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

ValiRxAnnouncement

26/09/2017 07:07

RNS Number : 7700R
ValiRx PLC
26 September 2017
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIOD ENDED 30 JUNE 2017 
London, UK., 26 September 2017: 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 2017.
HIGHLIGHTS
Operational Highlights
 Encouraging and positive period for ValiRx, with substantial progress seen across both clinical and pre-clinical portfolio and with the therapeutic compound, VAL401, addressing lung cancer, nearing trial completion 
 Phase l/ll Clinical Trial of VAL201 has demonstrated consistent safety and tolerability with signs of activity in patients with advanced prostate cancer 
 VAL401 clinical trial in patients with lung cancer expanded to 3 sites; recruitment now completed and the trial is expected to complete by year-end 2017
 VAL101 underwent drug optimisation to block/ silence Bcl-2 expression identified inter alia in Pancreatic Cancer cells
 VAL301 is in late pre-clinical phase initially for the treatment of the gynaecological condition, endometriosis - a reformulation of VAL201, which pre-clinical studies suggest does not compromise bone density or fertility
Financial Highlights
 Placing to raise 1.16m in March 2017 with existing and new investors
 ValiRx received R&D Tax Credits amounting to c. 650,000 in August 2017
 Loss before income taxation reduced slightly by 2.6% to 2.25m (H1 2016: 2.31m)
 Total comprehensive loss for the period of 1.99m (H1 2016: 2.07m); and
 Cash and cash equivalents as at 30 June 2017 of 383, 426 (H1 2016: 568,805).
Post-Period Highlights
 Placing in September 2017 with existing and new investors successfully raised 0.5 million
 VAL101 - ValiRx recently reported much improved technical efficacy and commercially viable efficient manufacturing capabilities and that preliminary results for the optimised second generation of the VAL101 molecule are demonstrating gene silencing levels that are similar to the original structure. VAL101's late pre-clinical studies to be accelerated in preparation for the compound's entry into the clinic.
Oliver de Giorgio-Miller, Non-Executive Chairman of ValiRx, commented:
"We have seen considerable progress across our therapeutic portfolio in the last 6 months, adding value to the company's assets and bringing us closer to the point where our clinical programmes for VAL201 and VAL401 will deliver meaningful data and will bring the Company closer to finding a partner. I am pleased with the momentum generated as we move towards clinical developmental milestones and potential value inflection points for VAL401 and VAL201 as we approach the year-end. "
"Our portfolio of therapeutic drugs collectively address multi-billion dollar markets and meet significant unmet need. I therefore strongly believe that ValiRx and its assets offer investors or joint venture partners an increasingly attractive and investable proposition as we strengthen our position among frontrunners in the fields of personalised and precision medicine."
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


Cairn Financial Advisers LLP (Nominated Adviser)
Liam Murray/Jo Turner/Richard Nash
Tel: +44 (0) 20 7213 0880


Beaufort Securities Limited (Broker)
Jon Belliss
Tel: +44 (0) 207 382 8300
Notes for Editors
About ValiRx 
ValiRx is a biotechnology oncology focused 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 two 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 World 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 AIM Market of the London StockExchange in October 2006 and trades under the ticker symbol: VAL


CHAIRMAN'S STATEMENT FORTHE HALF YEAR ENDED 30 JUNE 2017
Trialist reports on VAL201 and VAL401 in clinical trials for the treatment of Advanced Prostate Cancer and Non Small-Cell Lung Cancer remain buoyant as evidence of their safety and tolerability continues to mount and as evidence of their efficacy emerges.
VAL201
What makes VAL201 a potentially major breakthrough therapeutic treatment of Advanced Prostate Cancer is its novel mechanism of action. A number of studies have demonstrated that inhibiting Src activity strongly reduces prostate cancer growth. VAL201 specifically targets the association of androgen receptor with Src, a protein that is important in tumour cell proliferation without suppressing other hormone induced activities. This is in complete contrast to current therapies, which in addition to abolishing the receptor-dependent signalling pathways also inhibit the receptor's other functions leading to impotence, tumour flare and loss of bone mass.No serious adverse events have been reported in the ongoing clinical studies at University College London Hospital ("UCLH") and VAL201 continues to show signs of clinical activity in patients with advanced prostate cancer.
VAL401
The period under review has been a defining period in terms of VAL401's clinical development and the expansion of our drug pipeline. VAL401 is a re-formulation of anti-psychotic drug Risperidone into an orally administered gelatin capsule. The compound has shown pronounced anti-cancer properties in pre-clinical testing and has moved quickly through its Phase ll efficacy trial involving patients with locally advanced or metastatic non-small cell lung cancer, who have typically 6 - 12 months of life expectancy. First dosing of patients commenced in November 2016. Since then, further patients and clinical trial sites have been recruited and opened respectively, with initial pharmacokinetic analysis showing that the presence and levels of the active drug and known metabolite in blood samples, are as expected. In June 2017, we announced that the trial had completed its recruitment phase and that ValiSeek had decided there was no requirement to enrol further patients. Since then, data processing and analysis of the results to date has commenced and results from the preliminary datalock are expected this month. The trial remains on track to be completed by year-end following which further data processing and analysis will be performed, thereby defining the clinical activity of VAL401 and its potential positive effect on patient quality of life.
GeneICE/VAL101
Our GeneICE "rebelliousgene" technology has shown continued good progress in its late pre-clinical phase, with the programme currently benefitting from a second Eurostars grant for up to 1.6 million. Rebellious genes are genes that are overexpressed when they should not be or are erroneously expressed, e.g. in cancers, inflammatory conditions, Alzheimer's and autoimmune diseases. ValiRx's proprietary GeneICE technology enables the design of compounds for selective silencing ofspecific genes. The GeneICE lead compound has been designed against a gene expressing Bcl-2 protein, which has been implicated and associated with various cancers. Pre-clinical work during the period under review has been conducted with our partners, DKFZ, Heidelberg and Pharmatest in Finland, to generate a commercially viable molecular structure for VAL101, because whilst the molecule worked in its first generation and that Bcl-2, the gene associated with cancer, was seen to reduce and that cancer cell death occurred, the molecule's structure and manufacture however required optimisation for commercial production. ValiRx was pleased to report earlier this month, much improved technical efficacy and commercially viable efficient manufacturing capabilities and that preliminary results for the optimised second generation of the VAL101 molecule are demonstrating gene silencing levels that are similar to the original structure. As such, ValiRx intends to accelerate VAL101's late pre-clinical studies in preparation for the compound's entry into the clinic.
VAL301 
VAL301 is derived from our lead compound, VAL201 and is currently in late-stage pre-clinical development as a non-invasive, effective treatment for the non-cancerous, but hugely debilitating gynaecological condition, Endometriosis. Earlier pre-clinical work on VAL201 has highlighted the compound's potential to protect uterine tissue from the oestrogenic effects that give rise to Endometriosis, with minimal impact on bone density or fertility, which are major drawbacks frequently encountered with the current commonly used drugs for this condition. Our focus now is to complete the pre-clinical package and arrive at the optimal formulation so that the Company obtains the necessary regulatory approvals to enter VAL301 into a clinical trial in 2018.
Outlook
We have seen considerable progress across our therapeutic portfolio in the last 6 months, adding value to the company's assets and bringing us closer to the point where our clinical programmes for VAL201 and VAL401 will deliver meaningful data and will bring the Company closer to finding a partner. I am pleased with the momentum generated as we move towards clinical developmental milestones and potential value inflection points for VAL401 and VAL201 as we approach the year-end. 
Our portfolio of therapeutic drugs collectively address multi-billion dollar markets and meet significant unmet need. I therefore strongly believe that ValiRx and its assets offer investors or joint venture partners an increasingly attractive and investable proposition as we strengthen our position among frontrunners in the fields of personalised and precision medicine.
Oliver de Giorgio-Miller
Non-Executive Chairman
26 September 2017


Valirx Plc
Consolidated statement of comprehensive income



 Six months ended

 Six months ended

Year ended


Note
30 June 

30 June 

31 December



2017

2016

2016



(unaudited)

(unaudited)

(audited)













Revenue


 - 

 - 

 - 








Cost of sales


 - 

 - 

 - 
Gross profit


 - 

 - 

 - 








Research and development


(723,149)

(638,356)

(2,375,354)
Administrative expenses


(958,340)

(758,445)

(1,794,284)
















Operating loss


(1,681,849)

(1,396,801)

(4,169,638)








Fair value loss on derivative financial assets


(81,726)

(916,399)

(1,619,187)
Finance income


 489 

 6 

 17 
Fair value profit on derivative liability


(204,346)

 - 

 375,621 
Finance costs


(284,471)

(205)

(338,188)








Loss before income taxation


(2,251,543)

(2,313,399)

(5,751,375)








Income tax credit

3
 195,000 

 214,982 

 620,104 








Loss on ordinary activities after taxation


(2,056,543)

(2,098,417)

(5,131,271)








Discontinued operations







(Loss)/profit for the period from discontinued operations


 - 

(24,226)

182,750



(2,056,543)

(2,122,643)

(4,948,521)








Non-controlling interests


 59,119 

 52,055 

 200,518 








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


(1,997,424)

(2,070,588)

(4,748,003)








Loss per share - basic and diluted

4





From continuing operations


(1.79)p

(4.60)p

(8.54)p
From discontinued activities


 - 

(0.05)p

(0.03)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 2017
8,165,650 

 12,998,102 

(20,385,278)

 637,500 

 331,453 

 602,413 

 19,619 

 2,369,459 
Loss for the period
 - 

 - 

(1,997,424)

 - 

 - 

 - 

(59,119)

(2,056,543)
On acquisition of subsidiary assets
 - 

 - 

 - 

 - 

 - 

 - 

 55,303 

 55,303 
Issue of shares
 60,557 

 1,478,947 

 - 

 -

 - 

 - 

 - 

 1,539,504 
Costs of shares issued
 - 

(110,173)

 - 

 - 

 - 

 - 

 - 

(110,173)
Share based payment
 - 

 - 

 - 

 - 

 197,332 

 - 

 - 

 197,332 
Balance at 30 June 2017
 8,226,207 

 14,366,876 

(22,382,702)

 637,500 

 528,785 

 602,413 

15,803

1,994,882 
















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 assets
 - 

 - 

 - 

 - 

 - 

 - 

 32,531 

 32,531 
Issue of shares
 14,046 

 1,238,435 

 - 

 - 

 - 

 - 

 - 

 1,252,481 
Costs of shares issued
 - 

(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 
















Audited















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 year
 - 

 - 

(4,748,003)

 - 

 - 

 - 

(200,518)

(4,948,521)
On acquisition of subsidiary assets
 - 

 - 

 - 

 - 

 - 

 - 

 141,068 

 141,068 
Issue of shares
 44,914 

 3,060,507 

 - 

 - 

 - 

 - 

 - 

 3,105,421 
Costs of shares issued
 - 

(589,267)

 - 

 - 

 - 

 - 

 - 

(589,267)
Movement in period
 - 

 - 

 - 

 - 

 127,934 

 - 

 - 

 127,934 
Balance at 31 December 2016
 8,165,650 

 12,998,102 

(20,385,278)

 637,500 

 331,453 

 602,413 

 19,619 

 2,369,459 

Valirx Plx
Consolidated statement of financial position


As at 30 June

31 December


2017

2016

2016


(unaudited)

(unaudited)

(audited)




ASSETS






Non current assets






Intangible assets

 2,948,060 

 2,757,107 

 2,824,613 
Property, plant and equipment

 5,273 

 17,677 

 10,553 









 2,953,333 

 2,774,784 

 2,835,166 







Current assets






Inventories

 - 

 28,200 

 - 
Trade and other receivables

 1,537,535 

 948,775 

 1,425,439 
Derivative financial assets

 58,949 

 546,624 

 140,675 
Cash and cash equivalents

 383,426 

 568,805 

 560,763 


 1,979,910 

 2,092,404 

 2,126,877 







LIABILITIES






Current liabilities






Trade and other payables

 1,564,313 

 1,458,148 

1,254,139
Borrowings

 1,125,556 

 - 

 1,294,299 
Derivative liability

 248,492 

 - 

 44,146 


 2,938,361 

 1,458,148 

 2,592,584 







NET CURRENT (LIABILITIES)/ASSETS

(958,451)

 634,256 

(465,707)







NET ASSETS

 1,994,882 

 3,409,040 

 2,369,459 







SHAREHOLDERS' EQUITY






Share capital

 8,226,207 

 8,134,782 

 8,165,650 
Share premium account

 14,366,876 

 11,423,352 

 12,998,102 
Merger reserve

 637,500 

 637,500 

 637,500 
Reverse acquisition reserve

 602,413 

 602,413 

 602,413 
Share option reserve

 528,785 

 259,311 

 331,453 
Retained earnings

(22,382,702)

(17,707,863)

(20,385,278)









 1,979,079 

 3,349,495 

 2,349,840 
Non-controlling interest

 15,803 

 59,545 

 19,619 







Total equity

 1,994,882 

 3,409,040 

 2,369,459 


Valirx Plc
Consolidated cash flow statement






Year ended


Six months ended 30 June

31 December


2017

2016

2016


(unaudited)

(unaudited)

(audited)




Operating activities






Operating loss

(1,681,489)

(1,396,801)

(4,169,638)
Operating loss -discontinued operation

 - 

(24,226)

 - 
Depreciation of property plant and equipment

 5,280 

 5,420 

 10,560 
Amortisation of intangible assets

 46,300 

 59,031 

 92,275 
Decrease in inventories

 - 

 15,750 

 11,733 
Decrease/(increase) in receivables

 82,904 

(47,399)

(1,071,548)
Increase in payables within one year

 284,002 

 619,600 

 787,726 
Other non-cash movements

(61,922)

(18,584)

(22,454)
Share option charge

 197,352 

 55,792 

 127,934 







Cash outflows from operating activities

(1,127,573)

(731,417)

(4,233,412)







Taxation 

 - 

 - 

 375,926 







Investing activities






Interest received

 489 

 6 

 17 
Interest paid

(18,341)

(205)

(338,188)
Payments to acquire intangible assets

(114,444)

(91,781)

(386,625)
Sale of property plant and equipment

 - 

(799)

 3,470 







Net cash outflow from investing activities

(132,296)

(92,779)

(721,326)







Acquisitions and disposals






Sale of subsidiary undertakings (net of cash)

-

 - 

 857,136 
Non-controlling interest

 - 

 - 

 141,068 
Net cash inflow for acquisitions and disposals

 - 

 - 

 998,204 







Financing activities






Issue of ordinary share capital

 1,192,725 

 502,481 

 1,695,906 
Cost of share issue

(110,173)

(341,945)

(589,267)
New convertible loan notes

 - 

 1,000,000 

 2,993,113 
Costs of convertible loan notes issued

 - 

 - 

(190,846)







Net cash generated from financing activities

 1,082,552 

 1,160,536 

 3,908,906 







Net (decrease)/increase in cash and cash equivalents

(177,337)

 336,340 

 328,298 







Cash and cash equivalents at start of period

 560,763 

 232,465 

 232,465 







Cash and cash equivalents at end of period

 383,426 

 568,805 

 560,763 


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 3rd Floor, 16 Upper Woburn Place, London WC1H 0BS
2 Financial information
The interim consolidated financial information for the six months ended 30 June 2017 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 2016 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 2016.
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


2017

2016

2016


(unaudited)

(unaudited)

(audited)




United Kingdom corporation tax at 20%






 Current period - R & D Tax credit

(195,000)
-

(214,982)
-

(644,497)
24,393
 Prior years - R & D Tax credit










Income tax credit

(195,000)

(214,982)

(620,104)
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


2017

2016

2016


(unaudited)

(unaudited)

(audited)
Basic:






Loss for the financial period from continuing operations

(2,056,543)

(2,098,417)

(5,131,271)
Non controlling interest

 59,119 

 52,055 

 200,518 


(1,997,424)

(2,046,362)

(4,930,753)







Loss for the financial period - discontinued activities

 - 

(24,226)

 182,750 
Weighted average number of shares

 114,718,325 

 44,523,138 

 57,743,223 
Loss per share - continuing operations

(1.79)p

(4.60)p

(8.54)p
Loss per share - discontinued activities

 - 

(0.05)p

0.32p
5 Dividends
The directors do not propose to declare a dividend in respect of the period.
6 Share capital


30 June 2017

30 June 2016


Number 

 

Number 

 


(unaudited)

(unaudited)

(unaudited)

(unaudited)
Allotted, called up and fully paid








Ordinary shares of 0.1p each

143,809,745 

 143,809 

 52,383,488 

 52,385 
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 




 8,226,206 



 8,134,782 











31 December 2016






Number 

 




Allotted, called up and fully paid

(unaudited)

(unaudited)




Ordinary shares of 0.1p each

 83,253,312 

 83,253 




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 








 8,165,650 




 On 6 January 2017, the Company converted US$150,000 of Convertible Loan Notes (plus accrued interest of US$15,840) into 2,393,788 ordinary shares of 0.1p each at a price of 5.625p per share:
 On 15 March 2017, the Company raised 1.16 million, before expenses, by way of a placing of 46,509,015 ordinary shares of 0.1p each at a price of 2.5p per share;
 On 15 March 2017, the Company raised 30,000, before expenses, by way of a subscription for 1,200,000 ordinary shares of 0.1p each at a price of 2.5p per share, by certain Directors;
 On 7 June 2017, the Company converted US$250,000 of Convertible Loan Notes (plus accrued interest of US$22,724) into 10,453,630 ordinary shares of 0.1p each at a price of 2.0292p 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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