Tiziana Life Sciences Announces Initiation of Clinical Trial in a Secondary Progressive Multiple Sclerosis (SPMS) Patient with Nasal Administration of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, Under an Indiv

Tiziana Life Sciences Announces Initiation

of Clinical Trial in a Secondary Progressive Multiple Sclerosis (SPMS) Patient with Nasal Administration of Foralumab, a Fully Human Anti-CD3

Monoclonal Antibody, Under an Individual Patient Expanded Access Program

New York/London, 25 May 2021 - Tiziana

Life Sciences plc (NASDAQ: TLSA, LSE: TILS) ("Tiziana" or the "Company"), a biotechnology company focused on innovative

therapeutics for inflammatory diseases and cancers, is pleased to announce that the first patient with secondary progressive multiple

sclerosis (SPMS) was dosed with nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, at the Brigham and Women's

Hospital (BWH), Harvard Medical School, Boston, MA. Nasal Foralumab 50 mcg (25 mcg/nostril) will be administered in 3-week cycles, with

3 times/week dosing for the first 2 weeks followed by 1 week of rest period. This first-ever clinical study in SPMS patients, under an

Individual Patient Expanded Access IND, will continue for six months to evaluate routine safety, tolerability, and neurological behaviors.

The study will also examine microglial activation, by positron emission tomography (PET),

immunological and neurodegenerative markers to assess clinical responses following the treatment regimen.

Tiziana completed a Phase 1 trial of a single-site, double-blind, placebo-controlled, multiple ascending dose (MAD) once a day dosing

for 5 consecutive days with nasally administered Foralumab in healthy subjects. The treatment was well-tolerated with no drug-related

safety issues reported at doses of up to 250 mcg. (https://www.tizianalifesciences.com/news-item?s=2019-09-10-tiziana-reports-phase-1-clinical-data-demonstrating-nasal-treatment-with-foralumab-was-well-tolerated-and-produced-positive-trend-in-biomarkers-of-immunomodulation-and-anti-inflammation-in-healthy-volunteers)

Tiziana reported positive data from a clinical study with nasally administered Foralumab in COVID-19 patients in Brazil. Results from

this clinical study demonstrated that nasally administered Foralumab at 100 mcg/day for consecutive 10 days was well-tolerated and there

were no apparent severe adverse events. The clinical results demonstrated that the treatment provided significant reduction of lung inflammation

together with a reduction in interleukin-6 (IL-6) and C-reactive protein (CRP), biomarkers of inflammation, in the blood samples taken

from patients ( https://www.tizianalifesciences.com/news-item?s=2021-02-02-tiziana-reports-positive-data-from-the-clinical-study-of-nasal-administration-with-foralumab-its-proprietary-fully-human-anti-cd3-monoclonal-antibody-in-covid-19-patients-in-brazil)

Dr. Howard Weiner, Robert Kroc Professor of Neurology

at Harvard Medical School said, "Nasally administered anti-CD3 is an exciting, novel approach that has the ability to provide

safe treatment for a form of MS that currently has no effective treatment. We are excited to examine this first-in-class approach to treat

patients with SPMS for whom no effective treatment option is currently available."

Dr. Tanuja Chitnis, Professor of Neurology at

Harvard Medical School and senior neurologist at the BWH, adds, "Effective and targeted treatments for progressive MS are urgently

needed. Nasal Foralumab could revolutionize treatment for this disabling form of disease."

The person who arranged for the release of this

announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION

FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL)

ACT 2018) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED

TO BE IN THE PUBLIC DOMAIN.

Foralumab (formerly NI-0401), the only entirely

human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the

classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID

IL2 c-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of

the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases

without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal

studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases

in a safe manner by the induction of Tregs.

About Tiziana Life Sciences

Tiziana Life Sciences plc is a dual listed (NASDAQ:

TLSA, UK LSE: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in

oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with

orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab

is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound

has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis,

type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation

of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a

fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

Forward-Looking Statements

made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based

on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,'

expects,' intends,' plans,' believes,' 'seeks,' estimates,' and similar expressions are intended to identify forward-looking statements.

These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors,

some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those

expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not

to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement.

The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company

will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events,

circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate

regulatory authority.

For further enquiries: