<p>波士頓，2026 年 1 月 16 日（環球新聞通訊社）——Tiziana Life Sciences, Ltd.（納斯達克：TLSA）（“Tiziana”）是一家生物技術公司，正在開發其主要候選藥物——鼻用 foralumab，這是一種完全人源的抗 CD3 單克隆抗體，宣佈完成其之前宣佈的公司最佳努力註冊直接發行（“發行”），共計 7,040,000 股普通股，發行價格為每股 1.25 美元，未通過承銷商或配售代理，直接向高級管理人員和現有股東進行。Tiziana 從此次發行中獲得的總收入在扣除預計的發行費用之前為 880 萬美元。每認購一股普通股，參與者將獲得一份認股權證，持有人可在 2026 年 7 月 16 日（認股權證到期日）之前以 1.50 美元的價格認購一股新普通股，預計將帶來額外的總收入約為 1,056 萬美元。</p>
<p>此次發行由 Tiziana 的首席執行官 Ivor Elrifi 領導，他購買了 2,400,000 股普通股，使其總持股達到 2,757,848 股。Tiziana 的執行董事長兼創始人 Gabriele Cerrone 先生通過 Panetta Partners Ltd（他有實益權益的實體）購買了 1,600,000 股普通股，使其總持股達到 44,974,830 股。</p>
<p>此次發行的收益使公司能夠完成其第二階段 na-SPMS 和 MSA 臨牀試驗，並在這兩個試驗中獲得頂線數據結果。</p>
<p>上述證券是根據美國證券交易委員會（“SEC”）於 2025 年 3 月 24 日提交的 F-3 表格的架構註冊聲明（文件編號：333-286064）進行發行和銷售的，包括基礎招股説明書，並於 2025 年 3 月 27 日獲得有效。此次發行僅通過招股説明書補充及隨附的基礎招股説明書進行，可能還會進一步補充任何自由書面招股説明書和/或定價補充，具體取決於公司可能向 SEC 提交的文件。與此次發行相關的最終招股説明書補充已提交給 SEC，並可在 SEC 網站上獲取。</p>
<p>本新聞稿不構成出售要約或購買要約的徵求，也不應在任何州或司法管轄區進行這些證券的銷售，若該等要約、徵求或銷售在該州或司法管轄區的證券法下是非法的，須在註冊或資格之前進行。</p>
<p><strong>關於 Foralumab</strong></p>
<p>Foralumab 是一種完全人源的抗 CD3 單克隆抗體，是一種生物製劑候選藥物，已顯示在鼻用給藥時刺激 T 調節細胞。目前，已有 14 名非活動性繼發性進展性多發性硬化症（na-SPMS）患者在開放標籤的中型擴展使用（EA）項目（NCT06802328）中接受了給藥，所有患者在 6 個月內均顯示出疾病的改善或穩定。此外，鼻用 foralumab 目前正在針對非活動性繼發性進展性多發性硬化症進行第二階段 a 期隨機、雙盲、安慰劑對照、多中心、劑量範圍試驗（NCT06292923）。</p>
<p>Foralumab 是目前唯一在臨牀開發中的完全人源抗 CD3 單克隆抗體（mAb）。鼻用 foralumab 的免疫調節代表了治療神經炎症和神經退行性人類疾病的新途徑。[1],[2]</p>
<p><strong>關於 Tiziana Life Sciences</strong></p>
<p>Tiziana 是一家臨牀階段的生物製藥公司，開發突破性療法，利用變革性的藥物遞送技術實現免疫療法的替代途徑。Tiziana 創新的鼻用方法有潛力在療效、安全性和耐受性方面提供比靜脈（IV）給藥更好的改善。Tiziana 的主要候選藥物鼻用 foralumab 是目前唯一在臨牀開發中的完全人源抗 CD3 mAb，已在迄今為止的研究中顯示出良好的安全性和臨牀反應。Tiziana 的免疫療法替代途徑技術已獲得專利，多個申請正在待審，預計將允許廣泛的產品線應用。</p>
<p>有關 Tiziana 及其創新療法管線的更多信息，請訪問 www.tizianalifesciences.com。</p>
<p><strong>前瞻性聲明</strong></p>
<p>本新聞稿中的聲明可能是根據《1933 年美國證券法》第 27A 條和《1934 年美國證券交易法》第 21E 條的定義，屬於 “前瞻性聲明”，涉及可能導致實際結果與預期或預測的前瞻性聲明存在重大差異的風險和不確定性。這些前瞻性聲明不是歷史事實，而是基於公司對其行業的當前預期、估計和預測；其信念；以及假設。諸如 “預期”、“期望”、“打算”、“計劃”、“相信”、“尋求”、“估計” 等詞語旨在識別前瞻性聲明。這些前瞻性聲明反映了 Tiziana 管理層的當前信念和期望，包括關於發行結束的聲明。這些聲明並不保證未來的表現，並且受到已知和未知的風險、不確定性和其他因素的影響，其中一些超出了公司的控制範圍，難以預測，可能導致實際結果與前瞻性聲明中表達或預測的結果存在重大差異。公司提醒證券持有者和潛在證券持有者不要對這些前瞻性聲明過於依賴，這些聲明僅反映公司在本公告日期的觀點。實際結果可能因各種重要因素而與這些前瞻性聲明所指示的結果存在重大差異，包括：與市場條件相關的不確定性以及在 Tiziana 截至 2024 年 12 月 31 日的 20-F 表年度報告中更全面描述的其他因素，以及不時向 SEC 提交的其他定期報告。本公告中所作的前瞻性聲明僅與聲明作出之日的事件相關。除法律或任何適當監管機構要求外，公司不承擔公開發布任何修訂或更新這些前瞻性聲明以反映公告日期之後發生的事件、情況或意外事件的義務。</p>
<p><strong>如需進一步諮詢：</strong></p>
<p><strong>Tiziana Life Sciences Ltd</strong></p>
<p>Paul Spencer，業務發展與投資者關係</p>
<p>+44 (0) 207 495 2379</p>
<p>電子郵件：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 是一家生物技術公司，成功完成了一項超額認購的註冊直接發行，發行 704 萬股普通股，每股價格為 1.25 美元，籌集了 880 萬美元。此次發行是在沒有承銷商的情況下進行的，包含以 1.50 美元價格購買額外股份的認股權證。包括首席執行官 Ivor Elrifi 和執行董事長 Gabriele Cerrone 在內的關鍵高管參與了此次發行。籌集的資金將用於其主要候選藥物——鼻用 foralumab 的第二階段臨牀試驗，旨在治療神經炎症疾病。此次發行已向美國證券交易委員會（SEC）註冊，是 Tiziana 在免疫療法方面創新方法的一部分</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>波士頓，2026 年 1 月 16 日（環球新聞通訊社）——Tiziana Life Sciences, Ltd.（納斯達克：TLSA）（“Tiziana”）是一家生物技術公司，正在開發其主要候選藥物——鼻用 foralumab，這是一種完全人源的抗 CD3 單克隆抗體，宣佈完成其之前宣佈的公司最佳努力註冊直接發行（“發行”），共計 7,040,000 股普通股，發行價格為每股 1.25 美元，未通過承銷商或配售代理，直接向高級管理人員和現有股東進行。Tiziana 從此次發行中獲得的總收入在扣除預計的發行費用之前為 880 萬美元。每認購一股普通股，參與者將獲得一份認股權證，持有人可在 2026 年 7 月 16 日（認股權證到期日）之前以 1.50 美元的價格認購一股新普通股，預計將帶來額外的總收入約為 1,056 萬美元。</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>此次發行由 Tiziana 的首席執行官 Ivor Elrifi 領導，他購買了 2,400,000 股普通股，使其總持股達到 2,757,848 股。Tiziana 的執行董事長兼創始人 Gabriele Cerrone 先生通過 Panetta Partners Ltd（他有實益權益的實體）購買了 1,600,000 股普通股，使其總持股達到 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>此次發行的收益使公司能夠完成其第二階段 na-SPMS 和 MSA 臨牀試驗，並在這兩個試驗中獲得頂線數據結果。</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>上述證券是根據美國證券交易委員會（“SEC”）於 2025 年 3 月 24 日提交的 F-3 表格的架構註冊聲明（文件編號：333-286064）進行發行和銷售的，包括基礎招股説明書，並於 2025 年 3 月 27 日獲得有效。此次發行僅通過招股説明書補充及隨附的基礎招股説明書進行，可能還會進一步補充任何自由書面招股説明書和/或定價補充，具體取決於公司可能向 SEC 提交的文件。與此次發行相關的最終招股説明書補充已提交給 SEC，並可在 SEC 網站上獲取。</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>本新聞稿不構成出售要約或購買要約的徵求，也不應在任何州或司法管轄區進行這些證券的銷售，若該等要約、徵求或銷售在該州或司法管轄區的證券法下是非法的，須在註冊或資格之前進行。</p>
</div><p><strong>About Foralumab</strong></p>
<div class="lb-trans"><p><strong>關於 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 是一種完全人源的抗 CD3 單克隆抗體，是一種生物製劑候選藥物，已顯示在鼻用給藥時刺激 T 調節細胞。目前，已有 14 名非活動性繼發性進展性多發性硬化症（na-SPMS）患者在開放標籤的中型擴展使用（EA）項目（NCT06802328）中接受了給藥，所有患者在 6 個月內均顯示出疾病的改善或穩定。此外，鼻用 foralumab 目前正在針對非活動性繼發性進展性多發性硬化症進行第二階段 a 期隨機、雙盲、安慰劑對照、多中心、劑量範圍試驗（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 是目前唯一在臨牀開發中的完全人源抗 CD3 單克隆抗體（mAb）。鼻用 foralumab 的免疫調節代表了治療神經炎症和神經退行性人類疾病的新途徑。[1],[2]</p>
</div><p><strong>About Tiziana Life Sciences</strong></p>
<div class="lb-trans"><p><strong>關於 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 是一家臨牀階段的生物製藥公司，開發突破性療法，利用變革性的藥物遞送技術實現免疫療法的替代途徑。Tiziana 創新的鼻用方法有潛力在療效、安全性和耐受性方面提供比靜脈（IV）給藥更好的改善。Tiziana 的主要候選藥物鼻用 foralumab 是目前唯一在臨牀開發中的完全人源抗 CD3 mAb，已在迄今為止的研究中顯示出良好的安全性和臨牀反應。Tiziana 的免疫療法替代途徑技術已獲得專利，多個申請正在待審，預計將允許廣泛的產品線應用。</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>有關 Tiziana 及其創新療法管線的更多信息，請訪問 www.tizianalifesciences.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性聲明</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>本新聞稿中的聲明可能是根據《1933 年美國證券法》第 27A 條和《1934 年美國證券交易法》第 21E 條的定義，屬於 “前瞻性聲明”，涉及可能導致實際結果與預期或預測的前瞻性聲明存在重大差異的風險和不確定性。這些前瞻性聲明不是歷史事實，而是基於公司對其行業的當前預期、估計和預測；其信念；以及假設。諸如 “預期”、“期望”、“打算”、“計劃”、“相信”、“尋求”、“估計” 等詞語旨在識別前瞻性聲明。這些前瞻性聲明反映了 Tiziana 管理層的當前信念和期望，包括關於發行結束的聲明。這些聲明並不保證未來的表現，並且受到已知和未知的風險、不確定性和其他因素的影響，其中一些超出了公司的控制範圍，難以預測，可能導致實際結果與前瞻性聲明中表達或預測的結果存在重大差異。公司提醒證券持有者和潛在證券持有者不要對這些前瞻性聲明過於依賴，這些聲明僅反映公司在本公告日期的觀點。實際結果可能因各種重要因素而與這些前瞻性聲明所指示的結果存在重大差異，包括：與市場條件相關的不確定性以及在 Tiziana 截至 2024 年 12 月 31 日的 20-F 表年度報告中更全面描述的其他因素，以及不時向 SEC 提交的其他定期報告。本公告中所作的前瞻性聲明僅與聲明作出之日的事件相關。除法律或任何適當監管機構要求外，公司不承擔公開發布任何修訂或更新這些前瞻性聲明以反映公告日期之後發生的事件、情況或意外事件的義務。</p>
</div><p><strong>For further inquiries:</strong></p>
<div class="lb-trans"><p><strong>如需進一步諮詢：</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，業務發展與投資者關係</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>電子郵件：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>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZeU56TTJNQ00zTXpZMU1ERTBJekl4TWpNNE9EVT0" alt="" original-src="https://www.globenewswire.com/newsroom/ti?nf=OTYyNzM2MCM3MzY1MDE0IzIxMjM4ODU="/></p>
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Tiziana Life Sciences 宣佈超額認購的 880 萬美元普通股註冊直接發行已完成 | TLSA 股票新聞