Tiziana Life Sciences plc ("Tiziana" or the "Company") Tiziana Announces Initiation of a Phase 1 Clinical Trial with Orally Administered Foralumab, a Fully Human anti-CD3 monoclonal antibody, in Healthy Volunteers This a

Tiziana Life Sciences plc

("Tiziana" or the "Company")

Tiziana Announces Initiation of a Phase 1

Clinical Trial with Orally Administered Foralumab, a Fully Human anti-CD3 monoclonal antibody, in Healthy Volunteers

This announcement contains inside information

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

London/New York, 4 December 2019 -

Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a clinical-stage biotechnology company focused on developing innovative therapeutics

for inflammatory diseases and cancers, is pleased to announce initiation of a Phase I clinical trial in healthy volunteers with

a proprietary oral formulation of Foralumab encapsulated in enteric-coated capsules. The primary objective of this single ascending

dose (SAD) phase 1 study, being led by Dr. Tanuja Chitnis at the Brigham and Women's Hospital, Harvard Medical School, Boston,

MA USA, is to determine safety and tolerability of orally administered Foralumab. The clinical protocol also includes evaluation

of pharmacokinetics to determine if there is any systemic absorption of Foralumab following oral administration.

"Oral administration of Foralumab in

enteric-coated capsules is a novel approach to upregulate T regulatory cells (Tregs) that have the capability to cross-through

blood brain barrier and provide clinical benefits. Successful demonstration of safety in this study will facilitate immediate evaluation

of orally administered Foralumab in a phase 2 clinical study in patients with progressive multiple sclerosis, a neurodegenerative

disease for which there are limited treatment options", said Dr. Howard Weiner

"We are excited to initiate this trial

because this is the first-ever clinical study with orally administered Foralumab in enteric-coated capsules. The oral route of

administration is expected to minimize toxicities associated with intravenous administration of anti-CD3 mAbs and it may also improve

the clinical outcome through activation of gut mucosal immunity. Our proprietary oral formulation technology has the potential

to be useful for treatment of neurodegenerative and gastrointestinal diseases," commented Kunwar Shailubhai, CEO and CSO

About Dr. Howard Weiner

Dr. Howard L. Weiner is the Robert L. Kroc

Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director

of the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital in Boston. He has pioneered immunotherapy in

MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer's disease, amyotrophic lateral sclerosis,

stroke and brain tumors. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and

other diseases and the use of anti-CD3 to induce Tregs for the treatment of these diseases.

About Dr. Tanuja Chitnis

Dr. Tanuja Chitnis is a Professor of Neurology

at the Harvard Medical School, and Director of the Translational Neuroimmunology Research Center at Brigham & Women's Hospital

in Boston. She has led studies including the testing of nasal Foralumab in healthy volunteers and a study of fingolimod in pediatric

MS that led to FDA approval.

About Harvard Medical Centre

Brigham and Women's Hospital (BWH) is located

adjacent to Harvard Medical School, of which it is the second largest teaching affiliate. It is the largest hospital of the Longwood

Medical and Academic Area in Boston, Massachusetts, USA. With Massachusetts General Hospital, it is one of the two founding members

of Partners HealthCare, the largest healthcare provider in Massachusetts. BWH conducts the second largest hospital-based research

program in the world, with an annual research budget of more than $630 million. Pioneering milestones include the world's first

successful heart valve operation and the world's first solid organ transplant.

About Neurodegenerative diseases

diseases include Alzheimer's, multiple sclerosis, Huntington's disease, Parkinson's disease, ALS and others. Among

these, Alzheimer's is the most prevalent disease. In 2013 the global market for AD was 4.9 billion and expected to rise to

13 billion by the end of 2023. Current treatments for neurodegenerative diseases are mainly symptomatic, but new disease-modifying

drugs to slow or stop the progression of the disease are now emerging. Three AChE inhibitors are currently in use for AD, i.e.

donepezil (Aricept), rivastigmine (Exelon) and galantamine (Reminyl) and cladribine (Mavenclad) for MS. It

is recognized that inflammation plays a critical role in neurodegenerative diseases of the CNS. Immune-directed therapies for neurodegenerative

diseases target immune system cells such as the T cells that cause inflammatory and autoimmune disease in MS and microglia in ALS

and show promise. It has been shown in animal models of progressive MS that anti-CD3 antibody targeting T cells ameliorates disease.

These effects were shown to be IL-10 dependent, mediated by regulatory T cells leading to suppression of the disease. There is

great promise in ongoing studies of inflammation-targeted neuroprotective strategies, which may ultimately be used across neurodegenerative

About Tiziana Life Sciences

Tiziana 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 mAbs in clinical development

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

disease (CD), 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

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

The person who arranged for the release of

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