TIDMVAL
RNS Number : 6568X
ValiRx PLC
31 August 2022
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIODED 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 GBP2.5
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 GBP200,531 (2021: GBP166,500)
-- Administrative expenses GBP611,370 (2021: GBP618,228)
-- Share-based payment charge GBP261,052 (2021: GBPnil)
-- Total comprehensive loss for the period of GBP992,481 (2021: GBP743,178)
-- Loss before income taxation of GBP1,074,784 (2021: GBP785,434)
-- Loss per share from continuing operations of 1.53p (2021: Loss 1.14p)
-- Cash and cash equivalents at 30 June 2022 of GBP97,699 (2021:
GBP1,239,035) - GBP2.5m (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 GBP2.5m (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.
***S ***
For more information, please contact:
ValiRx plc Tel: +44 (0) 2476 796496
www.valirx.com
D r S J Dilly suzanne.dilly@valirx.com
V Formation (Public Relations) +44 (0) 115 787 0206
www.vformation.biz
Lucy Wharton - Senior PR Executive
Sue Carr - Director lucy@vformation.biz
sue@vformation.biz
Cairn Financial Advisers LLP (Nominated Tel: +44 (0) 20 7213
Adviser) 0880
Liam Murray/Jo Turner/Ludovico Lazzaretti
Cenkos Securities Limited (Joint Tel: +44 (0) 207397 8900
Broker)
Russell Kerr / Michael Johnson (Sales)
Callum Davidson / Giles Balleny (Corporate
Finance)
Turner Pope Investments (TPI) Limited Tel: +44 (0) 20 3657 0050
(Joint Broker)
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 YEARED 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 GBP2.5m (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 YEARED 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 Six months
ended ended Year ended
Note 30 June 30 June 31 December
------------------------ -------------------------- ------------------
2022 2021 2021
(unaudited) (unaudited) (audited)
GBP GBP GBP
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 the parent (992,481) (743,178) (1,518,212)
======================== ========================== ==================
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)
GBP GBP GBP
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-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
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)
GBP GBP GBP
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)
GBP GBP GBP
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: GBP GBP GBP
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 . 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.
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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IR BLGDIBXXDGDG
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