BOSTON, MA, December 2, 2025

美国马萨诸塞州波士顿，2025年12月2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 today announced that that it intends to develop its fully human anti-IL-6 receptor (IL-6R) monoclonal antibody, TZLS-501, and related assets (together “TZLS-501”) via a spinout into a separate publicly traded company, to enhance the strategic focus of each company and to drive value for shareholders.

）（“Tiziana”或“公司”），一家开发突破性免疫调节疗法的生物技术公司，今天宣布其计划通过分拆将其全人源抗IL-6受体（IL-6R）单克隆抗体TZLS-501及相关资产（统称“TZLS-501”）转入一家独立的公开上市的公司，以增强各公司的战略聚焦并为股东创造价值。

Tiziana shareholders at the record date will retain value from TZLS-501 through the distribution in specie of shares in the new TZLS-501 listed entity..

记录日期的Tiziana股东将通过新上市的TZLS-501实体的实物分配保留TZLS-501的价值。

The Company recently announced that it would advance development of TZLS-501, a dual-action IL-6R monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R. This decision was based in part on heightened industry interest in the IL-6 pathway—underscored by Novartis’ recent $1.4 billion acquisition of Tourmaline Bio for its IL-6 inhibitor pacibekitug.  The Company considers TZLS-501 as having the potential to be a standalone business.  Accordingly, the Company intends to proceed with steps for a publicly listed immunology-focused spin-out company, centered on the IL-6 market.

公司近期宣布将加速开发TZLS-501，这是一种双重作用的IL-6R单克隆抗体，靶向膜结合型和可溶性IL-6R。这一决定部分基于行业对IL-6通路的浓厚兴趣——诺华近期以14亿美元收购Tourmaline Bio及其IL-6抑制剂pacibekitug便是明证。公司认为TZLS-501有潜力成为一项独立业务。因此，公司计划推进成立一家公开上市、专注于免疫学的分拆公司，核心围绕IL-6市场。

The record date for this proposed transaction will be announced in the coming weeks and the transaction will formally be put to shareholders of Tiziana for approval. TZLS-501 will remain an asset of Tiziana Life Sciences until such time as shareholders formally approve proposals for the spin-out entity..

此项拟议交易的记录日期将在未来几周内公布，交易将正式提交给Tiziana的股东以获得批准。在股东正式批准分拆实体的提案之前，TZLS-501仍将是Tiziana Life Sciences的一项资产。

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “The recent Novartis acquisition of Tourmaline Bio for $1.4 billion highlights the tremendous value and strategic importance of IL-6 pathway therapeutics in addressing systemic inflammation and related diseases. Building on our September announcement to advance TZLS-501, we believe now is the ideal time to position this promising asset as a standalone entity.

Tiziana生命科学公司首席执行官Ivor Elrifi评论道：“诺华最近以14亿美元收购Tourmaline Bio，突显了IL-6通路治疗药物在应对系统性炎症及相关疾病方面的巨大价值和战略重要性。基于我们9月宣布推进TZLS-501的计划，我们认为现在是将这一有前景的资产定位为独立实体的理想时机。”

TZLS-501’s unique dual mechanism—blocking IL-6R signaling while reducing circulating IL-6 cytokines—offers significant potential as a monotherapy or in combination with other agents. This spin-out will unlock dedicated resources for its development, while allowing us to maintain focus on intranasal foralumab as our lead program.”.

TZLS-501独特的双重机制——阻断IL-6R信号传导同时减少循环中的IL-6细胞因子——作为单一疗法或与其他药物联合使用具有显著潜力。此次分拆将为其开发释放专用资源，同时使我们能够继续专注于鼻腔给药的foralumab作为我们的主要项目。

There can be no certainty that the transaction will proceed and any listing will be subject to meeting the required listing criteria.

无法确定该交易是否会进行，且任何上市均需符合所需的上市标准。

About TZLS-501

关于TZLS-501

TZLS-501, a fully human mAb, was licensed from Novimmune, SA, (Geneva, CH) in 2017. IL-6 is a cytokine that binds to its receptor subunit IL-6Rα on the cell membrane, and is a major determinant in priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood.

TZLS-501，一种全人源单克隆抗体，于2017年从Novimmune, SA（瑞士日内瓦）获得许可。IL-6是一种细胞因子，可与其在细胞膜上的受体亚基IL-6Rα结合，是致病性T细胞引发炎症反应的主要决定因素。受体IL-6Rα可以以可溶形式脱落，即sIL6Rα，它与血液中的循环IL-6细胞因子结合。

The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases. TZLS-501 acts via a dual mechanism by inhibiting IL-6R signaling and depleting circulating levels of IL-6..

该复合物的下游信号介导了炎症性疾病背后的促炎效应。TZLS-501通过双重机制发挥作用，抑制IL-6R信号传导并降低循环中IL-6的水平。

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，是一种生物药物候选物，已证明在鼻内给药时可刺激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目前正在进行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（。

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

关于蒂齐亚娜生命科学公司

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 nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery.

Tiziana生命科学公司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 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.

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，而是基于公司对其行业、信念和假设的当前预期、估计和预测。诸如“预期”、“预计”、“打算”、“计划”、“相信”、“寻求”、“估计”等词语以及类似表达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 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.

这些陈述并非对未来业绩的保证，且受已知和未知风险、不确定性及其他因素的影响，其中部分因素超出公司的控制范围，难以预测，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 the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission.

公司告诫证券持有者和潜在证券持有者不要过分依赖这些前瞻性陈述，这些陈述仅代表公司截至本公告发布当日的观点。实际结果可能与这些前瞻性陈述所表明的结果存在重大差异，原因包括多种重要因素，例如与市场状况相关的不确定性及其他因素，详见Tiziana于2024年12月31日终了年度的Form 20-F年报中题为“风险因素”部分的详细描述，以及其他向证券交易委员会提交的定期报告。

The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company 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 l.

本公告中作出的前瞻性陈述仅与作出该陈述之日的事件相关。公司不承担任何公开发布对这些前瞻性陈述的修订或更新的义务，以反映本公告日期之后发生的事件、情况或意外事件，除非法律要求。

For further inquiries:

如有进一步查询：

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