Released : Jun 07, 2018

RNS Number : 5680Q

Tiziana Life Sciences PLC

07 June 2018

 

Tiziana Life Sciences PLC

("Tiziana" or the "Company")

 

Financial Results for the Year Ended 31 December 2017

 

London, 7 June 2018 - Tiziana Life Sciences plc (AIM: TILS), the clinical stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, today announces its financial results for the year ended 31 December 2017.

 

Highlights during the period:

 

RESEARCH & DEVELOPMENT

·    Foralumab

o Exclusive license agreement entered into with The Brigham and Women's Hospital, Inc. relating to a novel formulation of Foralumab in a medical device for nasal administration

·    Milciclib

o Initiated Phase IIa trial of Milciclib safety and tolerability as a single therapy in patients with hepatocellular carcinoma in H1 2017 and continuing enrolment in Q2 2018.

o Independent Data Monitor committee completed second interim analysis of tolerability data from first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial.

·    TZLS-501 (Anti-IL6R)

o In preclinical studies, TZLS-501 demonstrated potential for overcoming limitations of other IL-6 pathway drugs.

o Demonstrated potential to block or reduce IL-6 signaling in mouse models of inflammation.

·    StemPrintER

o A multi-gene signature assay intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast cancers.

o Development team preparing for a retrospective validation study using an independent cohort and has conducted a pre-submission meeting with FDA.

 

LEADERSHIP

·    Dr Kunwar Shailubhai, previously a Non-Executive Director of the Company, was appointed as Chief Executive Officer and Chief Scientific Officer on 12 June 2017.

·    Dr Arun Sanyal was appointed to the Scientific Advisory Board on 14 March 2017. Dr Sanyal is the professor of medicine, physiology & molecular pathology at the Virginia Commonwealth University School of Medicine, and his work has been  focused on liver cirrhosis, non-alcoholic steatohepatitis and non-alcoholic fatty liver disease throughout his medical career.

·    Leopold Zambeletti appointed as a Non-Executive Director with responsibility for strategic development. Zambeletti will also chair the Nomination Committee.

 

FINANCIAL

·    In March 2017, Tiziana received notice from warrant holders to exercise warrants raising £0.57m. All "B" series warrants have now been exercised.

·    £0.62m (gross) raised through issue of new ordinary shares in November and December 2017 to fund development of the Group's clinical stage assets, Milcilib and Foralumab, meet the Group's ongoing liabilities in respect of licence agreements, and for general working capital purposes.

·    For the year to 31 December 2017 the consolidated Group made a loss of £6.77m (2016: £7.21m).

 

POST PERIOD

·    Entered into an exclusive license agreement for novel technology discovered by Dr Howard Weiner at the Brigham and Women's Hospital, Harvard Medical School.

·    The Group raised £1.6 million by the issue of 1,797,917 new ordinary shares subsequent to the period end.

 

 

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 / Richard Nash	+44 (0)20 7213 0880

 

About Tiziana

 

Tiziana 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 human anti-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 December 2017.

 

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 NAFLD patients develop to a more severe form of disease, known as non-alcoholic steatohepatitis (NASH). NASH is a progressive disease associated with chronic inflammation, fibrosis and cirrhosis. Based on data from US adult Liver Transplant (LT) databases, since 2004 the number of adults with NASH awaiting LTs has almost tripled. In 2013, NASH became the second-leading disease among liver transplant waitlist registrants, after the Hepatitis C virus.  It is predicted that NASH may 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. Liver transplant is the only effective option for end-stage patients, including HCC patients.  More effective therapeutic agents to treat HCC are needed. Currently approved therapeutic agents are marginally effective and have significant safety issues.

 

Tiziana Life Sciences has two lead clinical programmes, Foralumab and Milciclib:

 

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 inflammatory bowel disease (IBD).

As the only fully human engineered human anti-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 dosed by the intravenous route of administration, 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 autoimmune and inflammatory diseases.

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).

On April 16, 2018 we entered into an exclusive license agreement with The Brigham and Women's Hosptial, Inc. relating to a novel formulation of Foralumab in a medical device for nasal administration. We expect to file an investigational new drug application for the first-in-human evaluation of the nasal administration of Foralumab in healthy volunteers in Q2 2018 and commence a trial to evaluate biomarkers of immunomodulation of clinical responses in Q3 2018.

 

 

Milciclib (TZLS-201)

Milciclib, the Group's lead compound, was exclusively licenced in January 2015 from Nerviano Medical Sciences. Milciclib is an orally bioavailable, small molecule broad spectrum inhibitor of Cyclin Dependent Kinases (CDKs): 1, 2, 4, 5 and 7 and Src family kinases. Cyclin dependent kinases are a family of highly conserved enzymes that are involved in regulating the cell cycle, which is a series of events that takes place in cells leading to division and duplication of its DNA to produce two daughter cells. Src family kinases regulate cell growth and potential transformation of normal cells to cancer cells. A unique feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222, that silence gene expression. miR-221 and miR-222 promote the formation of blood vessels (angiogenesis) that are important for spread of cancer cells (metastasis). Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance to treatment with sorafenib. As a result, we are investigating Milciclib both as a monotherapy and plan a combination treatment with sorafenib.

 

To date, Milciclib has been studied in a total of seven completed and ongoing Phase I and Phase II clinical trials in 285 patients. In these trials, Milciclib was observed to be well-tolerated and showed initial signals of anti-tumor action. Prior to in-licensing, Milciclib was granted orphan designation by the European Commission and by the U.S. Food and Drug Administration ("FDA") for the treatment of malignant thymoma and the more aggressive form of thymic carcinoma in patients previously treated with chemotherapy. In two, Phase IIa trials, CDKO-125a-006 and CDKO125a-007, Milciclib showed signs of slowing disease progression and acceptable safety.

 

 We initiated a Phase IIa trial (CDKO-125a-010) of Milciclib safety and tolerability as a single therapy in patients with HCC in the first half of 2017 and are continuing enrolment in Q2 2018. We expect to initiate a Phase IIb trial (TZLS (201)-125a-011) for Milciclib in combination with sorafenib (the standard of care for treatment of HCC) in patients with HCC in 2018.

 

We have recently announced that the independent data monitor committee (IDMC) completed a second, interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial.

 

Pre-Clinical Programmes

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

TZLS-501 (Anti-IL6R)

TZLS-501 is a fully human engineered mAb targeting the interleukin-6 receptor (IL-6R). Tiziana Life Sciences licensed the intellectual property from Novimmune in January 2017. This fully human mAb has a unique mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R and depleting circulating levels of the IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation, associated with autoimmune diseases such as multiple myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501 may have potential therapeutic value for these indications.

 

In preclinical studies, TZLS-501 demonstrated the potential for overcoming the limitations of other IL-6 pathway drugs. Compared to tocilizumab and sarilumab, TZLS-501 has been observed to have a higher affinity for the soluble IL-6 receptor from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block or reduce IL-6 signaling in mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease progression compared to the receptor bound form (Kallen, K.J. (2002). "The role of transsignalling via the agonistic soluble IL-6 receptor in human diseases". Biochimica et Biophysica Acta. 1592 (3): 323-343.).

 

 

StemPrinter

StemPrintER is a multi-gene signature assay intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast cancers. We believe this in-vitro prognostic test will be used in conjunction with clinical evaluation to identify those patients at increased risk for early and/or late metastasis. StemPrintER is designed to help physicians distinguish ER+/HER2 negative patients:

 

■    with an elevated risk of early recurrence (<5 years) who could benefit from chemotherapy 
in addition to hormonal therapy

 

■     with a high risk of late recurrence who could benefit from prolonged endocrine treatment
up to 10 years

 

■    with a low risk of early recurrence who might be spared chemotherapy or be eligible for less 
aggressive treatments

 

Our diagnostic has a unique biological basis, being based on the detection of cancer stem cell markers, uses a reliable platform (qRT- PCR, FFPE), and has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer. The development team is preparing for a retrospective validation study using an independent cohort and has conducted a pre- submission meeting with the FDA.

 

Financial summary

Consolidated Statement of Comprehensive Income

The Group has made a loss for the year of £6,770k (2016: £7,208k).  The loss is detailed in the consolidated statement of comprehensive income on page 14.

 

Consolidated Statement of Financial Position

At the end of the year the Group cash balance amounted to £48k (2016: £4,703k) and the total assets of the Group amounted to £1,831k (2016: £5,051k).

 

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 23th March 2017, Tiziana received a notification from warrant holders to exercise warrants over 1,789,524 ordinary shares in the Company at an exercise price of 32p per share, providing the Company with gross proceeds of £572,648. All "B" series warrants have now been exercised.

On 20th November 2017, Tiziana announced that it had raised £150,000 in cash by the issue of 100,000 new ordinary shares at a price of 150p per share, each new ordinary share having a warrant attached entitling the holder to subscribe for one new ordinary share at a price of 160p per share, exercisable until 24 November 2022.

On 27th November 2017, Tiziana announced that it had raised £275,000 by the issue of 183,333 new ordinary shares at a price of 150p per share, with each issued Share having a warrant attached entitling the holder to subscribe for one new ordinary share at an exercise price of 160p per share, exercisable until 11 December 2022.

On 15th December 2017, Tiziana announced that it had raised £200,000 through the issue of 133,333 new ordinary shares at a price of 150p per share. Each issued Share has a warrant attached entitling the holder to subscribe for one new ordinary share at an exercise price of 160p per share, exercisable until 15 December 2022. Fees in connection with the Placing are to be satisfied through the issue of an additional 31,667 warrants on the same terms.

Funds raised by Tiziana were 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 early 2018 Tiziana outlined its clinical development plan for Foralumab with initial plans to evaluate Foralumab in two clinical indications; namely non-alcoholic steatohepatitis (NASH) and IDB. 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, completed two, Phase II atrials for thymic carcinoma  and thymoma  in patients previously treated with chemotherapy and showed signs of slowing disease progression and acceptable safety.

 

 

Appointments

 

Management team

Dr Kunwar Shailubhai

On 12th June 2017, Dr Kunwar Shailubhai (Shailu) was appointed as Chief Executive Officer and Chief Scientific Officer with immediate effect. Dr Shailubhai was previously a Non-Executive Director at the Company.

Dr Shailubhai has extensive experience within the sector, drawing on 30 years of experience in research and development of drug candidates for treatment of gastrointestinal disorders, inflammatory diseases and cancers. His appointment follows many years working at Synergy Pharmaceuticals Inc (SGYP: NASDAQ), which he co-founded and where he served as chief scientific officer since 2008.

 

His pioneering research programme culminated in the development of the drug Trulance™ (plecanatide) which received FDA approval in January, 2017 for the treatment of adults with chronic idiopathic constipation. A supplemental new drug application has been submitted for FDA review of Trulance for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Prior to joining Tiziana Life Sciences and Synergy Life Sciences, he worked at Callisto Pharmaceuticals, Monsanto Company and as a senior staff fellow at the National Institutes of Health (NIH).

 

Scientific Advisory Board

On the 14^th of March 2017, the Group announced the addition of Dr Arun Sanyal to the Scientific Advisory Board.

Dr Sanyal is the professor of medicine, physiology & molecular pathology at the Virginia Commonwealth University School of Medicine, and his work has been  focused on liver cirrhosis, non-alcoholic steatohepatitis and non-alcoholic fatty liver disease throughout his medical career.

 

Non-Executive Director

On 4th April, 2018, the Group announced the addition of  Mr Leopoldo Zambeletti as a non-executive director with responsibility for strategic development. Mr Zambeletti will also chair the Nomination Committee.

 During a 19 year career as an investment banker, Mr Zambeletti led the European Healthcare Investment Banking team at J.P. Morgan for eight years before taking up the same position at Credit Suisse for a further five years. Since 2013 he has been an independent strategic advisor to life science companies on merger and acquisitions, out-licensing deals and financing strategy. He is a non-executive director of, Qardio Inc., Summit Therapeutics plc, Nogra Pharma Limited, Faron Pharmaceuticals OY and DS Biopharma Limited. Mr. Zambeletti started his career at KPMG as an auditor. Mr. Zambeletti received a B.A. in Business from Bocconi University in Milan, Italy. He serves as a trustee to Barts and the London Charity, which helps to fund the hospitals of the Barts NHS Trust including St Bartholomew, the Royal London and the London Chest Hospitals. He is the founder of the cultural initiative 5x5 Italy.

 

Outlook

We have 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. The IND for Nasal administration for neurodegenerative diseases is anticipated to be submitted by end of the second quarter in FY18. The IND for Oral administration is anticipated to be submitted in the second half of FY18.

Milciclib is currently in phase II clinical trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy, and for hepatocellular carcinoma. We have also completed Phase I of our HCC combination treatment with Sorafenib and plan to move to Phase II in the near future.

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 2017

 

		2017		2016
Continuing Operations		£'000		£'000
Research and development costs		(4,672)		(2,956)
Operating expenses		(3,574)		(4,332)
Operating loss		(8,246)		(7,288)
Finance costs		(9)		(9)
Loss before taxation		(8,255)		(7,297)
Taxation		1,485		89
Loss for the year attributable to equity owners		(6,770)		(7,208)
Other comprehensive income		-		-
Total comprehensive loss for the year attributable to equity owners		(6,770)		(7,208)
Loss per share
Basic and diluted (loss) per share on continuing operations		(6.4p)		(7.7p)

 

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

FOR THE YEAR ENDED 31 DECEMBER 2017

 

				RESTATED
		2017		2016
		£'000		£'000
ASSETS
Non-Current assets
Property, plant and equipment		18		28
Total non-current assets		18		28
Current assets
Other receivables		1,548		103
Other current assets		217		217
Cash and cash equivalents		48		4,703
Total current assets		1,813		5,023
TOTAL ASSETS		1,831		5,051
EQUITY AND LIABILITIES
Equity
Capital and reserves attributable to equity holders of the company
Called up share capital		3,752		2,832
Share premium		18,650		2,071
Merger relief reserve		-		-
Capital redemption reserve		-		-
Capital reduction reserve		31,183		31,183
Share based payment reserve		2,354		1,935
Shares to be issued reserve (warrants)		419		191
Convertible loan note reserve		-		13,535
Other reserve		(28,286)		(28,286)
Retained earnings		(29,755)		(20,147)
Total equity		(1,683)		3,314
Liabilities
Current liabilities
Trade and other payables		3,514		1,737
		3,514		1,737
TOTAL EQUITY AND LIABILITIES		1,831		5,051

 

 

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE YEAR ENDED 31 DECEMBER 2017

 

Cash flows from operating activities		2017 £'000		2016 £'000
Total comprehensive loss for the year before taxation		(8,255)		(7,297)
Adjustments for:
Convertible loan interest accrued		9		9
Share based payment - options		419		927
Cancellation of options		(105)		-
Share based payment - warrants		228		89
Net (increase)/decrease in other receivables		40		(89)
Net increase/(decrease) in trade and other payables		1,790		866
Depreciation		11		8
Loss on foreign exchange		35		158
Lease adjustment		(24)		41
NET CASH USED IN OPERATING ACTIVITIES		(5,852)		(5,110)
Cash flows from financing activities
Proceeds from issuance of ordinary shares		1,198		453
Proceeds from issuance of convertible loan notes		-		709
NET CASH GENERATED FROM FINANCING ACTIVITIES		1,198		1,162
Cash flows from investing activities
Acquisition of property, plant and equipment		(1)		(35)
Acquisition of other investments		-		(217)
NET CASH GENERATED FROM INVESTING ACTIVITIES		(1)		(252)
NET (DECREASE) IN CASH AND CASH EQUIVALENTS		(4,655)		(4,200)
Cash and cash equivalents at beginning of year		4,703		8,903
CASH AND CASH EQUIVALENTS AT END OF YEAR		48		4,703

 

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE YEAR ENDED 31 DECEMBER 2017

		Share Capital	Share Premium	Merger Relief Reserve	Capital Redemption Reserve	Capital Reduction Reserve	Share Based Payment Reserve	Shares To Be Issued Reserve (warrants)	Convertible Loan Note Reserve	Other Reserve	Retained Earnings		Total Equity
		£'000	£'000	£'000	£'000	£'000	£'000	£'000	£'000	£'000	£'000		£'000
Balance at 1 January 2016		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
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)	-	31,183	927	89	1,248	-	(700)		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 - as previously reported		2,832	2,071	-	-	-	1,935	191	13,535	(28,286)	11,036		3,314
Prior year adjustment		-	-	-	-	31,183	-	-	-	-	(31,183)		-
Restated Balance as at 31 December 2016		2,832	2,071	-	-	31,183	1,935	191	13,535	(28,286)	(20,147)		3,314
Transactions with owners
Issue of share capital under share-based payment scheme		66	1,131	-	-	-	-	-	-	-	-		1,197
Share based payment (options)		-	-	-	-	-	980	-	-	-	-		980
Share based payment (warrants)		-	-	-	-	-	-	228	-	-	-		228
Options forfeited/cancelled in the year		-	-	-	-	-	(561)	-	-	-	(105)		(666)
Convertible loan note interest		-	-	-	-	-	-	-	2,767	-	(2,767)		-
Convertible loan note conversion		854	15,448	-	-	-	-	-	(16,302)	-	-		-
Prior year adjustments		-	-	-	-	-	-	-	-	-	34		34
					-	-
Total transactions with owners		920	16,579	-	-	-	419	228	(13,535)	-	(2,838)		1,773
Comprehensive income
Comprehensive loss for the year		-	-	-	-		-	-	-	-	(6,770)		(6,770)
Total comprehensive income		-	-	-	-	-	-	-	-	-	(6,770)		(6,770)
Balance as at 31 December 2017		3,752	18,650	-	-	31,183	2,354	419	-	(28,286)	(29,755)		(1,683)

 

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

1.   GENERAL INFORMATION

 

Tiziana Life Sciences PLC is a public limited company incorporated in the United Kingdom under the Companies Act and quoted on the AIM market of the London Stock Exchange (AIM: TILS). The address of its registered office is given on page 1. The principal activities of the Company and its subsidiaries (the Group) are that of a clinical stage biotechnology company focussed on targeted drugs to treat diseases in oncology and immunology.

 

These financial statements are presented in thousands of pounds sterling (£'000) which is the functional currency of the primary economic environment in which the Company operates.

 

The ultimate parent of the group is Planwise Group Limited, incorporated in the British Virgin Islands. Gabriele Cerrone is the ultimate beneficial owner of the entire issued share capital of Planwise Group Limited.

 

2.   LOSS PER SHARE

 

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

 

	2017	2016
(Loss) attributable to equity holders of the company (£)	(6,769,365)	(7,207,597)
Weighted average number of ordinary shares in issue	106,403,903	93,592,195
Basic loss per share (pence per share)	(6.4)	(7.7)

 

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 2017 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. A copy of the Report and Accounts and Notice of AGM are available to be downloaded from the Company's website at www.tizianalifesciences.com.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

 

END

 

 

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