For release at 07:00 on 19 March 2014
ValiRx Plc
("ValiRx" or "the Company")
Final Results
ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics
and therapeutics for personalised medicine, announces its final results
for the year ended 31 December 2013.
HIGHLIGHTS
· Administration expenses were £1,361,954 (2012: £1,481,717);
· Expenditure on Research and Development rose 60% on the previous year to £1,622,383 reflecting increased investment made in the VAL201 clinical trial programme;
· Net loss after taxation was £2,597,238 (2012: £2,163,948);
· As at 31 December 2013, the Company had cash and cash equivalents of £960,267 (2012: £2,260,783); this has since increased substantially following the raising of equity finance and the divestment of shares in the US-listed company, VolitionRx, in January and February 2014 respectively;
· Since November 2013, ValiRx has successfully secured over £4.3m of additional cash resource to strengthen the group's balance sheet and enable the group to drive the clinical process of its lead compound VAL201;
· GeneICE-based lead compound VAL101 continues to show good progress in the pre-clinical phase - the programme currently benefits from a second Eurostars grant for up to €1.6 million;
· Biomarker development programme, to support clinical and pre-clinical development, is now producing preliminary results. The programme is supported extensively by Finnish Government regional funding.
Oliver de Giorgio-Miller, Non-Exec Chairman of ValiRx, commented:
"The Company has achieved much this year and I am pleased to report that we now have a secure funding platform upon which we can consolidate the further development of VAL201, VAL101 and our biomarker portfolio and importantly, a platform from which we can advance VAL201 into First in-Human trials. I look forward to the Company updating shareholders on future developments".
- ENDS -
For more information, please contact:
ValiRx plc |
Tel: +44 (0) 20 3008 4416 |
Dr Satu Vainikka |
www.valirx.com |
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Cairn Financial Advisers LLP (Nominated Adviser) |
Tel: +44 (0) 20 7148 7900 |
Liam Murray / Avi Robinson |
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Daniel Stewart & Company Plc (Broker) |
Tel: +44 (0) 20 7776 6550 |
David Hart |
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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 FOR THE YEAR ENDED 31 DECEMBER 2013
I am pleased to report for the first time as Chairman, a solid performance by the Group, with real progress seen on a number of important fronts during the period. Our key therapeutic and diagnostic development programmes continue to advance and the recent equity investment and divestment of shares in a US-listed entity that we announced recently - all combine to position the Company strongly as we move into a new financial year.
Operating expenses rose to £2,984,337 (2012: £2,492,193) reflecting the group's increased investment in its Research & Development programmes, predominantly to take the lead drug candidate VAL201 to clinical trials and to a much lesser extent to advance our GeneICE products to the next stage of development. Revenues in the reporting period of £124,868 largely derived from our biomarkers division, ValiFinn. Research & Development tax credits were £309,541 (2012: £165,956) and bank interest income was £5,552 (2012: £19,001). Our net loss for the year increased to £2,597,228 (2012: £2,163,948), however, after adjustment to reflect a change in the fair value of available-for-sale assets, the loss for the year stood at £2,702,258 (2012: £2,150,055).
As at 31 December 2013 the Company had cash and cash equivalents of £960,267 (2012: £2,260,783). However, post the period end, our cash position has increased substantially following the raising of equity finance and the divestment of shares in the US-listed company, VolitionRx, in January and February 2014 respectively.
In terms of strategy and the appropriate positioning of the Company, it is good to see ValiRx steadily growing in stature and enhancing both the value and number of its development assets. I believe the Group is well placed to continue in this vein and towards those value inflection points that exist across its portfolio.
Looking forward, we now have a secure funding platform upon which we can consolidate the further development of VAL201, VAL101 and our biomarker portfolio and importantly, a platform from which we can advance VAL201 through First in-Human trials. I look forward to the Company updating shareholders on future developments.
Oliver de Giorgio-Miller
Non-Exec Chairman
19 March 2014
CHIEF EXECUTIVE'S REPORT FOR THE YEAR ENDED 31 DECEMBER 2013
2013 was a good year for ValiRx and I have been pleased to see its therapeutic development programmes moving forward encouragingly, giving a very positive outlook for the clinical trials. Our clinical trial Project Team has signed off on the protocol for VAL201, the Company's leading anti-cancer therapeutic and its enhanced Phase 1b trial and its expected advance to a Phase 2 study. Product development for VAL201 has been successful and world class clinical partners have been agreed for the forthcoming trials.
The period under review also saw VAL101, the Company's lead candidate deriving from the GeneICE platform, complete its first €1.4 million Eurostars programme and this progress was subsequently rewarded by a second grant of €1.6 million. The Company has grown its companion diagnostics and biomarker unit and both before and after the year-end, we strengthened the balance sheet via a successful fund raise.
Fundraising
Since November 2013, the Company has raised a total of over £4.3m in additional cash resource, through equity investment and the divestment of shares in the US-listed company, VolitionRx. This fundraising took place in a series of transactions, which comprised two equity fundraisings and an equity swap and a further US$601,578 (£364,000) through the divestment in shares of the US-listed entity. The impact of these transactions has been to substantially strengthen the group's balance sheet and to allow the continuing clinical development of the lead compounds, VAL101 and VAL201. This strengthening will hopefully enable the Company to potentially take advantage of corporate and technological opportunities as they may arise.
Divestment
The divestment occurred because the Board believed and continues to believe that the Company will obtain a better return for its shareholders by investing the proceeds received from the transaction in the continuing development of VAL101 and VAL201 and to see their development progress towards those respective value inflection points that exist across the portfolio.
VAL201
As has been reported in recent months, our trial protocol for our lead therapeutic, VAL201, has expanded significantly following advice from the principal investigators at University College Hospital, London and from the Medicines and Healthcare Products Regulatory Agency ("MHRA"). The trial has been expanded to include, not just patients with prostate cancer, but also patients with other solid tumours, such as breast cancer. In addition, the end points of the study have widened to give us an early indication of the efficacy of VAL201 in arresting and reducing tumour growth. Our number one priority in 2014 is to progress the compound through its expanded clinical trials and beyond, whilst in parallel, we will look to continue our dialogue with pharmaceutical companies vis-à-vis future partnering or out-licensing opportunities.
VAL101 & GeneICE
We have also been advancing pre-clinical studies of VAL101, one of our GeneICE drug candidates, with the support of another European Union "Eurostars" Grant. The grant for €1.6m was announced on 15 August 2013 and it endorses VAL101's novelty and potential and will enable ValiRx to accelerate the drug's development to build the associated cancer models and hopefully to provide new hope for patients with orphan cancers.
Biomarkers
Biomarkers continue to be evaluated by our subsidiary company, ValiFinn, which is based in Finland and we were pleased to announce recently that ValiFinn has identified companion diagnostics for VAL201, which potentially could be commercialised or licensed to other pharmaceutical companies.
Outlook
In what has been a busy year, I am happy to see the team's hard work rewarded with strong progress in our programme development activities. We will continue to energetically move our compounds forward to their next stage, whilst remaining alert for opportunities and ways in which to further grow the Company and enhance shareholder value. I look forward to ValiRx's continued progress and development with both excitement and confidence.
Dr Satu Vainikka
Chief Executive
19 March 2014
VALIRX PLC |
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CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME |
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FOR THE YEAR ENDED 31 DECEMBER 2013 |
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2013 |
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2012 |
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£ |
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£ |
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Revenue |
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124,868 |
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216,269 |
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Cost of sales |
(51,618) |
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(72,960) |
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Gross profit |
73,250 |
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143,309 |
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Research and development |
(1,622,383) |
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(1,010,476) |
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Administrative expenses |
(1,361,954) |
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(1,481,717) |
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Operating loss |
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(2,911,087) |
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(2,348,884) |
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Finance income |
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5,552 |
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19,001 |
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Finance costs |
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(180) |
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(21) |
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Loss on ordinary activities before taxation |
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(2,905,715) |
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(2,329,904) |
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Income tax expense |
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308,477 |
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165,956 |
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Loss for the year |
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(2,597,238) |
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(2,163,948) |
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Other comprehensive income |
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Change in fair value of available-for-sale assets |
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(105,020) |
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13,893 |
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Loss for the year and total comprehensive income |
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(2,702,258) |
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(2,150,055) |
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Loss per share - basic and diluted |
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From continuing operations |
(0.15)p |
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(0.17)p |
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