4 April 2024
LungLife AI, Inc.
(the "Company" or
"LungLife")
Preliminary audited results for year
ended 31 December 2023
LungLife AI (AIM: LLAI), a developer of
clinical diagnostic solutions for lung cancer, announces its audited preliminary results for the year
ended 31 December 2023.
Summary and Highlights for the year and post-period
end:
●
|
Cash as of 31 December 2023 of $2.83m (2022:
$8.01m).
|
●
|
Loss before tax of $5.41m (2022:
$7.60m).
|
●
|
Adjusted EBITDA1 loss of $5.19m
(2022: $6.84m).
|
●
|
Effective 1 January 2023, LungLB PLA code 0317U
was added to Medicare's Clinical Laboratory Fee Schedule ("CLFS")
at a National price of $2,030 per test.
|
●
|
LungLife's cost effectiveness analysis was
published in the
Journal of Medical Economics, providing evidence
that LungLB is cost effective when used to evaluate indeterminate
lung nodules when integrated into the current clinical care
pathway. This is a key publication for payors, including Medicare,
when considering coverage for LungLB.
|
●
|
The Company's lead-in multi-site validation of
LungLB was published in
Nature-Springer's BMC Pulmonary Medicine,
demonstrating high performance in smaller lung nodules and
outperforming PET scan and Mayo Nodule Calculator tools, and
indicating the potential to reduce delays in treatment from earlier
detection using LungLB.
|
●
|
Successful clinical validation of the Company's
LungLB test following conclusion of the multi-site validation trial
with a positive predictive value ("PPV") of 81% for those
indeterminate nodules less than 15mm in size and outperformed PET
scan and Mayo Nodule Calculator tools, replicated the findings from
the lead-in validation study.
|
●
|
In March 2024, the Company raised gross
proceeds of $2.28m (GBP1.81m) from the issue of 5,172,621 shares at
35 pence.
|
Commenting, Paul Pagano, Chief Executive Officer of LungLife,
said: "2023 was a year of considerable
achievement culminating in the conclusion of our multi-site
clinical validation study, which was the primary objective at our
IPO. A positive predictive value of over 80% in smaller
indeterminate nodules is significant. This is
where physicians consistently indicate the greatest unmet need and
where currently available tools fall
short.
"In March 2024 we concluded our fund raising to commence the
commercialisation of our test. This enables us to initiate our
Early Access Program, submit forms to MolDX for technical
assessment for Medicare coverage consideration, and continue other
matters necessary for commercialisation. We have also started the
process of considering all strategic options to get the LungLB test
into the hands of patients who need it most.
"Our revised cash runway to April 2025 has required
significant cost reductions, the largest being to headcount and
salaries for the executive team. We are now a smaller team focussed
on the key commercialisation activities. Those who have left the
Company played an important role in delivering our achievements to
date and on behalf of the whole Board, I would like to thank them
for their efforts."
For further
information please contact:
LungLife AI,
Inc.
|
www.lunglifeai.com
|
Paul Pagano, CEO
|
Via Walbrook PR
|
David Anderson, CFO
|
|
|
|
Investec Bank plc (Nominated Adviser &
Broker)
|
Tel: +44 (0)20 7597
5970
|
Virginia Bull / Cameron MacRitchie / Lydia
Zychowska
|
|
|
|
Goodbody (Joint Broker)
Tom Nicholson / Cameron Duncan /
Will Hall
|
Tel: +44 (0) 20 3841
6208
|
Walbrook PR Limited
|
Tel: +44 (0)20 7933
8780 or LungLifeAI@walbrookpr.com
|
Stephanie Cuthbert / Alice Woodings
/ Phillip Marriage
|
Mob: 07980
541 893 / 07407 804 654 / 07867 984 082
|
|
| |
1 Earnings before
interest, tax, depreciation and amortisation, adjusted to exclude
exceptional items, share based payments and other operating
income.
About LungLife
LungLife AI is a developer of
clinical diagnostic solutions designed to make a significant impact
in the early detection of lung cancer, the deadliest cancer
globally. Using a minimally invasive blood draw, the
Company's LungLB® test is designed to deliver additional
information to clinicians who are evaluating indeterminate lung
nodules. For more information visit
www.lunglifeai.com
Our Purpose is to be a driving force in the
early detection to lung cancer. And our Vision is to invert the
20:80 ratio such that in years to come at least 80% of lung cancer
is detected early.
Chairman's Statement
I am delighted to report on the
Company's results for the year ended 31 December 2023. We have
continued to deliver on the Company's objectives and remain
committed to creating shareholder value as we proceed with the aim
of being a driving force in the early detection of lung cancer
through the completion of our LungLB® test multi-centre clinical
validation study.
LungLB® test
According to the World Health
Organization, over 2.2 million new cases of lung cancer were
diagnosed in 2020 and approximately 1.8 million deaths from lung
cancer were recorded in 2020 globally. Nearly 80% of all lung
cancers in the United States are diagnosed in later stages when
survival rates are low because the options for curative treatment
are then limited. This is in part due to the lack of effective
early detection solutions and the fact that lung cancer largely
develops asymptomatically.
LungLB® is a blood-based test that
uses Circulating Genetically Abnormal Cells ("CGAC"), which include
circulating tumour cells ("CTC"), to stratify indeterminant lung
nodules as either cancerous or benign following their
identification by CT scan. Biopsy is currently part of the standard
care pathway for lung nodules and the LungLB® test is designed to
support the physician's decision to biopsy only when necessary, or
to monitor non-invasively using additional imaging. There are
estimated to be over 1.5 million indeterminant lung nodules
identified each year in the United States and LungLife's estimated
one week turnaround from receipt of the blood sample to results can
save a significant amount of stressful waiting time for the
participant as well as unnecessary costly and often dangerous
procedures.
Progress this year
2023 has been an important year in
the development of the Company, concluding with the announcement of
the results of our multi-site, prospective clinical study on 2
January 2024.
Clinical validation study
We completed enrolment of the 425
participants in our clinical validation study in May and its
findings were concluded by year end, being announced on 2 January
2024.
We were delighted by the findings
showing a strong positive predictive value of 81% in discriminating
benign from cancerous lung nodules in patients with smaller nodules
(< 15mm).
Publications - Health economics
study
We published two important documents
in the period, both of which are important components in
establishing the ability of the Company to be paid for its tests,
known as "coverage".
The first publication was a
cost-effectiveness analysis ("CEA") model on LungLB® which provides
evidence that the test can be utilised as a cost-effective tool
within the current diagnostic pathway.
The principal aim of the research
was to explore the incremental cost-effectiveness of LungLB® when
added to the current clinical diagnostic pathway for patients with
lung nodules, as described in guidelines. The greater cost savings
in the model were demonstrated by a reduction in unnecessary
procedures and better patient outcomes from reduced delays in
treatment.
Incremental Cost-Effectiveness Ratio
("ICER") is a key metric used in the publication to demonstrate
cost effectiveness. Integration of LungLB® leads to improvement in
outcomes and results in an ICER that was 25% below the willingness
to pay ("WTP") threshold commonly considered by US commercial
payors, suggesting overall savings when LungLB® is priced at $2,030
per test. ICERs remain below WTP thresholds at prices up to $3,647
per test.
Publication - Peer reviewed
publication of our test
We also announced the peer-reviewed
publication of the successful performance results for the Company's
LungLB® test from a multi-site prospective study in patients with
indeterminate pulmonary nodules. The pilot study was performed in
collaboration with MD Anderson Cancer Center (Houston, TX) and
Icahn School of Medicine at Mount Sinai (New York, NY) and appears
in the journal BMC Pulmonary Medicine. The primary objective of the
study was to compare the LungLB® test result with a lung biopsy
diagnosis and assess performance in a patient cohort where commonly
used nodule evaluation tools were not informative.
We are very pleased to have been
able to achieve these important milestones in this year.
People
Our revised cash runway to April
2025 has required significant cost reductions, the largest being to
headcount and salaries for the executive team. We are now a smaller
team focussed on the key commercialisation activities. Those who
have left the company played an important role in delivering our
achievements to date and on behalf of the whole Board, I would like
to thank them for their efforts.
Post balance sheet and
outlook
On 22 March 2024 the Company issued
5,172,621 new common shares at a price of 35 pence per share,
raising gross proceeds of US$2,280,000 (GBP1,810,000).
The Company intends to use the net
proceeds of the funding, along with the Company's existing cash
resources to establish the commercial proof of concept of the
Company's LungLB® test, as detailed below:
·
funding of evidence generating activities,
including the Early Access Program ("EAP") and clinical utility
studies, dependent on the factors noted below, to support
reimbursement and test adoption;
·
increasing expenditure to support engagement with
payors and clinicians, and support the wider need to raise clinical
awareness via key opinion leaders, publications and conferences;
and
·
accelerating the commercial pathway by pursuing
licensing or other similar agreements.
The net proceeds of the Fundraising
will allow the Company to consider all of its strategic options in
order to maximise shareholder value and, in conjunction with the
implementation of certain cost-cutting actions, is expected to
provide the Company with a cash runway to early April
2025.
This is our focus in 2024 and we look forward
to updating shareholders on our progress.
Roy
Davis
Chairman
3
April 2024
Financial Review
The financial performance of the
Company in the year to 31 December 2023 reflects the costs incurred
in concluding the clinical validation study, and the continued
groundwork in laying the foundations for
commercialisation.
Statement of Comprehensive
Income
The Company generated revenues of
US$46,000 in the year (2022 - US$34,000) comprising wholly of
royalty income from its sub licensee in China. The royalty income
is calculated at 6% of underlying net sales, and the Company pays a
3% royalty on this income to MD Anderson Cancer Center.
The largest cost incurred in the
year was employee expenses of US$2,908,000 (2022 - $3,264,000)
followed by research and development costs US$1,308,000 (2022 -
US$1,981,00), being those external costs incurred on our clinical
validation trial and in the continued development of our
LungLB® test. In the year, one of our part time
employees was offered a full-time position, bringing our
operational headcount to 15.
Other operating income of US$44,000
(2022 - US$102,000) relates to claims made under the US Government
Employee Retention Credits scheme, designed as COVID related
support for businesses. Finance income of US$223,000 (2022 -
US$88,000) was generated from funds held on deposit, benefiting
from high interest rates, and we incurred finance expense of
US$41,000 (2022 - US$52,000). Finance expense in both years related
to that arising on lease liabilities for certain tangible assets
and the leasehold premises.
EBITDA loss for 2023 excluding
share-based payments was $5,192,000 (2022 - EBITDA loss
$6,841,000).
Statement of Financial
Position
Cash and cash equivalents at the end
of the year was US$2,724,000 (2022 - US$3,088,000). In addition,
the Company holds money on short term deposit, on which notice is
95 days with the balance at year end US$104,000 (2022 -
US$4,922,000). We continue to hold the cost of acquiring the option
under the License Agreement with the Icahn School of Medicine of
Mount Sinai ("Mount Sinai") at its original purchase cost, without
amortisation. The option fee gives the Company access in the future
to the de-identified participant records held by Mount Sinai to
assist in the development of future products. As this asset is
therefore not currently being utilised no amortisation has been
charged to date.
Statement of Cash Flows
The net outflow from operating
activities was US$5,020,000 (2022 - US$5,845,000), with minimal
outflows for investing and financing activities such that net cash
outflow for the year was US$364,000 (2022 - outflow of
$6,129,000).
David Anderson
Chief Financial Officer
3 April 2024
Statement of Profit or Loss and Other
Comprehensive Income
For the year ended 31 December
2023
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
Note
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
|
|
|
Revenue
|
4
|
46
|
24
|
Cost of sales
|
|
-
|
-
|
|
|
_________
|
_________
|
|
|
|
|
Gross
margin
|
|
46
|
24
|
|
|
|
|
Administrative expenses
|
6
|
(5,238)
|
(6,865)
|
Share-based payments
|
6
|
(186)
|
(614)
|
Depreciation
|
6
|
(254)
|
(285)
|
|
|
_________
|
_________
|
|
|
|
|
Loss from
operations
|
|
(5,632)
|
(7,740)
|
|
|
|
|
Other operating income
|
6
|
44
|
102
|
Finance income
|
9
|
223
|
88
|
Finance expense
|
9
|
(41)
|
(52)
|
|
|
_________
|
_________
|
|
|
|
|
Loss before
tax
|
|
(5,406)
|
(7,602)
|
|
|
|
|
Tax expense
|
10
|
(7)
|
(4)
|
|
|
_________
|
_________
|
|
|
|
|
Loss from
continuing operations
|
|
(5,413)
|
(7,606)
|
|
|
|
|
Other
comprehensive income
|
|
-
|
-
|
|
|
|
|
|
|
_________
|
_________
|
Loss and total
comprehensive income attributable to the owners of the
Company
|
|
(5,413)
|
(7,606)
|
|
|
_________
|
_________
|
|
|
|
|
Earnings per share attributable to the
ordinary equity holders of the parent
|
11
|
|
|
|
|
|
|
Loss per share
|
|
|
|
Basic and diluted (US$
cents)
|
|
(21.2)
|
(29.8)
|
|
|
_________
|
_________
|
Statement of Financial
Position
As at 31 December 2023
|
Note
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
Assets
|
|
|
|
Current assets
|
|
|
|
Trade and other receivables
|
14
|
474
|
613
|
Short term deposits
|
5
|
104
|
4,922
|
Cash and cash equivalents
|
5
|
2,724
|
3,088
|
|
|
_________
|
_________
|
|
|
|
|
|
|
3,302
|
8,623
|
|
|
_________
|
_________
|
Non-current assets
|
|
|
|
Property, plant and
equipment
|
12
|
389
|
566
|
Intangible assets
|
13
|
5,818
|
5,818
|
Other receivables
|
14
|
13
|
13
|
|
|
_________
|
_________
|
|
|
|
|
|
|
6,220
|
6,397
|
|
|
_________
|
_________
|
|
|
|
|
Total assets
|
|
9,522
|
15,020
|
|
|
_________
|
_________
|
Liabilities
|
|
|
|
Current
liabilities
|
|
|
|
Trade and other payables
|
15
|
1,213
|
1,229
|
Lease liabilities
|
16
|
233
|
255
|
|
|
_________
|
_________
|
|
|
|
|
|
|
1,446
|
1,484
|
Non-current
liabilities
|
|
|
|
Lease liabilities
|
16
|
113
|
346
|
Provisions
|
17
|
50
|
50
|
|
|
_________
|
_________
|
|
|
|
|
Total
liabilities
|
|
1,609
|
1,880
|
|
|
_________
|
_________
|
|
|
|
|
NET
ASSETS
|
|
7,913
|
13,140
|
|
|
_________
|
_________
|
Issued capital and reserves attributable to
|
|
|
|
owners of the parent
|
|
|
|
Share capital
|
19
|
3
|
3
|
Share premium reserve
|
20
|
91,266
|
91,266
|
Share based payment
reserve
|
|
1,760
|
1,574
|
Accumulated losses
|
|
(85,116)
|
(79,703)
|
|
|
_________
|
_________
|
|
|
|
|
TOTAL EQUITY
|
|
7,913
|
13,140
|
|
|
_________
|
_________
|
Statement of Cash Flows
For the year ended 31 December
2023
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
Note
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
Cash flows from operating activities
|
|
|
|
Loss for the year
|
|
(5,413)
|
(7,606)
|
Adjustments for:
|
|
|
|
Depreciation of property, plant and
equipment
|
|
254
|
285
|
Gain on sale of tangible
assets
|
|
-
|
(43)
|
Foreign exchange loss on short term
deposits
|
|
-
|
562
|
Finance income
|
|
(223)
|
(88)
|
Finance expense
|
|
41
|
52
|
Taxation
|
|
7
|
4
|
Share-based payments
expense
|
|
186
|
614
|
|
|
_________
|
_________
|
|
|
|
|
|
|
(5,148)
|
(6,220)
|
|
|
|
|
(Increase) / decrease in trade and
other receivables
|
|
151
|
128
|
(Decrease) / increase in trade and
other payables
|
|
(16)
|
251
|
Income taxes paid
|
|
(7)
|
(4)
|
|
|
_________
|
_________
|
|
|
|
|
Net
cash outflow from operating activities
|
|
(5,020)
|
(5,845)
|
|
|
_________
|
_________
|
Cash flows from investing activities
|
|
|
|
Purchases of tangible
assets
|
|
(77)
|
(85)
|
Interest received
|
|
212
|
88
|
Proceeds from sale of tangible
assets
|
|
-
|
43
|
Short term deposits
|
|
4,817
|
(73)
|
|
|
_________
|
_________
|
|
|
|
|
Net
cash generated by / (used in) investing
activities
|
|
4,952
|
(27)
|
|
|
_________
|
_________
|
Cash flows from financing activities
|
|
|
|
Issue of Common Stock
|
|
-
|
2
|
Interest paid
|
|
(41)
|
(52)
|
Repayment of lease
liabilities
|
|
(255)
|
(207)
|
|
|
_________
|
_________
|
|
|
|
|
Net
cash (used in) / from financing activities
|
|
(296)
|
(257)
|
|
|
|
|
Net
decrease in cash and cash equivalents
|
|
(364)
|
(6,129)
|
Cash and cash equivalents at beginning of
year
|
|
3,088
|
9,217
|
|
|
_________
|
_________
|
|
|
|
|
Cash and cash equivalents at end of year
|
5
|
2,724
|
3,088
|
|
|
_________
|
_________
|
Notes to the financial
statements
For the year ended 31 December
2023
LungLife AI, Inc, (the "Company") is a company based in
Thousand Oaks, California which is developing a diagnostic test for
the early detection of lung cancer. The Company was incorporated
under the laws of the state of Delaware, USA, on 30 December
2009.
The Company's costs associated with
developing and commercialising its test include costs associated
with the development of intellectual property optimising the
technology, and obtaining regulatory
approval. To complete clinical trials the Company will continue to
require additional operating funds. The Company has raised funds
through offerings of debt, common stock and Series A Preferred
Shares.
There are no restrictions on the
Company's ability to access or use its assets and settle its
liabilities.
Information in this preliminary
announcement does not constitute statutory accounts of the
company. The financial information presented in this
preliminary announcement is based on, and is consistent with, that
in the company's audited financial statements for the year ended 31
December 2023, which will be delivered to shareholders for approval
at the Company's Annual General Meeting. The independent auditors
have reported on those financial statements and their report is
unqualified.
The financial statements have been
prepared in accordance with UK adopted
International Accounting Standards
("UK IFRS").
These financial statements are
prepared in accordance with UK IFRS under
the historical cost convention, as modified by the use of fair
value for certain financial instruments measured at fair value. The
historical financial information is presented in United States
Dollars ("US$") except
where otherwise indicated.
The principal accounting policies
adopted in the preparation of the financial statements are set out
below.
The policies have been consistently
applied to all the years presented, unless otherwise
stated.
(a)
Going concern
These financial statements have been
prepared on the going concern basis.
On 2 January 2024, LungLife reported
positive validation study results for its LungLB® test, a minimally
invasive blood draw test used for the early detection of lung
cancer. These results are the catalyst for the Company to begin its
commercialisation process for the test. In view of the early stage
of its commercial development the group currently funds its
activities from existing cash resources. In addition, it expects to
generate cash receipts from commercial revenues in future periods
and if required, from additional equity or debt funding for future
working capital needs.
At 31 December 2023 the Company had
available cash resources and short term deposits of $2.8 million
(2022 - $8.0 million. The Company is focused on the commercial
proof of concept of its test and expects minimal revenues in 2024.
As there are uncertainties in relation to the quantum and timing of
cash receipts the financial projections have been prepared without
including any assumed receipts from commercial revenues.
As set out in note 23, on 21 March
2024 a special meeting of the Company approved the issue of
5,172,621 new shares of common stock of the Company at a price of
35 pence per share. The new shares represent approximately 16.9 per
cent. of the enlarged share capital of the company. The issue of
shares raised approximately £1.8 million (approximately US$2.3
million) (before fees and expenses). The net proceeds of the
fundraising, along with the Company's existing cash resources, are
expected to be utilised to establish the commercial proof of
concept of the Company's LungLB® test, including:
·
funding of evidence generating activities,
including the Early Access Program and clinical utility studies to
support reimbursement and test adoption;
·
increasing expenditure to support engagement with
payors and clinicians, and support the wider need to raise clinical
awareness via key opinion leaders, publications and conferences;
and
·
accelerating the commercial pathway by pursuing
licensing or other similar agreements.
The net proceeds of the fundraising
will allow the Company to consider all of its strategic options in
order to maximise shareholder value and, in conjunction with the
implementation of certain cost-cutting actions, is expected to
provide the Company with a cash runway to early April
2025.
Having taken into account the
information and estimates available at the date of approving these
financial statements, the directors consider it is appropriate to
adopt the going concern basis in preparing the financial
statements. Although the company's projections, including expected
levels of revenue generation, indicate sufficient funds through to
the second quarter of 2025, it is reasonably possible that the
group will require additional funding during, or shortly after a
period of 12 months from the date of approval of these financial
statements. The directors will seek to put in place funding
arrangements which may from time to time be required but such
arrangements are not presently committed. This represents a
material uncertainty in relation to the group's funding
arrangements.
(b) New standards, amendments and
interpretations
New standards are not expected to
impact the Company as they are either not relevant to the Company's
activities or require accounting which is consistent with the
Company's current accounting policies.
The Directors have considered those
standards and interpretations which have not been applied in these
financial statements but which are relevant to the Company's
operations that are in issue but not yet effective and do not
consider that they will have a material effect on the future result
of operations, statement of position or statement of cash flows of
the Company.
(c)
Revenue
recognition
Royalty income
Under the terms of a patent and
technology sub license agreement the company is entitled to receive
royalty income at 6% of the quarterly net sales invoiced by the sub
licensee in the relevant quarter. Income is recognised in the
period in which the underlying net sales are generated.
Cash is received from revenues
recognised according to terms of trade within the relevant
contractual relationship, usually in
accordance with agreed events such as placing of order, fulfilment
of order and delivery.
(d)
Intangible assets
Licenses are measured at cost less
accumulated amortization and any accumulated impairment
losses.
(e)
Property, plant
and equipment
Owned assets
Items of property, plant and
equipment are stated at cost less accumulated depreciation and impairment losses. Cost includes
the original purchase price of the asset and the costs attributable
to bringing the asset to its working condition for its intended
use. When parts of an item of property, plant and equipment have
different useful lives, those components are accounted for as
separate items of property, plant and equipment.
Subsequent costs are included in the
asset's carrying amount or recognised as a separate asset, as
appropriate, only when it is probable that future economic benefits
associated with the item will flow to the Company and the cost of
the item can be measured reliably.
(e)
Property, plant
and equipment (continued)
Depreciation
Depreciation is charged to profit or
loss on a straight-line basis over the estimated useful lives of
each part of an item of property, plant and equipment. The
estimated useful lives are as follows:
·
computer and IT equipment - 33 per cent. straight
line
·
leasehold improvements - shorter of lease term and
useful life
· plant and
machinery - 20 per cent. straight line
·
laboratory equipment - 20 per cent. straight
line
The residual values, useful lives
and depreciation methods are reviewed, and adjusted if appropriate,
or if there is an indication of a significant change since the last
reporting date.
Gains and losses on disposals are
determined by comparing the proceeds with the carrying amount and
are recognised within "other operating income" in the statement of
income.
(f)
Impairment of
non-financial assets
Non-financial assets are reviewed
for impairment annually in the case of not being
available for use, and whenever events or changes in
circumstances indicate that the carrying amount may not be
recoverable. An impairment loss is recognised for the amount by
which the asset's carrying amount exceeds its recoverable amount.
The recoverable amount is the higher of an asset's fair value less
costs to sell and value in use. For the purposes of assessing
impairment, assets are considered at the lowest levels for which
there are separately identifiable cash flows (cash- generating
units).
(g)
Financial
assets
Classification
The Company classifies its financial
assets as loans and receivables. The classification depends on the
purpose for which the investments were acquired. Management
determines the classification of its investments at initial
recognition.
Loans and receivables
Loans and receivables are
non-derivative financial assets with fixed or determinable
payments. They are initially recognised at fair value and are
subsequently stated at amortised cost using the effective interest
method.
Impairment of financial assets
Impairment provisions are recognised
when there is objective evidence (such as significant financial
difficulties on the part of the counterparty or default or
significant delay in payment) that
the Company will be unable to collect all of the amounts due under
the term's receivable, the amount of such a provision being the
difference between the net carrying amount and the present value of
the future expected cash flows associated with the impaired
asset.
(h)
Cash and cash
equivalents
Cash and cash equivalents comprise
cash balances and call deposits with an original maturity of three
months or less.
(i)
Financial
liabilities
Trade and other payables
Trade and other payables are
initially recognised at fair value and subsequently measured at amortised cost. Accounts payable are
classified as current liabilities if payment is due within one year
or less. If not, they are presented as non-current
liabilities.
(j)
Provisions
A provision is recognised in the
statement of financial position when the Company has a present
legal or constructive obligation as a result of a past event, and
it is probable that an outflow of economic benefits will be
required to settle the obligation. If the effect is material,
provisions are determined by discounting the expected future cash
flows at a pre- tax rate that reflects current market assessments
of the time value of money and, when appropriate, the risks
specific to the liability. The increase in the provision due to the
passage of time is recognised in finance costs.
(k)
Share
capital
Ordinary shares are classified as
equity. There are various classes of ordinary shares in issue, as
detailed in note 19. Incremental costs directly attributable to the
issue of new shares are shown in share premium as a deduction from
the proceeds.
(l)
Net finance
costs
Finance costs
Finance costs comprise interest
payable on borrowings, direct issue costs and dividends on
preference shares, and are expensed in the period in which they are
incurred.
Finance income
Finance income comprises interest
receivable on funds invested.
Interest income is recognised in the
income statement as it accrues using the effective interest
method.
(m) Leases
All leases are accounted for by
recognising a right-of-use asset and a lease liability except
for:
·
Leases of low value assets; and
·
Leases with a duration of 12 months or
less.
Lease liabilities are measured at
the present value of the contractual payments due to the
lessor over the lease term, with the
discount rate determined by reference to the rate inherent in the
lease unless (as is typically the case) this is not readily
determinable, in which case the Company's incremental borrowing
rate on commencement of the lease is used. Other variable lease
payments are expensed in the period to which they
relate.
On initial recognition, the carrying
value of the lease liability also includes:
·
amounts expected to be payable under any residual
value guarantee
·
the exercise price of any purchase option granted
in favour of the Company if it is reasonably certain to assess that
option
·
any penalties payable for terminating the lease,
if the term of the lease has been estimated on the basis of
termination option being exercised.
Right of use assets are initially
measured at the amount of the lease liability, reduced for any
lease incentives received, and increased for:
·
lease payments made at or before commencement of
the lease
·
initial direct costs incurred; and
·
the amount of any provision recognised where the
Company is contractually required to dismantle, remove or restore
the leased asset (typically leasehold dilapidations - see note
17).
Subsequent to initial measurement
lease liabilities increase as a result of interest charged at a
constant rate on the balance outstanding and are reduced for lease
payments made. Right-of-use assets are amortised on a straight-line
basis over the remaining term of the lease or over the remaining
economic life of the asset if, rarely, this is judged to be shorter
than the lease term.
(n)
Leases (continued)
When the company revises its
estimate of the term of any lease (because, for example, it
re-assesses the probability of a lessee extension or termination
option being exercised) it adjusts the carrying amount of the lease
liability to reflect the payments to make over the revised term,
which are discounted using a revised discount rate. The carrying
value of lease liabilities is similarly revised when the variable
element of future lease payments dependent on a rate or index is
revised, except the discount rate remains unchanged. In both cases
an equivalent adjustment is made to the carrying value of the
right-of-use asset, with the revised carrying amount being
amortised over the remaining (revised) lease term. If the
carrying amount of the right-of-use asset is adjusted to zero, any
further reduction is recognised in profit or loss.
(o)
Income
tax
Income tax for the years presented
comprises current and deferred tax. Income tax is recognised in the
income statement except to the extent that it relates to items
recognised directly in equity, in which case it is recognised in
equity. Current tax is the expected tax payable on the taxable income for the year, using tax rates
enacted or substantively enacted at the statement of financial
position date, and any adjustment to tax payable in respect of
previous years.
Deferred tax is recognised on
temporary differences arising between the tax bases of assets and
liabilities and their carrying amounts.
The following temporary differences
are not recognised if they arise from (a) the initial recognition
of goodwill; and (b) for the initial recognition of other assets or
liabilities in a transaction other than a business combination that
at the time of the transaction affects neither accounting nor
taxable profit or loss. The amount of deferred tax provided is
based on the expected manner of realisation or settlement of
the carrying amount of assets and liabilities, using tax rates
enacted or substantively enacted at the statement of financial
position date.
A deferred tax asset is recognised
only to the extent that it is probable that future taxable profits
will be available against which the asset can be utilised. Deferred
tax assets are reduced to the extent that it is no longer probable
that the related tax benefit will be realised.
Deferred income tax assets and
liabilities are offset when there is a legally enforceable right to
offset current tax assets against current tax liabilities and when
the deferred income taxes assets and liabilities relate to income
taxes levied by the same taxation authority on either the taxable
entity or different taxable entities where there is an intention to
settle the balances on a net basis.
(p)
Foreign currency
translation
i) Function and
presentational currency
Items included in the financial
statements of the Company are measured using USD, the currency of
the primary economic environment in which the entity operates ('the
functional currency'), which is also the Company's presentation
currency.
ii) Transactions and
balances
Foreign currency transactions are
translated into the functional currency using the exchange rates
prevailing at the dates of the transactions. Foreign exchange gains
and losses resulting from the settlement of such transactions and
from the translation at year-end exchange rates, of monetary assets
and liabilities denominated in foreign currencies to USD, are
recognised in the income statement.
3
|
Critical accounting judgements and estimates
|
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 judgement is likely to have the most significant effect
on the amounts recognised in the financial information.
Classification of the Mount Sinai License as an intangible
asset
As set out in note 13, on 18
June 2021, the Company entered into the Mount Sinai License
Agreement, pursuant to which Mount Sinai granted an option to the
Company to obtain a licence, on a non-exclusive basis, to use
certain information held by Mount Sinai. After considering the
criteria in IAS38 the directors have judged that the recognition
criteria therein have been met and classified the Mount Sinai
license as an intangible asset.
IFRS 8 requires operating segments
to be identified on the basis of internal reports about components
of the Company that are regularly reviewed by the chief operating
decision maker (which takes the form of the Board of Directors) as
defined in IFRS 8, in order to allocate resources to the segment
and to assess its performance.
The chief operating decision maker
has determined that the Company has one operating segment, the development and commercialisation of
its lung cancer early detection test. Revenues are reviewed based
on the products and services provided. All revenue arises from the
same customer in both years.
The Company operates in the United
States of America. Revenue by origin of geographical segment is as follows:
|
|
Year to
31 December
2023
|
Year to
31 December
2022
|
|
|
US$'000
|
US$'000
|
|
Revenue
|
|
|
|
People's Republic of
China
|
46
|
24
|
|
|
________
|
________
|
|
|
|
|
|
|
46
|
24
|
|
|
________
|
________
|
|
|
|
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
Non-current assets
|
|
|
|
United States of America
|
6,220
|
6,397
|
|
|
________
|
________
|
|
|
|
|
|
|
6,220
|
6,397
|
|
|
________
|
________
|
|
|
|
|
|
|
Year to
31
December
2023
|
Year to
31 December
2022
|
|
|
US$'000
|
US$'000
|
|
Product and service revenue
|
|
|
|
Royalty income
|
46
|
24
|
|
|
________
|
________
|
|
|
|
|
|
|
46
|
24
|
|
|
________
|
________
|
5
|
Financial instruments - Risk
management
|
The Company is exposed through its operations
to the following financial risks:
- Credit
risk
- Foreign
exchange risk and
- Liquidity
risk
The Company is exposed to risks that arise from
its use of financial instruments. This note describes the Company's
objectives, policies and processes for managing those risks and the
methods used to measure them. Further quantitative information in
respect of these risks is presented throughout these financial
statements.
(i)
Principal financial instruments
The principal financial instruments used by the
Company, from which financial instrument risk arises, are as
follows:
-
Cash and cash equivalents
-
Short term cash deposits
-
Trade and other payables
(ii) Financial instruments by
category
Financial
asset
|
|
|
|
|
|
Amortised
|
Amortised
|
|
|
Cost
|
cost
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
|
|
|
|
Cash and cash equivalents
|
2,724
|
3,088
|
|
Short term cash deposits
|
104
|
4,922
|
|
Trade and other receivables
|
174
|
155
|
|
|
_________
|
_________
|
|
|
|
|
|
Total financial assets
|
3,002
|
8,165
|
|
|
_________
|
_________
|
|
|
|
| |
Financial
liabilities
|
|
|
|
|
|
Amortised
|
Amortised
|
|
|
Cost
|
cost
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
|
|
|
|
Trade and other payables
|
1,039
|
1,055
|
|
|
_________
|
_________
|
|
|
|
|
|
Total financial
liabilities
|
1,039
|
1,055
|
|
|
_________
|
_________
|
(iii) Financial instruments not measured
at fair value
Financial instruments not measured at fair
value includes cash and cash equivalents, trade and other
receivables, and trade and other payables.
Due to their short-term nature, the carrying
value of cash and cash equivalents, trade and other receivables,
and trade and other payables approximates their fair
value.
See note 16 for information on lease
liabilities.
(iv) Financial
instruments
General objectives, policies
and processes
The Board has overall responsibility for the
determination of the Company's risk management objectives and
policies and, whilst retaining ultimate responsibility for them, it
has delegated the authority for designing and operating processes
that ensure the effective implementation of the objectives and
policies to the Company's finance function.
The overall objective of the Board is to set
policies that seek to reduce risk as far as possible without unduly
affecting the Company's competitiveness and flexibility. Further
details regarding these policies are set out below:
Credit
risk
Credit risk is the risk of financial loss to
the Company if a customer or counterparty to a financial instrument
fails to meet its contractual obligations. Due to the current low
level of revenue, the Company's exposure to credit risk is on cash
at bank. The Company only deposits cash with major banks with high
quality credit standing.
Cash in bank
and short-term deposits
The credit quality of cash has been assessed by
reference to external credit rating, based on Standard and Poor's
long-term / senior issuer rating:
|
|
|
|
|
|
|
|
2023
|
2023
|
2022
|
2022
|
|
Cash in bank
|
|
Cash
|
|
Cash
|
|
|
Rating
|
at bank
|
Rating
|
at bank
|
|
|
|
US$'000
|
|
US$'000
|
|
|
|
|
|
|
|
Bank A
|
A+
|
58
|
A+
|
981
|
|
Bank B
|
BBB+
|
2,588
|
BBB+
|
2,002
|
|
Bank C
|
A+
|
78
|
A+
|
105
|
|
|
|
_________
|
|
_________
|
|
|
|
|
|
|
|
|
|
2,724
|
|
3,088
|
|
|
|
_________
|
|
_________
|
|
|
|
|
|
|
|
|
2023
|
2023
|
2022
|
2022
|
|
Short term
deposits
|
|
|
|
|
|
|
Rating
|
|
Rating
|
|
|
|
|
US$'000
|
|
US$'000
|
|
|
|
|
|
|
|
Bank B
|
BBB+
|
104
|
BBB+
|
4,922
|
|
|
|
_________
|
|
_________
|
|
|
|
|
|
|
|
|
|
104
|
|
4,922
|
|
|
|
_________
|
|
_________
|
Foreign
exchange risk
Foreign exchange risk arises when the Company
enters into transactions denominated in a currency other than its
functional currency. The Company's policy is, where possible, to
settle liabilities denominated in its functional currency.
Currently the Company's liabilities are either US dollar or UK
sterling. No forward contracts or other financial instruments are
entered into to hedge foreign exchange movements, with funds raised
in the UK being transferred to fund US operations using spot
rates.
As at 31 December 2023 assets held in Sterling
amounted to US$79,000 (2022 - US$5,275,000) and liabilities held in
Sterling amounted to US$92,000 (2022 - US$65,000).
The effect of a 5% strengthening of the
Sterling against US dollar at the reporting date on the Sterling
denominated net assets carried at that date would, all other
variables held constant, have resulted in a decrease in post-tax
loss for the year and decrease of net assets of US$1,000 (2022 -
increase US$260,000). A 5% weakening in the exchange rate
would, on the same basis, have increased post-tax loss and
decreased net assets by US$1,000 (2022 - US$260,000).
Liquidity
risk
Liquidity risk is the risk that the Company
will encounter difficulty in meeting its financial obligations as
they fall due. This risk is managed by the production of annual
cash flow projections. The Company's continued future operations
depend on its ability to raise sufficient working capital through
the issue of share capital and generating revenue.
The following table sets out the contractual
maturities (representing undiscounted contractual cash-flows) of
financial liabilities which can all be met from the cash resources
currently available:
|
|
|
Between
|
|
|
Up to 3
|
3 and 12
|
|
|
Months
|
months
|
|
At 31 December
2023
|
US$'000
|
US$'000
|
|
|
|
|
|
Trade and other payables
|
454
|
-
|
|
|
_________
|
_________
|
|
|
|
|
|
Total
|
454
|
-
|
|
|
_________
|
_________
|
|
|
|
Between
|
|
|
Up to 3
|
3 and 12
|
|
|
Months
|
months
|
|
At 31 December
2022
|
US$'000
|
US$'000
|
|
|
|
|
|
Trade and other payables
|
371
|
-
|
|
|
_________
|
_________
|
|
|
|
|
|
Total
|
371
|
-
|
|
|
_________
|
_________
|
Capital
Disclosures
The Company monitors its capital which
comprises all components of equity (i.e., share capital, share
premium, and accumulated losses).
The Company's objectives when maintaining
capital are to safeguard the entity's ability to continue as a
going concern.
6
|
Expenses by nature
|
|
|
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
|
|
|
|
Employee benefit expenses (see note
8)
|
2,908
|
3,264
|
|
Share-based payments charge -
non-employee and directors
|
17
|
37
|
|
Depreciation of property, plant and
equipment
|
254
|
285
|
|
Gain on disposal of
equipment
|
-
|
(43)
|
|
Research and development
expenditure
|
1,308
|
1,981
|
|
Professional costs
|
609
|
643
|
|
Foreign exchange (gains) /
losses
|
(146)
|
659
|
|
Other costs
|
728
|
938
|
Other operating income is claims made for
Employee Retention Credits.
During the year the Company obtained the
following services from the Company's auditor:
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
Fees payable to the Company's auditor for the audit
of the Company
|
56
|
48
|
|
|
_________
|
_________
|
|
|
|
|
|
Total
|
56
|
48
|
|
|
_________
|
_________
|
8
|
Employee benefit
expenses
|
|
|
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
Employee benefit expenses (including
Directors) comprise:
|
|
|
|
|
|
|
|
Wages and salaries
|
2,312
|
2,262
|
|
Benefits
|
185
|
164
|
|
Share-based payments
expense
|
169
|
577
|
|
Social security contributions and
similar taxes
|
171
|
177
|
|
Pension
|
71
|
84
|
|
|
_________
|
_________
|
|
|
|
|
|
|
2,908
|
3,264
|
|
|
_________
|
_________
|
Key
management personnel compensation
Key management personnel are those
persons having authority and responsibility for planning, directing
and controlling the activities of the Company, including the
Directors of the Company.
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
US$
|
US$
|
|
|
|
|
|
Salary
|
683
|
696
|
|
Share based payment expense
|
124
|
495
|
|
|
_________
|
_________
|
|
|
|
|
|
|
807
|
1,191
|
|
|
_________
|
_________
|
|
|
|
| |
The average number of employees (including
Directors) in the Company in the year was 19 (2022 -
18).
9
|
Net finance costs
|
|
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
Finance
expense
|
|
|
|
|
|
|
|
Interest expense on lease
liabilities
|
36
|
52
|
|
Interest on short term
funding
|
5
|
-
|
|
|
_________
|
_________
|
|
|
|
|
|
Total finance
expense
|
41
|
52
|
|
|
_________
|
_________
|
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
Finance
income
|
|
|
|
|
|
|
|
Bank interest
|
223
|
88
|
|
|
_________
|
_________
|
|
|
|
|
|
Total finance
income
|
223
|
88
|
|
|
_________
|
_________
|
10
|
Tax
expense
|
|
|
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
|
|
|
|
Current tax expense
|
|
|
|
Current tax on loss for the
year
|
-
|
-
|
|
Withholding tax on
royalties
|
7
|
4
|
|
|
_________
|
_________
|
|
|
|
|
|
Total current tax
|
7
|
4
|
|
|
|
|
|
Deferred tax asset
|
|
|
|
On losses generated in the
year
|
-
|
-
|
|
|
_________
|
_________
|
|
|
|
|
|
|
7
|
4
|
|
|
_________
|
_________
|
There were no charges to current
corporation taxation due to the losses incurred by the Company in
the year. The reasons for the difference between the actual tax
charge for the year and the US federal income tax rate of 21% and
state of California income tax rate of 8.84% are as
follows:
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
|
|
|
|
|
|
|
|
Loss for the year
|
(5,413)
|
(7,606)
|
|
|
_________
|
_________
|
|
|
|
|
|
Tax using 29.84%
|
(1,615)
|
(2,270)
|
|
Expenses not deductible for tax
purposes
|
37
|
34
|
|
Unrecognised deferred tax assets for
losses carried forward
|
1,578
|
2,236
|
|
|
_________
|
_________
|
|
|
|
|
|
Total tax expense
|
-
|
-
|
|
|
_________
|
_________
|
The unrecognised deferred tax is based on
Federal taxable losses carried forward of US$56,623,000 (2022 -
US$53,485,000) and a Federal capital loss of US$4,583,333 (2022 -
US$4,583,333). No deferred tax asset is recognised for these losses
due to early stage in the development of the Company's activities.
Of the total Federal losses carried forward US$35,281,000 (2022 -
US$35,281,000) expire in 2030 and can only be used against trading
profits from the same trade. Losses of US$21,342,000 (2022 -
US$18,204,000) do not expire but can only offset against 80% of
taxable profits from the same trade.
11
|
Loss per
share
|
|
|
|
|
|
|
|
|
Year to
|
Year to
|
|
|
31 December
|
31 December
|
|
|
2023
|
2022
|
|
|
Total
|
Total
|
|
Numerator
|
US$
|
US$
|
|
|
|
|
|
Loss for the year used in basic
EPS
|
(5,413,213)
|
(7,605,585)
|
|
|
|
|
|
Denominator
|
|
|
|
|
|
|
|
Weighted average number of ordinary
shares used in basic EPS
|
25,485,982
|
25,481,800
|
|
|
|
|
|
Resulting loss per share
|
(US$0.212)
|
(US$0.298)
|
The Company has one category of
dilutive potential ordinary share, being share options (see note
21). The potential shares were not dilutive in the year as the
Company made a loss per share in line with IAS 33. As described in
note 19, between 2 July 2021 and 7 July 2021 the Company
implemented a pre-Admission reorganisation of its capital which
included the conversion of Series A and B Preferred Shares into
Common Shares and a reverse share split by way of the issue of one
new Common Share and Preferred Share for every 18 old Common Shares
and Preferred Shares held.
12
|
Tangible
assets
|
|
|
|
|
|
|
|
|
Furniture
|
Computers
|
|
|
|
|
Leasehold
|
and
|
and IT
|
Plant &
|
|
|
|
improvements
|
equipment
|
Equipment
|
machinery
|
Total
|
|
|
US$'000
|
US$'000
|
US$'000
|
US$'000
|
US$
|
|
Cost or valuation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 1 January
2022
|
1,316
|
56
|
85
|
1,309
|
2,766
|
|
Additions
|
-
|
-
|
31
|
54
|
85
|
|
|
________
|
________
|
________
|
_________
|
_________
|
|
At 31 December
2022
|
1,316
|
56
|
116
|
1,363
|
2,851
|
|
Additions
|
-
|
-
|
-
|
77
|
77
|
|
|
________
|
________
|
________
|
________
|
________
|
|
At 31 December
2023
|
1,316
|
56
|
116
|
1,440
|
2,928
|
|
|
________
|
________
|
________
|
________
|
________
|
|
|
|
|
|
|
|
|
Accumulated depreciation and
impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 1 January
2022
|
945
|
56
|
53
|
946
|
2,000
|
|
Depreciation
|
140
|
-
|
19
|
126
|
285
|
|
|
________
|
________
|
________
|
________
|
________
|
|
At 31 December
2022
|
1,085
|
56
|
72
|
1,072
|
2,285
|
|
Depreciation
|
131
|
-
|
22
|
101
|
254
|
|
|
________
|
________
|
________
|
________
|
________
|
|
|
|
|
|
|
|
|
At 31 December
2023
|
1,216
|
56
|
94
|
1,173
|
2,539
|
|
|
________
|
________
|
________
|
________
|
________
|
|
|
|
|
|
|
|
|
Net
book value
|
|
|
|
|
|
|
At 31 December
2023
|
100
|
-
|
22
|
267
|
389
|
|
|
________
|
________
|
________
|
________
|
________
|
|
|
|
|
|
|
|
|
At 31 December
2022
|
231
|
-
|
44
|
291
|
566
|
|
|
________
|
________
|
________
|
________
|
________
|
Included in leasehold improvements
at 31 December 2023 are right of use assets with a cost of
$1,282,000 (2022 - $1,282,000) and accumulated depreciation of
$1,173,000 (2022 - $1,042,000).
13
|
Intangible
assets
|
|
|
|
|
|
|
|
|
License
|
Total
|
|
|
US$'000
|
US$'000
|
|
Cost
|
|
|
|
|
_________
|
_________
|
|
|
|
|
|
At 31 December
2022 and 2023
|
5,818
|
5,818
|
|
|
_________
|
_________
|
|
|
|
|
|
Accumulated amortisation and
impairment
|
|
|
|
|
|
|
|
At 1 January
2022
|
-
|
-
|
|
Amortisation charge
|
-
|
-
|
|
|
_________
|
_________
|
|
|
|
|
|
At 31 December
2022
|
-
|
-
|
|
Amortisation charge
|
|
|
|
|
_________
|
_________
|
|
|
|
|
|
At 31 December
2023
|
-
|
-
|
|
|
|
|
|
|
_________
|
_________
|
|
|
|
|
|
Net
book value
|
|
|
|
At 31 December
2023
|
5,818
|
5,818
|
|
|
_________
|
_________
|
|
|
|
|
|
At 31 December
2022
|
5,818
|
5,818
|
|
|
_________
|
_________
|
On 18 June 2021, the Company entered into the Mount
Sinai Licence Agreement, pursuant to which the Icahn School of
Medicine at Mount Sinai ("Mount Sinai") granted an option to the
Company to obtain a licence, on a non-exclusive basis, to use
certain information held by Mount Sinai. The Mount Sinai Licence
Agreement automatically became effective on Admission. Exercise of
the option contained in the Mount Sinai Licence Agreement is
conditional on: (i) Admission; (ii) clearance by Mount Sinai's
information security team; and (iii) IRB, data security and data
use approvals. Mount Sinai is under an obligation to use
commercially reasonable efforts to obtain such clearances and
approvals (other than Admission). Pursuant to the Mount Sinai
Licence Agreement, Mount Sinai has granted the Company an option to
obtain a licence, on a non-exclusive basis, to use certain
information held by Mount Sinai to be able to develop future
products.
14
|
Trade and other
receivables
|
|
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
Amounts
falling due within one year
|
|
|
|
|
|
|
|
Prepayments
Accrued income
|
299
31
|
458
5
|
|
Other debtors
|
144
|
150
|
|
|
_________
|
_________
|
|
|
|
|
|
|
474
|
613
|
|
|
_________
|
_________
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
Amounts
falling due after one year
|
|
|
|
|
|
|
|
Rent deposit
|
13
|
13
|
|
|
_________
|
_________
|
|
|
|
|
|
|
13
|
13
|
|
|
_________
|
_________
|
15
|
Trade and
other payables
|
|
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
|
|
|
|
|
|
|
|
Trade payables
|
439
|
358
|
|
Accruals and other payables
|
759
|
858
|
|
|
_________
|
_________
|
|
Total financial liabilities classified as
financial liabilities measured at amortised cost
|
1,198
|
1,216
|
|
|
|
|
|
Other payables - tax and social security
payments
|
15
|
13
|
|
|
_________
|
_________
|
|
|
|
|
|
Total trade and other payables
|
1,213
|
1,229
|
|
|
_________
|
_________
|
The carrying value of trade and
other payables classified as financial liabilities measured at
amortised cost approximates fair value.
16
|
Lease Liabilities
|
|
|
|
|
|
Land and
|
Plant and
|
|
|
|
buildings
|
machinery
|
Total
|
|
|
US$'000
|
US$'000
|
US$'000
|
|
|
|
|
|
|
At 1 January 2022
|
504
|
304
|
808
|
|
Interest expense
|
37
|
15
|
52
|
|
Repayments
|
(134)
|
(125)
|
(259)
|
|
|
________
|
________
|
________
|
|
|
|
|
|
|
At
31 December 2022
|
407
|
194
|
601
|
|
|
________
|
________
|
________
|
|
|
|
|
|
|
Repayments
|
(166)
|
(125)
|
(291)
|
|
Interest expense
|
27
|
9
|
36
|
|
|
________
|
________
|
________
|
|
|
|
|
|
|
At
31 December 2023
|
268
|
78
|
346
|
|
|
________
|
________
|
________
|
|
|
|
|
2023
|
2022
|
|
US$'000
|
US$'000
|
Maturity of
lease liabilities
|
|
|
Within 3 months
Between 3 - 12 months
Between 1 - 2 years
Between 2 - 5 years
|
74
179
117
-
|
75
225
253
117
|
|
________
|
________
|
|
|
|
|
370
|
670
|
|
________
|
________
|
17
|
Provisions
|
|
|
|
|
Dilapidations
|
Total
|
|
|
US$'000
|
US$'000
|
|
|
|
|
|
At 1 January 2022
|
50
|
50
|
|
Movement
|
-
|
-
|
|
|
_________
|
_________
|
|
|
|
|
|
At
31 December 2022
|
50
|
50
|
|
|
_________
|
_________
|
|
|
|
|
|
Movement
|
-
|
-
|
|
|
_________
|
_________
|
|
|
|
|
|
At
31 December 2023
|
50
|
50
|
|
|
_________
|
_________
|
Provision is made for the
anticipated cost of returning the Company's premises to their prior
state on termination of the lease.
The lease terminates in August 2025.
18
|
Net
cash /(debt) reconciliation
|
|
|
|
|
2023
|
2022
|
|
|
US$'000
|
US$'000
|
|
|
|
|
|
Cash and cash equivalents
|
2,724
|
3,088
|
|
Lease liabilities
|
(346)
|
(601)
|
|
|
_________
|
_________
|
|
|
|
|
|
Net
cash / (debt)
|
2,378
|
2,487
|
|
|
_________
|
_________
|
|
|
Cash and
|
Borrowings
|
|
|
|
cash
equivalents
|
and loans
|
Net Debt
|
|
|
US$'000
|
US$'000
|
US$'000
|
|
|
|
|
|
|
Net
debt at 1 January 2022
|
9,217
|
(808)
|
8,409
|
|
Cash flows
|
(6,129)
|
-
|
(6,129)
|
|
Other non-cash
movements:
|
|
|
|
|
Lease liabilities
|
-
|
207
|
207
|
|
|
_________
|
_________
|
_________
|
|
|
|
|
|
|
Net
debt at 31 December 2022
|
3,088
|
(601)
|
2,487
|
|
|
_________
|
_________
|
_________
|
|
|
|
|
|
|
Cash flows
|
|
|
|
|
Other non-cash
movements:
|
(364)
|
|
(364)
|
|
Lease liabilities
|
-
|
255
|
255
|
|
|
|
|
|
|
|
_________
|
_________
|
_________
|
|
|
|
|
|
|
Net
debt at 31 December 2023
|
2,724
|
(346)
|
2,378
|
|
|
_________
|
_________
|
_________
|
19
|
Share
capital
|
|
|
|
|
Issued and fully paid
|
|
|
Number
|
US$
|
|
|
|
|
|
Shares of
US$0.0001 par value each
|
|
|
|
|
|
|
|
At 1 January 2022
|
25,480,790
|
2,548
|
|
Exercise of 5,192 options in the
year
|
5,192
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total issued share capital at 31 December
2022
|
25,485,982
|
2,553
|
|
|
_________
|
_________
|
|
Total issued share capital at 31 December
2023
|
25,485,982
|
2,553
|
|
|
_________
|
_________
|
Between 2 July 2021 and 7 July 2021 the Company
implemented a pre-Admission reorganisation of its capital which
included, inter alia, the following:
· A
reverse share split by way of the issue of one new Common or
Preferred Share for every 18 old Common or Preferred Shares
held
·
Conversion of Series A-1 and Series A-2 Convertible Notes and
related Warrants into Common Shares
·
Conversion of Series A Preferred Shares and Series B
Preferred Shares into Common Shares
As a result the Company only has common shares
in issue.
The following describes the nature and purpose
of each reserve within equity:
|
Reserve
|
Description
and purpose
|
|
|
|
|
Share
premium
|
Amount subscribed for share capital in excess
of nominal value.
|
|
|
|
|
Share based
payment reserve
|
Amount charged to date in respect of share
based payment expense
|
|
|
|
|
Accumulated
losses
|
All other net gains and losses and transactions
with owners (e.g., dividends) not recognised elsewhere.
|
Prior to Admission to AIM the
Company operated two share option plans: the 2010 Stock Incentive
Plan and approved by the Board on 1 January 2010 and the 2020 Stock
Incentive Plan was approved on 14 May 2020:
(a)
options granted under the 2010 Stock Incentive
Plan fall into two groups:
(i)
options granted in or before 2016 over a total of
2,183,634 shares, with exercise prices ranging from $0.10 to $0.16
per share, these options are now fully vested; and
(ii)
options granted in 2019 over a total of 6,951,463
shares, with an exercise price of $0.025 per share: these options
generally vest on a monthly basis over three or four years from the
date of grant. However, those granted to current employees of the
Company were amended so that they became exercisable in full on
Admission.
(b) Options were granted in 2020 and 2021 under the 2020 Stock
Incentive Plan over a total of 5,364,385 shares with an exercise
price of $0.0044 per share. These options vest over four years from
the date of grant on a monthly basis, but certain of these options
accelerated immediately before Admission, and became fully
exercisable at Admission.
On 14 May 2021 the Board approved
the Company's 2021 Omnibus Long-Term Incentive Plan ("LTIP") and it
was approved by shareholders on 27 May 2021 to become effective
approximately three days prior to Admission. The LTIP provides for
the grant of both EMI Options and non-tax favoured options. Options
granted under the LTIP are subject to exercise conditions as
summarised below.
The LTIP 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
and a US sub-plan for the grant of Options to eligible participants
in the LTIP and the Non-Employee Sub-Plan who are US residents and
US taxpayers.
With the exception of options over
384,924 shares, which vested immediately on Admission, the options
issued under the LTIP vest 25% on the first anniversary of the
vesting commencement date and an additional one forty-eighth of the
total number of options after each subsequent calendar month for
employees. For consultants options issued under the LTIP vest 25%
on the first anniversary of the vesting commencement date and an
additional one sixteenth of the total number of options after each
subsequent quarter. If options remain unexercised after the date
one day before the tenth anniversary of grant such options expire.
Vesting shall accelerate in full in the event of a change of
control of the Company.
As described in note 19, between 2
July 2021 and 7 July 2021 the Company implemented a pre-Admission
reorganisation of its capital which included a reverse share split
by way of the issue of one new Common or Preferred Share for every
18 old Common or Preferred Shares held.
At the date of the reorganisation
there were 14,499,482 pre-Admission options outstanding to 32
option holders comprising Directors, former Directors and employees
with exercise prices between $0.0044 and $0.16 per share. Those
options were varied to reflect the reverse share split so that they
were replaced with 805,492 options with exercise prices of between
$0.0792 and $2.88 per share. The directors consider that this was a
mechanical variation modification of the awards and not a
modification for the purposes of IFRS2. Comparative figures have
been adjusted to restate numbers and values of share options issued
as if the reverse share split had been in effect from 1 January
2020.
On Admission on 8 July 2021 the
Board approved grants of 769,707 to Paul Pagano and 386,703 options
to David Anderson and on 23 November 2021 and 27 December 2021 the
Board approved further grants, of 112,500 and 5,000 options
respectively, to employees and consultants.
21
|
Share-based
payment (continued)
|
|
|
|
|
Weighted
|
|
|
|
average
|
|
|
|
exercise
|
|
|
|
price US$
|
Number
|
|
|
|
|
|
|
|
|
|
Outstanding at 31 December
2021
|
1.74
|
2,065,527
|
|
|
_________
|
|
|
|
|
|
|
Granted during 2022
|
2.37
|
75,000
|
|
Exercised during 2022
|
0.45
|
(5,192)
|
|
Expired during 2022
|
1.80
|
(18,356)
|
|
|
|
|
|
|
_________
|
_________
|
|
|
|
|
|
Outstanding at 31 December 2022 and
2023
|
1.76
|
2,116,979
|
|
|
_________
|
_________
|
|
|
|
|
|
Exercisable at 31 December
2022
|
1.62
|
1,506,180
|
|
|
_
|
_
|
|
Exercisable at 31 December
2023
|
1.71
|
1,817,206
|
|
|
_
|
_
|
The exercise price of options
outstanding at 31 December 2023 ranged between US$0.08
and US$2.70 and their weighted average remaining contractual
life was 6.92 years and weighted average expected life was 3.55
years.
The Company recognised total
expenses of US$186,000 (2022: US$614,000) within administrative
expenses relating to equity-settled share-based payment
transactions during the year.
22
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Related party
transactions
During the year an amount of
US$85,000 (2022 - US$130,000) was invoiced by The Icahn School of
Medicine at Mount Sinai for services rendered in the year. As of 31
December 2023 no amounts were owed to The Icahn School of Medicine
at Mount Sinai (2022 - Nil).
During the year Paul Pagano and
David Anderson, both directors of the Company, each purchased 7,123
shares in the Company using their own funds.
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23
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Events after the reporting
date
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On 21 March 2024 a special meeting
of the Company approved the issue of 5,172,621 new shares of common
stock of the Company at a price of 35 pence per share. The new
shares represent approximately 16.9 per cent. of the enlarged share
capital of the company. The issue of shares raised approximately
£1.8 million (approximately US$2.3 million) (before fees and
expenses).