REG - ValiRx PLC - Annual Report, AGM Notice & Director Resignation
07/06/2022 16:45
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RNS Number : 0482O ValiRx PLC 07 June 2022
7 June 2022
ValiRx PLC ("ValiRx" or the "Company")
Full Year Results, Notice of AGM and Director Resignation
London, UK - ValiRx Plc (AIM: VAL), a life science company focusing on
early-stage cancer therapeutics and women's health, announces its audited
results for the year ended 31 December 2021.
Highlights
Operational Highlights:
· Completion of analysis and regulatory required activities on the
VAL201 clinical trial
· Signed Letter of Intent to sub-license VAL201 to TheoremRx Inc.
· Evaluation agreements signed for three new pre-clinical projects (1
post-period).
· Evolution and presentation of the strategy to create a revenue
generating translational Contract Research Organisation.
Financial Highlights:
· Research and developments costs of £303,789 for the year ended 31
December 2021 as compared to £230,115 in 2020, an increase of £73,674.
· Administrative expenses of £1,216,391 (2020: £1,276,619 before loss
on disposal of intangible assets of £154,968) for the year ended 31 December
2021 a decrease of £60,228.
· Total comprehensive loss for the year ended 31 December 2021 of
£1,518,212 (2020: £1,443,248) and a loss per share of 2.34p (2020: 3.81p
loss per share).
· Cash balance at 31 December 2021 of £593,672 (2020: £1,846,901).
The Company's Annual General Meeting ("AGM") will be held at 11:00am on 30
June 2022 at the offices of DAC Beachcroft LLP at The Walbrook Building, 25
Walbrook, London EC4N 8AF. A copy of the Company's annual report and accounts,
together with the Notice of AGM, will today be posted to all shareholders and
will shortly be available on the Company's website www.valirx.com.
The Company also announces that Kevin Alexander has informed the Board that he
will stand down as a Non-executive Director of the Company at the AGM.
Suzanne Dilly, ValiRx's CEO, commented:
"The evolution of our strategy during 2021 to focus on pre-clinical
development both in our own pipeline and as a service to the broader industry
represents a turning point in ValiRx's activities. The work completed during
2021 provides a strong foundation from which we can continue to work towards
building a sustainable, high growth business"
Kevin Cox, ValiRx Chairman, commented:
"On behalf of the Board, I would like to thank Kevin Alexander for his
contribution to ValiRx during his tenure as a director. He has successfully
shepherded the Company through some significant changes and has provide me
with expert guidance. I wish him every success in his future endeavours."
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.
For more information, please contact:
ValiRx plc Tel: +44 (0) 2476 796496
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 088
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. www.valirx.com/ (http://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 Report for the year ended 31 December 2021
2021 was a year of continued strategy evolution and the transition of ValiRx
away from clinical development towards a pre-clinical development company with
a dual purpose to progress pre-clinical collaborative projects and develop our
revenue generating tCRO (translational Contract Research Organisation). We see
this as a continuation of our theme of 'connected innovation' with the tCRO
supporting the collaborative projects both financially and scientifically.
The company has made significant progress across three fronts through 2021:
· out-licencing of clinical assets (Letter of
Intent (LoI) to sub-license VAL201, active marketing of VAL401)
· building a pre-clinical pipeline of novel
technologies in cancer and Women's Health (three projects under evaluation)
· creating a revenue generating and profitable tCRO
We were very pleased to sign the LoI for sub-licencing of VAL201 to TheoremRx
Inc, a company we believe will bring the right level of expertise to progress
the compound through later stage clinical trials. We also see TheoremRx as a
prospective partner for assets in our pre-clinical pipeline. We continue to
support TheoremRx in their scientific activities and look forward to a
successful fund raise in the near future.
The interest in our novel approach to the translation of academic science has
been particularly encouraging, and we are now engaging with a wide range of
international institutions to identify new projects. The experience we have
gained through working with academia further exemplified the need to bring
industrial thinking to the challenges of technology translation, and
illustrated the importance of collecting pre-clinical data that improves
understanding of the underlying biology of new treatments. We believe the
adoption of VAL301 into our pre-clinical pipeline will serve as an exemplar of
our approach to pre-clinical development and provide a template for future
studies.
A combination of factors, including the need for high-quality data generation,
data analysis and interpretation, together with our experience of
out-sourcing, led to the realisation that a new approach to pre-clinical
development would benefit our internal collaborative pipeline and provide an
opportunity to generate revenue by offering similar advanced services to the
wider biopharmaceutical community. The outcome of this is our strategy to
create a new type of CRO, focused on accelerating the process of translation,
a tCRO.
The transition of our strategy has been actively supported by Cenkos and our
other advisors. We are pleased to have been able to benefit from their
expertise and extensive relationships with institutional investors, which has
led to a broadening of our investor base and ongoing support in building value
in ValiRx for the benefit of all shareholders.
Kevin Cox
Chairman
6 June 2022
Chief Executive's Report for the year ended 31 December 2021
2021 was a busy year. For ValiRx, 2021 was a year to consolidate the stability
gained over the previous twelve months, to draw to a close the outstanding
clinical activities on the legacy assets, and to further evolve and commence
implementation of our new strategic direction.
During 2021 we completed the evaluation of our first new pre-clinical project,
KTH222 from Kalos therapeutics, but on reviewing the data and commercial
prospects decided that was not sufficiently aligned with our ambitions. We
terminated the agreement and have no further input or interest in this
programme as announced on 27 May 2021. Our search for new preclinical projects
continued.
Seeking projects in both oncology and diseases associated with Women's Health
has led us to the realisation that while there is a wealth of early-stage
oncology research coming out of universities, there is comparatively less in
Women's Health.
Our conversations with universities have encompassed institutions from across
the world and we were delighted to have confirmed evaluation agreements
entered with both a London University, with a candidate for triple negative
Breast Cancer, announced on 16 September 2021, and Hokkaido University in
Japan for a programme for endometrial, pancreatic and bile duct cancers
announced on 16 December 2021. Post-period we have also confirmed our
signature of an evaluation agreement with Barcelona University in Spain for a
KRAS project against uterine and pancreatic cancers announced 10 February
2022.
The global reach of our scientific reviews ensures that we are able to see a
wealth of project opportunities and to seek those that really match our
criteria and expertise.
These projects will be progressed throughout 2022 and if the evaluations are
successful, the projects will enter full license agreements with dedicated
subsidiary companies of ValiRx.
During 2021 substantial progress was also made towards partnering and moving
on from our clinical stage projects. In January 2021, we submitted the
Clinical Study Report from the clinical trial of VAL201 and moved to a stage
of further analysis of the data and commercial development. Further analysis
has been completed from a commercial viewpoint of considering the data with
independent Key Opinion Leaders and an expert team on valuation benchmarking.
Further scientific analysis has been carried out in collaboration with
Physiomics, as announced on 15 February 2021, who have been considering the
clinical data in conjunction with the historic preclinical data and the newly
generated pre-clinical data generated across the VAL301 and BC201 projects.
Commercial development also advanced for VAL201 throughout the year,
culminating in the signature of the Letter of Intent with TheoremRx Inc to
sub-license the oncology use of the VAL201 peptide, announced on 2 November
2021. This detailed that ValiRx would receive near term payments and
milestones of $2M USD with a total of $61M USD after successful launch to the
market for the treatment of prostate cancer. $37M USD is available in
milestones for each additional oncology indication developed. A further
announcement on the VAL201 sub-license was made on 20 December 2021 confirming
that the license from Cancer Research technology to ValiRx for VAL201 had been
updated to align with the TheoremRx expectations.
Corporate progress has continued, with Cenkos Securities announced as our new
corporate broker on 25 August 2021, and substantial work has been carried out
between Cenkos and ValiRx in the intervening period to ensure that the
evolving strategy is ready for launch and providing support across all
corporate functions.
Outlook
2021 enabled us to continue building foundations of durability within ValiRx.
Completing the VAL201 clinical trial, entering the Letter of Intent with
TheoremRx to sub-license VAL201. The foundations of our renewed strategy were
also strengthened with two evaluation agreements being entered for new
pre-clinical projects and a further evaluation entered post period.
During 2022 we intend to build on these positions of strength by further
developing our pipeline of new pre-clinical projects by bringing further
assets into Evaluation, but also, as the first projects complete initial
evaluation we anticipate at least one of these programmes moving to a full
license and entering an appropriate subsidiary company during the year.
Our research strategy mitigates risks by ensuring that multiple programmes are
assessed in a rolling programme of in-licensing, with new projects arriving
across a range of oncology and disease associated with Women's Health and
varying modalities of small molecules and synthetic peptide drug candidates,
creating a risk balanced portfolio. Our strategy to run extensive scientific
and commercial evaluations under resource-limited agreements provides further
confidence before full in-licensing is contemplated.
Within 2022, ValiRx also intends to initiate the strategy to build our
Translational Contract Research Organisation (tCRO), offering the Connected
Innovation concept as a service to the wider industry. By acquiring our own
laboratory facility and using that as the baseline for integrating further
technologies and services, we will be able to present ourselves as a revenue
generating, expert facility for high quality, high impact science.
We anticipate that the build phase of the tCRO will commence in 2022, and will
require additional personnel to be recruited into ValiRx to ensure the breadth
of acquisition and integration skills are available to the Company. Further
project management expertise may also be required to support the subsidiary
companies developing the in-house pipeline should the evaluation projects
prove successful.
Financial overview
Our financial results show the total comprehensive loss for the year ended 31
December 2021 of £1,518,212 (2020: £1,443,248) and a loss per share of 2.34p
(2020: Loss - 3.81p).
Research and developments costs were £303,789 for the year ended 31 December
2021 as compared to £230,115 in 2020, an increase of £73,674. In addition,
total wage costs of £216,237 (2020: £118,754) were expended on research and
development during the year.
Administrative expenses were £1,216,391 (2020: £1,276,619 before loss on
disposal of intangible assets of £154,968) for the year ended 31 December
2021 a decrease of £60,228.
I would like to thank the staff and Board members for all their contributions
and shareholders for their continued support. We look forward to implementing
our evolving strategy while continuing to maintain our culture of openness and
transparency to all stakeholders.
Dr S J Dilly
Chief Executive Officer
6 June 2022
Consolidated Statement of Profit or Loss and Other Comprehensive Income for
the year ended 31 December 2021
2021 2020
£ £
CONTINUING OPERATIONS
Other operating income 26,952 11,077
Research and development (303,789) (230,115)
Administrative expenses (1,216,391) (1,431,587)
Share-based payment charge (184,611) -
OPERATING LOSS (1,677,839) (1,650,625)
Write back of equity swap debt - 122,000
Finance costs (2,765) (14,880)
LOSS BEFORE INCOME TAX (1,680,604) (1,543,505)
Income tax credit 133,413 75,182
LOSS AFTER INCOME TAX (1,547,191) (1,468,323)
Non-controlling interest 28,979 25,075
TOTAL COMPREHENSIVE LOSS FOR THE YEAR (1,518,212) (1,443,248)
LOSS PER SHARE - BASIC AND DILUTED (2.34p) (3.81p)
Consolidated Statement of Financial Position for the year ended
31 December 2021
2021 2020
£ £
ASSETS
NON-CURRENT ASSETS
Goodwill 1,602,522 1,602,522
Intangible assets 1,108,116 1,329,188
Property, plant and equipment - -
Right-of-use assets 13,278 20,995
2,723,916 2,952,705
CURRENT ASSETS
Trade and other receivables 72,925 66,735
Tax receivable 133,413 71,346
Cash and cash equivalents 593,672 1,846,901
800,010 1,984,982
TOTAL ASSETS 3,523,926 4,937,687
EQUITY
SHAREHOLDERS' EQUITY
Called up share capital 9,669,995 9,669,828
Share premium 24,490,618 24,380,356
Merger reserve 637,500 637,500
Reverse acquisition reserve 602,413 602,413
Share option reserve 491,219 540,803
Retained earnings (32,292,507) (30,919,728)
3,599,238 4,911,172
Non-controlling interests (184,867) (155,888)
TOTAL EQUITY 3,414,371 4,755,284
LIABILITIES
NON-CURRENT LIABILITIES
Borrowings 35,654 44,486
Lease liabilities 5,681 13,439
41,335 57,925
CURRENT LIABILITIES
Trade and other payables 50,835 111,342
Borrowings 9,627 5,514
Lease liabilities 7,758 7,622
68,220 124,478
TOTAL LIABILITIES 109,555 182,403
TOTAL EQUITY AND LIABILITIES 3,523,926 4,937,687
Consolidated Statement of Changes in Equity for the year ended
31 December 2021
Share capital Share premium Merger reserve Reverse acquisition reserve Share-based payment reserve Non-controlling interest Retained earnings Total
£ £ £ £ £ £ £ £
Balance at 1 January 2020 9,417,225 20,596,143 637,500 602,413 830,449 (130,813) (29,729,817) 2,223,100
Changes in equity
Loss for the year - - - - - (25,075) (1,443,248) (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 and warrants - - - - (253,337) - 253,337 -
Movement in year - (14,138) - - 14,138 - - -
Balance at 31 December 2020 9,669,828 24,380,356 637,500 602,413 540,803 (155,888) (30,919,728) 4,755,284
Changes in equity
Loss for the year - - - - - (28,979) (1,518,212) (1,547,191)
Issue of shares 167 21,500 21,667
Lapse of share options and warrants - 88,762 - - (234,195) - 145,433 -
Movement in year 184,611 184,611
Balance at 31 December 2021 9,669,995 24,490,618 637,500 602,413 491,219 (184,867) (32,292,507) 3,414,371
Consolidated Statement of Cash Flows for the year ended 31 December 2021
2021 2020
Notes £ £
Cash flows from operations
Cash outflow from operations 1 (1,331,136) (2,200,088)
Interest paid (782) (6,252)
Tax credit received 71,346 295,623
Net cash outflow from operating activities (1,260,572) (1,910,717)
Cash flows from investing activities
Proceeds from sale of intangible fixed assets - 2,000
Purchase of intangible fixed assets - (93,287)
Net cash outflow from investing activities - (91,287)
Cash flows from financing activities
Loan repayments - (80,000)
Bank loan (repayment/received) (5,324) 50,000
Repayment of lease liabilities (9,000) (2,500)
Share issue 21,667 4,132,714
Costs of shares issued - (245,675)
Net cash inflow from financing activities 7,343 3,854,539
Increase/(decrease) in cash and cash equivalents (1,253,229) 1,852,535
Cash and cash equivalents at beginning of year 2 1,846,901 (5,634)
Cash and cash equivalents at end of year 2 593,672 1,846,901
Notes to the Consolidated Statement of Cash Flows for the year ended
31 December 2021
1. RECONCILIATION OF OPERATING LOSS TO CASH GENERATED FROM OPERATIONS
2021 2020
£ £
Operating loss (1,677,839) (1,650,625)
Amortisation and impairment of intangible assets 221,072 227,338
Depreciation of right-of-use assets 7,717 2,157
Decrease in trade and other receivables (6,190) 23,348
(Decrease)/increase in trade and other payables (60,507) (957,274)
Loss on disposal of intangible fixed assets - 154,968
Share-based payments charge 184,611 -
Net cash outflow from operations (1,331,136) (2,200,088)
2. CASH AND CASH EQUIVALENTS
The amounts disclosed on the Statement of Cash Flows in respect of cash and
cash equivalents are in respect of these Statement of Financial Position
amounts:
31 December 2021 1 January 2021
£ £
Cash and cash equivalents 593,672 1,846,901
31 December 2020 1 January 2020
£ £
Cash and cash equivalents 1,846,901 (5,634)
Notes to the Consolidated Financial Statements for the year ended 31 December
2021
1. STATUTORY INFORMATION
ValiRx Plc is a company incorporated in the United Kingdom under the Companies
Act 2006, which is listed on the AIM market of the London Stock Exchange Group
Plc. The address of its registered office is Stonebridge House, Chelsmford
Road, Hatfield Heath, CM22 7BD.
The registered number of the Company is 03916791.
The principal activity of the Group is the development of oncology
therapeutics and companion diagnostics.
The presentation currency of the financial statements is the Pound Sterling
(£).
The above information has been extracted from the annual report and accounts
for the year ended 31 December 2021 and, accordingly, references and page
numbers may not be complete. Shareholders should read the report and accounts
in full which will shortly be available from the Company's website.
2. ACCOUNTING POLICIES
Basis of preparation
The Group's financial statements have been prepared in accordance with UK
adopted International Accounting Standards as they apply to the financial
statements of the Group for the year ended 31 December 2021. The Company's
financial statements have been prepared in accordance with UK adopted
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 year ended 31 December 2021 and as applied in accordance with the
provisions of the Companies Act 2006. The principal accounting policies
adopted by the Group and by the Company are set out in note 2. The Group
financial statements have been prepared under the historical cost convention
or fair value where appropriate.
Going concern
As part of their going concern review the Directors have followed the
guidelines published by the Financial Reporting Council entitled "Guidance on
the Going Concern Basis of Accounting and Reporting on Solvency Risks -
Guidance for directors of companies that do not apply the UK Corporate
Governance Code".
The Group and Parent Company are subject to a number of risks similar to those
of other development stage pharmaceutical companies. These risks include,
amongst others, generation of revenues in due course from the development
portfolio and risks associated with research, development, testing and
obtaining related regulatory approvals of its pipeline products. Ultimately,
the attainment of profitable operations is dependent on future uncertain
events which include obtaining adequate financing to fulfil the Group's
commercial and development activities and generating a level of revenue
adequate to support the Group's cost structure.
The current economic environment is challenging, and the Group has reported an
operating loss for the year. These losses will continue in the current
accounting year to 31 December 2022.
The Directors have prepared detailed financial forecasts and cash flows
looking beyond 12 months from the date of the approval of these financial
statements. In developing these forecasts, the Directors have made assumptions
based upon their view of the current and future economic conditions that are
expected to prevail over the forecast period. The Directors have concluded
that the ability of the Company to raise funds in the future represents a
material uncertainty which may cast significant doubt on the group's ability
to continue as a going concern. The Board is confident that shareholder
approval will be obtained and therefore has reasonable expectation that the
Group has adequate resources to continue in operational existence for a period
being at least the next twelve months from the date of approval of the Annual
Report and Accounts. On this basis, the Directors continue to adopt the going
concern basis in preparing these accounts. Accordingly, these accounts do not
contain any adjustments to the carrying amount of classification of assets and
liabilities that would result if the Group were unable to continue as a going
concern.
Basis of consolidation
The Group financial statements consolidate the financial statements of the
Company and all its subsidiaries ("the Group"). Subsidiaries include all
entities over which the Group has the power to govern financial and operating
policies. The existence and effect of potential voting rights that are
currently exercisable or convertible are considered when assessing whether the
Group controls another entity. Subsidiaries are consolidated from the date on
which control commences until the date that control ceases. Intra-group
balances and any unrealised gains and losses on income or expenses arising
from intra-group transactions, are eliminated in preparing the consolidated
financial statements.
On 3 October 2006, ValiRx Bioinnovation Limited ('Bioinnovation') acquired
60.28% of the issued share capital of ValiPharma Limited ('ValiPharma') in
exchange for shares in Bioinnovation. Concurrently, the Company, ("ValiRx"),
acquired the entire issued share capital of Bioinnovation in a share for share
transaction. As a result of these transactions, the former shareholders of
ValiPharma became the majority shareholders in ValiRx. Accordingly, the
substance of the transaction was that ValiPharma acquired ValiRx in a reverse
acquisition. Under IFRS 3 "Business Combinations", the acquisition of
ValiPharma has been accounted for as a reverse acquisition.
In May 2008 the Company acquired the remaining 39.72% of the issued share
capital of ValiPharma, which is now wholly owned by the Group. This
acquisition was accounted for using the acquisition method of accounting.
In November 2013 ValiSeek Limited was formed to enable the company to enter
into a joint venture agreement. The company has a 55.5% holding in the issued
share capital of ValiSeek.
3. LOSS PER SHARE
The loss and number of shares used in the calculation of loss per ordinary
share are set out below:
2021 2020
£ £
Loss for the financial period (1,547,191) (1,468,323)
Non-controlling interest 28,979 25,075
Loss attributable to owners of Parent Company (1,518,212) (1,443,248)
Basic:
Weighted average number of shares 65,004,957 37,898,019
Loss per share (2.34p) (3.81p)
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 outstanding share options and share warrants would have the effect of
reducing the loss per share and would therefore not be dilutive under IAS 33
'Earnings per Share'
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. While management believes that these
forward-looking statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be those that it
anticipates.
Factors that could cause actual results to differ materially from those in the
forward-looking statements include risks relating to unanticipated costs,
liabilities or delays; failure or delays in research and development programs;
the safety and efficacy of the Company's product candidates and the likelihood
of clinical data to be positive and of such product candidates to be approved
by the applicable regulatory authorities; unanticipated changes relating to
competitive factors in the Company's industry; risks relating to the Company's
capitalisation, resources and ownership structure, the availability of
sufficient resources for company operations and to conduct or continue planned
clinical development programs; the outcome of any legal proceedings; risks
related to the ability to correctly estimate operating expenses; risks related
to the ability to project future cash utilisation and reserves needed for
contingent future liabilities and business operations; risks related to the
changes in market prices of the Company's ordinary shares; the Company's
ability to hire and retain key personnel; changes in law or regulations
affecting the Company; international, national or local economic, social or
political conditions that could adversely affect the Company and its business;
conditions in the credit markets; risks associated with assumptions the
Company makes in connection with its critical accounting estimates and other
judgments.
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