# EDGAR Filing Document

**Accession Number:** 0001723069
**File Stem:** 0001213900-25-114407
**Filing Date:** 2025-11
**Character Count:** 10160
**Document Hash:** 046f739a9f20ca299da35f2af7a2492f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-114407.hdr.sgml**: 20251125

**ACCESSION NUMBER**: 0001213900-25-114407

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20251125

**FILED AS OF DATE**: 20251125

**DATE AS OF CHANGE**: 20251125

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Tiziana Life Sciences Ltd
- **CENTRAL INDEX KEY:** 0001723069
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** D0
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38723
- **FILM NUMBER:** 251515302

**BUSINESS ADDRESS:**
- **STREET 1:** 3RD FLOOR, 11-12 ST. JAMES'S SQUARE
- **CITY:** LONDON, ENGLAND
- **STATE:** X0
- **ZIP:** SW1Y 4LB
- **BUSINESS PHONE:** 0044(0) 207-495-2379

**MAIL ADDRESS:**
- **STREET 1:** 3RD FLOOR, 11-12 ST. JAMES'S SQUARE
- **CITY:** LONDON, ENGLAND
- **STATE:** X0
- **ZIP:** SW1Y 4LB

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Tiziana Life Sciences plc
- **DATE OF NAME CHANGE:** 20171116

**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**

**November 2025**

**Commission File Number: 001-38723**

**Tiziana Life Sciences LTD**

(Exact Name of Registrant as Specified in Its Charter)

**9<sup>th</sup> 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 November 25, 2025, Tiziana Life Sciences LTD (the "<u>Company</u>") issued this 6K announcing, that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted for inclusion in the ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham.

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.

**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** | **TIZIANA LIFE SCIENCES LTD** | **TIZIANA LIFE SCIENCES LTD** |
| Date: November 25, 2025 | By: | /s/ Keeren Shah | /s/ Keeren Shah |
|  |  | Name: | Keeren Shah |
|  |  | Title: | Chief Financial Officer |

---

**EXHIBIT INDEX**

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Tiziana Life Sciences LTD Press Release, dated November 25, 2025](ea026711201ex99-1_tiziana.htm) |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Tiziana Life Sciences Nasal Foralumab Phase 2 Clinical Trial Accepted into Healey ALS MyMatch Program**

**BOSTON, MA, November 25, 2025** – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies today announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted for inclusion in the ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham.

The study, supported by a grant from the ALS Association, will be led by Principal Investigators Suma Babu, MBBS, MPH, and James Berry, MD, MPH, at Mass General Brigham. The trial will enroll at multiple rapid-enrolling U.S. centers within the Network of Excellence for ALS (NEALS) Consortium. Successful investigational products from the Healey ALS MyMatch program may advance to future regimens of the HEALEY ALS Platform Trial – a perpetual, multi-regimen, late-phase clinical efficacy study – or transition directly to standalone Phase 3 trials.

ALS is a serious neurodegenerative disease characterized by progressive motor neuron loss, leading to muscle weakness and paralysis. Neuroinflammation and immune dysregulation, particularly involving T-cell dysfunction and microglial activation, are increasingly recognized as key drivers of disease progression. Preclinical and clinical evidence indicate that nasally administered foralumab – a fully human anti-CD3 monoclonal antibody – stimulates regulatory T cells in cervical lymph nodes, which then migrate to the central nervous system to suppress pathogenic inflammation and restore microglial homeostasis.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, stated: "The rapid progression to trial activation reflects the urgency of the ALS community and the compelling science behind nasal foralumab. By leveraging the immune-modulatory potential of the nasal route, we aim to deliver meaningful clinical impact with a non-invasive therapy. We are deeply grateful to the ALS Association for their partnership and to the NEALS Consortium for their operational excellence. Foralumab's ability to expand regulatory T cells and dampen CNS inflammation offers a biologically rational approach to slowing progression in a genetically defined ALS population. We are eager to translate these mechanisms into patient benefit."

Suma Babu, MBBS, MPH, Principal Investigator of the ALS MyMatch program and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Brigham, added: "This innovative multi-site randomized placebo-controlled trial will integrate innovative nasal immunology with cutting-edge blood, spinal fluid and cellular and advanced brain imaging markers to understand the effect of the drug".

A competitive grant has been awarded to Tiziana Life Sciences towards funding this study following rigorous peer review by the ALS Association.

**About ALS MyMatch**

ALS MyMatch is a multi-site, collaborative initiative that currently brings together four trial-ready, high enrolling ALS research centers and is a Network of Excellence for ALS (NEALS) affiliated program. Research centers include Mass General in Boston; University of Minnesota in Minneapolis, Minn.; Northwestern University in Evanston, Ill.; and Nova Southeastern University in Fort Lauderdale, Fla. ALS MyMatch has partnered with the Acceleration Centers of Enrollment (ACE) program, a community-driven philanthropic partnership program focused on expediting start up and recruitment at study centers. Additional trials and high performing sites will be added as the program grows. Organizations can apply on the ALS MyMatch website.

**About the Sean M. Healey & AMG Center for ALS at Mass General Brigham**

At the Sean M. Healey & AMG Center for ALS at Mass General Brigham, we are committed to bringing together a global network of scientists, physicians, nurses, foundations, federal agencies, and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and development.

Launched in November 2018, the Healey & AMG Center, under the leadership of Merit Cudkowicz, MD and a Science Advisory Council of international experts, is reimagining how to develop and test the most promising therapies to treat the disease, identify cures and ultimately prevent it.

**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).

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.<sup>[1],[2]</sup>

**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 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 Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

**For further inquiries:**

**Tiziana Life Sciences Ltd**

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

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

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