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REG - LungLife AI, INC - Preliminary Audited Results

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RNS Number : 2308J  LungLife AI, INC  04 April 2024

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 EBITDA(1) 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 (https://www.tandfonline.com/doi/full/10.1080/13696998.2023.2182493)
      , 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
      (https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02433-4) ,
      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 (https://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)                      Tel: +44 (0) 20 3841 6208

 Tom Nicholson / Cameron Duncan / Will Hall
 Walbrook PR Limited                                                         Tel: +44 (0)20 7933 8780 or LungLifeAI@walbrookpr.com
                                                                            (mailto: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
(http://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                                         11

 ordinary equity holders of the parent

 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
                                                               _________    _________

 

Statement of changes in equity

for the year ended 31 December 2023

 

                                                   Share      Share      Share-based  Accumulated losses  Total          Total

                                                   capital    premium    payment                          attributable   equity

                                                                         reserve                          to equity

                                                                                                          holders of

                                                                                                          parent
                                                   US$'000    US$'000    US$'000      US$'000             US$'000        US$'000

 1 January 2022                                    3          91,264     960          (72,097)            20,130         20,130

 Comprehensive income for the year
 Loss                                              -          -          -            (7,606)             (7,606)        (7,606)
 Other comprehensive Income                        -          -          -            -                   -              -
                                                   _________  _________  _________    _________           _________      _________
 Total comprehensive Income for the year           -          -          -            (7,606)             (7,606)        (7,606)
                                                   _________  _________  _________    _________           _________      _________
 Contributions by and distributions to owners
 Exercise of options                               -          2          -            -                   2              2
 Share-based payment                               -          -          614          -                   614            614
                                                   _________  _________  _________    _________           _________      _________
 Total contributions by and                        -          2          614          -                   616            616

 distributions to owners
                                                   _________  _________  _________    _________           _________      _________

 31 December 2022                                  3          91,266     1,574        (79,703)            13,140         13,140
                                                   _________  _________  _________    _________           _________      _________

 

 

 

 

Statement of changes in equity

for the year ended 31 December 2023 (continued)

 

                                                   Share      Share      Share-based  Accumulated losses  Total          Total

                                                   capital    premium    payment                          attributable   equity

                                                                         reserve                          to equity

                                                                                                          holders of

                                                                                                          parent
                                                   US$'000    US$'000    US$'000      US$'000             US$'000        US$'000

 1 January 2023                                    3          91,266     1,574        (79,703)            13,140         13,140

 Comprehensive income for the year
 Loss                                              -          -          -            (5,413)             (5,413)        (5,413)
 Other comprehensive Income                        -          -          -            -                   -              -
                                                   _________  _________  _________    _________           _________      _________
 Total comprehensive Income for the year           -          -          -            (5,413)             (5,413)        (5,413)
                                                   _________  _________  _________    _________           _________      _________
 Contributions by and distributions to owners
 Share-based payments                              -          -          186          -                   186            186
                                                   _________  _________  _________    _________           _________      _________
 Total contributions by and                        -          -          186          -                   186            186

 distributions to owners
                                                   _________  _________  _________    _________           _________      _________

 31 December 2023                                  3          91,266     1,760        (85,116)            7,913          7,913
                                                   _________  _________  _________    _________           _________      _________

Notes to the financial statements

For the year ended 31 December 2023

 

 

 1  General Information

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.

 

 2  Basis of preparation

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.

 

 4  Segment analysis

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       Year to

31 December

             31 December
                                  2023

                                               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         Year to

                                 31 December    31 December

                                 2023            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.

 

 7  Auditors' remuneration

 

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                          299        458

     Accrued income                       31         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  1,198      1,216
     amortised cost

     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                74        75

 Between 3 - 12 months          179       225

 Between 1 - 2 years            117       253

 Between 2 - 5 years            -         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.

 

 20  Reserves

 

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.

 

 21  Share-based payment

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                    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.
 23  Events after the reporting date

 

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).

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