LONDON, UNITED KINGDOM--(Marketwired - Jun 7, 2016) - Tiziana Life Sciences PLC (AIM: TILS)


Tiziana Life Sciences PLC

("Tiziana" or the "Company")

Final Results for the year ended 31 December 2015

June 07, 2016 - Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, today announces its Final Results for the year ended 31 December 2015.

Highlights during the period:

  • £12.8m (gross) raised through placing of shares and convertible loan notes
  • Licensed milciclib, which is currently in phase II clinical trials for thymoma cancer in patients previously treated with chemotherapy, from Nerviano Medical Sciences
  • Acquired 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
  • Acquired exclusive licence to a novel and currently the only fully human engineered anti-human CD3 antibody for treatment autoimmune diseases
    • Phase II asset with potential applications in a wide range of autoimmune and inflammatory diseases
  • James (Jim) Tripp appointed Chief Operating Officer
  • Dr. Kunwar Shailubhai and Willy Simon appointed to the Board as non-executive directors
  • Company director Riccardo Dalla-Favera elected to the U.S. National Academy of Sciences
  • Group loss for the year of £8.63m (2014: £3.33m*)
  • The Group ended the period with £8.90m cash as at 31 December 2015 (2014: £2.27m)

*as adjusted, see note 2

Post period highlights:

  • £709,406 raised through the issue of unsecured convertible loan notes to existing investors
  • Tiziano Lazzaretti appointed Chief Financial Officer
  • Professors Kevan Herold and Howard Weiner to Scientific Advisory Board, providing key leadership and experience in CD3 clinical development
  • Clinical development team expanded with the appointment of Robert Evans as Vice President of Clinical Sciences
  • Announced plans for further development of foralumab in two clinical indications: 1) graft vs host disease, and 2) ulcerative colitis
  • Research agreement with Cardiff University has led to the identification of lead clinical candidate, CB1, a Bcl-3 inhibitor with potent anti-metastatic activity, and impressive in vivo efficacy and safety profile
    • Investigational New Drug application to be filed in 2016, expecting to move into clinical trials before the end of the year

Gabriele Cerrone, Chairman and founder of Tiziana, commented:

"2015 was an important year for Tiziana as the Company continued to build and strengthen its portfolio of therapeutics to treat patients with significant unmet medical needs. We are focusing on two distinct disease areas: rare cancers and difficult to treat autoimmune diseases; and the addition of milciclib to our portfolio, as well as the acquisition of foralumab at the end of 2014, gives the Company two phase II candidates. We also remain on-track to progress our lead candidate in our Bcl-3 programme into the clinic in late 2016 or early 2017. The funds raised throughout the year demonstrate the confidence our shareholders have in Tiziana and we look forward to generating further shareholder value going forward."


Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder
+44 (0)20 7493 2853
Cairn Financial Advisers LLP
(Nominated adviser)
Liam Murray
  +44 (0)20 7148 7900
Beaufort Securities Limited (Broker)
Saif Janjua
  +44 (0)20 7382 8300
FTI Consulting
Simon Conway / 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 molecules that treat human disease in oncology and immunology.

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 thymic carcinoma in patients previously treated with chemotherapy and preparing and IND to enroll patients in an exploratory trial in Hepatic Cellular Carcinoma (HCC).

The Company is also in clinical development of foralumab. Foralumab is the only fully human engineered anti-human CD3 antibody in clinical development. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as 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.

Tiziana Life Sciences' clinical development teams are working on its Bcl-3 candidate; which 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 and has also determined that Bcl-3 inhibition suppresses cell motility in triple-negative, HER-2-positive PR- and ER-positive 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. The Company is preparing the IND package with the intention of progressing to clinical trials this year.

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This information is provided by RNS
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