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Half Yearly Report

20th Sep 2012 07:00

RNS Number : 6859M
ValiRx PLC
20 September 2012
 

20 September 2012

 

ValiRx Plc

("ValiRx" or "the Company")

 

Half Yearly Report

 

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, announces its unaudited results for the half-year ended 30 June 2012.

 

HIGHLIGHTS

 

·; Late stage pre-clinical R&D programmes have generated positive results to support therapeutic potential of our lead compounds, VAL201 and VAL101 (GeneICE).

·; VAL201, which has shown significant inhibition of aggressive tumour cell proliferation in prostate cancer, also reduces spread of secondary tumours.

·; Manufacturing of VAL201 to regulatory standards has also been successful and the drug is currently undergoing regulatory toxicology studies prior to entering clinical trials.

·; Focusing on potential indication for GeneICE drug candidate.

·; Secured additional shareholder support with a gross investment of GBP 900,000.

·; Acquisition by Finnish subsidiary, ValiRx Finland OY ("ValiFinn"), of biomarkers business unit together with several families of patents and patent applications and related intellectual property ("IP").

·; Material Transfer Agreement ("MTA") concluded with a distinguished cancer treatment and research centre, the Institut Paoli & Calmettes ("IPC") in Marseille, France to conduct translational and developmental studies on ValiRx's lead compound, VAL201 and assist with its progression towards clinical trials.

·; Establishment of Scientific Advisory Board ("SAB") to advise and assist the Company in the further development of its technologies and products in oncology therapeutics and diagnostics and provide world-class clinical expertise.

·; Continued collaboration with Imperial College, Cancer Research UK and Oxford University.

 

 

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

"Our progress during the period under review has been very encouraging. VAL201, which has been shown to significantly inhibit the aggressive tumour growth in prostate cancer, also reduces the spread of secondary tumours (metastasis) by up to 50 per cent. These findings are a major step forward, since patients with prostate cancer typically develop metastasis. The Company believes that this further strengthens the product offering."

 

"I am pleased that one of a number of our compounds is expected to be entering clinical trials. The preclinical results on VAL201 have exceeded our expectations and the Company is assessing its options; one of which is to conduct its own Phase I trial rather than out-licensing at this stage. We believe that we can drive greater shareholder value in conducting Phase I trials ourselves, but we continue to consider all options. With the Company's costs under control and with the Group and its lead therapeutics and other assets moving forward, as planned, I look forward to the future with growing confidence."

 

 

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

Claire Noyce / Deepak Reddy

Peckwater PR

Tel: +44 (0)7879 458 364

Tarquin Edwards

[email protected]

 

 

 

Chairman's Statement

I am pleased to report that during the half year ended 30 June 2012, the Company has continued its strong progress in the development of a sustainable platform for drug development. Costs have been kept under control and the Company and its compounds have moved forward as planned and we are particularly pleased to see the continuing development of our lead therapeutic compounds VAL101 and VAL201, and especially VAL201 towards the commencement of in-human clinical trials.

 

Revenues for the half-year were £157,535 (2011: £418,263). Administrative expenses were £709,148 (2011: £417,508). Losses after taxation were £1,088,122 (2011: losses £161,392). In the half-year £540,211 (2011: £152,935) was spent on Research and Development, which contributed to the higher losses.

 

In April 2012, we completed a placing through our broker Hybridan, to raise GBP 900,000 (before expenses) which has provided ValiRx with a secure base of funding from which the Company could accelerate and complete its pre-clinical work on VAL201 and also to continue pre-clinical work for VAL101 among other activities. Furthermore, the placing has enabled the Company to continue development of companion diagnostics methods and expand its IP portfolio and value, alongside providing scope for an increase in the marketing of our biomarkers business.

The period also saw our Finnish subsidiary, ValiRx Finland OY, acquire from Pharmatest Services Oy of Oulu, Finland, its biomarkers business unit together with several patents and patent applications and related intellectual property. Strategically, the acquisition will enhance the Company's R&D capability, as the specialist biomarker expertise within the unit is leveraged to advance in-house the development of companion biomarker diagnostics to complement ValiRx's therapeutics. This acquisition also provides ValiRx with an increased exposure to the Biomarker market, a key and increasingly exciting field within our industry, and to a revenue stream, derived from the provision of contract services.

At the end of March 2012, ValiRx concluded a Material Transfer Agreement ("MTA") with the Institut Paoli & Calmettes ("IPC") in Marseille, France. Under the terms of the MTA, the IPC has been conducting translational and developmental studies on ValiRx's lead compound, VAL201 and will assist the Company in the progression towards clinical trials.

The manufacturing of VAL201 to regulatory standards has been successful and during the period VAL201 has been undergoing regulatory toxicology studies.

Our progress during the period under review has been very encouraging and the advances in the development of our drug programmes represent a major step forward to further strengthen our product offering.

 

I am delighted that one of a number of our compounds is expected to be entering clinical trials imminently and based upon this increasingly secure corporate platform, I look forward to the future with growing confidence.

 

Nick Thorniley

Non-executive Chairman

20 September 2012

 

Consolidated statement of comprehensive income

For the six months ended 30 June 2012

 

Note

30 June

30 June

31 December

2012

2011

2011

(unaudited)

(unaudited)

(audited)

£

£

£

Revenue

Continuing operations

157,535

418,263

455,226

Cost of sales

(48,291)

(11,625)

(26,507)

Gross profit

109,244

406,638

428,719

Research and development

(540,211)

(152,935)

(420,683)

Administrative expenses

(709,148)

(417,508)

(1,092,492)

Operating loss

(1,140,115)

(163,805)

(1,084,456)

Finance income

11,993

2,413

20,726

Finance costs

-

-

(1,308)

Loss before taxation

(1,128,122)

(161,392)

(1,065,038)

Income tax credit

3

40,000

-

132,353

Loss for the period

(1,088,122)

(161,392)

(932,685)

Other comprehensive income

Change in fair value of available -for-sale assets

282,068

-

147,912

Loss for the period and total comprehensive income

(806,054)

(161,392)

(784,773)

Loss per share - basic and diluted

4

(0.09)p

(0.07)p

(0.10)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 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)

Change in fair value of available-for-sale assets

-

-

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

Unaudited

Balance at 1 January 2011

4,831,722

635,069

(4,730,855)

637,500

21,403

602,413

1,997,252

Loss for the period

-

-

(161,392)

-

-

-

(161,392)

Issue of shares

553,263

2,752,958

-

-

-

-

3,306,221

Movement in period

-

(237,592)

-

-

-

-

(237,592)

Share based payment

-

-

-

-

5,792

-

5,792

Balance at 30 June 2011

5,384,985

3,150,435

(4,892,247)

637,500

27,195

602,413

4,910,281

Audited

Balance at 1 January 2011

4,831,722

635,069

(4,730,855)

637,500

21,403

602,413

1,997,252

Loss for the year

-

-

(932,685)

-

-

-

(932,685)

Change in fair value of available-for-sale assets

-

-

147,912

-

-

-

147,912

Issue of shares

568,262

2,815,957

-

-

-

-

3,384,219

Movement in period

-

(203,487)

-

-

-

-

(203,487)

Share based payment

-

-

-

-

30,737

-

30,737

Balance at 31 December 2011

5,399,984

3,247,539

(5,515,628)

637,500

52,140

602,413

4,423,948

Consolidated statement of financial position

As at 30 June

31 December

2012

2011

2011

(unaudited)

(unaudited)

(audited)

£

£

£

ASSETS

Non current assets

Intangible assets

1,788,134

1,588,161

1,748,484

Property, plant and equipment

6,394

11,181

9,167

Financial assets: available-for-sale investments

1,141,518

-

859,450

2,936,046

1,599,342

2,617,101

Current assets

Inventories

15,035

15,956

19,484

Trade and other receivables

360,629

1,083,851

294,908

Cash and cash equivalents

1,383,653

2,323,910

1,634,148

1,759,317

3,423,717

1,948,540

TOTAL ASSETS

4,695,363

5,023,059

4,565,641

LIABILITIES

Current liabilities

Trade and other payables

(219,328)

(112,778)

(141,693)

(219,328)

(112,778)

(141,693)

NET ASSETS

4,476,035

4,910,281

4,423,948

SHAREHOLDERS' EQUITY

Share capital

5,599,984

5,384,985

5,399,984

Share premium account

3,891,410

3,150,435

3,247,539

Merger reserve

637,500

637,500

637,500

Reverse acquisition reserve

602,413

602,413

602,413

Share option reserve

66,410

27,195

52,140

Retained earnings

(6,321,682)

(4,892,247)

(5,515,628)

Total shareholders' equity

4,476,035

4,910,281

4,423,948

 

 

 

Consolidated cash flow statement

For the six months ended 30 June 2012

Six months ended

Six months ended

Year ended

30 June

30 June

31 December

2012

2011

2011

(unaudited)

(unaudited)

(audited)

£

£

£

Operating activities

Operating loss

(1,140,115)

(163,805)

(1,084,456)

Depreciation of tangible assets

3,438

1,354

3,829

Amortisation of intangible assets

11,764

13,798

30,096

Decrease/(increase) in inventories

4,449

(7,699)

(11,227)

Increase in receivables

(41,771)

(277,693)

(215,513)

Increase/(decrease) in creditors within one year

77,635

(390,668)

(361,753)

Other non-cash movements

5,466

-

147,912

Share option charge

14,270

5,792

30,737

Cash outflows from operating activities

(1,064,864)

(818,921)

(1,460,375)

Taxation

16,050

-

-

Investing activities

Interest received

11,993

2,413

20,726

Interest paid

-

-

(1,308)

Payments to acquire intangible assets

(56,880)

(27,640)

(193,511)

Payments to acquire tangible assets

(665)

(8,370)

(8,831)

Payment to acquire subsidiary

-

-

(13,546)

Net cash acquired with subsidiary undertaking

-

-

2,462

Net cash outflow for acquisitions and disposals

(45,552)

(33,597)

(194,008)

Financing activities

Issue of ordinary share capital

900,000

3,306,221

3,384,219

Cost of share issue

(56,129)

(237,592)

(203,487)

Net cash generated from financing activities

843,871

3,068,629

3,180,732

Net (decrease)/increase in cash and cash equivalents

(250,495)

2,216,111

1,526,349

Cash and cash equivalents at start of period

1,634,148

107,799

107,799

Cash and cash equivalents at end of period

1,383,653

2,323,910

1,634,148

 

Notes to the interim financial statements

1 General information

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

2 Financial information

The financial information for the six months ended 30 June 2012 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 2011 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 financial information for the six months ended 30 June 2012 has 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 2011.

 

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

2012

2011

2011

(unaudited)

(unaudited)

(audited)

£

£

£

United Kingdom corporation tax at 28%

Current period - R & D Tax credit

(40,000)

-

(116,303)

Prior period - R & D Tax credit

-

-

(16,050)

Tax charge

(40,000)

-

(132,353)

 

 

 

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

2012

2011

2011

(unaudited)

(unaudited)

(audited)

Basic:

Loss for the financial period

(1,088,122)

(161,392)

(932,685)

Weighted average number of shares

1,159,562,609

 226,497,358

 945,478,035

Loss per share

(0.09)p

(0.07)p

(0.10)p

 

There was no dilutive effect from the share options outstanding during the period.

 

5 Dividends

 

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

 

 

6 Share capital

 

30 June 2012

30 June 2011

Number

 £

Number

 £

(unaudited)

(unaudited)

(unaudited)

(unaudited)

Allotted, called up and fully paid

Ordinary shares of 0.1p each

1,259,562,609

1,259,561

1,044,562,609

1,044,562

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

5,599,984

5,384,985

31 December 2011

Number

 £

Allotted, called up and fully paid

(unaudited)

(unaudited)

Ordinary shares of 0.1p each

1,059,562,609

1,059,561

Deferred shares of 5.0p each

58,378,365

2,918,918

Deferred shares of 0.9p each

157,945,030

1,421,505

5,399,984

 

 

 

On 1 April 2012, 200 million ordinary shares of 0.1p each were issued at 0.45p per share, raising £900,000 before expenses.

The deferred shares effectively have no rights or value.

 

7 Copies of interim results

Copies of the interim results can be obtained from the website www.valirx.com.

 

 

 

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