("Tiziana" or "the Company")

Tiziana Life Sciences plc

("Tiziana" or "the Company")

Interim Results for the Six Months Ended

Advancing pipeline of next generation

therapeutics and diagnostics for oncology and immune

diseases of high unmet need

London, 30 September 2019 - Tiziana

Life Sciences plc ("Tiziana", AIM: TILS, NASDAQ: TLSA), the research and clinical stage biotechnology company focussing

on proprietary drug candidates to treat cancer and autoimmune diseases, today announces its interim results for the six months

Highlights during the period:

RESEARCH & DEVELOPMENT

Foralumab 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).

As 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

Foralumab 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.

On 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 was filed in the second quarter of 2018, and a Phase 1 trial to evaluate

biomarkers of immunomodulation of clinical responses was initiated in November 2018. The study was completed in September 2019

and Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated at all doses. Importantly, the treatment

showed significant positive effects on the biomarkers for activation of mucosal immunity, which is capable of inducing site-targeted

immunomodulation to elicit anti-inflammatory effects.

Milciclib, 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 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.

To 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.

The 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. 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 cohort to an additional 20 patients to complete the

trial enrolment, which was completed in December 2018. Top-line data is expected in the third quarter of 2019. This trial is conducted

in Sorafenib-resistant HCC patients. 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 March 2019, the IDMC reviewed

safety data from patients as of February 26, 2019 and concluded that the administration of Milciclib to patients with advanced

HCC was not associated with unexpected signs or signals of toxicity. 28 out of 31 treated patients were evaluable, 14 completed

the 6-month duration study. The most frequent adverse events such as diarrhea,

ascites, nausea, fatigue, asthenia, fever, ataxia, headache, and rash were manageable. No drug-related deaths were recorded.

protocol, data collection was limited to 6-months. Thus, clinical data were not collected from patients under compassionate use

treatment. The clinical activity assessment in evaluable patients was based on the investigators' review using the modified

Response Evaluation Criteria in Solid Tumors (mRECIST).

Preclinical data presented at the AASLD

meeting in November 2018, demonstrated significant tumour reduction in an orthotopic mouse model of HCC following five weeks of

treatment with Milciclib (-20% reduction, 30mg/kg/day)), Sorafenib (-20% reduction, 20 mg/kg/day) and the combination of Milciclib

and Sorafenib (-38% reduction) relative to vehicle control.

PRE-CLINICAL PROGRAMMES

TZLS-501, formerly NI-1201

TZLS-501 is a fully human engineered mAb

targeting the interleukin-6 receptor (IL-6R). Tiziana Life Sciences licensed the intellectual property from Novimmune in January

2017. This fully human mAb has a unique mechanism of action that binds to both the membrane-bound and soluble forms of the IL-6R

resulting in lowering of circulating levels of IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of chronic

inflammation, associated with autoimmune diseases such as multiple myeloma, oncology indications and rheumatoid arthritis, and

the Group believes that TZLS-501 may have potential therapeutic value for these indications.

In preclinical studies, TZLS-501 demonstrated

the potential to overcome limitations of other IL-6 blocking pathway drugs. Compared to tocilizumab and sarilumab, while binding

to the membrane-bound IL-6R complex TZLS-501 has shown a higher affinity for the soluble IL-6 receptor as seen from the antibody

binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block or reduce IL-6 signalling in mouse

models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease progression compared to the

membrane-bound form. (Kallen, K.J. (2002). "The role of transsignalling via the agonistic soluble IL-6 receptor in human

diseases". Biochimica et Biophysica Acta. 1592 (3): 323-343.).

StemPrintER is a multi-gene signature assay

intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast cancers. The Group believes this

in-vitro prognostic test will be used in conjunction with clinical evaluation to identify those patients at increased risk for

early and/or late metastasis.

The Company continues to carefully manage

its working capital position and continues the process, as referred to below, to seek to raise further funds through the issue

of ADSs through a United States Offering as well as through private placements.

Highlights post period:

About Tiziana Life Sciences

Tiziana Life Sciences plc

is a UK biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology

The Company is focused

on its lead compound, milciclib, a molecule which blocks the action of specific enzymes called cyclin-dependent kinases (CDK) involved

in cell division as well as a number of other protein kinases. Milciclib is currently completing phase II clinical trials for epithelial

thymic carcinoma and/or thymoma in patients previously treated with chemotherapy and has filed an IND to enroll patients in an

exploratory trial in Hepatocellular Carcinoma (HCC) in EU.

in clinical development of foralumab. We believe foralumab is the only fully human anti-human CD3 antibody in clinical development

in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as NASH, primary