We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Register to chat with like-minded investors on our interactive forums.
| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Valirx Plc | LSE:VAL | London | Ordinary Share | GB00BLH13C52 | ORD 0.1P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 3.25 | 3.20 | 3.30 | 3.25 | 3.25 | 3.25 | 63,583 | 08:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Medical Laboratories | 0 | -2.37M | -0.0262 | -1.24 | 2.93M |
From May 2019 to May 2024
TIDMVAL
RNS Number : 8701K
ValiRx PLC
27 September 2016
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIODED 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 GBP0.5m 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 GBP2.12m (H1 2015: GBP1.37m) due to increase in clinical R&D expenditure on VAL201 and 401;
-- Total comprehensive loss for the period of GBP2.074m (H1 2015: GBP1.34m); and -- Cash and cash equivalents as at 30 June 2016 of GBP568,805 (H1 2015: GBP391,884).
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 GBP1.2 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.
***S ***
For more information, please contact:
Hot Features
Premium
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 Tel: +44 (0) 7736
Manager 564 686
mark.treharne@valirx.com
Cairn Financial Advisers LLP Tel: +44 (0) 20 7148
(Nominated Adviser) 7900
Liam Murray / Jo Turner
Northland Capital Partners Tel: +44 (0) 203
Limited (Joint Broker) 861 6625
Patrick Claridge / David Hignell
(Corporate Finance)
John Howes / Abigail Wayne
(Broking)
Beaufort Securities Limited Tel: +44 (0) 207
(Joint Broker) 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 to engineer 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 Stock Exchange in October 2006 and trades under the ticker symbol: VAL.
CHAIRMAN'S STATEMENT FOR THE HALF YEARED 30 JUNE 2016
The Company continues to make good progress across all areas of our business 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) patient stratification 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 Six months
ended ended Year ended
Note 30 June 30 June 31 December
----------------------- ----------------------- ------------------------
2016 2015 2015
(unaudited) (unaudited) (audited)
GBP GBP GBP
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
Reverse acquisition Non-controlling
Share capital Share premium Retained earnings Merger reserve Share option reserve reserve interest Total
GBP GBP GBP GBP GBP GBP GBP GBP
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)
GBP GBP GBP
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)
GBP GBP GBP
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) (121,022) (368,940)
Proceeds from convertible
loan notes 1,000,000 - -
-------------------------- -------------------------- ----------------------
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 Six months
ended ended Year ended
30 June 30 June 31 December
------------ ------------ ------------
2016 2015 2015
(unaudited) (unaudited) (audited)
GBP GBP GBP
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 Six months
` ended 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 GBP Number GBP
(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 GBP
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 GBP502,480,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 GBP90,000 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 GBP120,000 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 GBP200,000 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 GBP90,000 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 GBP250,000 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
END
IR BLGDCUUDBGLL
(END) Dow Jones Newswires
September 27, 2016 02:00 ET (06:00 GMT)
1 Year Valirx Chart |
1 Month Valirx Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions
