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Tiziana Life Sci PLC (TILS)

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Thursday 07 June, 2018

Tiziana Life Sci PLC

Final Results

RNS Number : 5680Q
Tiziana Life Sciences PLC
07 June 2018
 

 

London, 7 June 2018

 

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).

 

·    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

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

 

 

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:

 

NI-0401)

 

 

■    

■    

■    

 

 

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)

 

 

 

 

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

 

 

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

 

 

 

 

 

 

 

 

 

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)

 

1.   GENERAL INFORMATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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