TIDMLLAI

RNS Number : 1446G

LungLife AI, INC

28 March 2022

LungLife AI, Inc.

(the "Company" or "LungLife")

Preliminary results

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces its maiden audited preliminary results for the year ended 31 December 2021, following admission to trading on AIM on 8 July 2021.

Summary and Highlights for the year:

-- Revenues of $196k (2020: $205k) of which $88k (2020: $Nil) represented first royalty income from sales under our sub license in China

-- Loss before tax of $7.43m, after charging IPO costs of $1.1m. Adjusted EBITDA(1) loss of $5.8m

-- Admission to AIM and successful GBP17m (gross) fundraising at an issue price of 176p on 8 July 2021

   --    Cash as of 31 December 2021 of $14.62m 

-- The Company's clinical laboratory in Thousand Oaks, California awarded accreditation by the College of American Pathologists (CAP)

Post-period end:

-- CPT(R) Proprietary Laboratory Analyses (PLA code), a key component towards reimbursement in the US market, awarded and scheduled to become effective on 1 April 2022

-- In February 2022, enrolled first participant into multi-centre clinical validation study for those with indeterminant lung nodules. The study will be used to validate the LungLB(R) test performance, enrolling 425 participants from sites across the US, with the study expected to complete by Q1 2023

-- Veterans Affairs (VA) sites added to validation study in March 2022, and first participant enrolled from the Bay Pines VA in Florida

-- Appointment of Dr Drew Moghanaki, an internationally recognised lung cancer specialist, to the Company's Scientific Advisory Board

Commenting, Paul Pagano, Chief Executive Officer of LungLife, said : "Since IPO, we have achieved several milestones which has kept us on track with our strategic vision. During the year, we laid the groundwork towards commencing our multi-centre validation study, and post-period end we enrolled our first participants. Our clinical laboratory in Thousand Oaks also achieved CAP accreditation in November 2021, confirming that we are maintaining the highest standards of excellence in laboratory testing for patients.

"Throughout the rest of the year we will continue with our validation study which we expect to complete in Q1 2023, as well as work towards regulatory authorisation and commercial reimbursement, which we made our first step towards post-period end when we were granted a CPT(R) PLA code. We remain focused on bringing early detection solutions to those who need them most, which will lead to better outcomes for people with lung cancer."

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                                  Tel: +44 (0)20 7597 5970 
  & Broker) 
Daniel Adams / Virginia Bull / Cameron 
 MacRitchie 
 
Walbrook PR Limited                       Tel: +44 (0)20 7933 8780 or LungLifeAI@walbrookpr.com 
Paul McManus / Alice Woodings / Phillip                    Mob: 07980 541 893 / 07407 804 654 / 
 Marriage                                                                         07867 984 082 
 

(1) Earnings before income tax, depreciation and amortisation, adjusted to exclude exceptional items 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(R) 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 first annual results for LungLife AI, Inc. since our admission to trading on AIM in July 2021. 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(R) test multi-centre clinical validation study.

LungLB(R) 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(R) is a blood-based test that uses 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(R) 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(1) and LungLife's estimated 1 week turnaround from receipt of the blood sample to results can save a significant amount of stressful waiting time for the patient as well as unnecessary costly and often dangerous procedures. In 2021, we completed a 149 participant pilot study in subjects with indeterminate lung nodules which showed a well-balanced performance and a Positive Predictive Value of 89 per cent which we believe will support physician decision making.

Progress

We enrolled our first participant in February 2022 in our multi-centre clinical validation study. The multi-centre clinical study will be used to validate the LungLB(R) test performance, looking to repeat the high performance already observed in the pilot study completed earlier in the year. The study will enrol 425 participants across multiple US sites, including MD Anderson Cancer Center, Mount Sinai Hospital in New York City and multiple medical centres of the Veterans Affairs, which we recently announced, involving participants who present with indeterminate lung nodules that would otherwise be scheduled for needle biopsy. This first participant enrolment confirms that the Company is on track to enrol participants over the next 12 months, with study completion expected in Q1 2023.

In November 2021, our clinical laboratory in Thousand Oaks, California was awarded accreditation by the College of American Pathologists (CAP), a significant further independent validation of the quality of our laboratory procedures.

The successful granting of a CPT(R) code marks the first step on the path for commercial reimbursement. In October 2021 we applied to the American Medical Association for a CPT(R) Proprietary Laboratory Analyses (PLA) code and this was granted post year end and is scheduled to become effective on 1 April 2022.

Reimbursement in the US is comprised of three components: code, price, and coverage. CPT(R) codes offer health care professionals a uniform language for coding medical services and procedures, and the CPT(R) code allows clinical laboratories to more specifically identify their tests when billing Medicare and commercial insurers.

AIM IPO

In July 2021 we successfully raised gross proceeds of GBP17 million as part of the Company's admission to trading on AIM. Since then we have already fulfilled several of the aims that we set out to achieve including commencement of the clinical validation study and obtaining a CPT(R) code for Medicare reimbursement for the LungLB(R) test.

We anticipate that the net proceeds of the fundraise will be sufficient to complete the multi-centre validation study and commence the utility study of the LungLB(R) test for indeterminate lung nodules, commence the post-surgical monitoring validation study for the LungLB(R) test, and take the Company to early revenues in 2023.

We are hugely grateful to the support received from new shareholders who participated in our 2021 fundraise and prior shareholders who had supported the company to that point, and I would like to thank all of our shareholders for their continued support.

People

On admission to trading on AIM, David Anderson formally joined the Company as CFO after serving as a consultant since the beginning of 2020.

Paul and David have done a great job of bringing the Company to market and delivering on the aims set out at the Company's IPO. I would like to thank them for their excellent leadership during this dynamic time for the Company.

We also made senior hires in Clinical Trials, Quality, Research and Development and Project Management in the year and post year end bringing the team up to 13 full time, and 2 part time employees.

We also recently announced the appointment of Dr Drew Moghanaki to our Scientific Advisory Board.

On behalf of the Board, I would like to thank our employees, clinical partners, study participants, professional advisors, suppliers and shareholders for their support, and we look forward to providing further updates on progress throughout the current year.

Outlook

In addition to the continued enrolment of participants into our validation study, our focus this year is on reimbursement. The three constituent parts are code, price and coverage. We have received our code, the next stage is the pricing process and determining whether we fall under "cross-walk" or "gap fill". We have submitted our application for the New York Clinical Laboratory Evaluation Program ("CLEP") permit. We will submit our Breakthrough Device application to the FDA when our advisors indicate the timing is right.

The next two years are incredibly exciting for LungLife and we look forward to updating shareholders on our progress during that time.

Roy Davis

Non-Executive Chairman

28 March 2022

(1) Gould MK et al. Am J Respir Crit Care Med. 2015 PMID: 26214244.

Financial Review

The financial performance of the Company in the year to 31 December 2021 reflects the IPO which took place on 8 July 2021 and involved the conversion of Convertible Loan Notes and existing shares prior to the Admission of the new common shares onto AIM.

Statement of Comprehensive Income

The loss for the year of $7,444,188 is after charging a portion of the expenses incurred on the share issue of $1,101,370, disclosed as exceptional, with the balance of expenses of the share issue of $1,000,354 charged directly to reserves. The loss excluding this exceptional item was $6,342,818.

The Company generated revenues of $195,566 comprising royalty income from its sub licensee in China of $88,553 and consumable sales of fluorescent in situ hybridisation (FISH) probes of $107,013 to the same sub-licensee. The royalty income represents the first such income under the sub licence calculated at 6% of underlying sales. In turn the Company pays a 6% royalty on this income to MD Anderson Cancer Center.

The largest cost incurred in the year was employee expenses ($1,760,012) followed by research and development costs ($1,343,132), being those external costs incurred in the development of our LungLB(R) test and AI algorithm.

Other operating income relates to payment received under the US Government Paycheck Protection Program, akin to the UK furlough scheme. This represented a one-time loan which was subsequently forgiven in full. Finance expense of $309,327 related to interest charged on the Convertible Loan Notes, which formed part of the balance on the Notes subsequently converted into new common shares at the time of IPO. The balance of $107,601 reflects the charge for lease liabilities, being leases for certain tangible assets and the leasehold premises occupied by the Company.

Statement of Financial Position

Cash at the end of the year was $14,628,351, reflecting the net proceeds of the AIM admission of $21,342,405, payment of $1,800,000 to the Icahn School of Medicine of Mount Sinai ("Mount Sinai") under the terms of the License Agreement with Mount Sinai, and working capital for the year. The payment of $1,800,000 together with the 1,656,888 consideration shares issued to Mount Sinai at issue price of 176p constitutes the intangible asset of $5,818,359. The option fee gives the Company access in the future to the de-identified patient 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.

Extension to the lease on the Company's premises and financing of a further microscope gave rise to movement on right of use assets and lease liabilities.

Statement of Cash Flows

The net outflow from operating activities was $7,538,876, funded in part by the gross proceeds from the AIM admission of $23,444,129 and in the period before the AIM admission $1,612,421 of new Convertible Loan Notes. These Notes were converted in full as part of the Company's reorganisation prior to the AIM admission. The net inflow of cash in the year was $14,500,723 contributing to the closing cash balance of $14,628,351.

David Anderson

Chief Financial Officer

28 March 2022

STATEMENT OF COMPREHENSIVE INCOME

For the year ended 31 December 2021

 
                                                                Year to       Year to 
                                                            31 December   31 December 
                                                     Note          2021          2020 
                                                                    US$           US$ 
 
 Revenue                                                4       195,566       205,180 
 Cost of sales                                                 (96,269)     (188,178) 
                                                              _________     _________ 
 
 Gross margin                                                    99,297        17,002 
 
 Administrative expenses                                6   (5,903,738)   (3,458,984) 
 Depreciation                                           6     (323,758)     (282,654) 
 Exceptional expense - costs of listing                     (1,101,370)     (337,201) 
                                                              _________     _________ 
 
 Loss from operations                                       (7,229,569)   (4,061,837) 
 
 Other operating income                                 6       206,164             - 
 Finance income                                         9        12,017             - 
 Finance expense                                        9     (416,928)     (777,186) 
                                                              _________     _________ 
 
 Loss before tax                                            (7,428,316)   (4,839,023) 
 
 Tax expense                                           10      (15,872)             - 
                                                              _________     _________ 
 
 Loss from continuing operations                            (7,444,188)   (4,839,023) 
 
 Other comprehensive income                                           -             - 
 
                                                              _________     _________ 
 Loss and total comprehensive income attributable 
  to the owners of the Company                              (7,444,188)   (4,839,023) 
                                                              _________     _________ 
 
 Earnings per share attributable to the 
  ordinary equity holders of the parent                11 
 
 Loss per share 
 Basic and diluted (US$ cents)                                 ($0.469)      ($0.743) 
                                                              _________     _________ 
 

The results reflected above relate to continuing operations

STATEMENT OF FINANCIAL POSITION

As at 31 December 2021

 
                                             Note           2021           2020 
                                                             US$            US$ 
 Assets 
 Current assets 
 Trade and other receivables                   14        740,865        169,801 
 Cash and cash equivalents                            14,628,351        127,628 
                                                       _________      _________ 
 
                                                      15,369,216        297,429 
                                                       _________      _________ 
 Non-current assets 
 Property, plant and equipment                 12        765,983        463,437 
 Intangible assets                             13      5,818,359              - 
 Other receivables                             14         13,235         13,235 
                                                       _________      _________ 
 
                                                       6,597,577        476,672 
                                                       _________      _________ 
 
 Total assets                                         21,966,793        774,101 
                                                       _________      _________ 
 Liabilities 
 Current liabilities 
 Trade and other payables                      15        803,738      1,225,836 
 Lease liabilities                             17        207,280        169,955 
 Discontinued operations                                 174,057        174,057 
 Convertible notes                             18              -     10,086,616 
 Borrowings and loans                          16              -        206,164 
                                                       _________      _________ 
 
                                                       1,185,075     11,862,628 
 Non-current liabilities 
 Lease liabilities                             17        601,622        167,488 
 Provisions                                    19         50,000         50,000 
                                                       _________      _________ 
 
 Total liabilities                                     1,836,697     12,080,116 
                                                       _________      _________ 
 
 NET ASSETS                                           20,130,096   (11,306,015) 
                                                       _________      _________ 
 Issued capital and reserves attributable 
  to 
 owners of the parent 
 Share capital                                 21          2,548          8,665 
 Share premium reserve                         22     91,264,305     52,194,390 
 Other equity                                  22              -        843,137 
 Share based payment reserve                             960,312        550,511 
 Accumulated losses                                 (72,097,069)   (64,902,718) 
                                                       _________      _________ 
 
 TOTAL EQUITY                                         20,130,096   (11,306,015) 
                                                       _________      _________ 
 

STATEMENT OF CHANGES IN EQUITY

For the year ended 31 December 2021

 
                                                                                                Total 
                                                                                         attributable 
                                            Share-based                                     to equity 
                       Share        Share       payment                   Accumulated      holders of          Total 
                     capital      premium       reserve   Other equity         losses          parent         equity 
                         US$          US$           US$            US$            US$             US$            US$ 
 
 1 January 2020        8,483   52,104,062       324,876        828,318   (60,063,695)     (6,797,956)    (6,797,956) 
 
 Comprehensive 
 income for 
 the year 
 Loss                      -            -             -              -    (4,839,023)     (4,839,023)    (4,839,023) 
 Other 
 comprehensive 
 Income                    -            -             -              -              -               -              - 
                   _________    _________     _________      _________      _________       _________      _________ 
 Total 
  comprehensive 
  Income 
  for the year             -            -             -              -    (4,839,023)     (4,839,023)    (4,839,023) 
                   _________    _________     _________      _________      _________       _________      _________ 
 Contributions 
 by and 
 distributions 
 to owners 
 Issue of common 
  stock                  182       90,328             -              -              -          90,510         90,510 
 Issue of 
  Convertible 
  Loan 
  Note                     -            -             -         14,819              -          14,819         14,819 
 Share-based 
  payment                  -            -       225,635              -              -         225,635        225,635 
                   _________    _________     _________      _________      _________       _________      _________ 
 Total 
  contributions 
  by 
  and 
  distributions 
  to owners              182       90,328       225,635         14,819              -         330,964        330,964 
                   _________    _________     _________      _________      _________       _________      _________ 
 
 31 December 
  2020                 8,665   52,194,390       550,511        843,137   (64,902,718)    (11,306,015)   (11,306,015) 
                   _________    _________     _________      _________      _________       _________      _________ 
 

STATEMENT OF CHANGES IN EQUITY

For the year ended 31 December 2021 (continued)

 
                                                                                                Total 
                                                                                         attributable 
                                             Share-based                                    to equity 
                       Share         Share       payment                   Accumulated     holders of          Total 
                     capital       premium       reserve   Other equity         losses         parent         equity 
                         US$           US$           US$            US$            US$            US$            US$ 
 
 1 January 2021        8,665    52,194,390       550,511        843,137   (64,902,718)   (11,306,015)   (11,306,015) 
 
 Comprehensive 
 income for 
 the year 
 Loss                      -             -             -              -    (7,444,188)    (7,444,188)    (7,444,188) 
 Other 
 comprehensive 
 Income                    -             -             -              - 
                   _________     _________     _________      _________      _________      _________      _________ 
 Total 
  comprehensive 
  Income 
  for the year             -             -             -              -    (7,444,188)    (7,444,188)    (7,444,188) 
                   _________     _________     _________      _________      _________      _________      _________ 
 Contributions 
 by and 
 distributions 
 to owners 
 Issue of 
  Convertible 
  Loan 
  Notes                    -             -             -         99,263              -         99,263         99,263 
 Reverse split       (8,184)         8,184             -              -              -              -              - 
 Issue of common 
  shares 
  on conversion 
  of preference 
  shares and 
  Convertible 
  Loan Notes             935    12,600,730             -              -              -     12,601,665     12,601,665 
 Issue of share 
  capital              1,132    27,461,355             -              -              -     27,462,487     27,462,487 
 Transfer of 
  balance 
  following 
  conversion of 
  Convertible 
  Loan Note                -             -             -      (942,400)        249,837      (692,563)      (692,563) 
 Share issue 
  costs                    -   (1,000,354)             -              -              -    (1,000,354)    (1,000,354) 
 Share-based 
  payments                 -             -       409,801              -              -        409,801        409,801 
                   _________     _________     _________      _________      _________      _________      _________ 
 Total 
  contributions 
  by 
  and 
  distributions 
  to owners          (6,117)    39,069,915       409,801      (843,137)        249,837     38,880,299     38,880,299 
                   _________     _________     _________      _________      _________      _________      _________ 
 
 31 December 
  2021                 2,548    91,264,305       960,312              -   (72,097,069)     20,130,096     20,130,096 
                   _________     _________     _________      _________      _________      _________       ________ 
 

STATEMENT OF CASH FLOWS

For the year ended 31 December 2021

 
                                                             Year to       Year to 
                                                         31 December   31 December 
                                                  Note          2021          2020 
                                                                 US$           US$ 
 Cash flows from operating activities 
 Loss for the year                                       (7,444,188)   (4,839,023) 
 Adjustments for: 
 Depreciation of property, plant and equipment               323,758       282,654 
 Forgiveness of Paycheck Protection Program                (206,164)             - 
  Loan 
 Gain on sale of tangible assets                            (35,752)             - 
 Finance income                                             (12,017)             - 
 Finance expense                                             416,928       777,186 
 Taxation                                                     15,872             - 
 Share-based payments expense                                409,801       225,635 
                                                           _________     _________ 
 
                                                         (6,531,762)   (3,553,548) 
 
 (Increase) / decrease in trade and other 
  receivables                                              (569,143)        82,127 
 (Decrease) / increase in trade and other 
  payables                                                 (422,097)       597,396 
 Income taxes paid                                          (15,872)             - 
                                                           _________     _________ 
 
 Net cash outflow from operating activities              (7,538,876)   (2,874,025) 
                                                           _________     _________ 
 Cash flows from investing activities 
 Purchases of tangible assets                               (47,365)       (5,328) 
 Proceeds from sale of tangible assets                        35,752             - 
 Landlord improvement contribution                            15,588             - 
 Purchase of intangibles                                 (1,800,000)             - 
                                                           _________     _________ 
 
 Net cash used in investing activities                   (1,796,025)       (5,328) 
                                                           _________     _________ 
 Cash flows from financing activities 
 Issue of Convertible Notes                                1,612,421     2,290,899 
 Issue of Common Stock                                    23,444,129        90,510 
 Expenses of issue of Common Stock                       (1,000,354)             - 
 Interest received                                            10,097             - 
 Interest paid                                             (107,601)       (6,297) 
 Paycheck Protection Program loan                                  -       205,822 
 Repayment of loans                                                -     (120,368) 
 Repayment of lease liabilities                            (123,068)     (180,379) 
                                                           _________     _________ 
 
 Net cash from financing activities                       23,835,624     2,280,187 
 
 Net increase / (decrease) in cash and 
  cash equivalents                                        14,500,723     (599,166) 
 Cash and cash equivalents at beginning 
  of year                                                    127,628       726,794 
                                                           _________     _________ 
 
 Cash and cash equivalents at end of year            5    14,628,351       127,628 
                                                           _________     _________ 
 

LungLife AI, Inc.

Notes forming part of the financial statements

for the year ended 31 December 2021

 
 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 
 

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 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.

The directors of the Company have a reasonable expectation that the Company has adequate resources,to continue in operational existence for the foreseeable future and for at least one year from the date of the financial statements. For that reason, they continue to adopt the going concern basis in preparing the Company's financial statements.

   (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 results of the Company.

 
 2   Basis of preparation (continued) 
 
   (c)      Revenue recognition 

Sale of goods

Revenue comprises the fair value of the sale of FISH probes used to identify the properties of blood samples under the terms of a sub license agreement with a third party, net of applicable sales taxes. Revenue is recognised on the sale of goods when the significant risks and rewards of ownership of the goods have passed to the buyer and the amount of revenue can be measured reliably. Revenue on goods delivered is recognised when the customer accepts delivery and on services when those services have been rendered.

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 recognized 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 

Research expenditure is recognised as an expense when incurred. Development expenditure is recognized as an expense except those costs incurred on development projects are capitalised as long term assets to the extent that such expenditure is expected to generate future economic benefits. Development expenditure is capitalised only if it meets the criteria for capitalisation under IAS 38. Capitalised development expenditure is measured at cost less accumulated amortisation and impairment losses, if any. Development expenditure initially recognised as an expense is not recognised as an asset in future years. Capitalised development expenditure is amortised on a straight-line basis over the estimated useful life of the asset when the asset is available for use.

   (e)      Property, plant and equipment 

Owned assets

Items of property, plant and equipment are stated at cost or deemed 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.

Gains and losses on disposals are determined by comparing the proceeds with the carrying amount and are recognised in the income statement.

 
 2   Basis of preparation (continued) 
 
   (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 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).

Non-financial assets other than goodwill that suffered impairment are reviewed for possible reversal of the impairment at each reporting date.

   (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.

 
 2   Basis of preparation (continued) 
 
   (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.

Convertible debt

The proceeds received on issue of the Company's convertible debt are allocated into their liability and equity components. The amount initially attributed to the debt component equals the discounted cash flows using a market rate of interest that would be payable on a similar debt instrument that does not include an option to convert. Subsequently, the debt component is accounted for as a financial liability measured at amortised cost until extinguished on conversion or maturity of the bond. The remainder of the proceeds is allocated to the conversion option and is recognised in the "Other equity" within shareholders' equity, net of income tax effects.

   (j)       Borrowings 

Borrowings are recognised initially at fair value, net of transaction costs incurred. Borrowings are subsequently carried at amortised cost; any difference between the proceeds (net of transaction costs) and the redemption value is recognised in the income statement over the period of the borrowings using the effective interest method.

Borrowings are de-recognised from the statement of financial position when the obligation specified in the contract is discharged, is cancelled or expires. The difference between the carrying amount of a financial liability that has been extinguished or transferred to another party and the consideration paid, including any non-cash assets transferred or liabilities assumed, is recognised in the income statement as other operating income or finance costs.

Borrowings are classified as current liabilities unless the Company has an unconditional right to defer settlement of the liability for at least 12 months after the reporting period.

   (k)      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.

   (l)       Share capital 

Ordinary shares are classified as equity. There are various classes of ordinary shares in issue, as detailed in note 21. Incremental costs directly attributable to the issue of new shares are shown in share premium as a deduction from the proceeds.

 
 2   Basis of preparation (continued) 
 
   (m)     Net finance costs 

Finance costs

Finance costs comprise interest payable on borrowings, direct issue costs, dividends on preference shares and foreign exchange losses, and are expensed in the period in which they are incurred.

Finance income

Finance income comprises interest receivable on funds invested, and foreign exchange gains.

Interest income is recognised in the income statement as it accrues using the effective interest method.

   (n)      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. Variable lease payments are only included in the measurement of the lease liability if they depend on an index or rate. In such cases, the initial measurement of the lease liability assumes the variable element will remain unchanged throughout the lease term. 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 19).

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.

 
 2   Basis of preparation (continued) 
 
   (n)      Leases (continued) 

When the group 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 estimates and judgements are likely to have the most significant effect on the amounts recognised in the financial information.

Carrying value of intangible assets, property, plant and equipment

In determining whether there are indicators of impairment of the Company's intangible assets, the directors take into consideration various factors including the economic viability and expected future financial performance of the asset and when it relates to the intangible assets arising on a business combination, the expected future performance of the business acquired.

Classification of the Mount Sinai License as an intangible asset

As set out in note 13, o n 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.

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 
                                        2021           2020 
                                         US$            US$ 
  Revenue 
  People's Republic of China         195,566        205,180 
                                    ________       ________ 
 
                                     195,566        205,180 
                                    ________       ________ 
 
 
 4    Segment analysis (continued) 
 
                                             2021           2020 
                                              US$            US$ 
      Non-current assets 
  United States of America              6,597,577        476,672 
                                         ________       ________ 
 
                                        6,597,577        476,672 
                                         ________       ________ 
 
                                          Year to        Year to 
                                      31 December    31 December 
                                             2021           2020 
                                              US$            US$ 
      Product and service revenue 
      Royalty income                       88,553              - 
  Consumable items                        107,013        205,180 
                                         ________       ________ 
 
                                          195,566        205,180 
                                         ________       ________ 
 
 
 
 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 
   -     Trade and other payables 
 
 5   Financial instruments - Risk Management (continued) 
 

(ii) Financial instruments by category

Financial asset

 
 
                                  Amortised   Amortised 
                                       cost        cost 
                                       2021        2020 
                                        US$         US$ 
 
  Cash and cash equivalents      14,628,351     127,628 
  Trade and other receivables       740,865     169,801 
                                  _________   _________ 
 
  Total financial assets         15,369,216     297,429 
                                  _________   _________ 
 

Financial liabilities

 
 
                                       Amortised   Amortised 
                                            cost        cost 
                                            2021        2020 
                                             US$         US$ 
 
  Trade and other payables and loan      803,738   1,225,836 
                                       _________   _________ 
 
  Total financial liabilities            803,738   1,225,836 
                                       _________   _________ 
 

(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.

 
 5   Financial instruments - Risk Management (continued) 
 

(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:

 
 
               2021         2021     2020        2020 
                            Cash                 Cash 
             Rating      at bank   Rating     at bank 
                             US$                  US$ 
 
  Bank A         A+    8,140,196       A+     127,628 
  Bank B       BBB+    6,425,645                    - 
  Bank C         A+       62,510                    - 
                       _________            _________ 
 
                      14,628,351              127,628 
                       _________            _________ 
 
 
 5   Financial instruments - Risk Management (continued) 
 

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 2021 assets held in Sterling amounted to US$6,488,154 (2020 - US$ Nil) and liabilities held in Sterling amounted to US$65,772 (2020 - US$340,371).

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 increase of net assets of US$321,119. A 5% weakening in the exchange rate would, on the same basis, have increased post-tax loss and decreased net assets by US$321,119.

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 2021              US$         US$ 
 
   Trade and other payables     275,276           - 
                              _________   _________ 
 
   Total                        275,276           - 
                              _________   _________ 
 
 
                                            Between 
                                Up to 3    3 and 12 
                                 months      months 
   At 31 December 2020              US$         US$ 
 
   Trade and other payables     822,758           - 
   Loan                         206,164           - 
                              _________   _________ 
 
   Total                      1,028,922           - 
                              _________   _________ 
 
 
 5   Financial instruments - Risk Management (continued) 
 

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 
                                                              2021          2020 
                                                               US$           US$ 
 
  Employee benefit expenses (see note 8)                 1,760,012     1,295,786 
  Share-based payments charge - non-employee 
   and directors                                            86,602        83,657 
  Depreciation of property, plant and equipment            323,758       282,654 
  Research and development expenditure                   1,343,132       647,147 
  Professional costs                                       720,232       811,660 
  Legal settlement                                         687,409       525,000 
      Foreign exchange losses                               96,690             - 
  Other costs                                            1,209,661       179,391 
 

Other operating income included the forgiveness of the Paycheck Protection Program Loan of US$206,164 (2020 - US$Nil)

 
 7   Auditor's remuneration 
 

During the year the Company obtained the following services from the Company's auditor:

 
 
                                                    Year to       Year to 
                                                31 December   31 December 
                                                       2021          2020 
                                                        US$           US$ 
       Fees payable to the Company's auditor 
        for the audit of the Company                 47,472             - 
       Fees payable to the Company's auditor 
        for other services: 
       Services in connection with listing          108,423        41,864 
   Taxation services                                      -         2,500 
                                                  _________     _________ 
 
  Total                                             155,895        44,364 
                                                  _________     _________ 
 
 
 8    Employee benefit expenses 
 
                                                             Year to       Year to 
                                                         31 December   31 December 
                                                                2021          2020 
                                                                 US$           US$ 
      Employee benefit expenses (including Directors) 
       comprise: 
 
  Wages and salaries                                       1,304,022       911,560 
  Benefits                                                    75,350        79,433 
  Share-based payments expense (note xx )                    323,199       141,978 
  Social security contributions and similar 
   taxes                                                      52,601        79,158 
      Pension                                                  4,840             - 
                                                           _________     _________ 
 
                                                           1,760,012     1,212,129 
                                                           _________     _________ 
 

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 
                                        2021          2020 
                                         US$           US$ 
 
  Salary                             599,232       299,042 
  Share based payment expense        312,706       126,175 
                                   _________     _________ 
 
                                     911,938       425,217 
                                   _________     _________ 
 

The average number of employees (excluding Directors) in the Company in the year was 8 (2020 - 10).

 
 9    Net finance costs 
 
                                                      Year to       Year to 
                                                  31 December   31 December 
                                                         2021          2020 
                                                          US$           US$ 
      Finance expense 
 
  Interest expense on lease liabilities               107,601        23,390 
  Interest expense on liabilities measured 
   at amortised cost                                  309,327       747,157 
  Interest expense on other loans                           -         6,639 
                                                    _________     _________ 
 
  Total finance expense                               416,928       777,186 
                                                    _________     _________ 
 
 
 9   Net finance costs (continued) 
 
                                Year to       Year to 
                            31 December   31 December 
                                   2021          2020 
                                    US$           US$ 
     Finance income 
 
     Bank interest               12,017             - 
                              _________     _________ 
 
     Total finance income        12,017             - 
                              _________     _________ 
 
 
 10   Tax expense 
 
                                             Year to       Year to 
                                         31 December   31 December 
                                                2021          2020 
                                                 US$           US$ 
 
      Current tax expense 
      Current tax on loss for the year             -             - 
      Withholding tax on royalties            15,872             - 
                                           _________     _________ 
 
      Total current tax                       15,872             - 
 
      Deferred tax asset 
      On losses generated in the year              -             - 
                                           _________     _________ 
 
                                              15,872             - 
                                           _________     _________ 
 
 
 10   Tax expense (continued) 
 

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 
                                                        2021          2020 
                                                         US$           US$ 
 
  Loss for the year                              (7,428,316)   (4,839,023) 
                                                   _________     _________ 
 
  Tax using 29.84%                               (2,216,610)   (1,443,964) 
  Expenses not deductible for tax purposes           688,811       410,500 
  Unrecognised deferred tax assets for losses 
   carried forward                                 1,527,799     1,033,464 
                                                   _________     _________ 
 
  Total tax expense                                                      - 
                                                   _________     _________ 
 

The unrecognised deferred tax is based on total taxable losses carried forward of US$49,393,180 (2020 - US$44,940,832 and a capital loss of US$4,583,333 (2020 - 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. The losses do not expire but can only be used against trading profits from the same trade.

 
 11    Loss per share 
 
                                                         Year to       Year to 
                                                     31 December   31 December 
                                                            2021          2020 
                                                           Total         Total 
       Numerator                                             US$           US$ 
 
  Loss for the year used in basic EPS                (7,444,188)   (4,839,023) 
 
       Denominator 
 
  Weighted average number of ordinary shares 
   used in basic EPS                                  15,870,143     6,515,838 
 
  Resulting loss per share                            (US$0.469)    (US$0.743) 
 

The Company has one category of dilutive potential ordinary share, being share options (see note 23). 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 21, on between 2 July 2021 and 7 July 2021the 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.

As required by IAS33, the number of shares presented as the denominator in calculating loss per share has been adjusted from 1 January 2020, the beginning of the earliest period for which loss per share information is presented in order to maintain comparability.

 
 12    Tangible assets 
                                                 Furniture   Computers 
                                   Leasehold           and      and IT     Plant & 
                                improvements     equipment   equipment   machinery       Total 
                                         US$           US$         US$         US$         US$ 
       Cost or valuation 
 
  At 1 January 
   2020                              981,613     1,102,464      49,831           -   2,133,908 
  Re-classification                        -   (1,045,962)           -   1,045,962           - 
  Additions                                -             -           -       5,328       5,328 
                                    ________      ________    ________   _________   _________ 
  At 31 December 
   2020                              981,613        56,502      49,831   1,051,290   2,139,236 
  Landlord contribution             (15,588)             -           -           -    (15,588) 
  Additions                          349,338             -      35,126     257,428     641,892 
                                    ________      ________    ________    ________    ________ 
  At 31 December 
   2021                            1,315,363        56,502      84,957   1,308,718   2,765,540 
                                    ________      ________    ________    ________    ________ 
 
       Accumulated 
        depreciation 
        and impairment 
 
  At 1 January 
   2020                              558,051       786,784      48,310               1,393,145 
  Re-classification                        -     (730,282)           -     730,282           - 
  Depreciation                       153,126             -       1,521     128,007     282,654 
                                    ________      ________    ________    ________    ________ 
  At 31 December 
   2020                              711,177        56,502      49,831     858,289   1,675,799 
  Depreciation                       233,253             -       3,173      87,332     323,758 
                                    ________      ________    ________    ________    ________ 
 
  At 31 December 
   2021                              944,430        56,502      53,004     945,621   1,999,557 
                                    ________      ________    ________    ________    ________ 
 
       Net book value 
  At 31 December 
   2021                              370,933             -      31,953     363,097     765,983 
                                    ________      ________    ________    ________    ________ 
 
  At 31 December 
   2020                              270,436             -           -     193,001     463,437 
                                    ________      ________    ________    ________    ________ 
 

Included in leasehold improvements at 31 December 2021 are right of use assets with a cost of $1,282,052 and accumulated depreciation of $898,393.

 
 13    Intangible assets 
 
                                                    License       Total 
                                                        US$         US$ 
       Cost 
 
       At 1 January 2020                                  -           - 
       Additions                                          -           - 
                                                  _________   _________ 
 
       At 31 December 2020                                -           - 
  Additions                                       5,818,359   5,818,359 
                                                  _________   _________ 
 
  At 31 December 2021                             5,818,359   5,818,359 
                                                  _________   _________ 
 
       Accumulated amortisation and impairment 
 
       At 1 January 2020                                  -           - 
       Amortisation charge                                -           - 
                                                  _________   _________ 
 
       At 31 December 2020                                -           - 
       Amortisation charge 
                                                  _________   _________ 
 
       At 31 December 2021                                -           - 
 
                                                  _________   _________ 
 
       Net book value 
  At 31 December 2021                             5,818,359   5,818,359 
                                                  _________   _________ 
 
  At 31 December 2020                                     -           - 
                                                  _________   _________ 
 

On 18 June 2021, the Company entered into the Mount Sinai License Agreement, pursuant to which the Icahn School of Medicine at 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 License Agreement automatically became effective on Admission. Exercise of the option contained in the Mount Sinai License 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 License 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 
                                                   2021        2020 
                                                    US$         US$ 
       Amounts falling due within one year 
 
  Prepayments and accrued income                692,274     169,801 
       Other debtors                             48,591           - 
                                              _________   _________ 
 
                                                740,865     169,801 
                                              _________   _________ 
 
 
                                             2021        2020 
                                              US$         US$ 
  Amounts falling due after one year 
 
  Rent deposit                             13,235      13,235 
                                        _________   _________ 
 
                                           13,235      13,235 
                                        _________   _________ 
 
 
 15    Trade and other payables 
                                                                   2021        2020 
                                                                    US$         US$ 
 
 
  Trade payables                                                211,718     786,018 
  Accruals and other payables                                   570,920     439,818 
                                                              _________   _________ 
  Total financial liabilities classified as financial 
   liabilities measured at amortised cost                       782,638   1,225,836 
 
       Other payables - tax and social security payments         21,100           - 
                                                              _________   _________ 
 
  Total trade and other payables                                803,738   1,225,836 
                                                              _________   _________ 
 

The carrying value of trade and other payables classified as financial liabilities measured at amortised cost approximates fair value.

 
 16    Borrowings and Loans 
                                    2021       2020 
                                     US$        US$ 
 
  Loans payable                        -    206,164 
                                ________   ________ 
 
                                       -    206,164 
                                ________   ________ 
 

In May 2020 the Company applied for and received a loan under the US Government Paycheck Protection Program. An application for forgiveness of the entire principal balance as permitted under the Program was made subsequent to 31 December 2020 and was granted in the year to 31 December 2021.

 
 17    Lease Liabilities 
                                Land and   Plant and 
                               buildings   machinery       Total 
                                     US$         US$         US$ 
 
  At 1 January 2020              349,803     144,629     494,432 
  Interest expense                23,390           -      23,390 
  Repayments                   (151,859)    (28,520)   (180,379) 
                                ________    ________    ________ 
 
  At 31 December 2020            221,334     116,109     337,443 
                                ________    ________    ________ 
 
  Additions                      349,338     245,189     594,527 
  Repayments                   (156,306)    (74,363)   (230,669) 
  Interest expense                89,625      17,976     107,601 
                                ________    ________    ________ 
 
  At 31 December 2021            503,991     304,911     808,902 
                                ________    ________    ________ 
 

The Company acquired certain tangible assets under capital lease financing arrangements.

The Company operates from one office which is rented under a lease agreement ending on 1 July 2022 under which rent is payable monthly. During the year the Company extended this lease until 31 August 2025 commencing 1 July 2022 and with a two-month rent free period.

 
 
                                                2021       2020 
                                                 US$        US$ 
           Maturity of lease liabilities 
           Within 3 months                    56,727     40,951 
            Between 3 - 12 months            150,553    131,045 
            Between 1 - 2 years              255,070    108,346 
            Between 2 - 5 years              346,552     57,101 
                                            ________   ________ 
 
                                             808,902    337,443 
                                            ________   ________ 
 
 
 18    Convertible Notes 
                                                     2021         2020 
                                                      US$          US$ 
       Due within one year: 
  Convertible Secured Promissory Notes                  -   10,086,616 
                                                _________    _________ 
 
                                                        -   10,086,616 
                                                _________    _________ 
 

On 26 October 2017 the Company issued a Convertible Secured Promissory Note Purchase Agreement (the "Notes") that provided for the issuance of up to a principal amount US$3m on which interest of eight per cent. Accrued. Unless converted into shares the principal and accrued interest are payable in full at the earlier of the maturity date of 26 January 2020 or the occurrence of a defined corporate transaction.

On 31 December 2018 the total principal amount of Notes that could be issued increased to US$6m and on 20 August 2019 the total principal amounts of Notes that could be issued increased to US$7.5m. On 20 August 2019 the Company determined that the Notes issued before that date should be classified as Series A-1 Notes and those issued after that date Series A-2 Notes. The Series A-2 Notes have a different conversion term and are repayable in preference to the Series A-1 Notes.

As the conversion feature results in the conversion of a fixed amount of stated principal into a fixed number of shares, it satisfies the 'fixed for fixed' criterion and, therefore, it is classified as an equity instrument.

The value of the liability component and the equity conversion component were determined at the date the instrument was issued.

The fair value of the liability component, included above, at inception was calculated using a market interest rate for an equivalent instrument without conversion option. The discount rate applied was eight per cent.

On 15 June 2020 the Company entered into an agreement to extend the maturity date of the Notes to 30 June 2021.

On [date] all the principal and accrued interest in the Convertible Notes was converted into new Common Stock shares.

The interests of the Directors and their connected persons in the Convertible Notes was:

 
                                                  2021        2020 
                                                   US$         US$ 
 
  Simon Raab (resigned 1 July 2021)                  -   3,232,380 
  Frederick Gluck (resigned 1 July 2021)             -   1,711,953 
                                             _________   _________ 
 
                                                     -   4,944,333 
                                             _________   _________ 
 
 
 19    Provisions 
                              Dilapidations       Total 
                                        US$         US$ 
 
  At 1 January 2020                  50,000      50,000 
       Movement                           -           - 
                                  _________   _________ 
 
  At 31 December 2020                50,000      50,000 
                                  _________   _________ 
 
       Additions                          -           - 
                                  _________   _________ 
 
  At 31 December 2021                50,000      50,000 
                                  _________   _________ 
 

Provision is made for the anticipated cost of returning the Company's premises to their prior state on termination of the lease.

 
 20    Net cash /(debt) reconciliation 
                                                2021           2020 
                                                 US$            US$ 
 
  Cash and cash equivalents               14,628,351        127,628 
  Convertible notes                                -   (10,086,616) 
  Other borrowings and loans                       -      (206,164) 
  Lease liabilities                        (808,902)      (337,443) 
                                           _________      _________ 
 
  Net cash / (debt)                       13,819,449   (10,502,595) 
                                           _________      _________ 
 
 
                                                  Cash and     Borrowings 
                                          cash equivalents      and loans       Net Debt 
                                                       US$            US$            US$ 
 
  Net debt at 1 January 2020                       726,794    (7,678,186)    (6,951,392) 
  Cash flows                                     (599,166)    (2,376,353)    (2,975,519) 
  Other non-cash movements: 
                                                         -              -              - 
  Lease liabilities 
                                                         -        156,647        156,647 
  Accretion of interest on convertible 
   notes                                                 -      (732,331)      (732,331) 
                                                 _________      _________      _________ 
 
  Net debt at 31 December 2020                     127,628   (10,630,223)   (10,502,595) 
                                                 _________      _________      _________ 
 
  Cash flows                                    14,500,723              -     14,500,723 
  Other non-cash movements: 
  Conversion of Convertible Loan Notes                   -     10,395,943     10,395,943 
  Forgiveness of Payroll Protection 
   Program loan                                          -        206,164        206,164 
  Lease liabilities                                      -      (471,459)      (471,459) 
 
  Accretion of interest on convertible 
   notes                                                 -      (309,327)      (309,327) 
                                                 _________      _________      _________ 
 
  Net debt at 31 December 2021                  14,628,351      (808,902)     13,819,449 
                                                 _________      _________      _________ 
 
 
 21    Share capital 
                                                             Issued and fully paid 
                                                                  Number         US$ 
 
       Shares of US$0.0001 par value each 
       At 1 January 2020 
  Common shares                                                5,092,839         510 
  Preference shares, Series A and B                           79,738,560       7,973 
  Issue of common shares in the year                           1,820,407         184 
                                                               _________   _________ 
 
  Total at 31 December 2020                                   86,651,806       8,665 
 
  Reverse stock split, at ratio of 1 new common 
   share                                                    (81,837,883)     (8,184) 
  Issue of common shares on conversion of the 
   Convertible Loan Notes and Warrants                         9,350,888         935 
  Issue of common shares for cash                              9,659,091         966 
  Issue of common shares for non-cash consideration            1,656,888         166 
                                                               _________   _________ 
 
  Total issued share capital at 31 December 
   2021                                                       25,480,790       2,548 
                                                               _________   _________ 
 

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 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 
 
 22   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. 
 
   Other equity        Amount of proceeds on issue of convertible 
                        debt relating to the equity component 
                        (i.e., option to convert the debt into 
                        share capital). 
 
   Retained earnings   All other net gains and losses and transactions 
                        with owners (e.g., dividends) not recognised 
                        elsewhere. 
 
 
 23   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 21, between 2 July 2021 and 7 July 2021the 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.

 
 23    Share-based payment (continued) 
                                                         Weighted 
                                                          average 
                                                         exercise 
                                                        price US$         Number 
 
  Outstanding at 1 January 2020                                       12,230,198 
  Granted during the year                                              2,345,845 
  Cancelled                                                             (25,000) 
  Exercised during the year                                             (51,561) 
                                                                       _________ 
 
  Outstanding at 31 December 2020 and 1 January 
   2021                                                               14,499,482 
 
  Reverse share split                                               (13,693,990) 
                                                                       _________ 
 
  Revised balance outstanding at 31 December 
   2020                                                      0.74        805,492 
 
  Granted during the year                                    2.19      1,260,035 
  Exercised or expired during the year                       0.74       (13,913) 
                                                        _________      _________ 
 
  Outstanding at 31 December 2021                            1.74      2,065,527 
                                                        _________      _________ 
 
  Vested at 31 December 2021                                 1.35      1,030,627 
                                                        _________      _________ 
 

The exercise price of options outstanding at 31 December 2021 ranged between US$0.08 and US$2.70 and their weighted average contractual life was 7.66 years and weighted average expected life was 1.8 years. The fair value of each share option granted has been estimated using a Black-Scholes model. The inputs into the model are share prices of between US$0.08 and US$2.51, exercise prices of between US$0.45 and US$2.77, expected volatility of 57.9%, expected dividend yield of 0%, expected lives of between 1.25 and 3.75 years and a risk-free interest rate of 0.29%. In the absence of historic volatility data available at the grant date the expected volatility of 57.9% was estimated based on comparable companies.

The Company recognised total expenses of US$409,801 (2020: US$225,635) within administrative expenses relating to equity-settled share-based payment transactions during the year.

 
 24   Events after the reporting date 
 

There have been no events subsequent to the year-end that require disclosure in these financial statements.

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March 28, 2022 02:00 ET (06:00 GMT)

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