Tiziana shows PET brain inflammation drop in MSA

Tiziana Life Sciences reported early brain imaging results from the first two Multiple System Atrophy (MSA) patients treated with its intranasal anti-CD3 antibody foralumab in an ongoing Phase 2 trial.

Rhea-AI Filing Summary

Tiziana Life Sciences reported early brain imaging results from the first two Multiple System Atrophy (MSA) patients treated with its intranasal anti-CD3 antibody foralumab in an ongoing Phase 2 trial. PET scans showed up to approximately 35% reduction in standardized uptake value and about 24% reduction in standardized uptake value ratio in affected brain regions, including the basal ganglia and cerebellar white matter.

The company notes this is the third indication where intranasal foralumab has shown marked reduction in inflammation on PET scans, alongside previous findings in non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease. Tiziana plans to continue enrolling MSA patients to further evaluate foralumab’s potential to reduce neuroinflammation.

Insights

Biotech clinical-trials analyst

Early PET data in first two MSA patients show reduced brain inflammation but remain very preliminary.

Tiziana Life Sciences released initial PET imaging data from two Multiple System Atrophy patients in a Phase 2 study of intranasal foralumab. Investigators observed up to about 35% reduction in standardized uptake value and around 24% reduction in SUV ratio in disease-relevant brain regions.

These imaging changes are consistent with the drug’s proposed anti-inflammatory mechanism and align with prior PET findings in non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease. However, the current dataset covers only two patients, so it mainly serves as biological proof-of-activity rather than evidence of clinical benefit.

The company is also dosing patients with non-active secondary progressive multiple sclerosis in an Expanded Access program and running a Phase 2a randomized trial, indicating a broader development strategy around intranasal foralumab. Subsequent data from larger patient groups and controlled settings, as described for the ongoing Phase 2a trial, will be needed to understand how these PET changes translate into clinical outcomes.

Key Figures

SUV reduction: up to ~35% SUVR reduction: approximately 24% Expanded Access patients: 14 patients +2 more

5 metrics

SUV reduction up to ~35% Reduction in standardized uptake value in affected brain regions in first two MSA patients

SUVR reduction approximately 24% Reduction in standardized uptake value ratio in affected brain regions in first two MSA patients

Expanded Access patients 14 patients Non-active secondary progressive multiple sclerosis patients dosed in an open-label Expanded Access program

Follow-up period 6 months Improvement or stability of disease seen within six months in na-SPMS Expanded Access program

Phase 2a trial design randomized, double-blind, placebo-controlled Ongoing intranasal foralumab trial in non-active secondary progressive multiple sclerosis

Key Terms

Multiple System Atrophy, standardized uptake value, standardized uptake value ratio, non-active secondary progressive multiple sclerosis, +2 more

6 terms

Multiple System Atrophy medical

"the first two patients with Multiple System Atrophy (MSA) in the Phase 2 clinical trial"

A progressive neurological disorder that damages multiple areas of the nervous system, causing problems with movement, balance and involuntary functions like blood pressure and bladder control; think of it as critical wiring in the body slowly failing. Investors care because the condition defines the size and urgency of the market for treatments, influences clinical trial difficulty and regulatory risk, and can lead to high per-patient pricing but also greater development uncertainty.

standardized uptake value medical

"observed up to approximately 35% reduction in standardized uptake value (SUV)"

Standardized uptake value (SUV) is a single-number measure from a PET scan that shows how much of a radioactive tracer a specific area of the body absorbs, adjusted for the amount of tracer given and the patient’s size. Think of it like a brightness setting on a heat map that is normalized so different scans can be compared; higher or changing SUV values can indicate disease activity, treatment response, or drug effect, making it a useful metric for investors assessing clinical results or healthcare technologies.

standardized uptake value ratio medical

"approximately 24% reduction in standardized uptake value ratio (SUVR)"

A standardized uptake value ratio (SUVr) is a number from a PET scan that compares how much of a radioactive tracer collects in a target area (like a tumor or brain region) versus a reference area of the body. Think of it as measuring how much brighter one spot is compared with normal background lighting. Investors care because SUVr provides an objective, repeatable signal of disease activity or drug effect, and changes in SUVr often drive clinical decisions, trial endpoints, regulatory reviews and market adoption for diagnostics and therapies.

non-active secondary progressive multiple sclerosis medical

"14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed"

Expanded Access (EA) Program regulatory

"dosed in an open-label intermediate sized Expanded Access (EA) Program"

anti-CD3 monoclonal antibody medical

"intranasal foralumab, a fully human, anti-CD3 monoclonal antibody"

A lab-made antibody engineered to attach to CD3, a protein found on T cells, so it can change how those immune cells behave. Investors care because these drugs can act like a targeted brake on an overactive immune system—useful for autoimmune disease, transplant rejection or as part of cancer therapies—but they also carry clinical trial, safety and regulatory risks that determine commercial success.

FAQ

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What did Tiziana Life Sciences (TLSA) report in its May 2026 6-K?

Tiziana Life Sciences reported early PET imaging results from the first two Multiple System Atrophy patients treated with intranasal foralumab in a Phase 2 trial. Scans showed reduced inflammatory activity in key brain regions, supporting the drug’s proposed anti-inflammatory mechanism in this rare neurodegenerative disease.

What brain inflammation reductions were seen with intranasal foralumab in MSA patients?

Investigators observed up to approximately 35% reduction in standardized uptake value and about 24% reduction in standardized uptake value ratio in affected brain regions. These reductions occurred in areas such as the basal ganglia and cerebellar white matter that are known to be involved in Multiple System Atrophy.

Why are the intranasal foralumab PET findings important for Tiziana Life Sciences (TLSA)?

The findings provide quantitative imaging evidence that intranasal foralumab reduces neuroinflammatory activity in Multiple System Atrophy. This is the third indication showing marked PET inflammation reductions, complementing prior data in non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease and supporting a broader neuroinflammation-focused strategy.

What other clinical experience with intranasal foralumab does Tiziana (TLSA) highlight?

Tiziana notes that 14 patients with non-active secondary progressive multiple sclerosis have been dosed in an open-label Expanded Access program, with improvement or stability of disease seen within six months. Intranasal foralumab is also being tested in a Phase 2a randomized, double-blind, placebo-controlled trial in that population.

What is Multiple System Atrophy and why is it a focus for Tiziana Life Sciences?

Multiple System Atrophy is a rare, progressive neurodegenerative disorder marked by autonomic dysfunction, parkinsonism, and cerebellar ataxia. There are currently no approved disease-modifying treatments. Tiziana is exploring intranasal foralumab as a way to reduce neuroinflammation that contributes to MSA’s underlying disease processes.

How does intranasal foralumab work according to Tiziana Life Sciences (TLSA)?

Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system via mucosal tolerance mechanisms. Tiziana states this approach aims to reduce inflammation without the systemic toxicities associated with traditional anti-CD3 therapies, potentially improving safety and tolerability for chronic neuroinflammatory conditions.

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Accepted by SEC EDGAR 05/14/2026 - 07:00 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

May 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 May 14, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, initial quantitative PET imaging results from the first two patients with Multiple System Atrophy (MSA) in the Phase 2 clinical trial treated with intranasal foralumab. This is the third indication that has shown a marked reduction in inflammation on PET scans following treatment with intranasal foralumab.

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: May 14, 2026	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 May 14, 2026

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Exhibit 99.1

Tiziana Reports Reduced Brain Inflammation in Multiple System Atrophy Patients Treated with Intranasal Foralumab

● Foralumab is the first intranasal immune modulator in clinical trials for patients with Multiple System Atrophy

BOSTON, MA, May 14, 2026 – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces initial quantitative PET imaging results from the first two patients with Multiple System Atrophy (MSA) in the Phase 2 clinical trial treated with intranasal foralumab. This is the third indication that has shown a marked reduction in inflammation on PET scans following treatment with intranasal foralumab.

Quantitative analysis of PET scans demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment with intranasal foralumab. In the first two treated patients, investigators observed up to approximately 35% reduction in standardized uptake value (SUV) and approximately 24% reduction in standardized uptake value ratio (SUVR) in affected areas of the brain.

Figure 1. 2nd MSA patient on nasal foralumab

Significant reduction in basal ganglia and thalamic uptake following nasal foralumab

Figure 2. 2nd MSA patient on nasal foralumab

Marked reduction in Cerebellar white matter uptake following nasal foralumab

Figure 3. 1^st MSA patient on nasal foralumab

Marked reduction in basal ganglia uptake following nasal foralumab

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The reductions were observed in regions including the basal ganglia and cerebellar white matter, which are known to be involved in the neurodegenerative processes underlying MSA.

“These early PET imaging findings provide quantitative evidence supporting the biological activity of intranasal foralumab in patients with MSA,” said Tarun Singhal, MBBS, M.D., Founding Director, NeuroPET Program, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Mass General Brigham. “In the first two MSA patients we evaluated, we observed up to approximately 35% reduction in standardized uptake value and a 24% reduction in SUV ratio in the affected brain regions. We focused on the most severely affected, clinically relevant areas known to be involved in MSA. Based on the available data, these appear to be robust quantitative findings and are comparable to results previously observed in patients with multiple sclerosis treated with intranasal foralumab, although there are methodological differences.”

“This is the third indication that we have seen a marked reduction in inflammation on PET scans following treatment with intranasal foralumab,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “Building on the encouraging results previously reported in non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease, these initial MSA data further highlight the potential of our therapy to meaningfully address neuroinflammation across multiple neurodegenerative conditions with high unmet need.”

PET imaging comparisons conducted before and after treatment demonstrated marked reductions in radiotracer uptake across several disease-relevant brain regions. These findings suggest a reduction in neuroinflammatory activity following administration of intranasal foralumab.

Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system through mucosal tolerance mechanisms and reduce inflammation without the systemic toxicities associated with traditional anti-CD3 therapies.

MSA is a rare, progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar ataxia. There are currently no approved disease-modifying treatments for the condition.

Tiziana plans to continue evaluating intranasal foralumab in additional patients to further validate these early findings and better characterize the therapy’s potential to reduce neuroinflammation in MSA.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 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],[3]

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

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

[3] https://www.neurology.org/doi/10.1212/NXI.0000000000200543

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About Tiziana Life Sciences

Tiziana is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal 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 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 Tiziana’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 Tiziana’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. Tiziana cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of Tiziana 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 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. Tiziana 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

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Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED MAY 14, 2026 17.7 KB