TIDMVAL
RNS Number : 7026N
ValiRx PLC
26 September 2019
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIODED 30 JUNE 2019
London, UK., 26 September 2019: ValiRx Plc (AIM: VAL), a life
science company, which focuses on clinical stage cancer therapeutic
development, taking proprietary and novel technology for precision
medicines towards commercialisation and partnering, today announces
its Half Yearly Report for the period ended 30 June 2019 and
provides an update e on significant post-period events.
HIGHLIGHTS
Operational Highlights
-- MHRA and REC approve a major update to the trial of VAL201
including the appointment of a Principal Investigator to the
clinical team, with results from the first clinical trial of the
compound being prepared for an independent evaluation following the
completion of the current patient group.
-- The period saw further strengthening of ValiRx's IP patent
portfolio. Grant allowances for VAL301 were permitted for the
European Union, China and the Russian Federation, building on an
earlier patent granted in 2018 for the US. VAL201 had its IP
protection extended during the period, with a patent grant allowed
in the US for the use of the compound in the prevention and
treatment of metastatic cancer. This allowance builds on previously
granted worldwide rights for the use of the compound against
prostate cancer.
-- ValiRx acquired the IP assets of FIT Biotech OY (announced 2
May 2019) to complement its other drug discovery (drug enhancing)
technologies and is currently in discussions with a potential JV
partner over further developing certain of the Company's
genetic-based diagnostic assets
Financial Highlights
-- Loss before income tax narrowed substantially by 56.9% to
GBP927,342 (H1 2018: GBP2,155,788); largely as a result of a profit
on the sale of fixed asset investments and no requirement to
manufacture additional VAL201 drug as sufficient quantities were
produced in H2 2018;
-- Total comprehensive loss for the period of GBP750,569 (H1 2018: GBP1,914,453);
-- Cash and cash equivalents as at 30 June 2019 of GBP171,443 (H1 2018: GBP590,615); and
-- Loss per share - basic and diluted reduced by 78.4% to (0.11)p (H1 2018: (0.51)p.
Post-Period highlights
-- R&D Tax Credit of GBP423,000 received in September 2019
-- The Company announced (10 September 2019) that in addition to
pharmacokinetic and toxicology data, clinical trial results show
VAL201 behaves as predicted in reducing prostate cancer progression
- evidence that is supported from tumour imaging (MRI and CT) in
subjects.
-- VAL301's clinical team signed an agreement in July 2019 with
Aptus Clinical Ltd ("Aptus"), the UK based, clinical Contract
Research Organisation ("CRO"), to effectuate a clinical development
plan for VAL301 incorporating a Phase I/II study design concept in
Endometriosis.
-- Two placings and a subscription raised GBP1.226m of gross
proceeds with existing and new investors. The funds were raised for
working capital needs and to progress the development of the
Company's therapeutic drug portfolio.
Oliver de Giorgio-Miller, Non-Executive Chairman of ValiRx,
commented:
"Throughout the reporting period, ValiRx has continued to
sustain valuable momentum in terms of progressing its therapeutic
assets and along their respective clinical and pre-clinical
pathways. We have made important strides forward across both our
therapeutic and technology portfolios, with the expectation that
these will deliver added-value in the near term for our
shareholders."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
***S ***
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 Tel: +44 (0) 20 7213 0880
Adviser)
Liam Murray/Jo Turner/Ludovico Lazzaretti
Novum Securities Limited (Broker) Tel: +44 (0) 20 7399 9400
Colin Rowbury
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 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 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 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 AIM Market of the London Stock
Exchange in October 2006 and trades under the ticker symbol:
VAL.
CHAIRMAN'S STATEMENT FOR THE HALF YEARED 30 JUNE 2019
Throughout the reporting period, ValiRx has continued to sustain
valuable momentum in terms of progressing its therapeutic assets
and along their respective clinical and pre-clinical pathways.
VAL201
We were very pleased to announce in June 2019 that based on our
clinical results for VAL201, a substantial amendment to the
clinical trial protocol had received regulatory approval from the
Medicines and Healthcare products Regulatory Agency ("MHRA") and
the Research Ethics Committee ("REC").
Following approval of this substantial amendment, an
authoritative prostate cancer specialist, Dr Mark Linch was
appointed Principal Investigator to the clinical trial team at
University College London Hospital ("UCLH"). Dr Linch is the
Consultant Medical Oncologist specialising in the treatment of
prostate and bladder cancer at UCLH and as a recognised specialist,
we are pleased to benefit from his deep understanding and
experience of the condition.
To date, the results generated by the trial, showed that the
compound is safe and can be given to humans at a therapeutic level
and beyond. The approval given to relax the restrictions previously
applied to the trial, means that a more effective use of VAL201 can
be achieved, with respect to concentration and timing and regarding
increased flexibility in the administration of the drug. The trial
is providing practical information back to the trialling of VAL201,
so that the next stage of clinical development, in which ValiRx
will endeavour to show how effective the compound actually is, can
be entered into with confidence and support from all those
involved.
Building on this progress, ValiRx was able to announce in
September 2019, that in addition to pharmacokinetic and toxicology
data, clinical trial results to date show that VAL201 behaves as
predicted in reducing prostate cancer progression - evidence that
is supported from tumour imaging (MRI and CT) in subjects. The full
data set is currently being reviewed and collated and additional
data surrounding the possibility of an effect on metastatic tumour
lesions is being collated in the few subjects exhibiting such
tumours. This phase I/II trial will be finalised from a regulatory
viewpoint with the trial focused on confirming and validating the
optimum treatment regime and its particular use in clinical
practice. Data relating to the pharmacology, pharmacokinetics and
pharmacodynamics will be published as it is collated, verified and
submitted.
VAL301
In July 2019 and just after the period end, VAL301's clinical
team signed an agreement with Aptus Clinical Ltd ("Aptus"), the UK
based, clinical Contract Research Organisation ("CRO"), to
effectuate a clinical development plan for VAL301 incorporating a
Phase I/II study design concept in endometriosis. With VAL301 being
derived from the same active pharmaceutical ingredient as VAL201,
the positive results from the VAL201 trial will be used to
strengthen the clinical application of the VAL301 development
programme and this agreement with Aptus represents an important
stage in the preparation of the VAL301 compound for a clinical
study.
Pre-clinical studies of the compound indicated that treatment
with VAL301 should not affect bone density or fertility, two of the
major problems associated with current medical treatments for
endometriosis and ValiRx intends to develop VAL301 as a
non-invasive, effective and better tolerated treatment for this
debilitating condition.
Acquisition of IP & Joint Venture Discussions
In May 2019, ValiRx acquired the IP assets of FIT Biotech OY
("FIT Bio"). FIT Bio had been publicly listed on the First North
Finland marketplace and had been developing gene delivery
technologies for a number of indications and was positioning its
technology as an alternative to biologics, such as vaccines,
antibodies and protein-based drugs. Indeed, FIT Bio's principle
technology - its Gene Transport Unit platform - had seen an initial
product enter into clinical trials.
In addition to the IP assets of FIT Bio, ValiRx currently owns a
potentially complementary portfolio of other genetic-based
diagnostic assets. The Company is currently in discussions with a
potential joint venture partner over the profitable collaboration,
development and exploitation of these assets.
Financial review
At period end, ValiRx had net assets of GBP4,378,572 (2018:
GBP4,647,127) of which GBP171,443 (2018: GBP590,615) comprised cash
and equivalents. The Company was also pleased to announce (on 24
September 2019) its post period receipt of proceeds from a R&D
Tax Credit of GBP0.423m.
The operating loss for the period narrowed substantially by 49%
to GBP1,071,334 (2018: GBP2,104,689) reflecting stringent
budgeting, while conducting the necessary discussions with the MHRA
on VAL201 and with Aptus on VAL301 to advance both assets in
clinical trials. The Company's loss before income tax similarly was
substantially reduced to GBP927,342 (H1 2018: GBP2,151,788) largely
as a result of a profit on the sale of fixed asset investments and
no requirement to manufacture additional VAL201 drug as sufficient
quantities were produced in H2 2018.
The Company continues to carefully monitor its working capital
position.
Outlook
The Board is pleased with the progress of the Company in the
first half of the year. We have made important strides forward
across both our therapeutic and technology portfolios, with the
expectation that these will deliver added value in the near term
for our shareholders.
Oliver de Giorgio-Miller
Non-Executive Chairman
26 September 2019
Valirx Plc
Consolidated statement of comprehensive income
Year ended
Six months ended 30
June 31 December
---------------------------------------------------- ------------------------
Note 2019 2018 2018
(unaudited) (unaudited) (audited)
GBP GBP GBP
Continuing operations
Research and development (206,666) (851,688) (1,698,791)
Administrative expenses (864,668) (920,760) (2,166,798)
Share option charge - (332,241) -
Operating loss (1,071,334) (2,104,689) (3,865,589)
Fair value loss on
derivative
financial assets - (46,892) (442,229)
Profit on the sale of
fixed asset
investments 153,416 - -
Provision for bad debt - - (506,755)
Finance costs (9,424) (207) (14,565)
-------------------------- ------------------------ --------------------------
Loss before income
taxation (927,342) (2,151,788) (4,829,138)
Income tax credit 3 150,000 206,000 461,296
-------------------------- ------------------------ --------------------------
Loss on ordinary
activities after
taxation (777,342) (1,945,788) (4,367,842)
Non-controlling
interests 26,773 31,335 69,020
-------------------------- ------------------------ --------------------------
Loss for the period and
total
comprehensive income
attributable
to owners of the parent (750,569) (1,914,453) (4,298,822)
========================== ======================== ==========================
Loss per share - basic
and diluted 4 (0.11)p (0.51)p (0.94)p
========================== ======================== ==========================
Valirx Plc
Consolidated statement of changes in shareholders' equity
Share Reverse
Share Share Retained Merger option acquisition Non-controlling
capital premium earnings reserve reserve reserve interest Total
GBP GBP GBP GBP GBP GBP GBP GBP
Unaudited
Balance at
1 January
2019 8,680,694 19,779,905 (27,461,771) 637,500 885,963 602,413 (93,764) 3,030,940
Loss for
the
period - - (750,569) - - - (26,773) (777,342)
Issue of
shares 425,762 1,012,738 - - - - - 1,438,500
Costs of
shares
issued - (332,285) - - - - - (332,285)
Share
based
payment - (39,268) - - 39,268 - - -
Balance at
30 June
2019 9,106,456 20,421,090 (28,212,340) 637,500 925,231 602,413 (120,537) 3,359,813
====================== ====================== ====================== ====================== ====================== ====================== ====================== ======================
Unaudited
Balance at
1 January
2018 8,432,708 16,419,494 (23,378,744) 637,500 464,000 602,413 (24,744) 3,152,627
Loss for
the
period - - (1,914,453) - - - (31,335) (1,945,788)
Issue of
shares 104,653 2,354,512 - - - - - 2,459,165
Costs of
shares
issued - (239,853) - - - - - (239,853)
Exercise
of share
options
and
warrants - 147,394 - - (147,394) - - -
Lapse of
share
options - - 2,400 - (2,400) - - -
Share
based
payment - - - - 394,094 - - 394,094
Balance at
30 June
2018 8,537,361 18,681,547 (25,290,797) 637,500 708,300 602,413 (56,079) 3,820,245
====================== ====================== ====================== ====================== ====================== ====================== ====================== ======================
Audited
Balance at
1 January
2018 8,432,708 16,419,494 (23,378,744) 637,500 464,000 602,413 (24,744) 3,152,627
Loss for
the year - - (4,298,822) - - - (69,020) (4,367,842)
Issue of
shares 247,986 3,861,177 - - - - - 4,109,163
Costs of
shares
issued - (500,766) - - - - - (500,766)
Lapse of
share
options - - 215,795 - (215,795) - -
Share
based
payment - - - - 637,758 - - 637,758
Balance at
31
December
2018 8,680,694 19,779,905 (27,461,771) 637,500 885,963 602,413 (93,764) 3,030,940
====================== ====================== ====================== ====================== ====================== ====================== ====================== ======================
Valirx Plc
Consolidated statement of financial position
As at 30 June 31 December
--------------------------------------------------- ------------------------
2019 2018 2018
(unaudited) (unaudited) (audited)
GBP GBP GBP
ASSETS
Non-current assets
Goodwill 1,602,522 1,602,522 1,602,522
Intangible assets 1,813,405 1,379,876 1,623,950
Property, plant and equipment - - -
------------------------ ------------------------- ------------------------
3,415,927 2,982,398 3,226,472
------------------------ ------------------------- ------------------------
Current assets
Trade and other receivables 180,009 746,532 174,089
Tax receivable 611,193 257,244 461,193
Derivative financial assets - 70,338 -
Cash and cash equivalents 171,443 590,615 372,872
------------------------
962,645 1,664,729 1,008,154
------------------------ ------------------------- ------------------------
Total assets 4,378,572 4,647,127 4,234,626
======================== ========================= ========================
SHAREHOLDERS' EQUITY
Share capital 9,106,456 8,537,361 8,680,694
Share premium account 20,421,090 18,681,547 19,779,905
Merger reserve 637,500 637,500 637,500
Reverse acquisition reserve 602,413 602,413 602,413
Share option reserve 925,231 708,300 885,963
Retained earnings (28,212,340) (25,290,797) (27,461,771)
------------------------ ------------------------- ------------------------
3,480,350 3,876,324 3,124,704
Non-controlling interest (120,537) (56,079) (93,764)
------------------------ ------------------------- ------------------------
Total equity 3,359,813 3,820,245 3,030,940
------------------------ ------------------------- ------------------------
LIABILITIES
Current liabilities
Trade and other payables 804,841 826,882 889,987
Borrowings 213,918 - 313,699
------------------------ ------------------------- ------------------------
1,018,759 826,882 1,203,686
------------------------ ------------------------- ------------------------
Total equity and liabilities 4,378,572 4,647,127 4,234,626
======================== ========================= ========================
Valirx Plc
Consolidated cash flow statement
Year ended
Six months ended 30 June 31 December
------------------------------------------------ -----------------------
2019 2018 2018
(unaudited) (unaudited) (audited)
GBP GBP GBP
Cash flows from operating
activities
Operating loss (1,071,334) (2,104,689) (3,865,589)
Amortisation of intangible fixed
assets 92,012 84,800 142,988
Increase in receivables (5,920) (25,005) (31,996)
Decrease in payables within one year (85,146) (567,384) (504,279)
Other non-cash movements - 43,991 (957)
Share option charge - 332,342 482,993
----------------------- ----------------------- -----------------------
Net cash outflows from operations (1,070,388) (2,235,945) (3,776,840)
Tax credit received - 372,850 424,197
Interest paid (1,205) (207) (866)
----------------------- ----------------------- -----------------------
Net cash outflow from operating
activities (1,071,593) (1,863,302) (3,353,509)
----------------------- ----------------------- -----------------------
Cash flows from investing
activities
Purchase of intangible fixed assets (281,467) (139,393) (324,028)
Sale of non-current investments 153,416 - -
----------------------- ----------------------- -----------------------
Net cash outflow from investing
activities (128,051) (139,393) (324,028)
----------------------- ----------------------- -----------------------
Cash flows from financing
activities
Share issue 1,226,000 2,070,000 3,720,000
Costs of shares issued (119,785) (178,100) (346,001)
Repayment of loan notes (108,000) - (25,000)
----------------------- ----------------------- -----------------------
Net cash generated from financing
activities 998,215 1,891,900 3,348,999
----------------------- ----------------------- -----------------------
Net decrease in cash and cash
equivalents (201,429) (110,795) (328,538)
Cash and cash equivalents at start
of period 372,872 701,410 701,410
----------------------- ----------------------- -----------------------
Cash and cash equivalents at end of
period 171,443 590,615 372,872
======================= ======================= =======================
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
Stonebridge House, Chelmsford Road, Hatfield Heath, England, CM22
7BDFinancial information
The interim consolidated financial information for the six
months ended 30 June 2019 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 2018 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 2018.
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.
2 Taxation
Six months Six months
ended ended Year ended
30 June 30 June 31 December
------------------ --------------------- ------------
2019 2018 2018
(unaudited) (unaudited) (audited)
GBP GBP GBP
United Kingdom corporation tax
at 19%
Current period - R & D Tax
credit (150,000) (206,000) (461,193)
Prior period - R & D Tax credits - - (103)
------------------ --------------------- ------------
Income tax credit (150,000) (206,000) (461,296)
================== ===================== ============
3 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
------------------- --------------- ------------------
2019 2018 2018
(unaudited) (unaudited) (audited)
Basic:
Loss for the financial period (777,342) (1,945,788) (4,367,842)
Non-controlling interest 26,773 31,335 69,020
------------------- --------------- ------------------
(750,569) (1,914,453) (4,298,822)
=================== =============== ==================
Weighted average number of shares 691,640,169 384,343,833 458,715,753
Loss per share (0.11)p (0.51)p (0.94)p
=================== =============== ==================
The outstanding share options and share warrants would have no
dilutive effect on the loss per share.
4 Dividends
The directors do not propose to declare a dividend in respect of
the period.
5 Share capital
30 June 2019 30 June 2018
--------------------------------------- --------------------------------------
Number GBP Number GBP
(unaudited) (unaudited) (unaudited) (unaudited)
Allotted, called up
and fully paid
Ordinary shares of
0.1p each 1,024,057,953 1,024,059 454,962,717 454,964
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
==================== ==================
9,106,456 8,537,361
================= ==================
31 December 2018
---------------------------------------
Number GBP
Allotted, called up
and fully paid (unaudited) (unaudited)
Ordinary shares of
0.1p each 598,296,049 598,297
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
====================
8,680,694
=================
-- On 28 February 2019, the Company raised GBP0.50 million,
before expenses, by way of a placing of 83,333,333 ordinary shares
of 0.1p each at a price of 0.60p per share;
-- On 1 May 2019, the Company raised GBP0.426 million, before
expenses, under the Subscription Agreement previously reported, by
the issue of 71,000,000 at a price of 0.60p per share;
-- On 18 June 2019, the Company raised GBP0.30 million, before
expenses, by way of a placing of 150,000,000 ordinary shares of
0.1p each at a price of 0.20p per share;
-- On 25 June 2019, the Company issued 121,428,571 ordinary
shares of 0.1p each at a price of 0.175p per share in consideration
for the termination of the Subscription Agreement at an agreed fee
of GBP212,500.
6 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 news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
IR BIGDCSXDBGCU
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