Tiziana Life Sciences (TLSA) begins Phase 2 intranasal foralumab AD trial

Rhea-AI Filing Summary

Tiziana Life Sciences LTD reported 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. This milestone comes shortly after enrollment began, when the first patient was expected to be dosed imminently. The Phase 2 study is evaluating intranasal foralumab both as a standalone treatment and in combination with FDA-approved anti-amyloid therapies lecanemab (Leqembi) or donanemab in early Alzheimer’s patients.

Insights

Biotech clinical development analyst

First patient dosing marks tangible progress in Tiziana’s Phase 2 Alzheimer’s trial.

Tiziana Life Sciences has moved its intranasal foralumab program for early Alzheimer’s disease from enrollment to active treatment, with the first patient now dosed in a Phase 2 randomized, placebo-controlled trial. This indicates that trial logistics, such as site activation and patient screening, have advanced to the dosing stage.

The design includes both monotherapy and combination arms with FDA-approved anti-amyloid therapies lecanemab (Leqembi) and donanemab. That structure may help compare intranasal foralumab alone versus its use alongside existing anti-amyloid treatments in early Alzheimer’s patients, as described.

This update is an operational milestone rather than an efficacy or safety readout, so its importance lies in confirming that the Phase 2 study is underway as planned. Subsequent company communications would be needed to understand recruitment progress, interim findings, or any changes to the trial design.

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 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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FAQ

What did Tiziana Life Sciences (TLSA) announce in this update?

Tiziana Life Sciences announced 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.

What is being tested in Tiziana Life Sciences (TLSA) Phase 2 trial?

The Phase 2 trial is testing intranasal foralumab in patients with early Alzheimer’s disease, both as a monotherapy and in combination with FDA-approved anti-amyloid therapies lecanemab (Leqembi) or donanemab.

How advanced is the Tiziana Life Sciences (TLSA) Alzheimers study?

The study is in Phase 2, randomized and placebo-controlled, and has progressed to the point where the first patient has now been dosed with intranasal foralumab.

Which approved Alzheimers drugs are included alongside foralumab in the TLSA trial?

The trial evaluates intranasal foralumab in combination with FDA-approved anti-amyloid therapies lecanemab (Leqembi) and donanemab for patients with early Alzheimers disease.

How does this milestone relate to earlier TLSA trial communications?

This dosing milestone follows an earlier announcement that enrollment had begun and that the first patient was expected to be dosed imminently, showing progress from enrollment to active treatment.