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)--Omeros Corporation (Nasdaq: OMER) today announced statistical sensitivity analysis results related to the primary endpoint analysis for narsoplimab, Omeros’ first-in-class monoclonal antibody inhibiting the lectin pathway of complement, in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication in both adult and pediatric hematopoietic stem cell transplantation.

)--Omeros Corporation（Nasdaq:OMER）今天宣布了与narsoplimab主要终点分析相关的统计敏感性分析结果，narsoplimab是Omeros第一种抑制补体凝集素途径的单克隆抗体，用于治疗造血干细胞移植相关的血栓性微血管病（TA-TMA），这是成人和儿童造血干细胞移植中危及生命的并发症。

The sensitivity analyses, conducted by an independent statistical group, demonstrate the robustness of the results of the previously reported primary endpoint analysis, with representative hazard ratios ranging from 0.24 (95 percent confidence interval: 0.13, 0.47) to 0.42 (95 percent confidence interval: 0.21, 0.83) and p-values ranging from less than 0.00001 to 0.0124..

由独立统计小组进行的敏感性分析证明了先前报告的主要终点分析结果的稳健性，代表性风险比范围为0.24（95%置信区间：0.13，0.47）至0.42（95%置信区间：0.21，0.83），p值范围小于0.00001至0.0124。。

The following are representative sensitivity analyses conducted by the independent statistical group:

以下是独立统计小组进行的具有代表性的敏感性分析：

1.

1.

Overall survival with only treatment as a factor using Inverse Probability of Treatment Weighting (IPTW):

仅使用治疗加权逆概率（IPTW）作为因素的总生存率：

Hazard ratio = 0.40 (95 percent confidence interval: 0.29, 0.54)

风险比=0.40（95%置信区间：0.29、0.54）

P-value < 0.00001

P值<0.00001

2.

2.

Testing proportional hazards assumptions in a sequence of four models in which patient follow-up is truncated at 100 days, 6 months, 1 year, and 2 years using IPTW:

在四个模型的序列中测试比例风险假设，其中使用IPTW在100天，6个月，1年和2年时截断患者随访：

100 days:

100天：

Hazard ratio = 0.37 (95 percent confidence interval: 0.25, 0.54)

风险比=0.37（95%置信区间：0.25、0.54）

P-value < 0.00001

P值<0.00001

6 months:

6个月：

Hazard ratio = 0.32 (95 percent confidence interval: 0.22, 0.45)

风险比=0.32（95%置信区间：0.22、0.45）

P-value < 0.00001

P值<0.00001

1 year:

1年：

Hazard ratio = 0.30 (95 percent confidence interval: 0.22, 0.42)

风险比=0.30（95%置信区间：0.22、0.42）

P-value < 0.00001

P值<0.00001

2 years:

2年：

Hazard ratio = 0.29 (95 percent confidence interval: 0.21, 0.41)

风险比=0.29（95%置信区间：0.21、0.41）

P-value < 0.00001

P值<0.00001

3.

3.

Overall survival with day zero for the external control registry patients set at the median time between the date of TA-TMA diagnosis and the date of narsoplimab treatment initiation for the patients in the OMS721-TMA-001 pivotal trial using IPTW:

在使用IPTW的OMS721-TMA-001关键试验中，外部对照注册患者的总生存期为零天，设定为TA-TMA诊断日期与narsoplimab治疗开始日期之间的中位时间：

Hazard ratio = 0.32 (95 percent confidence interval: 0.23, 0.44)

风险比=0.32（95%置信区间：0.23、0.44）

P-value < 0.00001

P值<0.00001

4.

4.

Overall survival with and without all specified risk factors (RFs) using 1:1 and 1:2 patient propensity score matching (OMS721-TMA-001 trial patients versus external control registry patients):

1:1 with RFs:

1： 1个RFs：

Hazard ratio = 0.29 (95 percent confidence interval: 0.14, 0.61)

风险比=0.29（95%置信区间：0.14、0.61）

P-value = 0.0012

P值=0.0012

1:1 w/out RFs:

1：

Hazard ratio = 0.42 (95 percent confidence interval: 0.21, 0.83)

风险比=0.42（95%置信区间：0.21、0.83）

P-value = 0.0124

P值=0.0124

1:2 with RFs:

1： 2个RFs：

Hazard ratio = 0.24 (95 percent confidence interval: 0.13, 0.47)

风险比=0.24（95%置信区间：0.13、0.47）

P-value < 0.0001

P值<0.0001

1:2 w/out RFs:

1： 2个不带RFs：

Hazard ratio = 0.40 (95 percent confidence interval: 0.22, 0.72)

风险比=0.40（95%置信区间：0.22、0.72）

P-value = 0.0024

P值=0.0024

As reported on December 19, 2024, narsoplimab met its primary endpoint, with TA-TMA patients in its OMS721-TMA-001 pivotal trial demonstrating clinically meaningful and statistically significant superiority in overall survival – a hazard ratio of 0.32 (95 percent confidence interval: 0.23 to 0.44) with p-value less than 0.00001 – compared to the TA-TMA registry patients.

据2024年12月19日报道，narsoplimab达到了其主要终点，在其OMS721-TMA-001关键试验中，TA-TMA患者在总生存率方面表现出临床意义和统计学上的显着优势-与TA-TMA登记患者相比，风险比为0.32（95%置信区间：0.23至0.44），p值小于0.00001。

The hazard ratio of 0.32 indicates that the narsoplimab-treated TA-TMA patients had an over 3-fold reduction in risk of mortality. Across all its clinical trials in various indications to date, narsoplimab has been well tolerated and has shown no safety signal of concern..

0.32的风险比表明，接受narsoplimab治疗的TA-TMA患者的死亡风险降低了3倍以上。迄今为止，在各种适应症的所有临床试验中，narsoplimab的耐受性良好，没有显示出安全性问题。。

“While we have long been confident in the benefits of narsoplimab in TA-TMA patients, it is gratifying to see the consistency and strength of the sensitivity analyses, which collectively demonstrate the robustness of our previously reported primary analysis results,” said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer.

奥梅罗斯主席兼首席执行官格雷戈里·德莫普洛斯（Gregory A.Demopulos）医学博士说：“虽然我们长期以来对那索普利马在TA-TMA患者中的益处充满信心，但令人欣慰的是，敏感性分析的一致性和强度，共同证明了我们之前报告的主要分析结果的稳健性。”。

“We now await the final set of analyses comparing survival of high-risk TA-TMA patients in our narsoplimab global expanded access program – and, importantly, combined with the 28 high-risk TA-TMA patients in OMS721-TMA-001 – to survival of similarly at-risk control TA-TMA registry patients. We expect those soon from the independent statistical group and, again, analyses will be shared publicly when available.

“我们现在等待最后一组分析，比较我们的narsoplimab全球扩展接入计划中高危TA-TMA患者的生存率-重要的是，结合OMS721-TMA-001中的28名高危TA-TMA患者-与同样处于风险控制中的TA-TMA登记患者的生存率。我们预计独立统计组很快就会提供这些分析，并且再次，分析将在可用时公开分享。

Given the strength of the data already in hand, we are moving ahead with narsoplimab as quickly as possible, targeting BLA resubmission for later this quarter and European MAA submission before mid-year.”.

鉴于现有数据的优势，我们正在尽快推进narsoplimab，目标是在本季度晚些时候重新提交BLA，并在年中之前提交欧洲MAA。”。

Prior to the independent statistical group conducting any narsoplimab analyses, Omeros had received and incorporated FDA’s recommendations on the statistical analysis plan for the primary analysis and sensitivity analyses comparing overall survival from time of first dosing in the 28 narsoplimab-treated TA-TMA patients in OMS721-TMA-001 to overall survival, adjusted for immortal time bias, of the more than 100 TA-TMA patients in the external control registry, none of whom received narsoplimab.

在独立统计小组进行任何narsoplimab分析之前，Omeros已经收到并纳入了FDA关于统计分析计划的建议，用于初步分析和敏感性分析，比较了OMS721-TMA-001中28名接受narsoplimab治疗的TA-TMA患者首次给药时的总生存率，以及外部对照登记处100多名TA-TMA患者的总生存率，这些患者均未接受narsoplimab治疗。

The two cohorts had similar demographics, diagnostic criteria, baseline characteristics, underlying diseases, conditioning regimens, and transplant procedures. All patients in both cohorts met the published criteria for high risk of death as defined by an international expert panel tasked with reaching consensus on diagnostic and prognostic criteria and representing the American Society for Transplantation and Cellular Therapy, the Center for International Bone Marrow Transplant Research, the Asia-Pacific Blood and Marrow Transplantation Group, and the European Society for Blood and Marrow Transplantation..

这两个队列具有相似的人口统计学，诊断标准，基线特征，潜在疾病，调理方案和移植程序。这两个队列中的所有患者均符合国际专家组定义的高死亡风险标准，该专家组负责就诊断和预后标准达成共识，并代表美国移植和细胞治疗学会，国际骨髓移植研究中心，亚太血液和骨髓移植组以及欧洲血液和骨髓移植学会。。

While awaiting the results from the expanded access program (EAP)-related analyses, international groups of transplant experts have begun preparing two manuscripts – one directed to primary endpoint analyses and the other to EAP-related analyses – for submission to peer-reviewed journals.

在等待扩展获取计划（EAP）相关分析的结果的同时，国际移植专家组已经开始准备两份手稿-一份针对主要终点分析，另一份针对EAP相关分析-提交给同行评审期刊。

About Narsoplimab

关于Narsoplimab

Narsoplimab, also known as “OMS721,” is an investigational fully human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 has been demonstrated to leave intact the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection.

Narsoplimab，也称为“OMS721”，是一种研究性全人单克隆抗体，靶向甘露聚糖结合凝集素相关丝氨酸蛋白酶-2（MASP-2），一种新型促炎蛋白靶标和补体凝集素途径的效应酶。重要的是，已经证明抑制MASP-2可以完整地保留抗体依赖性经典补体激活途径，这是获得性感染免疫应答的关键组成部分。

A biologics license application (BLA) is pending before the FDA for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Omeros will resubmit the BLA for narsoplimab in TA-TMA followed by our planned submission of the corresponding European marketing authorisation application (MAA) in 2025.

FDA正在等待生物制剂许可证申请（BLA），以使用纳索普利单抗治疗造血干细胞移植相关的血栓性微血管病（TA-TMA）。Omeros将在TA-TMA中重新提交narsoplimab的BLA，然后我们计划在2025年提交相应的欧洲上市授权申请（MAA）。

FDA has granted narsoplimab breakthrough therapy and orphan drug designations for TA-TMA and orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies. The European Medicines Agency (EMA) has granted orphan drug designation to narsoplimab for treatment in hematopoietic stem-cell transplant..

FDA已批准narsoplimab突破性治疗和TA-TMA孤儿药指定以及预防（抑制）补体介导的血栓性微血管病的孤儿药状态。欧洲药品管理局（EMA）已将孤儿药指定给纳索普利单抗用于造血干细胞移植治疗。。

About Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)

关于造血干细胞移植相关血栓性微血管病（TA-TMA）

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is a significant and often lethal complication of stem cell transplantation. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation.

造血干细胞移植相关血栓性微血管病（TA-TMA）是干细胞移植的重要且通常致命的并发症。这种情况是由调理方案，免疫抑制剂治疗，感染，移植物抗宿主病和其他与干细胞移植相关的因素引起的内皮细胞损伤引起的全身性多因素疾病。

Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of TA-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 30,000 allogeneic transplants are performed annually.

激活补体凝集素途径的内皮损伤在TA-TMA的发展中起着核心作用。这种情况发生在自体和同种异体移植中，但在同种异体人群中更常见。在美国和欧洲，每年大约进行30000次同种异体移植。

Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of TA-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of TA-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common.

最近在成人和儿科异基因干细胞移植人群中的报道发现，TA-TMA的发病率约为40%，其中高达80%的患者可能存在高风险特征。在严重的TA-TMA病例中，死亡率可能超过90%，即使在存活的患者中，长期肾sequalae（例如透析）也很常见。

There is no approved therapy or standard of care for TA-TMA..

TA-TMA没有批准的治疗方法或护理标准。。

About Omeros Corporation

关于Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders.

Omeros是一家创新的生物制药公司，致力于发现、开发和商业化一流的小分子和蛋白质疗法，用于大市场和针对免疫性疾病（包括补体介导的疾病和癌症，以及成瘾和强迫性疾病）的孤儿适应症。

Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros’ long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies.

Omeros的主要MASP-2抑制剂narsoplimab靶向补体的凝集素途径，并且是FDA正在等待的用于治疗造血干细胞移植相关血栓性微血管病的生物制剂许可证申请的主题。Omeros的长效MASP-2抑制剂OMS1029已成功完成1期单剂量和多剂量递增临床研究。

Zaltenibart, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing toward Phase 3 clinical trials for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder.

Zaltenibart是Omeros的MASP-3抑制剂，它是补体替代途径的关键激活剂，正在向阵发性夜间血红蛋白尿和补体3肾小球病的3期临床试验迈进。由国家药物滥用研究所资助，奥梅罗斯的磷酸二酯酶7铅抑制剂OMS527正在临床开发中，用于治疗可卡因使用障碍。

Omeros also is advancing a broad portfolio of five novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit .

Omeros还正在推进五个新型细胞和分子免疫肿瘤学项目的广泛组合。有关Omeros及其程序的更多信息，请访问。

www.omeros.com

www.omeros.com

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Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would” and similar expressions and variations thereof.

本新闻稿包含《1933年证券法》第27A节和《1934年证券交易法》第21E节所指的前瞻性声明，这些声明受这些章节为此类声明创建的“安全港”的约束。除历史事实陈述外，所有陈述都是前瞻性陈述，通常用“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“目标”、“打算”、“可能”、“期待”、“可能”、“目标”、“计划”、“潜力”、“预测”、“项目”、“应该”、“板岩”、“目标”、“意志”、“将会”等术语以及类似的表达和变化来表示。

Forward-looking statements, including statements regarding the anticipated resubmission of the BLA for narsoplimab in the United States and the submission of a marketing authorization application with the EMA, the timing and outcomes of regulatory events, the availability and outcomes of additional analyses, the prospects for obtaining FDA or EMA approval of narsoplimab in any indication, expectations regarding future cash expenditures, and expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the potential commercialization of narsoplimab if it is approved by FDA or the EMA, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release.

前瞻性声明，包括关于预期在美国重新提交narsoplimab的BLA和向EMA提交营销授权申请的声明，监管事件的时间和结果，额外分析的可用性和结果，获得FDA或EMA批准narsoplimab的任何迹象的前景，对未来现金支出的预期，以及对我们资本资源的充足性和可用性的预期，以资助当前和计划的运营，包括narsoplimab的潜在商业化，如果它得到FDA或EMA的批准，是基于管理层的信念和假设，以及仅在本新闻稿发布之日管理层可用的信息。

Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unfavorable, unexpected or inconclusive results of our statistical analyses relating to an external registry of TA-TMA patients, potential differences between the diagnostic criteria used in .

由于许多原因，Omeros的实际结果可能与这些前瞻性声明中预期的结果存在实质性差异，包括但不限于我们与TA-TMA患者外部登记相关的统计分析的不利，意外或不确定结果，所用诊断标准之间的潜在差异。