<p>波士顿，2026 年 1 月 16 日（环球新闻通讯社）—— Tiziana Life Sciences, Ltd.（纳斯达克：TLSA）（“Tiziana”）是一家生物技术公司，正在开发其主要候选药物——鼻用 foralumab，这是一种完全人源的抗 CD3 单克隆抗体，宣布以公司最佳努力进行的注册直接发行（“发行”）定价，发行 640 万普通股，发行价格为每股 1.25 美元，向高级管理层成员和现有股东进行，未通过承销商或配售代理。预计在扣除 Tiziana 应支付的估计发行费用之前，Tiziana 从此次发行中获得的总毛收入将达到 800 万美元。每认购一股普通股，参与者将获得一份认股权证，持有人有权在 2026 年 7 月 16 日（认股权证到期日）之前以 1.50 美元的价格认购一股新普通股，从而带来额外的毛收入，预计可达约 960 万美元。此次发行预计于 2026 年 1 月 16 日完成，前提是满足惯例的交割条件。</p>
<p>此次发行由 Tiziana 的首席执行官 Ivor Elrifi 领导，他购买了 240 万普通股，使其总持股达到 2757848 股。Tiziana 的执行董事长兼创始人 Gabriele Cerrone 先生通过 Panetta Partners Ltd 购买了 160 万普通股，该实体是他拥有实益权益的公司，使其总持股达到 44974830 股。</p>
<p>此次发行的收益使公司能够完成其第二阶段 na-SPMS 和 MSA 临床试验，并在这两个试验中获得顶线数据。</p>
<p>“我们对忠实的股东在这个关键时刻的坚定支持表示感谢。您对 Tiziana Life Sciences 的信任在我们推进 na-SPMS 和 MSA 临床试验的顶线数据时发挥了重要作用，使我们更接近可能改变生活的突破，” Tiziana Life Sciences 的创始人兼执行董事长 Gabriele Cerrone 说道。</p>
<p>上述证券是根据美国证券交易委员会（“SEC”）提交的 F-3 表格的架构注册声明（文件编号 333-286064）进行的，包括基础招股说明书，并于 2025 年 3 月 27 日生效。此次发行仅通过招股说明书补充及随附的基础招股说明书进行，可能还会通过公司向 SEC 提交的任何自由书面招股说明书和/或定价补充进行进一步补充。与此次发行相关的最终招股说明书补充将提交给 SEC，并将在 SEC 网站上提供。</p>
<p>本新闻稿不构成出售要约或购买要约的征求，也不构成在任何州或司法管辖区内出售这些证券的行为，除非在该州或司法管辖区的证券法下注册或合格之前，此类要约、征求或销售将是非法的。</p>
<p><strong>关于 Foralumab</strong></p>
<p>Foralumab 是一种完全人源的抗 CD3 单克隆抗体，是一种生物制剂候选药物，已显示在鼻用给药时刺激 T 调节细胞。目前，已有 14 名非活动性继发性进展性多发性硬化症（na-SPMS）患者在开放标签的中型扩展使用（EA）项目（NCT06802328）中接受了给药，所有患者在 6 个月内均出现了疾病改善或稳定。此外，鼻用 foralumab 目前正在一项针对非活动性继发性进展性多发性硬化症患者的第二阶段随机双盲安慰剂对照多中心剂量范围试验中进行研究（NCT06292923）。</p>
<p>Foralumab 是目前唯一处于临床开发中的完全人源抗 CD3 单克隆抗体（mAb）。鼻用 foralumab 的免疫调节代表了治疗神经炎症和神经退行性人类疾病的一种新途径。[1],[2]</p>
<p><strong>关于 Tiziana Life Sciences</strong></p>
<p>Tiziana 是一家临床阶段的生物制药公司，开发突破性疗法，利用变革性的药物递送技术实现免疫疗法的替代途径。Tiziana 的创新鼻用方法有潜力在疗效、安全性和耐受性方面提供改善，相较于静脉（IV）给药。Tiziana 的主要候选药物鼻用 foralumab 是目前唯一处于临床开发中的完全人源抗 CD3 mAb，已在迄今为止的研究中显示出良好的安全性和临床反应。Tiziana 的替代免疫疗法技术已获得专利，多个申请正在待审，预计将允许广泛的管线应用。</p>
<p>有关 Tiziana 及其创新疗法管线的更多信息，请访问 www.tizianalifesciences.com。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿中的声明可能是根据《1933 年美国证券法》第 27A 条和《1934 年美国证券交易法》第 21E 条的定义所指的 “前瞻性声明”，涉及可能导致实际结果与前瞻性声明中预期或预测的结果存在重大差异的风险和不确定性。这些前瞻性声明不是历史事实，而是基于公司对其行业的当前预期、估计和预测；其信念；以及假设。诸如 “预期”、“期望”、“打算”、“计划”、“相信”、“寻求”、“估计” 等词语旨在识别前瞻性声明。这些前瞻性声明反映了 Tiziana 管理层的当前信念和期望，并包括关于发行结束的声明。这些声明并不保证未来的表现，并且受到已知和未知的风险、不确定性和其他因素的影响，其中一些超出了公司的控制范围，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。公司提醒证券持有人和潜在证券持有人不要对这些前瞻性声明过度依赖，这些声明仅反映公司在本公告日期的观点。实际结果可能因各种重要因素而与这些前瞻性声明所指示的结果存在重大差异，包括：与市场条件相关的不确定性以及在 Tiziana 截至 2024 年 12 月 31 日的 20-F 年度报告中更全面描述的其他因素，以及不时向 SEC 提交的其他定期报告。本公告中所作的前瞻性声明仅与声明作出之日的事件相关。除法律或任何适当监管机构要求外，公司不承担公开发布任何修订或更新这些前瞻性声明的义务，以反映公告日期之后发生的事件、情况或意外事件。</p>
<p><strong>如需进一步咨询：</strong></p>
<p><strong>Tiziana Life Sciences Ltd</strong></p>
<p>Paul Spencer，业务发展与投资者关系</p>
<p>+44 (0) 207 495 2379</p>
<p>电子邮件：info@tizianalifesciences.com</p>
<p>[1] https://www.pnas.org/doi/10.1073/pnas.2220272120</p>
<p>[2] https://www.pnas.org/doi/10.1073/pnas.2309221120</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZeU5qazBPU00zTXpZMU1EQTVJekl4TWpNNE9EVT0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZeU5qazBPU00zTXpZMU1EQTVJekl4TWpNNE9EVT0"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/Yzg4ZjI0ZWUtYTk2ZS00ZDBmLTkxZWItYjI2ZGI1ZDc3NDA5LTExMzU0NTYtMjAyNi0wMS0xNi1lbg==/tiny/Tiziana-Life-Sciences-Plc.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/Yzg4ZjI0ZWUtYTk2ZS00ZDBmLTkxZWItYjI2ZGI1ZDc3NDA5LTExMzU0NTYtMjAyNi0wMS0xNi1lbg==/tiny/Tiziana-Life-Sciences-Plc.png"/></p>

TLSA

<p>Tiziana Life Sciences 是一家生物技术公司，宣布进行约 1760 万美元的注册直接发行，定价为 640 万股普通股，每股 1.25 美元。此次发行由首席执行官 Ivor Elrifi 和执行董事长 Gabriele Cerrone 主导，旨在为其主要候选药物——鼻用 foralumab 的第二阶段临床试验提供资金。参与者将获得以 1.50 美元价格购买额外股份的认股权证。此次发行预计将在 2026 年 1 月 16 日完成，需满足常规条件。Tiziana 的创新疗法专注于替代免疫疗法途径，在正在进行的试验中取得了令人鼓舞的结果</p>

<p>BOSTON, Jan. 16, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces the pricing of a Company best efforts registered direct offering (&#34;Offering&#34;) of 6,400,000 ordinary shares at an Offering price of $1.25 per ordinary share conducted without an underwriter or placement agent to members of senior management and existing shareholders. The total gross proceeds to Tiziana from the Offering, before deducting estimated Offering expenses payable by Tiziana, are expected to be $8.0 million. For every ordinary share subscribed, participants will receive one warrant entitling the holder to subscribe for one new ordinary share at a price of $1.50 at any time up to and including July 16, 2026 (when the warrants expire) resulting in additional gross proceeds of up to approximately $9.6 million. The Offering is expected to close on January 16, 2026, subject to the satisfaction of customary closing conditions.</p>
<div class="lb-trans"><p>波士顿，2026 年 1 月 16 日（环球新闻通讯社）—— Tiziana Life Sciences, Ltd.（纳斯达克：TLSA）（“Tiziana”）是一家生物技术公司，正在开发其主要候选药物——鼻用 foralumab，这是一种完全人源的抗 CD3 单克隆抗体，宣布以公司最佳努力进行的注册直接发行（“发行”）定价，发行 640 万普通股，发行价格为每股 1.25 美元，向高级管理层成员和现有股东进行，未通过承销商或配售代理。预计在扣除 Tiziana 应支付的估计发行费用之前，Tiziana 从此次发行中获得的总毛收入将达到 800 万美元。每认购一股普通股，参与者将获得一份认股权证，持有人有权在 2026 年 7 月 16 日（认股权证到期日）之前以 1.50 美元的价格认购一股新普通股，从而带来额外的毛收入，预计可达约 960 万美元。此次发行预计于 2026 年 1 月 16 日完成，前提是满足惯例的交割条件。</p>
</div><p>The Offering was led by Tiziana's Chief Executive Officer, Ivor Elrifi, who purchased 2,400,000 ordinary shares, bringing his total holding to 2,757,848 ordinary shares. Executive Chairman and Founder of Tiziana, Mr. Gabriele Cerrone purchased 1,600,000 ordinary shares in the Offering through Panetta Partners Ltd, an entity in which he has a beneficial interest, bringing his total holdings to 44,974,830 ordinary shares.</p>
<div class="lb-trans"><p>此次发行由 Tiziana 的首席执行官 Ivor Elrifi 领导，他购买了 240 万普通股，使其总持股达到 2757848 股。Tiziana 的执行董事长兼创始人 Gabriele Cerrone 先生通过 Panetta Partners Ltd 购买了 160 万普通股，该实体是他拥有实益权益的公司，使其总持股达到 44974830 股。</p>
</div><p>The proceeds from this offering enable the company to complete its Phase 2 na-SPMS and MSA clinical trials, and achieve top line data readouts in both trials.</p>
<div class="lb-trans"><p>此次发行的收益使公司能够完成其第二阶段 na-SPMS 和 MSA 临床试验，并在这两个试验中获得顶线数据。</p>
</div><p>“We are grateful to our dedicated shareholders for their steadfast support during this pivotal time. Your belief in Tiziana Life Sciences has been instrumental as we push forward to topline data in our clinical trials in na-SPMS and MSA, bringing us closer to potential breakthroughs that could transform lives,” said Gabriele Cerrone, Founder and Executive Chairman of Tiziana Life Sciences.</p>
<div class="lb-trans"><p>“我们对忠实的股东在这个关键时刻的坚定支持表示感谢。您对 Tiziana Life Sciences 的信任在我们推进 na-SPMS 和 MSA 临床试验的顶线数据时发挥了重要作用，使我们更接近可能改变生活的突破，” Tiziana Life Sciences 的创始人兼执行董事长 Gabriele Cerrone 说道。</p>
</div><p>The securities described above are being offered and sold pursuant to a shelf registration statement on Form F-3 (File No. 333-286064), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the &#34;SEC&#34;) and declared effective on March 27, 2025. The Offering is being made only by means of a prospectus supplement and the accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. The final prospectus supplement related to the Offering will be filed with the SEC and will also be available on the SEC website.</p>
<div class="lb-trans"><p>上述证券是根据美国证券交易委员会（“SEC”）提交的 F-3 表格的架构注册声明（文件编号 333-286064）进行的，包括基础招股说明书，并于 2025 年 3 月 27 日生效。此次发行仅通过招股说明书补充及随附的基础招股说明书进行，可能还会通过公司向 SEC 提交的任何自由书面招股说明书和/或定价补充进行进一步补充。与此次发行相关的最终招股说明书补充将提交给 SEC，并将在 SEC 网站上提供。</p>
</div><p>This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.</p>
<div class="lb-trans"><p>本新闻稿不构成出售要约或购买要约的征求，也不构成在任何州或司法管辖区内出售这些证券的行为，除非在该州或司法管辖区的证券法下注册或合格之前，此类要约、征求或销售将是非法的。</p>
</div><p><strong>About Foralumab</strong></p>
<div class="lb-trans"><p><strong>关于 Foralumab</strong></p>
</div><p>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 (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 (NCT06292923).</p>
<div class="lb-trans"><p>Foralumab 是一种完全人源的抗 CD3 单克隆抗体，是一种生物制剂候选药物，已显示在鼻用给药时刺激 T 调节细胞。目前，已有 14 名非活动性继发性进展性多发性硬化症（na-SPMS）患者在开放标签的中型扩展使用（EA）项目（NCT06802328）中接受了给药，所有患者在 6 个月内均出现了疾病改善或稳定。此外，鼻用 foralumab 目前正在一项针对非活动性继发性进展性多发性硬化症患者的第二阶段随机双盲安慰剂对照多中心剂量范围试验中进行研究（NCT06292923）。</p>
</div><p>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.[1],[2]</p>
<div class="lb-trans"><p>Foralumab 是目前唯一处于临床开发中的完全人源抗 CD3 单克隆抗体（mAb）。鼻用 foralumab 的免疫调节代表了治疗神经炎症和神经退行性人类疾病的一种新途径。[1],[2]</p>
</div><p><strong>About Tiziana Life Sciences</strong></p>
<div class="lb-trans"><p><strong>关于 Tiziana Life Sciences</strong></p>
</div><p>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’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.</p>
<div class="lb-trans"><p>Tiziana 是一家临床阶段的生物制药公司，开发突破性疗法，利用变革性的药物递送技术实现免疫疗法的替代途径。Tiziana 的创新鼻用方法有潜力在疗效、安全性和耐受性方面提供改善，相较于静脉（IV）给药。Tiziana 的主要候选药物鼻用 foralumab 是目前唯一处于临床开发中的完全人源抗 CD3 mAb，已在迄今为止的研究中显示出良好的安全性和临床反应。Tiziana 的替代免疫疗法技术已获得专利，多个申请正在待审，预计将允许广泛的管线应用。</p>
</div><p>For more information about Tiziana and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.</p>
<div class="lb-trans"><p>有关 Tiziana 及其创新疗法管线的更多信息，请访问 www.tizianalifesciences.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>Statements in this press release may be &#34;forward-looking statements&#34; 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. 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. 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. 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 SEC from time to time. 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 law or by any appropriate regulatory authority.</p>
<div class="lb-trans"><p>本新闻稿中的声明可能是根据《1933 年美国证券法》第 27A 条和《1934 年美国证券交易法》第 21E 条的定义所指的 “前瞻性声明”，涉及可能导致实际结果与前瞻性声明中预期或预测的结果存在重大差异的风险和不确定性。这些前瞻性声明不是历史事实，而是基于公司对其行业的当前预期、估计和预测；其信念；以及假设。诸如 “预期”、“期望”、“打算”、“计划”、“相信”、“寻求”、“估计” 等词语旨在识别前瞻性声明。这些前瞻性声明反映了 Tiziana 管理层的当前信念和期望，并包括关于发行结束的声明。这些声明并不保证未来的表现，并且受到已知和未知的风险、不确定性和其他因素的影响，其中一些超出了公司的控制范围，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。公司提醒证券持有人和潜在证券持有人不要对这些前瞻性声明过度依赖，这些声明仅反映公司在本公告日期的观点。实际结果可能因各种重要因素而与这些前瞻性声明所指示的结果存在重大差异，包括：与市场条件相关的不确定性以及在 Tiziana 截至 2024 年 12 月 31 日的 20-F 年度报告中更全面描述的其他因素，以及不时向 SEC 提交的其他定期报告。本公告中所作的前瞻性声明仅与声明作出之日的事件相关。除法律或任何适当监管机构要求外，公司不承担公开发布任何修订或更新这些前瞻性声明的义务，以反映公告日期之后发生的事件、情况或意外事件。</p>
</div><p><strong>For further inquiries:</strong></p>
<div class="lb-trans"><p><strong>如需进一步咨询：</strong></p>
</div><p><strong>Tiziana Life Sciences Ltd</strong></p>
<div class="lb-trans"><p><strong>Tiziana Life Sciences Ltd</strong></p>
</div><p>Paul Spencer, Business Development, and Investor Relations</p>
<div class="lb-trans"><p>Paul Spencer，业务发展与投资者关系</p>
</div><p>+44 (0) 207 495 2379</p>
<div class="lb-trans"><p>+44 (0) 207 495 2379</p>
</div><p>email: info@tizianalifesciences.com</p>
<div class="lb-trans"><p>电子邮件：info@tizianalifesciences.com</p>
</div><p>[1] https://www.pnas.org/doi/10.1073/pnas.2220272120</p>
<div class="lb-trans"><p>[1] https://www.pnas.org/doi/10.1073/pnas.2220272120</p>
</div><p>[2] https://www.pnas.org/doi/10.1073/pnas.2309221120</p>
<div class="lb-trans"><p>[2] https://www.pnas.org/doi/10.1073/pnas.2309221120</p>
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