TIDMVAL
RNS Number : 1284Y
ValiRx PLC
07 September 2020
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIODED 30 JUNE 2020
London, UK., 7 September 2020: 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 2020 and
provides an update on significant post-period events.
HIGHLIGHTS
Operational Highlights
Financial Highlights
-- Placings raised GBP1.4m during the period under review (2019: GBP1.2m)
-- Research and developments costs GBP99,879 (2019: GBP206,666)
-- Administrative expenses GBP791,866 (2019: GBP864,668)
-- Loss on disposal of FitBio and Trac included in
administrative expenses GBP118,000 (2019: GBPnil)
-- Total comprehensive loss for the period of GBP805,082 (2019: GBP750,569)
-- Loss before income taxation of GBP884,523 (2019: GBP927,342)
-- Loss per share from continuing operations of 4.43p (2019: Loss 13.57p)
-- Cash and cash equivalents as at 30 June 2020 of GBP258,753 (2019: GBP171,443)
Post-Period highlights
-- Placing GBP1.35m (July 2020)
-- Receipt of R&D tax credits of GBP270,000 (August 2020)
Dr Kevin Cox, Non-Executive Chairman of ValiRx, commented :
"Throughout the reporting period, ValiRx experienced a number of
significant changes, including changes to the Board, the management
team, the underlying cost base and the long-term strategy. Having
raised additional funds, the Company is now in a strong position to
continue development of existing products and create a pipeline of
novel compounds for further development and partnering. I look
forward to working with the Board to continue building value in the
Company and delivering on the mission of developing innovative
medicines to improve the lives of patients."
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
D r S J 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 Tel: +44 (0) 20 7469 0930
Broker)
Duncan Vasey / Lucy Williams / Eran
Zucker
Notes for Editors
About ValiRx
ValiRx PLC accelerates the development of innovative medicines
that enhance patient experience. We do this by combining
intellectual and financial resources to select, progress and
partner a balanced portfolio of risk-reduced, early-stage
technologies for translation into clinical candidates.
The Company listed on the AIM Market of the London Stock
Exchange in October 2006 and trades under the ticker symbol:
VAL.
CHIEF EXECUTIVE OFFICER'S STATEMENT FOR THE HALF YEARED 30 JUNE
2020
During the period of this Half Year Report the Company has
undergone significant structural changes, with the updates reported
below being contributed to by both the previous and current
management teams. While these long-term structural developments
will take time for the full effects to be seen, ValiRx is
continuing to progress its existing scientific programmes and build
a pipeline of new opportunities. The Company released a
comprehensive update on all scientific programmes on 19 May 2020,
summarised below.
VAL201
The Phase 1/2 clinical trial of VAL201 in the treatment of men
with prostate cancer was closed to further recruitment on 27
January 2020, with recruitment standing at a total of 12 patients
dosed across 5 cohorts. The dose escalation was carried out from
0.5 mg/kg up to 8 mg/kg with dosing being carried out once a
week.
The trial considered the safety and tolerability of drug
administration, alongside pharmacokinetics and disease impact.
Although the COVID-19 pandemic lockdown initially cast concern on
the time schedules for data verification processes, the project
remains on track to release headline results within Q3 2020, which
will provide basic details of safety, tolerability and disease
impact. More detailed observations on the pharmacokinetics and
complete summaries of patient demographics, biochemistry and study
conduct will be available when the Clinical Study Report is
completed in Q4 2020.
VAL301
VAL301, the same peptide ingredient as VAL201, is being
investigated for the treatment of women with endometriosis in the
preclinical stage of development.
The Company announced on 1 May 2020 that a Material Transfer
Agreement was signed with an undisclosed Japanese pharmaceutical
company, which is carrying out laboratory-based evaluations using
their own processes to determine whether to enter a licensing
agreement with ValiRx for further development of the project.
VAL401
On 14 January 2020, the Company announced that its subsidiary,
ValiSeek Limited, signed a letter of intent with Tangent
Reprofiling Limited and Black Cat Bio Limited to enable Black Cat
Bio Limited to seek funding for the development of the VAL401
clinical program. When an undisclosed threshold of funding is
reached, the VAL401 IP license will be transferred from ValiSeek to
Black Cat Bio, and all shareholders of ValiSeek, including ValiRx,
will become shareholders of Black Cat Bio.
BC201
On 2 June 2020, the Company announced that it has entered into a
collaboration agreement with Oncolytika Limited and Black Cat Bio
Limited to consider the potential for VAL201 to be used in
conjunction with other components for treatment of patients
suffering a hyperimmune response after Coronavirus SARS-CoV2
infection.
Black Cat Bio is co-ordinating the project overall, with project
management of specific elements contributed by ValiRx and
Oncolytika. ValiRx will provide samples of VAL201 to enable the
testing program. Subject to a successful outcome, ValiRx will
receive 40% of any licensing income generated by the project.
Non-core assets
As a result of the business review notified on 19 May 2020,
several projects were identified as non-core assets and deemed not
to fit with the future strategy of the Company. Subsequent to this
review, the assets acquired from FitBiotech Oy and the portfolio
surrounding the TRAC technology were disposed of via a patent
assignment as announced on 29 May 2020; and the licenses for the
GeneICE technology are in the process of being terminated as
announced on 29 May 2020.
Post-period highlights
Strategy development
On 6 July 2020, the Company announced that it had launched a new
strategy with the intent to expand the development pipeline with
new preclinical therapeutic assets. Recognising the Company's
strength in Women's Health and Oncology, ValiRx has prioritised
these indications in seeking new projects for further development
and possible spin-out into Special Purpose Vehicles (SPV). Such
SPVs will operate as subsidiary companies and reduce risk by
seeking partners to finance clinical trials. By providing
intellectual, corporate and financial resources, the Company
believes it can add value to early stage drug development projects
and present a strong commercial package for external funding and
partnering.
Project identification and screening is underway and an Advisory
Board is being appointed.
Outlook
With the structural changes in the Company nearly complete, the
Company intends to accelerate the strategy of risk-managed growth
and build on the existing pipeline of projects to ensure progress
is obtained in a resource-efficient manner.
Dr S Dilly
7 September 2020
ValiRx Plc
Consolidated statement of comprehensive income
Six months Six months
ended ended Year ended
Note 30 June 30 June 31 December
---------------- ---------------- -----------------
2020 2019 2019
(unaudited) (unaudited) (audited)
GBP GBP GBP
Continuing operations
Research and development (99,879) (206,666) (984,457)
Administrative expenses (791,866) (864,668) (1,860,379)
Other income 10,453 153,416 146,517
Operating loss (881,292) (917,918) (2,698,319)
Finance costs (3,231) (9,424) (21,175)
---------------- ---------------- -----------------
Loss before income taxation (884,523) (927,342) (2,719,494)
Income tax credit 2 60,000 150,000 293,738
---------------- ---------------- -----------------
Loss on ordinary activities
after taxation (824,523) (777,342) (2,425,756)
Non-controlling interests 19,441 26,773 37,049
---------------- ---------------- -----------------
Loss for the period and total
comprehensive income attributable
to owners of the parent (805,082) (750,569) (2,388,707)
================ ================ =================
Loss per share - basic and
diluted
From continuing operations 3 (4.43)p (13.57)p (33.08)p
================ ================ =================
ValiRx Plc
Consolidated statement of financial position
As at 30 June 31 December
---------------------------------------------- ----------------------
2020 2019 2019
Note (unaudited) (unaudited) (audited)
GBP GBP GBP
ASSETS
NON-CURRENT ASSETS
Goodwill 1,602,522 1,602,522 1,602,522
Intangible assets 1,489,598 1,813,405 1,620,207
Property, plant and equipment - - -
---------------------- ---------------------- ----------------------
3,092,120 3,415,927 3,222,729
---------------------- ---------------------- ----------------------
CURRENT ASSETS
Trade and other receivables 100,805 180,009 90,083
Tax receivable 351,787 611,193 291,787
Cash and cash equivalents 258,753 171,443 -
----------------------
711,345 962,645 381,870
---------------------- ---------------------- ----------------------
TOTAL ASSETS 3,803,465 4,378,572 3,604,599
====================== ====================== ======================
SHAREHOLDERS' EQUITY
Share capital 5 9,641,009 9,106,456 9,417,225
Share premium account 21,598,766 20,421,090 20,596,143
Merger reserve 637,500 637,500 637,500
Reverse acquisition reserve 602,413 602,413 602,413
Share option reserve 992,252 925,231 830,449
Retained earnings (30,534,899) (28,212,340) (29,729,817)
---------------------- ---------------------- ----------------------
2,937,041 3,480,350 2,353,913
Non-controlling interest (150,254) (120,537) (130,813)
---------------------- ---------------------- ----------------------
TOTAL EQUITY 2,786,787 3,359,813 2,223,100
---------------------- ---------------------- ----------------------
LIABILITIES
NON-CURRENT LIABILITIES
Bank loans and overdrafts 50,000 - -
---------------------- ---------------------- ----------------------
CURRENT LIABILITIES
Trade and other payables 772,897 804,841 1,182,084
Bank overdraft - - 5,634
Borrowings 193,781 213,918 193,781
---------------------- ---------------------- ----------------------
966,678 1,018,759 1,381,499
---------------------- ---------------------- ----------------------
TOTAL LIABILITIES 1,016,678 1,018,759 1,381,499
---------------------- ---------------------- ----------------------
TOTAL EQUITY AND LIABILITIES 3,803,465 4,378,572 3,604,599
====================== ====================== ======================
ValiRx Plc
Consolidated statement of changes in shareholders' equity
Share-based Reverse
Share Share Retained Merger payment acquisition Non-controlling
capital premium earnings reserve reserve reserve interest Total
GBP GBP GBP GBP GBP GBP GBP GBP
Unaudited
Balance at
1 January
2020 9,417,225 20,596,143 (29,729,817) 637,500 830,449 602,413 (130,813) 2,223,100
Loss for
the
period - - (805,082) - - - (19,441) (824,523)
Issue of
shares 223,784 1,260,384 - - - - - 1,484,168
Costs of
shares
issued - (95,958) - - - - - (95,958)
Share
based
payment - (161,803) - - 161,803 - - -
Balance at
30 June
2020 9,641,009 21,598,766 (30,534,899) 637,500 992,252 602,413 (150,254) 2,786,787
=================== ====================== ====================== ====================== ====================== ====================== ====================== ======================
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
=================== ====================== ====================== ====================== ====================== ====================== ====================== ======================
Audited
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 year - - (2,388,707) - - - (37,049) (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) - -
Share
based
payment - - - - 65,147 - - 65,147
Balance at
31
December
2019 9,417,225 20,596,143 (29,729,817) 637,500 830,449 602,413 (130,813) 2,223,100
=================== ====================== ====================== ====================== ====================== ====================== ====================== ======================
ValiRx Plc
Consolidated cash flow statement
Year ended
Six months ended
30 June 31 December
---------------------------------------------- ----------------------
2020 2019 2019
(unaudited) (unaudited) (audited)
GBP GBP GBP
Cash flows from operating
activities
Operating loss (881,292) (917,918) (2,698,319)
Amortisation of intangible
fixed assets 83,723 92,012 400,519
(Increase)/decrease in receivables (10,722) (5,920) 84,006
(Decrease)/increase in payables
within one year (325,019) (85,146) 346,097
Profit on sale of investments - (153,416) (146,517)
Loss on sale of intangible
assets 118,000 - -
Share option charge - - 212,500
---------------------- ---------------------- ----------------------
Net cash outflows from operations (1,015,310) (1,070,388) (1,801,714)
Tax credit received - - 463,144
Interest paid (3,231) (1,205) (3,093)
---------------------- ---------------------- ----------------------
Net cash outflow from operating
activities (1,018,541) (1,071,593) (1,341,663)
---------------------- ---------------------- ----------------------
Cash flows from investing
activities
Purchase of intangible fixed
assets (73,114) (281,467) (396,776)
Proceeds from sale of investments 2,000 - -
Proceeds from sale of investments - 153,416 146,517
---------------------- ---------------------- ----------------------
Net cash outflow from investing
activities (71,114) (128,051) (250,259)
---------------------- ---------------------- ----------------------
Cash flows from financing
activities
Share issue 1,400,000 1,226,000 1,576,000
Costs of shares issued (95,958) (119,785) (224,584)
Bank loan 50,000 - -
Repayment of loan notes - (108,000) (138,000)
---------------------- ---------------------- ----------------------
Net cash generated from financing
activities 1,354,042 998,215 1,213,416
---------------------- ---------------------- ----------------------
Net increase/(decrease) in
cash and cash equivalents 264,387 (201,429) (378,506)
Cash and cash equivalents
at start of period (5,634) 372,872 372,872
---------------------- ---------------------- ----------------------
Cash and cash equivalents
at end of period 258,753 171,443 (5,634)
====================== ====================== ======================
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, Essex CM22
7BD
Financial information
The interim consolidated financial information for the six
months ended 30 June 2019 and 2020 have not been audited or
reviewed and do 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 2019 have been
delivered to the Registrar of Companies. The report of the
independent auditors on those financial statements was unqualified,
drew attention to a material uncertainty relating to going concern
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
Group for the year ended 31 December 2019.
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
------------------ --------------------- ------------
2020 2019 2019
(unaudited) (unaudited) (audited)
GBP GBP GBP
United Kingdom corporation tax
at 19%
Current period - R & D Tax (2 91,788
credit (60,000) (150,000) )
Prior period - R & D Tax credits - - (1,950)
------------------ --------------------- ------------
Income tax credit (60,000) (150,000) (293,738)
================== ===================== ============
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
---------------- ------------------- ------------------
2020 2019 2019
(unaudited) (unaudited) (audited)
Basic:
Loss for the financial
period (824,523) (777,342) (2,425,756)
Non-controlling interest 19,441 26,773 37,049
---------------- ------------------- ------------------
(805,082) (750,569) (2,388,707)
================ =================== ==================
Weighted average number
of shares 18,191,261 5,533,121 7,221,102
Loss per share (4.43)p (13.57)p (33.08)p
================ =================== ==================
The comparative figures for 30 June 2019 and 31 December 2019
have been adjusted to account for the share re-organisation
described in note 5 below.
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 2020 30 June 2019
---------------------------------------------------- ----------------------------------------------------
Number GBP Number GBP
(unaudited) (unaudited) (unaudited) (unaudited)
Allotted,
called up
and
fully paid
New
Ordinary
shares of
0.1p each 36,062,373 36,063 - -
Ordinary
shares of
0.1p
each - - 1,024,057,953 1,024,059
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 42,455,832 5,264,523 30,177,214 3,741,974
========================== ==========================
9,641,009 9,106,456
======================== ========================
31 December 2019
----------------------------------------------------
Number GBP
Allotted,
called up
and
fully paid (audited) (audited)
Ordinary
shares of
0.1p
each 1,334,827,184 1,334,828
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
==========================
9,417,225
========================
-- On 10 January 2020, the Company raised GBP0.20 million,
before expenses, by way of a placing of 200,000,000 ordinary shares
of 0.1p each at a price of 0.10p per share;
-- At a general meeting in April 2020, the shareholders approved
a Capital Reorganisation. This was achieved by consolidating 125
Existing Shares into 1 Consolidated Share of 12.5 pence, followed
by the Sub-Division of each Consolidated Share into 1 New Ordinary
Share of 0.1 pence each and 1 New Deferred Shares of 12.4 pence
each.
-- On 15 April 2020, the Company raised GBP0.20 million, before
expenses, by way of a placing, by the issue of 5,714,288 at a price
of 3.5p per share;
-- On 26 May 2020, the Company raised GBP1 million, before
expenses, by way of a placing of 16,666,667 ordinary shares of 0.1p
each at a price of 6.00p per share;
-- On 26 May 2020, the Company issued 1,402,800 ordinary shares
of 0.1p each at a price of 6.00p per share in to settle existing
liabilities amounting to GBP84,168.
-- On 29 July 2020, the Company raised GBP1.35m, before
expenses, by way of a placing, subscription, conversion and broker
option, of 18,000,000 ordinary shares of 0.1p each at a price of
7.5p per share.
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.
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identi ed by their use of terms and phrases such as "believe",
"could", "should" "envisage", "estimate", "intend", "may", "plan",
"potentially", "expect", "will" or the negative of those,
variations or comparable expressions, including references to
assumptions. These forward looking statements are not based on
historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of
operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof),
competitive advantages, business prospects and opportunities. Such
forward looking statements re ect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
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