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)--Omeros Corporation (Nasdaq: OMER) today announced two presentations that will be featured at the 2025 Tandem Meetings – the Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research, to be held February 12-15, 2025 in Honolulu, Hawaii..

)--Omeros Corporation（纳斯达克股票代码：OMER）今天宣布将在2025年串联会议上发表两篇演讲——美国移植与细胞治疗学会和国际血液与骨髓移植研究中心的移植与细胞治疗会议，将于2025年2月12日至15日在夏威夷火奴鲁鲁举行。。

Both presentations report real world outcomes from patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) treated with narsoplimab supplied by Omeros under an expanded access program, also referred to as compassionate use.

这两篇演讲都报告了造血干细胞移植相关血栓性微血管病（TA-TMA）患者在扩大获取计划（也称为同情使用）下接受Omeros提供的narsoplimab治疗的现实世界结果。

The first reports overall survival of 128 allogeneic transplant patients with TA-TMA treated with narsoplimab under the expanded access program and will be featured as a podium presentation by Michelle Schoettler, M.D., Assistant Professor of Pediatric Oncology and Hematopoietic Cellular Therapy at Emory University School of Medicine..

。。

The second reports on a single-center cohort of adult TA-TMA patients who were treated with narsoplimab after failing eculizumab treatment. The abstract will be featured in a poster session and presented by Piyatida Chumnumsiriwath, M.D., of the Hematopoietic Stem Cell Transplantation and Cellular Therapy Program at the University of California, Irvine..

第二篇报道了一个单中心队列的成人TA-TMA患者，他们在依库利珠单抗治疗失败后接受了纳索普利单抗治疗。该摘要将在海报会议上展出，并由加州大学欧文分校造血干细胞移植和细胞治疗项目的医学博士Piyatida Chumnumsiriwath介绍。。

The presentation abstracts are available now on the Tandem Meetings website. Details of the presentations and links to each abstract follow:

。演示文稿的详细信息和每个摘要的链接如下：

Narsoplimab Treatment for Hematopoietic Cell Transplant Associated Thrombotic Microangiopathy – Real World Outcomes from an Expanded Access Program

Narsoplimab治疗造血细胞移植相关血栓性微血管病-扩大获取计划的现实结果

Presentation Session

演讲环节

: Toxicity and Supportive Care (Oral Abstract Session D)

：毒性和支持治疗（口头摘要会议D）

Date

日期

: Thursday, February 13, 2025

：2025年2月13日，星期四

Presentation Time

演示时间

: 3:15 - 3:30 p.m. HST

: 3:15 - 3:30 p.m. HST

Location

位置

: Ballroom A (HCC)

：宴会厅A（HCC）

Presenting Author:

演示作者：

Michelle Schoettler, M.D.

医学博士Michelle Schoettler。

Abstract Link

抽象链接

Narsoplimab for Refractory Transplantation-Associated Thrombotic Microangiopathy in Adult Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation

Narsoplimab治疗接受异基因造血干细胞移植的成年患者难治性移植相关血栓性微血管病

Poster Session

海报会议

: Late Effects, Quality of Life and Accelerated Aging

：晚期影响，生活质量和加速衰老

Date

日期

: Thursday, February 13, 2025

：2025年2月13日，星期四

Presentation Time

演示时间

: 6:45 - 7:45 p.m. HST

: 6:45 - 7:45 p.m. HST

Location

位置

: Exhibit Hall 3 (HCC)

：展览厅3（HCC）

Presenting Author:

演示作者：

Piyatida Chumnumsiriwath, M.D.

很高兴认识你，医学博士。

Abstract Link

抽象链接

The poster and presentation materials are expected to be made available on Omeros’ website at

海报和演示材料预计将在Omeros的网站上提供

investor.omeros.com

investor.omeros.com

shortly after the meeting presentations.

会议结束后不久进行演讲。

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.

。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，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），都是基于管理层的信念和假设，以及截至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。