Tiziana Life Sciences plc ("Tiziana" or the "Company") Tiziana Life Sciences Announces an Expedited Clinical Development Plan for Its Anti-Interleukin-6-Receptor, a Fully Human Monoclonal Antibody, for the Treatment of C

Tiziana Life Sciences plc

("Tiziana" or the "Company")

Tiziana Life Sciences Announces an Expedited

Clinical Development Plan for Its Anti-Interleukin-6-Receptor, a Fully Human Monoclonal Antibody, for the Treatment of COVID-19

This announcement contains inside information

for the purposes of Article 7 of EU Regulation 596/2014.

New York/London, August 4, 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, today announced that it has signed

agreements with four CROs to expedite clinical development of TZLS-501, a novel fully human anti-interleukin-6 receptor (anti-IL6R)

monoclonal antibody (mAb) for the treatment of COVID-19 (SARS-CoV-2) patients. The Company intends to initiate the clinical study

in Q1 2021 and will work with the following CROs:

Tiziana holds a worldwide exclusive license

for TZLS-501 (a.k.a NI-1201) from Bristol Myers Squibb . TZLS-501 is a novel fully human mAb that binds to both the membrane-bound

and soluble forms of IL-6R and rapidly depletes circulating levels of IL-6 in the blood (1). Excessive production of IL-6 is regarded

as a key driver of cytokine release syndrome (CRS) and chronic inflammation in the lungs of patients with COVID-19 and acute respiratory

illness such as Acute Respiratory Distress Syndrome (ARDS). Tiziana's novel and proprietary approach to treatment is to deliver

TZLS-501 directly to the lung via inhalation.

Chairman of Tiziana, Gabriele Cerrone, commented: "We have moved quickly to accelerate our clinical development plan for

TZLS-501 using our innovative delivery platform, which was developed by Howard Weiner, a world-renowned neurologist and Chairman

of our Scientific Advisory Board. I look forward to beginning our human clinical trials in the first quarter of 2021."

Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "Our

proprietary inhalation technology for delivery of TZLS-501 to the lungs in COVID-19 patients is an attractive and most logical

approach to deplete excessive levels of IL-6 to provide rapid relief. We are focusing on the development of oral, nasal and inhalation

routes of mAb administration for immunotherapy. The common underlying concept in these alternative delivery approaches is to enable

local or topical actions to maximize clinical action and minimize undesirable side effects commonly associated with intravenous

and subcutaneous administration. Being a fully human anti-IL-6 receptor mAb, TZLS-501 is most suitable for long-term immunotherapies.

(1) Lacroix, M. et al., Novel

Insights into Interleukin 6 (IL-6) Cis- and Trans-signaling Pathways by Differentially Manipulating the Assembly of the IL-6 signaling

Complex. J Biol Chem. 2015 Nov 6; 290 (45): 26943-26953

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.

TZLS-501, a fully human mAb,

was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of

pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6R (IL-6R alpha) on the cell membrane.

IL-6 appears be a major determinant in the priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6R

can be shed as a soluble entity, sIL6R , which binds to circulating IL-6 cytokine in the blood. The downstream signaling

from this complex is believed to mediate the pro-inflammatory effects underlying the inflammatory diseases such as rheumatoid arthritis

(RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its

dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating

IL-6 cytokines, a major cause of lung damage, suggests a potential role for TZLS-501 in the patient management and treatment of

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.

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