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Tiziana Life Sciences (Nasdaq: TLSA) reports promising Long COVID preclinical results

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(Neutral)
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Form Type
6-K

Rhea-AI Filing Summary

Tiziana Life Sciences Ltd filed a Form 6-K announcing positive preclinical results for its lead candidate, intranasal foralumab, in a Long COVID mouse model. The study showed that nasal anti-CD3 treatment reduced neuroinflammation, increased regulatory T cells in the brain, restored hippocampal neurogenesis, and improved short‑term memory.

The work, led by researchers at Yale and Brigham and Women’s/Harvard, used a mild respiratory SARS‑CoV‑2 model mimicking Long COVID without direct brain infection and included human observational data showing lower circulating Tregs in Long COVID patients. Tiziana highlights these findings as mechanistic support for intranasal foralumab, which has already shown favorable safety and signs of clinical benefit in an expanded access program and is being tested in a Phase 2a trial in non‑active secondary progressive multiple sclerosis.

Positive

  • None.

Negative

  • None.
Expanded Access patients 14 patients Non-active secondary progressive multiple sclerosis Expanded Access Program
Observation period 6 months Improvement or stability seen within 6 months in Expanded Access patients
Expanded Access trial ID NCT06802328 Intermediate sized Expanded Access Program in na-SPMS
Phase 2a trial ID NCT06292923 Phase 2a trial of intranasal foralumab in non-active secondary progressive multiple sclerosis
regulatory T cells (Tregs) medical
"boosts regulatory T cells (Tregs) in the brain, restores hippocampal"
Regulatory T cells (Tregs) are a type of immune cell that quiets or controls other immune responses to prevent excessive inflammation or self‑attack. For investors, Tregs matter because drugs that increase or block their activity can shift a treatment’s effectiveness and safety for autoimmune disease, transplant tolerance, or cancer immunotherapy; think of them as the immune system’s thermostat that affects a drug’s potential market and risk profile.
microglia medical
"reprogrammed microglia from a pro-inflammatory to a regulatory phenotype"
Microglia are the brain’s resident immune cells that act like on-site janitors and security guards: they clear damaged cells and debris, patrol for threats, and coordinate local repair. For investors, microglia matter because they are a major target and biomarker in drug development for neurological and psychiatric conditions; therapies that modulate microglial activity can drive clinical trial outcomes, regulatory decisions, and the commercial value of biotech investments.
Expanded Access Program regulatory
"have been dosed in an open-label intermediate sized Expanded Access (EA) Program"
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.
non-active secondary progressive multiple sclerosis medical
"ongoing programs in non active secondary progressive multiple sclerosis, MSA, Alzheimer’s disease"
bioRxiv preprint technical
"positive preclinical data in a bioRxiv preprint. The study, titled"
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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

 

April 2026

 

 

 

Commission File Number:  001-38723

 

 

 

Tiziana Life Sciences LTD

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

9th 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 April 16, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, the publication of positive preclinical data in a bioRxiv preprint. The study, titled “Intranasal Anti-CD3 Antibody Treatment Attenuates Post COVID Neuroinflammation and Enhances Hippocampal Neurogenesis and Cognitive Function in Mice,” demonstrates that nasal anti-CD3 treatment significantly reduces neuroinflammation, boosts regulatory T cells (Tregs) in the brain, restores hippocampal neurogenesis, and improves short-term memory in a model of Long COVID.

 

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: April 16, 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 April 16, 2026

 

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Exhibit 99.1

 

 

Tiziana Life Sciences Announces Publication of Positive Data Demonstrating Intranasal Anti-CD3 Antibody Attenuates Long COVID Neuroinflammation and Improves Cognitive Function

 

Data from independent academic collaborators published on bioRxiv support the therapeutic potential of the Company’s lead candidate, intranasal foralumab, for Long COVID associated “brain fog”.

 

BOSTON, MA, April 16, 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 the publication of positive preclinical data in a bioRxiv preprint. The study, titled “Intranasal Anti-CD3 Antibody Treatment Attenuates Post COVID Neuroinflammation and Enhances Hippocampal Neurogenesis and Cognitive Function in Mice,” demonstrates that nasal anti-CD3 treatment significantly reduces neuroinflammation, boosts regulatory T cells (Tregs) in the brain, restores hippocampal neurogenesis, and improves short-term memory in a model of Long COVID.

 

Conducted by leading researchers including co-corresponding authors Akiko Iwasaki, Ph.D. (Yale University) and Howard L. Weiner, M.D. (Brigham and Women’s Hospital, Harvard Medical School), the study used a respiratory restricted mild SARS-CoV-2 mouse model that recapitulates key neurological features of Long COVID without direct brain infection. Nasal administration of anti-CD3 monoclonal antibody either shortly after infection or in the chronic phase increased brain FoxP3+ IL-10+ Tregs, reprogrammed microglia from a pro-inflammatory to a regulatory phenotype, reduced gliosis (astrocytes and microglia) in white matter and hippocampus, normalized CCL11 levels, restored neurogenesis, and rescued cognitive deficits. Human observational data in the study further showed that Long COVID patients with neurological symptoms exhibit lower circulating Treg levels, reinforcing the translational relevance.

 

The full preprint is available on bioRxiv and has not yet been peer-reviewed.

Link here: https://www.biorxiv.org/content/10.64898/2026.04.07.716934v1

 

These findings show that nasal anti-CD3 can potently induce regulatory T cells that cross into the brain and dampen persistent neuroinflammation triggered by even mild respiratory viral infection. By reprogramming microglia, reducing harmful chemokines like CCL11, and restoring the hippocampal neurogenic niche, this approach offers a promising, non-invasive strategy to address the cognitive impairment often called ‘brain fog’ that continues to affect millions of Long COVID patients worldwide.

 

 

 

Dr. Howard L. Weiner, co-corresponding author, Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, and Chair of the Scientific Advisory Board of Tiziana Life Sciences, added: “This study builds on our extensive work with nasal anti-CD3 and highlights its ability to modulate the immune system at the mucosal surface to promote central nervous system repair. The broad therapeutic window, effective both early and late after infection, and the lack of impact on antiviral immunity make intranasal foralumab an exciting candidate for clinical development in post-viral neuroinflammatory conditions.”

 

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “We are thrilled to see these robust preclinical data in BioRxiv, further validating the broad therapeutic potential of our intranasal foralumab platform. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development, and these results directly support the mechanistic foundation for our ongoing programs in non active secondary progressive multiple sclerosis, MSA, Alzheimer’s disease, and ALS.”

 

Tiziana’s intranasal foralumab has previously demonstrated favorable safety and signals of clinical benefit in an expanded access program in non-active secondary progressive multiple sclerosis, with reductions in microglial activation observed via PET imaging.

 

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, 2024, 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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FAQ

What did Tiziana Life Sciences (TLSA) disclose in this Form 6-K?

Tiziana Life Sciences reported positive preclinical data for intranasal foralumab in a Long COVID mouse model. The study showed reduced neuroinflammation, increased brain regulatory T cells, restored hippocampal neurogenesis, and improved short-term memory, supporting its broader development in neuroinflammatory and neurodegenerative conditions.

How does intranasal anti-CD3 therapy work in Tiziana’s Long COVID study?

The intranasal anti-CD3 antibody increased brain FoxP3+ IL-10+ regulatory T cells and reprogrammed microglia from pro-inflammatory to regulatory phenotypes. It reduced gliosis, normalized chemokine CCL11 levels, restored neurogenesis, and rescued cognitive deficits in a mouse model that mimics Long COVID neurological features.

What is the clinical status of intranasal foralumab at Tiziana Life Sciences (TLSA)?

Intranasal foralumab has been used in an open-label expanded access program in non-active secondary progressive multiple sclerosis and showed favorable safety with disease stability or improvement at six months. It is also being tested in a Phase 2a randomized, placebo-controlled trial in the same patient population.

Why is intranasal foralumab considered unique in Tiziana’s pipeline?

Foralumab is described as the only fully human anti-CD3 monoclonal antibody currently in clinical development. Delivered intranasally, it aims to modulate immune responses via mucosal surfaces, potentially improving safety, tolerability, and efficacy versus intravenous delivery across several neuroinflammatory and neurodegenerative indications.

Has the Long COVID intranasal anti-CD3 study announced by TLSA been peer-reviewed?

The Long COVID study has been posted as a preprint on bioRxiv and has not yet undergone peer review. Preprints allow rapid scientific communication, but their findings should be interpreted cautiously until validated through formal peer-review and, eventually, clinical trial results.

Filing Exhibits & Attachments

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