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

ValiRxAnnouncement

27/09/2016 07:05

RNS Number : 8701K
ValiRx PLC
27 September 2016
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIOD ENDED 30 JUNE 2016 
London, UK., 27 September 2016: ValiRx Plc (AIM: VAL), a life science company, which focuses on clinical stage cancer therapeutic development, taking proprietary & novel technology for precision medicines towards commercialisation and partnering, today announces its Half Yearly Report for the period ended 30 June 2016.
HIGHLIGHTS
Operational Highlights
 Progressive period for ValiRx, which has seen substantial advances made in clinical trials by both therapeutic compounds
 The Phase l/ll Clinical Trial of VAL201 confirmed at the end of the period that the compound was well tolerated and safe, with no significant adverse events being reported. Post period studies continue to show preliminary indications of VAL201 efficacy
 VAL401 completed its submission to commence Phase llb clinical trial in patients with lung cancer. Ethics and regulatory approval to commence patient recruitment was received just after the period-end and now ready to start recruiting
 VAL401 received two patent grants in the period - a US patent grant in April followed by a post period allowance in July of a New Zealand patent grant 
 ValiRx successfully engaged with its UK and international life-sciences audiences by exhibiting at both the UK Investor Show in London and at the prestigious AACR conference in New Orleans
 March 2016 - The Company engaged US investor relations firm, Burns McClelland, to help create broader recognition of and enhanced engagement for ValiRx within the US Life Science investor community. This follows the Company's recently established presence in the US and the opening in November 2015 of a ValiRx office in Cambridge, Boston, Massachusetts. 
Financial Highlights
 Placing to raise 0.5m in February 2016 with existing and new investors
 March 2016 - Convertible Loan Facility agreed with Bracknor to facilitate the expansion of the VAL201 trial into a multi-centre study - Board concluded in July that it would not make further use of the facility
 Loss after taxation increased 55% to 2.12m (H1 2015: 1.37m) due to increase in clinical R&D expenditure on VAL201 and 401;
 Total comprehensive loss for the period of 2.074m (H1 2015: 1.34m); and
 Cash and cash equivalents as at 30 June 2016 of 568,805 (H1 2015: 391,884).
Post-Period Highlights
 Sale in July of TRAC Technology Rights for EUR 0.8 million. This sale should be seen within the context of ValiRx's original purchase of the technology for EUR75,000, only months earlier
 Placing in September with existing and new investors successfully raised 1.2 million - Convertible Loan Facility with Yorkville also concluded for up to US$3.75 million in potential 3 tranches
 VAL301 in development - reformulation of VAL201 for new indication, endometriosis
Oliver de Giorgio-Miller, Non-Executive Chairman of ValiRx, commented:
"ValiRx is making good progress in its clinical trials and is receiving welcome support from both existing and new shareholders as well as from our academic and commercial partners. I am also very pleased to see our subsidiary, ValiSeek, on the cusp of dosing patients and that we can expect to see results in its Phase IIb trial start arriving in the coming months". 
"Our review of the pre-clinical data obtained with VAL201 has also revealed a major gynaecological indication for the compound, namely endometriosis; this condition is not adequately served with current medications as they are frequently poorly tolerated and/or impair fertility during treatment. VAL301 should show that it is completely devoid of these complications and that it also shows signs of maintaining bone density while treating this chronic debilitating condition". 
"We are now well into the second half of the year and I am pleased that we have been able to sustain our momentum as we move towards exciting clinical developmental milestones and potential value inflection points as far as our VAL201, 301 and 401 therapeutic compounds are concerned. The funding recently secured provides a cash runway towards reaching these. I look forward to updating the market with our future progress in due course".
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
*** ENDS ***
For more information, please contact:
ValiRx Plc
Tel: +44 (0) 20 3008 4416
www.valirx.com
Dr Satu Vainikka, Chief Executive
Tel: +44 (0) 20 3008 4416
Tarquin Edwards, Head of Communications.
Tel: +44 (0) 7879 458 364
tarquin.edwards@valirx.com
Mark Treharne, Corporate Development Manager
Tel: +44 (0) 7736 564 686
mark.treharne@valirx.com


Cairn Financial Advisers LLP (Nominated Adviser)
Tel: +44 (0) 20 7148 7900
Liam Murray / Jo Turner



Northland Capital Partners Limited (Joint Broker)
Tel: +44 (0) 203 861 6625
Patrick Claridge / David Hignell (Corporate Finance)
John Howes / Abigail Wayne (Broking)



Beaufort Securities Limited (Joint Broker)
Tel: +44 (0) 207 382 8300
Jon Belliss

Notes for Editors 
ValiRx Plc
ValiRx is a biotechnology oncology focussed company specialising in developing novel treatments for cancer and associated biomarkers. It aims to make a significant contribution in "precision" medicine and science, namely toengineer a breakthrough into human health and well-being, through the early detection of cancer and its therapeutic intervention.
The Company's business model focuses on out-licensing therapeutic candidates early in the development process. By aiming for early-stage value creation, the company reduces risk considerably while increasing the potential for realising value. The group is already in licensing discussions with major players in the oncology field. 
ValiRx's three classes of drugs in development, which each have the potential for meeting hitherto unmet medical needs by existing methods, have worldwide patent filings and agreed commercial rights. They originate or derive from Word class institutions, such as Cancer Research UK and Imperial College. 
Until recently, cancer treatments relied on non-specific agents, such as chemotherapy. With the development of target-based agents, primed to attack cancer cells only, less toxic and more effective treatments are now possible. New drugs in this group-such as those in ValiRx's pipeline-promise to greatly improve outcomes for cancer patients. 
The Company listed on the Alternative Investment Market ("AIM") of the London StockExchange in October 2006 and trades under the ticker symbol: VAL.


CHAIRMAN'S STATEMENT FORTHE HALF YEAR ENDED 30 JUNE 2016
The Company continues to make good progress across all areas of ourbusiness and I am particularly pleased to see VAL401 and VAL201 on the clinical trial development pathway, with VAL201 patients being dosed and VAL401 patients on the cusp of being dosed. Results from these will shortly be forthcoming thereafter. VAL201's Phase I/II clinical development is proceeding well and as planned in its clinical trial at UCLH. Just after the period end, we were able to commercialise a part of our portfolio, through the sale of TRAC, a gene expression and biomarker technology, at a considerable premium to its purchase price a year earlier. In so doing, we have freed up resource and management time, while retaining a license to the technology for its future use in our therapeutic developments.
VAL201
Our lead compound, VAL201, continues to perform well in its Phase l/ll Clinical Trial in patients with hormone resistant prostate cancer and we confirmed in June, at the end of the period, that VAL201 was tolerated and safe. Since then VAL201 not only continues to show no drug related significant adverse events, but it also demonstrates early efficacy. These positive efficacy indications also extend to include some subjects at an early stage in their therapeutic dose ranging and elevation safety studies. Furthermore, additional Clinical Trial Centres are now being integrated into the study to assist with the dose expansion stage of the trial. 
With the encouraging, independently, generated information that has been gathered during the clinical trial, ValiRx has continued to design the follow-up therapeutic and applicability trial protocols for VAL201 in prostate cancer. This is progressing well and is expected to be completed and in place by the time that the current Phase I/II trial reports.
The Company continues with the design of a trial for VAL201's use in treating the debilitating female condition, endometrioses and other endometrial conditions. The associated partnerships - both commercial and technical - are expected to be in place before the final reporting of the current 'safety and tolerability-focused' Phase I/II clinical trial completes. 
VAL401
This half-year has been an important period for progressing VAL401 towards the clinic. ValiSeek completed its first submission in the regulatory approval process during the period and was pleased to receive just after the period-end, full regulatory and ethics approval for the clinical trial site at the Medulla Immunotherapy and Chemotherapy Clinic, Tbilisi. This is to test VAL401 as an oral treatment of late stage non-small cell lung adenocarcinoma. Since these regulatory approvals were received, the site initiation visit has been carried out, introducing the team at Clinical Accelerator to the site, and ensuring the protocol and recruitment requirements. 
ValiSeek have confirmed the data management plan for the trial of VAL401 and the use of the proprietary "KEM" (Knowledge Extraction and Management) patientstratification technology, to fully exploit complex datasets of small numbers of patients.
ValiSeek received two patent grants for VAL401 in recent months - a US patent grant in April followed by a post period allowance in July of a New Zealand patent grant. The patents strongly endorse the science lying behind the VAL401 compound and courtesy of their IP protection, they add value to shareholder funds and endorse ValiRx's joint venture with ValiSeek, in terms of its international scope and worldwide commercial ambition. 
Outlook
We are now well into the second half of the year and I am pleased that we have been able to sustain our momentum as we move towards exciting clinical developmental milestones and potential value inflection points as far as our VAL201, 301 and 401 therapeutic compounds are concerned. The funding recently secured provides a cash runway towards reaching these. I look forward to updating the market with our future progress in due course.
Oliver de Giorgio-Miller
Non-Executive Chairman
27 September 2016


Valirx Plc
Consolidated statement of comprehensive income



 Six months ended

 Six months ended

Year ended


Note
30 June 

30 June 

31 December



2016

2015

2015



(unaudited)

(unaudited)

(audited)





















Revenue


 239,855 

 153,099 

 82,603 








Cost of sales


(101,184)

(25,639)

(77,875)
Gross profit


 138,671 

 127,460 

 4,728 








Research and development


(638,356)

(859,391)

(1,543,441)
Administrative expenses


(921,318)

(989,846)

(1,694,089)
Other income


 - 

 158,623 

 203,391 
















Operating loss


(1,421,003)

(1,563,154)

(3,029,411)








Fair value loss on derivative financial assets


(916,399)

 - 

463,023
Finance income


 6 

 660 

 1,074 
Finance costs


(229)

(7)

(1,793)








Loss before income taxation


(2,337,625)

(1,562,501)

(2,567,107)








Income tax credit

3
 214,982 

 190,000 

 391,202 








Loss on ordinary activities after taxation


(2,122,643)

(1,372,501)

(2,175,905)








Non-controlling interests


 52,055 

 35,557 

 57,570 








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


(2,070,588)

(1,336,944)

(2,118,335)








Loss per share - basic and diluted

4
(0.48)p

(4.80)p

(6.66)p



Valirx Plc
Consolidated 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 2016
8,120,736 

 10,526,862 

(15,637,275)

 637,500 

 203,519 

 602,413 

 79,069 

4,532,824 
Loss for the period
 - 

 - 

(2,070,588)

 - 

 - 

 - 

(52,055)

(2,122,643)
On acquisition of subsidiary
 - 

 - 

 - 

 - 

 - 

 - 

 32,531 

 32,531 
Issue of shares
 14,046 

 1,238,435 

 - 

 - 

 - 

 - 

 - 

1,252,481 
Movement in period
 - 

(341,945)

 - 

 - 

 - 

 - 

 - 

(341,945)
Share based payment
 - 

 - 

 - 

 - 

 55,792 

 - 

 - 

 55,792 
Balance at 30 June 2016
 8,134,782 

 11,423,352 

(17,707,863)

 637,500 

 259,311 

 602,413 

59,545

 3,409,040 
















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)
On acquisition of subsidiary assets
 - 

 - 

 - 

 - 

 - 

 - 

 41,876 

 41,876 
Issue of shares
 830,770 

 849,230 

 - 

 - 

 - 

 - 

 - 

 1,680,000 
Costs of shares issued
 - 

(121,022)

 - 

 - 

 - 

 - 

 - 

(121,022)
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 
















Audited















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 year
 - 

 - 

(2,118,335)

 - 

 - 

 - 

(57,570)

(2,175,905)
On acquisition of subsidiary assets
 - 

 - 

 - 

 - 

 - 

 - 

 110,265 

 110,265 
Issue of shares
 838,930 

 3,291,070 

 - 

 - 

 - 

 - 

 - 

 4,130,000 
Costs of shares issued
 - 

(368,940)

 - 

 - 

 - 

 - 

 - 

(368,940)
Movement in period
 - 

 - 

 - 

 - 

 49,375 

 - 

 - 

 49,375 
Balance at 31 December 2015
 8,120,736 

 10,526,862 

(15,637,275)

 637,500 

 203,519 

 602,413 

 79,069 

 4,532,824 

Valirx Plx
Consolidated statement of financial position


As at 30 June

31 December


2016

2015

2015


(unaudited)

(unaudited)

(audited)




ASSETS






Non current assets






Intangible assets

 2,757,107 

 2,537,881 

 2,673,363 
Property, plant and equipment

 17,677 

 1,359 

 22,177 









 2,774,784 

 2,539,240 

 2,695,540 







Current assets






Inventories

 28,200 

 30,107 

 43,950 
Trade and other receivables

 948,775 

 770,961 

 686,394 
Derivative financial assets

 546,624 

 - 

 1,463,023 
Cash and cash equivalents

 568,805 

 391,884 

 232,465 


 2,092,404 

 1,192,952 

 2,425,832 







LIABILITIES






Current liabilities






Trade and other payables

(1,458,148)

(666,435)

(588,548)







NET CURRENT ASSETS

 634,256 

 526,517 

 1,837,284 







NET ASSETS

 3,409,040 

 3,065,757 

 4,532,824 







SHAREHOLDERS' EQUITY






Share capital

 8,134,782 

 8,112,576 

 8,120,736 
Share premium account

 11,423,352 

 8,332,940 

 10,526,862 
Merger reserve

 637,500 

 637,500 

 637,500 
Reverse acquisition reserve

 602,413 

 602,413 

 602,413 
Share option reserve

 259,311 

 203,519 

 203,519 
Retained earnings

(17,707,863)

(14,855,884)

(15,637,275)









 3,349,495 

 3,033,064 

 4,453,755 
Non-controlling interest

 59,545 

32,693

 79,069 







Total equity

 3,409,040 

 3,065,757 

 4,532,824 


Valirx Plc
Consolidated cash flow statement






Year ended


Six months ended 30 June

31 December


2016

2015

2015


(unaudited)

(unaudited)

(audited)




Operating activities






Operating loss

(1,421,003)

(1,563,154)

(3,029,411)
Depreciation of property plant and equipment

 5,420 

 - 

 10,906 
Amortisation of intangible assets

 59,031 

 44,938 

 91,831 
Decrease/(increase) in inventories

 15,750 

(18,957)

(32,800)
(Increase)/decrease in receivables

(47,399)

 196,641 

94,663
Increase/(decrease) in payables within one year

 619,600 

(88,640)

(166,527)
Other non-cash movements

(18,584)

 11,236 

4,847
Share option charge

 55,792 

 49,375 

 49,375 







Cash outflows from operating activities

(731,393)

(1,368,561)

(2,977,116)







Taxation 

 - 

 - 

 387,747 







Investing activities






Interest received

 6 

 660 

 1,074 
Interest paid

(229)

(7)

(1,793)
Payments to acquire intangible assets

(91,781)

(172,010)

(389,926)
Payments to acquire property plant and equipment

(799)

 - 

(31,670)







Net cash outflow from investing activities

(92,803)

(171,357)

(422,315)







Acquisitions and disposals






Non-controlling interest

 - 

 - 

 110,265 
Net cash inflow for acquisitions and disposals

 - 

 - 

 110,265 







Financing activities






Issue of ordinary share capital

 502,481 

 1,600,000 

 3,050,000 
Cost of share issue

(341,945)
1,000,000

(121,022)
-

(368,940)
-
Proceeds from convertible loan notes










Net cash generated from financing activities

 1,160,536 

 1,478,978 

 2,681,060 







Net increase/(decrease) in cash and cash equivalents

 336,340 

(60,940)

(220,359)







Cash and cash equivalents at start of period

 232,465 

 452,824 

 452,824 







Cash and cash equivalents at end of period

 568,805 

 391,884 

 232,465 


Valirx Plc
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 2016 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 2015 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 2015.
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


2016

2015

2015


(unaudited)

(unaudited)

(audited)




United Kingdom corporation tax at 20%






 Current period - R & D Tax credit

(214,982)

(190,000)

(391,202)







Income tax credit

(214,982)

(190,000)

(391,202)
4 Loss per ordinary share
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


2016

2015

2015


(unaudited)

(unaudited)

(audited)
Basic:






Loss for the financial period 

(2,122,643)

(1,372,501)

(2,118,335)
Weighted average number of shares

 44,523,138 

 28,603,733 

 31,789,529 
Loss per share 

(4.77)p

(4.80)p

(6.66)p
5 Dividends
The directors do not propose to declare a dividend in respect of the period.


6 Share capital


30 June 2016

30 June 2015


Number 

 

Number 

 


(unaudited)

(unaudited)

(unaudited)

(unaudited)
Allotted, called up and fully paid








Ordinary shares of 0.1p each

 52,383,488 

 52,385 

 30,177,214 

 30,179 
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 

 3,741,974 

 30,177,214 

 3,741,974 




 8,134,782 



 8,112,576 











31 December 2015






Number 

 




Allotted, called up and fully paid

(audited)

(audited)




Ordinary shares of 0.1p each

 38,338,851 

 38,339 




Deferred shares of 5.0p each

 58,378,365 

 2,918,918 




Deferred shares of 0.9p each

 157,945,030 

 1,421,505 




Deferred shares of 12.4p each

 30,177,214 

 3,741,974 








 8,120,736 




 On 17 February 2016, the company raised 502,480,before expenses, by way of a placing of 4,187,333 ordinary shares of 0.1p each at a price of 12p per share;
 On 1 April 2016, the Company converted 90,000 of Convertible Loan Notes into 1,184,211 ordinary shares of 0.1p each at a price of 7.6p per share:
 On 18 April 2016, the Company converted 120,000 of Convertible Loan Notes into 1,621,622 ordinary shares of 0.1p each at a price of 7.4p per share:
 On 19 April 2016, the Company converted 200,000 of Convertible Loan Notes into 2,702,703 ordinary shares of 0.1p each at a price of 7.4p per share:
 On 26 April 2016, the Company converted 90,000 of Convertible Loan Notes into 1,184,211 ordinary shares of 0.1p each at a price of 7.6p per share:
 On 18 May 2016, the Company converted 250,000 of Convertible Loan Notes into 3,164,557 ordinary shares of 0.1p each at a price of 7.9p per share:
7 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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