TILS.L Regulatory News (TILS)

Tiziana Life Sciences plc

("Tiziana" or "the Company")

Final Results and Notice of AGM

Building Momentum

London, 05 June 2015 - Tiziana Life Sciences plc ("Tiziana", AIM: TILS), the 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 2014 and provides Notice of its AGM.

Highlights during the period:

· Shares began trading on the AIM market of the London Stock Exchange on 24 April 2014 through reverse acquisition of Alexander David Investments plc

o £2.73m (gross) raised through placing of shares and convertible loan note

o Further £1.45m raised through convertible loan note in June 2014

· Acquires exclusive license from Novimmune, for clinical stage asset, foralumab, a fully human antihuman CD3 receptor monoclonal antibody (CD3 mAb) broadening pipeline into inflammatory diseases

· Licensing agreement with TTFactor S.r.l. to develop stem cell based breast cancer diagnostics

· Gabriele Cerrone and Dr Riccardo Dalla-Favera appointed to the Board

· Dr Napoleone Ferrara was appointed as Chairman of the Scientific Advisory Board and Professor Pier Paolo Di Fiore and Professor Roberto Pellicciari were appointed as a members of the Scientific Advisory Board

· Loss for the year of £3,570,000 (2013: nil). Year-end Group cash balance at 31 December 2014 was £2,266,000 (2013: nil)

Post period highlights:

· Licensed milciclib, which is currently in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy, from Nerviano in January 2015

· Placing of shares to raise £2.55m (gross) in March 2015

· Issued £6.14m Convertible Loan Notes in April 2015

· Licenses anti-cancer stem cell technology from the University of Cardiff in May 2015

· Professor Chris McGuigan and Dr Kunwar Shailubhai appointed to the Board

Gabriele Cerrone, Chairman and founder of Tiziana, commented:

"Tiziana Life Sciences has had a successful first year as a publicly listed Company and we exited the period with strong momentum. We significantly bolstered our pipeline, which now addresses several areas of significant unmet medical need in both cancer and inflammatory disease. Looking ahead, we are confident of being well positioned to progress these programmes to their next respective value inflection points."

Contacts:

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.

In January 2015, the Company entered into an exclusive licence from Nerviano Medical Sciences relating to 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 in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy.

The Company also in-licensed another clinical asset in December 2014 from Novimmune. Foralumab is the only fully human engineered anti-human CD3 antibody in clinical development. This phase II asset has potential application 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, 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.

Executive Chairman's statement

I am pleased to report on the Company's results for the year ended 31st December 2014.

Background

Tiziana Pharma Ltd (TPL), Tiziana Life Sciences plc's operating subsidiary, was established in November 2013 with the aim of developing novel therapeutics for cancer with a focus on late stage metastases. TPL, founded on research from the European Cancer Stem Cell Institute, University of Cardiff, identified the B-cell Lymphoma 3 (Bcl-3) gene as a potential drug target to halt cancer metastasis, where malignant tumours spread to other parts of the body, a process typically associated with poor patient prognosis. TPL entered into an agreement with the European Cancer Stem Cell Institute for the exclusive worldwide license to any compound with potential therapeutic application against Bcl-3.

On 24th April 2014 Tiziana Life Sciences plc (the Company; Tiziana) began trading on AIM under the ticker symbol "TILS" following the completion of the reverse acquisition of Alexander David Investments plc and concurrent name change to Tiziana Life Sciences plc. The Company issued 16,666,667 ordinary shares at a price of 12p through a placing to new investors raising £2m and a convertible loan note raising £0.73m to complete the reverse acquisition. On the first day of trading the Company's shares closed at 27.50 pence.

Licensing Agreements

In addition to the license with the University of Cardiff for Bcl-3, at the end of June 2014, TTFactor S.r.l. (TTFactor) granted Tiziana an exclusive licensing agreement covering the use of 20 defined stem cell markers (the "TOP 20") for patient stratification in breast cancer. TTFactor is the technology transfer company of the European Institute of Oncology and the Italian Foundation for Cancer Research (FIRC), Institute of Molecular Oncology. The TOP 20 model is a gene expression signature capable of predicting disease aggressiveness and prognosis in breast cancer patients.

During the second half of the financial year the Company entered into negotiations with two organisations, Novimmune SA and Nerviano Medical Sciences Group, to acquire two different assets that already had some clinical validation and therefore would add to the Company's value proposition. The license agreement with Novimmune S.A., a company focused on the discovery and development of antibody-based drugs to benefit patients with inflammatory, auto-immune disorders, and cancer, was concluded on 20 December 2014. The agreement provides the Company with an exclusive license for the clinical development and commercialisation of foralumab, a fully human antihuman CD3 receptor monoclonal antibody (CD3 mAb) and broadens the Company's interests beyond oncology to include inflammatory diseases.

Since the financial year end the Company has signed two more license agreements. It concluded negotiations with Nerviano. On 20th January 2015, Nerviano, an Italian company dedicated to the discovery and development of breakthrough treatments for cancer, exclusively licensed milciclib to the Company. Milciclib 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 is currently in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy. Milciclib has demonstrated that it is well tolerated in over 263 patients in phase I and II clinical trials and has been granted orphan designation by the European Commission and by the U.S. Food and Drug Administration ("FDA") for the treatment of malignant thymoma / thymic epithelial tumours. Subject to successful completion of the ongoing phase II trials, Tiziana is committed to initiate a phase III study in this indication in 2016.

Most recently, on 7th May 2015, the Company signed an agreement with the University of Cardiff to license their anti-cancer stem cell technology. The novel agent, known as OH14, is an inhibitor of c-FLIP (cellular FLICE (FADD-like IL-1β-converting enzyme)-inhibitory protein), a known suppressor of apoptosis (programmed cell death). c-FLIP acts inside the cell by preventing the instructive cell death that occurs when a signal protein produced by neighbouring cells attaches to the target cell's surface. c-FLIP blocks this death signal from entering the cell. Suppression of apoptosis is a recognised driver of cancer cell proliferation, thus by inhibiting this suppression it should be possible for cell death to occur and proliferation of cancer to be thwarted. Under the terms of the agreement, Tiziana will fund a research project at the University focused on building the structure activity relationships (SARs) around OH14 and to improve the activity of this series of compounds.

We therefore now have a total of two research projects and two clinical programmes together with research into a cancer stem cell diagnostic as a solid foundation for the Company's growth.

Financial summary

Group Income Statement

The Group has made a loss for the year of £3,570,000 (2013: nil). The loss is detailed in the consolidated statement of comprehensive income.

Balance Sheet

At the end of the year the Group cash balance amounted to £2,266,000 (2013: nil) and the total assets of the Group amounted to £2,400,000 (2013: nil).

The lack of comparable income statement and balance sheet data in 2013 is due to the accounting treatment of the reverse acquisition and is explained in the accounting policies note in the notes to the consolidated financial statements.

Post year end fund raising

On 31st March 2015, Tiziana Life Sciences plc raised £2.55m through the issue of 3.4m ordinary shares through a placing to new investors at a price of £0.75 per share.

On 21st April 2015, Tiziana Life Sciences plc entered into an agreement to issue £6.14m of Investor Convertible Loan Notes: Tranche C. The notes, plus accrued interest are redeemable by the holders any time after 25th June 2016, and will be redeemed at the election of the Company in cash, or by conversion into new ordinary shares at a conversion price of £0.70 per share at the election of the note holders. Further details of the post year end fund raising can be found at Note 24 Post Balance Sheet Events.

Appointments

Board of Directors

On 24th April 2014 the Company appointed Gabriele Cerrone and Dr Riccardo Dalla-Favera to the Board.

Mr Cerrone has a successful track record and extensive experience in the financing and restructuring of micro-cap biotechnology companies. He has founded nine biotechnology companies in oncology, infectious diseases and molecular diagnostics, and has taken six of these companies to the Nasdaq Market and one to the AIM Market in London. Mr Cerrone co-founded Trovagene, Inc. (NASDAQ: TROV), a molecular diagnostic company and served as its Co-Chairman; he was a co-founder and served as Chairman of both Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) and Callisto Pharmaceuticals, Inc. (OTCMKTS: CLSP), and was a Director of and led the restructuring of Siga Technologies, Inc. (NASDAQ: SIGA). Mr Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman of the Board until its merger in September 2007 with Inhibitex, Inc. Mr Cerrone served as a Director of Inhibitex, Inc. until its US$2.5bn sale to Bristol Myers Squibb Co in 2012. Mr Cerrone is the Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics company focused on oncology using microRNA technology; Chairman and Co-Founder of Rasna Therapeutics Limited, a company focused on the development of therapeutics for leukaemias; Co-Founder of ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV); and founder of BioVitas Capital Ltd.

Dr Riccardo Dalla-Favera obtained his MD from the University of Milan, Italy in 1976. Following his residency in Haematology, Dr Dalla-Favera joined the National Cancer Institute of USA as a visiting fellow. He joined the New York University of Medicine as an assistant Professor in 1983 and then moved to Columbia University College of Physicians and Surgeons in 1991. Here he helped to found the Institute for Cancer Genetics and has been its Director since 1999. Dr Dalla-Favera was a Director of the Herbert Irving Comprehensive Cancer Centre (HICCC) from 2005 to 2011 and the Percy and Joanne Uris Professor of Pathology and Genetics & Development. He served as the Chair of the Scientific Advisory Board of the Yale Cancer Centre. He served as the Co-Chair of the National Centre Institute Program Review Group for Leukaemia, Lymphoma and Myeloma, as a member of the Board of Scientific Counsellors of the National Institute of Environmental Health and of the National Cancer Institute. He has been a Member of Scientific Advisory Board at TrovaGene, Inc., since April 2010. He serves as a Member of Scientific Advisory Board at Xigen SA. He serves as a Member of Scientific Advisory Board at Cancer Genetics, Inc. and served as its Director till 2011. Dr Dalla-Favera served as a Director of Callisto Pharmaceuticals Inc. from June 30, 2005 to April 15, 2011. He served as a Director at Synergy Pharmaceuticals, Inc. until April 2011.

Dr Dalla-Favera has been a leader in the field of molecular oncology and has made fundamental contributions to the field of cancer, especially in the study of the molecular genetics of B cell malignancies. As a researcher, he has contributed much of the current knowledge on the genetic lesions responsible for human B cell lymphoma, which have led to the development of diagnostic tests and are being tested as targets in clinical trials with lymphoma patients. He has been awarded numerous prizes for his research including the 2007 William Dameshek Prize from the American Society of Hematology, The 2009 San Salvatore Foundation Prize for Outstanding Achievements in Lymphoma Research, and the 2014 Oncomed Giants of Cancer Care Award. He is an elected member of Institute of Medicine of The National Academy of Sciences, USA.

On 23rd January 2015 the Company appointed Professor Chris McGuigan to the Board. Professor McGuigan is Chairman of Life Sciences Hub Wales Limited, Professor of Medicinal Chemistry, School of Pharmacy and Pharmaceutical Sciences, Cardiff University and Director of the National Research Network in Health and Life Sciences of the Welsh Government. He is also on the boards of Synergy Pharmaceuticals and ContraVir Pharmaceuticals, both New York biotechnology companies listed on NASDAQ and on the scientific advisory board of Nucana Biomed, an Edinburgh based company with assets in clinical trials. To date Professor McGuigan has invented three new agents that have reached clinical trials, with peak value of US$3bn. He has over 220 peer reviewed scientific publications with over 100 patents filed.

Also on 23rd January 2015 the Company appointed Dr Kunwar Shailubhai to the Board. Dr Shailubhai is a Co-Founder and Chief Scientific Officer of Synergy Pharmaceuticals, Inc. (previously senior vice president), a NASDAQ-listed biotechnology company focusing on innovative therapeutics for treatment of gastrointestinal disorders and diseases, and colon cancer. Dr Shailubhai has held leadership positions at Monsanto Life Sciences Company (St. Louis, MO), where he worked on a number of projects in inflammatory diseases, and Callisto Pharmaceuticals. Dr Shailubhai previously served as a Senior Staff Fellow at the National Institutes of Health and as an Assistant Professor at the University of Maryland. Dr Shailubhai has 17 issued patents, several pending patent applications and 40 research publications in journals of international repute.

Scientific Advisory Board

Professor Pier Paolo Di Fiore was appointed as a member of the Scientific Advisory Board and consultant to the Company on 1st February 2014. Prof Di Fiore, a recognised specialist in molecular oncology and cell biology, is the inventor of the TOP 20 model. He is a Full Professor at the University of Milan in Italy and a Director of Molecular Medicine at the European Institute of Oncology in Cardiff. Prof Di Fiore is also the Senior Editor of The Journal of Cell Biology, and Associate Editor of Cell.

Dr Napoleone Ferrara was appointed as Chairman of the Scientific Advisory Board and consultant to the Company on 19th May 2014. Dr Ferrara's research into the process of angiogenesis led to the development and subsequent commercialisation of the anti-VEGF (vascular endothelial growth factor) Avastin®, a drug that is now used in a broad range of cancers in combination with chemotherapy. Additionally, his studies of the role of VEGF in intraocular neovascularisation led to the development and commercialisation of Lucentis®, a treatment for age-related macular degeneration, a leading cause of blindness in the elderly.

Professor Roberto Pellicciari was appointed as a member of the Scientific Advisory Board and consultant to the Company on 12th September 2014. Prof Pellicciari was the co-founder and is the current Head of Medicinal Chemistry at Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT), a clinical stage biopharmaceutical company focused on the development and commercialisation of novel bile acid therapeutics to treat chronic liver and intestinal diseases. Professor Pellicciari is Professor of Medicinal Chemistry at the University of Perugia in Italy, he has held a number of prestigious scientific posts and has an international reputation in molecular design, synthesis, mechanism of reaction, and modelling, with over 300 publications in international journals and 40 patents granted.

Outlook

All of the Company's programmes address areas of significant unmet medical need; either as a potential new approach to metastatic cancer with Bcl-3 or stratification of patients to provide more personalised treatment with the "TOP 20", to new molecules to help sufferers of thymic and other cancers (milciclib), or a fully human monoclonal antibody with potential application in a number of autoimmune and inflammatory diseases (foralumab). Now with the latest in-licensing of anti-cancer stem cell technology from the University of Cardiff (c-FLIP) the Company has an innovative research portfolio with two clinical assets. These programmes will use the funds raised in the March and April 2015 fundraisings to reach the individual programme's inflection points.

Gabriele Cerrone

Executive Chairman

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME FOR THE YEAR ENDED 31 DECEMBER 2014

CONSOLIDATED STATEMENT OF FINANCIAL POSITION FOR THE YEAR ENDED 31 DECEMBER 2014

The financial statements were approved by the Board of Directors and authorised for issue on 3rd June 2015

COMPANY STATEMENT OF FINANCIAL POSITION FOR THE YEAR ENDED 31 DECEMBER 2014

The financial statements were approved by the Board of Directors and authorised for issue on 3rd June 2015

CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE YEAR ENDED 31 DECEMBER 2014

COMPANY STATEMENT OF CASH FLOWS FOR THE YEAR ENDED 31 DECEMBER 2014

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE YEAR ENDED 31 DECEMBER 2014

COMPANY STATEMENT OF CHANGES IN EQUITY FOR THE YEAR ENDED 31 DECEMBER 2014

EARNINGS PER SHARE

Basic earnings per share is calculated by dividing the profit attributable to equity holders of the company by the weighted average number of ordinary shares in issue during the year.

As the Group is reporting a loss from continuing operations for the year then, in accordance with IAS 33, the share options are not considered dilutive because the exercise of the share options would have an anti-dilutive effect. The basic and diluted earnings per share as presented on the face of the income statement are therefore identical. All earnings per share figures presented above arise from continuing and total operations and therefore no earnings per share for discontinued operations are presented.

Availability of Report and Accounts and Notice of Annual General Meeting

The Company has posted its audited Report and Accounts to 31 December 2014 and Notice of AGM to shareholders. The AGM will be held at Mishcon de Reya, Summit House, 12 Red Lion Square, London WC1R 4QD on 30 June 2015 at 10:30 a.m.. A copy of the Report and Accounts and Notice of AGM is available to be downloaded from the Company's Rule 26 website at www.tizianalifesciences.com.