– 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天與安慰劑相比，LDL-C的平均降低達到36.3%，在第365天達到41.5% –
– Lp(a)在第84天與安慰劑相比減少了45.9%，在第365天減少了54.3% –
– 總LDL-P在第180天與安慰劑相比減少了52.5%，小LDL-P減少了102.4% –
– 安全性結果與安慰劑相當 –
荷蘭納爾登和邁阿密，2024年11月18日 （環球新聞稿）-- NewAmsterdam製藥公司N.V.（納斯達克：NAMS或「NewAmsterdam」或「公司」），是一家晚期臨床生物製藥公司，開發用於面臨心血管疾病（「CVD」）風險的患者的口服非他汀藥物，這些患者的低密度脂蛋白膽固醇（「LDL-C」）升高，現有療法效果不足或耐受性差。今天，公司宣佈了來自公司第三階段BROOKLYN臨床試驗（NCT05425745）的額外結果，該試驗評估了obicetrapib在伴有異質性家族性高膽固醇血癥（「HeFH」）的成人患者中的應用，這些患者的LDL-C未能得到良好控制，儘管已經接受了最大耐受的降脂治療。這些數據今天在美國心臟協會（AHA）科學會議上進行了口頭的快報展示。
「我們相信，今天展示的額外數據強調了obicetrapib顯著降低LDL-C以及Lp(a)、LDL顆粒（包括總量和小顆粒）和其他多種生物標誌物的潛力，與安慰劑治療相比，在HeFH患者中尤爲明顯。在HeFH患者社區，患者常常服用多種降脂療法，考慮到迄今爲止觀察到的療效和安全性，我們相信，如果獲得批准，obicetrapib有潛力爲醫生提供一種新工具，以滿足這些患者的未滿足需求，」莫納什維多利亞心臟研究所董事、莫納什大學心臟病學教授Stephen Nicholls萬.b.b.S.，博士表示。
「儘管可用降脂療法，但CVD風險仍然很高，許多患有HeFH的人未能達到目標膽固醇水平。我們相信，來自BROOKLYN關鍵試驗的這些額外結果進一步突顯了obicetrapib在顯著降低LDL-C方面的潛力，同時顯著改善其他CVD風險參數，包括Lp(a)、非HDL-C、Apob和HDL-C，」NewAmsterdam首席執行官Michael Davidson萬.D.表示。「再加上迄今爲止生成的支持性數據，這些結果強化了我們的信念，如果獲得批准，obicetrapib將有潛力顯著改善全球CVD患者的治療。我們期待在2024年第四季度通過我們的TANDEm和BROADWAY研究獲得的頂線數據基礎上繼續推進這些結果。」
三期BROOKLYN試驗結果
BROOKLYN試驗達到了主要終點，在第84天與安慰劑相比，實現了LS均值減少36.3% (p < 0.0001)，並在第365天維持了LS均值LDL-C減少41.5% (p < 0.0001)。次要療效終點包括脂蛋白(a)（"Lp(a)"），在第84天與安慰劑相比爲45.9% (p<0.0001)，在第365天爲54.3% (p=0.16)，載脂蛋白b（"ApoB"），高密度脂蛋白膽固醇（"HDL-C"）和非HDL-C均達到了統計顯著性，結果與NewAmsterdam之前的臨床試驗報告的數據一致。與安慰劑相比，所有次要終點的LS均值p值在接受obicetrapib治療84天后爲<0.0001。
| | % LS均值相較於基線的變化 | 與安慰劑相比，Obicetrapib的LS均值%變化 | |
| | 安慰劑（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 |
| 總LDL顆粒 | 10.7% | -41.8% | -52.5% | <0.0001 |
| 小型LDL顆粒 | 32.4% | -70.0% | -102.4% | <0.0001 |
| 高密度脂蛋白膽固醇（HDL-C） | 1.3% | 140.0% | 138.7% | <0.0001 |
| 注意：截至第84天，除了第180天的粒子數據外 |
「我們對BROOKLYN研究的這些額外結果感到非常鼓舞，我們觀察到了obicetrapib在一群難治患者中的脂質和脂蛋白降低能力。儘管這些患者正在接受多種降脂治療，但LDL-C水平仍然升高，」NewAmsterdam公司的首席科學官John Kastelein萬.D.博士表示。「我們對整體耐受性特徵也感到滿意，包括特殊關注的不良事件。」
estic
obicetrapib被觀察到耐受性良好，安全性結果與安慰劑相當，且血壓沒有升高。obicetrapib組的治療中斷率爲7.6%，而安慰劑組爲14.4%。特殊關注的不良事件在下面的表格中總結。
| 安慰劑
N=118
n (%) | Obicetrapib 10 毫克
N=236
n (%) |
| 新發糖尿病或血糖控制惡化 (%) | 26 (22.0) | 48 (20.5) |
| HbA1c 從基線增加 >0.5% | 6 (5.1) | 8 (3.4) |
| 心血管事件 | 5 (4.2) | 6 (2.6) |
數據展示可以通過NewAmsterdam Pharma網站的出版物和演示部分訪問，網址爲newamsterdampharma.com/publications。
關鍵第三階段BROOKLYN臨床試驗的設計
這項爲期52周的全球關鍵性第三階段隨機雙盲安慰劑對照多中心研究評估了10毫克obicetrapib與安慰劑相比，在高膽固醇家族性高膽固醇血癥（HeFH）患者中作爲最大耐受劑量降脂治療的輔助藥物的療效和安全性。研究在北美、歐洲和非洲的多個地點進行。共有354名患者按照2:1的比例隨機接受10毫克obicetrapib或安慰劑，劑量爲每日一次口服，無論是否伴隨進食。進入obicetrapib組的患者基線LDL-C平均值爲123 mg/dL，儘管在篩查期間約79%的患者報告使用了高強度他汀類藥物，其中54%使用了依澤替米貝，14%使用了PCSK9抑制劑。女性約佔研究人群的53%，參與者的中位年齡爲57歲。
主要終點是obicetrapib 10毫克與安慰劑相比在84天后LDL-C相對基線的百分比變化。次要終點還包括obicetrapib 10毫克與安慰劑在84天后HDL-C、非HDL-C、Apob和Lp(a)相對基線的百分比變化。該試驗還評估了obicetrapib的安全性和耐受性特徵。
關於NewAmsterdam的全球關鍵性第三階段項目
NewAmsterdam的全球關鍵性第三階段臨床開發項目包括四項研究，涉及超過12,250名患者，三項爲obicetrapib單藥治療，一項爲固定劑量組合（"FDC"）的obicetrapib和依澤替米貝：
- BROOKLYN評估了在最大耐受藥物降脂治療的情況下，LDL-C未能得到良好控制的HeFH患者中的obicetrapib療效。NewAmsterdam在2024年第三季度報告了BROOKLYN的頂部數據。
- BROADWAY正在評估obicetrapib用於已確診動脈粥樣硬化性心血管疾病（"ASCVD"）和/或家族性高膽固醇血癥（HeFH）的成人患者，這些患者的LDL-C水平未能得到有效控制，儘管正在接受最大耐受劑量的降脂治療。NewAmsterdam於2023年7月完成了2500多名患者的招募，並預計將在2024年第四季度報告頂線數據。
- TANDEm正在評估obicetrapib作爲與依澤替米貝（ezetimibe，一種非他汀類口服降LDL藥物）聯合的FDC藥片，適用於已確診ASCVD或多種ASCVD風險因素和/或HeFH的患者，且這些患者的LDL-C水平未能得到有效控制，儘管正在接受最大耐受劑量的降脂治療。NewAmsterdam於2024年7月完成了400多名患者的招募，並預計將在2024年第四季度報告頂線數據。
- PREVAIL是一項心血管預後試驗，評估obicetrapib在有ASCVD病史的患者中的效果，這些患者的LDL-C水平未能得到有效控制，儘管正在接受最大耐受劑量的降脂治療。NewAmsterdam於2024年4月完成了9500多名患者的招募。
關於Obicetrapib
Obicetrapib是一種新型的口服低劑量CETP抑制劑，由NewAmsterdam公司開發，旨在克服目前降低LDL的治療方法的侷限性。在公司的第2期試驗ROSE2、TULIP、ROSE和OCEAN，以及公司的第3期BROOKLYN試驗中，對obicetrapib作爲單藥或聯合治療進行評估時，公司觀察到在明顯降低LDL的同時，出現類似於安慰劑的副作用概況。公司正在進行額外的第3期關鍵性試驗BROADWAY，評估obicetrapib作爲單藥與最大耐受的降脂治療聯合使用，爲CVD患者提供額外的LDL降低，同時還有TANDEm試驗，評估obicetrapib和依澤替米（ezetimibe）作爲固定劑量組合使用。公司於2022年1月開始在BROADWAY招募患者，並於2023年7月完成了BROADWAY的招募，於2024年3月開始在TANDEm招募患者，並於2024年7月完成了TANDEm的招募。公司還於2022年3月開始了第3期PREVAIL心血管結果試驗，這一試驗旨在評估obicetrapib減少主要不良心血管事件發生的潛力，包括心血管死亡、非致命性心肌梗塞、非致命性中風和非計劃性冠狀動脈重建。NewAmsterdam於2024年4月完成了PREVAIL的招募，並對9500多名患者進行了隨機分組。obicetrapib在歐洲的商業化權利，無論是作爲單藥還是作爲與依澤替米固定劑量組合的一部分，均已獨家授予意大利Menarini集團，Menarini集團是一家總部位於意大利的國際領先製藥和診斷公司。
關於新阿姆斯特丹，新阿姆斯特丹製藥公司(NASDAQ：NAMS)是一家晚期的生物製藥公司，其使命是改善代謝疾病患者的醫療護理，而當前已批准的治療方法並不足夠或耐受性不佳。我們尋求填補一個很大的需求，即需要一種安全、耐受、方便的降低低密度脂蛋白膽固醇的治療方法。在多個3期研究中，新阿姆斯特丹正在研究obicetrapib，一種口服的、低劑量的、每日一次的CETP抑制劑，單獨或與依他酸替代治療聯合使用，作爲LDL-C降低療法，用於心血管疾病風險患者，其LDL-C升高，現有治療方法療效不足或耐受性不佳。
紐約荷蘭醫藥（納斯達克：NAMS）是一家處於晚期的生物製藥公司，旨在改善代謝性疾病人群的患者護理，目前批准的治療方法並不足夠有效或耐受。我們致力於填補一項重大未滿足需要，即提供安全、耐受良好且便捷的降低低密度脂蛋白（LDL）藥物療法。在多個3期研究中，紐約荷蘭正在研究obicetrapib，作爲一種口服、低劑量、每日一次的CETP抑制劑，或與依非韋伯固定劑量組合一起使用，作爲降低LDL-C療法，用作降低患有心血管疾病風險的患者的輔助他汀治療，對於那些現有療法並不足夠有效或耐受的患者。
前瞻性聲明
本文件中包含的某些非歷史事實的陳述是根據1995年美國私人證券訴訟改革法案的安全港條款的目的而提出的前瞻性陳述。前瞻性陳述通常伴隨有"相信、" "可能、" "將、" "估計、" "繼續、" "預期、" "打算、" "期待、" "應該、" "會、" "計劃、" "預測、" "潛在、" "似乎、" "尋求、" "未來、" "前景"及類似表達，這些表達預測或指示未來事件或趨勢，或不是歷史事宜的陳述。這些前瞻性陳述包括但不限於關於公司知識產權及其執行能力和專利的充分性的陳述，公司的業務和戰略計劃，公司的商業機會，公司的候選藥物的治療和治癒潛力，公司的臨床試驗以及患者招募的時間，數據公告的時間和論壇，監管批准的達成和時間，以及商業化計劃。這些陳述基於各種假設，無論是否在本文件中標識，以及基於公司管理層的當前預期，並非對實際表現的預測。這些前瞻性陳述僅供說明目的，並不旨在作爲保證、保證、預測或確鑿的事實或概率的陳述，且不應依賴於此。實際事件和情況難以或不可能預測，可能與假設有所不同。許多實際事件和情況超出了公司的控制範圍。這些前瞻性陳述受若干風險和不確定性的影響，包括國內外商業、市場、金融、政治和法律條件的變化；與公司候選藥物的批准及預期監管和商業里程碑的時間有關的風險，包括潛在商業化；與潛在客戶談判確定性合同安排的能力；競爭性候選產品的影響；獲得足夠材料供應的能力；全球經濟和政治條件，包括俄羅斯-烏克蘭和以色列-哈馬斯衝突；競爭對公司未來業務的影響；以及在公司向證券交易委員會的公共文件中描述的那些因素。與公司業務相關的其他風險包括但不限於：關於公司正在進行的臨床試驗結果的不確定性，特別是與監管審查及潛在批准其候選藥物相關的風險；與公司商業化候選藥物的努力相關的風險；公司就有利條款達成並簽署確定性協議的能力（如果可以的話）；競爭產品候選對公司業務的影響；與知識產權相關的索賠；公司吸引和保留合格人員的能力；繼續爲其候選藥物採購原材料的能力。如果這些風險中的任何一個實現，或公司的假設證明不正確，實際結果可能與這些前瞻性陳述的暗示結果有實質性差異。可能還有公司當前未知或認爲不重要的額外風險，也可能導致實際結果與前瞻性陳述中包含的結果不同。此外，前瞻性陳述反映了公司在本文件日期時的預期、計劃或對未來事件的預測和觀點，並且在其全部內容中受到此處的警示陳述的限定。公司預期後續事件和發展可能導致公司的評估發生變化。這些前瞻性陳述不應被視爲代表公司在本通訊日期後任何日期的評估。因此，不應對這些前瞻性陳述給予不當的依賴。公司及其任何附屬機構都沒有義務更新這些前瞻性陳述，除非法律要求。
公司聯繫
Marcia Novero
Innodata Inc.
Mnovero@innodata.com
(201) 371-8015
Matthew Philippe
電話：1-917-882-7512
電子郵件：matthew.philippe@newamsterdampharma.com
媒體聯繫
NewAmsterdam的Spectrum Science代表
Bryan Blatstein
P: 1-917-714-2609
bblatstein@spectrumscience.com
投資者聯繫人
Precision AQ代表NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com
