TIDMVRCI
RNS Number : 5177Y
Verici Dx PLC
07 September 2022
Verici Dx plc
("Verici Dx" or the "Company")
Half-year report
Strong data in validation study for Tuteva(TM) paving the way
for commercial launch
Verici Dx plc (AIM: VRCI), a developer of advanced clinical
diagnostics for organ transplant, announces its unaudited interim
results for the six months ended 30 June 2022.
Operational highlights (including post-period end)
-- Positive data from multi-centre, international validation
study for Tuteva(TM) presented at American Transplant Congress
("ATC") 2022, paving way for soft commercial launch of Tuteva(TM)
in the United States in 2022
-- Announced a collaboration with Illumina, Inc., to expedite
the operational launch of data analysis processing and predictive
artificial intelligence component of our products, using early
access to the Illumina Connected Analytics (ICA) platform
-- Received, ahead of schedule, CPT(R) Proprietary Laboratory
Analyses ("PLA") codes for Clarava(TM) and Tuteva(TM)
-- Completed analytical validation for Clarava(TM) and
Tuteva(TM) in February 2022, an essential element of defining the
performance characteristics and platform capabilities of in vitro
diagnostic assays and a key milestone towards commercialisation
-- Raised gross proceeds of GBP10.0m in March 2022 via Placing and Subscription
-- Appointed initial commercial team to support Tuteva(TM) launch
-- Confirmed positive initial results, in September 2022, for
Clarava(TM) from an international clinical validation study; an
expanded cohort from the ongoing trial will be used to enrich the
utility data for the assay and support a statistically robust and
clinically meaningful case for its adoption in due course
Financial highlights
-- Adjusted EBITDA loss of $4.91m (2021: loss of $2.52m),
excluding share-based payments and costs of new share issue
-- $15.7m cash balance as at 30 June 2022 (31 December 2021:
$10.3m), augmented by the net proceeds of $12.5m from the issue of
28,571,429 new ordinary shares in March 2022
-- Net cash outflow from operating activities in the six months
to 30 June 2022 was $4.9m (excluding the share issue costs charged
to the Income Statement) (six months to 30 June 2021: $2.8m) with
investing activities consuming a further $0.7m (six months to 30
June 2021: $0.7m)
Sara Barrington, Chief Executive Officer, said: "I have been
delighted with the significant progress that we have made over this
six-month period, as Verici Dx advances towards becoming a company
with commercial products.
"The business is well funded following our March 2022 fundraise
to advance all three of our products as well as potential new
growth opportunities, including new partnerships such as our
collaboration with Illumina. I am looking forward to making further
progress over the rest of the year and beyond, as we move from
being a purely research and development company to one with
commercial products."
Investor briefing
Sara Barrington, Chief Executive Officer, and David Anderson,
Chief Financial Officer, will provide a live presentation relating
to the interim results via the Investor Meet Company platform today
at 15:00 BST.
The presentation is open to all existing and potential
shareholders. Questions can be submitted at any time during the
live presentation.
Investors can sign up to Investor Meet Company for free and add
to meet VERICI DX PLC via:
https://www.investormeetcompany.com/verici-dx-plc/register-investor
Investors who already follow Verici Dx on the Investor Meet
Company platform will automatically be invited.
A copy of the Company's interim results report will shortly be
made available on the Company's website.
Enquiries:
Verici Dx www.vericidx.com
Sara Barrington, CEO Via Walbrook PR
Julian Baines, Chairman
Singer Capital Markets (Nominated Tel: 020 7496 3000
Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Rachel
Hayes
Walbrook PR Limited Tel: 020 7933 8780 or vericidx@walbrookpr.com
Paul McManus / Sam Allen / Mob: 07980 541 893 / 07502 558 258
Phillip Marriage /
07867 984 082
About Verici Dx plc www.vericidx.com
Verici Dx is a developer of a complementary suite of
leading-edge tests forming a kidney transplant platform for
personalised patient and organ response risk to assist clinicians
in medical management for improved patient outcomes. The underlying
technology is based upon artificial intelligence assisted
transcriptomic analysis to provide RNA signatures focused upon the
immune response and other biological pathway signals critical for
transplant prognosis of risk of injury, rejection and graft failure
from pre-transplant to late stage. The Company also has a mission
to accelerate the pace of innovation by research using the fully
characterised data from the underlying technology and collaboration
with medical device, biopharmaceutical and data science
partners.
The foundational research was driven by a deep understanding of
cell-mediated immunity and is enabled by access to expertly curated
collaborative studies in highly informative cohorts in kidney
transplant.
Chairman's statement
I am pleased to report strong progress over the six months to 30
June 2022, in what has been a highly positive period for the
Company, with significant milestones achieved that have left us
well positioned for further progress towards commercialisation over
the remainder of 2022 and beyond.
Our commercialisation pathway is now starting to be realised,
and critically, by the end of 2022, we will have moved from being a
purely R&D company to one with a commercial product, with
Tuteva(TM) set for a soft sales launch later this year, with a view
to scaling up operations in 2023. Post-period end, Clarava(TM) also
demonstrated clinical significance via the recently reported
initial validation study results and Verici Dx is poised to take
advantage of the larger cohorts presented by the current wider
validation clinical trial to support further utility work and the
clinical adoption of Clarava(TM) in due course.
We made strong progress against our strategy during the period,
particularly related to our two lead products, Clarava(TM) and
Tuteva(TM), for which we achieved pricing codes as the first
milestone for the two tests towards commercial reimbursement, as
well as having submitted both for pricing consideration.
This progress culminated in the positive results of our clinical
validation study for Tuteva(TM), our post-transplant blood test
focused on acute rejection, including sub-clinical rejection, that
were initially announced in May, before the full results were
presented to the clinical community at the American Transplant
Congress (ATC) in June. The results of the validation study were
highly positive, with Tuteva(TM) shown to have a significantly
higher PPV than currently available single kidney transplant blood
tests and, most significantly, from an inclusion of an 'all-comers'
population which has been very warmly received by the scientific
community, as well as the positive data itself. We believe this
establishes a new industry standard in the detection of acute
kidney transplant rejection, and positions Tuteva(TM) well for its
soft commercial launch in the United States later this year.
Additionally, in March 2022, we completed a fundraise which
raised gross proceeds of GBP10.0 million (c.$13.0 million). We
intend to use the funds, along with the Company's existing
resources, to accelerate and broaden our platform, through
advancing towards key milestones for our third product Protega(TM),
a liquid biopsy that aims to predict the risk of fibrosis and
long-term graft failure, continuing to push our commercialisation
strategy for Clarava(TM) and Tuteva(TM), and carrying out planned
improvements to our CLIA-certified laboratory. Some of the funds
are also set to be used to explore potential new commercial
opportunities to enhance our platform, such as adding new
technology and AI capabilities.
The completion of this fundraise, amidst a difficult
macroeconomic environment which has particularly affected
AIM-listed healthcare companies, is a testament to the vast
potential of our kidney transplant platform, and the potential of
our technology in wider applications. I would like to thank both
our existing and new shareholders for their support in the raise.
Our current cash position of $13.5 million provides us with a cash
runway to the start of 2024.
In January 2022 we were proud to announce our collaboration with
Illumina, Inc. (NASDAQ: ILMN), a leading developer, manufacturer
and marketer of life science tools and integrated systems for large
scale analysis of genetic variation and function, whereby Verici Dx
has clinically validated on Illumina Connected Analytics (ICA),
Illumina's new software platform, a strategic focus area for
Illumina.
On behalf of the Board, I would like to thank our employees,
shareholders and partners for their support, and we look forward to
further updates throughout the year, including working towards the
soft commercial launch of our two lead products, and further
information on the progress of Protega(TM).
Julian Baines
Non-Executive Chairman
7 September 2022
Chief Executive Officer's Report
Overview
At our preliminary results earlier this year, we set out that by
the end of 2022 Verici Dx will have transitioned from a fully
R&D-focused company, to one with commercial products. I have
been delighted with the execution of our strategy as we remain on
track to achieve this goal, with the soft commercial launch of
Tuteva(TM) set for later this year and Clarava(TM) expanding its
validation cohort to support the commercial pathway of utility
studies and publications for its launch.
The highlight of this period was the publication of the data
from our international, multi-centre validation study for
Tuteva(TM). In the study, Tuteva(TM) demonstrated a significantly
higher Positive Predictive Value ("PPV") than currently available
kidney transplant single blood tests, which was our key performance
metric, in order for the test to provide clinicians with an
appropriate, reliable call to action to improve patient outcomes
post-transplant. The response to these results, as well as the
robust design of the validation study from the scientific
community, was highly positive, and reflects our excitement in
having developed a powerful, highly specific predictive tool that
can enable clinicians to detect acute cellular rejection accurately
post-transplant.
Over H1 2022, we also achieved several other notable milestones,
including progressing our lead products towards commercial
reimbursement, signing a collaboration agreement with Illumina,
Inc. (NASDAQ: ILMN), our March fundraising which extended our cash
runway, and a strengthening of our commercial team with senior
appointments.
Pipeline
Our platform of innovative kidney transplant tests use advanced
next-generation sequencing to define a personalised risk profile
for each patient. We believe we have unique products that support
accurate, data-driven clinical decisions, such as the most
appropriate immunosuppressive therapy for that patient. This has
not only near-term scope to reduce the unnecessary and serious
consequences from over- or under-dosing for immunosuppression in
conjunction with kidney transplant, but also to improve the
longevity of transplanted kidneys and, by reducing the risk and
rate of transplant failure, much broader potential to deliver huge
health economic benefits by improving transplant outcomes.
Our three products are:
-- Clarava(TM) , a pre-transplant prognosis test for the risk of early acute rejection;
-- Tuteva(TM) , a post-transplant test focused upon acute
cellular rejection, including sub-clinical rejection; and
-- Protega(TM), a liquid biopsy that aims to predict the risk of
fibrosis and long-term graft failure.
In early 2022, we received CPT(R) Proprietary Laboratory
Analyses ("PLA") codes, from the American Medical Association, and
successfully completed analytical validation for Clarava(TM) and
Tuteva(TM). The PLA codes marked the first step for the two tests
on the path for commercial reimbursement, which is comprised of
three components: code, price and coverage. CPT(R) codes offer
health care professionals a uniform language for coding medical
services and procedures and allow clinical laboratories to more
specifically identify their tests when billing Medicare and
commercial insurers. Analytical validation is an essential element
of defining the performance characteristics and platform
capabilities of in vitro diagnostic assays, including
reproducibility, accuracy, limits of detection, and risk of
interferences for any clinician wanting comprehensive data about
the reliability of testing.
In June, we presented highly positive data from our
international, multi-centre, all-comers validation study for
Tuteva(TM) at the 2022 American Transplant Congress ("ATC") and are
due to present at ASN's Kidney Week on November 3-6, 2022.
Currently available single blood tests that look for signs of
transplant damage typically have a high Negative Predictive Value
("NPV"), but a low Positive Predictive Value. These values mean
that if the blood test returns a negative result, clinicians can be
confident that there is no current rejection occurring but
uncertain as to a positive result is from a rejection or an
infection, or physical trauma. Consequently, these tests are
functioning primarily as a 'rule out' tool, rather than a 'rule in'
one. This has proved difficult for clinicians, who need to know
with some degree of confidence whether or not their patient
requires further intervention in the form of immunosuppression.
This is especially true in the case of kidney transplant, where
approximately half of cases have a rejection event. Clinicians need
a 'rule in' test so they can take appropriate action with
confidence. Inappropriate dosing of immunosuppressant medication
(in either direction) can have harmful consequences for the patient
and create additional or unnecessary healthcare costs. There has
therefore been a growing demand for a kidney transplant test that
is more capable of identifying those patients that are experiencing
acute cellular rejection post-transplant and can empower clinicians
to initiate further treatment for their patients, which we believe
Tuteva (TM) will now be able to meet. This is why the significantly
higher PPV result seen with Tuteva (TM), compared to other
available tests, is such an important performance metric.
Importantly, our validation study was a blinded 'all-comers'
patient population across 14 international transplant centres. This
means that we were able to test the power of Tuteva(TM) within a
clinically realistic context that included all types of rejection.
Our FDA-standard study design, alongside the positive results, was
well received by the scientific community at ATC, providing
validation of our strategic decision earlier in the year to prolong
the final close of the study in order to ensure inclusion from all
of our European sites. We believe that the highly positive results
reflect the wide clinical applicability of the test for
comprehensive commercial adoption in a real-world setting, and
position Tuteva(TM) for a soft commercial launch in the US later
this year.
Clarava(TM) was also able to identify and validate successfully
a blood-based RNA signature (profile) that effectively identified
patients most likely to experience a future kidney rejection event.
These early validation results announced in September confirm and
expand the previous feasibility study, through the incorporation of
advanced next sequencing technology combined with sophisticated
bioinformatics, to identify patient-level immune cell-type and
biological pathways associated with kidney rejection. Clarava(TM)
represents a completely novel approach to characterising a
pre-transplant patient's immune profile which has broad
implications for treatment planning and monitoring. To generate a
broad clinical acceptance within the diverse transplant community,
we are extending enrolment for a wider cohort for publication over
the next six months using our existing clinical trial network. It
is anticipated that the expansion of our validation cohort will
serve to enrich the utility of the assay and ultimately improve
outcomes. This has no material cost impact, as the study is ongoing
for our other products.
Partnerships and agreements
In January 2022 we entered into a collaboration with Illumina,
granting us early access to Illumina Connected Analytics (ICA),
Illumina's new software platform, which provides us with the
ability to process large datasets in a streamlined manner. This
supports our leading-edge technology approach and provides a
foundation for future data science discovery, expansion and
collaboration opportunities.
Collaborating with such a high-quality partner as Illumina is an
indicator of the strength of our platform, and access to the ICA
platform has materially enhanced our data processing capabilities,
as well as boosted our ability to develop highly predictive
products in the future. This partnership supports our wider goal of
improving patient outcomes within organ transplantation, where
there remains an urgent clinical need.
Management and staff
During the period, we hired our initial commercial team focused
upon the commercial soft launch of Tuteva(TM) in the US later this
year, ahead of a wider launch in 2023.
As of 30 June 2022, the Company had 13 staff members.
Financials
Cash balance as of 30 June 2022 was $15.7m (31 December 2021:
$10.3m), augmented by the net proceeds from the issue of 28,571,429
new ordinary shares in March 2022 of $12.5m. Net cash outflow in
the six months to 30 June 2022 from operating activities was $4.9m
(excluding the share issue costs charged to the Income Statement)
(six months to 30 June 2021: $2.8m) with investing activities
consuming a further $0.7m (six months to 30 June 2021: $0.7m) and
unrealised foreign exchange loss of $1.5m (six months to 30 June
2021: gain of $0.2m).
The most significant expenditure continued to relate to the work
done on our clinical validation study of $2.3m (year to 31 December
2021: $2.8m) followed by our total employee cost in the period of
$1.3m, including share-based payment charge of $0.1m (year to 31
December 2021: $2.4m, including share-based payment charge of
$0.4m). For the period to 30 June 2022 the average number of
employees was 11, and as of the date of this report we employ 14
people.
Outlook
Over the remainder of the rest of the year, we are focused on
the soft commercial launch of Tuteva(TM), with a view to scaling up
to a wider launch in 2023. Our transition to having a commercially
launched product, a little over two years after our IPO, is a
reflection of the huge amount of work that has been put in by our
entire team.
We are developing a health economics model to aid our
commercialisation efforts, which we expect to submit for
publication by the end of the year. We are also expected to engage
in clinical utility and real-world evidence studies to support
adoption of our two lead products both later this year and into
next year.
Following our fundraising in March 2022, we have the capital
required to not only progress our platform through the
commercialisation of both Clarava(TM) and Tuteva(TM), but also
progress Protega (TM) and explore exciting growth opportunities.
Having already obtained CPT codes, we will seek to determine
pricing for both of our lead products, and coverage determinations
for Clarava(TM). Pricing pathways will be announced later this year
with a crosswalk determination being effective by the end of 2022
and a gapfill process would take the pricing into 2023 with the
MolDx proposed pricing expected by the end of Q2. Tuteva(TM) is
expected to be eligible for and covered by an existing local
coverage determination issued by Palmetto under the MolDX
system.
On behalf of the Company, I would like to thank the shareholders
for their ongoing support in this transitional year and look
forward to the commercial progress and further milestones for the
rest of the year.
Sara Barrington
Chief Executive Officer
7 September 2022
Consolidated condensed statement of profit or loss and other
comprehensive income
for the six months ended 30 June 2022
Six months Six months Year to
to to
30 June 30 June 31 December
Note 2022 2021 2021
US$'000 US$'000 US$'000
Unaudited Unaudited Audited
Administrative expenses 5 (4,914) (2,525) (7,151)
Depreciation and amortisation 5 (275) (183) (438)
Share-based payments 5 (195) (128) (740)
Exceptional expense - costs
of share issue 5 (90) - -
_________ _________ _________
Loss from operations (5,474) (2,836) (8,329)
Finance income / (expense) 7 (3) -
_________ _________ _________
Loss before tax (5,467) (2,839) (8,329)
Tax expense - - -
_________ _________ _________
Loss from continuing operations (5,467) (2,839) (8,329)
Other comprehensive income:
Exchange (losses) / gains arising
on translation of foreign operations (1,729) 281 (50)
_________ _________ _________
Loss and total comprehensive
income attributable to the owners
of the Company (7,196) (2,558) (8,379)
_________ _________ _________
Earnings per share attributable
to the
ordinary equity holders of
the parent
Loss per share
Basic and diluted (US$ cents) 6 ($0.034) ($0.02) ($0.059)
_________ _________ _________
The results reflected above relate to continuing operations
Consolidated statement of financial position
as at 30 June 2022
30 June 30 June 31 December
Note 2022 2021 2021
US$'000 US$'000 US$'000
Unaudited Unaudited Audited
Assets
Current assets
Trade and other receivables 7 516 426 656
Cash and cash equivalents 15,717 14,549 10,340
_________ _________ _________
16,233 14,975 10,996
_________ _________ _________
Non-current assets
Property, plant and equipment 1,310 912 786
Intangible assets 1,944 1,884 2,007
_________ _________ _________
3,254 2,796 2,793
_________ _________ _________
Total assets 19,487 17,771 13,789
_________ _________ _________
Liabilities
Current liabilities
Trade and other payables 8 (1,874) (577) (1,804)
_________ _________ _________
NET ASSETS 17,613 17,194 11,985
_________ _________ _________
Issued capital and reserves attributable to
owners of the parent
Share capital 219 182 182
Share premium reserve 32,946 20,354 20,354
Share-based payments reserve 3,730 2,923 3,535
Foreign exchange reserve (750) 1,310 979
Retained earnings (18,532) (7,575) (13,065)
_________ _________ _________
TOTAL EQUITY 17,613 17,194 11,985
_________ _________ _________
Consolidated statement of cash flows
for the six months ended 30 June 2022
Six months Six months Year to
to to
30 June 30 June 31 December
2022 2021 2021
US$'000 US$'000 US$'000
Unaudited Unaudited Audited
Cash flows from operating activities
Loss for the period (5,467) (2,839) (8,329)
Adjustments for:
Depreciation of property, plant and equipment 203 122 295
Amortisation of intangible fixed assets 72 61 143
Finance (income) / expense (7) 3 -
Share-based payment expense 195 128 740
_________ _________ _________
(5,004) (2,525) (7,151)
(Increase) / decrease in trade and other receivables (140) (103) (331)
Increase / (decrease) in trade and other payables 116 (160) 1,146
Income taxes paid - - -
_________ _________ _________
Net cash outflow from operating activities (5,028) (2,788) (6,336)
_________ _________ _________
Cash flows from investing activities
Purchases of property, plant and equipment (561) (508) (618)
Purchase of intangibles (161) (154) (348)
_________ _________ _________
Net cash used in investing activities (722) (662) (966)
Cash flows from financing activities
Issue of ordinary shares 13,070 - -
Expenses of share issue (441) - -
Loan repayments - - (74)
Interest received / (paid) 7 (3) -
_________ _________ _________
Net cash from financing activities 12,636 (3) (74)
Net increase / (decrease) in cash and cash equivalents 6,886 (3,453) (7,376)
Cash and cash equivalents at beginning of period 10,340 17,751 17,751
Exchange movement on cash and cash equivalents (1,509) 251 (35)
_________ _________ _________
Cash and cash equivalents at end of period 15,717 14,549 10,340
_________ _________ _________
Consolidated statement of changes in equity
for the six months ended 30 June 2022
Total
attributable
to equity
Share-based Foreign holders
Share Share payment exchange Retained of Total
capital premium reserve reserve earnings parent equity
US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000
1 January 2021 182 20,354 2,795 1,029 (4,736) 19,624 19,624
Comprehensive income for
the period
Loss for the period - - - - (2,839) (2,839) (2,839)
Other comprehensive income - - - 281 - 281 281
Contributions by and
distributions to owners
Share based payments charge - - 128 - - 128 128
_________ _________ _________ _________ _________ _________ _________
At 30 June 2021 182 20,354 2,923 1,310 (7,575) 17,194 17,194
_________ _________ _________ _________ _________ _________ _________
At 30 June 2021 182 20,354 2,923 1,310 (7,575) 17,194 17,194
Comprehensive income
Loss for the period - - - - (5,490) (5,490) (5,490)
Other comprehensive income - - - (331) - (331) (331)
Contributions by and
distributions to owners
Share-based payment - - 612 - - 612 612
_________ _________ _________ _________ _________ _________ _________
At 31 December 2021 182 20,354 3,535 979 (13,065) 11,985 11,985
_________ _________ _________ _________ _________ _________ _________
Consolidated statement of changes in equity
for the six months ended 30 June 2022
Total
attributable
to equity
Share-based Foreign holders
Share Share payment exchange Retained of Total
capital premium reserve reserve earnings parent equity
US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000
31 December 2021 182 20,354 3,535 979 (13,065) 11,985 11,985
Comprehensive income for
the period
Loss for the period - - - - (5,467) (5,467) (5,467)
Other comprehensive income - - - (1,729) - (1,729) (1,729)
Contributions by and
distributions to owners
Issue of share capital 37 13,033 - - - 13,070 13,070
Costs of share issue - (441) - - - (441) (441)
Share-based payment - - 195 - - 195 195
_________ _________ _________ _________ _________ _________ _________
At 30 June 2022 219 32,946 3,730 (750) (18,532) 17,613 17,613
_________ _________ _________ _________ _________ _________ _________
Notes forming part of the consolidated financial statements
for the six months ended 30 June 2022
General information
1
The principal activity of Verici Dx plc (the "Company") is the
development of prognostic and diagnostic tests for kidney
transplant patients.
The Company is a public limited company incorporated in England
and Wales and domiciled in the UK. The address of the registered
office is Avon House, 19 Stanwell Road, Penarth, Cardiff CF64 2EZ
and the company number is 12567827.
The Company was incorporated as Verici Dx Limited on 22 April
2020 as a private company and on 9 September 2020 the Company was
re-registered as a public company and changed its name to Verici Dx
plc.
Summary of significant accounting policies
2
The principal accounting policies adopted in the preparation of
the historical financial information of the Company, which have
been applied consistently to the period presented, are set out
below:
Basis of preparation
The accounting policies adopted in the preparation of the
interim consolidated financial information are consistent with
those of the preparation of the Group's annual consolidated
financial statements for the year ended 31 December 2021. No new
IFRS standards, amendments or interpretations became effective in
the six months to 30 June 2022.
Statement of compliance
This interim consolidated financial information for the six
months ended 30 June 2022 has been prepared in accordance with IAS
34, 'Interim financial reporting' and the AIM Rules of UK
companies. This interim consolidated financial information is not
the Group's statutory financial statements and should be read in
conjunction with the annual financial statements for the year ended
31 December 2021, which have been prepared in accordance with UK
adopted International Accounting Standards (UK IFRS) and have been
delivered to the Registrar of Companies. The auditors have reported
on those accounts; their report was unqualified, did not include
references to any matters to which the auditors drew attention by
way of emphasis of matter without qualifying their report and did
not contain statements under section 498(2) or (3) of the Companies
Act 2006.
The interim consolidated financial information for the six
months ended 30 June 2022 is unaudited. In the opinion of the
Directors, the interim consolidated financial information presents
fairly the financial position, and results from operations and cash
flows for the period. Comparative numbers for the six months ended
30 June 2021 are unaudited.
Measurement convention
The financial information has been prepared under the historical
cost convention. Historical cost is generally based on the fair
value of the consideration given in exchange for assets.
The preparation of the financial information in compliance with
IFRS requires the use of certain critical accounting estimates and
management judgements in applying the accounting policies. The
significant estimates and judgements that have been made and their
effect is disclosed in note 3.
Basis of consolidation
Where the company has control over an investee, it is classified
as a subsidiary. The company controls an investee if all three of
the following elements are present: power over the investee,
exposure to variable returns from the investee, and the ability of
the investor to use its power to affect those variable returns.
Control is reassessed whenever facts and circumstances indicate
that there may be a change in any of these elements of control.
The consolidated financial statements present the results of the
company and its subsidiaries ("the Group") as if they formed a
single entity. Intercompany transactions and balances between group
companies are therefore eliminated in full.
The consolidated financial statements incorporate the results of
business combinations using the acquisition method. In the
statement of financial position, the acquiree's identifiable
assets, liabilities and contingent liabilities are initially
recognised at their fair values at the acquisition date. The
results of acquired operations are included in the consolidated
statement of profit or loss and other comprehensive income from the
date on which control is obtained. They are deconsolidated from the
date on which control ceases.
Going concern
The Group is in the development phase of its business and has
not generated any revenues. At 30 June 2022 the Group has available
cash resources of $15.7m following its fund raise in March
2022.
The Board has considered the impact of the ongoing COVID-19
pandemic. There has been minimal impact on the Company to date.
Given the impact of COVID-19 in the economy generally, the Board
has performed a number of stress tests to assess the ability of the
Company to continue as a going concern.
The Directors have prepared cash flow forecasts for the Group
for a review period of 12 months from the date of approval of this
historical financial information. These forecasts reflect an
assessment of current and future market conditions and their impact
on the Company's future cash flow performance.
The forecasts have been sensitised for additional costs which
may be incurred in the review period. In the sensitised scenario,
the forecasts indicate the Company would still have sufficient cash
to continue as a going concern.
Having considered the points above, the Directors remain
confident in the long-term future prospects for the Group, and
their ability to continue as a going concern for the foreseeable
future. They therefore adopt the going concern basis in preparing
the historical financial information of the Group.
Taxation
Income tax expense represents the sum of the tax currently
payable and deferred tax.
Judgements and key sources of estimation uncertainty
3
The preparation of the Company's historical financial
information under UK IFRS requires the Directors to make estimates
and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and
liabilities. Estimates and judgements are continually evaluated and
are based on historical experience and other factors including
expectations of future events that are believed to be reasonable
under the circumstances. Actual results may differ from these
estimates.
The Directors consider that the following estimates and
judgements are likely to have the most significant effect on the
amounts recognised in the financial information.
Carrying value of intangible assets, property, plant and
equipment
In determining whether there are indicators of impairment of the
Company's intangible assets, the Directors take into consideration
various factors including the economic viability and expected
future financial performance of the asset and when it relates to
the intangible assets arising on a business combination, the
expected future performance of the business acquired.
4 Segment information
The Group has one division being the development of prognostic
and diagnostic tests for kidney transplant patients. The directors
consider that all activities relate to this segment. All the
non-current assets of the Group are located in, or primarily relate
to, the USA.
Expenses by nature
5
Six months Six months Year to
to to
30 June 30 June 31 December
2022 2021 2021
US$'000 US$'000 US$'000
Unaudited Unaudited Audited
Employee benefit expenses 1,289 848 2,392
Depreciation of property, plant
and equipment 203 122 295
Amortisation of intangible assets 72 61 143
Research and development costs 2,290 1,044 2,810
Licenses and milestones 550 - 250
Professional costs 515 455 921
Share-based payment expense for
non-employees 77 44 309
Foreign exchange losses / (gains) (510) 3 (182)
Costs of share issue 90 - -
Other costs 898 259 1,391
Earnings per share
6
Six months to Six months Year to
to
30 June 30 June 31 December
2022 2021 2021
US$ US$ US$
Unaudited Unaudited Audited
Numerator
Loss for the period used in basic EPS (5,466,168) (2,839,233) (8,329,829)
Denominator
Weighted average number of ordinary shares used in basic EPS 158,890,673 141,747,816 141,747,816
Resulting loss per share (US$0.034) (US$0.02) (US$0.059)
The Company has one category of dilutive potential ordinary
share, being share options. The potential shares were not dilutive
in the period as the Group made a loss per share in line with IAS
33.
Trade and other receivables
7
30 June 30 June 31 December
2022 2021 2021
US$'000 US$'000 US$'000
Unaudited Unaudited Audited
Prepayments 324 207 406
Other debtors 192 219 250
_________ _________ _________
516 426 656
_________ _________ _________
Trade and other payables
8
30 June 30 June 31 December
2022 2021 2021
US$'000 US$'000 US$'000
Unaudited Unaudited Audited
Trade payables 385 253 160
Other creditors 186 - -
Accruals 1,303 324 1,644
_________ _________ _________
Total trade and other payables 1,874 577 1,804
_________ _________ _________
The carrying value of trade and other payables classified as
financial liabilities measured at amortised cost approximates fair
value.
Share-based payment
9
On 28 October 2020, the Board adopted the Share Option Plan to
incentivise certain of the Group's employees and Directors. The
Share Option Plan provides for the grant of both EMI Options and
non-tax favoured options. Options granted under the Share Option
Plan are subject to exercise conditions as summarised below.
The Share Option Plan has a non-employee sub-plan for the grant
of Options to the Company's advisors, consultants, non-executive
directors, and entities providing, through an individual, such
advisory, consultancy, or office holder services. In addition there
isa US sub-plan for the grant of Options to eligible participants
in the Share Option Plan and the Non-Employee Sub-Plan who are US
residents and US taxpayers.
With the exception of options over 10,631,086 shares, which
vested immediately on grant, the options vest equally over twelve
quarters from the grant date. If options remain unexercised after
the date one day before the tenth anniversary of grant such options
expire. The Options are subject to exercise conditions such that
they shall, subject to certain exceptions, vest in equal quarterly
instalments over the three years immediately following the date of
grant, which vesting shall accelerate in full in the event of a
change of control of the Company.
Weighted
average
exercise
price Number
(p)
Outstanding at 22 April 2020 - -
Granted during the period 32.0 14,574,782
Exercised during the period 32.0 (10,631,086)
_________ _________
Outstanding at 31 December 2020 and 30 June
2021 32.0 3,943,696
Granted during the period 62.61 990,000
_________ _________
Exercisable at 31 December 2021 26.03 4,933,696
Granted during the period 37.97 454,370
Cancelled during the period 69.50 (120,000)
_________ _________
Outstanding at 30 June 2022 26.04 5,268,066
_________ _________
The Group recognised total expenses of $195,000 as exceptional
expenses separate to administrative expenses relating to
equity-settled share-based payment transactions during the period
to 30 June 2022, $740,000 in the year to 31 December 2021 and
$128,070 in the six months to 30 June 2021.
10 Events after the reporting date
There have been no events subsequent to the period end that
require disclosure in these financial statements.
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IR EAANKEEFAEAA
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