TIDMVAL
RNS Number : 5901R
ValiRx PLC
01 July 2020
VALIRX PLC
("ValiRx", the "Company" or the "Group")
Final Results
London, UK , 1 July 2020: ValiRx (AIM:VAL) , the clinical stage
biotechnology company today announces its final results for the
year ended 31 December 2019.
Highlights
Operational Highlights:
-- The final patients were recruited into the Phase 1/2 clinical
trial of VAL201, with the trial being formally closed to
recruitment post-period (27 January 2020). The trial continued to
produce good safety and tolerability reports, with data on the
disease impact currently undergoing verification and analysis.
Headline results impact expected to be released after verification
and analysis is complete (estimated Q3 2020 as announced on 19 May
2020).
-- ValiSeek reported that it has agreed Letters of Intent with
one European and one US partner in relation to the further
advancement of VAL401 into the next proposed clinical trial, on a
co-financing basis and that ValiSeek will seek external financing
towards the next trial (announced 26 March 2019).
-- VAL301 was progressed by the initiation of the construct of a
clinical development plan (announced 4 July 2019). A Material
Transfer Agreement was signed post-period (announced 1 May 2020) to
allow an undisclosed Japanese Pharmaceutical Company to evaluate
VAL301 to contemplate a potential future license.
Financial Highlights:
-- Placings during the period of GBP1.84m (2018: GBP3.7m)
completed to continue the advancement of the clinical trial of
VAL201 and the pre-clinical progress of VAL301;
-- Research and developments costs were GBP984,457 (2018: GBP1,698,791)
-- Administrative expenses were GBP1,860,379 (2018: GBP2,166,798)
-- Total comprehensive loss for the year of GBP2,388,707 (2018: GBP4,298,822);
-- Loss before income taxation of GBP2,719,492 (2018: GBP4,829,138);
-- Loss per share from continuing operations of 0.26p (2018: Loss 0.94p);
-- Cash and cash equivalents as at 31 December 2019 of GBPnil (2018: GBP372,872).
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 7073 2628
www.valirx.com
Suzanne Dilly Suzanne.Dilly@valirx.com
Cairn Financial Advisers LLP (Nominated Tel: +44 (0) 20 7213 0880
Adviser)
Liam Murray / Jo Turner / Ludovico
Lazzaretti
Peterhouse Capital Limited (Sole Broker) Tel: +44 (0) 20 7469 0930
Duncan Vasey / Lucy Williams / Eran
Zucker
Notes for Editors
About ValiRx
ValiRx is a biotechnology oncology focused company specialising
in developing novel treatments for cancer.
The Company's business model focuses on identifying and
in-licensing early stage projects, adding value through scientific
development and then out-licensing therapeutic candidates early in
the development process. By aiming for early-stage value creation,
the Company reduces risk while increasing the potential for
realising value.
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.
The Company listed on the AIM Market of the London Stock
Exchange in October 2006 and trades under the ticker symbol:
VAL.
Independent Directors Report for the year ended 31 December
2019
The period from 1 January 2019 to date has marked some profound
changes in the composition of the Company's board. It was with
great sadness that we reported that the Chairman, Oliver
Degiorgio-Miller, passed away suddenly in October 2019. He was a
key member of the board and is greatly missed.
In more recent times, the former Chief Executive, Dr Satu
Vainikka ceased to be a director, and Chief Operating Officer, Dr
George Morris, resigned. They had both been founder-directors of
ValiRx since 2006 and had made significant contributions to the
selection of the drug candidates which still form a large part of
the Company's drug development activities. We wish them well for
the future.
Dr Suzanne Dilly has been appointed to the board as Chief
Executive to take the Company forward into the future. We were
fortunate to have her as an employee within the Group, and for many
years she has been a member of our Senior Management Team. She is
therefore very familiar with the Company's operations at the time
of these significant changes to the board. Her familiarity with the
Company has permitted operations to continue with minimum
disruption as is indicated in her Chief Executive's Report.
Martin Lampshire, an experienced small cap corporate financier
who also knew the Company well, joined the board in May 2020 and
will be a valuable source of advice.
Finally, we have also been fortunate to attract a well-respected
biotechnology professional, Dr Kevin Cox, as the Non-executive
Chairman of the board. We look forward to working with him
following his appointment to the board.
The departures from the board led to some financial and
organisational disruption but we have been able to stabilise the
situation. Since the year end, we have completed three share issues
in February, April and May 2020, raising an aggregate of
approximately GBP1.4m, before expenses, and concluded a
consolidation and subdivision of the issued share capital to permit
the raising of capital.
We very much look forward to the continued development of the
Company and supporting the implementation of an exciting and
sustainable growth strategy.
K Alexander
Director
Chief Executive's Report for the year ended 31 December 2019
After a brief period of transition at ValiRx, I am pleased to
report on our progress over the period of 2019, and to reflect on
the post period changes in the first half of 2020.
With the coronavirus SARs-CoV2 pandemic dominating world events
in 2020, the public spotlight is on biotech and pharmaceuticals
companies as never before. I find it hard to believe that any
investigative scientist has been able to resist considering their
own area of science to understand the challenges and help to search
for solutions.
The area of drug repurposing, where drugs developed for one
disease are recycled into another, has become of particular
interest as many known drugs are being tested for beneficial
effects in patients affected by the viral infection. In ValiRx,
this technique is well known, with VAL401 being the repurposing of
an anti-psychotic treatment being tested for use in oncology, and
our oncology therapeutic, VAL201 also being tested in
endometriosis, as well as more latterly being evaluated for use in
patients following SARS-CoV2 infection.
The ongoing pandemic presents an unpredictable economic
environment, which ValiRx faces with renewed strength by the
post-period changes on the board. In particular, we welcome our new
chairman, Dr Kevin Cox, and the strength his presence will
contribute to the board.
The reporting period saw scientific development in both VAL201
and VAL301, with the final patients being recruited and dosed in
the VAL201 clinical trial, and the clinical development plan for
VAL301 being defined and developed, leading to a clearer
understanding of the steps required.
Commercial development was ongoing for VAL401, with the
post-period announcement of a Letter of Intent signed with UK SME,
Black Cat Bio Limited ('Black Cat'). This development could see
VAL401 move from the ValiRx Joint Venture subsidiary, ValiSeek
Limited, into Black Cat for development using third party private
financing.
The current status of the scientific programs is shown below and
was announced on 19 May 2020.
Clinical Programs:
VAL201 has been subject to an open label Phase 1/2 clinical
trial in patients with prostate cancer entitled: "A Phase I/II,
Dose Escalation Study to Assess the Safety and Tolerability of
VAL201 in Patients with Locally Advanced or Metastatic Prostate
Cancer and Other Advanced Solid Tumours".
Brief details of this trial are disclosed below. Details can
also be found on the Clinical Trials register at
www.clinicaltrials.gov, using trial identifier number: NCT02280317;
when results are available, these will also be available within
this database.
Recruitment open December 2014 - January 2020
End of Trial Documentation submitted 27 January 2020
------------------------------------------
Patients dosed 12
------------------------------------------
Single Site UCLH (University College London Hospital,
UK)
------------------------------------------
Eligible Patients:
Adult men (over the age of 18), with incurable locally advanced
or metastatic prostate cancer who have relapsed following
radiotherapy treatment, are in 'watchful waiting' or where a policy
of intermittent hormone therapy had been decided. Patients were
expected to have no or only mild symptoms relating to their
prostate cancer.
Primary endpoint:
"To estimate the Maximum Tolerated Dose (MTD) or Maximum
Administered Dose (MAD) of VAL201"
This states the principal aim of the clinical trial as assessing
how high a dose can or should be given to the patient in order to
attempt to elicit a disease relevant response. As a dose escalation
trial, as is typical for first in human studies, the dose level was
started at a fraction of the dose tested in Pre-clinical studies
(in this case 0.5 mg/kg - so a typical 80 kg adult man received 40
mg per dose), and gradually increased to 8 mg/kg.
As well as assessing the tolerability of the dose (MTD) the
trial considers the MAD, hence which doses are practical to give,
based primarily on pharmacokinetics (a measure of how the body
processes the drug) - considering how long the drug stays in the
body, at what level, and whether that level continues to increase
with increasing dose in a predictable manner.
Secondary endpoints:
"To assess the safety and tolerability of VAL201"
This endpoint requires a listing of adverse events that occur
for each patient, regardless of whether or not the event is related
to either the drug or the disease. These events are categorised by
whether they are "serious", that is they require significant
medical intervention to resolve; the severity of the event; whether
it is likely to be related to administration of the drug; whether
it results in the patient stopping or reducing intake of the drug;
and how many patients the event occurs in.
As previously reported, the most common event during VAL201
administration was the occurrence of an injection site reaction,
reported varyingly as bruising, rash or pain.
No drug-related events were reported that resulted in the
patient being removed prematurely from the clinical trial.
"To evaluate the pharmacokinetics of VAL201"
Full pharmacokinetic profiles were successfully collected and
analysed in two patients, on different doses, at multiple time
points during their dosing schedule. When the data has been
verified and entered into the database, this will be fully analysed
to aid understanding of how the drug behaves in the body.
"To assess anti-tumour activity of VAL201"
Although primarily a safety and tolerability focussed trial, the
patients involved undergo continuous monitoring of their disease
throughout (as they would have regardless of trial participation).
This includes measurement of disease markers (such as PSA), regular
CT or MRI scans and symptom assessments to assess disease
progression.
Outlook
When the datasets have been formally verified and locked against
further alteration, analysis and success against each endpoint can
be assessed. Until the analyses are complete it would be premature
to remark with confidence on the achievement or the content of any
of the endpoints.
Headline data will be released on completion of the initial
analysis; after which the clinical study report will be compiled
and submitted to the relevant regulatory authorities; the
clinicialtrial.gov database will be updated according to regulatory
requirements; and finally details of the results will be assembled
into research papers - authored by ValiRx and the clinical trial
team for publishing in peer-reviewed journals.
Data verification requires access to the clinic by staff on our
behalf, which is currently restricted due to the ongoing
Coronavirus pandemic. Dependent on this access, it is anticipated
that headline results will be available and announced in Q3.
Reporting will then be completed in line with regulatory
requirements.
VAL401
VAL401 has been developed by ValiSeek Limited, a 55% owned
ValiRx subsidiary. ValiSeek was set up in 2014 as a Joint Venture
between ValiRx and Tangent Reprofiling Limited (a SEEK group
company) whereby ValiRx provided funding and Tangent Reprofiling
provided a licence to the patents for VAL401.
VAL401 has completed an open label, pilot phase 2 clinical trial
in late stage non-small cell lung cancer patients. Although in a
small patient group, with just 8 patients receiving VAL401, data
indicated that some patients benefited from an improved quality of
life, in particular in measures of pain and nausea; and when
compared to a case-matched group of 20 patients from the same
clinic who did not participate in the trial, demonstrated
statistically significant improved overall survival from time of
diagnosis.
Pharmacokinetic data was collected in all patients, and the
analysis of this data published in 2019 Eur J Drug Metab
Pharmacokinet 44, 557-565 (2019).
https://doi.org/10.1007/s13318-018-00538-4
A randomised, placebo controlled clinical trial has been planned
to test VAL401 in recently diagnosed patients with pancreatic
ductal adenocarcinoma in combination with standard of care
therapy.
ValiRx recently announced (14(th) January 2020) an arrangement
with UK SME, Black Cat, whereby on completion of successful
fund-raising by Black Cat, the VAL401 project will be exclusively
licenced to Black Cat with the ValiSeek shareholders each holding a
share in the equity of Black Cat; and the ValiSeek shareholders
having an entitlement to future royalty payments.
Under this agreement Black Cat would be solely responsible for
the funding and execution of the next VAL401 clinical trial.
Outlook
Confirmation of funding is expected within Q2 or Q3 2020, with
licensing to be completed shortly after. If this arrangement is
unsuccessful, alternative exploitation will be sought.
Pre-clinical Programs
VAL301
VAL301 uses the same active drug as VAL201 but is focussed on
the treatment of women with endometriosis.
On 4 July 2019 it was announced that Aptus Clinical had been
engaged to work with ValiRx to develop an outline of the work
required to prepare VAL301 for a clinical trial.
Endometriosis typically affects women of child-bearing potential
who are otherwise healthy, therefore different Pre-clinical
toxicology requirements are considered than were required for the
clinical trial of men with prostate cancer. Aptus has helped to
identify these requirements, and to outline appropriate clinical
trial designs.
Outlook
On 1 May 2020 it was announced that a Japanese pharma company
has agreed a Material Transfer Agreement with ValiRx whereby ValiRx
are supplying the VAL301 drug material, and the Japanese company
will carry out a series of Pre-clinical proof of concept and
efficacy studies of VAL301.
VAL201 in treatment of patients following SARS-CoV2
infection
On 2 June 2020, ValiRx announced entering into a collaboration
agreement with Oncolytika Limited ("Oncolytika") and Black Cat Bio
Limited ("Black Cat") to evaluation the potential use of VAL201 in
a combination treatment for patients suffering a hyperimmune
response to Coronavirus SARS-CoV2 infection.
Many patients infected with Coronavirus SARS-CoV2 exhibit more
severe symptoms, with significant damage believed to be caused by
an excessive response of the immune system, even after the viral
infection has reduced. This is known as a hyperimmune response.
Oncolytika, a private UK based technical consultancy, has
proposed a combination therapy which includes a selective SRC
kinase inhibitor, such as VAL201 (which inhibits a potential
oncogenic pathway), alongside one or two complementary treatments
to treat the excessive response of the immune system. Oncolytika
and Black Cat have filed a patent to protect the proposed use of
the combination therapy.
ValiRx's contribution to the collaboration is to provide samples
of its proprietary SRC kinase inhibitor, VAL201, for preclinical
testing, and provide access to safety and tolerability data
collected in the recently completed clinical trial in men with
prostate cancer. No cash funding is committed to the project by
ValiRx under this agreement.
Under this agreement, ValiRx will receive 40% of all licensing
income generated. The collaboration addresses an emergent and
immediate unmet medical need and details the commencement of a
short-term experimental plan, with the agreement covering a maximum
of two years.
Non-core Programs
GeneICE
GeneICE is a technology platform designed to control expression
levels of genes that may be over or under expressed in disease
states. VAL101 is the lead candidate produced by the platform,
proposed to modulate BCl2 expression - implicated in many
cancers.
At an early discovery/Pre-clinical stage of development, the
GeneICE program requires further significant scientific
development. As announced on 30(th) April 2020, GeneICE was
considered a "non-core" program and as announced on 16(th) June
2020 will not be further maintained by the Company.
TRAC
TRAC is a technology acquired by ValiRx for 75,000 Euros on 5
February 2015. Announced as conditionally sold for 800,000 Euros on
7 July 2016, 202,000 Euros was received, and, following the failure
of the purchaser to settle the balance, the technology reverted to
ValiRx in 2018, as reported in the 2018 financial statements.
TRAC is a tool to study expression characteristics of genes and
has potential use in the diagnostics arena - and has been used by a
previous owner as part of a commercial service provision. As
announced on 30(th) April 2020, TRAC was considered a "non-core"
program and was transferred out of the ValiRx pipeline under the
patent assignment announced on 29(th) May 2020.
FitBio
The Intellectual Property assets acquired from FitBiotech Oy by
ValiRx for 5,000 Euros on 2 May 2019 encompass a gene transfer
unit, initially envisaged to be paired with the GeneICE products to
create potential therapeutic products. As announced on 30 April
2020, FitBio was considered a "non-core" program and was
transferred out of the ValiRx pipeline under the patent assignment
announced on 29 May 2020.
Financial overview
Our financial results show the total comprehensive loss for the
year ended 31 December 2019 of GBP2,388,707 (2018: GBP4,298,822)
and a loss per share of 0.26p (2018: Loss 0.94p).
Research and developments costs were GBP984,457 for the year
ended 31 December 2019 as compared to GBP1,698,791 in 2018, a
decrease of GBP714,334.
Administrative expenses were GBP1,860,379 for the year ended 31
December 2019 as compared with GBP2,166,798 in 2018, a decrease of
GBP306,419.
I would like to thank the staff and Board members for all their
contributions and shareholders for their continued support during
these difficult times.
Dr S J Dilly
Director
Consolidated Statement of Profit or Loss and Other Comprehensive
Income for the year ended 31 December 2019
2019 2018
GBP GBP
------------------------------- ------------ -------------
CONTINUING OPERATIONS
Other operating income 146,517 -
Research and developments (984,457) (1,698,791)
Administrative expenses (1,860,379) (2,166,798)
OPERATING LOSS (2,698,319) (3,865,589)
Fair value loss on derivative
financial assets - (442,229)
Provision for bad debt - (506,755)
Finance costs (21,175) (14,565)
--------------------------------- ------------ -------------
LOSS BEFORE INCOME TAX (2,719,494) (4,829,138)
Income tax credit 293,738 461,296
--------------------------------- ------------ -------------
LOSS AFTER INCOME TAX (2,425,756) (4,367,842)
Non-controlling interest 37,049 69,020
--------------------------------- ------------ -------------
TOTAL COMPREHENSIVE LOSS
FOR THE YEAR (2,388,707) (4,298,822)
--------------------------------- ------------ -------------
LOSS PER SHARE - BASIC AND
DILUTED (0.26p) (0.94)p
--------------------------------- ------------ -------------
Consolidated Statement of Financial Position - continued 31
December 2019
2019 2018
GBP GBP
ASSETS
NON-CURRENT ASSETS
Goodwill 1,602,522 1,602,522
Intangible assets 1,620,207 1,623,950
Property, plant and equipment - -
Investments - -
------------------------------- ------------- -------------
3,222,729 3,226,472
------------------------------- ------------- -------------
CURRENT ASSETS
Trade and other receivables 90,083 174,089
Tax receivable 291,787 461,193
Cash and cash equivalents - 372,872
381,870 1,008,154
------------------------------- ------------- -------------
TOTAL ASSETS 3,604,599 4,234,626
--------------------------------- ------------- -------------
EQUITY
SHAREHOLDERS' EQUITY
Called up share capital 9,417,225 8,680,694
Share premium 20,596,143 19,779,905
Merger reserve 637,500 637,500
Reverse acquisition reserve 602,413 602,413
Share option reserve 830,449 885,963
Retained earnings (29,729,817) (27,461,771)
--------------------------------- ------------- -------------
2,353,913 3,124,704
Non-controlling interests (130,813) (93,764)
--------------------------------- ------------- -------------
TOTAL EQUITY 2,223,100 3,030,940
--------------------------------- ------------- -------------
LIABILITIES
CURRENT LIABILITIES
Trade and other payables 1,182,084 889,987
Bank overdraft 5,634 -
Borrowings 193,781 313,699
TOTAL LIABILITIES 1,381,499 1,203,686
--------------------------------- ------------- -------------
TOTAL EQUITY AND LIABILITIES 3,604,599 4,234,626
--------------------------------- ------------- -------------
Consolidated Statement of Changes in Equity for the year ended
31 December 2019
Reverse Share-based
Share Share Merger acquisition payment Non-controlling Retained
capital premium reserve reserve reserve interest earnings Total
GBP GBP GBP GBP GBP GBP GBP GBP
Balance at
1
January
2018 8,432,708 16,419,494 637,500 602,413 464,000 (24,744) (23,378,744) 3,152,627
Changes
in equity
Loss for
the
year - - - - - (69,020) (4,298,822) (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
and
warrants - - - - (215,795) - 215,795 -
Movement
in
year - - - - 637,758 - - 637,758
Balance at
31
December
2018 8,680,694 19,779,905 637,500 602,413 885,963 (93,764) (27,461,771) 3,030,940
----------- ------------ ---------------- --------- ------------- ------------- ----------------- ---------------- -------------
Changes
in equity
Loss for
the
year - - - - - (37,049) (2,388,707) (2,425,756)
Issue of
shares 736,531 1,105,969 - - - - - 1,842,500
Costs of
shares
issued - (289,731) - - - - - (289,731)
Lapse of
share
options - - - - (120,661) - 120,661 -
Movement
in
year - - - - 65,147 - - 65,147
Balance at
31
December
2019 9,417,225 20,596,143 637,500 602,413 830,449 (130,813) (29,729,817) 2,223,100
----------- ------------ ---------------- --------- ------------- ------------- ----------------- ---------------- -------------
Merger reserve
The merger reserve of GBP637,500 exists as a result of the
acquisition of ValiRx Bioinnovation Limited. The merger reserve
represents the difference between the nominal value of the share
capital issued by the Company and the fair value of ValiRx
Bioinnovation at 3 October 22, the date of acquisition.
Reverse acquisition reserve
The reverse acquisition reserve exists as a result of the method
of accounting for the acquisition of ValiRx Bioinnovation Limited
and ValiPharma Limited.
Consolidated Statement of Cash Flows for the year ended 31
December 2019
2019 2018
GBP GBP
Cash flows from operations
Cash outflow from operations (1,801,714) (3,776,840)
Interest paid (3,093) (866)
Tax credit received 463,144 424,197
----------------------------------------- ------------ ------------
Net cash outflow from operating
activities (1,341,663) (3,353,509)
----------------------------------------- ------------ ------------
Cash flows from investing activities
Proceeds from sale of investments 146,517 -
Purchase of intangible fixed assets (396,776) (324,028)
----------------------------------------- ------------ ------------
Net cash outflow from investing
activities (250,259) (324,028)
----------------------------------------- ------------ ------------
Cash flows from financing activities
Loan repayments (138,000) (25,000)
Share issue 1,576,000 3,720,000
Costs of shares issued (224,584) (346,001)
----------------------------------------- ------------ ------------
Net cash inflow from financing
activities 1,213,416 3,348,999
----------------------------------------- ------------ ------------
Decrease in cash and cash equivalents (378,506) (328,538)
Cash and cash equivalents at beginning
of year 372,872 701,410
----------------------------------------- ------------ ------------
Cash and cash equivalents at end
of year (5,634) 372,872
----------------------------------------- ------------ ------------
Notes to the Consolidated Financial Statements for the year
ended 31 December 2019
1) STATUTORY INFORMATION
ValiRx Plc is a company incorporated in the United Kingdom under
the Companies Act 1985, which is listed on the AIM market of the
London Stock Exchange Plc. The address of its registered office is
Stonebridge House, Chelsmford Road, Hatfield Heath, CM22 7BD.
The registered number of the Company is 03916791.
The principal activity of the Group is the development of
oncology therapeutics and companion diagnostics.
The presentation currency of the financial statements is the
Pound Sterling (GBP).
Basis of preparation
The Group financial statements have been prepared in accordance
with International Financial Reporting Standard as adopted by the
European Union ('IFRSs'), International Financial Reporting
Interpretations Committee ('IFRIC') interpretations and the
Companies Act 2006 applicable to companies reporting under
IFRS.
The Group financial statements have been prepared under the
historical cost convention or fair value where appropriate.
Going concern
As part of their going concern review the Directors have
followed the guidelines published by the Financial Reporting
Council entitled "Guidance on the Going Concern Basis of Accounting
and Reporting on Solvency Risks - Guidance for directors of
companies that do not apply the UK Corporate Governance Code".
The Group and Parent Company are subject to a number of risks
similar to those of other development stage pharmaceutical
companies. These risks include, amongst others, generation of
revenues in due course from the development portfolio and risks
associated with research, development, testing and obtaining
related regulatory approvals of its pipeline products. Ultimately,
the attainment of profitable operations is dependent on future
uncertain events which include obtaining adequate financing to
fulfil the Group's commercial and development activities and
generating a level of revenue adequate to support the Group's cost
structure.
The current economic environment is challenging, and the Group
has reported an operating loss for the year. These losses will
continue in the current accounting year to 31 December 2020.
In addition, there are significant uncertainties around the
impact of the COVID-19 pandemic including the extent and duration
of social distancing measures, the inability to travel, the closure
of academic institutions and the impact on the economy. Management
has considered the current economic uncertainty and market
volatility caused by the COVID-19 outbreak. In assessing whether
the going concern assumption is appropriate, management has
reviewed the impact on the business to date and developed a range
of downside scenarios that could impact the business together with
mitigating actions.
In the downside scenarios a liquidity shortfall would result.
Accordingly, a series of cost saving and cashflow measures have
been implemented. These actions include, temporary pay cuts,
delaying non-essential capital expenditure and tightening of
working capital. This is supplemented by additional funding in
respect of share placings, explained further in note 22. The net
proceeds of the placings have been used to strengthen the Group's
balance sheet, working capital and liquidity position.
The company carries out regular fund-raising exercises in order
that it can provide the necessary working capital for the Group.
Further funds will be required to finance the Group's work
programme. As detailed in note 22, since the year end, the Group
has raised approximately GBP1.4m before expenses through 3 issues
of new ordinary shares. The board expects to continue to raise
additional funding as and when required to cover the Group's
development, primarily from the issue of further shares.
The Directors have prepared detailed financial forecasts and
cash flows looking beyond 12 months from the date of the approval
of these financial statements. In developing these forecasts, the
Directors have made assumptions based upon their view of the
current and future economic conditions that are expected to prevail
over the forecast period. The Directors estimate that the cash held
by the Group together with known receivables will be sufficient to
support the current level of activities into the fourth quarter of
2020. The Directors are continuing to explore sources of finance
available to the Group and based upon initial discussions with a
number of existing and potential investors they have a reasonable
expectation that they will be able to secure sufficient cash
inflows for the Group to continue its activities for not less than
12 months from the date of approval of these financial statements;
they have therefore prepared the financial statements on a going
concern basis.
Basis of consolidation
The Group financial statements consolidate the financial
statements of the Company and all its subsidiaries ("the Group").
Subsidiaries include all entities over which the Group has the
power to govern financial and operating policies. The existence and
effect of potential voting rights that are currently exercisable or
convertible are considered when assessing whether the Group
controls another entity. Subsidiaries are consolidated from the
date on which control commences until the date that control ceases.
Intra-group balances and any unrealised gains and losses on income
or expenses arising from intra-group transactions, are eliminated
in preparing the consolidated financial statements.
On 3 October 2006, ValiRx Bioinnovation Limited
('Bioinnovation') acquired 60.28% of the issued share capital of
ValiPharma Limited ('ValiPharma') in exchange for shares in
Bioinnovation. Concurrently, the Company, ("ValiRx"), acquired the
entire issued share capital of Bioinnovation in a share for share
transaction. As a result of these transactions, the former
shareholders of ValiPharma became the majority shareholders in
ValiRx. Accordingly, the substance of the transaction was that
ValiPharma acquired ValiRx in a reverse acquisition. Under IFRS 3
"Business Combinations", the acquisition of ValiPharma has been
accounted for as a reverse acquisition.
In May 2008 the Company acquired the remaining 39.72% of the
issued share capital of ValiPharma, which is now wholly owned by
the Group. This acquisition was accounted for using the acquisition
method of accounting.
In November 2013 ValiSeek Limited was formed to enable the
company to enter into a joint venture agreement. The company has a
55.5% holding in the issued share capital of ValiSeek.
2) LOSS PER SHARE
The loss and number of shares used in the calculation of loss
per ordinary share are set out below:
2019 2018
GBP GBP
Loss for the financial period (2,425,756) (4,367,842)
Non-controlling interest 37,049 69,020
------------------------------------ ------------ ------------
Loss attributable to owners of
Parent Company (2,388,707) (4,298,822)
------------------------------------ ------------ ------------
Basic:
Weighted average number of shares 902,637,711 458,715,753
Loss per share (0.26p) (0.94p)
------------------------------------ ------------ ------------
The loss and the weighted average number of shares used for
calculating the diluted loss per share are identical to those for
the basic loss per share. The outstanding share options and share
warrants would have the effect of reducing the loss per share and
would therefore not be dilutive under IAS 33 'Earnings per
Share'.
3) Publication of report and accounts
The report and accounts for the year ended 31 December 2019 will
be posted to shareholders shortly and will be available from the
Company's website: http://valirx.com/
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
FR SDMFISESSEFM
(END) Dow Jones Newswires
July 01, 2020 02:00 ET (06:00 GMT)
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