BOSTON, MA, September 30, 2026

马萨诸塞州波士顿，2026年9月30日

– Tiziana Life Sciences, Ltd. (Nasdaq:

– Tiziana Life Sciences, Ltd.（纳斯达克：

TLSA

TLSA

) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for intranasal foralumab for the treatment of Multiple System Atrophy (MSA)..

（“Tiziana”或“公司”），一家致力于开发突破性免疫调节疗法的生物技术公司，其领先研发候选药物为鼻用foralumab（一种全人源抗CD3单克隆抗体），今日宣布已向美国食品药品监督管理局（FDA）提交申请，请求将鼻用foralumab用于治疗多系统萎缩症（MSA）认定为孤儿药。

MSA is a rare, rapidly progressive neurodegenerative disorder that affects autonomic functions (such as blood pressure and bladder control) and motor control, leading to severe disability and shortened life expectancy. There are currently no FDA-approved disease-modifying therapies for MSA. The disease has a mean incidence in the U.S.

多系统萎缩（MSA）是一种罕见且快速进展的神经退行性疾病，影响自主功能（如血压和膀胱控制）及运动控制，导致严重残疾并缩短预期寿命。目前尚无美国食品药品监督管理局（FDA）批准的针对MSA的疾病修饰疗法。该病在美国的平均发病率

of approximately 0.6 per 100,000 person-years, rising to about 3 per 100,000 in those aged 50 and older, with prevalence estimates of roughly 1.9–4.9 per 100,000 worldwide. Median survival is typically 6–9 years. Neuroinflammation and microglial activation are increasingly recognized as key contributors to MSA pathogenesis..

发病率约为每10万人年0.6例，在50岁及以上人群中上升至约每10万人3例，全球患病率估计约为每10万人1.9–4.9例。中位生存期通常为6–9年。神经炎症和小胶质细胞激活日益被认为是多系统萎缩（MSA）发病机制的关键因素。

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. The FDA’s Office of Orphan Products Development (OOPD) aims to complete its review of an orphan drug designation (ODD) request within 90 days of receipt.

孤儿药资格认定由美国食品药品监督管理局（FDA）授予，适用于旨在治疗影响美国少于20万人的罕见疾病或状况的药物或生物制品。FDA孤儿产品开发办公室（OOPD）旨在在收到孤儿药资格认定（ODD）申请后的90天内完成审查。

If granted, the designation would provide potential benefits including seven years of market exclusivity upon approval, tax credits for qualified clinical testing, waiver of certain FDA application fees, and eligibility for protocol assistance..

如果获得批准，该认定将带来潜在益处，包括在获批后享有七年的市场独占期、合格临床试验的税收抵免、免除某些FDA申请费用，以及有资格获得方案协助。

Tiziana is currently evaluating intranasal foralumab in a Phase 2a open-label clinical trial (ClinicalTrials.gov Identifier:

Tiziana 目前正在一项 IIa 期开放标签临床试验中评估鼻用 foralumab（ClinicalTrials.gov 标识符：

NCT06868628

NCT06868628

) in patients with MSA. The six-month study is designed to assess effects on microglial activation (via PET imaging), clinical outcomes, and safety. Foralumab is administered via nasal spray across eight 3-week dosing cycles. The Phase 2a trial is being conducted within the MyTrial Program at Brigham and Women’s Hospital in Boston under the leadership of Principal Investigator Vikram Khurana, MD, PhD, Tracy T.

)在多系统萎缩（MSA）患者中。这项为期六个月的研究旨在评估对微胶质细胞活化（通过PET成像）、临床结局和安全性的影响。Foralumab通过鼻喷雾剂在八个为期3周的给药周期中给药。Phase 2a试验正在波士顿布里格姆妇女医院的MyTrial项目中进行，由首席研究员Vikram Khurana医学博士、哲学博士Tracy T.领导。

Batchelor Endowed Chair and Division Chief of Movement Disorders at Mass General Brigham..

马萨诸塞州总医院布里格姆妇女医院巴切洛讲席教授及运动障碍科主任。

Dr Khurana commented: “Multiple system atrophy remains one of the most challenging neurodegenerative diseases we face, with rapid progression and no approved therapies that alter its course. The growing recognition of neuroinflammation and microglial activation as central drivers of MSA pathology makes intranasal foralumab a particularly compelling candidate.

库拉纳博士评论道：“多系统萎缩仍然是我们面临的最具挑战性的神经退行性疾病之一，其进展迅速，且尚无获批的疾病修正疗法。随着神经炎症和小胶质细胞激活被广泛认为是多系统萎缩病理机制的核心驱动因素，鼻用foralumab成为一种尤为引人注目的候选药物。”

By harnessing the immune system’s regulatory pathways in a targeted, non-systemic way, this approach has the potential to address a critical unmet need. The ongoing clinical study, which includes PET imaging of microglial activity, will provide important early insights into whether this strategy can meaningfully impact the disease process.”.

通过以靶向且非全身性的方式利用免疫系统的调节通路，该方法有望满足一项关键且尚未被满足的临床需求。目前正在进行的临床研究包括对小胶质细胞活性进行正电子发射断层扫描（PET）成像，将为该策略能否对疾病进程产生有意义的影响提供重要的早期见解。

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “Filing for Orphan Drug Designation for intranasal foralumab in MSA represents an important regulatory step as we advance this novel therapy for patients facing a devastating disease with no approved disease-modifying options.

Tiziana Life Sciences 首席执行官 Ivor Elrifi 评论道：“就鼻用 foralumab 用于多系统萎缩（MSA）提交孤儿药资格认定申请，是我们推进这一新型疗法过程中的重要监管步骤；该疾病极具破坏性，且目前尚无获批的疾病修饰治疗选项。”

Foralumab administered intranasally induces regulatory T cells and modulates T-cell-driven inflammation. Its ability to reduce microglial activation offers a promising strategy to slow neuronal damage in neuroinflammatory and neurodegenerative conditions including MSA. This non-systemic approach is designed to promote immune tolerance while minimizing systemic immune suppression.”.

鼻内给药的Foralumab可诱导调节性T细胞，并调节T细胞驱动的炎症。其减少小胶质细胞活化的能力，为延缓包括多系统萎缩（MSA）在内的神经炎症和神经退行性疾病中的神经元损伤提供了一种有前景的策略。这种非全身性给药方式旨在促进免疫耐受，同时最大限度地减少全身性免疫抑制。

About Foralumab

关于 Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (.

Foralumab是一种全人源抗CD3单克隆抗体，作为一种生物药候选药物，已显示在鼻内给药时能够刺激调节性T细胞。目前，在一项开放标签、中等规模的扩大 access（EA）项目中，已有14名非活动性继发进展型多发性硬化症（na-SPMS）患者接受了给药。

NCT06802328

NCT06802328

) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (.

）所有患者在6个月内均观察到病情改善或稳定。此外，鼻用foralumab目前正在一项针对非活动性继发进展型多发性硬化症患者的IIa期、随机、双盲、安慰剂对照、多中心、剂量范围试验中进行研究。

NCT06292923

NCT06292923

), as well as additional Phase 2 trials in AD and MSA.

），以及在阿尔茨海默病（AD）和多系统萎缩症（MSA）中开展的其他二期临床试验。

Intranasal foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.

鼻用foralumab是目前临床开发中唯一的全人源抗CD3单克隆抗体（mAb）。通过鼻用foralumab进行免疫调节，为治疗人类神经炎症和神经退行性疾病开辟了一条新途径。

[1],[2]

[1],[2]

About Tiziana Life Sciences

关于 Tiziana 生命科学公司

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery.

Tiziana Life Sciences 是一家处于临床阶段的生物制药公司，致力于利用变革性的药物递送技术开发突破性疗法，以实现免疫治疗的替代给药途径。与静脉注射（IV）给药相比，Tiziana 创新的鼻内给药方法有望在疗效、安全性和耐受性方面带来改善。

Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications..

Tiziana 的主要候选药物鼻用 foralumab 是目前临床开发中唯一的全人源抗 CD3 单克隆抗体，在迄今的研究中已展现出良好的安全性和临床反应。Tiziana 的替代免疫疗法给药技术已获得专利，多项申请正在审批中，预计将支持其广泛的产品管线应用。

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit

如需了解更多关于 Tiziana Life Sciences 及其创新治疗产品管线的信息，请访问

www.tizianalifesciences.com

www.tizianalifesciences.com

.

。

Forward-Looking Statements

前瞻性陈述

Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements.

本新闻稿中的陈述可能构成经修订的《1933年美国证券法》第27A条和经修订的《1934年美国证券交易法》第21E条所定义的“前瞻性陈述”，这些陈述涉及某些风险和不确定性，可能导致实际结果与前瞻性陈述中预期或预测的结果存在重大差异。

These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements.

这些前瞻性陈述并非历史事实，而是基于本公司对其行业、信念及假设的当前预期、估计和预测。“预期”、“预计”、“打算”、“计划”、“相信”、“寻求”、“估计”等词语及类似表述旨在识别前瞻性陈述。

These forward-looking statements reflect the current beliefs and expectations of Tiziana’s management and include statements regarding the closing of the Offering. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements.

这些前瞻性陈述反映了Tiziana管理层当前的信念和预期，包括有关本次发行完成的陈述。这些陈述并非对未来表现的保证，并受到已知和未知风险、不确定性及其他因素的影响，其中一些因素超出公司控制范围，难以预测，并可能导致实际结果与前瞻性陈述中表达或预测的结果存在重大差异。

The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for t.

本公司提醒证券持有人及潜在证券持有人，切勿过度依赖这些前瞻性陈述，因为这些陈述仅反映本公司在本公告发布之日的观点。由于各种重要因素，实际结果可能与这些前瞻性陈述所指示的结果存在重大差异，其中包括：与市场状况相关的不确定性，以及在Tiziana的20-F表格年度报告中“风险因素”一节更全面描述的其他因素。

For further inquiries:

如需进一步咨询：

Tiziana Life Sciences Ltd

提齐亚纳生命科学有限公司

Paul Spencer, Business Development, and Investor Relations

保罗·斯宾塞，业务发展与投资者关系

+44 (0) 207 495 2379

+44 (0) 207 495 2379

email:

电子邮件：

info@tizianalifesciences.com

info@tizianalifesciences.com

[1]

[1]

https://www.pnas.org/doi/10.1073/pnas.2220272120

https://www.pnas.org/doi/10.1073/pnas.2220272120

[2]

[2]

https://www.pnas.org/doi/10.1073/pnas.2309221120

https://www.pnas.org/doi/10.1073/pnas.2309221120