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Tiziana Life Sciences Ltd Reports Annual Results for the Twelve Months Ended

Key Takeaway: Tiziana Life Sciences Ltd. reported its annual financial results for the year ending December 31, 2022, along with a corporate update on its leading therapeutic program, intranasal foralumab. The company is focusing on advancing this unique therapy aimed at addressing various CNS-mediated inflammatory diseases, including Long Covid, Alzheimer's, and Type 1 diabetes. Tiziana has positive expectations regarding its Phase 2 trials expected to commence in Q3 2023. The firm emphasizes its innovative drug delivery technologies as key to improving immunotherapy efficacy and safety.

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POSITIVE FACTORS

  • Successful financial report for the year ended December 31, 2022.
  • Advancement of intranasal foralumab for treating CNS-related inflammatory diseases.
  • Potential applications announced for long Covid, Alzheimer's, and Type 1 diabetes.
  • Favorable safety profile and clinical response for intranasal foralumab in studies.

Full Press Release Details

Life Sciences Ltd Reports Annual Results for the Twelve Months Ended
December 31, 2022, and Corporate Update
YORK, April 26, 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 financial results for the
twelve months ended December 31, 2022, and provided a corporate update on its lead programs in development.
Cerrone, Executive Chairman, founder and interim Chief Executive Officer of Tiziana, commented, "After announcing our focus on
advancing intranasal foralumab to address CNS-mediated inflammatory diseases, we have started this year with a stream of continuous,
positive program-related developments. Intranasal foralumab's unique action on regulatory
T-cells and its potential to treat multiple inflammatory pathology indications has been published in a major medical journal and recognized
in the media. We also recently announced intranasal foralumab's potential to treat Long Covid, Alzheimer's and Type 1 diabetes.
Our near-term strategic focus is to prioritize resources for the clinical development of this unique therapeutic candidate to
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 inflammatory diseases".
Quarter 2022 Developments Related to Foralumab
Recent Clinical Program Updates
Year End Financial Results
Annual Report on Form 20-F can be accessed by visiting either the SEC's website at www.sec.gov or the Investors section of the
Company's website at ir.tizianalifesciences.com/financial-information/annual-reports.
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
Tiziana Life Sciences
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.
Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
LifeSci Advisors, LLC

Frequently Asked Questions

What are Tiziana Life Sciences' lead programs?

Tiziana focuses on developing intranasal foralumab for CNS-mediated inflammatory diseases.

What indications is intranasal foralumab being investigated for?

It may treat Long Covid, Alzheimer's, and Type 1 diabetes, among other conditions.

What type of antibody is foralumab?

Foralumab is the only fully human anti-CD3 monoclonal antibody.

When will Phase 2 trials for foralumab begin?

Phase 2 trials are expected to start in Q3 2023 for non-active SPMS patients.

How is Tiziana's nasal approach different from IV delivery?

The nasal approach may improve efficacy, safety, and tolerability compared to IV.

Last updated: Apr 26, 2023