Tiziana Life Sciences plc ("Tiziana" or the "Company") Tiziana Granted a Patent on Methods and Use of Anti-CD3 Monoclonal Antibodies for Treatment of Crohn's Disease New York/London, 18 August, 2020 - Tiziana Life Scienc

Tiziana Life Sciences plc

Tiziana Granted a Patent on Methods

and Use of Anti-CD3 Monoclonal Antibodies for Treatment of Crohn's Disease

New York/London, 18 August, 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 the United States Patent

and Trademark Office ("USPTO") has granted a patent on use and methods of treatment of Crohn's disease with Foralumab,

its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies (mAb). The CD3 (cluster of

differentiation 3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent will

be published by the USPTO on 1 September, 2020 as Patent No. 10,759,858. Recently, Tiziana also announced the issuance of

the first-ever patent on oral administration of anti-CD3 mAbs for treatment of human diseases (Patent No. 10,688,186). The

grant of this additional composition-of-matter and use patent further strengthens the Company's intellectual property, consisting

of proprietary technologies on oral and nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of human diseases.

Tiziana previously reported the successful

completion of a Phase 1 trial utilizing oral administration of Foralumab on 9 January 2020, which was designed to evaluate its

safety and tolerability in healthy subjects. The trial was conducted at Brigham and Women's Hospital, Harvard Medical School,

Boston, Mass., and indicated that oral administration of Foralumab was well-tolerated up to a 5 mg dose (https://www.tizianalifesciences.com/news-item?s=2020-01-09-tiziana-reports-phase-1-clinical-data-demonstrating-oral-treatment-with-foralumab-a-fully-human-anti-cd3-monoclonal-antibody-is-well-tolerated-in-healthy-volunteers).

The Company plans to move forward with a phase 2 trial in the 4th quarter of 2020 with orally administered Foralumab for the evaluation

of moderate-to-severe patients with Crohn's Disease.

Dr. Kunwar Shailubhai, CEO & CSO

of Tiziana Lifesciences, commented, "We are delighted that this key patent on composition-of-matter and use for treatment

of Crohn's Disease is granted. We are very excited about the continued development of the oral administration of Foralamab

for the treatment of Crohn's disease because this alternative route of administration seems to minimize toxicity and we believe

it would maximize clinical activity by acting topically in the gut to inhibit inflammation."

Additionally, Tiziana previously reported

the successful completion of a Phase 1 study evaluating safety and analysis of biomarkers for clinical activity of nasally administered

stabilized solution of Foralumab on 28 November 2018 (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).

Additionally, a Phase 2 trial in patients

with progressive multiple sclerosis will commence in the 4th quarter. Importantly, in both clinical studies, the severe toxicities

commonly associated with intravenous administration of anti-CD3 mAbs were not observed with oral or nasal administration of Foralumab.

The person who arranged for the release

of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

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 while 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 AIM: 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 II 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 hospitalized COVID-19

patients with severe respiratory symptoms.

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.

This announcement contains inside information

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

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