Collaboration Integrates Stem-Cell-Derived Islets with Targeted Immune Modulation

整合干细胞衍生胰岛与靶向免疫调节的合作

ZURICH, Switzerland

苏黎世，瑞士

,

，

March 9, 2026

2026年3月9日

/PRNewswire/ -- NewcelX Ltd. ('NewcelX') (Nasdaq:

/PRNewswire/ -- NewcelX Ltd.（“NewcelX”）（纳斯达克：

NCEL

NCEL

), a clinical-stage company advancing stem-cell-derived therapies for Type 1 Diabetes, today announced a collaborative research agreement with Eledon Pharmaceuticals, Inc. ('Eledon') (Nasdaq:

），一家致力于推进1型糖尿病干细胞衍生疗法的临床阶段公司，今天宣布与Eledon Pharmaceuticals, Inc.（“Eledon”）（纳斯达克：）达成一项合作研究协议。

ELDN

ELDN

), a clinical-stage immunology company with a focus on transplant medicine.

），一家专注于移植医学的临床阶段免疫学公司。

The collaboration is designed to advance combination strategies integrating NewcelX's lead program, NCEL-101, with Eledon's investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501), with the goal of supporting durable, immune-protected islet replacement and advancing a potential functional cure for Type 1 Diabetes..

该合作旨在推进将NewcelX的主导项目NCEL-101与Eledon的在研抗CD40L单克隆抗体特戈鲁巴特（AT-1501）相结合的策略，目标是支持持久的、受免疫保护的胰岛替代，并推动实现1型糖尿病潜在的功能性治愈。

Eledon's tegoprubart is a next-generation anti-CD40L monoclonal antibody designed to modulate immune activation pathways central to T-cell–mediated transplant rejection. The collaboration leverages clinical experience from over 100 transplant patients treated with tegoprubart, including patients in kidney, heart and diabetes-related transplant settings, developed under multiple U.S.

Eledon的tegoprubart是一种下一代抗CD40L单克隆抗体，旨在调节与T细胞介导的移植排斥反应相关的关键免疫激活途径。该合作利用了来自100多名接受tegoprubart治疗的移植患者的临床经验，包括肾脏、心脏和糖尿病相关的移植环境下的患者，这些研究是在美国多个机构开展的。

Food and Drug Administration–cleared Investigational New Drug (IND) applications. This extensive transplant experience provides clinically informed insights and data relevant to cell replacement therapies, and could potentially lead to a clearer regulatory pathway for NCEL-101 while streamlining the development program.

食品和药物管理局批准的试验性新药（IND）申请。这一广泛的移植经验提供了与细胞替代疗法相关的临床信息和数据，可能会为NCEL-101提供更清晰的监管路径，同时简化开发计划。

Integrating targeted immune modulation with NCEL-101 is intended to support durable graft survival comparable to outcomes observed with donor human islets (see press .

将靶向免疫调节与NCEL-101相结合，旨在支持持久的移植物存活，其效果可与供体人胰岛观察到的结果相媲美（见新闻发布）。

release link

发布链接

).

）。

Importantly, NCEL-101 remains NewcelX's core therapeutic product, designed to address the shortage of functional insulin-producing cells through scalable, off-the-shelf manufacturing. The immune modulation component is intended to enhance durability and graft survival of the cells.

重要的是，NCEL-101 仍然是 NewcelX 的核心治疗产品，旨在通过可扩展的、现成的制造方式来解决功能性胰岛素生成细胞短缺的问题。免疫调节组件旨在增强细胞的持久性和移植物存活率。

Professor Michel Revel, MD, PhD, CSO of NewcelX:

米歇尔·雷维尔教授，医学博士，哲学博士，NewcelX首席科学官：

'The collaboration marks an important strategic milestone for NewcelX, enhancing its execution-focused clinical programs and broadening collaboration with established leaders in immune biology and transplant medicine'.

“此次合作标志着NewcelX的一个重要战略里程碑，加强了其以执行为重点的临床项目，并拓宽了与免疫生物学和移植医学领域知名领袖的合作。”

The collaboration is anticipated to accelerate timelines, establish a well-defined regulatory pathway, and enhance development visibility, supporting NewcelX's strategy to advance its clinical programs efficiently toward pivotal milestones.

预计此次合作将加快进程，建立明确的监管路径，并提高开发的可见性，支持NewcelX高效推进其临床项目迈向关键里程碑的战略。

Ronen Twito, Executive Chairman & CEO of NewcelX, added:

纽赛尔公司的执行主席兼首席执行官罗南·特维托补充道：

'Collaborating with Eledon Pharmaceuticals represents a meaningful milestone of our product and a strategic step forward for NewcelX. Leveraging Eledon's extensive transplant experience across more than 100 procedures provides us with clinically grounded insight that potentially supports a clearer regulatory pathway and a more efficient development plan for NCEL-101.

“与Eledon制药公司合作代表了我们产品的一个重要里程碑，也是NewcelX向前迈出的战略性一步。借助Eledon在100多例移植手术中的丰富经验，我们获得了基于临床的洞察，这可能有助于为NCEL-101提供更清晰的监管路径和更高效的开发计划。”

Our focus is to translate this advantage into disciplined execution and long-term shareholder value.'.

我们的重点是将这一优势转化为有纪律的执行和长期的股东价值。

About NewcelX

关于NewcelX

NewcelX is an innovative biopharmaceutical company focused on developing transformative stem-cell-derived therapies for Type 1 Diabetes. Built on a validated human pluripotent stem cell (hPSC) platform, the company's lead program, NCEL-101, is designed to restore functional insulin production through scalable, off-the-shelf cell replacement.

NewcelX 是一家创新的生物制药公司，专注于开发用于治疗 1 型糖尿病的变革性干细胞衍生疗法。公司依托经过验证的人类多能干细胞 (hPSC) 平台，其主导项目 NCEL-101 旨在通过可扩展的、现成的细胞替代方案来恢复功能性胰岛素生产。

NewcelX is advancing a comprehensive therapeutic approach for Type 1 Diabetes integrating cell therapy, immune protection, and translational science to address critical unmet medical needs..

NewcelX 正在推进一种综合性的 1 型糖尿病治疗方案，整合细胞疗法、免疫保护和转化科学，以解决关键的未满足医疗需求。

Social Media:

社交媒体：

LinkedIn

领英

,

，

Facebook

脸书

,

，

X

X

,

，

Instagram

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Website:

网站：

www.newcelx.com

www.newcelx.com

Forward-Looking Statements

前瞻性声明

This press release contains expressed or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. For example, NewcelX is using forward-looking statements when it discusses how this collaboration is designed to advance combination strategies integrating NCEL-101 with Eledon's investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501), advancing a potential cure for Type 1 Diabetes, how the collaboration is anticipated to accelerate timelines, establish a well-defined regulatory pathway, and enhance development visibility, NewCelX's strategy to advance its clinical programs efficiently toward pivotal milestones, and creating long-term shareholder value.

本新闻稿包含根据1995年《私人证券诉讼改革法案》及其他适用证券法律所定义的明示或暗示的前瞻性陈述。例如，NewcelX在讨论此次合作如何旨在推进将NCEL-101与Eledon公司的实验性抗CD40L单克隆抗体特戈普鲁巴特（AT-1501）相结合的策略、推动1型糖尿病潜在疗法的发展、预计合作将加速时间表、建立明确的监管路径并提升开发透明度、NewCelX有效推进其临床项目迈向关键里程碑的战略以及创造长期股东价值时，使用了前瞻性陈述。

These forward-looking statements and their implications are based on the current expectations of the management of NewcelX and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; potential delays or obstacles in launching or completing clinical trials; products that may not be approved by regulatory agencies; technologies that may not be validated or accepted by the scientific community; the inability to retain or attract key employees; unforeseen scientific difficulties with products in development; higher-than-expected product costs; results in the laboratory that do not translate to clinical success; insufficient patent protection; possible adverse safety outcomes; legislative changes; delays in developing or introducing new t.

这些前瞻性声明及其含义基于 NewcelX 管理层的当前预期，并受许多因素和不确定性的影响，可能导致实际结果与前瞻性声明中描述的结果有重大差异。以下因素（其中包括）可能导致实际结果与前瞻性声明中描述的结果有重大差异：技术及市场需求的变化；在启动或完成临床试验时可能出现的潜在延迟或障碍；产品可能未获监管机构批准；技术可能未被科学界验证或接受；无法保留或吸引关键员工；开发中的产品可能遇到无法预见的科学困难；产品成本高于预期；实验室结果未能转化为临床成功；专利保护不足；可能出现不利的安全结果；立法变更；新产品开发或推出的延迟。

www.sec.gov

www.sec.gov

, as well as in subsequent filings made by NewcelX, including under the heading 'Risk Factors' in its proxy statement/prospectus filed with the SEC on November 6, 2025.

以及NewcelX随后提交的文件中，包括其于2025年11月6日向美国证券交易委员会（SEC）提交的代理声明/招股说明书中的“风险因素”部分。

Investor & Media Contacts

投资者和媒体联系人

Sarah Bazak, Investors relations

萨拉·巴扎克，投资者关系

[email protected]

电子邮件地址

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SOURCE NewcelX Ltd.

来源：新赛尔X有限公司

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