TIDMVAL
RNS Number : 2736K
ValiRx PLC
24 August 2023
VALIRX PLC
("ValiRx", "the Company" or "the Group")
HALF YEARLY REPORT FOR THE PERIODED 30 JUNE 2023
London, UK., 2023 : ValiRx Plc (AIM : VAL), a life science
company, focussing on early-stage cancer therapeutics and women's
health, , today announces its Half Yearly Report for the period
ended 30 June 2023 and provides an update on significant
post-period events.
HIGHLIGHTS
Operational
-- Launch of wholly owned subsidiary, Inaphaea BioLabs Limited
("Inaphaea"), with post-period event of first external sales
-- Acquisition of scientific assets of Imagen Therapeutics Limited ("Imagen Therapeutics")
-- Signature of collaboration service agreements for Inaphaea
with Physiomics PLC ("Physiomics"), OncoBone Limited ("OncoBone"),
and post-period with Agility Life Sciences Limited ("Agility")
-- Expansion of evaluation agreement with the University of
Barcelona to enable study of a second KRAS project and to establish
standard terms for future agreements
Financial
-- Research and developments costs GBP207,721 (2022: GBP200,531)
-- Administrative expenses GBP925,866 (2022: GBP611,370)
-- Share-based payment charge GBP17,733 (2022: GBP261,052)
-- Total comprehensive loss for the period of GBP1,035,424 (2022: GBP992,481)
-- Loss before income taxation of GBP1,152,325 (2022: GBP1,074,784)
-- Expenditure in H1 includes one-off costs associated with the
set-up of Inaphaea and acquisition of Imagen assets
-- Loss per share from continuing operations of 1.03p (2022: Loss 1.53p)
-- Cash and cash equivalents at 30 June 2023 of GBP 891,246 (2022: GBP97,699)
-- Post period receipt of the FY22 R&D tax credits of GBP192,671 (2021: GBP133,413)
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
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) 20 7397 8900
Broker)
Dale Bellis / 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 2023
Having shifted the tCRO(R) strategy towards a build-and-buy
approach in the latter part of 2022, the primary activity in the
first half of 2023 has been to establish in-house, cell-based
testing capabilities to support both our collaborative development
pipeline and generate income through third-party business.
The outcome of this has been the launch of a wholly owned
subsidiary, Inaphaea, which has been set up and become operational
at a fraction of the cost of acquiring a company with existing
infrastructure. The business is already developing a strong
pipeline of potential customers and successfully completed its
first deal quickly after launch, a testament to the hard work of
all those involved in the lab set up, business development and
operations.
The launch of Inaphaea and subsequent successful acquisition of
the scientific assets of Imagen Therapeutics was made possible
through the funds raised in 2022 and the placing and broker offer
in January 2023.
Following its launch, Inaphaea has continued to build the
tCRO(R) concept by developing collaborations with companies that
provide complementary capabilities, such as Physiomics, Oncobone
and, more recently, Agility Life Sciences. Their services, when
aligned with the cell-based testing of Inaphaea, present a very
compelling service offering to companies seeking to translate
preclinical assets into clinical candidates, including ValiRx's own
development pipeline.
The ValiRx R&D team are continuing to build a risk-balanced
portfolio of novel science in oncology and women's health, with a
number of potential candidates in late-stage discussions. Building
and funding a strong portfolio of evaluation projects also means
that not all the science will meet our rigorous selection criteria,
as evidenced by the conclusion of the Hokkaido project as announced
on 16 June 2023. The benefit of such decisions is that funds can be
re-directed towards projects that may have a greater chance of
success and value creation for shareholders, such as the expansion
of the Barcelona evaluation agreement to investigate new drug
candidates in oncology, as announced on 7 June 2023.
The continued progress of ValiRx during the first half of 2023
has been encouraging. However, this has been against the backdrop
of challenging market conditions, with the biotechnology sector in
general suffering from a change in sentiment in a post-Covid world.
Although there are expectations of additional income from Inaphaea,
the Company will be managing its resources in the most efficient
manner to maintain momentum over the next period.
Kevin Cox
Chairman
24 August 2023
CHIEF EXECUTIVE OFFICER'S STATEMENT FOR THE HALF YEARED 30 JUNE
2023
The key event for ValiRx in the first half of 2023 was the
launch of our service-providing subsidiary, Inaphaea. A wholly
owned subsidiary, Inaphaea is intended to be central to our designs
for a translational Contract Research Organisation (tCRO(R))
offering capabilities to the ValiRx internal pipeline projects as
well as to third party, fee-for-service clients.
Initially offering a cell-based assay capability, Inaphaea's
intention is to incorporate and validate a suite of in vitro and in
silico testing technologies to enhance the central ethos of
building strong preclinical evidence to de-risk the later stages of
drug development. Focussing on reproducibility, translatability
(suitability for later and clinical stages of development), and
humanisation of preclinical science, Inaphaea's tCRO(R) offering is
intended to occupy a high value segment of the market.
In June 2023, the establishment of Inaphaea's initial service
offering was substantially accelerated by the acquisition of the
scientific assets of Imagen Therapeutics. These assets included
several high specification items of equipment, providing Inaphaea
with capabilities around partial automation and live imaging during
cell-based assays. Additionally, a biobank of patient derived
cancer cells, consisting of over 500 unique samples was included,
enabling Inaphaea to take the first step towards improving
humanisation and relevance of the cell-based assays on offer. Soon
after, the first external customer was signed up, with an initial
multi-stage, defined project taking place between July and
September.
In order to build out the service offering within Inaphaea,
several collaboration agreements have already been set up, with
others currently proposed and under negotiation. This includes the
collaboration with Physiomics to offer biological modelling and
advanced data analysis; with Agility to offer pre-formulation and
formulation assessments and with OncoBone to enable Inaphaea to be
incorporated into their virtual CRO offering. Inaphaea has also
successfully listed on the Scientist.com database to increase
visibility to a larger field of potential clients.
Throughout this period work has also continued to advance the
ValiRx internal pipeline of research, with current projects
progressing to expected milestones, and new projects sought. These
are detailed individually below.
Evaluation Projects:
Hokkaido University
The project under Evaluation from Hokkaido University completed
its evaluation period in June 2023. The data did not support the
launch of the full in-licensing process for this project at this
time, so we returned all the data to the originating academics
along with our suggestions for their further development. We intend
to maintain a relationship with the University to assess other
programmes, or to re-assess this programme in the future.
Barcelona University
On completion of the evaluation programme from the University of
Barcelona, we were delighted to share the news that the University
has been awarded further funding to develop the project in their
own group. Barcelona University has a number of research groups
working on areas of interest to ValiRx, and we have agreed an
over-arching agreement that states standard terms on which we can
commence evaluations on subsequent projects; with the first of
these being a further KRAS project. KRAS(2) consists of a lead
series of molecules that bind to a different proposed binding
domain of KRAS, with our evaluation considering the activity of a
selection of molecules from the lead series.
Further Evaluation Projects
With an ambition to secure 3-4 new evaluation projects every
year, we have been focussing substantial effort on identifying and
qualifying further assets that meet our criteria to build a
diversified preclinical project pipeline.
Clinical Stage Assets
VAL201 remains subject to the Letter of Intent ("LoI") with
TheoremRx Inc, and we maintain good lines of communications with
the TheoremRx team to ensure that they are focussed on securing the
financing which will enable the VAL201 sub-license to complete.
In June 2023, we announced the carve-out of the Greater China
region from the exclusivity clause in the TheoremRx letter of
intent. This enables us to re-commence active marketing of the
project in this region in order to explore additional lines of
revenue.
VAL401 is subject to an intensive business development programme
with an external provider of partnering services who are exploring
options around partners focussed on oncology and supportive
care.
Preclinical Stage Assets
CLX001 was placed in the single asset subsidiary company,
Cytolytix Limited ("Cytolytix") in Q4 2022, and has undergone a
programme of formulation development during the first half of 2023.
The peptide active ingredient requires a nanoformulation to ensure
that the peptide is delivered to cancer cells at appropriate levels
and to stabilise the active ingredient within the therapeutic agent
with the lead formulation now proposed and undergoing testing in
the Inaphaea facility.
Once the lead formulation has been confirmed as being
biologically active, a full programme of preclinical development
including manufacturing, toxicology, disease impact and regulatory
activities will be pursued.
Opportunities for early partnering are being explored for
Cytolytix, with active commercial development to promote the
project to potential industry partners.
VAL301 in vitro preclinical optimisation is ongoing within the
Inaphaea tCRO(R) facility, with variations of the molecule being
studied for impact on growth rates of estrogen dependent cells
under a variety of stimulatory conditions. These assays will
determine whether an alternative molecular structure can improve
the potential for disease modifying impact for endometriosis, as
well as offering the potential for new patent filings to refresh
the intellectual property portfolio surrounding the project.
BC201 remains in assessment in the collaboration between Black
Cat Bio Limited and Oncolytika, with preclinical assessments
considering the impact of the active ingredient against viral
infections and immune responses.
Dr S J Dilly
CEO
24 August 2023
ValiRx Plc
Consolidated statement of comprehensive income
Six months Six months
ended ended Year ended
Note 30 June 30 June 31 December
------------------ -------------------- -----------------
2023 2022 2022
(unaudited) (unaudited) (audited)
GBP GBP GBP
Continuing operations
Research and development (207,721) (200,531) (551,233)
Administrative expenses (925,866) (611,370) (1,502,355)
Share-based payment charge (17,733) (261,052) (539,791)
Operating loss (1,151,320) (1,072,953) (2,593,379)
Finance costs (1,005) (1,831) (5,456)
------------------ -------------------- -----------------
Loss before income taxation (1,152,325) (1,074,784) (2,598,835)
Income tax credit 2 90,000 70,000 192,671
------------------ -------------------- -----------------
Loss on ordinary activities
after taxation (1,062,325) (1,004,784) (2,406,164)
Non-controlling interests 26,901 12,303 39,676
------------------ -------------------- -----------------
Loss for the period and total
comprehensive income attributable
to owners of the parent (1,035,424) (992,481) (2,366,488)
================== ==================== =================
Loss per share - basic and
diluted
From continuing operations 3 (1.03)p (1.53)p (3.06)p
================== ==================== =================
ValiRx Plc
Consolidated statement of financial position
As at 30 June 31 December
---------------------------------------------------- ------------------------
2023 2022 2022
(unaudited) (unaudited) (audited)
GBP GBP GBP
ASSETS
NON-CURRENT ASSETS
Goodwill 1,602,522 1,602,522 1,602,522
Intangible assets 818,097 1,007,770 903,900
Property, plant and equipment 274,744 - -
Right-of-use assets 1,702 9,278 5,561
------------------------ -------------------------- ------------------------
2,697,065 2,619,570 2,511,983
------------------------ -------------------------- ------------------------
CURRENT ASSETS
Trade and other receivables 201,368 79,291 133,815
Tax receivable 282,671 203,413 192,671
Cash and cash equivalents 891,246 97,699 1,137,477
------------------------
1,375,285 380,403 1,463,963
------------------------ -------------------------- ------------------------
TOTAL ASSETS 4,072,350 2,999,973 3,975,946
======================== ========================== ========================
SHAREHOLDERS' EQUITY
Share capital 9,707,266 9,669,995 9,695,120
Share premium account 27,873,048 24,519,456 26,772,630
Merger reserve 637,500 637,500 637,500
Reverse acquisition reserve 602,413 602,413 602,413
Share-based payment reserve 1,062,960 723,433 986,816
Retained earnings (35,679,063) (33,284,988) (34,643,639)
------------------------ -------------------------- ------------------------
4,204,124 2,867,809 4,050,840
Non-controlling interest (251,440) (197,170) (224,539)
------------------------ -------------------------- ------------------------
TOTAL EQUITY 3,952,684 2,670,639 3,826,301
------------------------ -------------------------- ------------------------
LIABILITIES
NON-CURRENT LIABILITIES
Borrowings 16,818 28,056 22,070
Lease liabilities - 2,486 -
------------------------ -------------------------- ------------------------
16,818 30,542 22,070
------------------------ -------------------------- ------------------------
CURRENT LIABILITIES
Trade and other payables 90,830 281,955 111,933
Borrowings 10,264 9,747 9,962
Lease liabilities 1,754 7,090 5,680
------------------------ -------------------------- ------------------------
102,848 298,792 127,575
------------------------ -------------------------- ------------------------
TOTAL LIABILITIES 119,666 329,334 149,645
------------------------ -------------------------- ------------------------
TOTAL EQUITY AND LIABILITIES 4,072,350 2,999,973 3,975,946
======================== ========================== ========================
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
2023 9,695,120 26,772,630 (34,643,639) 637,500 986,816 602,413 (224,539) 3,826,301
Loss for the
period - - (1,035,424) - - - (26,901) (1,062,325)
Issue of
shares 12,146 1,287,854 - - - - - 1,300,000
Costs of
shares
issued - (129,025) - - - - - (129,025)
Share-based
payment
movement - (58,411) - - 76,144 - - 17,733
Balance at
30 June
2023 9,707,266 27,873,048 (35,679,063) 637,500 1,062,960 602,413 (251,440) 3,952,684
================== ======================== ======================== ================== =================== =================== =================== ======================
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
options
and
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
================== ======================== ======================== ================== =================== =================== =================== ======================
Audited
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
year - - (2,366,488) - - - (39,676) (2,406,164)
Issue of
shares 25,125 2,462,250 - - - - - 2,487,375
Costs of
shares
issued - (209,076) - - - - - (209,076)
Lapse of
share
options
and
warrants - 28,838 15,356 - (44,194) - - -
Movement in
year - - - - 539,791 - 4 539,795
Balance at
31 December
2022 9,695,120 26,772,630 (34,643,639) 637,500 986,816 602,413 (224,539) 3,826,301
================== ======================== ======================== ================== =================== =================== =================== ======================
ValiRx Plc
Consolidated cash flow statement
Year
ended
Six months ended
30 June 31 December
---------------------------------------------- -------------------
2023 2022 2022
(unaudited) (unaudited) (audited)
GBP GBP GBP
Cash flows from operating activities
Operating loss (1,151,320) (1,072,953) (2,593,379)
Depreciation of property plant
and equipment 13,558 - -
Amortisation of intangible fixed
assets 100,803 102,850 204,216
Depreciation of right-of-use
assets 3,859 4,000 7,717
(Increase) in receivables (67,552) (6,366) (60,886)
(Decrease)/increase in payables
within one year (21,103) 231,120 61,098
Share-based payment charge 17,733 261,052 539,791
------------------------ -------------------- -------------------
Net cash outflows from operations (1,104,022) (480,297) (1,841,443)
Tax credit received - - 133,413
Interest paid (432) (1,702) (4,215)
------------------------ -------------------- -------------------
Net cash outflow from operating
activities (1,104,454) (481,999) (1,712,245)
------------------------ -------------------- -------------------
Cash flows from investing activities
Purchase of intangible fixed
assets (15,000) (2,504) -
Purchase of property plant and
equipment (288,302) - -
------------------------ -------------------- -------------------
Net cash outflow from investing
activities (303,302) (2,504) -
------------------------ -------------------- -------------------
Cash flows from financing activities
Share issue 1,300,000 - 2,487,375
Costs of shares issued (129,025) - (209,076)
Repayment of lease liabilities (4,500) (4,500) (9,000)
Bank loan (4,950) (6,970) (13,249)
------------------------ -------------------- -------------------
Net cash generated from/(used
in) financing activities 1,161,525 (11,470) 2,256,050
------------------------ -------------------- -------------------
Net (decrease)/increase in
cash and cash equivalents (246,231) (495,973) 543,805
Cash and cash equivalents at
start of period 1,137,477 593,672 593,672
------------------------ -------------------- -------------------
Cash and cash equivalents at
end of period 891,246 97,699 1,137,477
======================== ==================== ===================
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 Group 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 2023 and 2022 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 2022 has been derived from the audited
financial statements for that period. A copy of those statutory
financial statements for the year ended 31 December 2022 has been
delivered to the Registrar of Companies. The report of the
independent auditors on those financial statements was unqualified,
drew attention to a material uncertainty relating to going concern
and did not contain a statement under Sections 498 (2) or (3) of
the Companies Act 2006.
The interim financial statements have been prepared in
accordance with International Accounting Standards in conformity
with the requirements of the Companies Act 2006 as they apply to
the financial statements of the Company for the six months ended 30
June 2023 and as applied in accordance with the provisions of the
Companies Act 2006 and under the historical cost convention or fair
value where appropriate. They have also been prepared on a basis
consistent with the accounting policies expected to be applied for
the year ending 31 December 2023 and which are also consistent with
those set out in the statutory accounts of the Group for the year
ended 31 December 2022.
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 Six months
ended ended Year ended
30 June 30 June 31 December
------------ ------------ ------------
2023 2022 2022
(unaudited) (unaudited) (audited)
GBP GBP GBP
United Kingdom corporation tax
at 25% (2022: 19%)
Current period - R & D Tax
credit (90,000) (70,000) (192,671)
------------ ------------ ------------
Income tax credit (90,000) (70,000) (192,671)
============ ============ ============
3 Loss per ordinary share
The loss and number of shares used in the calculation of loss
per share are as follows:
Six months Six months
ended ended Year ended
30 June 30 June 31 December
----------------- --------------- --------------
2023 2022 2022
(unaudited) (unaudited) (audited)
Basic: GBP GBP GBP
Loss for the financial period (1,062,325) (1,004,784) (2,406,164)
Non-controlling interest 26,901 12,303 39,676
----------------- --------------- --------------
(1,035,424) (992,481) (2,366,488)
================= =============== ==============
Weighted average number of shares 100,808,008 65,049,156 77,301,896
Loss per share (1.03)p (1.53)p (3.06)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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