Tiziana Life Sciences PLC ("Tiziana" or the "Company") Final Results for the Year Ended 31 December 2019 London / New York 18 June 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), (the "Company" or "Tiziana")

Results for the Year Ended 31 December 2019

/ New York 18 June 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), (the "Company" or "Tiziana"),

the U.S. and U.K. biotechnology company that focuses on the discovery and development of novel molecules to treat human disease

in oncology and immunology, today announces its financial results for the year ended 31 December 2019.

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

Tiziana Life Sciences plc

Life Sciences is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease

in oncology and immunology. We believe Foralumab is the only fully human anti-CD3 mAb in clinical development in the world. This

compound has potential application in a wide range of autoimmune and inflammatory diseases, such as NASH, primary biliary cholangitis

(PBS), ulcerative colitis, MS, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where

modulation of a T-cell response is desirable.

more information go to http://www.tizianalifesciences.com

CHAIRMAN'S STATEMENT

am pleased to report on the Company (Tiziana Life Sciences PLC) and its subsidiaries, together the Group', results

for the year ended 31 December 2019.

Life Sciences plc is a publicly-listed (NASDAQ: TLSA; AIM: TILS) biotechnology company focused on the discovery and clinical development

of innovative therapeutics for cancers, autoimmune and inflammatory diseases. The Group combines field-leading medical scientists,

providing deep knowledge and novel insights into disease mechanisms, together with a highly experienced clinical development team.

Since its foundation in 2013, Tiziana Life Sciences has expanded its pipeline of assets to include clinical stage development

therapeutic candidates in both oncology and immunology, as well as a pre-clinical drug discovery pipeline.

Group is focused on the discovery and development of novel molecules and related diagnostics to treat high unmet medical needs

in oncology and immunology.

lead product candidate in immunology are Foralumab (TZLS-401), which we believe is the only fully human anti-CD3 monoclonal antibody,

or mAb, in clinical development. MAbs represent a single pure antibody produced by single clones and are an important class of

human therapeutics for treating cancers and autoimmune diseases. In addition, we are accelerating development of another fully

human monoclonal antibody anti-IL6R (TZLS-501) to treat acute inflammation resulting from infection with viral agents such as

Coronaviruses. Antibodies produced in animals for use in humans, lead to strong, immune responses limiting their effectiveness

and potentially leading to severe side effects. A process known as "humanization" removes most of the animal components

of the antibody thereby lowering the immune response from the human immune system. The entire omission of other animal material,

as in fully human antibodies, is the optimal goal to avoid incompatibility with the human immune system.

lead product candidate in oncology is Milciclib (TZLS-201), which is an orally bioavailable, small molecule broad spectrum inhibitor

of cyclin-dependent kinases, or CDKs, and Src family kinases. CDKs are a highly conserved family of enzymes that phosphorylate

a specific group of proteins that are involved in regulating the cell cycle. The cell cycle is a series of events that takes place

in cells leading to division and duplication of its DNA to produce two daughter cells. Src family kinases are non-receptor tyrosine

kinase proteins encoded by the Src gene also involved in regulating cell growth and potential transformation of normal cells to

cancer cells. We have a drug discovery pipeline of small molecule new chemical entities, or NCEs, and biologics. We employ a lean

and virtual research and development, or R&D, model using highly experienced teams of experts for each business function to

maximize value accretion by focusing resources on the drug discovery and development processes. Our mission is to design and deliver

next generation therapeutics and diagnostics for oncology and immune diseases of high unmet medical need by combining deep understanding

of disease biology with clinical development expertise.

(TZLS-401 / NI-0401)

is a fully human engineered anti-CD3 monoclonal antibody (mAB). It was in-licensed in December 2014 from Novimmune. In January

2016, Tiziana outlined its clinical development plan for Foralumab with initial plans to evaluate the drug in two clinical indications:

non-alcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD).

the only fully human engineered human anti-CD3 mAB in clinical development, Foralumab has significant potential advantages such

as a shorter treatment duration and reduced immunogenicity. With completion of the intravenous dosing for our Phase 2a trial in

Crohn's Disease, Foralumab's ability to modulate T-cell response enables potential extension into a wide range of

other autoimmune and inflammatory diseases, such as GvHD, ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory

bowel disease (IBD), psoriasis and rheumatoid arthritis.

is being developed as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable

to orchestrate an immune response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential

for Foralumab to be combined with the Company's TZLS-501, a fully human anti-IL-6R mAB in development to target autoimmune

and inflammatory diseases.

November 2016, Tiziana announced new data for oral efficacy in humanized mouse models with Foralumab, a major milestone and a

potential breakthrough for the treatment of NASH and autoimmune disease. This unique oral technology stimulates the natural gut

immune system and potentially provides a therapeutic effect in inflammatory and autoimmune diseases with greatly reduced toxicity.

Positive therapeutic effects with Foralumab were consistently demonstrated in animal studies conducted by Prof. Kevan Herold (Yale

University) and Prof. Howard Weiner (Harvard University).

16 April, 2018, the Group entered into an exclusive license agreement with The Brigham and Women's Hospital, Inc. relating

to a novel formulation of Foralumab dosed in a medical device for nasal administration. An investigational new drug application

(IND) for the first-in-human evaluation of the nasal administration of Foralumab in healthy volunteers for progressive multiple

sclerosis indication was filed in the second quarter of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled,

dose-ranging Phase 1 trial with nasally administered Foralumab at 10, 50 and 250 g per day, consecutively for 5 days to

evaluate biomarkers of immunomodulation of clinical responses was initiated in November 2018. The trial conducted at the Brigham

and Women's Hospital, Harvard Medical School, Boston, MA, in healthy volunteers. 18 subjects received Foralumab treatment and

9 patients received placebo. All nasal doses were well tolerated. The study was completed in September 2019. Phase 1 clinical

data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported at any

of the doses. No drug-related changes were observed in vital signs among subjects at pre-dose, during treatment and at discharge.

The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 g/d):124/73, Cohort B (50 g/d): 119/67

and Cohort C (250 g/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged

among the 3 cohorts compared to the placebo. Nasally administered Foralumab at the 50 g dose suppressed cytotoxic CD8+

as well as perforin secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment

at 50 mg stimulated production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN- .

Taken together, the treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which

are capable of inducing site-targeted immunomodulation to elicit anti-inflammatory effects.

enteric-coated capsule formulation using a proprietary and novel technology has been developed for oral administration of Foralumab.

cGMP manufacturing of clinical trial materials for a Phase 1 study has been completed and an IND has been submitted in March 2019.

September 9, 2019, the FDA granted approval to initiate the Phase I clinical trials to evaluate the safety and pharmacokinetics

of oral Foralumab at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December 2019 at Brigham

and Women's Hospital (Boston, MA USA). Formulated Foralumab powder encapsulated in enteric-coated capsule was well-tolerated

at all doses tested and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial. Based

on successful Phase 1 data, we intend to conduct a Phase 2 study using Crohn's Disease patients starting in the second half

Tiziana's lead small molecule drug, was exclusively licenced in January 2015 from Nerviano Medical Sciences. Milciclib is

an orally bioavailable, broad spectrum inhibitor of Cyclin Dependent Kinases (CDKs): 1, 2, 4, 5 and 7 and Src family kinases.

Cyclin dependent kinases are a family of highly conserved enzymes that are involved in regulating the cell cycle. Src family kinases

regulate cell growth and potential transformation of normal cells to cancer cells. A unique feature of Milciclib is its ability

to reduce microRNAs, miR- 221 and miR-222, which silence gene expression. miR-221 and miR-222 promote the formation of blood vessels

(angiogenesis) that are important for the spread of cancer cells (metastasis). Levels of these microRNAs are consistently increased

in hepatocellular carcinoma ("HCC") patients and may contribute towards resistance to treatment with Sorafenib. As

a result, the Group are investigating Milciclib both as a monotherapy and as a combination treatment with Sorafenib.

date, Milciclib has been studied in a total of eight completed and ongoing Phase 1 and 2 clinical trials in 316 patients. In these

trials, Milciclib was observed to be well-tolerated and showed initial signals of anti-tumour action. Prior to in-licensing, Milciclib

was granted orphan designation by the European Commission and by the U.S. Food and Drug Administration ("FDA") for

the treatment of malignant thymoma and an aggressive form of thymic carcinoma in patients previously treated with chemotherapy.

In two Phase 2a trials, CDKO-125a-006 and CDKO125a-007, Milciclib showed signs of slowing disease progression and acceptable safety.

Group initiated a Phase 2a trial (CDKO-125a-010) of Milciclib safety and tolerability as a single therapy in Sorafenib-resistant

patients with HCC in the first half of 2017. Typically, this population of patients have an advanced form of the disease with

poor prognosis and an average overall survival expectancy of 3-5 months In May 2018, the Independent Data Monitor committee (IDMC)

completed an interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial