Tiziana (TLSA) FDA IND Approval for Phase 2a Foralumab in MSA

Tiziana Life Sciences reported that the U.S. Food and Drug Administration has approved an Investigational New Drug (IND) application for a Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA).

Rhea-AI Filing Summary

Tiziana Life Sciences reported that the U.S. Food and Drug Administration has approved an Investigational New Drug (IND) application for a Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA).

The company states MSA is an unmet medical need with no FDA-approved therapies and is described as an orphan-designated disease. The announcement is furnished as Exhibit 99.1 to this Form 6-K.

Positive

• FDA-approved IND for a Phase 2a clinical trial of intranasal foralumab
• Program targets Multiple System Atrophy (MSA), described as an unmet medical need
• MSA is described as an orphan-designated disease in the filing

Negative

• None.

Insights

Financial Analyst

TL;DR: IND approval is a clinical milestone that can increase program visibility and potential valuation, while clinical risk remains.

FDA acceptance of an IND for a Phase 2a study is a tangible development-stage milestone that formally enables U.S. clinical testing of intranasal foralumab in Multiple System Atrophy. For investors, this advances a pipeline program from preclinical/early-clinical planning toward efficacy assessment, which can affect program valuation and partnership interest. The filing highlights the orphan nature of MSA and the absence of FDA-approved therapies, both factors that can influence regulatory incentives and commercial potential if clinical results are positive. The company provided the announcement as an exhibit; financial impacts and trial timelines are not included in the filing.

Clinical Development Specialist

TL;DR: IND clearance allows progression to Phase 2a testing in the U.S., marking an important operational step for development of intranasal foralumab.

Approval of an IND for a Phase 2a study indicates the FDA reviewed the submitted preclinical and clinical safety package and permitted the proposed protocol to proceed in patients. Targeting Multiple System Atrophy, a condition the filing describes as orphan-designated with no approved treatments, focuses the program on a high-unmet-need population where safety and early efficacy signals in Phase 2a could be especially informative. The filing does not provide protocol details, endpoints, enrollment size, or timeline, so the operational scope of the Phase 2a study is not available from this document.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Tiziana (TLSA) announce in this Form 6-K?

The company announced that the FDA approved an IND for a Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy; the announcement is furnished as Exhibit 99.1.

What clinical stage is foralumab for MSA according to the filing?

The filing states foralumab is moving into a Phase 2a clinical trial with an FDA-approved IND.

Does the filing say whether there are approved treatments for MSA?

Yes. The filing states there are currently no FDA-approved therapies to treat Multiple System Atrophy.

Is Multiple System Atrophy described as an orphan disease in the filing?

Yes. The filing refers to MSA as an orphan-designated disease.

Where can I find the company announcement referenced in the Form 6-K?

The company furnished the announcement as Exhibit 99.1 to the Form 6-K.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 08/11/2025 - 09:00 AM EDT Learn about SEC filing dates

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

August 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 August 11, 2025, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, that the U.S. Food & Drug Administration (FDA) have approved the IND for its Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA). Multiple System Atrophy is an unmet medical need as there are currently no FDA approved therapies to treat this life limiting, orphan designated disease.

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: August 11, 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 August 11, 2025

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