Resource consumption will be reduced by 50% to accelerate ALS development

资源消耗将减少50%，以加速ALS的发展

Plans underway for registrational Phase 3b U.S. clinical trial for NurOwn in ALS

正在计划在ALS注册3b期美国临床试验

NEW YORK, Oct. 24, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced a strategic realignment to enable accelerated development of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS).

纽约，2023年10月24日/PRNewswire/-BrainStorm Cell Therapeutics Inc.（纳斯达克股票代码：BCLI），神经退行性疾病成人干细胞疗法的领先开发商，今天宣布进行战略调整，以加速NurOwn®的发展。治疗肌萎缩侧索硬化症（ALS）。

This realignment is designed to 1) support the company plans to conduct a double-blind, placebo-controlled Phase 3b U.S. clinical trial for NurOwn in ALS with an open-label extension and 2) continue to publish data from NurOwn's Phase 3 clinical trial on: biomarkers, long-term safety and survival, and the Expanded Access Program, providing transparency around NurOwn data and progressing ALS drug development.

这种重新调整旨在1）支持公司计划对ALS中的NurOwn进行双盲，安慰剂对照的3b期美国临床试验，并进行开放标签扩展；2）继续发布NurOwn的3期临床试验数据：生物标志物，长期安全性和生存率，以及扩大获取计划，提供有关护理数据和ALS药物开发进展的透明度。

In preparation for the trial design and subsequent meeting with FDA, BrainStorm is consulting with the NurOwn Principal Investigators, who are most familiar with NurOwn, an additional panel of independent ALS experts, and a patient advisory group..

为了准备试验设计和随后与FDA的会议，BrainStorm正在与最熟悉NurOwn的NurOwn首席调查员，一个额外的独立ALS专家小组和一个患者咨询小组进行咨询。。

'While the Phase 3 trial was confounded by the ALSFRS-R scale's inability to measure disease progression in participants with advanced ALS, the trial did demonstrate a clinically meaningful response in a pre-specified subgroup of patients with less advanced disease. This finding was further supported by biomarker data,' said Stacy Lindborg PhD, co-Chief Executive Officer of BrainStorm.

“虽然3期试验因ALSFRS-R量表无法测量晚期ALS患者的疾病进展而感到困惑，但该试验确实在预先指定的疾病较轻的患者亚组中显示出临床上有意义的反应。BrainStorm联合首席执行官Stacy Lindborg博士说，这一发现得到了生物标志物数据的进一步支持。

'Based on learnings from the Phase 3 trial, we believe in the utility of NurOwn in mild to moderate ALS and that the ALS community deserves every effort we can give to definitively demonstrate its clinical value.'.

“基于第3阶段试验的学习，我们相信护士在轻度至中度ALS中的效用，ALS社区值得我们尽一切努力明确证明其临床价值。”。

To fund the Phase 3b study and ALS priorities, BrainStorm is actively exploring various options to raise capital including non-dilutive grants and capitalizing on its exosome technology. At the same time, the company will reduce and refocus resources by streamlining clean room operations and undertaking a targeted reduction in headcount of approximately 30 percent.

为了资助3b期研究和ALS优先事项，BrainStorm正在积极探索筹集资本的各种选择，包括非稀释性拨款和利用其外泌体技术。与此同时，公司将通过简化洁净室操作并有针对性地减少约30%的人数来减少和重新调整资源。

Positions most critical to the implementation of the Phase 3b trial and regulatory submission and review will be retained. The strategic realignment will cut total resource consumption by approximately half..

将保留对实施3b期试验和监管提交和审查最关键的职位。战略调整将使资源消耗总量减少约一半。。

As part of this strategic realignment, Dr. Kirk Taylor, EVP and Chief Medical Officer, will be stepping down from his post, which largely focused on leading global medical affairs and broader launch activities. Certain other positions that are outside the current prioritized scope will be eliminated..

作为战略调整的一部分，EVP的Kirk Taylor博士和首席医疗官将从他的职位上退下来，该职位主要侧重于领先的全球医疗事务和更广泛的启动活动。将消除当前优先范围之外的某些其他职位。。

'We are extremely grateful for the dedication and contributions of our impacted colleagues, particularly Dr. Taylor who added tremendous value during his time with BrainStorm,' said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. 'We remain steadfast in our goal to make NurOwn available to the ALS community as quickly as possible, and we believe that this strategic realignment offers our best chance for success.

“我们非常感谢我们受影响的同事的奉献精神和贡献，特别是泰勒博士，他在脑干时间增加了巨大的价值，”脑干总裁兼首席执行官Chaim Lebovits说我们始终坚定地致力于尽快向ALS社区提供托儿所，我们相信这种战略调整为我们提供了最佳的成功机会。

While remaining open to partnership opportunities that could accelerate growth, the steps we are taking now reflect our unwavering commitment to those battling this horrific disease and our firm belief in the potential value of NurOwn.'.

在保持开放伙伴关系机会以加速增长的同时，我们现在采取的步骤反映了我们对那些与这种可怕疾病作斗争的人的坚定承诺，以及我们对护理的潜在价值的坚定信念。

About NurOwn®

关于NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases.

NurOwn®技术平台（自体MSC-NTF细胞）代表了一种有前途的研究性治疗方法，用于靶向神经退行性疾病中重要的疾病途径。从患有ALS的每个人收获MSC-NTF细胞，并使用创新和专有方法制造以分泌神经营养因子以靶向特定的神经退行性疾病。

The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals..

NurOwn的主要计划是治疗ALS。BrainStorm对ALS的长期承诺在临床前研究和一系列临床研究中得到证实，所有这些研究均已发表在同行评审期刊上。。

The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted, but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS..

护士临床计划已经对ALS的病理学以及疾病进展和治疗产生了有价值的见解。自从最初的第3阶段读数以来，BrainStorm通过严格的同行评审分析共享了完整的数据集，包括：已经注意到的地板效应的量化，但从未深入探讨过；评估多个预先指定的生物标志物，在试验期间的20周内在七个不同点收集，允许纵向观察；和遗传数据分析，这是首批前瞻性调用临床结果药物基因组学分析的ALS试验之一，为未来ALS治疗方法的发展提供了广阔的前景。。

About BrainStorm Cell Therapeutics Inc.

关于BrainStorm Cell Therapeutics Inc。

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement.

BrainStorm Cell Therapeutics Inc.是创新的自体成体干细胞疗法的领先开发人员，用于治疗神经退行性疾病。BrainStorm拥有通过独家全球许可协议生产自体MSC-NTF细胞的NurOwn®技术平台的临床开发和商业化的权利。

Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS.

自体MSC-NTF细胞已经从美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）获得用于治疗肌萎缩侧索硬化症（ALS）的孤儿药指定状态。BrainStorm已完成ALS的3期试验（NCT03280056）；该试验调查了重复给予自体MSC-NTF细胞的安全性和有效性，并得到了加利福尼亚再生医学研究所（CIRM CLIN2-0989）的资助，以及ALS协会和I AM ALS的另一项资助。

BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS)..

脑干在研究性新药申请下完成了进行性MS中自体MSC-NTF细胞的2期开放标签多中心试验（NCT03799718），并得到了美国国家MS协会（NMSS）的资助。。

Notice Regarding Forward-Looking Statements

关于前瞻性声明的通知

This press release contains 'forward-looking statements' that are subject to substantial risks and uncertainties, including the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements.

本新闻稿包含受到重大风险和不确定性影响的“前瞻性声明”，包括NurOwn作为治疗ALS的疗法的临床开发，患者未来可用的NurOwn以及脑干的未来成功。本新闻稿中包含的除历史事实陈述外的所有陈述均为前瞻性陈述。

Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words.

本新闻稿中包含的前瞻性陈述可以通过使用诸如“预期”，“相信”，“思考”，“可以”，“估计”，“期望”，“意图”，“寻求”，“可能”，“可能”，“潜在”，“预测”，“项目”，“目标”，“应该”，“将会”或这些词语或其他类似表达的否定，尽管并非所有前瞻性陈述都包含这些词语。

Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital..

前瞻性陈述基于BrainStorm目前的预期，并受到难以预测的内在不确定性，风险和假设的影响。这些潜在的风险和不确定性包括但不限于管理层成功实现其目标的能力，BrainStorm筹集额外资本的能力。。

BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov.

BrainStorm持续关注的能力，未来监管机构批准护士的前景，BrainStorm未来与FDA的互动是否会产生成果，以及BrainStorm关于10-K表格的年度报告和关于10-Q表格的季度报告中详述的其他因素http://www.sec.gov.

These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release.

应仔细考虑这些因素，读者不应过分依赖脑干的前瞻性陈述。本新闻稿中包含的前瞻性声明基于截至本新闻稿发布之日的管理层的信念，期望和意见。

We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements..

除非法律另有要求，否则如果情况或管理层的信念，期望或意见发生变化，我们不承担更新前瞻性陈述以反映实际结果或假设的义务。虽然我们认为前瞻性陈述中反映的期望是合理的，但我们无法保证未来的结果，活动水平，表现或成就。。

CONTACTS:

联络：

Investor Relations:

投资者关系：

John Mullaly

约翰·穆拉利

LifeSci Advisors, LLC

LifeSci Advisors，LLC

Phone: +1 617-429-3548

电话：+1617-429-3548

jmullaly@lifesciadvisors.com

jmullaly@lifesciadvisors.com

Media:

媒体：

Lisa Guiterman

Lisa Guiterman

Phone: +1 202-330-3431

电话：+1202-330-3431

lisa.guiterman@gmail.com

lisa.guiterman@gmail.com

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SOURCE BrainStorm Cell Therapeutics Inc.

来源脑干细胞治疗公司。

Company Codes: NASDAQ-SMALL:BCLI

公司代码：NASDAQ-SMALL:BCLI