– Met primary endpoint with LDL-C mean reduction versus placebo of 36.3% at day 84 and 41.5% at day 365 –
– Lp(a) mean reduction versus placebo of 45.9% at day 84 and 54.3% at day 365 –
– Total LDL-P mean reduction versus placebo of 52.5% at day 180, with small LDL-P reduction of 102.4% –
– Safety results comparable to placebo –
NAARDEN, the Netherlands and MIAMI, Nov. 18, 2024 (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 additional results from the Company's Phase 3 BROOKLYN clinical trial (NCT05425745) evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia ("HeFH"), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The data were presented today in an oral late-breaker presentation at the American Heart Association (AHA) Scientific Sessions.
"We believe the additional data presented today underscore obicetrapib's potential to significantly reduce not only LDL-C but also Lp(a), LDL particles, both total and small, along with several other biomarkers in HeFH patients when compared to treatment with placebo. Within the HeFH patient community, it is common for patients to be on multiple lipid-lowering therapies, and given the efficacy and safety profile observed to date, we believe obicetrapib has the potential, if approved, to provide physicians with a new tool to address unmet need in these patients," said Stephen Nicholls, M.B.B.S., Ph.D., Director, Monash Victorian Heart Institute and Professor of Cardiology, Monash University.
"Despite the availability of lipid lowering therapies, CVD risk remains high and many people suffering from HeFH fail to meet their target cholesterol levels. We believe these additional results from the BROOKLYN pivotal trial further highlight obicetrapib's potential to meaningfully reduce LDL-C, while also significantly improving additional CVD risk parameters including Lp(a), non- HDL-C, ApoB, and HDL-C," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. "Together with the supportive data generated to date, these results reinforce our belief that, if approved, obicetrapib has the potential to meaningfully improve treatment for CVD patients worldwide. We look forward to building on these results with topline data from our TANDEM and BROADWAY studies expected in the fourth quarter of 2024."
Phase 3 BROOKLYN Trial Results
The BROOKLYN trial met its primary endpoint, achieving an LS mean reduction of 36.3% (p < 0.0001) compared to placebo at day 84, which was sustained at day 365 with an LS mean LDL-C reduction of 41.5% (p < 0.0001). Secondary efficacy endpoints, including lipoprotein(a) ("Lp(a)"), which was 45.9% (p<0.0001) compared to placebo at day 84 and 54.3% (p=0.16) at day 365, apolipoprotein B ("ApoB"), high-density lipoprotein cholesterol ("HDL-C") and non-HDL-C met statistical significance and results were consistent with data reported from NewAmsterdam's prior clinical trials. The p-value for the LS mean for all secondary endpoints compared to placebo was <0.0001 following 84 days of treatment with obicetrapib.
| | % LS mean change from baseline | Obicetrapib LS mean % change compared to placebo | |
| | Placebo (n=118) | Obicetrapib (n=236) | p-value |
| LDL-C | 0.3% | -36.1% | -36.3% | <0.0001 |
| Lp(a) | 10.5% | -35.4% | -45.9% | <0.0001 |
| Non-HDL-C | 2.8% | -31.6% | -34.5% | <0.0001 |
| ApoB | 2.9% | -21.5% | -24.4% | <0.0001 |
| Total LDL particles | 10.7% | -41.8% | -52.5% | <0.0001 |
| Small LDL particles | 32.4% | -70.0% | -102.4% | <0.0001 |
| HDL-C | 1.3% | 140.0% | 138.7% | <0.0001 |
| Note: As of day 84, except for particle data as of day 180 |
"We are very encouraged by these additional results from BROOKLYN, where we observed obicetrapib's lipid- and lipoprotein-lowering capabilities in a difficult to treat patient population that, despite being on multiple lipid-lowering therapies, still has elevated LDL-C," said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. "We are also pleased with the overall tolerability profile, including adverse events of special interest."
Obicetrapib was observed to be well tolerated, with safety results comparable to placebo and no increase in blood pressure. The treatment discontinuation rate for the obicetrapib arm was 7.6% versus 14.4% for placebo. Adverse events of special interest are summarized in the table below.
| Placebo
N=118
n (%) | Obicetrapib 10 mg
N=236
n (%) |
| New diabetes or worsening glycemic control (%) | 26 (22.0) | 48 (20.5) |
| HbA1c increase >0.5% from baseline | 6 (5.1) | 8 (3.4) |
| Cardiovascular events | 5 (4.2) | 6 (2.6) |
The data presentation is available through the publications and presentations section of the NewAmsterdam Pharma website at newamsterdampharma.com/publications.
Design of the Pivotal Phase 3 BROOKLYN Clinical Trial
The 52-week, global, pivotal, Phase 3, randomized, double-blind, placebo-controlled multicenter study evaluated the efficacy and safety of 10 mg obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with HeFH whose LDL-C is not adequately controlled. The study was conducted at sites in North America, Europe and Africa. A total of 354 patients were randomized 2:1 to receive 10 mg obicetrapib or placebo dosed as a once-daily oral treatment, with or without food. The mean baseline LDL-C for enrolled patients in the obicetrapib arm was 123 mg/dL despite high intensity statin use reported by approximately 79% of patients during screening, with 54% on ezetimibe and 14% on PCSK9 inhibitors. Females comprised approximately 53% of the study population and the median age of participants at baseline was 57 years.
The primary endpoint was percent change from baseline in LDL-C of obicetrapib 10 mg compared to placebo after 84 days. Secondary endpoints also included percent changes from baseline of obicetrapib 10 mg compared to placebo after 84 days in HDL-C, non- HDL-C, ApoB, and Lp(a). The trial also evaluated the safety and tolerability profile of obicetrapib.
About NewAmsterdam's Global Pivotal Phase 3 Program
NewAmsterdam's global, pivotal Phase 3 clinical development program consists of four studies in over 12,250 patients, three for obicetrapib monotherapy and one for a fixed-dose combination ("FDC") of obicetrapib and ezetimibe:
- BROOKLYN evaluated obicetrapib in patients with HeFH whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam reported topline data from BROOKLYN in the third quarter of 2024.
- BROADWAY is evaluating obicetrapib in adult patients with established atherosclerotic cardiovascular disease ("ASCVD") and/or HeFH whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 2,500 patients in July 2023 and expects to report topline data in the fourth quarter of 2024.
- TANDEM is evaluating obicetrapib as part of a FDC tablet with ezetimibe, a non-statin oral LDL-lowering therapy, in patients with established ASCVD or multiple risk factors for ASCVD and/or HeFH whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 400 patients in July 2024 and expects to report topline data in the fourth quarter of 2024.
- PREVAIL is a cardiovascular outcomes trial evaluating obicetrapib in patients with a history of ASCVD whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 9,500 patients in April 2024.
About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company's Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company's Phase 3 BROOKLYN trial, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company is conducting an additional Phase 3 pivotal trial BROADWAY, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients, and TANDEM, to evaluate obicetrapib and ezetimibe as a fixed-dose combination. The Company began enrolling patients in BROADWAY in January 2022 and in TANDEM in March 2024; completing enrollment of BROADWAY in July 2023, and TANDEM in July 2024. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. NewAmsterdam completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed dose combination with ezetimibe, for cardiovascular diseases have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
Forward-Looking Statements
Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company's intellectual property and its ability to enforce, and sufficiency of, its patents, the Company's business and strategic plans, the Company's commercial opportunity, the therapeutic and curative potential of the Company's product candidate, the Company's clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company's product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflict; the effects of competition on the Company's future business; and those factors described in the Company's public filings with the Securities Exchange Commission. Additional risks related to the Company's business include, but are not limited to: uncertainty regarding outcomes of the Company's ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company's efforts to commercialize a product candidate; the Company's ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company's business; intellectual property related claims; the Company's ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company's expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company's assessments to change. These forward-looking statements should not be relied upon as representing the Company's assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law.
Company Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdam
Bryan Blatstein
P: 1-917-714-2609
bblatstein@spectrumscience.com
Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com
– 在第84天与安慰剂相比，LDL-C的平均降低达到36.3%，在第365天达到41.5% –
– Lp(a)在第84天与安慰剂相比减少了45.9%，在第365天减少了54.3% –
– 总LDL-P在第180天与安慰剂相比减少了52.5%，小LDL-P减少了102.4% –
– 安全性结果与安慰剂相当 –
荷兰纳尔登和迈阿密，2024年11月18日 （环球新闻稿）-- NewAmsterdam制药公司N.V.（纳斯达克：NAMS或“NewAmsterdam”或“公司”），是一家晚期临床生物制药公司，开发用于面临心血管疾病（“CVD”）风险的患者的口服非他汀药物，这些患者的低密度脂蛋白胆固醇（“LDL-C”）升高，现有疗法效果不足或耐受性差。今天，公司宣布了来自公司第三阶段BROOKLYN临床试验（NCT05425745）的额外结果，该试验评估了obicetrapib在伴有异质性家族性高胆固醇血症（“HeFH”）的成人患者中的应用，这些患者的LDL-C未能得到良好控制，尽管已经接受了最大耐受的降脂治疗。这些数据今天在美国心脏协会（AHA）科学会议上进行了口头的快报展示。
“我们相信，今天展示的额外数据强调了obicetrapib显著降低LDL-C以及Lp(a)、LDL颗粒（包括总量和小颗粒）和其他多种生物标志物的潜力，与安慰剂治疗相比，在HeFH患者中尤为明显。在HeFH患者社区，患者常常服用多种降脂疗法，考虑到迄今为止观察到的疗效和安全性，我们相信，如果获得批准，obicetrapib有潜力为医生提供一种新工具，以满足这些患者的未满足需求，”莫纳什维多利亚心脏研究所董事、莫纳什大学心脏病学教授Stephen Nicholls万.b.b.S.，博士表示。
“尽管可用降脂疗法，但CVD风险仍然很高，许多患有HeFH的人未能达到目标胆固醇水平。我们相信，来自BROOKLYN关键试验的这些额外结果进一步突显了obicetrapib在显著降低LDL-C方面的潜力，同时显著改善其他CVD风险参数，包括Lp(a)、非HDL-C、Apob和HDL-C，”NewAmsterdam首席执行官Michael Davidson万.D.表示。“再加上迄今为止生成的支持性数据，这些结果强化了我们的信念，如果获得批准，obicetrapib将有潜力显著改善全球CVD患者的治疗。我们期待在2024年第四季度通过我们的TANDEm和BROADWAY研究获得的顶线数据基础上继续推进这些结果。”
三期BROOKLYN试验结果
BROOKLYN试验达到了主要终点，在第84天与安慰剂相比，实现了LS均值减少36.3% (p < 0.0001)，并在第365天维持了LS均值LDL-C减少41.5% (p < 0.0001)。次要疗效终点包括脂蛋白(a)（"Lp(a)"），在第84天与安慰剂相比为45.9% (p<0.0001)，在第365天为54.3% (p=0.16)，载脂蛋白b（"ApoB"），高密度脂蛋白胆固醇（"HDL-C"）和非HDL-C均达到了统计显著性，结果与NewAmsterdam之前的临床试验报告的数据一致。与安慰剂相比，所有次要终点的LS均值p值在接受obicetrapib治疗84天后为<0.0001。
| | % LS均值相较于基线的变化 | 与安慰剂相比，Obicetrapib的LS均值%变化 | |
| | 安慰剂（n=118） | Obicetrapib（n=236） | p值 |
| LDL-C | 0.3% | -36.1% | -36.3% | <0.0001 |
| Lp(a) | 10.5% | -35.40% | -45.9% | <0.0001 |
| 非 HDL-C | 2.8% | -31.6% | -34.5% | <0.0001 |
| ApoB | 2.9% | -21.5% | -24.4% | <0.0001 |
| 总LDL颗粒 | 10.7% | -41.8% | -52.5% | <0.0001 |
| 小型LDL颗粒 | 32.4% | -70.0% | -102.4% | <0.0001 |
| 高密度脂蛋白胆固醇（HDL-C） | 1.3% | 140.0% | 138.7% | <0.0001 |
| 注意：截至第84天，除了第180天的粒子数据外 |
“我们对BROOKLYN研究的这些额外结果感到非常鼓舞，我们观察到了obicetrapib在一群难治患者中的脂质和脂蛋白降低能力。尽管这些患者正在接受多种降脂治疗，但LDL-C水平仍然升高，”NewAmsterdam公司的首席科学官John Kastelein万.D.博士表示。“我们对整体耐受性特征也感到满意，包括特殊关注的不良事件。”
estic
obicetrapib被观察到耐受性良好，安全性结果与安慰剂相当，且血压没有升高。obicetrapib组的治疗中断率为7.6%，而安慰剂组为14.4%。特殊关注的不良事件在下面的表格中总结。
| 安慰剂
N=118
n (%) | Obicetrapib 10 毫克
N=236
n (%) |
| 新发糖尿病或血糖控制恶化 (%) | 26 (22.0) | 48 (20.5) |
| HbA1c 从基线增加 >0.5% | 6 (5.1) | 8 (3.4) |
| 心血管事件 | 5 (4.2) | 6 (2.6) |
数据展示可以通过NewAmsterdam Pharma网站的出版物和演示部分访问，网址为newamsterdampharma.com/publications。
关键第三阶段BROOKLYN临床试验的设计
这项为期52周的全球关键性第三阶段随机双盲安慰剂对照多中心研究评估了10毫克obicetrapib与安慰剂相比，在高胆固醇家族性高胆固醇血症（HeFH）患者中作为最大耐受剂量降脂治疗的辅助药物的疗效和安全性。研究在北美、欧洲和非洲的多个地点进行。共有354名患者按照2:1的比例随机接受10毫克obicetrapib或安慰剂，剂量为每日一次口服，无论是否伴随进食。进入obicetrapib组的患者基线LDL-C平均值为123 mg/dL，尽管在筛查期间约79%的患者报告使用了高强度他汀类药物，其中54%使用了依泽替米贝，14%使用了PCSK9抑制剂。女性约占研究人群的53%，参与者的中位年龄为57岁。
主要终点是obicetrapib 10毫克与安慰剂相比在84天后LDL-C相对基线的百分比变化。次要终点还包括obicetrapib 10毫克与安慰剂在84天后HDL-C、非HDL-C、Apob和Lp(a)相对基线的百分比变化。该试验还评估了obicetrapib的安全性和耐受性特征。
关于NewAmsterdam的全球关键性第三阶段项目
NewAmsterdam的全球关键性第三阶段临床开发项目包括四项研究，涉及超过12,250名患者，三项为obicetrapib单药治疗，一项为固定剂量组合（"FDC"）的obicetrapib和依泽替米贝：
- BROOKLYN评估了在最大耐受药物降脂治疗的情况下，LDL-C未能得到良好控制的HeFH患者中的obicetrapib疗效。NewAmsterdam在2024年第三季度报告了BROOKLYN的顶部数据。
- BROADWAY正在评估obicetrapib用于已确诊动脉粥样硬化性心血管疾病（"ASCVD"）和/或家族性高胆固醇血症（HeFH）的成人患者，这些患者的LDL-C水平未能得到有效控制，尽管正在接受最大耐受剂量的降脂治疗。NewAmsterdam于2023年7月完成了2500多名患者的招募，并预计将在2024年第四季度报告顶线数据。
- TANDEm正在评估obicetrapib作为与依泽替米贝（ezetimibe，一种非他汀类口服降LDL药物）联合的FDC药片，适用于已确诊ASCVD或多种ASCVD风险因素和/或HeFH的患者，且这些患者的LDL-C水平未能得到有效控制，尽管正在接受最大耐受剂量的降脂治疗。NewAmsterdam于2024年7月完成了400多名患者的招募，并预计将在2024年第四季度报告顶线数据。
- PREVAIL是一项心血管预后试验，评估obicetrapib在有ASCVD病史的患者中的效果，这些患者的LDL-C水平未能得到有效控制，尽管正在接受最大耐受剂量的降脂治疗。NewAmsterdam于2024年4月完成了9500多名患者的招募。
关于Obicetrapib
Obicetrapib是一种新型的口服低剂量CETP抑制剂，由NewAmsterdam公司开发，旨在克服目前降低LDL的治疗方法的局限性。在公司的第2期试验ROSE2、TULIP、ROSE和OCEAN，以及公司的第3期BROOKLYN试验中，对obicetrapib作为单药或联合治疗进行评估时，公司观察到在明显降低LDL的同时，出现类似于安慰剂的副作用概况。公司正在进行额外的第3期关键性试验BROADWAY，评估obicetrapib作为单药与最大耐受的降脂治疗联合使用，为CVD患者提供额外的LDL降低，同时还有TANDEm试验，评估obicetrapib和依泽替米（ezetimibe）作为固定剂量组合使用。公司于2022年1月开始在BROADWAY招募患者，并于2023年7月完成了BROADWAY的招募，于2024年3月开始在TANDEm招募患者，并于2024年7月完成了TANDEm的招募。公司还于2022年3月开始了第3期PREVAIL心血管结果试验，这一试验旨在评估obicetrapib减少主要不良心血管事件发生的潜力，包括心血管死亡、非致命性心肌梗塞、非致命性中风和非计划性冠状动脉重建。NewAmsterdam于2024年4月完成了PREVAIL的招募，并对9500多名患者进行了随机分组。obicetrapib在欧洲的商业化权利，无论是作为单药还是作为与依泽替米固定剂量组合的一部分，均已独家授予意大利Menarini集团，Menarini集团是一家总部位于意大利的国际领先制药和诊断公司。
关于新阿姆斯特丹，新阿姆斯特丹制药公司(NASDAQ：NAMS)是一家晚期的生物制药公司，其使命是改善代谢疾病患者的医疗护理，而当前已批准的治疗方法并不足够或耐受性不佳。我们寻求填补一个很大的需求，即需要一种安全、耐受、方便的降低低密度脂蛋白胆固醇的治疗方法。在多个3期研究中，新阿姆斯特丹正在研究obicetrapib，一种口服的、低剂量的、每日一次的CETP抑制剂，单独或与依他酸替代治疗联合使用，作为LDL-C降低疗法，用于心血管疾病风险患者，其LDL-C升高，现有治疗方法疗效不足或耐受性不佳。
纽约荷兰医药（纳斯达克：NAMS）是一家处于晚期的生物制药公司，旨在改善代谢性疾病人群的患者护理，目前批准的治疗方法并不足够有效或耐受。我们致力于填补一项重大未满足需要，即提供安全、耐受良好且便捷的降低低密度脂蛋白（LDL）药物疗法。在多个3期研究中，纽约荷兰正在研究obicetrapib，作为一种口服、低剂量、每日一次的CETP抑制剂，或与依非韦伯固定剂量组合一起使用，作为降低LDL-C疗法，用作降低患有心血管疾病风险的患者的辅助他汀治疗，对于那些现有疗法并不足够有效或耐受的患者。
前瞻性声明
本文件中包含的某些非历史事实的陈述是根据1995年美国私人证券诉讼改革法案的安全港条款的目的而提出的前瞻性陈述。前瞻性陈述通常伴随有"相信、" "可能、" "将、" "估计、" "继续、" "预期、" "打算、" "期待、" "应该、" "会、" "计划、" "预测、" "潜在、" "似乎、" "寻求、" "未来、" "前景"及类似表达，这些表达预测或指示未来事件或趋势，或不是历史事宜的陈述。这些前瞻性陈述包括但不限于关于公司知识产权及其执行能力和专利的充分性的陈述，公司的业务和战略计划，公司的商业机会，公司的候选药物的治疗和治愈潜力，公司的临床试验以及患者招募的时间，数据公告的时间和论坛，监管批准的达成和时间，以及商业化计划。这些陈述基于各种假设，无论是否在本文件中标识，以及基于公司管理层的当前预期，并非对实际表现的预测。这些前瞻性陈述仅供说明目的，并不旨在作为保证、保证、预测或确凿的事实或概率的陈述，且不应依赖于此。实际事件和情况难以或不可能预测，可能与假设有所不同。许多实际事件和情况超出了公司的控制范围。这些前瞻性陈述受若干风险和不确定性的影响，包括国内外商业、市场、金融、政治和法律条件的变化；与公司候选药物的批准及预期监管和商业里程碑的时间有关的风险，包括潜在商业化；与潜在客户谈判确定性合同安排的能力；竞争性候选产品的影响；获得足够材料供应的能力；全球经济和政治条件，包括俄罗斯-乌克兰和以色列-哈马斯冲突；竞争对公司未来业务的影响；以及在公司向证券交易委员会的公共文件中描述的那些因素。与公司业务相关的其他风险包括但不限于：关于公司正在进行的临床试验结果的不确定性，特别是与监管审查及潜在批准其候选药物相关的风险；与公司商业化候选药物的努力相关的风险；公司就有利条款达成并签署确定性协议的能力（如果可以的话）；竞争产品候选对公司业务的影响；与知识产权相关的索赔；公司吸引和保留合格人员的能力；继续为其候选药物采购原材料的能力。如果这些风险中的任何一个实现，或公司的假设证明不正确，实际结果可能与这些前瞻性陈述的暗示结果有实质性差异。可能还有公司当前未知或认为不重要的额外风险，也可能导致实际结果与前瞻性陈述中包含的结果不同。此外，前瞻性陈述反映了公司在本文件日期时的预期、计划或对未来事件的预测和观点，并且在其全部内容中受到此处的警示陈述的限定。公司预期后续事件和发展可能导致公司的评估发生变化。这些前瞻性陈述不应被视为代表公司在本通讯日期后任何日期的评估。因此，不应对这些前瞻性陈述给予不当的依赖。公司及其任何附属机构都没有义务更新这些前瞻性陈述，除非法律要求。
公司联系
Marcia Novero
Innodata Inc.
Mnovero@innodata.com
(201) 371-8015
Matthew Philippe
电话：1-917-882-7512
电子邮件：matthew.philippe@newamsterdampharma.com
媒体联系
NewAmsterdam的Spectrum Science代表
Bryan Blatstein
P: 1-917-714-2609
bblatstein@spectrumscience.com
投资者联系人
Precision AQ代表NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com
