BrainStorm Cell Therapeutics Inc. (NASDAQ:), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate its Phase

BrainStorm Cell Therapeutics Inc. (NASDAQ:），一家专注于神经退行性疾病成人干细胞疗法的领先开发商，今天宣布美国食品药物监督管理局 (FDA) 已批准该公司启动其第三阶段临床试验。

clinical trial of NurOwn

NurOwn的临床试验

(autologous MSC-NTF cells) for the treatment of amyotrophic lateral sclerosis (ALS).

用于治疗肌萎缩侧索硬化症（ALS）的自体MSC-NTF细胞。

The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA), confirming the study's endpoints and statistical methodology are appropriate to support a future Biologics License Application (BLA) submission. This clearance allows the company to proceed with patient enrollment..

该试验设计此前已通过特别协议评估（SPA）与FDA达成一致，确认研究的终点和统计方法适合支持未来的生物制品许可申请（BLA）提交。此批准允许公司继续进行患者招募。

'This FDA clearance is a defining milestone for BrainStorm and the ALS community,' said

“这一FDA的批准是BrainStorm公司和ALS社区的一个决定性里程碑，”

Chaim Lebovits

柴姆·列博维奇

, President and Chief Executive Officer of BrainStorm. 'We are now positioned to swiftly activate clinical sites in a phased manner, diligently preparing to enroll the first patient in the Phase

，BrainStorm的总裁兼首席执行官。“我们现在已准备好以分阶段的方式迅速启动临床站点，并认真准备招募第一期试验的首位患者。

trial. At the same time, we are actively working to secure funding through multiple avenues, including non-dilutive grants, to ensure the timely and successful launch of this critical study.'

试验。同时，我们正在积极通过多种途径争取资金，包括非稀释性拨款，以确保这项关键研究能够及时且成功地启动。

trial will enroll approximately 200 participants at leading academic medical centers and will consist of a 24-week randomized, double-blind, placebo-controlled phase followed by a 24-week open-label extension where all participants will receive NurOwn®. The primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R).

试验将招募大约200名参与者，来自领先的学术医疗中心，试验包括一个24周的随机、双盲、安慰剂对照阶段，随后是一个24周的开放标签延长期，在此期间所有参与者都将接受NurOwn®治疗。主要终点是从基线到第24周的ALS功能评定量表修订版（ALSFRS-R）的变化。

For more details on the trial, refer to ClinicalTrials.gov .

有关试验的更多详细信息，请参阅 ClinicalTrials.gov。

ID NCT06973629

ID NCT06973629

.

。

BrainStorm management will discuss this important development on its corporate update conference call and webcast, taking place today,

BrainStorm管理团队将在今天举行的公司更新电话会议和网络直播中讨论这一重要进展。

May 19

5月19日

at

在

8.30am ET

上午8点30分（东部时间）

. To access the call, refer to the events page on the company's website

要访问电话会议，请参阅公司网站上的活动页面。

The company will provide further ongoing updates as the trial progresses and key milestones are achieved.

公司将在试验进展过程中并在达成关键里程碑时提供进一步的持续更新。

About BrainStorm Cell Therapeutics Inc.

关于BrainStorm细胞治疗公司

BrainStorm Cell Therapeutics Inc. (NASDAQ:

BrainStorm细胞治疗公司（纳斯达克：

BCLI

BCLI

) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection. .

）是一家致力于开发治疗衰弱性神经退行性疾病的自体成人干细胞疗法的领先开发商。该公司专有的NurOwn®平台利用自体间充质干细胞（MSCs）生成分泌神经营养因子的细胞（MSC-NTF细胞），旨在传递靶向生物信号，调节神经炎症并促进神经保护。

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase .

NurOwn® 是 BrainStorm 公司针对肌萎缩侧索硬化症（ALS）的主要研究性疗法，已获得美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）的孤儿药资格认定。ALS 的第三阶段试验（NCT03280056）已经完成，第二阶段试验正在进行中。

trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the 'Floor Effect' — a critical challenge in measuring clinical outcomes in advanced ALS.

试验将在与FDA达成的特殊协议评估（SPA）协议下启动。NurOwn的临床项目已经为ALS疾病生物学提供了宝贵的见解，包括与UNC13A基因型相关的药物基因组学反应、在七个纵向时间点收集的生物标志物数据，以及对“地板效应”的全面分析——这是衡量晚期ALS临床结果中的一个关键挑战。

BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids.

BrainStorm 已在多个同行评审的期刊上发表了其研究结果。除了 ALS，BrainStorm 还完成了 MSC-NTF 细胞在进展型多发性硬化症（MS）中的二期开放标签多中心试验（NCT03799718），该试验得到了国家多发性硬化症协会的资助。BrainStorm 还在推进一种专有的基于同种异体外泌体的平台，旨在递送治疗性蛋白质和核酸。

The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit .

该公司最近收到了美国专利商标局发出的一份关于其外泌体技术的基础专利的允许通知，进一步增强了 BrainStorm 在这一新兴再生医学领域的不断增长的知识产权组合。欲了解更多信息，请访问 。