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
April 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): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On April 27, 2023, Tiziana Life Sciences LTD (the “Company”) issued a press release, announcing Findings from Intranasal Anti-CD3 mAb Treatment in Intracerebral Hemorrhage at the Annual American Academy of Neurology Conference
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.
1
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: April 27, 2023 | By: | /s/ Keeren Shah | |
| Name: | Keeren Shah | ||
| Title: | Chief Financial Officer | ||
2
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | News Service Announcement, dated April 27, 2023 |
3
Exhibit 99.1
Tiziana Life Sciences Announces Findings from Intranasal Anti-CD3 mAb Treatment in Intracerebral Hemorrhage at the Annual American Academy of Neurology Conference
| ● | There are no effective treatments for intracerebral hemorrhage (ICH), which has a 30% to 40% mortality rate |
| ● | Intranasal anti-CD3 mAb treatment showed a reduction in Intracerebral Hemorrhage injury severity |
| ● | Intranasal foralumab could represent a novel therapeutic approach for treating ICH and potentially other types of acute brain injury |
NEW YORK, April 27, 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 broad-based findings on the utility of nasal anti-CD3 mAb in the treatment of intracerebral hemorrhage (ICH). The data using a mouse model of collagenase-induced ICH was presented at the Annual American Academy of Neurology conference. The full presentation can be viewed at https://www.aan.com/MSA/Public/Events/AbstractDetails/52974 until May 14, 2023.
Howard L. Weiner, M.D., Chairman of Tiziana's Scientific Advisory Board and 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, stated, “Intracerebral hemorrhages are the deadliest form of acute stroke with early mortality ranging from 30% to 40%. It has been well demonstrated that microglial activation and edema play a critical role in the morbidity and mortality of this devastating event.”
Saef Izzy, M.D., MBCHB., Neurocritical Care faculty at Brigham and Women’s Hospital and Assistant Professor of Neurology at Harvard Medical School and presenter of the study at AAN, commented, “Currently, there are no effective interventions for ICH. Our research studied the effect of an intranasal anti-CD3 antibody in a mouse model of induced ICH. I believe that intranasal anti-CD3 represents a novel therapeutic approach for treating ICH as well as potentially other types of acute brain injury.”
Specifically, the study demonstrated that intranasal anti-CD3 antibody:1
| ● | Reduced ICH injury severity |
| ● | Improved motor coordination recovery |
| ● | Improved memory retention and functional recovery |
| ● | Accelerated hematoma resolution at 7 days after ICH |
| ● | Reduced neuronal cell death at 7 days after ICH |
| ● | Reduced BBB leakage at 3 days after ICH |
| ● | Reduced microgliosis at 7 days after ICH |
| ● | Reduced astrocytosis at 7 days after ICH |
| ● | Increased CD4+FoxP3+ and FoxP3+ IL10+ dependent Tregs at the site of hematoma at 7 days after ICH |
| ● | Increased anti-inflammatory and reduced pro-inflammatory cytokines at the site of hematoma at 7 days after ICH |
| ● | Upregulated microglial phagocytic transcriptomic profile at 7 days after ICH |
| ● | Modulated microglial and astrocyte transcriptomic inflammatory profile after ICH |
“The comprehensive and consistent findings of Dr. Izzy’s research strongly supports the promising role of intranasal foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), and its potential for broad applications in neuroinflammation, including the treatment of acute ICH,” said Gabriele Cerrone, Executive Chairman, Founder, and interim Chief Executive Officer of Tiziana. “These exciting findings may allow Tiziana to explore additional intranasal foralumab neuroinflammatory indications to help patients with unmet needs and create further shareholder value”.
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.2
1 https://www.aan.com/MSA/Public/Events/AbstractDetails/52974
2 https://www.pnas.org/doi/10.1073/pnas.2220272120
2
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
3