Tiziana Life Sciences (NASDAQ: TLSA) posts positive nasal anti-CD3 data in aging model
Rhea-AI Filing Summary
Tiziana Life Sciences Ltd filed a Form 6-K to share positive preclinical data on its nasal anti-CD3 approach, using intranasal foralumab, as a potential way to address neuroinflammation linked to aging and associated cognitive decline. In a preclinical aging model, nasal anti-CD3 reversed key aspects of brain aging and improved cognition.
The company explains that intranasal foralumab, a fully human anti-CD3 monoclonal antibody, stimulates regulatory T cells to reduce neuroinflammation. Tiziana notes that 14 patients with non-active secondary progressive multiple sclerosis in an expanded access program showed either disease improvement or stability within six months, and intranasal foralumab is also being evaluated in a Phase 2a trial and other neurodegenerative indications.
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Key Figures
Key Terms
intranasal foralumab medical
Expanded Access (EA) Program regulatory
Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial medical
non-active secondary progressive multiple sclerosis medical
monoclonal antibody medical
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 1, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, positive preclinical data highlighting nasal anti-CD3’s potential as a novel approach to address neuroinflammation associated with aging, which contributes to cognitive decline in age-related disorders. In the study, nasal anti-CD3 reversed key aspects of brain aging, and improved cognition.
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 1, 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 April1, 2026 |
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Exhibit 99.1
Tiziana Announces Data Showing Nasal Anti-CD3 Improves Cognition Associated with Aging
BOSTON, MA, April 1, 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 positive preclinical data highlighting nasal anti-CD3’s potential as a novel approach to address neuroinflammation associated with aging, which contributes to cognitive decline in age-related disorders. In the study, nasal anti-CD3 reversed key aspects of brain aging, and improved cognition.
Key study findings:
| ● | Nasal anti-CD3 dampens microglial activation that drives chronic neuroinflammation. This reduction in inflammation, which is strongly linked to cognitive decline, suggests the therapy could help mitigate the inflammatory burden and slow aspects of the aging process. |
| ● | Nasal anti-CD3 enhances neurogenesis in the hippocampus, a region critical for learning and memory and reduces cellular senescence by down regulating inflammatory markers and age-related genes. |
“These preclinical results are highly encouraging and build on our growing body of evidence that nasal foralumab modulates the immune system to reduce neuroinflammation,” said Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital. “By targeting T cells to influence microglial behavior and promote brain repair mechanisms like neurogenesis, nasal anti-CD3 offers a differentiated, non-invasive approach with potential applications in age related cognitive impairment.”
“These aging model findings reinforce the mechanism of action of intranasal foralumab, which stimulates regulatory T cells that reduce neuroinflammation,” said Ivor Elrifi, CEO of Tiziana Life Sciences. “Tiziana continues to advance its clinical programs for intranasal foralumab, including ongoing trials in Non-Active Secondary Progressive Multiple Sclerosis, MSA, ALS, Alzheimer’s disease, and other neurodegenerative indications, while expanding preclinical research into additional areas such as aging.”
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).
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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]
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
| [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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