Tiziana Life Sciences plc ( Tiziana or the Company ) Tiziana to Conduct a Clinical Study with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, for Treatment of COVID-19 Patients in Brazil Nasal

to Conduct a Clinical Study with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, for Treatment of

COVID-19 Patients in Brazil

Nasal Administration

of Foralumab is a potentially transformative approach for treating patients with Covid-19.

York/London, September 17, 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) ("Tiziana" or the "Company"),

a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that

it has signed an agreement for a collaborative clinical study investigating nasally administered Foralumab in COVID-19 patients

in Brazil, either alone or in combination with orally administered dexamethasone. The Company announced on July 31, 2020 its filing

of a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb),

for the treatment of COVID-19 either alone or in combination with other anti-viral drugs.

"Cytokine storm" (aka cytokine release syndrome) and hyperinflammation resulting in severe lung damage, followed by

respiratory failure are the main underlying reasons for morbidity and mortality in COVID-19 patients (1). Recent clinical

evidence suggests that the level of peripheral T regulatory cells (Tregs) is prominently reduced in severely ill COVID-19 patients

(2), which could be one of the reasons for the hyperactivated immune system and damaged lungs in these patients. Since the reduction

in Tregs and activation of the immune system are commonly observed in patients with Middle Eastern Middle

Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS-CoV-1), COVID-19 and Acute Respiratory Distress Syndrome

(ARDS), we believe that stimulation of Tregs is a highly innovative approach for the treatment of patients with these diseases.

Company has developed a robust formulation for delivery of Foralumab using a nasal spray device and has successfully completed

a Phase 1 clinical trial demonstrating that the treatment was well-tolerated up to 250 microg/day and that it stimulated Tregs

(https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers).

Thus, we believe the clinical strategy with nasal administration of Foralumab either alone or in combination with dexamethasone

to treat COVID-19 patients is highly innovative and scientifically very sound.

"Nasal administration

of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety

of human diseases with dysregulated immune systems. Results from studies, conducted in our laboratory have established that nasal

administration of anti-CD3 induces Tregs that can suppress inflammation and ameliorate diseases in animal models. Furthermore,

nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. This scientific advancement provides

the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease," commented Dr.

Howard Weiner, who is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners

Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's

Hospital. He continued, "modulating the immune system with nasal anti-CD3 is a first-in-class immunotherapeutic approach

to treat COVID-19 disease."

proprietary immunotherapeutic approach, employing nasal administration of Foralumab to modulate the immune system, aims to supercharge

Tregs to suppress inflammation, and to dampen cytotoxic CD8+ T cell responses in the nasal and respiratory tract, the primary

sites of Covid-19. In view of the importance and urgency to develop an effective therapy for COVID-19 immediately, our Tiziana

Life Sciences team, scientists at the Harvard Medical School and the scientific team at Santa

Casa de Miseric rdia de Santos Hospital (Jabaquara, Santos, Brazil) are working very

quickly to start this clinical study in the next few weeks such that clinical data could be available before the end of this year."

commented Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

THIS ANNOUNCEMENT CONTAINS

INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014

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.

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 (CRS) 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 AIMS: 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

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.