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Pin to quick picksValiRx Regulatory News (VAL)

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Half Yearly Report

5 Sep 2013 07:00

RNS Number : 2666N
ValiRx PLC
05 September 2013
 

 

 

 

For release at 07:00 on 5 September 2013

 

ValiRx Plc

("ValiRx", "the Company" or "the Group")

 

Half Yearly Report

 

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and personalised therapeutic development announces its unaudited results for the half year ended 30 June 2013.

 

HIGHLIGHTS

· Revenues for the half-year - £103,999 (2012: £157,535);

· Administrative expenses - £683,593 (2012: £709,148);

· Loss after taxation - £1,497,699 (2012: loss £1,088,122) reflecting an increased expenditure of £972,219 (2012: £540,211) being spent during the half-year on Research and Development;

· Development programmes across the Group are progressing well on all fronts and these include ValiRx's leading anti-cancer therapeutic VAL201; its first GeneICE-derived compound VAL101 and Biomarker development to complement the Company's therapeutics;

· VAL201 continues to progress in a "First-in-(Hu)Man study" Phase I trial involving cancer patients - results anticipated before the end of 2013;

· VAL101 continues to show good progress in the pre-clinical phase - the programme is to benefit from a secondEurostars grant for up to €1.6 million;

· Biomarker development programme, to support clinical and pre-clinical development, is progressing well and producing preliminary results. The programme is supported extensively by Finnish Government regional funding; and

· Appointment of Dr. Alan Boyd as Medical Monitoring Officer to oversee VAL201 clinical development and further collaboration with internationally respected centres of excellence.

 

Nicholas Thorniley, Non-Executive Chairman of ValiRx, commented:

"The Company has made some very encouraging progress over the past half year with some excellent advances in our clinical and pre-clinical development pipeline. We have also taken the opportunity of further establishing the Group's scientific base with internationally respected advisers and research partners. These steps forward permit your Company an increasingly confident perspective and I also look forward to reporting on the results of ourclinical trial, which are anticipated in late December 2013".

 

- ENDS -

 

For more information, please contact:

 

ValiRx plc

Tel: +44 (0) 20 3008 4416

Dr Satu Vainikka

www.ValiRx.com

 

Cairn Financial Advisers LLP (Nominated Adviser)

Tel:+44 (0) 20 7148 7900

Liam Murray / Avi Robinson

 

 

Hybridan LLP (Broker)

Tel: +44 (0) 20 7947 4350 / 4361

Claire Louise Noyce / William Lynne

 

 

Peckwater PR

Tel: +44 (0)7879 458 364

Tarquin Edwards

tarquin.edwards@peckwaterpr.co.uk

 

Notes for Editors

ValiRx Plc

ValiRx Plc is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics. The product focus is in the epigenomic analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.

 

The Company listed on AIM in October 2006 and is creating a portfolio of innovative products through investment in specific development projects. It actively manages projects within this portfolio as a trading company and is not an investment vehicle. The ValiRx business model spreads the risks of life science technology developments by minimising financial exposure and running a set of projects to defined commercial endpoints. This maximises returns to shareholders by adding value at the earlier stages where value increases per investment unit are the greatest.

 

The Company operates through the following divisional companies:

1. ValiFinn is the biomarkers and diagnostic development division

2. ValiPharma is the therapeutics division with two embedded technologies primarily directed at the treatment of cancers.

 

Chairman's Statement

I am pleased to report solid progress during the half year ended 30 June 2013. The Group has seen progress across a number of fronts and has seen VAL201 advancing into a Phase I first in-human trial. We were pleased to provide several updates during the period, reporting on the respective clinical and pre-clinical developments of our lead compounds, VAL201 and VAL101, from both regulatory and production perspectives.

 

Administrative costs have been kept under control, with an increase in expenditure seen on research and development; investing in the Company's future. Revenues for the half-year were £103,999 (2012: £157,535). Administrative expenses were £683,593 (2011: £709,148). Loss after taxation was £1,497,699 (2012: loss £1,088,122). In the half-year £972,219 (2012: £540,211) was spent on Research and Development, which contributed to the higher loss.

 

The Company was pleased to confirm that VAL201, its leading anti-cancer therapeutic, continues to progress through its clinical development on all fronts. This is a "First-in-(Hu)Man"study involving cancer patients, as opposed to healthy volunteers and is a Phase 1 trial. As previously reported on 31 July 2013, ValiRx anticipates that results from the Phase 1 trial will be available before the end of 2013.

 

VAL101, the Company's lead candidate deriving from the GeneICE platform, continues to show good progress in the pre-clinical phase and its development programme moves ahead as planned. The €1.4 millionEurostars development programme has been successfully completed (announced 31/07/13). Subsequently, ValiRx and its Finnish partner, Pharmatest Services Limited, have won an additional Eurostars grantfor up to €1.6 million  (announced 15/08/13) and the funds will be used to progress the pre-clinical studies of VAL101 and to build the associated cancer models.

 

Our Biomarker development programme in support of clinical and pre-clinical development progressed well during the half year and we are now seeing some preliminary results. This division provides the Company with exposure to the Biomarker market, a key and increasingly exciting field within our industry, and with a potential revenue stream, derived from the provision of contract services. Our programme continues to be supported by Finnish Government regional funding.

 

The period has seen the continued strengthening of our IP portfolio with VAL201 granted a new patent in Australia and we were delighted to see the further strengthening of the Group's scientific base with the appointment of Dr. Alan Boyd, a world-class medical monitoring officer to oversee the VAL201 clinical development. The growing of our scientific credentials has been enhanced further with our collaboration with internationally respected centres of excellence, including Imperial College, London, Heidelberg Cancer institute, Germany, Cancer Research UK and the Paoli-Calmettes Cancer Institute in France.

 

The Company has made some very encouraging progress over the past half year with some excellent advances in our clinical and pre-clinical development pipeline. We have also taken the opportunity of further establishing the Group's scientific base with internationally respected advisers and research partners. These steps forward permit your Company an increasingly confident perspective and I also look forward to reporting on the results of ourclinical trial, which are anticipated in late December 2013.

 

Nick Thorniley

Non-executive Chairman

5 September 2013

 

 

 

 

Consolidated statement of comprehensive income

Six months ended

Six months ended

Year ended

Note

30 June

30 June

31 December

2013

2012

2012

(unaudited)

(unaudited)

(audited)

£

£

£

Revenue

103,999

157,535

216,269

Cost of sales

(25,179)

(48,291)

(72,960)

Gross profit

78,820

109,244

143,309

Research and development

(972,219)

(540,211)

(1,010,476)

Administrative expenses

(683,593)

(709,148)

(1,481,717)

Operating loss

(1,576,992)

(1,140,115)

(2,348,884)

Finance income

4,319

11,993

19,001

Finance costs

(26)

-

(21)

Loss before taxation

(1,572,699)

(1,128,122)

(2,329,904)

Income tax credit

3

75,000

40,000

165,956

Loss for the period

(1,497,699)

(1,088,122)

(2,163,948)

Other comprehensive income

Change in fair value of available-for-sale assets

(134,400)

282,068

13,893

Loss for the period and total comprehensive income

(1,632,099)

(806,054)

(2,150,055)

Loss per share - basic and diluted

4

(0.09)p

(0.09)p

(0.17)p

 

Statement of changes in shareholders' equity

Share capital

Share premium

Retained earnings

Merger reserve

Share option reserve

Reverse acquisition reserve

 Total

£

£

£

£

£

£

£

Unaudited

Balance at 1 January 2013

6,051,607

 5,337,152

(7,665,683)

637,500

73,852

602,413

5,036,841

Loss for the period

-

-

(1,497,699)

-

-

-

(1,497,699)

Change in fair value of available-for-sale assets

-

-

(134,400)

-

-

-

(134,400)

Share based payment

-

-

-

-

21,002

-

21,002

Balance at 30 June 2013

6,051,607

5,337,152

(9,297,782)

637,500

94,854

602,413

3,425,744

Unaudited

Balance at 1 January 2012

 5,399,984

 3,247,539

(5,515,628)

637,500

52,140

602,413

 4,423,948

Loss for the period

-

-

(1,088,122)

-

-

-

(1,088,122)

Statement of changes in shareholders' equity

-

-

282,068

-

-

-

282,068

Issue of shares

200,000

700,000

-

-

-

-

900,000

Movement in period

-

(56,129)

-

-

-

-

(56,129)

Share based payment

-

-

-

-

14,270

-

14,270

Balance at 30 June 2012

5,599,984

3,891,410

(6,321,682)

637,500

66,410

602,413

4,476,035

Audited

Balance at 1 January 2012

 5,399,984

 3,247,539

(5,515,628)

637,500

52,140

602,413

 4,423,948

Loss for the year

-

-

(2,163,948)

-

-

-

(2,163,948)

Change in fair value of available-for-sale assets

-

-

13,893

-

-

-

13,893

Issue of shares

651,623

 2,280,675

-

-

-

-

 2,932,298

Movement in period

-

(191,062)

-

-

-

-

(191,062)

Share based payment

-

-

-

-

21,712

-

21,712

Balance at 31 December 2012

6,051,607

5,337,152

(7,665,683)

637,500

73,852

602,413

5,036,841

 

Consolidated statement of financial position

 

As at 30 June

31 December

2013

2012

2012

(unaudited)

(unaudited)

(audited)

£

£

£

ASSETS

Non current assets

Intangible assets

1,850,735

1,788,134

1,803,405

Property, plant and equipment

1,126

6,394

4,363

Financial assets: available-for-sale investments

738,943

1,141,518

873,343

2,590,804

2,936,046

2,681,111

Current assets

Inventories

3,789

15,035

2,727

Trade and other receivables

477,928

360,629

353,855

Cash and cash equivalents

1,172,191

1,383,653

2,260,783

1,653,908

1,759,317

2,617,365

TOTAL ASSETS

4,244,712

4,695,363

5,298,476

LIABILITIES

Current liabilities

Trade and other payables

(818,968)

(219,328)

(261,635)

(818,968)

(219,328)

(261,635)

NET ASSETS

3,425,744

4,476,035

5,036,841

SHAREHOLDERS' EQUITY

Share capital

6,051,607

5,599,984

6,051,607

Share premium account

5,337,152

3,891,410

5,337,152

Merger reserve

637,500

637,500

637,500

Reverse acquisition reserve

602,413

602,413

602,413

Share option reserve

94,854

66,410

73,852

Retained earnings

(9,297,782)

(6,321,682)

(7,665,683)

Total shareholders' equity

3,425,744

4,476,035

5,036,841

 

Cash flow statement

Six months ended

Six months ended

Year ended

30 June

30 June

31 December

2013

2012

2012

(unaudited)

(unaudited)

(audited)

£

£

£

Operating activities

Operating loss

(1,576,992)

(1,140,115)

(2,348,884)

Depreciation of property plant and equipment

3,277

3,438

6,762

Amortisation of intangible assets

22,490

11,764

48,579

Loss on disposal of property, plant and equipment

-

-

93

Loss on disposal of intangible assets

-

-

25,218

(Increase)/decrease in inventories

(1,062)

4,449

16,757

Increase in receivables

(49,073)

(41,771)

(25,344)

Increase in creditors within one year

557,333

77,635

119,942

Other non-cash movements

627

5,466

3,420

Share option charge

21,002

14,270

21,712

Cash outflows from operating activities

(1,022,398)

(1,064,864)

(2,131,745)

Taxation

-

16,050

132,353

Investing activities

Interest received

4,319

11,993

19,001

Interest paid

(26)

-

(21)

Payments to acquire intangible assets

(70,447)

(56,880)

(132,145)

Payments to acquire property plant and equipment

(40)

(665)

(2,579)

Receipts from sale of property plant and equipment

-

-

535

Net cash outflow for acquisitions and disposals

(66,194)

(45,552)

(115,209)

Financing activities

Issue of ordinary share capital

-

900,000

2,932,298

Cost of share issue

-

(56,129)

(191,062)

Net cash generated from financing activities

-

843,871

2,741,236

Net (decrease)/increase in cash and cash equivalents

(1,088,592)

(250,495)

626,635

Cash and cash equivalents at start of period

2,260,783

1,634,148

1,634,148

Cash and cash equivalents at end of period

1,172,191

1,383,653

2,260,783

 

Notes to the interim financial statements

1 General information

Valirx Plc is a company incorporated in the United Kingdom, which is listed on the AIM market of the London Stock Exchange Plc. The address of its registered office is 24 Greville Street, London EC1N 8SS.

2 Financial information

The interim consolidated financial information for the six months ended 30 June 2013 has not been audited or reviewed and does not constitute statutory accounts within the meaning of Section 434 of the Companies Act 2006. The Group's statutory accounts for the year ended 31 December 2012 have been delivered to the Registrar of Companies. The report of the independent auditors on those financial statements was unqualified and did not contain a statement under Sections 498 (2) or (3) of the Companies Act 2006.

 

The interim financial statements have been prepared in accordance with International Financial Reporting Standards ('IFRS') as adopted by the European Union, IFRIC interpretations and the Companies Act 2006 applicable to companies reporting under IFRS and under the historical cost convention. The accounting policies applied in preparing the interim financial information are consistent with those set out in the statutory accounts of the Company for the year ended 31 December 2012.

 

The interim consolidated financial statements are presented in pounds sterling because that is the currency of the primary economic environment in which the group operates.

 

 

3 Taxation

 

Six months ended

Six months ended

Year ended

30 June

30 June

31 December

2013

2012

2012

(unaudited)

(unaudited)

(audited)

£

£

£

United Kingdom corporation tax at 24%

Current period - R & D Tax credit

(75,000)

(40,000)

(165,956)

Income tax credit

(75,000)

(40,000)

(165,956)

 

4 Loss per ordinary shares

The loss and number of shares used in the calculation of loss per share are as follows:

Six months ended

Six months ended

Year ended

30 June

30 June

31 December

2013

2012

2012

(unaudited)

(unaudited)

(audited)

Basic:

Loss for the financial period

(1,497,699)

(1,088,122)

(2,163,948)

Weighted average number of shares

 1,711,184,409

 1,159,562,609

 1,288,079,027

Loss per share

(0.09)p

(0.09)p

(0.17)p

 

5 Dividends

The directors do not propose to declare a dividend in respect of the period.

 

6 Share capital

30 June 2013

30 June 2012

Number

 £

Number

 £

(unaudited)

(unaudited)

(unaudited)

(unaudited)

Allotted, called up and fully paid

Ordinary shares of 0.1p each

1,711,184,409

1,711,184

 1,259,562,609

1,259,561

Deferred shares of 5.0p each

58,378,365

2,918,918

58,378,365

2,918,918

Deferred shares of 0.9p each

157,945,030

1,421,505

157,945,030

1,421,505

6,051,607

5,599,984

31 December 2012

Number

 £

Allotted, called up and fully paid

(unaudited)

(unaudited)

Ordinary shares of 0.1p each

1,711,184,409

1,711,184

Deferred shares of 5.0p each

58,378,365

2,918,918

Deferred shares of 0.9p each

157,945,030

1,421,505

6,051,607

 

The deferred shares effectively have no rights or value.

 

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
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