REG - ValiRx PLC - Half-year Report
07/09/2021 07:00
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RNS Number : 9079K ValiRx PLC 07 September 2021
7 September 2021
ValiRx PLC ("ValiRx" or the "Company")
Half Year report for period to 30 June 2021 and
Investor Presentation
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 2021.
Financial Highlights
· Research and developments costs £166,500 (2020: £99,879)
· Administrative expenses £618,228 (2020: £791,866)
· Total comprehensive loss for the period of £743,178 (2020:
£805,082)
· Loss before income taxation of £785,434 (2020: £884,523)
· Loss per share from continuing operations of 1.14p (2020: Loss 4.43p)
· Cash and cash equivalents at 30 June 2021 of £1,239,035 (2020:
£258,753)
Investor Presentation
ValiRx plc is pleased to announce that Suzanne Dilly (CEO), Dr Kevin Cox
(Non-Executive Chairman) and Mark Treharne (Corporate Development
Manger) will provide a live Investor update presentation via the Investor
Meet Company platform on 28th Sep 2021 at 1:00pm BST.
The presentation is open to all existing and potential shareholders. Questions
can be submitted pre-event via your Investor Meet Company dashboard up until
9am the day before the meeting or at any time during the live presentation.
Investors can sign up to Investor Meet Company for free and add to
meet ValiRx plc via:
https://www.investormeetcompany.com/valirx-plc/register-investor
(https://eu-west-1.protection.sophos.com?d=investormeetcompany.com&u=aHR0cHM6Ly93d3cuaW52ZXN0b3JtZWV0Y29tcGFueS5jb20vdmFsaXJ4LXBsYy9yZWdpc3Rlci1pbnZlc3Rvcg==&i=NTdmYjZhY2YwMGFiZGYxNGYzOTNjYzlm&t=bEY3djlyVUVPVDJMZ3JKbG8rV1BncmNDVUtHM2VNbUJlNVpUVmEwTG9uVT0=&h=13e4490b52594708bcf22955d098e738)
Investors who already follow ValiRx plc on the Investor Meet Company
platform will automatically be invited.
This announcement contains inside information for the purposes of Article 7 of
EU Regulation 596/2014.
*** ENDS ***
For more information, please contact:
ValiRx plc Tel: +44 (0) 2476 796 496
www.valirx.com (http://www.valirx.com)
Dr Suzanne Dilly, CEO Suzanne.Dilly@valirx.com
Cairn Financial Advisers LLP (Nominated Adviser) Tel: +44 (0) 20 7213 0880
Liam Murray/Jo Turner/Ludovico Lazzaretti
Cenkos Securities Limited (Broker) Tel: +44 (0) 20 7397 8900
Russell Kerr/Michael Johnson (Sales)
Callum Davidson/Giles Balleny (Corporate Finance)
Notes for Editors
About ValiRx
ValiRx accelerates the development of treatments in oncology and women's
health to improve patient lives. We provide the scientific, financial and
commercial framework towards enabling rapid translation of innovative science
into clinical development.
With our extensive and proven experience in research and drug development, we
select and incubate promising novel drug candidates and guide them through an
optimised process of development, from pre-clinical studies to clinic and
investor-ready assets.
Integrating science and business
We connect diverse disciplines across scientific, technical and commercial
domains, with the aim of achieving a more streamlined, less costly, drug
development process. We work closely with our selected collaborators and
leverage the combined expertise required for science to advance.
Lead candidates from our portfolio are out-licensed or partnered with
investors through ValiRx subsidiary companies for further clinical development
and commercialisation. https://www.valirx.com/ (https://www.valirx.com/)
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
The first half of 2021 has been a period of intense activity for ValiRx,
involving discussions with potential partners for out-licensing our clinical
projects and in-licensing preclinical projects. While we have confidence
that these will result in a beneficial outcome, none of these have reached the
stage where they can be announced. We know this lack of news can be
frustrating for shareholders but we take the view that announcements should be
substantive and not just about making a noise.
The Company remains stable and our cash position is strong and sufficient to
support our therapeutic development strategy.
The last six months has also been a period of learning for ValiRx. Learning
how to maintain momentum with the effects of Covid still restricting normal
business processes; learning how best to identify and progress new early-stage
drug development projects with academia; and learning of the gaps in knowledge
and capability that generally exist in the development of novel and innovative
treatments particularly in Women's Health.
We are confident that ValiRx's proposition of 'connected innovation' can add
value to the earlier development of novel compounds in our chosen markets. Our
strategy is evolving and, with an increasing focus on Women's Health, we
believe our growth can be enhanced through targeted investments that build on
the skills and capabilities we already offer to prospective partners.
We have retained Cenkos as our broker to work with us on this process. We
believe their breadth of skills will assist in delivering the strategy and
securing the necessary funding for investment in value-adding capabilities
that both accelerate the translation of women's health treatments and deliver
value to all our shareholders.
I look forward to continued progress with our existing projects and the
opportunity to build on our concept of connected innovation.
Kevin Cox, Non-executive Chairman
7 September 2021
CEO's Statement
I am pleased that we are now building from a position of financial stability
and look to build growth in value through the acquisition of new assets to
expand and progress our pipeline of therapeutic candidates in both Women's
Health and Oncology.
We are looking to establish a greater foothold in the arena of Women's Health,
building on the existing overlap in oncology. Developing therapeutics in
Women's Health brings some specific and varied challenges and we believe that
enabling innovative new therapeutic candidates and technologies to address
these challenges provides an opportunity for ValiRx to provide much needed
therapeutics alongside company growth.
We continue to liaise with a wide range of university departments and biotech
companies to assess the development of early-stage therapeutic programmes to
incorporate into our translational pipeline. This translation from academic
project to industry-ready drug candidate, and the translation from preclinical
studies into clinical testing are crucial activities to de-risk development
programmes and make assets attractive for external investors and industry
partners. The opportunity for academic innovators to stay involved with
their science, and develop their own capabilities, has been acknowledged as an
attractive differentiating feature of our approach to innovation. Indeed, we
believe it is crucial to maintain continuity of scientific understanding for
successful delivery of our projects.
Our conversations with university representatives have highlighted some of the
challenges faced by academic innovators during the commercialisation process,
demonstrating a need for support earlier in development than initially
anticipated. As we consider how best to support these programmes to fulfil a
much-needed solution for better therapeutics, we are also considering whether
specialised techniques and capabilities could be developed to improve
translation.
This evolving strategy sits alongside the work we have been progressing on
both the pipeline and existing projects, as summarised below.
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.
Developments after the VAL201-001 clinical trial
Since the results of the VAL201 Phase I/II clinical trial were released in
2020, several further analyses and commercial development activities have been
taking place.
In February 2021, ValiRx entered into a new agreement with Physiomics PLC
(AIM:PYC) ("Physiomics"), an oncology consultancy using mathematical models to
support the development of cancer treatment regimens and personalised medicine
solutions.
Under the terms of the new agreement, ValiRx will benefit from Physiomics'
experience in modelling the effects of prostate cancer treatment, as well the
use of the latest version of its Virtual Tumour™ technology, which will be
applied to derive valuable information from the additional data generated by
the completed clinical trial of VAL201. Physiomics will also support ValiRx
in modelling the use of the VAL201 peptide in endometriosis (VAL301) and
Coronavirus (BC201).
Physiomics has developed a quantitative systems pharmacology approach that
uses pre-clinical and clinical data to model the activity of a drug
candidate. This data can be used to explore the mechanism of action, disease
impact and optimal dosing strategies.
The data from the VAL201 Phase I/II clinical trial has been considered by
independent experts who have helped to define the likely patient populations
for the next clinical trial, and to clarify the market landscape.
VAL201 is under license to ValiRx from Cancer Research Technology (a division
of Cancer Research UK) and they are supporting the Company in negotiation with
potential licensees who will progress VAL201 into the next stages of
development if the correct commercial terms can be agreed by all parties.
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.
Currently one of our preclinical pipeline products, this potential benefit
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 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.
Alongside 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 provides greater insight
into the interactions of the peptide with multiple cellular proteins which can
be applied to all disease applications being considered with the VAL201
peptide.
The Company continues to actively pursue options with other interested parties
during the period of evaluation by the Japanese company.
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.
Consequently, the next trial for VAL401, expected to be a Phase 2/3 clinical
trial, will include pancreatic cancer patients with the aim to help exemplify
both the therapeutic and palliative effects of VAL401.
As VAL401 is the reformulation of a widely used generic drug, with a
well-documented safety profile and targeting an underserved disease with low
survival rates, we expect regulators to have a favourable view on approval
subject to successful completion of the next clinical trial.
ValiRx continues to seek partners to advance VAL401 into the next stages of
development. Several external parties are assisting in this activity, with
Black Cat Bio seeking financing to execute a trial, and an external
development agency has been engaged to seek corporate partners.
BC201 in Covid-19
BC201 is a combination of the peptide ingredient of VAL201/VAL301 with
complementary active components to dampen this 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 is postulated to
down-regulate the expression of TMPRSS2 a transmembrane protein believed to be
required for Coronavirus cell entry; and by directly dampening the immune
response.
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 be used in conjunction with other components for
treatment of patients suffering a hyperimmune response after Coronavirus
SARS-CoV2 infection.
Black Cat Bio Limited 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.
Preclinical experiments to date have included: measuring the impact of the
expression of receptor TMPRSS2, which is important for the virus to enter the
cell after treatment; activity of Neutrophil Extracellular Traps after
stimulation and treatment by the peptide; and viral infectivity/replication.
Suzanne Dilly, Chief Executive Officer
7 September 2021
Consolidated statement of comprehensive income
Six months ended Six months ended Year ended
Note 30 June 30 June 31 December
2021 2020 2020
(unaudited) (unaudited) (audited)
£ £ £
Continuing operations
Research and development (166,500) (99,879) (230,115)
Administrative expenses (618,228) (791,866) (1,431,587)
Other income 702 10,453 11,077
Operating loss (784,026) (881,292) (1,650,625)
Discount on settlement of financial liability - - 122,000
Finance costs (1,408) (3,231) (14,880)
Loss before income taxation (785,434) (884,523) (1,543,505)
Income tax credit 2 35,000 60,000 75,182
Loss on ordinary activities after taxation (750,434) (824,523) (1,468,323)
Non-controlling interests 7,256 19,441 25,075
Loss for the period and total comprehensive income attributable to owners of (743,178) (805,082) (1,443,248)
the parent
Loss per share - basic and diluted
From continuing operations 3 (1.14)p (4.43)p (3.81)p
Consolidated statement of financial position
As at 30 June 31 December
2021 2020 2020
(unaudited) (unaudited) (audited)
£ £ £
ASSETS
NON-CURRENT ASSETS
Goodwill 1,602,522 1,602,522 1,602,522
Intangible assets 1,233,184 1,489,598 1,329,188
Property, plant and equipment - - -
Right-of-use assets 17,136 - 20,995
2,852,842 3,092,120 2,952,705
CURRENT ASSETS
Trade and other receivables 27,414 100,805 66,735
Tax receivable 35,000 351,787 71,346
Cash and cash equivalents 1,239,035 258,753 1,846,901
1,301,449 711,345 1,984,982
TOTAL ASSETS 4,154,291 3,803,465 4,937,687
SHAREHOLDERS' EQUITY
Share capital 9,669,995 9,641,009 9,669,828
Share premium account 24,401,856 21,598,766 24,380,356
Merger reserve 637,500 637,500 637,500
Reverse acquisition reserve 602,413 602,413 602,413
Share option reserve 484,088 992,252 540,803
Retained earnings (31,606,191) (30,534,899) (30,919,728)
4,189,661 2,937,041 4,911,172
Non-controlling interest (163,144) (150,254) (155,888)
TOTAL EQUITY 4,026,517 2,786,787 4,755,284
LIABILITIES
NON-CURRENT LIABILITIES
Borrowings 40,473 50,000 44,486
Lease liabilities 9,576 - 13,439
50,049 50,000 57,925
CURRENT LIABILITIES
Trade and other payables 60,506 772,897 111,342
Borrowings 9,527 193,781 5,514
Lease liabilities 7,692 - 7,622
77,725 966,678 124,478
TOTAL LIABILITIES 127,774 1,016,678 182,403
TOTAL EQUITY AND LIABILITIES 4,154,291 3,803,465 4,937,687
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 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 warrants - - 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
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 movement - (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
Audited
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 year - - (1,443,248) - - - (25,075) (1,468,323)
Issue of shares 252,603 3,993,579 - - - - - 4,246,182
Costs of shares issued - (245,675) - - - - - (245,675)
Exercise of warrants - 50,447 - - (50,447) - - -
Lapse of share options - - 253,337 - (253,337) - -
Share-based payment movement - (14,138) - - 14,138 - - -
Balance at 31 December 2020 9,669,828 24,380,356 (30,919,728) 637,500 540,803 602,413 (155,888) 4,755,284
Consolidated cash flow statement
Year ended
Six months ended 30 June 31 December
2021 2020 2020
(unaudited) (unaudited) (audited)
£ £ £
Cash flows from operating activities
Operating loss (784,026) (881,292) (1,650,625)
Amortisation of intangible fixed assets 104,843 83,723 227,338
Depreciation of right-of-use assets 3,859 - 2,157
Decrease/(increase) in receivables 39,321 (10,722) 23,348
(Decrease)/increase in payables within one year (50,836) (325,019) (957,274)
Loss on disposal of intangible assets - 118,000 154,968
Net cash outflows from operations (686,839) (1,015,310) (2,200,088)
Tax credit received 71,346 - 295,623
Interest paid (701) (3,231) (6,252)
Net cash outflow from operating activities (616,194) (1,018,541) (1,910,717)
Cash flows from investing activities
Purchase of intangible fixed assets (8,839) (73,114) (93,287)
Proceeds from sale of intangible assets - 2,000 2,000
Net cash outflow from investing activities (8,839) (71,114) (91,287)
Cash flows from financing activities
Share issue 21,667 1,400,000 4,132,714
Costs of shares issued - (95,958) (245,675)
Repayment of lease liabilities (4,500) - (2,500)
Bank loan - 50,000 50,000
Repayment of loan notes - - (80,000)
Net cash generated from financing activities 17,167 1,354,042 3,854,539
Net (decrease)/increase in cash and cash equivalents (607,866) 264,387 1,852,535
Cash and cash equivalents at start of period 1,846,901 (5,634) (5,634)
Cash and cash equivalents at end of period 1,239,035 258,753 1,846,901
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 2021 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
comparative financial information for the year ended 31 December 2020 has been
derived from the audited financial statements for that period. A copy of those
statutory financial statements for the year ended 31 December 2020 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 2021 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 2021 and which are also consistent with those set out in
the statutory accounts of the Group for the year ended 31 December 2020.
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 ended Six months ended Year ended
30 June 30 June 31 December
2021 2020 2020
(unaudited) (unaudited) (audited)
£ £ £
United Kingdom corporation tax at 19%
Current period - R & D Tax credit (35,000) (60,000) (71,346)
Prior period - R & D Tax credits - - (3,836)
Income tax credit (35,000) (60,000) (75,182)
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
2021 2020 2020
(unaudited) (unaudited) (audited)
Basic:
Loss for the financial period (750,434) (824,523) (1,468,323)
Non-controlling interest 7,256 19,441 25,075
(743,178) (805,082) (1,443,248)
Weighted average number of shares 65,004,957 18,191,261 37,898,019
Loss per share (1.14)p (4.43)p (3.81)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.
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