Tiziana Life Sciences (TLSA) begins Phase 2 intranasal foralumab Alzheimer’s study

Rhea-AI Filing Summary

Tiziana Life Sciences LTD reports that enrollment has begun in its Phase 2 randomized, placebo-controlled clinical trial in patients with early Alzheimer’s disease. The study is testing intranasal foralumab, an experimental therapy, both on its own and together with FDA‑approved anti‑amyloid drugs lecanemab or donanemab.

The company plans to dose the first patient next week, indicating the trial is moving from screening into active treatment. Baseline clinical assessments, cognitive testing, TSPO‑PET brain imaging, and fluid biomarker measurements have already been completed for the first participants, laying the groundwork to track how patients respond over time.

Insights

Biotech clinical-trials analyst

Tiziana starts a Phase 2 early Alzheimer’s trial of intranasal foralumab.

Tiziana Life Sciences has initiated enrollment in a Phase 2 randomized, placebo-controlled trial in early Alzheimer’s disease using intranasal foralumab. The design includes testing the drug both as monotherapy and in combination with approved anti-amyloid therapies lecanemab or donanemab, positioning the study to explore potential added benefit on top of existing standards of care.

Baseline clinical assessments, cognitive testing, TSPO-PET imaging, and fluid biomarkers are already completed for the first participants. Having these measurements at the start allows more precise evaluation of how patients change over time on treatment versus placebo.

Key upcoming steps mentioned are dosing the first patient next week and then continuing enrollment. As the trial progresses, outcomes across cognition, imaging, and biomarker readouts will be central to understanding intranasal foralumab’s potential role in early Alzheimer’s disease.

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)

9^th 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 12, 2025, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, that enrolment has begun in its Phase 2 randomized, placebo-controlled early Alzheimer’s clinical trial and plans to dose the first patient next week. The Phase 2 clinical trial will evaluate intranasal foralumab both as monotherapy and in combination with an FDA approved anti-amyloid therapy, lecanemab or donanemab, in patients with early Alzheimer’s disease (AD). Baseline clinical assessments, cognitive testing, TSPO-PET imaging, and fluid biomarkers have been completed in the first participants screened in the trial.

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 12, 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 12, 2025

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FAQ

What did Tiziana Life Sciences (TLSA) disclose in this report?

Tiziana Life Sciences disclosed that enrolment has begun in its Phase 2 randomized, placebo-controlled early Alzheimer’s clinical trial of intranasal foralumab and that it plans to dose the first patient next week.

What is being tested in Tiziana Life Sciences’ Phase 2 Alzheimer’s trial?

The Phase 2 trial evaluates intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies lecanemab or donanemab in patients with early Alzheimer’s disease.

What progress has been made so far in the TLSA Phase 2 Alzheimer’s study?

Baseline clinical assessments, cognitive testing, TSPO-PET imaging, and fluid biomarker evaluations have been completed in the first participants screened in the trial, preparing for treatment and follow-up.

How is intranasal foralumab being used in the Tiziana Alzheimer’s trial?

Intranasal foralumab is being used in two ways: as a standalone therapy and in combination with lecanemab or donanemab, allowing comparison of monotherapy versus add-on treatment in early Alzheimer’s disease.

Is Tiziana Life Sciences’ announcement part of an official SEC submission?

Yes. The information is included in a Report on Form 6-K, with the related press release furnished as Exhibit 99.1, and is described as being furnished rather than filed for certain Securities Exchange Act purposes.

Who signed this Tiziana Life Sciences report and in what capacity?

The report was signed on behalf of Tiziana Life Sciences LTD by Keeren Shah, who is identified as the company’s Chief Financial Officer.