Core Insights - NewAmsterdam Pharma has appointed Adele Gulfo as an independent director to its Board of Directors, bringing over 30 years of experience in the healthcare industry [1][2][4] - The company is preparing for the potential launch of obicetrapib, an oral, non-statin medicine aimed at lowering LDL-C for patients at risk of cardiovascular disease [2][5] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing therapies for cardiometabolic diseases, specifically targeting patients with elevated LDL-C who do not respond well to existing treatments [5] - The company is investigating obicetrapib as a cholesterol ester transfer protein (CETP) inhibitor, which is being tested in multiple Phase 3 trials [5] Leadership and Experience - Adele Gulfo has a strong background in commercial leadership, having previously held executive roles at Sumitomo Pharma America, Sumitovant Biopharma, and Pfizer, where she contributed to the launch of major brands like LIPITOR® and CRESTOR® [2][3] - Her expertise in global strategy and operations is expected to be crucial for NewAmsterdam as it finalizes its commercial strategy and prepares for its first product launch [2][4] Clinical Development - NewAmsterdam has reported positive outcomes from its three pivotal Phase 3 clinical trials, indicating progress in its development efforts [4]

NAARDEN, the Netherlands and MIAMI, March 31, 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 Ian Somaiya, Chief Financial Officer of NewAmsterdam Ph ...

Company Overview - NewAmsterdam Pharma (NASDAQ: NAMS) is a biotech company focused on developing obicetrapib, a second-generation CETP inhibitor aimed at addressing cardiovascular risk indications [1] Investment Focus - The company targets growth markets, particularly in biotech, and seeks undervalued stocks with significant potential [1] - The investment strategy includes a diverse portfolio ranging from megacap to microcap stocks, primarily in the U.S. market, with occasional interest in European or Canadian stocks [1] Market Position - Obicetrapib is positioned as a potentially best-in-class treatment, indicating a strong competitive edge in the biotech sector [1]

Group 1 - NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) has a strong late-stage cardiovascular pipeline in the biotech sector, which remains relatively unnoticed in the market [1] - The current market focus is primarily on GLP-1s and their potential impacts, indicating a competitive landscape in the biotech industry [1] - The company is positioned in a high-growth sector that is expected to experience exponential expansion, highlighting its potential for substantial returns through innovation [1]

Financial Position - As of December 31, 2024, the company had cash and cash equivalents of $771.7 million, up from $340.5 million as of December 31, 2023, primarily due to proceeds from offerings and milestone achievements[570]. - Cash and cash equivalents as of December 31, 2024, were $771.7 million, with plans to utilize these funds primarily for research and development initiatives[600]. - As of December 31, 2024, the company had cash and cash equivalents of $771.7 million, sufficient to fund estimated obligations of $11.8 million due within one year[617]. - Net cash used in operating activities increased by $17.4 million from $141.2 million in 2023 to $158.6 million in 2024[613]. - Net cash flows provided by financing activities was $659.5 million in 2024, an increase of $650.6 million from 2023[615]. Clinical Trials and Research - The Phase 3 BROADWAY clinical trial demonstrated a statistically significant LDL-C reduction of 33% (p<0.0001) for obicetrapib compared to placebo[572]. - The Phase 3 TANDEM clinical trial achieved an LS mean reduction of LDL-C of 48.6% (p < 0.0001) for the fixed-dose combination of obicetrapib and ezetimibe compared to placebo[573]. - The Phase 3 BROOKLYN clinical trial met its primary endpoint with statistically significant reductions in LDL-C compared to placebo, with p-values <0.0001 for key secondary endpoints[574]. - Approximately 30 million patients in the U.S. do not reach their LDL-C goals despite lipid-lowering therapy, highlighting a significant unmet need in the market[566]. - Research and development expenses are expected to be significant as the company advances obicetrapib through clinical trials and regulatory approval processes[581]. Revenue and Expenses - Revenue increased by $31.5 million, or 223.4%, to $45.6 million for the year ended December 31, 2024, compared to $14.1 million for the year ended December 31, 2023[589]. - Research and development expenses decreased by $8.0 million, or 5.0%, to $151.4 million for the year ended December 31, 2024, compared to $159.4 million for the year ended December 31, 2023[590]. - Selling, general and administrative expenses increased by $32.8 million, or 87.2%, to $70.4 million for the year ended December 31, 2024, compared to $37.6 million for the year ended December 31, 2023[591]. - Loss for the year increased by $64.7 million, to $241.6 million for the year ended December 31, 2024, compared to $176.9 million for the year ended December 31, 2023[595]. - As of December 31, 2024, the accumulated loss was $558.6 million, with expectations of continued significant losses in the foreseeable future[598]. Partnerships and Licensing - The company has partnered with Menarini for the commercialization of obicetrapib in Europe, with plans to pursue U.S. development independently[568]. - The company has not generated revenue from product sales, relying solely on a $120.9 million upfront payment from Menarini for licensing[575]. - Menarini made a non-refundable upfront payment of €115 million and committed to provide €27.5 million for R&D activities over two years[605]. - As of December 31, 2024, the company received a total of €30 million in milestone payments from Menarini, with €25 million received in 2024[606]. Market and Future Outlook - The company anticipates increased expenses as it no longer qualifies as an "emerging growth company" and will face higher reporting requirements[570]. - The company's net exposure to foreign currency risk was $108.6 million, mainly related to the Euro, with a potential change in future earnings of approximately $1.1 million from a 1% change in exchange rates[628]. - The fair value of derivative warrant liabilities and derivative earnout liability as of December 31, 2024, were $37.5 million and $44.8 million, respectively[630]. - The company has not included potential cash proceeds from the exercise of Warrants in its liquidity projections[608].

Financial Performance - Revenue for the year ended December 31, 2024, was $45.6 million, up from $14.1 million in 2023, primarily due to clinical success milestones[9][15] - Revenue for the year ended December 31, 2024, was $45,563,000, a significant increase from $14,090,000 in 2023, representing a growth of 223%[20] - Net loss for the year ended December 31, 2024, was $241.6 million, compared to a net loss of $176.9 million in 2023[9][15] - The company reported a loss for the year of $241,598,000 in 2024, compared to a loss of $176,937,000 in 2023, indicating an increase in losses of approximately 36.5% year-over-year[25] - The operating loss for 2024 was $176,289,000, slightly improved from a loss of $182,967,000 in 2023[20] Cash and Assets - NewAmsterdam reported $834.2 million in cash, cash equivalents, and marketable securities as of December 31, 2024, an increase from $340.5 million at the end of 2023[2][9] - Cash and cash equivalents increased to $771,743,000 in 2024 from $340,450,000 in 2023, marking a growth of 126.6%[19] - Total assets rose to $864,620,000 in 2024, compared to $347,097,000 in 2023, indicating an increase of 149.5%[19] - Shareholders' equity increased to $757,500,000 in 2024 from $288,393,000 in 2023, a growth of 163.5%[19] Expenses - Research and Development expenses decreased to $151.4 million in 2024 from $159.4 million in 2023, attributed to reduced manufacturing and clinical costs[9][10] - Selling, General and Administrative expenses rose to $70.4 million in 2024, compared to $37.6 million in 2023, driven by increased personnel and marketing costs[9][15] - Total operating expenses for 2024 were $221,852,000, up from $197,057,000 in 2023, reflecting an increase of 12.6%[20] - The company incurred share-based compensation expenses of $33,619,000 in 2024, compared to $24,572,000 in 2023, marking a 36.8% increase[25] Clinical Trials and Regulatory Plans - The BROADWAY trial achieved a statistically significant LS mean LDL-C reduction of 33% (p<0.0001) at day 84 compared to placebo[6][7] - The TANDEM trial met all co-primary endpoints, achieving an LS mean LDL-C reduction of 49% (p<0.0001) at day 84 compared to placebo[6][7] - The BROOKLYN trial reported an LS mean LDL-C reduction of 36% (p<0.0001) at day 84 compared to placebo[6][7] - NewAmsterdam plans to submit for EMA approval in the second half of 2025 and is preparing for the potential launch of obicetrapib in the U.S. and Europe[3][4] - The company completed enrollment of over 9,500 patients in the PREVAIL Phase 3 trial in April 2024, which evaluates obicetrapib's impact on major adverse cardiac events[9][11] Cash Flow and Financing Activities - Net cash used in operating activities was $158,564,000 in 2024, an increase from $141,218,000 in 2023, reflecting a decline in operational cash flow[25] - The company generated net cash provided by financing activities of $659,507,000 in 2024, a significant increase from $8,912,000 in 2023, primarily due to new equity offerings[25] - The company reported a net cash used in investing activities of $62,848,000 in 2024, compared to $24,000 in 2023, indicating increased investment expenditures[25] Other Financial Changes - The fair value change of derivative earnout and warrants was $75,593,000 in 2024, a substantial increase from $10,284,000 in 2023[25] - Changes in working capital included a decrease in accounts payable by $12,948,000 in 2024, contrasting with an increase of $5,070,000 in 2023[25] - The company had cash paid for income taxes of $1,000 in 2024, a slight decrease from $27,000 in 2023[25] - The company recognized a noncash financing obligation related to the Business Combination of $6,815,000 in prior years, which was not present in the current year[25]

Core Insights - NewAmsterdam Pharma Company is advancing its development of obicetrapib, an oral, non-statin medicine aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [1][2][4] - The company reported significant financial results for 2024, including a net loss of $241.6 million, but also highlighted a strong cash position of $834.2 million as of December 31, 2024 [1][9][19] Clinical Development Updates - NewAmsterdam has completed three pivotal Phase 3 trials: BROADWAY, TANDEM, and BROOKLYN, all demonstrating significant LDL-C reduction [2][5][7] - The BROADWAY trial showed a 33% reduction in LDL-C with obicetrapib compared to placebo, while the TANDEM trial achieved a 49% reduction in a fixed-dose combination with ezetimibe [7][10] - The PREVAIL cardiovascular outcomes trial is ongoing, with over 9,500 patients enrolled, aimed at evaluating the impact of obicetrapib on major adverse cardiac events (MACE) [6][10] Financial Performance - For the year ended December 31, 2024, NewAmsterdam reported revenue of $45.6 million, a significant increase from $14.1 million in 2023, primarily due to clinical success milestones [9][19] - Research and development expenses decreased to $151.4 million from $159.4 million in the previous year, while selling, general, and administrative expenses rose to $70.4 million from $37.6 million [9][19] - The company’s cash and cash equivalents increased to $771.7 million from $340.5 million in 2023, driven by successful financing efforts [9][26] Regulatory and Market Outlook - An EMA submission for obicetrapib is anticipated in the second half of 2025, with plans to build inventory and commercial capabilities in preparation for potential U.S. and European launches [1][3][2] - The company aims to address the significant unmet need in the LDL-lowering therapy market, particularly for patients who are not adequately treated with existing therapies [12][11]

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] - The company aims to address the unmet need for safe and well-tolerated LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [3] Company Overview - NewAmsterdam Pharma is investigating obicetrapib, a low-dose, once-daily CETP inhibitor, in multiple Phase 3 trials as a potential LDL-C lowering therapy [3] - The company is also exploring the use of obicetrapib in combination with ezetimibe as an adjunct to statin therapy for patients with elevated LDL-C [3] Upcoming Events - Company management will participate in the TD Cowen 45th Annual Healthcare Conference in Boston on March 4-5, 2025, with a presentation scheduled for 1:50 p.m. ET on March 4 [4] - The company will also present at the Leerink Partners Global Healthcare Conference in Miami on March 10, 2025, at 8:00 a.m. ET [4] - Additionally, management will be available for one-on-one meetings at the Jefferies Biotech on the Beach Summit in Miami on March 12, 2025 [4]

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][3] - 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 [3] Product Development - NewAmsterdam is conducting multiple phase 3 trials for obicetrapib, an oral, low-dose, once-daily CETP inhibitor, which is being investigated as a standalone treatment and in combination with ezetimibe [3] - The target population includes patients at risk of CVD with elevated LDL-C levels, for whom current therapies are insufficiently effective or poorly tolerated [3] Upcoming Events - Ian Somaiya, the Chief Financial Officer of NewAmsterdam Pharma, will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 5, 2025, at 10:00 a.m. ET [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 - NewAmsterdam Pharma is advancing its clinical development program for obicetrapib, a CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease, with significant milestones expected in 2025 [1][2][12] Clinical Development - Positive topline results were announced for three pivotal Phase 3 trials: BROADWAY, TANDEM, and BROOKLYN, which demonstrated safety profiles comparable to placebo and significant LDL-C reductions [2][3][4] - The BROADWAY trial showed a 33% reduction in LDL-C (p<0.0001) and a 21% reduction in major adverse cardiovascular events (MACE) [4][6] - The TANDEM trial achieved a 49% reduction in LDL-C (p<0.0001) with the obicetrapib-ezetimibe combination [7] - The BROOKLYN trial reported a 36% reduction in LDL-C (p<0.0001) [7] Regulatory and Intellectual Property - NewAmsterdam plans to submit global regulatory filings for obicetrapib, including EMA submission in the second half of 2025 [1] - The company has secured a new patent for obicetrapib, providing protection until July 2043 in the U.S., with a total of nine patents issued or allowed [5] Financial Position - The company reported an unaudited cash balance of $835 million at year-end 2024, following an oversubscribed public offering [1][9] - This financial strength is expected to support operations through the anticipated PREVAIL cardiovascular outcomes trial readout and potential commercial launch of obicetrapib [2] Future Plans - NewAmsterdam aims to present additional data from its Phase 3 studies and publish findings in high-impact journals throughout 2025 [6][8] - The company is also focused on commercial readiness, including scaling up manufacturing capacity and building inventory for potential U.S. and European launches [9]