# EDGAR Filing Document

**Accession Number:** 0001723069
**File Stem:** 0001213900-25-076077
**Filing Date:** 2025-8
**Character Count:** 9082
**Document Hash:** 2129f5eb199ad3ed94c4993986de9679
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-076077.hdr.sgml**: 20250814

**ACCESSION NUMBER**: 0001213900-25-076077

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20250814

**FILED AS OF DATE**: 20250814

**DATE AS OF CHANGE**: 20250814

**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:** 251214549

**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**

**August 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 August 14, 2025, Tiziana Life Sciences LTD (the "<u>Company</u>") issued this 6K announcing that the first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients living with Multiple System Atrophy (MSA) at Brigham and Women's Hospital in Boston, Massachusetts.

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: August 14, 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 August 14, 2025](ea025325501ex99-1_tiziana.htm) |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab for Multiple System Atrophy**

BOSTON, MA, August 14, 2025 – 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 first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients living with Multiple System Atrophy (MSA) at Brigham and Women's Hospital in Boston, Massachusetts.

MSA is a rare, rapidly progressive neurodegenerative disorder affecting the body's movement, balance, and autonomic functions. Classified as an orphan disease by the FDA, MSA affects an estimated 15,000–50,000 people in the United States. There are no FDA-approved treatments that alter its course, creating a critical need for new therapeutic strategies.

The six-month open-label study (ClinicalTrials.gov Identifier: NCT06868628) will assess the potential of foralumab to reduce harmful neuroinflammation by engaging the body's regulatory T cells through a novel, non-systemic delivery approach. Participants will receive treatment over eight dosing cycles, with the goal of determining whether this approach can slow disease progression and improve quality of life.

"We are excited to begin dosing nasal foralumab in MSA patients," Said Dr. Vikram Khurana, MD, PhD, Tracy T. Batchelor Endowed Chair in Neurology, and Division Chief of Movement Disorders and Director of the MSA Center of Excellence at Brigham and Women's Hospital and Principal Investigator of the MSA trial, commented: "Every patient I meet with MSA faces a reality of mounting symptoms and few options. This trial represents an important opportunity to explore a treatment aimed directly at the immune processes that may drive the disease. The intranasal route allows us to reach the brain's immune environment in a way that is both targeted and potentially more tolerable for patients."

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, added: "Our mission is to bring forward therapies that tackle the root causes of neurodegeneration, not just the symptoms. Dosing our first patient in this MSA study marks an important milestone in that mission. We are hopeful that foralumab's unique mechanism – modulating immune response through the nasal pathway – can open new doors in treating diseases where inflammation and degeneration are intertwined."

The trial builds on Tiziana's broader research into foralumab in neuroinflammatory and neurodegenerative diseases, where early studies have suggested benefits in stabilizing or improving function in conditions such as multiple sclerosis.

**About Multiple System Atrophy**

Multiple System Atrophy is a rare and debilitating disorder involving the progressive loss of nerve cells in several areas of the brain. Symptoms may include severe problems with movement, balance, bladder control, and blood pressure regulation. The disease progresses quickly, and most patients survive only 6–9 years after diagnosis. No treatments are currently approved to slow or halt its progression.

**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, 10 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. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. 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 <br> [2] https://www.pnas.org/doi/10.1073/pnas.2309221120