Tiziana Life Sciences plc ("Tiziana Life Sciences" or the "Company") Tiziana Life Sciences Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy in Advanced Sorafenib-re

Life Sciences" or the "Company")

Life Sciences Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy in Advanced

Sorafenib-refractory or -intolerant Patients with Unresectable or Metastatic Hepatocellular Carcinoma

York, 4 September 2019 - Tiziana Life Sciences plc (NASDAQ: TLSA), a biotechnology company focusing on the discovery

and development of innovative therapeutics for inflammation and oncology indications, today announced additional positive Phase

2a clinical data exhibiting impressive clinical activity of Milciclib monotherapy in patients with advanced Sorafenib-resistant

or -intolerant patients with unresectable or metastatic hepatocellular carcinoma (HCC).

Phase 2a multi-center, single-arm, repeated-dose (100 mg once daily; 4 days on/3 days off for 4 weeks; defining each cycle) and

6-month duration study was conducted to evaluate the safety, tolerability and anti-tumor activity of Milciclib in Sorafenib-resistant

patients with unresectable or metastatic advanced HCC. The trial enrolled 31 patients in Italy, Greece and Israel, of which 28

patients were evaluable. While the primary endpoint of this study was overall safety, secondary endpoints were also evaluated.

previously announced on 22 July 2019, the clinical data from the Phase 2a trial indicated that Milciclib was well tolerated with

manageable toxicities and no recorded drug related deaths, thereby meeting the trial's primary endpoint. The Company now

announces all the major highlights of the clinical data from the trial, which also indicate positive clinical activity relating

to the secondary endpoints including progression-free survival ("PFS") and time to progression ("TTP").

HIGHLIGHTS OF THE CLINICAL DATA

per the study 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).

(Bayer) was approved, based on the clinical data from the pivotal Phase 3 (SHARP) clinical trial1, as the first line

therapy for naive HCC patients. The clinical data from that study showed median TTP of 5.5 months (95% CI 4.1-6.9 months), CBR

of 43% and 71% SD by RECIST criteria1. Conversely, the clinical data from a phase 2 trial with Sorafenib in

patients with advanced HCC, showed SD (33.6%), TTP of 4.2 months and median OS of 9.2 months2.

was approved, based on the clinical data from the pivotal Phase 3 (RESORCE) clinical trial3, as the second line

therapy for sorafenib-resistant HCC patients. In this study, Regorafenib showed median PFS of 3.1 months (95% CI 2.8-4.2 months),

median TTP of 3.2 months (95% CI 2.9-4.2 months) and disease control rate (DCR, similar to CBR) of 65% by mRECIST. On the other

hand, the clinical data from a Phase 2 study in patients with intermediate and advanced HCC, Regorafenib showed median TTP of

4.3 months (95% CI 2.9-13.1 months), SD (69%) and PR was 3%4.

current therapies for HCC are often associated with severe toxicities, resulting in poor patient compliance. Hence, there is an

immediate need for efficacious therapies that will not compromise patients' quality of life. We believe that the overall

safety profile of Milciclib is an important competitive advantage over existing therapies currently used for treating HCC"

said Gabriele Cerrone, Chairman and founder of Tiziana Life Sciences.

positive clinical activity and tolerability data of Milciclib in Sorafenib-resistant and advanced HCC patients are very encouraging

and provides affirmation for continued development of Milciclib, either as monotherapy or combination therapy" said Dr. Kunwar

Shailubhai, CEO & CSO of Tiziana. "We reported last year at AASLD that Milciclib produced pronounced synergistic anti-HCC

activity in combination with any one of the FDA approved tyrosine kinase inhibitor (TKI) class of drugs, including Sorafenib (Nexavar ),

Regorafenib (Stivarga ), and Lenvatinib (Lenvima )5. Thus, we believe that Milciclib in combination

with any one of the TKI drugs has good potential to expand the Clinical Benefit Rate in HCC patients."

person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

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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.

is the fifth most common cancer and the third highest cause of cancer mortality worldwide. The primary risk factor for HCC is

hepatic cirrhosis. Between 2003 to 2012, rates of new liver cancer cases went up 38% according to the Centers for Disease Control

and Prevention. Most HCC patients present with advanced disease and do not benefit from transplantation, surgical resection, or

locoregional therapies. Sorafenib (standard of care) and Lenvatinib are approved in the United States and EU as first line-treatment

for advanced HCC patients.

(Stivarga ) and Nivolumab (Opdivo ) are both approved by the FDA for second line treatment of advanced 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).

(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.

Tiziana Life Sciences

Life Sciences plc is a 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.