NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results – EMA submission expected in 2H25 by partner Menarini – – PREVAIL Phase 3 CVOT remains on track – -- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively -- -- Company to host R&D day on June 11 th , 2025 in New York City -- –$808.5 million in cash, cash equivalents and marketable securities at March 31, 2025 – Naarden, the Nethe ...

Core Insights - NewAmsterdam Pharma is advancing its clinical development of obicetrapib, an oral, low-dose CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [4][14] - The company reported a cash position of $808.5 million as of March 31, 2025, indicating strong financial backing for ongoing and future projects [11][3] - NewAmsterdam plans to submit for EMA approval in the second half of 2025 through its partner Menarini, highlighting its regulatory progress [3][4] Financial Performance - For the first quarter of 2025, NewAmsterdam recognized $3.0 million in revenue, up from $1.4 million in the same period in 2024, primarily due to increased transaction prices related to R&D contributions from Menarini [11] - Research and Development (R&D) expenses increased to $44.8 million in Q1 2025 from $42.4 million in Q1 2024, driven by higher personnel costs and investments in pipeline expansion [11] - Selling, General and Administrative (SG&A) expenses rose significantly to $27.2 million in Q1 2025 from $14.5 million in Q1 2024, reflecting increased costs associated with the planned commercial launch of obicetrapib [11] Clinical Development Updates - NewAmsterdam is conducting several pivotal Phase 3 trials, including PREVAIL, which has enrolled over 9,500 patients to evaluate obicetrapib's impact on major adverse cardiac events (MACE) [5][10] - The company is also progressing with the VINCENT Phase 2 trial, assessing the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) [5] - The REMBRANDT Phase 3 trial will evaluate the effect of obicetrapib plus ezetimibe on coronary plaque in high-risk ASCVD patients [6] Corporate Updates - NewAmsterdam appointed Adele Gulfo to its Board of Directors in April 2025, bringing over three decades of pharmaceutical experience [7] - The company will host an R&D Day on June 11, 2025, to discuss its research and development initiatives [8] 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 with current treatments [13][14] - The company aims to address the needs of the approximately 30 million under-treated U.S. adults who are not at their risk-based LDL-C goal [13]

Core Insights - NewAmsterdam Pharma has presented compelling clinical data from the BROADWAY and TANDEM Phase 3 trials, demonstrating significant reductions in LDL-C and Lp(a) levels, which are critical for patients at risk of cardiovascular disease [1][2][6] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medications for patients with elevated LDL-C who are at risk of cardiovascular disease [1][13] - The company is investigating obicetrapib, a low-dose CETP inhibitor, as a potential adjunct therapy to statins for improving LDL-C levels [8][13] Clinical Trial Findings - The BROADWAY trial showed that obicetrapib reduced LDL-C by 50% when used with statins and by 35% as monotherapy, with a notable 21% reduction in major adverse cardiovascular events [4][5] - The TANDEM trial demonstrated that the fixed-dose combination of obicetrapib and ezetimibe achieved a statistically significant LDL-C reduction of 48.6% compared to placebo [3][4] - Pooled data from the BROADWAY, TANDEM, and BROOKLYN trials indicated a median placebo-adjusted reduction of 45% in Lp(a) levels after 12 weeks of treatment [6][7] Market Context - Cardiovascular disease remains the leading cause of death globally, with a significant number of patients unable to reach their LDL-C goals despite the availability of lipid-lowering therapies [9][12] - Approximately 30 million under-treated adults in the U.S. are not at their risk-based LDL-C goal, highlighting a substantial clinical need for effective therapies [12] Future Prospects - The data presented at EAS 2025 is expected to support global regulatory filings for obicetrapib, reinforcing its potential as a foundational therapy in cardiovascular disease management [2][7] - The company has completed enrollment for the Phase 3 PREVAIL trial, which aims to assess the impact of obicetrapib on major adverse cardiovascular events [8]

Core Insights - NewAmsterdam Pharma is presenting new clinical and preclinical data on obicetrapib, an oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society Congress in May 2025 [1] - The company aims to address the unmet need for effective LDL-C lowering therapies for patients at risk of cardiovascular disease [4] Clinical Trial Presentations - A Phase 3 randomized trial on the fixed-dose combination of obicetrapib and ezetimibe for LDL-C reduction will be presented on May 5, 2025 [2] - Safety and efficacy data of obicetrapib in high cardiovascular risk patients will also be discussed on the same day [2] Additional Session Details - Obicetrapib's effects on atherosclerosis and vascular inflammation will be presented, highlighting its role in reducing non-HDL cholesterol and improving lesion stability [3] - The therapy's impact on reverse cholesterol transport and its safety in combination with moderate-dose statins will be showcased in various sessions [3] Company Overview - NewAmsterdam Pharma focuses on developing oral, non-statin medicines for patients with elevated LDL-C, aiming to improve patient care in populations with metabolic diseases [4] - The company is conducting multiple Phase 3 trials to investigate obicetrapib as a CETP inhibitor, both alone and in combination with ezetimibe [4]

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]