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 2022
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): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On November 10, 2022, Tiziana Life Sciences LTD (the “Company”) issued a news service announcing the Company will host an Investor Call on November 10, 2022: Near- Term Strategic Focus on Intranasal Foralumab for Diseases of the Central Nervous System (CNS).
The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibit 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: November 10, 2022 | By: | /s/ Keeren Shah | |
| Name: | Keeren Shah | ||
| Title: | Finance Director | ||
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EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | News Service Announcement, dated November 10, 2022 |
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Exhibit 99.1
Tiziana Life Sciences Announces Near- Term Strategic Focus on Intranasal Foralumab for Diseases of the Central Nervous System (CNS)
- Company to host conference call via webcast at 10 am ET -
NEW YORK, November 10, 2022-- 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 a corporate update, including its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System (CNS) such as non-active secondary-progressive Multiple Sclerosis (SPMS), Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).
Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana, remarked, “We look forward to leveraging the exciting clinical and preclinical results from our very promising formulation of intranasal foralumab that we have generated so far in CNS-based autoimmune diseases to guide our pipeline investment. Our near-term strategic focus to prioritize resources for the clinical development of this unique therapeutic candidate will allow Tiziana to focus on areas of greatest potential success, be highly efficient in our development timelines and maximize shareholder value while still maintaining optionality for our other research programs, including milciclib in oncology. We aim to become a leading company pioneering intranasal therapies for CNS-based diseases and have sufficient capital to fund our programs until the first quarter of 2024.”
To date, Tiziana’s fully human anti-CD3 monoclonal antibody, foralumab, administered intranasally through Tiziana’s proprietary drug delivery technology, has shown benefit in several different pre-clinical models of CNS-based inflammatory disease. These studies confirmed the uptake of the drug in the cervical lymph nodes of these animal models – an area rich in lymphocytes that is a key site of action to target since it then spurs the production of T-cells and reduces inflammation.
Matthew W. Davis, M.D., RPh, Chief Medical Officer of Tiziana, added, “Tiziana along with our academic partners collectively believe that many inflammatory CNS disease pathologies could benefit from intranasally administered foralumab and, as such, are focusing our efforts in this area due to the positive clinical and pre-clinical findings we’ve seen to date across several CNS inflammatory diseases. We embark on this journey with our partners at Brigham and Women’s Hospital and look forward to studying intranasal foralumab to address a range of underserved inflammatory CNS conditions.”
MS program updates:
Tiziana expects to announce the result of the six-month PET scan on patient EA2 and the nine-month PET scan on patient EA1 also in the first quarter of 2023. Additionally, Tiziana recently announced the completion of enrollment for the first cohort of its intermediate-size patient population (four patients) to continue to evaluate the safety and activity of intranasal foralumab in non-active SPMS patients, as part of its Expanded Access Program (EAP). During the first quarter of 2023, the Company then plans to perform three-month PET scans on patients EA3 through EA6 anticipating the results to be available in Q2 2023.
Separately, in the fourth quarter of 2022, Tiziana expects to request a “Type C” meeting with FDA to discuss its Phase 2 program for evaluating foralumab in non-active SPMS patients and receive feedback from FDA by the end of the first quarter of 2023.
Conference Call Webcast Information
Please register to listen to the conference call via webcast at the following link:
https://edge.media-server.com/mmc/p/tqy9xnrc.
After registering, participants will be able to ask management text-based questions.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough immunomodulation therapies using transformational drug delivery technologies with a focus on its lead candidate, intranasal foralumab, as a treatment for diseases of the central nervous system (CNS). 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 intranasal foralumab is the only fully human anti-CD3 mAb and 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
Hana Malik, Business Development and Investor
Relations Manager
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
Investors:
Irina Koffler
LifeSci Advisors, LLC
646.970.4681
ikoffler@lifesciadvisors.com
Source: Tiziana Life Sciences Ltd.