BOSTON, MA, January 20, 2026

美国马萨诸塞州波士顿，2026年1月20日

– Tiziana Life Sciences, Ltd. (Nasdaq:

– Tiziana Life Sciences, Ltd. (纳斯达克:

TLSA

TLSA

) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces the peer-reviewed publication of its open-label study in patients with non-active secondary progressive multiple sclerosis (na-SPMS) in

）（“Tiziana”），一家开发现阶段主导候选药物——鼻内给药的foralumab，一种全人源化抗CD3单克隆抗体的生物技术公司，宣布其在非活动性继发进展型多发性硬化症（na-SPMS）患者中的开放标签研究已经通过同行评审并发表在

Neurology Neuroimmunology & Neuroinflammation

神经病学 神经免疫学与神经炎症

, a prestigious journal of the American Academy of Neurology.

，美国神经病学学会的权威期刊。

The publication, titled “Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis,” details the comprehensive positive results previously announced by the Company on May 6, 2025. This marks the first study to integrate TSPO-PET imaging, proteomics, and clinical assessments in na-SPMS, highlighting nasal foralumab’s novel mechanism in addressing progression independent of relapse activity (PIRA)—a critical unmet need in multiple sclerosis (MS) treatment..

这篇题为《鼻用Foralumab治疗非活动性继发进展型多发性硬化症患者独立于复发的进展》的出版物详细介绍了公司于2025年5月6日先前宣布的全面积极结果。这是首个在非活动性继发进展型多发性硬化症（na-SPMS）中整合TSPO-PET成像、蛋白质组学和临床评估的研究，突显了鼻用Foralumab在解决独立于复发活动的进展（PIRA）方面的全新机制——这是多发性硬化症（MS）治疗中一个关键的未满足需求。

Key Study Highlights:

关键研究亮点：

Ten patients with na-SPMS, progressing despite prior B-cell therapies, received nasal foralumab for at least six months.

十名患有na-SPMS的患者在接受鼻腔给药foralumab至少六个月之前，尽管曾接受过B细胞疗法，病情仍在进展。

No serious or severe treatment-related adverse events occurred.

未发生严重或重度的与治疗相关的不良事件。

All patients showed stabilization of Expanded Disability Status Scale (EDSS) scores; three of four treated for 12 months demonstrated improvement.

所有患者的扩展残疾状态量表 (EDSS) 评分均保持稳定；治疗 12 个月的四名患者中有三名表现出改善。

Fatigue improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale (MFIS)—a vital quality-of-life measure for MS patients.

十名患者中有六名患者的疲劳症状有所改善，这一结果通过修正疲劳影响量表 (MFIS) 进行了测量，该量表是多发性硬化症 (MS) 患者生活质量的重要衡量标准。

No new T2 lesions appeared on MRI.

MRI上未出现新的T2病灶。

TSPO-PET imaging revealed significant reductions in microglial activation at three and six months (p<0.05).

TSPO-PET成像显示，三个月和六个月时小胶质细胞活化显著减少（p<0.05）。

Single-cell RNA sequencing demonstrated sustained increases in regulatory T cells (Tregs) and TGFβ expression, supporting induction of regulatory immunity.

单细胞RNA测序显示调节性T细胞（Tregs）和TGFβ表达持续增加，支持了调节性免疫的诱导。

“This peer-reviewed publication in a leading neurology journal represents a major milestone and external validation of intranasal foralumab’s therapeutic potential in secondary progressive MS,” said Tanuja Chitnis, M.D., Principal Investigator and Senior neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system.

“这篇发表在领先神经学杂志上的同行评审文章代表了鼻内给药Foralumab在继发进展型多发性硬化症治疗潜力方面的一个重要里程碑和外部验证，”Brigham and Women's Hospital的首席研究员兼资深神经学家Tanuja Chitnis博士说道，该医院是Mass General Brigham医疗系统创始成员之一。

“The integration of advanced imaging, immune profiling, and clinical outcomes underscores how nasal foralumab uniquely targets CNS inflammation through mucosal tolerance, offering hope for patients with limited options.”.

“先进的成像、免疫分析和临床结果的整合，强调了鼻用foralumab如何通过黏膜耐受独特地靶向中枢神经系统的炎症，为选择有限的患者带来了希望。”

Dr. Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system, noted: “The observed clinical stabilization and microglial PET findings are supported by these new biomarker discoveries, providing compelling evidence of nasal foralumab’s biological effects in addressing PIRA in na-SPMS.”.

Tiziana科学顾问委员会主席、布里格姆妇女医院安·罗姆尼神经疾病中心联合主任、麻总百瀚医疗系统创始成员霍华德·L.韦纳博士指出：“这些新的生物标志物发现支持了观察到的临床稳定和小胶质细胞PET结果，为鼻腔给药的foralumab在治疗na-SPMS中的PIRA提供了令人信服的生物学效应证据。”

Nasal foralumab’s innovative intranasal delivery modulates the immune system to suppress microglial-driven neuroinflammation without broad systemic immunosuppression, distinguishing it from existing MS therapies.

鼻用福拉鲁单抗的创新鼻腔递送方式通过调节免疫系统来抑制小胶质细胞驱动的神经炎症，而不会引起广泛的全身免疫抑制，这使其有别于现有的多发性硬化症疗法。

Tiziana is advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS, with top-line data expected in 1H of 2026.

Tiziana公司正在na-SPMS患者中进行一项持续的随机、双盲、安慰剂对照的2期试验，以推进鼻内给药foralumab的研究，预计将在2026年上半年获得顶线数据。

“We are thrilled that these groundbreaking results have now been peer-reviewed and published, reinforcing our confidence in intranasal foralumab as a potential paradigm-shifting therapy for progressive MS and beyond,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences.

“我们非常激动，这些突破性的结果已经过同行评审并发表，这进一步增强了我们对鼻内Foralumab作为潜在的变革性治疗方案用于进展型多发性硬化症及其他领域的信心，”Tiziana生命科学公司首席执行官Ivor Elrifi表示。

The full publication can be found here:

完整出版物可以在这里找到：

https://www.neurology.org/doi/10.1212/NXI.0000000000200543

https://www.neurology.org/doi/10.1212/NXI.0000000000200543

About Foralumab

关于Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 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，已被证明在鼻内给药时能够刺激T调节细胞。目前，在一项开放标签的中等规模扩大使用（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）患者接受了该药物的给药。

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个月内病情均得到改善或稳定。此外，鼻内给药的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2a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

).

）。

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.

Foralumab是目前临床开发中唯一的全人源抗CD3单克隆抗体（mAb）。通过鼻内给予foralumab进行免疫调节，代表了治疗神经炎症和神经退行性人类疾病的新途径。

[1],[2]

[1],[2]

About Tiziana Life Sciences

关于蒂齐亚纳生命科学

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

Tiziana是一家临床阶段的生物制药公司，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途径。Tiziana创新的鼻腔给药方法相比静脉注射（IV）有可能在疗效以及安全性和耐受性方面提供改善。

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的主打候选药物——鼻腔给药的foralumab，是目前临床开发中唯一的全人源抗CD3单克隆抗体，在迄今为止的研究中已显示出良好的安全性和临床反应。Tiziana用于免疫治疗替代途径的技术已获得专利，还有多项申请正在审批中，预计可实现广泛的产品管线应用。

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

如需更多关于Tiziana及其创新疗法管道的信息，请访问

www.tizianalifesciences.com

www.tizianalifesciences.com

.

。

Forward-Looking Statements

前瞻性声明

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Tiziana’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.

本公告中的一些声明属于前瞻性陈述。这些前瞻性陈述并非历史事实，而是基于Tiziana当前对其行业、信念和假设的预期、估计和预测。诸如“预期”、“预计”、“意图”、“计划”、“相信”、“寻求”、“估计”以及类似表达的词语旨在识别前瞻性陈述。

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 Tiziana’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements.

这些声明并非对未来业绩的保证，且受到已知和未知风险、不确定性及其他因素的影响，其中部分因素是Tiziana无法控制的，难以预测，并可能导致实际结果与前瞻性声明中表达或预测的结果存在重大差异。

Tiziana cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of Tiziana 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 the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission.

蒂齐亚娜提醒证券持有者和潜在证券持有者不要过分依赖这些前瞻性声明，这些声明仅反映蒂齐亚娜截至本公告日期的观点。实际结果可能与这些前瞻性声明所表明的结果存在重大差异，原因包括多种重要因素：与市场状况相关的不确定性以及其他因素，这些因素在蒂齐亚娜截至2024年12月31日的年度报告中标题为“风险因素”的章节以及提交给证券交易委员会的其他定期报告中有更详尽的描述。

The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. Tiziana will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any.

本公告中作出的前瞻性陈述仅与作出这些陈述之日的事件相关。Tiziana 除法律或任何其他规定要求外，不会承担公开发布对这些前瞻性陈述的任何修订或更新以反映本公告日期之后发生的事件、情况或意外事件的责任。

For further inquiries:

如需进一步查询：

Tiziana Life Sciences Ltd

蒂齐亚娜生命科学有限公司

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