Tiziana Life Sciences Ltd 6-K, filed Dec 17, 2025
Tiziana Life Sciences Ltd (TLSA)
About this 6-K
Tiziana Life Sciences Ltd filed this 6-K on December 17, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
December 2025
Commission File Number: 001-38723
Tiziana Life Sciences LTD
(Exact Name of Registrant as Specified in Its Charter)
9th Floor
107 Cheapside
London
EC2V 6DN
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On December 17, 2025, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, that the first patient has been dosed with intranasal foralumab in its Phase 2 randomized, placebo-controlled clinical trial in patients with early Alzheimer’s disease (AD). This milestone follows the Company’s December 12, 2025 announcement that enrolment had begun and the first patient was expected to be dosed imminently. The Phase 2 trial evaluates intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab (Leqembi®) or donanemab, in patients with early AD.
The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| TIZIANA LIFE SCIENCES LTD | |||
| Date: December 17, 2025 | By: | /s/ Keeren Shah | |
| Name: | Keeren Shah | ||
| Title: | Chief Financial Officer | ||
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EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Tiziana Life Sciences LTD Press Release, dated December 17, 2025 |
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Exhibit 99.1
Tiziana Life Sciences Doses First Patient in Phase 2 Alzheimer’s Clinical Trial
| ● | First Patient Dosed with Intranasal Foralumab in Randomized, Placebo-Controlled Phase 2 Trial |
| ● | Builds on Recent Evidence of Persistent Neuroinflammation in Alzheimer’s Patients Treated with Anti-Amyloid Therapies |
BOSTON, MA, December 17, 2025 – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces that the first patient has been dosed with intranasal foralumab in its Phase 2 randomized, placebo-controlled clinical trial in patients with early Alzheimer’s disease (AD). This milestone follows the Company’s December 12, 2025 announcement that enrolment had begun and the first patient was expected to be dosed imminently. The Phase 2 trial evaluates intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab (Leqembi®) or donanemab, in patients with early AD.
The trial is supported by TSPO-PET imaging data demonstrating persistent and widespread microglial activation—a hallmark of neuroinflammation—in Alzheimer’s patients, even after amyloid plaque reduction with lecanemab. This evidence underscores the need for therapies targeting residual neuroinflammation, which intranasal foralumab is designed to address by modulating immune responses and calming activated microglia.
Gabriele Cerrone, Chairman & Founder of Tiziana Life Sciences stated, “Dosing the first patient marks a pivotal moment in exploring a novel immunomodulatory approach to Alzheimer’s disease. Our prior TSPO-PET data in multiple sclerosis patients showed that intranasal foralumab can significantly reduce microglial activation, and we are eager to evaluate its potential impact—alone or combined with anti-amyloid treatments—in slowing disease progression in early AD.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented, “We are thrilled to have rapidly advanced from enrolment to first patient dosing in this important Phase 2 trial. This achievement reflects the dedication of our team and clinical sites, as well as the urgent need for new treatment strategies that go beyond amyloid clearance to target chronic neuroinflammation. We look forward to continuing enrolment and generating data that could redefine disease modification in Alzheimer’s disease.”
About the Phase 2 Trial
The Phase 2 study is a randomized, placebo-controlled trial assessing the safety, tolerability, and potential efficacy of intranasal foralumab as monotherapy and in combination with lecanemab or donanemab in early/mild Alzheimer’s disease. Primary endpoints include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers. Interim data are anticipated in 2026, with results intended to guide future development and potentially establish neuroimmune modulation as a key pillar in AD therapy.
About 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 (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).
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]
About Tiziana Life Sciences
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 intranasal 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.
For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.
Forward-Looking Statements
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. 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 Securities and Exchange Commission. 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.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
| [1] | https://www.pnas.org/doi/10.1073/pnas.2220272120 | |
| [2] | https://www.pnas.org/doi/10.1073/pnas.2309221120 |