This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. Tiziana Life Sciences plc (" Tiziana " or the " Company ") Tiziana Granted a Patent on the Use of Milciclib in Combin

announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

Granted a Patent on the Use of Milciclib in Combination with Tyrosine Kinase Inhibitors for Treatment of Hepatocellular Carcinoma

York/London, 21 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 of Milciclib in combination with

tyrosine kinase inhibitors (TKIs) such as Sorafenib (Nexavar ), Regorafenib (Stivarga ) and Lenvatinib (Lenvima )

for the treatment of hepatocellular carcinoma (HCC) and other cancers in humans. This patent will be published by the USPTO

on 1 September 2020 as Patent No. 10,758,541 (Inventor: Kunwar Shailubhai). Like most human cancers, HCC is a complex multi-factorial

cancer with multiple underlying mechanisms causing enormous heterogeneity in patient populations. Consequently, patients with

HCC often develop resistance towards the monotherapies of existing therapeutics. Thus, there is an urgent need for combination

drug treatment approaches targeting different mechanisms to achieve better clinical outcomes.

the Company presented two posters on clinical evaluation of Milciclib at the American Society of Clinical Oncology 2020 (ASCO2020).

The poster on Phase 2a clinical evaluation of Milciclib, a broad-spectrum inhibitor of cyclin dependent kinases, indicated that

the treatment was well-tolerated, and it produced encouraging clinical activity in sorafenib-resistant patients of HCC(1). The

second poster was on the evaluation of Milciclib in combination with Regorafenib, a specific TKI drug, in liver transplant patients

with HCC recurrence in the MiHRCO (Milciclib and Half Regorafenib CO administration) trial. The combination treatment was safe

and produced promising clinical response(2) in these delicate and difficult to treat patients. Additionally, the Company earlier

reported data from an animal study suggesting that the combination of Milciclib with Sorafenib, both acting via different mechanisms,

suppressed expression of protooncogene c-Myc to produce pronounced synergistic anti-HCC activity(3).

Kunwar Shailubhai, CEO & CSO of Tiziana Lifesciences, commented, "Advanced

cases of patients with HCC have limited therapeutic options because of the heterogeneity of the multiple mechanisms underlying

the development of drug resistance and limited clinical responses. Thus, combination of drugs with different mechanism of actions

are necessary to achieve superior clinical outcome. We are delighted that we now have this key patent on use of Milciclib

in combination with other HCC drugs, including a TKI. Issuance of this patent strengthens our clinical strategy as we move forward

with the combination of Milciclib and a TKI for the clinical evaluation of advanced cases of HCC as well as in patients with recurrent

HCC after liver transplantation."

person who arranged for the release of this announcement was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific

Officer of the Company

Villa, E., Piscaglia, F., Geva, R., Dalecos, G., Papatheodoridis, G., Ciomei, M., Davite, C., Crivori, P., Palejwala, V.,

Jacob, J., Hamzeh, F., Shailubhai, K., Santoro, A., and A., S. (2020) Phase 2a Safety and Efficacy of Milciclib, a

Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma

Patients. ASCO Abstract #29856

Pivetti, A., Di Marco, L., Bristot, L., Milosa, F., Maria Critelli, R., De Maria, N., Di Benedetto, F., Palejwala, V., Jacob,

J., Shailubhai, K., and Villa, E. (2020) Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib

in Liver Transplant Patients with Hepatocellular Carcinoma Recurrence. ASCO Abstract #307309

Jindal, A., Palejwala, V. a., and Shailubhai, K. (2018) Oral Treatment with Milciclib Either Alone or in Combination with Sorafenib

Inhibited Tumor Growth in an Orthotopic Model of Hepatocellular Carcinoma. Hepatology 68, 879A

Milciclib (TZLS-201)

(PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs

are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression

of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently found to be associated with development

of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and

the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon

cancer, thymic carcinoma and thymoma.

Tiziana Life Sciences

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.

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.