TLSA Tiziana Life Sciences Ltd

 

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 2023

 

 

Commission File Number:  001-38723

 

 

Tiziana Life Sciences LTD

(Exact Name of Registrant as Specified in Its Charter)

 

 

9^th 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 23, 2023, Tiziana Life Sciences LTD (the “Company”) issued a press release, announcing an oral presentation of “Nasal anti-CD3 mAb induces Tregs that dampen microglial activation and treat neuroinflammatory diseases including MS, AD and ALS” at the 16th International Society of Neuroimmunology (ISNI) Congress in Quebec City, Canada, being held August 21-24, 2023. Dr. Weiner’s live presentation is scheduled for 11:42 a.m. ET on August 24, 2023.

 

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
Date: August 23, 2023	By:	/s/ Keeren Shah
		Name:	Keeren Shah
		Title:	Chief Financial Officer

 

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		News Service Announcement, dated August 23, 2023

 

 

3

 

Exhibit 99.1

 

 

 

Tiziana Life Sciences Announces Foralumab Presentation by Dr. Howard Weiner at the Annual Meeting of the International Society of Neuroimmunology

 

NEW YORK, August 23 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 an oral presentation of “Nasal anti-CD3 mAb induces Tregs that dampen microglial activation and treat neuroinflammatory diseases including MS, AD and ALS” at the 16^th International Society of Neuroimmunology (ISNI) Congress in Quebec City, Canada, being held August 21-24, 2023. Dr. Weiner’s live presentation is scheduled for 11:42 a.m. ET on August 24, 2023.

 

“We are expanding our understanding of foralumab through rigorous research¹ and clinical trials designed to study this potential treatment for neuroinflammatory diseases,” said Howard L. Weiner, MD, Chairman of Tiziana’s Scientific Advisory Board. Dr. Weiner is also co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system.

 

“Dr. Weiner’s presentation on foralumab, or nasal anti-CD3 mAb will also include updates on our Multiple Sclerosis Expanded Access (EA) program”, commented Gabriele Cerrone, Executive Chairman, Founder, and interim Chief Executive Officer of Tiziana. “I am truly excited at the rapid progress of our foralumab program. This quarter, we have successfully filed our Alzheimer’s IND and received a “may proceed” FDA response. In addition, we will conduct our multiple sclerosis Phase 2a investigator’s meeting, announce our 6-month clinical findings and PET scans for EA Patients 3 through 6 and lastly enroll EA patients 7 through 10.”

 

About the ISNI Annual Congress

 

The 16^th ISNI Congress focuses on the latest fundamental, clinical, and technological advances in neuroimmunology. Topics include not only neuroimmune diseases, such as multiple sclerosis, but also neurodegenerative disorders involving inflammatory processes, such as Alzheimer’s disease, stroke, spinal cord injury, and brain cancer.

 

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 and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been 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 the third quarter of 2023 in patients with non-active SPMS. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases.¹

 

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

 

 

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, 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
email: info@tizianalifesciences.com

 

Investors:

 

Irina Koffler
LifeSci Advisors, LLC
+1 646 970 4681
ikoffler@lifesciadvisors.com

 

 

  

 

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