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

 

March 2023

 

 

 

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 ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

 

 

 

 

 

 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

 

On March 17, 2023, Tiziana Life Sciences LTD (the “Company”) issued a press release, announcing the Company was highlighted in a FORBES article highlighting foralumab, the Company’s unique intranasal monoclonal antibody, which is currently in clinical development to treat multiple sclerosis and a range of other neurodegenerative diseases. Foralumab is the world’s only fully human, anti-CD3 mAb in clinical development.

 

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: March 17, 2023 By: /s/ Keeren Shah
    Name:  Keeren Shah
    Title: Chief Financial Officer

 

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EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   News Service Announcement, dated March 17, 2023

 

 

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Exhibit 99.1

 

 

Tiziana Life Sciences Highlighted in Forbes Article

 

Article entitled “New T Cell Antibody Treatment Improves Outcomes For Covid Patients” reviews the company’s first in class foralumab, a unique Intranasal monoclonal antibody designed to treat multiple sclerosis and a range of other neurodegenerative diseases

 

NEW YORK, March 17, 2023 -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the Company was highlighted in a FORBES article highlighting foralumab, the Company’s unique intranasal monoclonal antibody, which is currently in clinical development to treat multiple sclerosis and a range of other neurodegenerative diseases. Foralumab is the world’s only fully human, anti-CD3 mAb in clinical development.

 

Forbes contributing author, William A. Haseltine, highlighted foralumab in his article entitled “New T Cell Antibody Treatment Improves Outcomes for Covid Patients”.

 

Noted in the article was:

 

“Foralumab induces many factors that impact improved tissue remodeling, induction of immune cells, and restriction of effector function, improving disease outcomes while fighting the virus to full strength. These benefits are not limited to Covid-19 patients, as similar results were observed in patients with multiple sclerosis.”

 

“The anti-CD3 monoclonal treatment effectively modulates the T cell inflammatory response by up or downregulating specific gene and protein expressions, resulting in less severe disease. This novel avenue should be further explored, as more drugs with similar mechanisms could prevent the deaths of thousands.”

 

To access the full Forbes article, please visit the following link:

 

https://www.forbes.com/sites/williamhaseltine/2023/03/16/new-t-cell-antibody-treatment-improves-outcomes-for-covid-patients/?sh=4cfb63eb670f

 

About Foralumab

 

Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor, dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets, an effect demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. Intranasal foralumab Phase 2 trials are expected to start in Q3 2023 in patients with non-active SPMS. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases. 1

 

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, oral and inhalation approaches in development have 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, the only fully human anti-CD3 mAb, 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 further inquiries:

 

Tiziana Life Sciences Ltd

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

 

Investors:
Irina Koffler
LifeSci Advisors, LLC
646.970.4681
ikoffler@lifesciadvisors.com

  

 

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