $0.3 million, a significant decrease from $29.1 million in the same period in 2024, mainly due to the absence of clinical milestone revenue[8] - Revenue for Q3 2025 was $348,000, a significant decrease from $29,111,000 in Q3 2024, representing a decline of approximately 98.8%[23] - The net loss for the quarter ended September 30, 2025, was $72.0 million, compared to a net loss of $16.6 million for the same period in 2024[9] - The operating loss for Q3 2025 was $55,143,000, compared to an operating loss of $25,003,000 in Q3 2024, reflecting a deterioration of 120.5%[23] - The company reported a loss for the nine months ended September 30, 2025, of $128,896,000, an improvement compared to a loss of $149,421,000 for the same period in 2024, showing a reduction of approximately 13.7%[26] Cash and Assets - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities of $756.0 million, down from $834.2 million as of December 31, 2024, primarily due to ongoing operating expenditures[8] - Cash and cash equivalents as of September 30, 2025, were $538,407,000, down from $771,743,000 at the end of 2024, a decrease of approximately 30.1%[21] - Total assets decreased to $786,427,000 as of September 30, 2025, from $864,620,000 at the end of 2024, a decline of about 9.0%[21] - The company had a total shareholders' equity of $728,070,000 as of September 30, 2025, compared to $757,500,000 at the end of 2024, a decrease of approximately 3.9%[21] Expenses - Research and Development (R&D) expenses were $31.0 million for the quarter ended September 30, 2025, compared to $35.7 million for the same period in 2024, reflecting a decrease in clinical and manufacturing expenses[8] - Selling, General and Administrative (SG&A) expenses increased to $24.5 million in the quarter ended September 30, 2025, from $18.4 million in the same period in 2024, driven by higher personnel costs[8] - Total operating expenses for Q3 2025 were $55,491,000, slightly up from $54,114,000 in Q3 2024, indicating an increase of about 2.5%[23] - Research and development expenses for Q3 2025 were $30,971,000, down from $35,702,000 in Q3 2024, a decrease of about 13.5%[23] Clinical Development - The European Medicines Agency accepted for review marketing authorization applications for obicetrapib monotherapy and the fixed-dose combination with ezetimibe in August 2025, marking a significant regulatory milestone[5] - NewAmsterdam plans to initiate the RUBENS Phase 3 clinical trial in Q4 2025 to evaluate obicetrapib in combination with ezetimibe for patients with type 2 diabetes or metabolic syndrome[4] - In the BROADWAY trial, obicetrapib was shown to reduce p-tau217 levels by 20.5% over 12 months in ApoE4/E4 carriers, indicating potential benefits for Alzheimer's disease[3] - The company completed enrollment of over 9,500 patients in the PREVAIL Phase 3 cardiovascular outcomes trial in April 2024[7] - NewAmsterdam continues to advance its clinical development strategy, including ongoing trials such as PREVAIL and REMBRANDT, to support the potential launch of obicetrapib[2] Interest Income - Interest income for the nine months ended September 30, 2025, was $21,119,000, an increase from $12,396,000 in the same period of 2024, representing a growth of about 70.5%[23] Cash Flow - The company experienced a net cash used in operating activities of $106,908,000 for the nine months ended September 30, 2025, compared to $121,083,000 for the same period in 2024, indicating a decrease of approximately 11.7%[26]

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 is set to present additional safety and efficacy data from pivotal Phase 3 trials at the 2025 AHA Scientific Sessions, highlighting its focus on oral, non-statin medicines for cardiovascular disease patients [1][4] Group 1: Upcoming Presentations - The company will present a pooled analysis of the BROOKLYN and BROADWAY Phase 3 clinical trials, focusing on the effects of CETP inhibition with obicetrapib on LDL particles [2] - A digital poster presentation will discuss the combination of obicetrapib with ezetimibe on atorvastatin and its effects on atherosclerotic plaque lesions in specific mouse models [2] Group 2: Investor Conferences - NewAmsterdam management will participate in several investor conferences, including a fireside chat at the Guggenheim Annual Healthcare Innovation Conference on November 11, 2025 [3] - Additional fireside chats are scheduled at the Stifel Healthcare Conference on November 12, 2025, and the Jefferies London Healthcare Conference on November 19, 2025 [3] Group 3: Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing therapies for metabolic diseases, particularly targeting LDL-C levels in patients at risk of cardiovascular disease [4] - The company is investigating obicetrapib, a low-dose CETP inhibitor, as a potential adjunct therapy to statins for patients who do not respond well to existing treatments [4]

Core Insights - Wall Street anticipates a year-over-year decline in earnings for NewAmsterdam Pharma Company N.V. (NAMS) due to lower revenues, with a consensus expectation of a quarterly loss of $0.38 per share, reflecting a -111.1% change from the previous year [1][3] - Revenues are projected to be $3.88 million, which is an 86.7% decrease compared to the same quarter last year [3] - The stock's price movement will largely depend on how actual results compare to these estimates, with a potential for upward movement if results exceed expectations [2] Earnings Estimates and Revisions - The consensus EPS estimate has been revised down by 6.95% over the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for NewAmsterdam Pharma is higher than the Zacks Consensus Estimate, resulting in a positive Earnings ESP of +19.13%, suggesting a likelihood of beating the consensus EPS estimate [12] Earnings Surprise History - In the last reported quarter, NewAmsterdam Pharma was expected to post a loss of $0.52 per share but actually reported a loss of -$0.15, resulting in a positive surprise of +71.15% [13] - Over the past four quarters, the company has beaten consensus EPS estimates two times [14] Industry Context - In the Zacks Medical - Drugs industry, Corcept Therapeutics is expected to report earnings of $0.18 per share, indicating a year-over-year decline of -56.1%, with revenues expected to be $219.18 million, up 20.1% from the previous year [19] - Corcept's consensus EPS estimate has been revised down by 9.7% over the last 30 days, and it has a negative Earnings ESP of -72.60%, combined with a Zacks Rank of 5 (Strong Sell), making it challenging to predict an earnings beat [20]

Core Insights - The article highlights stocks reaching new 52-week highs, indicating market recognition of strong fundamentals and potential catalysts for growth [1][2]. Company Summaries Cogent Biosciences Inc. (COGT) - Cogent Biosciences plans to file its first New Drug Application for Bezuclastinib by the end of 2025, targeting non-advanced systemic mastocytosis [3]. - A phase III trial comparing Bezuclastinib with Sutent is ongoing, with results expected in the second half of 2025 [4]. - The stock reached a 52-week high of $16.99, up from $7.25 when last featured [5]. Assembly Biosciences Inc. (ASMB) - Assembly Biosciences is advancing four key development programs, with ABI-5366 expected to enter phase 2 studies in mid-2026 [6]. - Interim data for ABI-1179 is anticipated this fall, while ABI-6250 is in a phase 1a trial [7]. - The stock hit a 52-week high of $28, up from $14.53 when last featured [8]. Compass Therapeutics Inc. (CMPX) - Compass Therapeutics is conducting a phase 2/3 study of Tovecimig for advanced biliary tract cancer, with analyses of secondary endpoints expected in Q1 2026 [9][10]. - The stock reached a 52-week high of $4.39, up from $2.91 when last featured [11]. NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam Pharma is developing Obicetrapib as a cholesterol-lowering therapy, with positive data from the BROADWAY trial [12][13]. - The company has completed two additional phase III trials and submitted marketing applications to the EMA [16]. - The stock reached a 52-week high of $39.76, up from $21.56 when last featured [17]. Mineralys Therapeutics Inc. (MLYS) - Mineralys is developing Lorundrostat for uncontrolled hypertension, with a pivotal phase III trial achieving its primary endpoint [19]. - A phase II trial for overweight participants with OSA is ongoing, with topline results expected in 1H 2026 [20]. - The stock hit a 52-week high of $43.88, up from $10.34 when last featured [20]. Kymera Therapeutics Inc. (KYMR) - Kymera is set to report data from its phase I trial of KT-621 this quarter, with phase 2b studies planned for late 2025 and early 2026 [21][22]. - The stock reached a 52-week high of $60, up from $40 when last featured [22]. Insmed Inc. (INSM) - Insmed has two approved drugs and is conducting a phase 3 trial of Arikayce, with topline results expected in 1H 2026 [24][25]. - The stock hit a high of $166.54, up from $76.54 when last featured [26]. Adaptive Biotechnologies Corp. (ADPT) - Adaptive Biotechnologies expects MRD revenue between $190 million and $200 million for 2025, up from $145.5 million in 2024 [28][29]. - The stock reached a 52-week high of $15.94, up from $9.80 when last featured [29]. BridgeBio Pharma Inc. (BBIO) - BridgeBio has upcoming topline results from the FORTIFY and CALIBRATE studies expected in Fall 2025 [30]. - The stock reached a 3-year high of $56.24, up from $25.10 when last featured [31]. Tarsus Pharmaceuticals Inc. (TARS) - Tarsus reported strong sales for Xdemvy, with Q2 2025 sales of $102.7 million, compared to $40.8 million in Q2 2024 [32]. - The stock hit an all-time high of $70.15, up from $25.01 when last featured [34]. Palvella Therapeutics Inc. (PVLA) - Palvella's QTORIN is under development for various skin diseases, with a phase 2 trial expected to report data in mid-December 2025 [35][36]. - The stock reached a 52-week high of $76.76, up from $25 when last featured [36]. Merus N.V. (MRUS) - Merus agreed to be acquired by Genmab for $97 per share, with the deal expected to close in early Q1 2026 [37]. - The stock was at $39.71 when last featured [39]. Nephros Inc. (NEPH) - Nephros reported net revenue of $4.4 million for Q2 2025, marking its third consecutive quarter of profitability [40][41]. - The stock hit a 52-week high of $5.98, up from $2.93 when last featured [42].

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]