Released : May 23, 2017

RNS Number : 8921F

Tiziana Life Sciences PLC

23 May 2017

 

Tiziana Life Sciences plc

("Tiziana" or "the Company")

 

Financial Results for the Year Ended 31 December 2016

 

Strong progress continues across clinical and pre-clinical programmes

 

London, 23 May 2017 - Tiziana Life Sciences plc ("Tiziana", AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and autoimmune diseases, today announces its financial results for the year ended 31 December 2016.

 

Highlights during the period:

 

RESEARCH & DEVELOPMENT

 

·      Foralumab

-    A key milestone achieved with foralumab as new data demonstrated oral efficacy in humanized mouse models.

-    Clinical development plan for foralumab outlined with initial focus in two clinical indications: graft vs host disease and non-alcoholic steatohepatitis (NASH).

 

·      Milciclib

-    Continuing to progress through phase II trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy.

 

·      TZLS-101

-    Research agreement with Cardiff University, focused on developing Bcl-3 inhibitors as potential drugs to treat cancer, has led to the identification of a first-in-class lead clinical candidate, CB1, with potent anti-metastatic activity, and with an impressive in vivo efficacy and safety profile. 

-    Partnership recognised as the winner of the Innovation in Healthcare category at Cardiff University's Innovation and Impact Awards 2016.

 

·      TZLS-214 / c-FLIP

-    Currently under analysis to identify a lead candidate.

 

·      StemPrinter

-    Currently under analysis with more operational details expected later this year.

 

·      LonGevia

-    Unique bio-repository of local samples and data from Sardinian company Shardna SpA acquired in July 2016.

-    Residents of Sardinia are among the world's longest living people, with on average 5x greater likelihood of reaching age 100 compared with the USA.

-    The Group has established LonGevia Genomics Srl, a regional subsidiary specifically to develop these assets to identify novel drug targets and diagnostic applications.

 

LEADERSHIP

 

·      Highly experienced executives joined senior leadership team and Scientific Advisory Board:

-    Tiziano Lazzaretti appointed as Chief Financial Officer, formerly Group Finance Director at Pharmentis.

-    Professors Kevan Herold and Howard Weiner joined the Scientific Advisory Board, providing key leadership and experience in CD3 clinical development.

 

FINANCIAL

 

·      £0.71m (gross) raised through a convertible loan note in January 2016.

·      In April 2016 and June 2016, Tiziana received notice from warrant holders to exercise warrants raising £0.22m and £0.07m respectively.

·      For the year to 31 December 2016 the consolidated Group made a loss of £7.21m (2015: £8.63m).

·      The Group ended the period with £4.70m cash as at 31 December 2016 (2015: £8.90m). 

 

POST PERIOD

 

·      TZLS-501 (Anti-IL6R)

-    Exclusive world-wide licence for NI-1201 (now TZLS-501), a fully human anti-interleukin-6 receptor (IL-6R) monoclonal antibody (mAb), acquired from Novimmune SA.

-    Currently in pre-clinical development for multiple myeloma.

 

·      Dr. Arun Sanyal appointed as a new member of the Scientific Advisory Board.

 

Gabriele Cerrone, Chairman and founder, commented: "We are proud of our achievements over the last twelve months. We have continued to make progress with our pipeline of drugs, which now addresses several areas of unmet medical need in both cancer and autoimmune diseases. In particular, we have outlined our clinical development plan for foralumab in graft vs host disease and NASH; and we are making good progress with milciclib, which is currently in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy, and for hepatocellular carcinoma. 2017 is set to be an important year for Tiziana and the Board remains 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 / Jo Turner	+44 (0)20 7213 0880
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. 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 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.

 

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

 

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

 

 

EXECUTIVE CHAIRMAN'S STATEMENT

 

I am pleased to report on the Company and its subsidiaries, together the 'Group', results for the year ended 31^st December 2016.

 

Background

 

Tiziana Life Sciences plc is a UK AIM-listed biotechnology company (AIM:TILS) focused on the discovery and development of next generation therapeutics for cancers and immune diseases in man. The Group combines field-leading medical scientists, providing deep knowledge and novel insights into disease mechanisms, together with a highly experienced clinical development team. Since its foundation in 2013, Tiziana Life Sciences has expanded its pipeline of assets to include clinical stage development therapeutic candidates in both oncology and immunology, as well as a pre-clinical drug discovery pipeline of small molecule New Chemical Entities. 

 

Clinical Programmes

 

The Group's approach is to target large markets with high-unmet medical need. Driven by an obesity epidemic, non-alcoholic fatty liver disease (NAFLD) has become the most common liver disease, affecting one-third of the Western world. Between 3 and 5% of patients progress to a more severe form of disease, non-alcoholic steatohepatitis (NASH), which is predicted to become the leading cause of liver transplantation in USA by 2020.

 

The race for therapeutics that address the market for NASH, which is estimated to reach £16.2 billion by 2025 (10.7% CAGR from 2015 to 2025), has led to a flurry of acquisitive activity in 2016 with four announced deals, totalling more than £2.3 billion in value. Around 20% of NASH patients progress further to cirrhosis of the liver, which may ultimately develop into lethal hepatocellular carcinoma (HCC), the primary cause of obesity-related cancer death in middle-aged men in the USA. No currently approved drugs for HCC exist - liver transplant being the only option for end-stage patients.

 

Tiziana Life Sciences has two lead clinical programmes:

 

Foralumab (TZLS-401 / NI-0401)

Foralumab is a fully human engineered anti-CD3 monoclonal antibody (mAB). It was in-licensed in December 2014 from Novimmune. Also in January 2016, Tiziana outlined its clinical development plan for foralumab with initial plans to evaluate foralumab in two clinical indications: non-alcoholic steatohepatitis (NASH) and graft vs host disease (GvHD).

 

As the only fully human engineered anti-human CD3 mAB in clinical development, foralumab has significant potential with advantages of short duration of treatment regimen and reduced immunogenicity. With phase IIa development for Crohn's Disease completed, modulation of T-cell response provides potential extension into a wide range of other autoimmune and inflammatory diseases, such as GvHD, ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis.

 

Foralumab is being developed as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to orchestrate an immune response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential for foralumab to be combined with another of the Group's assets, TZLS-501, a fully human anti-IL-6R mAB in development to target Crohn's disease, NASH and primary biliary cholangitis (PBC).          

 

In November 2016, the Group announced new data for oral efficacy in humanized mouse models with foralumab, a major milestone and a potential breakthrough for treatment of NASH and autoimmune disease. This unique oral technology stimulates the natural gut immune system and potentially provides a therapeutic effect in inflammatory and autoimmune diseases with apparently greatly reduced toxicity. Positive therapeutic effects with foralumab were consistently demonstrated in animal studies conducted by Prof. Kevan Herold (Yale University) and Prof. Howard Weiner (Harvard University).

 

Milciclib (TZLS-201)

Milciclib, the Group's lead compound, was exclusively licensed in January 2015 from Nerviano Medical Sciences. Milciclib blocks the action of a set of enzymes called cyclin-dependent kinases (CDKs) involved in cell division processes that are key to the progression of cancers.

 

Prior to in-licensing, 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. Milciclib is currently in phase II clinical trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy, and for hepatocellular carcinoma.       
 

Pre-Clinical Programmes

 

In pre-clinical development, the Group has two programmes:

 

TZLS-501 (Anti-IL6R)

TZLS-501 is a fully human anti IL-6R monoclonal antibody, acquired from Novimmune, with a novel mechanism of action targeting multiple myeloma. The mAb possesses a high affinity for IL-6R and the IL-6/IL-6R complex and effectively blocks the complex even at high IL-6 circulating levels, showing superiority and overcoming the limitations of other IL-6 pathway drugs. Therefore, TZLS-501 demonstrates a decreased potential for adverse events with improved efficacy in patients with high circulating levels of IL-6 and controlling chronic inflammation in diseases such as multiple myeloma, rheumatoid arthritis and other autoimmune diseases.

 

StemPrinter

StemPrinter, a diagnostic kit for triple negative breast cancer, is currently under analysis, with more details expected later this year.

 

Other early-stage therapeutic and diagnostic technologies under evaluation

 

TZLS-101

In January 2016, the Group announced that its research agreement with Cardiff University, focused on pioneering the development of Bcl-3 inhibitors as potential drugs to treat cancer, has led to the identification of a first-in-class lead clinical candidate, CB1 (TZLS-101), with potent anti-metastatic activity, and with an impressive in vivo efficacy and safety profile. Metastatic spreading of cancers is the single most important cause of their high mortality. This partnership was recognised as the winner of the Innovation in Healthcare category at Cardiff University's Innovation and Impact Awards 2016.

 

TZLS-214

Tiziana's novel anti-cancer stem cell agent, TZLS-214 / c-FLIP is currently under analysis.

 

LonGevia

In July 2016, Tiziana acquired a unique bio-repository of local samples and data from a Sardinian company, Shardna SpA. Residents of Sardinia are among the world's longest living people, with on average five times greater likelihood of reaching age 100 compared with the USA. The Group has established LonGevia Genomics Srl, a regional subsidiary specifically to develop these assets to identify novel drug targets and diagnostic applications through leveraging next generation gene sequencing and state of the art "-omics" technologies.

 

Financial summary

 

Consolidated Statement of Comprehensive Income

The Group has made a loss for the year of £7,208k (2015: £8,632k). The loss is detailed in the consolidated statement of comprehensive income.

 

Consolidated Statement of Financial Position

At the end of the year the Group cash balance amounted to £4,703,367 (2015: £8,903,000) and the total assets of the Group amounted to £5,051,148 (2015: £9,250,000).

 

Fund raising

 

In the period, the Group successfully raised funds to further progress its on-going clinical trials and give the Group the resources to expand its presence internationally.

 

On 13^st January 2016, Tiziana entered into an agreement to issue £709,407 of Investor Convertible Loan Notes: Tranche F through the issue of 472,938 unsecured convertible loan notes. The notes are redeemable by the holders at any time after 31 December 2016 and will be redeemed, at the election of the Group, in cash or by conversion into new ordinary shares in the Group at a conversion price of £1.50 per share. 

 

On 18^th April 2016 and 28^th June 2016, Tiziana received notice from warrant holders to exercise warrants raising £219,000 and £66,000 respectively.

 

Funds raised by Tiziana will be used to fund the development of the Group's clinical stage assets, Milciclib and foralumab, to meet the Group's ongoing liabilities in respect of licence agreements, and for general working capital purposes.

 

Research & Development

 

In January 2016, the Company announced that its research agreement with Cardiff University, focused on pioneering the development of Bcl-3 inhibitors as potential drugs to treat cancer, has led to the identification of a first-in-class lead clinical candidate, CB1 (TZLS-101), with potent anti-metastatic activity, and with an impressive in vivo efficacy and safety profile. This partnership was recognised as the winner of the Innovation in Healthcare category at Cardiff University's Innovation and Impact Awards 2016. Tiziana intends to file an Investigational New Drug (IND) application for CB1 and expects to move this drug candidate into clinical trials shortly thereafter.

 

Also in January 2016 Tiziana outlined its clinical development plan for foralumab with initial plans to evaluate foralumab in two clinical indications; namely, graft vs host disease and non-alcoholic steatohepatitis (NASH). Foralumab is the only fully human anti-CD3 monoclonal antibody currently in development for the modulation of autoimmune disease.

 

The Company's small molecule drug candidate, milciclib, continues to progress through phase II trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy.

 

Tiziana's novel anti-cancer stem cell agent, TZLS-214 / c-FLIP is currently under analysis. StemPrinter is also currently under analysis with more detailed expected later this year.

 

In July 2016, Tiziana acquired a unique bio-repository of local samples and data from Sardinian company Shardna SpA. Residents of Sardinia are among the world's longest living people, with on average five times greater likelihood of reaching age 100 compared with the USA. The Company has established LonGevia Genomics Srl, a regional subsidiary specifically to develop these assets to identify novel drug targets and diagnostic applications through leveraging next generation gene sequencing and state of the art "-omics" technologies.

 

Appointments

 

Management team

On 4 April 2016, Tiziano Lazzaretti was appointed as Chief Financial Officer, taking over from Phil Boyd, who tendered his resignation on 7th May 2015 in order to focus on other opportunities.

 

Mr Lazzaretti has extensive experience in the healthcare and pharmaceutical industry and joins Tiziana from Pharmentis Srl, an Italian pharmaceutical business, where he served as Group Finance Director since 2011.  Prior to this, Mr Lazzaretti held senior roles at Alliance Boots Healthcare, Accenture and other listed companies such as SNIA Spa and Fiat Group.  He has a Bachelor of Science (BSc hons) in Accounting and Finance from the University of Turin, Italy and was awarded a Master in Business Administration (MBA) from Bocconi University, Milan.

 

Scientific Advisory Board

On 11 January 2016, the Group announced the addition of two key members to the Scientific Advisory Board: Professors Kevan Herold, MD and Howard Weiner, MD.

 

Dr. Kevan Herold

Dr. Kevan Herold is Professor of Immunobiology and of Medicine (Endocrinology) as well as Deputy Director, Yale Center for Clinical Investigation, Director of the Yale Diabetes Center and Director of the TrialNet Center at Yale.  His investigative work has focused on developing new ways to prevent and treat autoimmune diseases, using novel translational immunologic and metabolic approaches to prevent progression, in particular anti-CD3 monoclonal antibody therapy.  His clinical interests are in the management of endocrine diseases, and he is involved in a number of national and international clinical studies of new treatments.

 

Dr. Howard Weiner

Dr. Howard 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. The Partners MS Center is the first integrated MS Center that combines clinical care, MRI imaging and immune monitoring to the MS patient as part of the 2000 patient CLIMB cohort study.  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 tumours.  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 regulatory T cells for the treatment of these diseases.

 

Outlook

 

It has been a busy twelve months for the Group as we have bolstered our senior leadership team and Scientific Advisory Board, and continued to progress our pipeline of drugs to treat rare cancers and difficult to treat autoimmune inflammatory diseases.

 

We have outlined our clinical development plan for foralumab with initial plans to evaluate foralumab in two clinical indications: graft vs. host disease and NASH. Milciclib is currently in phase II clinical trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy, and for hepatocellular carcinoma.

 

Looking forward, we are confident of being well positioned to progress these programmes to their next respective value inflection points.

 

 

Gabriele Cerrone

Executive Chairman

 

 

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE YEAR ENDED 31 DECEMBER 2016

 

		2016		2015
Continuing Operations		£'000		£'000
Research and development costs		(2,956)		(6,287)
Operating expenses		(4,332)		(2,327)
Operating loss		(7,288)		(8,614)
Finance costs		(9)		(18)
Loss before taxation		(7,297)		(8,632)
Taxation		89		-
Loss for the year attributable to equity owners		(7,208)		(8,632)
Other comprehensive income		-		-
Total comprehensive loss for the year attributable to equity owners		(7,208)		(8,632)
Loss per share
Basic and diluted (loss) per share on continuing operations		(7.7p)		(9.5p)

 

 

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

FOR THE YEAR ENDED 31 DECEMBER 2016

 

		2016		2015
		£'000		£'000
ASSETS
Non-Current assets
Property, plant and equipment		28		-
Total Non-current assets		28		-
Current assets
Other receivables		103		347
Other current assets		217		-
Cash and cash equivalents		4,703		8,903
Total current assets		5,023		9,250
TOTAL ASSETS		5,051		9,250
EQUITY AND LIABILITIES
Equity
Capital and reserves attributable to equity holders of the company
Called up share capital		2,832		9,375
Share premium		2,071		20,632
Share based payment reserve		1,935		1,008
Shares to be issued reserve (warrants)		191		102
Shares to be issued reserve		13,535		12,287
Merger relief reserve		-		5,625
Other reserve		(28,286)		(28,286)
Capital redemption reserve		-		-
Retained earnings		11,036		(12,239)
Total equity		3,314		8,504
Liabilities
Current liabilities
Trade and other payables		1,737		746
		1,737		746
TOTAL EQUITY AND LIABILITIES		5,051		9,250

 

 

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE YEAR ENDED 31 DECEMBER 2016

 

Cash flows from operating activities		2016 £'000		2015 £'000
Total comprehensive loss for the period before taxation		(7,208)		(8,632)
Convertible loan interest accrued		9		-
Share based payment - options		927		972
Share based payment - warrants		89		102
Net (increase)/decrease in operating assets/other receivables		0		(153)
Net increase/(decrease) in operating liabilities /other liabilities		866		63
Depreciation		8		-
Other share based payments		-		2,138
Loss on foreign exchange		158		-
Lease adjustment		41		-
NET CASH USED IN OPERATING ACTIVITIES		(5,110)		(5,510)
Cash flows from financing activities
Proceeds from issuance of ordinary shares		453		2,638
Proceeds from issuance of convertible loan notes		709		10,235
Fundraising cost		-		(726)
NET CASH GENERATED FROM FINANCING ACTIVITIES		1,162		12,147
Cash flows from investing activities
Acquisition of property, plant and equipment		(35)		-
Acquisition of other investments		(217)
NET CASH GENERATED FROM INVESTING ACTIVITIES		(252)		-
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS		(4,200)		6,637
Cash and cash equivalents at beginning of year		8,903		2,266
CASH AND CASH EQUIVALENTS AT END OF YEAR		4,703		8,903

 

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE YEAR ENDED 31 DECEMBER 2016
		Share Capital		Share Premium		Merger Relief Reserve		Capital Redemption Reserve		Share Based Payment Reserve		Restated Shares To Be Issued Reserve		Convertible Loan Note Reserve		Other Reserve		Retained Earnings		Total Equity
		£'000		£'000		£'000		£'000		£'000		£'000		£'000		£'000		£'000		£'000
Balance at 1 January 2015		9,144		16,294		5,625		-		146		-		2,259		(28,286)		(3,405)		1,777
Transactions with owners
Issue of share capital under share-based payment scheme		231		4,338		-		-		-		-		-		-		-		4,569
Share based payment (options)		-		-		-		-		972		-		-		-		-		972
Share based payment (warrants)		-		-		-		-		-		102		-		-		-		102
Convertible loan note - equity component		-		-		-		-		-		-		10,028		-		(312)		9,716
Options cancelled in the year				-		-		-		(110)		-		-		-		110		-
Total transactions with owners		9,375		20,632		5,625		-		862		102		10,028		-		(202)		15,539
Comprehensive income
Comprehensive loss for the year		-		-		-		-		-		-		-		-		(8,632)		(8,632)
Total comprehensive income
Balance as at 31 December 2015		9,375		20,632		5,625		-		1,008		102		12,287		(28,286)		(12,239)		8,504
Transactions with owners
Issue of share capital under share-based payment scheme		61		393		-		-		-		-		-		-		-		454
Share based payment (options)		-		-		-		-		927		-		-		-		-		927
Share based payment (warrants)		-		-		-		-		-		89		-		-		-		89
Convertible loan note - equity component		-		-		-		-		-		-		1,248		-		(690)		558
Options cancelled in the year		-		-		-		-		-		-		-		-		-		-
Cancellation of deferred shares		(6,604)		-		-		6,604		-		-		-		-		-		-
Capital reduction		-		(18,954)		(5,625)		(6,604)		-		-		-		-		31,183		-
Prior year adjustments		-		-		-		-		-		-		-		-		(10)		(10)
								-
Total transactions with owners		(6,543)		(18,561)		(5,625)		-		927		191		1,248		-		30,483		2,018
Comprehensive income
Comprehensive loss for the year		-		-		-		-		-		-		-		-		(7,208)		(7,208)
Total comprehensive income		-		-		-		-		-		-		-		-		(7,208)		(7,208)
Balance as at 31 December 2016		2,832		2,071		-		-		1,935		191		13,535		(28,286)		11,036		3,314

 

 

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

 

 

1.     General Information

 

The financial information set out above does not constitute the Company's statutory accounts for the years ended 31 December 2016 or 2015 but is derived from those accounts. Statutory accounts for 2015 have been delivered to the registrar of companies, and those for 2016 will be delivered in due course. The auditors have reported on those accounts; their reports were (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006.

 

 

2.     Loss per Share

 

Basic loss 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.

 

	2016	2015
(Loss) attributable to equity holders of the company (£)	(7,207,597)	(8,632,226)
Weighted average number of ordinary shares in issue	93,592,195	91,242,884
Basic loss per share (pence per share)	(7.7)	(9.5)

 

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.

 

 

3.     Availability of Report and Accounts and Notice of Annual General Meeting

 

The Company has posted its audited Report and Accounts to 31 December 2016 and Notice of AGM to shareholders.  The AGM will be held at the offices of Cooley (UK) LLP, Dashwood, 69 Old Broad Street, London EC2M 1QS on 29 June 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 website at www.tizianalifesciences.com.

 

This information is provided by RNS

The company news service from the London Stock Exchange

 

END

 

 

FR EAKSAADSXEFF