REG - ValiRx PLC - Half-year Report
31/08/2022 07:01
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220831:nRSe6568Xa&default-theme=true
RNS Number : 6568X ValiRx PLC 31 August 2022
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIOD ENDED 30 JUNE 2022
London, UK., 2022: ValiRx Plc (AIM: VAL), a life science company, which
focuses on clinical stage cancer therapeutic development and women's health,
taking proprietary and novel technology for precision medicines towards
commercialisation and partnering, today announces its half yearly report for
the period ended 30 June 2022 and provides an update on significant
post-period events.
HIGHLIGHTS
Operational Highlights:
· Evaluation agreement signed with University of Barcelona
providing future licensing opportunity for peptidomimetic drug candidate for
the treatment of uterine and pancreatic cancers
· Continued progression of Evaluation project with Hokkaido
University for a peptide drug candidate for the treatment of endometrial,
pancreatic and bile duct cancers
· Announced equity issue raising gross proceeds of £2.5 million
(post period end) to support continued development of its assets, as well as
strengthen its balance sheet with a view to pursuing acquisitive tCRO strategy
· Post period end - successful evaluation of triple negative breast
cancer programme with King's College London, now progressing to full
in-licensing
· Progression of tCRO strategy working towards identifying a target
lab infrastructure acquisition to establish future revenue flows into the
Company
Financial Highlights
· Research and developments costs £200,531 (2021: £166,500)
· Administrative expenses £611,370 (2021: £618,228)
· Share-based payment charge £261,052 (2021: £nil)
· Total comprehensive loss for the period of £992,481 (2021:
£743,178)
· Loss before income taxation of £1,074,784 (2021: £785,434)
· Loss per share from continuing operations of 1.53p (2021: Loss
1.14p)
· Cash and cash equivalents at 30 June 2022 of £97,699 (2021:
£1,239,035) - £2.5m (gross) fundraising post period
Dr Kevin Cox, Non-Executive Chairman of ValiRx, commented:
"Despite a challenging market, I am pleased that we have been able to complete
a £2.5m (before expenses) equity raise at the period end with new and
existing investors. We now have sufficient funding to continue building the
collaborative development pipeline and continue to explore options to create a
translational contract research organisation (tCRO)."
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) 2476 796496
www.valirx.com (http://www.valirx.com)
Dr S J Dilly suzanne.dilly@valirx.com
V Formation (Public Relations) +44 (0) 115 787 0206
www.vformation.biz (http://www.vformation.biz)
Lucy Wharton - Senior PR Executive
Sue Carr - Director lucy@vformation.biz
sue@vformation.biz
Cairn Financial Advisers LLP (Nominated Adviser) Tel: +44 (0) 20 7213 0880
Liam Murray/Jo Turner/Ludovico Lazzaretti
Cenkos Securities Limited (Joint Broker) Tel: +44 (0) 207397 8900
Russell Kerr / Michael Johnson (Sales)
Callum Davidson / Giles Balleny (Corporate Finance)
Turner Pope Investments (TPI) Limited (Joint Broker) Tel: +44 (0) 20 3657 0050
James Pope / Andy Thacker
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.
CHAIRMAN'S STATEMENT FOR THE HALF YEAR ENDED 30 JUNE 2022
Market conditions in the first half of 2022 have been challenging for the
majority of public companies, driven in large part by the Russian invasion of
Ukraine and the macro-economic impacts of the Covid aftermath. While ValiRx
has not been immune to these external factors, we have continued to make
significant progress with the strategic changes initiated in 2021.
Despite these challenges, we were pleased to have been able to complete a
£2.5m (before expenses) equity raise at the period end with new and existing
investors which ensured that we now have a comfortable cash position that will
enable continued progression of the collaborative development pipeline and
provide ValiRx with an opportunity to explore a range of options to build our
translational contract research organisation (tCRO) with a view to adding
further revenue streams to the business.
Understandably, our partners in the clinical development of VAL201, TheoremRx
Inc, have faced similar market challenges, with associated delays to their
financing process. Nevertheless, at this time we have no reason to believe
they will not be successful in due course.
Over the last six months the Company's strategic shift towards a tCRO business
model has been further refined and the concept shared widely with
institutional investors, receiving very positive feedback and a strong
interest to support future acquisitions that fit with the proposed
buy-and-build strategy.
Success with the tCRO strategy and the conversion of assets from our
evaluation pipeline into full licencing will require ValiRx to add additional
resource and experience at all levels of the Company. To this end, we hope to
be able to strengthen the Board, and the executive and operational teams in
the near future.
Kevin Cox
30 August 2022
CHIEF EXECUTIVE OFFICER'S STATEMENT FOR THE HALF YEAR ENDED 30 JUNE 2022
The first half of 2022 has been notable within ValiRx for making steady,
sustained progress on all scientific fronts and continued evolution of our
ambitions to build a tCRO.
Our Evaluation Project brought in from Barcelona in February was added to the
two evaluation projects brought in towards the end of 2021 from Kings College
London and Hokkaido Universities respectively. These projects demonstrate
the global reach of our search capability for early-stage drug candidates and
the assessment of all three of these has actively progressed during this
period.
Post-period, we were delighted to be able to confirm successful completion of
the Evaluation stage of the triple negative breast cancer project from Kings
College London and our decision to move forward with full in-licencing as
announced 13 July 2022. As the first successful Evaluation project within
our new strategy, this progression marks a major milestone, increasing the
breadth of the ValiRx pipeline. We continue to seek further opportunities to
bring under our Evaluation process, as well as continuing to assess the
Barcelona and Hokkaido projects for suitability for full in-licencing.
A summary of progress of each project is provided below, forming our quarterly
project update.
Scientific Update Summary
VAL201 in prostate cancer
VAL201 is a short peptide being studied for the treatment of prostate
cancer. The peptide structure is inspired by the structure of the naturally
occurring androgen receptor and is designed to intercept and prevent the
binding of the androgen receptor to SRC kinase; an enzyme implicated in
cancerous cell growth pathways. By preventing the androgen-mediated
activation of SRC kinase, VAL201 can prevent cancerous cell proliferation (or
growth) without interfering with other functions of the androgen receptor or
SRC kinase. This precision method, mimicking a natural process, proposes a
high specificity of cancer treatment, with a lower side effect profile.
Our Phase 1/2 clinical trial treating men with prostate cancer with varying
doses of VAL201 concluded in January 2020, with the clinical study report
submitted in January 2021.
Sub-licensing VAL201
A Letter of Intent (LOI) to sub-license VAL201 to the US biotech company
TheoremRx Inc has been in place since November 2021. On completion of
TheoremRx financing, a sub-license will be executed between ValiRx and
TheoremRx enabling TheoremRx to develop VAL201 globally in oncology in
exchange for upfront, milestone and royalty payments.
Although TheoremRx has faced challenges relating to the current macro-economic
conditions, they have demonstrated good progress towards completion of the
financing process, and we remain confident that they have the commercial,
scientific and financial experience to honour their commitment to the project.
VAL301 in endometriosis
VAL301, the same peptide ingredient as VAL201, is being investigated for the
treatment of women with endometriosis and is in the preclinical stage of
development.
VAL301 presents an opportunity to suppress hormone-driven cellular growth in
the absence of outright hormone suppression. By interrupting only the
hormone driven cell growth while sparing the other hormone activities,
infertility and related side effects are potentially avoided.
VAL301 is one of our preclinical pipeline products and this potential benefit
of selectivity will be investigated in future clinical trials. The Company
announced on 1 May 2020 that a Material Transfer Agreement was signed with an
undisclosed Japanese pharmaceutical company, which enables them to carry out
their own laboratory-based evaluations.
Independently of the work being carried out in Japan, ValiRx has commissioned
further preclinical testing of the peptide to support the mechanism of action
in the treatment of endometriosis. This additional work will provide greater
insight into the interactions of the peptide with multiple cellular proteins
under differing stimulation conditions as well as considering formulation
aspects of the project.
If successful, this new preclinical data may trigger the positioning of VAL301
into a new ValiRx subsidiary to facilitate further commercial development and
partnering of this programme.
VAL401 in adenocarcinoma
VAL401 was originally developed for treating lung cancer. VAL401 completed
an exploratory Phase II trial in late-stage cancer patients in 2017. The
data indicated that some patients treated with VAL401 benefited from an
improvement in quality of life, particularly in measures of pain, nausea,
anxiety and insomnia; and a statistically significant improvement in overall
survival from time of diagnosis when compared to case matched control patients
from the same clinic. Following discussions with clinical key opinion
leaders, it was suggested that patients with pancreatic cancer could derive
great benefit from a product like VAL401 due to improvements to severe
abdominal pain, lack of appetite and nausea related to the disease.
ValiRx continues to seek partners to advance VAL401 into the next stages of
development and has engaged an external business development agency to assist
in identifying and approaching potential partners.
BC201 in Covid-19
BC201 uses the peptide ingredient of VAL201 to diminish the excessive immune
response and consequently reduce severe symptoms of Covid-19.
The theoretical action of the peptide is two-fold: by blocking the Androgen
Receptor mediated activity of SRC Kinase, the peptide down-regulates the
expression of TMPRSS2 a transmembrane protein believed to be required for
Coronavirus cell entry; and by directly dampening the immune response. This
latter mechanism has potential for use against sepsis and autoimmune
conditions in addition to the current Covid-19 programme of work.
On 2 June 2020, the Company announced that it had entered into a collaboration
agreement with Oncolytika Limited and Black Cat Bio Limited to consider the
potential for VAL201 to develop BC201.
ValiRx provides samples of VAL201 to enable the testing programme and access
to the clinical data but has no commitment to support the project
financially. Subject to a successful outcome, ValiRx will receive 40% of any
licensing income generated by the project.
Evaluation Projects
Kings College London, triple negative breast cancer
Successfully completing the Evaluation Stage, this peptide drug candidate will
now be licensed into a subsidiary company of ValiRx in order to progress
through preclinical development. Terms were negotiated at the time of
entering the evaluation and are now being finalised to enable the in-license
to be completed.
Hokkaido University, endometrial, pancreatic and bile duct cancers
This peptide-based programme targets a novel mechanism of action, binding a
target that is identified as being over-expressed in endometrial, pancreatic
and bile duct cancers. A programme of work is underway to ensure that the
peptide can be synthesised to industry standards using industry standard
techniques; formulated to access the protein target; that the biological
activity is as expected, with sufficient anti-cancer activity within the safe
dosing limits; and whether the range of cancer (or other disease) types can be
expanded.
Barcelona University, uterine and pancreatic cancers
This peptidomimetic drug candidate targets a novel binding pocket of KRAS, a
protein that is well recognised to be important in cancer cell processes. A
programme of work is underway to confirm the lead optimisation data and
mechanism of action through a series of in silico and in vitro techniques; to
synthesise and standardise the drug candidate molecule; to confirm the
anti-cancer activity and safety profile; and to assess whether there is scope
to expand the range of diseases to be targeted for treatment by the candidate.
Dr S J Dilly
30 August 2022
ValiRx Plc
Consolidated statement of comprehensive income
Six months ended Six months ended Year ended
Note 30 June 30 June 31 December
2022 2021 2021
(unaudited) (unaudited) (audited)
£ £ £
Continuing operations
Other operating income - 702 26,952
Research and development (200,531) (166,500) (303,789)
Administrative expenses (611,370) (618,228) (1,216,391)
Share-based payment charge (261,052) - (184,611)
Operating loss (1,072,953) (784,026) (1,677,839)
Finance costs (1,831) (1,408) (2,765)
Loss before income taxation (1,074,784) (785,434) (1,680,604)
Income tax credit 2 70,000 35,000 133,413
Loss on ordinary activities after taxation (1,004,784) (750,434) (1,547,191)
Non-controlling interests 12,303 7,256 28,979
Loss for the period and total comprehensive income attributable to owners of (992,481) (743,178) (1,518,212)
the parent
Loss per share - basic and diluted
From continuing operations 3 (1.53)p (1.14)p (2.34)p
ValiRx Plc
Consolidated statement of financial position
As at 30 June 31 December
2022 2021 2021
(unaudited) (unaudited) (audited)
£ £ £
ASSETS
NON-CURRENT ASSETS
Goodwill 1,602,522 1,602,522 1,602,522
Intangible assets 1,007,770 1,233,184 1,108,116
Property, plant and equipment - - -
Right-of-use assets 9,278 17,136 13,278
2,619,570 2,852,842 2,723,916
CURRENT ASSETS
Trade and other receivables 79,291 27,414 72,925
Tax receivable 203,413 35,000 133,413
Cash and cash equivalents 97,699 1,239,035 593,672
380,403 1,301,449 800,010
TOTAL ASSETS 2,999,973 4,154,291 3,523,926
SHAREHOLDERS' EQUITY
Share capital 9,669,995 9,669,995 9,669,995
Share premium account 24,519,456 24,401,856 24,490,618
Merger reserve 637,500 637,500 637,500
Reverse acquisition reserve 602,413 602,413 602,413
Share option reserve 723,433 484,088 491,219
Retained earnings (33,284,988) (31,606,191) (32,292,507)
2,867,809 4,189,661 3,599,238
Non-controlling interest (197,170) (163,144) (184,867)
TOTAL EQUITY 2,670,639 4,026,517 3,414,371
LIABILITIES
NON-CURRENT LIABILITIES
Borrowings 28,056 40,473 35,654
Lease liabilities 2,486 9,576 5,681
30,542 50,049 41,335
CURRENT LIABILITIES
Trade and other payables 281,955 60,506 50,835
Borrowings 9,747 9,527 9,627
Lease liabilities 7,090 7,692 7,758
298,792 77,725 68,220
TOTAL LIABILITIES 329,334 127,774 109,555
TOTAL EQUITY AND LIABILITIES 2,999,973 4,154,291 3,523,926
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 2022 9,669,995 24,490,618 (32,292,507) 637,500 491,219 602,413 (184,867) 3,414,371
Loss for the period - - (992,481) - - - (12,303) (1,004,784)
Lapse of share warrants - 28,838 - - (28,838) - - -
Share-based payment movement - - - - 261,052 - - 261,052
Balance at 30 June 2022 9,669,995 24,519,456 (33,284,988) 637,500 723,433 602,413 (197,170) 2,670,639
Unaudited
Balance at 1 January 2021 9,669,828 24,380,356 (30,919,728) 637,500 540,803 602,413 (155,888) 4,755,284
Loss for the period - - (743,178) - - - (7,256) (750,434)
Issue of shares 167 21,500 - - - - - 21,667
Lapse of share options - - 56,715 - (56,715) - - -
Balance at 30 June 2021 9,669,995 24,401,856 (31,606,191) 637,500 484,088 602,413 (163,144) 4,026,517
Audited
Balance at 1 January 2021 9,669,828 24,380,356 (30,919,728) 637,500 540,803 602,413 (155,888) 4,755,284
Loss for the year - - (1,518,212) - - - (28,979) (1,547,191)
Issue of shares 167 21,500 - - - - - 21,667
Lapse of share options - 88,762 145,433 - (234,195) - -
Share-based payment movement - - - - 184,611 - - 184,611
Balance at 31 December 2021 9,669,995 24,490,618 (32,292,507) 637,500 491,219 602,413 (184,867) 3,414,371
ValiRx Plc
Consolidated cash flow statement
Year ended
Six months ended 30 June 31 December
2022 2021 2021
(unaudited) (unaudited) (audited)
£ £ £
Cash flows from operating activities
Operating loss (1,072,953) (784,026) (1,677,839)
Amortisation of intangible fixed assets 102,850 104,843 221,072
Depreciation of right-of-use assets 4,000 3,859 7,717
(Increase)/decrease in receivables (6,366) 39,321 (6,190)
Increase/(decrease) in payables within one year 231,120 (50,836) (60,507)
Share option charge 261,052 - 184,611
Net cash outflows from operations (480,297) (686,839) (1,331,136)
Tax credit received - 71,346 71,346
Interest paid (1,702) (701) (782)
Net cash outflow from operating activities (481,999) (616,194) (1,260,572)
Cash flows from investing activities
Purchase of intangible fixed assets (2,504) (8,839) -
Net cash outflow from investing activities (2,504) (8,839) -
Cash flows from financing activities
Share issue - 21,667 21,667
Repayment of lease liabilities (4,500) (4,500) (9,000)
Bank loan (6,970) - (5,324)
Net cash (used in)/generated from financing activities (11,470) 17,167 7,343
Net decrease in cash and cash equivalents (495,973) (607,866) (1,253,229)
Cash and cash equivalents at start of period 593,672 1,846,901 1,846,901
Cash and cash equivalents at end of period 97,699 1,239,035 593,672
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 financial information for the six months ended 30 June 2022 and
2021 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 2021 has been
derived from the audited financial statements for that period. A copy of those
statutory financial statements for the year ended 31 December 2021 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 2022 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 2022 and which are also consistent with those set out in
the statutory accounts of the Group for the year ended 31 December 2021.
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
2022 2021 2021
(unaudited) (unaudited) (audited)
£ £ £
United Kingdom corporation tax at 20%
Current period - R & D Tax credit (70,000) (35,000) (133,413)
Income tax credit (70,000) (35,000) (133,413)
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
2022 2021 2021
(unaudited) (unaudited) (audited)
Basic: £ £ £
Loss for the financial period (1,004,784) (750,434) (1,547,191)
Non-controlling interest 12,303 7,256 28,979
(992,481) (743,178) (1,518,212)
Weighted average number of shares 65,049,156 65,004,957 65,004,957
Loss per share (1.53)p (1.14)p (2.34)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.
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 (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END IR BLGDIBXXDGDGRecent news on ValiRx
See all newsREG - ValiRx PLC - Directorate Changes
AnnouncementREG - ValiRx PLC - Evaluation Agreement with Imperial College London
AnnouncementREG - ValiRx PLC - Board Re-structuring and update on requisition
AnnouncementREG - ValiRx PLC - Shareholder Requisition Notice
AnnouncementREG - ValiRx PLC - Proposed Appointment of Non-Executive Director
Announcement