Tiziana Life Sciences plc ("Tiziana" or the "Company") Tiziana Announces Initiation of Clinical Trial with Covid-19 Patients in Brazil with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody - Hig

Initiation of Clinical Trial with Covid-19 Patients in Brazil with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal

November 2, 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 initiation

of a collaborative clinical study investigating nasally administered Foralumab either alone or in combination with orally administered

dexamethasone in COVID-19 patients in Brazil. In view of the importance and urgency, scientific

teams at the Harvard Medical School, Santa Casa de Miseric rdia de Santos Hospital (Jabaquara, Santos, Brazil)

and at Tiziana are closely collaborating to facilitate initiation of this study in expedited time frames. This clinical trial will

be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO),

based in Sao Paulo City, Brazil. The clinical data from this trial is expected to available by the end of this year.

has reported almost 5.5M Coronavius cases and 159,000 deaths and is considered a global epicenter of the outbreak. Brazil is now

experiencing almost 1000 deaths per day. Thus, our clinical study is both timely and potentially a life changer for the COVID-19

patients. The scientific concept, to activate nasal mucosal immunity by nasally administered Foralumab, is to fight against the

virus in the respiratory tract and lungs," stated Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

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,

commented: "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." He continued, "My colleague Dr. Thais Moreira worked very closely with clinicians at the Brazilian hospital

and the team at the INTRIALS to expedite this highly innovative first-in-class study for treating COVID-19 disease."

Rog rio Dedivitis, the Clinical director of Santa Casa de Santos, stated: "The Santa Casa hospital, the first hospital

founded in Brazil almost 500 years ago, is very pleased to be involved in such an important international clinical study. We

are excited and confident that this study will contribute to the better understanding of COVID-19 disease, and importantly also

benefit our patients."

cytokine storm 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 Tregs is prominently reduced in severely ill COVID-19 patients (2). The clinical

data from a recently completed clinical study indicated that the nasal administration of Foralumab stimulated production of Tregs

in healthy volunteers (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),

suggesting that nasal treatment with Foralumab might improve clinical outcome by stimulating Tregs in patients. This is a highly

innovative approach, which could also be useful for treatment of patients with Middle Eastern Respiratory

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

depletion of functional Tregs are commonly observed in these diseases.

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.

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 (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 patients.

Forward-Looking Statements

Certain 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.