Tiziana Life Sciences Plc Release: Interim Results For The Six Months Ended 30 June 2015

Building momentum to develop innovative drugs for treatment of cancer and autoimmune diseases

London, 30 September 2015 – Tiziana Life Sciences plc (“Tiziana”, AIM: TILS), 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 ended 30 June 2015.

Highlights during the period:

• £8.3m (gross) raised through placing of shares and convertible loan note including:
o £2.7m raised through a share placing in March 2015; and
o £5.6m through convertible loan note in April 2015
• Acquires exclusive licence from Nerviano Medical Sciences, for milciclib, a small molecule drug candidate, which blocks the action of specific enzymes called cyclin-dependent kinases (“CDKs”), which are involved in cell division as well as a number of other protein kinases. Milciclib has been granted orphan designation by the European Commission and by the U.S. Food and Drug Administration for the treatment of malignant thymoma / thymic epithelial tumour. It has also been shown in preclinical studies that milciclib has potential in other cancer indications, in particular liver cancer and breast cancer. Milciclib is currently in advanced stages of clinical development for treatment of thymoma cancer in human. Additional plans to further explore its potential for treatments of hepatocellular carcinoma and breast cancer are underway
• Acquires exclusive licence to a novel anti-cancer stem cell agent, capable of targeting aggressive tumour forming cells originating from the breast, pancreas, colon and prostate, from Cardiff University scientists
• Acquires exclusive licence to a novel and currently the only fully human engineered anti-human CD3 antibody for treatment autoimmune diseases. This phase II asset has potential applications in a wide range of autoimmune and inflammatory diseases
• Company director Riccardo Dalla-Favera has been elected to the U.S. National Academy of Sciences
• Professor Chris McGuigan and Dr Kunwar Shailubhai appointed to the Board
• For the six months to 30 June 2015 the consolidated Group made a loss of £4.11m
• The Group ended the period with £6.96m cash as at 30 June 2015

Gabriele Cerrone, Chairman and founder of Tiziana, commented:

“Tiziana Life Sciences has had a successful six months. We have built on our strong end to last year and the funds raised have enabled us to significantly bolster our pipeline, which now addresses several areas of significant unmet medical need in both cancer and autoimmune diseases. Looking ahead, we are confident of being well positioned to progress these programmes to their next respective value inflection points.”

Contacts:

Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder
+44 (0)20 7493 2853
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray / Avi Robinson
+44 (0)20 7148 7900
Beaufort Securities Limited (Broker)
Saif Janjua
+44 (0)20 7382 8300
FTI Consulting
Simon Conway / Rob Winder / Natalie Garland-Collins
+44 (0)20 3727 1000

About Tiziana Life Sciences

Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel drug candidates for treatment of cancer and autoimmune diseases in humans.

In May 2015, the Company entered in an exclusive licence from Cardiff University scientists relating to a novel anti-cancer stem cell agent, capable of targeting aggressive tumour forming cells originating from the breast, pancreas, colon and prostate.

In January 2015, the Company entered into an exclusive licence from Nerviano Medical Sciences relating to milciclib, a small molecule drug candidate, 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 in phase II clinical trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy.

The Company also in-licensed another clinical asset Foralumab in December 2014 from Novimmune. Foralumab is currently the only fully human engineered anti-human CD3 antibody in clinical development. This phase II asset has potential applications in a wide range of autoimmune and inflammatory diseases, such as multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

Tiziana Life Sciences’ research team has discovered that Bcl-3 has a prominent role in the metastasis of mammary cancers, and has elucidated the mechanism of Bcl-3 action to be a regulator of cancer cell motility. Tiziana has also determined that Bcl-3 inhibition suppresses cell motility in triple-negative and other breast cancer sub-types, suggesting that Bcl-3 may be a master regulator of this metastatic property not only in aggressive breast cancers, but across the clinical spectrum of breast disease. Triple negative breast cancer (testing negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-), is an unmet medical needs with high mortality rates. Metastatic spreading of the cancer is the single most important cause of the high mortality. Our technology with drug candidate inhibiting specifically Bcl-3 is an innovative approach to suppress growth of metastases.

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