Tiziana completes Phase 2a MS trial treatment phase

Tiziana Life Sciences Ltd (TLSA) reports that the last patient has completed the last visit in its Phase 2a INFORM-MS clinical trial of intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

Rhea-AI Filing Summary

Tiziana Life Sciences Ltd (TLSA) reports that the last patient has completed the last visit in its Phase 2a INFORM-MS clinical trial of intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

The randomized, double-blind, placebo-controlled study enrolled 48 patients across three cohorts at multiple U.S. sites and evaluated two doses of intranasal foralumab versus placebo over 12 weeks. The primary endpoint is change in microglial activation measured by PET imaging, with secondary endpoints including EDSS and MFIS. Tiziana expects to lock the database this week and announce 12-week topline data in October. All participants can enter a six-month open-label extension to receive intranasal foralumab, and 14 na-SPMS patients have already been treated in an Expanded Access Program, where the company reports improvement or stability of disease within six months in all patients.

Key Figures

INFORM-MS enrollment: 48 patients Blinded treatment duration: 12 weeks Open-label extension duration: 6 months +3 more

6 metrics

INFORM-MS enrollment 48 patients Randomized Phase 2a na-SPMS trial across three cohorts at multiple U.S. sites

Blinded treatment duration 12 weeks Treatment period for intranasal foralumab versus placebo in INFORM-MS

Open-label extension duration 6 months Follow-on intranasal foralumab treatment offered to all INFORM-MS participants

Expanded Access patients 14 patients na-SPMS patients dosed with intranasal foralumab in an intermediate-sized Expanded Access Program

Expanded Access 6‑month outcome Improvement or stability in all patients within 6 months Clinical outcomes reported for 14 na-SPMS patients on intranasal foralumab

Topline data timing October Planned announcement of 12-week treatment topline data from INFORM-MS

Key Terms

Secondary Progressive Multiple Sclerosis, intranasal foralumab, microglial activation, positron emission tomography (PET), +2 more

6 terms

Secondary Progressive Multiple Sclerosis medical

"patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS)"

A long-term form of multiple sclerosis that typically begins with episodes of symptoms that come and go, then shifts into a phase of steady worsening without clear recovery—like a car that moves forward in fits and starts and then gradually loses speed for good. It matters to investors because the condition creates a persistent need for new treatments, long-term care services, and medical devices, shaping market size, clinical trial design, regulatory risk, and reimbursement dynamics in the healthcare sector.

intranasal foralumab medical

"Phase 2a clinical trial evaluating intranasal foralumab in patients"

Intranasal foralumab is an experimental antibody medication given as a spray or drops into the nose that aims to change how the immune system behaves rather than attack a virus directly. Investors care because results from trials, safety findings, and regulatory decisions determine whether this approach can become a marketed therapy, affecting a company’s future sales, development costs and competitive position — similar to betting on a new product that could reshape a company’s revenue stream.

microglial activation medical

"primary endpoint focused on change in microglial activation as measured"

Microglial activation is when the brain’s resident immune cells — microglia — switch from a resting, maintenance role into an alert, defensive state, similar to a neighborhood cleanup crew suddenly racing to douse a small fire. For investors, this matters because persistent or excessive activation is a hallmark of many neurological diseases, affects how drugs perform in trials, and can drive regulatory and market reactions to therapies aimed at calming or harnessing this response.

positron emission tomography (PET) medical

"as measured by positron emission tomography (PET) imaging"

Positron emission tomography (PET) is a medical imaging method that uses tiny amounts of radioactive tracer to create detailed pictures of biological activity inside the body, like a camera that highlights where cells are most active. For investors, PET matters because it helps diagnose disease, track how well drugs or treatments are working, and drives demand for scanners, tracer production and clinical trial services—factors that can affect company revenues and regulatory outcomes.

Expanded Access Program medical

"data from the Company’s Expanded Access Program in na-SPMS have shown"

A program that allows patients with serious or life‑threatening conditions to receive an experimental drug or therapy before it is fully approved by regulators, when they cannot join clinical trials. Investors care because expanded access can change a treatment’s market perception, create early real‑world safety or demand signals, and affect regulatory timelines and potential revenue — like a pre‑order system that also reveals how the product performs outside controlled testing.

open-label extension medical

"receive intranasal foralumab in a six-month follow on open-label extension"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

FAQ

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

What milestone did TLSA announce in the INFORM-MS Phase 2a trial?

Tiziana Life Sciences announced that the last patient completed their last visit in the Phase 2a INFORM-MS trial of intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis, marking completion of the blinded 12-week treatment phase for all enrolled participants.

How many patients were enrolled in Tiziana Life Sciences’ INFORM-MS trial for TLSA?

The INFORM-MS Phase 2a trial enrolled 48 patients with non-active Secondary Progressive Multiple Sclerosis across three cohorts at multiple leading U.S. clinical sites, testing two doses of intranasal foralumab against placebo over a 12-week treatment period.

What is the primary endpoint of the INFORM-MS Phase 2a trial for TLSA?

The primary endpoint of the INFORM-MS Phase 2a trial is the change in microglial activation as measured by positron emission tomography (PET) imaging, with secondary clinical endpoints including the Expanded Disability Status Scale (EDSS) and the Modified Fatigue Impact Scale (MFIS).

When does Tiziana Life Sciences (TLSA) expect INFORM-MS topline data?

Tiziana Life Sciences expects to lock the INFORM-MS database this week and to announce 12-week treatment topline data in October, following completion of the last patient’s last visit in the blinded Phase 2a trial.

What follow-on treatment is available to INFORM-MS trial participants in TLSA’s study?

After completing the blinded phase, all INFORM-MS participants, including those initially on placebo, may receive intranasal foralumab in a six-month open-label extension designed to generate longer term safety and efficacy data in na-SPMS.

What results has Tiziana reported from its Expanded Access Program in na-SPMS?

Tiziana reports that 14 na-SPMS patients treated with intranasal foralumab in an open-label Expanded Access Program showed either improvement or stability of disease within 6 months, based on clinical outcomes over extended treatment duration.

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

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Available on EDGAR 09/21/2026 - 07:00 AM Accepted by SEC EDGAR 09/21/2026 - 07:00 AM 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

September 2026

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 September 21, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, that the last patient has completed their last visit in the Company’s Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

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.

1

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: September 21, 2026	By:	/s/ Keeren Shah
		Name:	Keeren Shah
		Title:	Chief Financial Officer

2

EXHIBIT INDEX

Exhibit No.		Description
99.1		Tiziana Life Sciences LTD Press Release, dated September 21, 2026

3

Exhibit 99.1

Tiziana Announces Last Patient Completes Last Visit in Phase 2a INFORM-MS Trial of Intranasal Foralumab

BOSTON, MA, September 21, 2026 – 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, today announced that the last patient has completed their last visit in the Company’s Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

The randomized, double-blind, placebo-controlled Phase 2a trial, known as INFORM-MS (NCT06292923), enrolled a total of 48 patients across three cohorts at multiple leading U.S. clinical sites. The study is evaluating the safety, tolerability, and efficacy of two doses of intranasal foralumab versus placebo over a 12-week treatment period, with the primary endpoint focused on change in microglial activation as measured by positron emission tomography (PET) imaging, along with secondary clinical endpoints including the Expanded Disability Status Scale (EDSS) and the Modified Fatigue Impact Scale (MFIS). Tiziana expects to lock the database this week, and announce 12-week treatment topline data in October.

Following completion of the blinded phase, all participants, including those who initially received placebo, have the opportunity to receive intranasal foralumab in a six-month follow on open-label extension (OLE). The OLE is designed to generate longer term safety and efficacy data. Encouragingly, data from the Company’s Expanded Access Program in na-SPMS have shown that most patients treated with intranasal foralumab either stabilized or improved in clinical outcomes over an extended treatment duration.

“I congratulate the entire Tiziana team, our clinical investigators, study sites, and most importantly the patients and their families who made this milestone possible,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “Completing the last patient last visit in our Phase 2a INFORM-MS trial is a significant achievement. The dedication and hard work of everyone involved have brought us to this important point in the development of intranasal foralumab for patients living with na-SPMS, a condition with unmet medical need. We look forward to unblinding and presenting the topline data next month.”

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), as well as additional Phase 2 trials in AD and MSA.

Intranasal 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]

[1]	https://www.pnas.org/doi/10.1073/pnas.2220272120
[2]	https://www.pnas.org/doi/10.1073/pnas.2309221120

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

Statements in this press release may be “forward-looking statements” 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, 2025, 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.

For further inquiries:

Tiziana Life Sciences Ltd

Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED SEPTEMBER 21, 2026 15.5 KB