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IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON PUBLICATION

OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Tiziana Life Sciences plc

(the Company', Tiziana

Life Sciences' or Tiziana')

Tiziana Reports Phase 2a Clinical Data

with Milciclib Monotherapy in Sorafenib-refractory or -intolerant patients with unresectable or metastatic Hepatocellular Carcinoma

New York/London, 22 July 2019 -

Tiziana Life Sciences plc (NASDAQ: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative

therapeutics for inflammation and oncology indications, today announced preliminary topline clinical data from a Phase 2a trial

of Milciclib as a monotherapy in patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The

primary endpoint of the study was overall safety. Under compassionate use, a few patients continued with total treatment for up

to 16 months. Overall, treatment with Milciclib was well-tolerated and no drug-related deaths were recorded. Secondary endpoints

of efficacy including progression-free survival (PFS) and time to progression (TTP) are currently being evaluated and will subsequently

This Phase 2a trial with Milciclib monotherapy

was a multi-centered, single-arm, repeated-dose (100 mg once daily; 4 days on/3 days off every 4 weeks; defining each cycle), 6-month

duration study to evaluate the safety, tolerability and anti-tumor activity of Milciclib in sorafenib-refractory or intolerant

patients with unresectable or metastatic advanced HCC. This trial enrolled 31 patients in Italy, Greece, and Israel.

Among the 28 evaluable patients, 14 completed

the 6-month duration study. Oral treatment with Milciclib was well-tolerated with manageable toxicities. The most frequent adverse

events such as diarrhea, ascites, nausea, fatigue, asthenia, fever, ataxia, headache, and rash were manageable.

9 out of the 14 patients, after completing

the 6-month trial period, requested to continue the treatment under compassionate use and were approved by their respective ethical

committees. Four of the patients received Milciclib for a total of 9, 11, 13 and 16 months. The remaining 5 patients are continuing

treatment with Milciclib are at 8th, 9th, 9th, 9th and 11th month currently.

Objective tumor assessments according to

the modified Response Evaluation Criteria in Solid Tumors (mRECIST) guideline and the conventional RECIST 1.1 criteria are being

conducted by Independent Central Review and data will be available in September 2019.

very pleased with the clinical activity and tolerability of Milciclib in these advanced cases of HCC. It is an important milestone

to move forward with further clinical development of Milciclib either as a single agent or in combination with other HCC drugs,'

said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana.

consistent with the earlier reported long-term safety and clinical activity of Milciclib in thymic carcinoma, thymoma1

and other solid cancers2.

The global market for liver cancer drugs

is estimated to reach $1.47 billion by 2022. The current standard of care drugs is not entirely satisfactory due to low response

rates and severe toxicities. Importantly, patients often become resistant or unresponsive to the treatment. Milciclib works through

a unique mechanism of action and the Company therefore believes it may have the potential for long-term efficacy with a good safety

profile in a larger subset of patients.

The person who arranged for the release

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

1. Besse, B., Garassino, M., Rajan,

A., Novello, S., Mazieres, J., Weiss, G., Kocs, D., Barnett, J, Davite, C, Crivori, P and G. Giaccone. Efficacy of milcicilib (PHA-848125AC),

a pan-cyclin D -dependent kinase inhibitor in tow phase II studies with Thymic carcinoma and B3 thymoma patients. (2018) J. Clin.

Onc 36 (15 suppl): 8519

2. Aspeslagh, S., Shailubhai, K.,

Bahleda, R. et al. (2017). Phase I dose-escalation study of Milciclib in combination with gemcitabine in patients with refractory

solid tumors. Cancer Chemother Pharmacol. 79:1257-1265.

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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.

HCC is the fifth most common cancer and

the third highest cause of cancer mortality worldwide. In 2007, the approval by the European Medical Agency and U.S. Food and Drug

Administration of Sorafenib (Nexavar ), an inhibitor of several receptor tyrosine kinases, in HCC represented the first systemic

therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment

for the disease. However, although significant in respect to placebo, the benefits of Sorafenib are modest, with a response rate

less than 3%, an improvement in median survival of 2-3 months and drug-related symptoms that are not ordinary. More recently, lenvatinib

(Lenvima ), another multi-tyrosine kinase inhibitor was also approved for first line treatment of HCC. The complex multi-factorial

etiology of HCC warrants a need for systemic therapies that target different signaling cascades to provide improved efficacy and

safety for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments

(resection, ablation and transplantation).

Milciclib (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 associated with development of resistance towards chemotherapies. In a Phase 1 study,

oral treatment with Milciclib was 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. Additionally, milciclib met its primary

endpoint in two separate Phase 2 multi-center clinical trials (CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in thymic

carcinoma and thymoma patients.

About Tiziana Life Sciences

Tiziana Life Sciences plc is a UK biotechnology

company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In

addition to milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3

monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune

and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis,

multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation

of a T-cell response is desirable.