REG - ValiRx PLC - Half Yearly Report <Origin Href="QuoteRef">VALX.L</Origin>

ValiRxAnnouncement

17/09/2015 12:20

RNS Number : 3859Z
ValiRx PLC
17 September 2015
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIOD ENDED 30 JUNE 2015 
London, UK 17 September 2015 - ValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics and diagnostics for personalised medicine, today announces its Half Yearly Report for the period ended 30 June 2015.
HIGHLIGHTS
Operational Highlights
 VAL201 clinical trial progressing and continuing to show favourable safety profile with early indications of efficacy even at low dosage
 VAL401 entering the clinical trial pathway
 Substantial extension of the Group's global patent coverage to provide a strong platform for future global commercialisation of ValiRx's therapeutic and biomarker technologies
 Acquisition of TRAC, a gene expression and biomarker technology, broadens ValiFinn's service offering for growing revenue streams
 Invited to participate at the 2015 BIO International Convention in Philadelphia with other leading UK biotech and biopharma companies - to build relationships and explore partnering opportunities with leading pharmaceutical and biotechnology companies
Financial Highlights
 Placing raised 800,000 in March 2015;
 Legal, due diligence and administration expenses increased following acquisition of new technologies, & licensing deals executed, expansion of ValiFinn R&D team, upgrading of IT capabilities and engaging with US drug licensing consultants;
 Loss after taxation increased marginally to 1.37m (H1 2014: 1.34m);
 Total comprehensive loss for the period reduced by 23% to 1.34m (H1 2014: 1.75m); and
 Cash and cash equivalents as at 30 June 2015 of 391,884 (H1 2014: 757,589).
Post Period Highlights
 Fundraising and equity swap to raise 2.45 million gross in September 2015
Oliver de Giorgio-Miller, Non-Executive Chairman of ValiRx, commented:
"We continue to make progress across all areas of ourbusiness and I am particularly pleased to see VAL201's development proceeding well and as planned in the clinical trial at UCLH; VAL401, our second therapeutic compound, entering the clinical trial pathway; and our biomarker division in Finland substantially boosted by the acquisition of TRAC, a gene expression and biomarker technology".
"We have entered the second half of the year well placed to maintain our growth momentum and we look forward to reporting further advancements".
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



Northland Capital Partners Limited (Broker)
Tel: +44 (0) 20 7382 1100
Patrick Claridge / David Hignell (Corporate Finance)
John Howes / Abigail Wayne (Broking) 

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 has undertaken todevelop a novel and groundbreaking class of therapeutics across a number offields in oncology and has taken its lead compound, Val201, into Phase I/IIclinicaltrials. The Company listed onthe AIM Market of the London StockExchange in October 2006.
The Company has a pipeline ofother therapeutic drugs, which are currently progressing towards clinicaltrials. The product focus is in the targeted analysis and treatment of cancer,but thetechnologies can be applied to other fields as well, such as neurologyand inflammatory diseases.
It actively manages projectswithin its portfolio as a trading company. The ValiRx business model spreads the risks of life science technologydevelopment by minimising financial exposure andrunning a set of projects todefined commercial endpoints. This maximises returns to shareholders by adding value at the earlier stages where value increases per investment unit are thegreatest.
The Company operates through thefollowing divisional companies:
1. ValiPharma is the therapeuticsdivision, with two embedded technologies primarily directed at the treatment ofcancers.
2. ValiFinn is the biomarkers anddiagnostic development division. ValiRx acquired through its ValiFinn subsidiary, the complimentary TRAC technologylater in the year to strengthen the portfolio.
3. ValiSeek is a joint venturebetween ValiRx and Tangent Ltd to develop Val401 in lung cancer and potentiallyother indications.


CHAIRMAN'S STATEMENT FORTHE HALF YEAR ENDED 30 JUNE 2015
We continue to make progress across all areas of ourbusiness and I am particularly pleased to see VAL201's development proceeding well and as planned in the clinical trial at UCLH; VAL401, our second therapeutic compound, entering the clinical trial pathway; and our biomarker division in Finland substantially boosted by the acquisition of TRAC, a gene expression and biomarker technology.
VAL201
Our lead compound, VAL201, is in a Phase l/ll dose escalation clinical trial, which is approved to include patients with locally advanced or metastatic prostate cancer and other advanced solid tumours. In recent months, the approved incremental dose escalation has caused no significant adverse effects and continued to demonstrate safety and tolerability. As a result the next dose escalation has been approved, which may prove sufficient to show anti-tumour activity. This would follow the trend seen in our pre-clinical studies.
VAL401
Just after the period end, ValiSeek announced that following the completion of its pre-clinical studies, a clinical trial contract had been established with Clinical Accelerator, a UK-based clinical trial management organisation, to manage and execute the Phase 2b clinical trial of VAL401 in patients with non-small-cell lung adenocarcinoma. The parameters to be assessed during the trial will include (i) effectiveness of the treatment (as observed by measurements of disease progression, quality of life and survival); (ii) pharmacokinetics of VAL401 and (iii) safety and tolerability of the VAL401 treatment in the patient population. The trial is on track and is proceeding according to timetable. 
TRAC & ValiFinn
The acquisition of TRAC six months ago is already delivering revenues and benefit to our biomarker business in Finland. We announced in May 2015 that Admescope Limted ("Admescope") had purchased a global, non-exclusive licence from ValiFinn to use the TRAC technology in its provision of toxicological testing services to drug discovery and development companies. This was the first contract for TRAC technology under the ownership of ValiRx and, since the period end, we are delighted to report the signing of further contracts for access to this technology.


Patent Protection
Extension of the Group's patent coverage has continued during the period, both in terms of new geographies and across our therapeutic compound and biomarker portfolio.
In February 2015, we received patent approval by the European Patent Office covering the means for diagnosing and monitoring of patients using biomarker testing for B-cell lymphomas and its prognostic outcome. The Patent is based around the NAV3 gene and comprises a novel methodtopermit early diagnosis by use of the biomarker for diagnosing and separating types of B-cell lymphomas into different prognostic groups. 
In the same month, the Company also received patent approval by the UK Patent Office regarding its lead therapeutic compound VAL201 for a further indication in endometriosis or hormone induced abnormal cell growth in women. Based on results in endometrial models, VAL201 has been shown to reduce abnormal endometrial growth, whilst leaving other hormone-induced activities working normally and this grant will expand the opportunities for the compound beyond solid tumours. Endometriosis, an excessively debilitating gynaecological medical condition, is typically seen during the reproductive years and it represents one of the major causes of female infertility.
Then in May 2015, we reported thatthe Group, through ValiSeek Limited ("ValiSeek"), our joint venture with Tangent Reprofiling Limited ("Tangent"),had received patent approval from the US Patent Office covering the composition of formulation for ValiSeek's novel cancer treatment VAL401 and that such a grant significantly strengthened and validated the science, novelty and founding basis behind the VAL401 project.
These latest patent grants substantially extend the Group's patent protection, both domestically and internationally and they provide a strong platform for the future global commercialisation of ValiRx's therapeutic and biomarker technologies.
2015 BIO International Convention in Philadelphia
In June 2015, we were delighted to be invited to join with leading UK biotechnology and biopharma-facing businesses and to participate in a 'Market Visit' to the 2015 BIO International Convention in Philadelphia, Pennsylvania.
The Market Visit had been organised by the Mayor of London's Export Programme, in partnership with UK Trade & Investment (UKTI) to offer London SMEs an opportunity to attend this major industry international event and a chance to partner with the world's leading pharmaceutical and biotechnology companies.
Not only was it gratifying to be in such esteemed company, but it provided ValiRx with an excellent opportunity to build profile and relationships on the US biotech stage and a chance to explore partnering opportunities with the world's leading pharmaceutical and biotechnology companies.
We have entered the second half of the year well placed to maintain our growth momentum and we look forward to reporting further advancements.
Oliver de Giorgio-Miller
Non-Executive Chairman
17 September 2015


Consolidated statement of comprehensive income


 Six months ended

 Six months ended

Year ended

Note
30 June 

30 June 

31 December


2015

2014

2014


(unaudited)

(unaudited)

(audited)


















Revenue

 153,099 

 59,574 

 87,558 







Cost of sales

(25,639)

 - 

(61,025)
Gross profit

 127,460 

 59,574 

 26,533 







Research and development
3
(859,391)

(672,127)

(2,008,513)
Administrative expenses
3
(989,846)

(526,475)

(1,366,953)
Other income

158,623

 - 

210,802














Operating loss

(1,563,154)

(1,139,028)

(3,138,131)







Fair value loss on derivative financial assets

 - 

(361,218)

(72,202)
Finance income

 660 

 7,214 

 8,023 
Loss on disposal of finance assets

 - 

 - 

(437,493)
Finance costs

(7)

 - 

(1,532)







Loss before income taxation

(1,562,501)

(1,493,032)

(3,641,335)







Income tax credit
4
 190,000 

 150,000 

 396,864 







Loss on ordinary activities after taxation

(1,372,501)

(1,343,032)

(3,244,471)







Non-controlling interests

 35,557 

 32,044 

 84,440 


(1,336,944)

(1,310,988)

(3,160,031)
Other comprehensive income






Change in fair value of available-for-sale assets

 - 

(437,492)

 - 







Loss for the period and total comprehensive income attributable to owners of the parent

(1,336,944)

(1,748,480)

(3,160,031)







Loss per share - basic and diluted
5
(4.80)p

(5.71)p

(10.25)p



Statement of changes in shareholders' equity


Share capital

Share premium

Retained earnings

Merger reserve

Share option reserve

Reverse acquisition reserve

Non-controlling interest 

Total 









Unaudited
















Balance at 1 January 2015

 7,281,806 

 7,604,732 

(13,518,940)

 637,500 

 154,144 

 602,413 

 26,374 

 2,788,029 
Loss for the period

 - 

 - 

(1,336,944)

 - 

 - 

 - 

(35,557)

(1,372,501)
Movement in period

 - 

 - 

 - 

 - 

 - 

 - 

 41,876 

 41,876 
Issue of shares

 830,770 

 849,231 

 - 

 - 

 - 

 - 

 - 

 1,680,001 
Movement in period

 - 

(121,023)

 - 

 - 

 - 

 - 

 - 

(121,023)
Share based payment

 - 

 - 

 - 

 - 

 49,375 

 - 

 - 

 49,375 
Balance at 30 June 2015

 8,112,576 

 8,332,940 

(14,855,884)

 637,500 

 203,519 

 602,413 

32,693

 3,065,757 

















Unaudited
















Balance at 1 January 2014

 6,359,357 

 5,925,231 

(10,367,941)

 637,500 

 73,852 

 602,413 

 - 

 3,230,412 
Loss for the period

 - 

 - 

(1,310,988)

 - 

 - 

 - 

(32,044)

(1,343,032)
On acquisition of subsidiary

 - 

 - 

 - 

 - 

 - 

 - 

 30 

 30 
Change in fair value of available-for-sale assets

 - 

 - 

(437,492)

 - 

 - 

 - 

 - 

(437,492)
Issue of shares

 922,448 

 2,069,701 

 - 

 - 

 - 

 - 

 - 

 2,992,149 
Costs in respect of shares issued

 - 

(390,200)

 - 

 - 

 - 

 - 

 - 

(390,200)
Share based payment

 - 

 - 

 - 

 - 

 54,542 

 - 

 - 

 54,542 
Balance at 30 June 2014

 7,281,805 

 7,604,732 

(12,116,421)

 637,500 

 128,394 

 602,413 

(32,014)

 4,106,409 

















Audited
















Balance at 1 January 2014

 6,359,357 

 5,925,231 

(10,367,941)

637,500

 73,852 

 602,413 

 - 

 3,230,412 
Loss for the year

 - 

 - 

(3,160,031)

 - 

 - 

 - 

(84,440)

(3,244,471)
Change in fair value of available-for-sale assets

 - 

 - 

 - 

 - 

 - 

 - 

 110,814 

 110,814 
Issue of shares

 922,449 

 2,069,701 

 - 

 - 

 - 

 - 

 - 

 2,992,150 
Costs in respect of shares issued

 - 

(390,200)

 - 

 - 

 - 

 - 

 - 

(390,200)
Movement in period

 - 

 - 

 - 

 - 

 89,324 

 - 

 - 

 89,324 
Transfer between share option reserve and retained earnings

 - 

 - 

 9,032 

 - 

(9,032)

 - 

 - 

 - 
Balance at 31 December 2014

 7,281,806 

 7,604,732 

(13,518,940)

 637,500 

 154,144 

 602,413 

 26,374 

 2,788,029 



Consolidated statement of financial position


As at 30 June

31 December

Note
2015

2014

2014


(unaudited)

(unaudited)

(audited)




ASSETS






Non current assets






Intangible assets

 2,537,881 

 2,074,111 

 2,380,021 
Property, plant and equipment

 1,359 

 657 

 1,507 
Derivative financial assets

 - 

 63,440 

 - 









 2,539,240 

 2,138,208 

 2,381,528 







Current assets






Inventories

 30,107 

 6,255 

 11,150 
Trade and other receivables

 770,961 

 568,670 

 777,602 
Derivative financial assets

 - 

 761,282 

 - 
Cash and cash equivalents

 391,884 

 757,589 

 452,824 


 1,192,952 

 2,093,796 

 1,241,576 







LIABILITIES






Current liabilities






Trade and other payables

(666,435)

(125,595)

(835,075)







NET CURRENT ASSETS

 526,517 

 1,968,201 

 406,501 







NET ASSETS

 3,065,757 

 4,106,409 

 2,788,029 







SHAREHOLDERS' EQUITY






Share capital

 8,112,576 

 7,281,805 

 7,281,806 
Share premium account

 8,332,940 

 7,604,732 

 7,604,732 
Merger reserve

 637,500 

 637,500 

 637,500 
Reverse acquisition reserve

 602,413 

 602,413 

 602,413 
Share option reserve

 203,519 

 128,394 

 154,144 
Retained earnings

(14,855,884)

(12,116,421)

(13,518,940)









 3,033,064 

 4,138,423 

 2,761,655 
Non-controlling interest

 32,693 

(32,014)

 26,374 







Total equity

 3,065,757 

 4,106,409 

 2,788,029 


Cash flow statement






Year ended


Six months ended 30 June

31 December


2015

2014

2014


(unaudited)

(unaudited)

(audited)




Operating activities






Operating loss

(1,563,154)

(1,139,028)

(3,138,131)
Depreciation of property plant and equipment

 - 

 - 

 517 
Amortisation of intangible assets

 44,938 

 26,998 

 90,697 
Increase in inventories

(18,957)

(2,177)

(7,072)
Decrease/(increase) in receivables

 196,641 

 71,725 

(199,884)
Decrease in payables within one year

(88,640)

(718,354)

(158,873)
Other non-cash movements

 11,236 

 4,593 

6,710
Share option charge

 49,375 

 54,542 

 89,324 







Cash outflows from operating activities

(1,368,561)

(1,701,701)

(3,316,712)







Taxation 

 - 

 - 

 309,541 







Investing activities






Interest received

 660 

 7,214 

 8,023 
Interest paid

(7)

 - 

(1,532)
Payments to acquire intangible assets

(172,010)

(162,881)

(273,846)
Payments to acquire property plant and equipment

 - 

 - 

(1,408)
Receipts from sale of financial investments

 - 

 330,830 

 330,830 







Net cash (outflow)/inflow from investing activities

(171,357)

175,163

62,067







Acquisitions and disposals






Non-controlling interest

 - 

 - 

 63 
Net cash inflow for acquisitions and disposals

 - 

 - 

 63 







Financing activities






Issue of ordinary share capital

 1,600,000 

 2,900,000 

 2,900,000 
Cost of share issue

(121,022)

(390,200)

(390,200)
Payments to acquire derivative financial assets

 - 

(1,500,000)

(1,500,000)
Receipts from issue of derivative financial assets

 - 

 314,060 

 1,427,798 







Net cash generated from financing activities

 1,478,978 

 1,323,860 

 2,437,598 







Net decrease in cash and cash equivalents

(60,940)

(202,678)

(507,443)







Cash and cash equivalents at start of period

 452,824 

 960,267 

 960,267 







Cash and cash equivalents at end of period

 391,884 

 757,589 

 452,824 


Notes to the interim financial statements
1 General information
Valirx Plc is a company incorporated in the United Kingdom, which is listed on the Alternative Investment 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 2015 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 2014 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 2014.
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 Comparative figures for research and development and administrative expenses
The comparative figures for research and development and administrative expenses for the six months ended 30 June 2014 and the year ended 31 December 2014 have been adjusted by transferring 113,925 and 236,175 from administrative expenses to research and development respectively. This represents the proportion of directors' remuneration which is allowable as a research and development expense. The charge for the six months ended 30 June 2015 was 200,856.
The re-analysis has no impact on the loss for the periods concerned.
4 Taxation


 Six months ended

 Six months ended

Year ended


30 June 

30 June 

31 December


2015

2014

2014


(unaudited)

(unaudited)

(audited)




United Kingdom corporation tax at 23%






 Current period - R & D Tax credit

(190,000)

(150,000)

(396,864)







Income tax credit

(190,000)

(150,000)

(396,864)
5 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


2015

2014

2014


(unaudited)

(unaudited)

(audited)
Basic:






Loss for the financial period 

(1,372,501)

(1,343,032)

(3,160,031)
Weighted average number of shares

28,603,733 

23,531,060 

30,837,844 
Loss per share 

(4.80)p

(5.71)p

(10.25)p
Following the consolidation of share capital (note 7 below) the loss per share for the comparative periods have been recalculated as if the consolidation had occurred in those periods, to make the loss per share comparable.
6 Dividends
The directors do not propose to declare a dividend in respect of the period.
7 Share capital



30 June 2015

30 June 2014



Number 

 

Number 

 



(unaudited)

(unaudited)

(unaudited)

(unaudited)
Allotted, called up and fully paid









Ordinary shares of 0.1p each


 30,177,214 

 30,177 

 2,941,382,514 

 2,941,381 
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 
Deferred shares of 12.4p each


 30,177,214 

 3,741,976 

 - 

 - 





 8,112,577 



 7,281,804 













31 December 2014







Number 

 




Allotted, called up and fully paid


(unaudited)

(unaudited)




Ordinary shares of 0.1p each


 2,941,382,514 

 2,941,383 




Deferred shares of 5.0p each


 58,378,365 

 2,918,918 




Deferred shares of 0.9p each


 157,945,030 

 1,421,505 









 7,281,806 




The shareholders approved of the following capital reorganisation at the 2015 Annual General Meeting:
 Every 125 existing ordinary shares of 0.1p each was consolidated into one consolidated share of 12.5p each ("Consolidation"); and
 Immediately following the consolidation, each consolidated share was sub-divided into one new ordinary share of 0.1p and one new deferred share of 12.4p.
The deferred shares effectively have no rights or value.
8 Copies of interim results
Copies of the interim results can be obtained from the website www.valirx.com. From this site you may access our financial reports and presentations, recent press releases and details about the company and its operations.

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