REG - ValiRx PLC - Half-year Report
27/09/2024 07:00
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RNS Number : 8818F ValiRx PLC 27 September 2024
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIOD ENDED 30 JUNE 2024
London, UK., 2024: 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 2023 and provides an update on significant post-period events.
HIGHLIGHTS
Operational Highlights
· First US customer signed for Inaphaea tCRO® in multistage deal
· Development of Inaphaea Biobank to include 2D and 3D Patient
derived cell models
· Signature of collaboration service agreements for Inaphaea with
DefiniGen
· Overarching evaluation agreement signed with Dundee University
with first project on pro-senescence initiated
· Second new evaluation project signed with Imperial College
centred on drug resistant ovarian cancer
· Cytolytix evaluation in prostate cancer with Open University
Financial Highlights
· Research and developments costs (excluding employee costs)
£121,490 (2023: £207,721)
· Administrative expenses £947,565 (2023: £925,866)
· Share-based payment charge £18,994 (2023: £17,733)
· Loss before income taxation of £1,052,006 (2023: £1,152,325)
· Total comprehensive loss for the period of £970,908 (2023:
£1,035,424)
· Loss per share from continuing operations of 0.74p (2023: Loss
1.03p)
· Cash and cash equivalents at 30 June 2024 of £809,147 (2023:
£891,246)
The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulations
(EU) No. 596/2014 as it forms part of UK Domestic Law by virtue of the
European Union (Withdrawal) Act 2018 ("UK MAR"). The Directors of the Company
take responsibility for this announcement.
*** ENDS ***
For more information, please contact:
ValiRx plc Tel: +44 (0) 115 784 0026
www.valirx.com (http://www.valirx.com)
Dr Mark Eccleston, CEO info@valirx.com
V Formation (Public Relations) + 44 (0) 115 787 0206
www.vformation.biz (http://www.vformation.biz)
Lucy Wharton - Senior PR Executive lucy@vformation.biz (mailto:lucy@vformation.biz)
Sue Carr - Director sue@vinformation.biz (mailto:sue@vinformation.biz)
Cairn Financial Advisers LLP (Nominated Adviser) Tel: +44 (0) 20 7213 0880
Liam Murray / Jo Turner / Ludovico Lazzaretti
Shard Capital Partners LLP (Sole Broker) Tel: +44 (0) 20 7186 9000
Damon Heath
Notes for Editors
About ValiRx
ValiRx is a life science company focused on early-stage cancer therapeutics
and women's health, accelerating the translation of innovative science into
impactful medicines to improve patient lives.
ValiRx provides the scientific, financial, and commercial framework for
enabling rapid translation of innovative science into clinical development.
Using its extensive and proven experience in research and drug development,
the team at ValiRx selects and incubates promising novel drug candidates and
guides them through an optimised process of development, from pre-clinical
studies to clinic and investor-ready assets.
ValiRx connects diverse disciplines across scientific, technical, and
commercial domains, with the aim of achieving a more streamlined, less costly,
drug development process. The team works closely with carefully selected
collaborators and leverages the combined expertise required for science to
advance.
Lead candidates from ValiRx's portfolio are outlicensed or partnered with
investors through ValiRx subsidiary companies for further clinical development
and commercialisation.
ValiRx listed on the AIM Market of the London Stock Exchange in October 2006
and trades under the ticker symbol: VAL.
For further information, visit: www.valirx.com (http://www.valirx.com/)
CHAIRMAN'S STATEMENT FOR THE HALF YEAR ENDED 30 JUNE 2024
During the period significant changes have occurred to the management of the
Company. Stella Panu stepped down and I joined the board as a non-executive
director along with Adrian de Courcey. Suzanne Dilly stepped down as CEO after
10 years of service to the Company, and Mark Eccleston was appointed as her
replacement. With Kevin Cox standing down as a director and Chairman I have
now recently been appointed as chairman. Additionally, Cathy Tralau-Stewart,
has been appointed to the executive board whilst continuing her duties as CSO.
The primary objective for these board changes was to bring additional
commercial and business development experience to the Company as ValiRx looks
to refocus its commercial strategy. As well as a renewed commitment to the
development of therapeutic assets, ValiRx also intends to realise the
potential of the assets within its translational Contract Research
Organisation ("tCRO®") subsidiary, Inaphaea BioLabs Limited ("Inaphaea"). As
part of a strategic review, Inaphaea expanded its business development
activities into the immune oncology space and began to target the US markets,
having previously focussed mainly in the domestic and European markets. ValiRx
signed its first immune-oncology service contract in June 2024 with a
multi-stage service agreement which leveraged the primary asset of Inaphaea,
its Patient Derived Cell bank and associated data in conjunction with the deep
technical expertise of its scientific team to develop a detailed proposal for
the US based client.
Throughout the first half of the year, the Inaphaea team have worked
diligently to develop the cell bank offering, not only for services, but also
to service growing interest in the cells and their derivatives as products.
Inaphaea's collaborative partnered capabilities now include in-silico toxicity
testing and in-vitro toxicity testing.
ValiRx is renewing its focus on asset development as it sees this as its core
purpose. The R&D team continue their work on two new evaluation projects
from Dundee University and Imperial College alongside the ongoing Stingray
evaluation whilst we are evaluating the results of the Barcelona collaboration
with the academic team. We remain focussed on building a strong portfolio of
evaluation projects and directing funds to the most positive projects as we
seek the best assets to in-license into our next Special Purpose Vehicle
(SPV). Work on new Cytolytix formulations in an increased range of cancers is
ongoing and builds on new collaborations with non-dilutive funding from the
Open University through its Knowledge transfer Voucher scheme.
The commercial and technical progress made in the first half of 2024 has been
positive despite funding restrictions and difficult market conditions, which
remain challenging. The Company anticipates additional short-term income from
both service and product offerings through Inaphaea and we will continue to
leverage our biobank resources and collaboration partnerships to advance
ValiRx's development programs as efficiently as possible.
Alongside its ongoing fiscal prudence, the Company will implement further cost
savings through streamlining and resource management to ensure its cash is
focused on supporting its development assets.
Martin Gouldstone
26 September 2024
CHIEF EXECUTIVE OFFICER'S STATEMENT FOR THE HALF YEAR ENDED 30 JUNE 2024
In my first Chief Executive's Interim report, I am reporting on the final
period overseen by the previous CEO Dr Suzanne Dilly.
Over the first half of 2024 Inaphaea has delivered on two key objectives.
The first is to service the expanding internal ValiRx pipeline. This has been
achieved through provision of rapid and flexible initial assessment for each
of the evaluation projects as well as a significant amount of development work
for Cytolytix. In addition, the partner network established as part of the
tCRO® service offering has been utilised for peptide formulation of CL X001
and in-silico toxicity screening of the Stingray compounds.
As part of its second objective, revenue generation, Inaphaea broadened its
marketing activities into the US. The Bio International Convention generated
23 leads as part of an expanding deal pipeline. In the same month, the first
US customer signed up with a multi-stage, revenue generating contract
leveraging both RNA-sequence data and bespoke screening using Inaphaea's
Patient Derived Cell (PDC) bank. The deal was enabled by the scientific
insight and technical expertise of the Inaphaea team and addresses the rapidly
growing immune-oncology sector of the market. The specialist services required
by the client builds on the PDC cells to provide both 2 dimensional and
3-dimensional cell systems grown in co-culture with human immune cells to
model human disease states.
Evaluation projects:
Barcelona University
Work on the KRAS(2) program, carried out under our over-arching evaluation
agreement with Barcelona University, was completed on time in June 2024 and
the results are being evaluated with the academic team.
Post period, on reflection of the initial promising results, the development
programme was deemed to be still at an early stage, and the Company has
decided to return the project to the university researchers for further
development, with no further financial commitment from the Company currently
in place.
The University of Barcelona is currently receiving grant funding for both
"KRAS1" and "KRAS2" projects and the broader collaboration agreement will
enable the Company to review the data produced during these grant periods as
well as other programmes of interest within the research group, for commercial
potential until the expiry of the agreement in 2027. This is in line with
ValiRx's objective of directing funds to assets most likely to progress
rapidly and deliver value for its shareholders.
Stingray
Several compounds have been provided by Stingray across multiple series and
initial work has been carried out to assess efficacy against a range of cell
lines, including Inaphaea's Patient Derived Cells. In-silico screening has
been performed with our partner Ignota Labs to identify potential toxicity
issues which will be addressed during a round of chemical optimisation.
Two further evaluations projects were initiated in the first half of 2024.
Dundee University
The Company entered into an over-arching evaluation agreement with Dundee
University and the first asset to be evaluated is a class of pro-senescence
inducing compounds. Senescence in a state in which cells stop dividing and
pro-senescence drugs can be used in combination with "senolytic" compounds or
immune activation in order to remove the senescent cells. As such,
pro-senescence drugs offer natural partnering opportunities for
commercialisation. Several compounds across multiple series provided by Dundee
have been screened using an assay developed at Dundee and transferred to our
tCRO® Inaphaea. This process is being used to identify the best compound to
take forward into in-silico screening to better understand the mechanism of
action.
Imperial College
Chemical synthesis of the lead molecules was commissioned in March 2024 and
preliminary efficacy testing has been performed at Inaphaea. A drug-resistant
cancer cell line is being developed at Inaphaea to support the project which
has cis-platin resistant ovarian cancer as its primary indication.
Further Evaluation Projects
The Company maintains active surveillance of opportunities across a range of
established collaborators, through partnering meetings and from direct
approaches. It is essential to maintain an active pipeline to account for high
attrition within the evaluation process. Further negotiations are underway
with a view to securing up to 2 new programmes by year end.
Clinical Stage Assets
VAL201 currently remains subject to the Letter of Intent ("LoI") with
TheoremRx Inc, who maintain they are focussed on securing the financing to
enable the VAL201 sub-license to complete.
VAL401 is currently under an option agreement with Ambrose Healthcare which
will expire at the end of 2024. Ambrose remains committed to progress VAL401
through remaining clinical development and commercialisation and the Company
looks forward to progressing this asset in the second half of the year.
Preclinical Stage Assets
CLX001 has been developed into freeze dried nanoformulation, an essential step
for continued evaluation. Biological activity has been confirmed in Inaphaea's
lab using a range of cell lines. Cytolytix also received funding for a pilot
study in prostate cancer cells via a collaboration with the Open University.
Encouragingly, the results demonstrated increased activity of CLX001 under low
oxygen conditions often seen within tumours. This collaboration has led to
additional non-dilutive grant funding applications in prostate cancer and is a
good opportunity to expand evaluation of our therapeutic approaches outside of
our internal women's health focus.
Additional formulation options are being examined with the aim of identifying
application specific versions to target various routes of administration. Once
the lead formulation has been confirmed as being biologically active, a full
programme of preclinical development including manufacturing, toxicology,
disease impact and regulatory activities will be pursued.
Opportunities for early partnering are being explored for Cytolytix, with
active commercial development to promote the project to potential industry
partners.
ValiRx is prioritising its resources towards completing the current round of
evaluation programmes and selecting the next asset to in-license, in order to
best direct the efforts of our lab team.
VAL301 in vitro preclinical testing is currently on hold whilst we clarify the
position around VAL201.
BC201 assessment in the collaboration between Black Cat Bio Limited and
Oncolytika has also been put on hold.
Dr Mark Eccleston
26 September 2024
ValiRx Plc
Consolidated statement of comprehensive income
Six months ended Six months ended Year ended
Note 30 June 30 June 31 December
2024 2023 2023
(unaudited) (unaudited) (audited)
£ £ £
Continuing operations
Revenue - - 9,600
Cost of sales - - (1,440)
Gross profit - - 8,160
Continuing operations
Research and development (121,490) (207,721) (383,362)
Administrative expenses (947,565) (925,866) (1,886,401)
Share-based payment charge (18,994) (17,733) (36,936)
Operating loss (1,088,049) (1,151,320) (2,298,539)
Other income 30,000 - -
Loss before interest (1,058,049) (1,151,320) (2,298,539)
Finance income 6,291 - -
Finance costs (248) (1,005) (4,419)
Loss before income taxation (1,052,006) (1,152,325) (2,302,958)
Income tax credit 2 52,290 90,000 175,173
Loss on ordinary activities after taxation (999,716) (1,062,325) (2,127,785)
Non-controlling interests 28,808 26,901 90,084
Loss for the period and total comprehensive income attributable to owners of (970,908) (1,035,424) (2,037,701)
the parent
Loss per share - basic and diluted
From continuing operations 3 (0.74)p (1.03)p (2.01)p
ValiRx Plc
Consolidated statement of financial position
As at 30 June 31 December
2024 2023 2023
(unaudited) (unaudited) (audited)
£ £ £
ASSETS
NON-CURRENT ASSETS
Goodwill 1,602,522 1,602,522 1,602,522
Intangible assets 623,262 818,097 718,814
Property, plant and equipment 231,901 274,744 242,625
Right-of-use assets - 1,702 -
Investments 30,000 - -
2,487,685 2,697,065 2,563,961
CURRENT ASSETS
Inventory 69,002 - 69,002
Trade and other receivables 99,190 201,368 147,618
Tax receivable 227,463 282,671 175,173
Cash and cash equivalents 809,147 891,246 174,684
1,204,802 1,375,285 566,477
TOTAL ASSETS 3,692,487 4,072,350 3,130,438
SHAREHOLDERS' EQUITY
Share capital 9,737,295 9,707,266 9,707,266
Share premium account 29,422,094 27,873,048 27,870,548
Merger reserve 637,500 637,500 637,500
Reverse acquisition reserve 602,413 602,413 602,413
Share-based payment reserve 1,101,157 1,062,960 1,082,163
Retained earnings (37,652,248) (35,679,063) (36,681,340)
3,848,211 4,204,124 3,218,550
Non-controlling interest (343,431) (251,440) (314,623)
TOTAL EQUITY 3,504,780 3,952,684 2,903,927
LIABILITIES
NON-CURRENT LIABILITIES
Borrowings 6,653 16,818 11,857
6,653 16,818 11,857
CURRENT LIABILITIES
Trade and other payables 170,712 90,830 204,441
Borrowings 10,342 10,264 10,213
Lease liabilities - 1,754 -
181,054 102,848 214,654
TOTAL LIABILITIES 187,707 119,666 226,511
TOTAL EQUITY AND LIABILITIES 3,692,487 4,072,350 3,130,438
ValiRx Plc
Consolidated statement of changes in shareholders' equity
Share capital Share premium Retained earnings Merger reserve Share-based payment reserve Reverse acquisition reserve Non-controlling interest Total
£ £ £ £ £ £ £ £
Unaudited
Balance at 1 January 2024 9,707,266 27,870,548 (36,681,340) 637,500 1,082,163 602,413 (314,623) 2,903,927
Loss for the period - - (970,908) - - - (28,808) (999,716)
Issue of shares 30,029 1,771,715 - - - - - 1,801,744
Costs of shares issued - (220,169) - - - - - (220,169)
Share-based payment movement - - - 18,994 - - 18,994
Balance at 30 June 2024 9,737,295 29,422,094 (37,652,248) 637,500 1,101,157 602,413 (343,431) 3,504,780
Unaudited
Balance at 1 January 2023 9,695,120 26,772,630 (34,643,639) 637,500 986,816 602,413 (224,539) 3,826,301
Loss for the period - - (1,035,424) - - - (26,901) (1,062,325)
Issue of shares 12,146 1,287,854 - - - - - 1,300,000
Costs of shares issued - (129,025) - - - - - (129,025)
Share-based payment movement - (58,411) - - 76,144 - - 17,733
Balance at 30 June 2023 9,707,266 27,873,048 (35,679,063) 637,500 1,062,960 602,413 (251,440) 3,952,684
Audited
Balance at 1 January 2023 9,695,120 26,772,630 (34,643,639) 637,500 986,816 602,413 (224,539) 3,826,301
Loss for the year - - (2,037,701) - - - (90,084) (2,127,785)
Issue of shares 12,146 1,323,854 - - - - - 1,336,000
Costs of shares issued - (167,525) - - - - - (167,525)
Movement in year - (58,411) - - 95,347 - - 36,936
Balance at 31 December 2023 9,707,266 27,870,548 (36,681,340) 637,500 1,082,163 602,413 (314,623) 2,903,927
ValiRx Plc
Consolidated cash flow statement
Year ended
Six months ended 30 June 31 December
2024 2023 2023
(unaudited) (unaudited) (audited)
£ £ £
Cash flows from operating activities
Operating loss (1,058,049) (1,151,320) (2,298,539)
Depreciation of property plant and equipment 38,636 13,558 48,556
Amortisation of intangible fixed assets 95,552 100,803 200,086
Depreciation of right-of-use assets - 3,859 5,561
Increase in inventory - - (69,002)
Decrease/(increase)in receivables 48,428 (67,552) (13,803)
(Decrease)/increase in payables within one year (33,729) (21,103) 128,508
Share-based payment charge 18,994 17,733 36,936
Net cash outflows from operations (890,168) (1,104,022) (1,961,697)
Tax credit received - - 192,671
Interest paid (248) (432) (3,325)
Net cash outflow from operating activities (890,416) (1,104,454) (1,772,351)
Cash flows from investing activities
Purchase of intangible fixed assets - (15,000) (15,000)
Purchase of investments (30,000) - -
Purchase of property plant and equipment (27,912) (288,302) (291,181)
Interest received 6,291 - -
Net cash outflow from investing activities (51,621) (303,302) (306,181)
Cash flows from financing activities
Share issue 1,801,744 1,300,000 1,300,000
Costs of shares issued (220,169) (129,025) (167,525)
Repayment of lease liabilities - (4,500) (6,774)
Bank loan (5,075) (4,950) (9,962)
Net cash generated from financing activities 1,576,500 1,161,525 1,115,739
Net increase/(decrease)in cash and cash equivalents 634,463 (246,231) (962,793)
Cash and cash equivalents at start of period 174,684 1,137,477 1,137,477
Cash and cash equivalents at end of period 809,147 891,246 174,684
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.
The principal activity of Valirx Plc and its subsidiaries is the development
of oncology therapeutics and companion diagnostics.
Financial information
The interim financial information for the six months ended 30 June 2024 and
2023 have not been audited or reviewed and do not constitute statutory
accounts within the meaning of Section 434 of the Companies Act 2006. The
comparative financial information for the year ended 31 December 2023 has been
derived from the audited financial statements for that period. A copy of those
statutory financial statements for the year ended 31 December 2023 has 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 Accounting Standards in conformity with the requirements of the
Companies Act 2006 as they apply to the financial statements of the Company
for the six months ended 30 June 2023 and as applied in accordance with the
provisions of the Companies Act 2006 and under the historical cost convention
or fair value where appropriate. They have also been prepared on a basis
consistent with the accounting policies expected to be applied for the year
ending 31 December 2024 and which are also consistent with those set out in
the statutory accounts of the Group for the year ended 31 December 2023.
The interim consolidated financial statements are presented in pounds sterling
which is the currency of the primary economic environment in which the Group
operates.
2 Taxation
Six months ended Six months ended Year ended
30 June 30 June 31 December
2024 2023 2023
(unaudited) (unaudited) (audited)
£ £ £
United Kingdom corporation tax at effective rate of tax of 25% (2023: 23.5%)
Current period - R & D Tax credit (62,000) (90,000) (175,173)
Prior period - R & D Tax credits 9,710 - -
Income tax credit (52,290) (90,000) (175,173)
3 Loss per ordinary share
The loss and number of shares used in the calculation of loss per share are as
follows:
Six months ended Six months ended Year ended
30 June 30 June 31 December
2024 2023 2023
(unaudited) (unaudited) (audited)
Basic: £ £ £
Loss for the financial period (999,716) (1,062,325) (2,127,785)
Non-controlling interest 28,808 26,901 90,084
(970,908) (1,035,424) (2,037,701)
Weighted average number of shares 131,193,709 100,808,008 101,570,021
Loss per share (0.74)p (1.03)p (2.01)p
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 exercise prices of the outstanding share options and share warrants are
above the average market price of the shares and would therefore not be
dilutive under IAS 33 'Earnings per Share.
4 Dividends
The Directors do not propose to declare a dividend in respect of the period.
5 Copies of interim results
Copies of the interim results can be obtained from the website www.valirx.com
(http://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 identified 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 reflect the
Directors' current beliefs and assumptions and are based on information
currently available to the Directors.
Such statements are based on current expectations and assumptions and are
subject to a number of risks and uncertainties that could cause actual events
or results to differ materially from any expected future events or results
expressed or implied in these forward-looking statements. Persons receiving
and reading this announcement should not place undue reliance on
forward-looking statements. Unless otherwise required by applicable law,
regulation or accounting standard, the Company does not undertake to update or
revise any forward-looking statements, whether as a result of new information,
future developments or otherwise.
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