<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，宣布完成其之前宣布的公司最佳努力注册直接发行（“发行”），共计 7,040,000 股普通股，发行价格为每股 1.25 美元，未通过承销商或配售代理，直接向高级管理人员和现有股东进行。Tiziana 从此次发行中获得的总收入在扣除预计的发行费用之前为 880 万美元。每认购一股普通股，参与者将获得一份认股权证，持有人可在 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，预计将带来额外的总收入约为 1,056 万美元。</p>
<p>此次发行由 Tiziana 的首席执行官 Ivor Elrifi 领导，他购买了 2,400,000 股普通股，使其总持股达到 2,757,848 股。Tiziana 的执行董事长兼创始人 Gabriele Cerrone 先生通过 Panetta Partners Ltd（他有实益权益的实体）购买了 1,600,000 股普通股，使其总持股达到 44,974,830 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结果。</p>
<p>上述证券是根据美国证券交易委员会（“SEC”）于 2025 年 3 月 24 日提交的 F-3 表格的架构注册声明（文件编号：333-286064）进行发行和销售的，包括基础招股说明书，并于 2025 年 3 月 27 日获得有效。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，可能还会进一步补充任何自由书面招股说明书和/或定价补充，具体取决于公司可能向 SEC 提交的文件。与此次发行相关的最终招股说明书补充已提交给 SEC，并可在 SEC 网站上获取。</p>
<p>本新闻稿不构成出售要约或购买要约的征求，也不应在任何州或司法管辖区进行这些证券的销售，若该等要约、征求或销售在该州或司法管辖区的证券法下是非法的，须在注册或资格之前进行。</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 个月内均显示出疾病的改善或稳定。此外，鼻用 foralumab 目前正在针对非活动性继发性进展性多发性硬化症进行第二阶段 a 期随机、双盲、安慰剂对照、多中心、剂量范围试验（NCT06292923）。</p>
<p>Foralumab 是目前唯一在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 创新的鼻用方法有潜力在疗效、安全性和耐受性方面提供比静脉（IV）给药更好的改善。Tiziana 的主要候选药物鼻用 foralumab 是目前唯一在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 的免疫疗法替代途径技术已获得专利，多个申请正在待审，预计将允许广泛的产品线应用。</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，属于 “前瞻性声明”，涉及可能导致实际结果与预期或预测的前瞻性声明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，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，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。公司提醒证券持有者和潜在证券持有者不要对这些前瞻性声明过于依赖，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 表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以反映公告日期之后发生的事件、情况或意外事件的义务。</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-bmY9T1RZeU56TTJNQ00zTXpZMU1ERTBJekl4TWpNNE9EVT0?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-bmY9T1RZeU56TTJNQ00zTXpZMU1ERTBJekl4TWpNNE9EVT0"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/M2I5NTBkMmYtZjRmOC00NjM3LTgwYTQtNzBlMGE2ZWU2NjNjLTExMzU0NTYtMjAyNi0wMS0xNi1lbg==/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/M2I5NTBkMmYtZjRmOC00NjM3LTgwYTQtNzBlMGE2ZWU2NjNjLTExMzU0NTYtMjAyNi0wMS0xNi1lbg==/tiny/Tiziana-Life-Sciences-Plc.png"/></p>

TLSA

<p>Tiziana Life Sciences 是一家生物技术公司，成功完成了一项超额认购的注册直接发行，发行 704 万股普通股，每股价格为 1.25 美元，筹集了 880 万美元。此次发行是在没有承销商的情况下进行的，包含以 1.50 美元价格购买额外股份的认股权证。包括首席执行官 Ivor Elrifi 和执行董事长 Gabriele Cerrone 在内的关键高管参与了此次发行。筹集的资金将用于其主要候选药物——鼻用 foralumab 的第二阶段临床试验，旨在治疗神经炎症疾病。此次发行已向美国证券交易委员会（SEC）注册，是 Tiziana 在免疫疗法方面创新方法的一部分</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 closing of its previously announced Company best efforts registered direct offering (&#34;Offering&#34;) of 7,040,000 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 gross proceeds to Tiziana from the Offering, before deducting estimated Offering expenses payable by Tiziana, were $8.8 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 $10.56 million.</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，宣布完成其之前宣布的公司最佳努力注册直接发行（“发行”），共计 7,040,000 股普通股，发行价格为每股 1.25 美元，未通过承销商或配售代理，直接向高级管理人员和现有股东进行。Tiziana 从此次发行中获得的总收入在扣除预计的发行费用之前为 880 万美元。每认购一股普通股，参与者将获得一份认股权证，持有人可在 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，预计将带来额外的总收入约为 1,056 万美元。</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 2,400,000 股普通股，使其总持股达到 2,757,848 股。Tiziana 的执行董事长兼创始人 Gabriele Cerrone 先生通过 Panetta Partners Ltd（他有实益权益的实体）购买了 1,600,000 股普通股，使其总持股达到 44,974,830 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结果。</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;) on March 24, 2025, 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 has been filed with the SEC and is 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”）于 2025 年 3 月 24 日提交的 F-3 表格的架构注册声明（文件编号：333-286064）进行发行和销售的，包括基础招股说明书，并于 2025 年 3 月 27 日获得有效。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，可能还会进一步补充任何自由书面招股说明书和/或定价补充，具体取决于公司可能向 SEC 提交的文件。与此次发行相关的最终招股说明书补充已提交给 SEC，并可在 SEC 网站上获取。</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，也不应在任何州或司法管辖区进行这些证券的销售，若该等要约、征求或销售在该州或司法管辖区的证券法下是非法的，须在注册或资格之前进行。</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 个月内均显示出疾病的改善或稳定。此外，鼻用 foralumab 目前正在针对非活动性继发性进展性多发性硬化症进行第二阶段 a 期随机、双盲、安慰剂对照、多中心、剂量范围试验（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 是目前唯一在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 创新的鼻用方法有潜力在疗效、安全性和耐受性方面提供比静脉（IV）给药更好的改善。Tiziana 的主要候选药物鼻用 foralumab 是目前唯一在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 的免疫疗法替代途径技术已获得专利，多个申请正在待审，预计将允许广泛的产品线应用。</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，属于 “前瞻性声明”，涉及可能导致实际结果与预期或预测的前瞻性声明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，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，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。公司提醒证券持有者和潜在证券持有者不要对这些前瞻性声明过于依赖，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 表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以反映公告日期之后发生的事件、情况或意外事件的义务。</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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