TIDMGENI

RNS Number : 9060L

GENinCode PLC

16 September 2021

16 September 2021

GENinCode Plc

("GENinCode" or the "Company")

Interim Results to 30 June 2021

GENinCode Plc (AIM: GENI), the cardiovascular disease company focused on predictive genetics for the prevention of cardiovascular disease, announces today its interim results for the six months ended 30 June 2021. The first half of the 2021 financial year saw GENinCode accelerate its commercial expansion program followed by the successful completion of its IPO and admission to the LSE:AIM market post-period end in July 2021.

Financial and Operating Highlights

-- Announcement of EVERSANA Life Science Services strategic collaboration to act as US commercial services partner

-- Announcement of Royal Brompton and Harefield and Guys and St Thomas' NHS foundation trust collaboration in CVD polygenic risk assessment and preparations for launch of Lipid inCode(R) testing for hypercholesterolemia

-- Ongoing discussions with FDA regarding Breakthrough Device Designation for Cardio inCode(R) (Genetic Risk Score) for the onset of CVD

   --    Preparations for FDA de-novo filing for launch of Cardio inCode(R) in 2022 
   --    Growth in first half revenues to GBP0.6m (2020: GBP0.4m) from European operations 

-- Increased levels of investment in our commercialisation program giving rise to a reported adjusted EBITDA loss of (GBP978k) (H1 2020: (GBP369k))

-- Cash reserves of GBP1.0m at 30 June 2021 (Cash reserves post admission at 31 July 2021 were GBP16.7m)

Recent Developments

-- Successful completion of IPO and admission to the LSE:AIM in July 2021 raising gross proceeds of GBP17m

-- Publication of Karolinska Institute Study showing Thrombo inCode(R) as a leading diagnostic product for the diagnosis of inherited thrombophilia and venous thromboembolism risk assessment

Commenting on the outlook for GENinCode, Matthew Walls, chief executive officer of GENinCode Plc said: "We have enjoyed a productive year to date with the successful completion of the IPO and a gross GBP17m fundraise in July 2021, enabling the expansion of our commercial program across our core EU, UK and US markets. We are now delivering the plans set out in our IPO Admission Document focused on preparations for the US launch of Cardio inCode(R) for cardiovascular disease preventative care.

We are working closely with our US collaborative partner, Eversana, on launch planning and advancing our collaborative discussions with Indiana University and New York Presbyterian - Weill Cornell. Discussions are ongoing with the FDA for both 'breakthrough' status and we are preparing for the submission of our de-novo market authorisation submission for Cardio inCode(R). We are commissioning Lipid inCode(R) testing for hypercholesterolemia with the NHS and expect testing to commence over the coming months. We anticipate continued revenue growth over the second half of this financial year and look forward to advising on further developments."

For further information:

 
 GENinCode Plc                                        www.genincode.com or via Walbrook 
                                                                                     PR 
 Matthew Walls, CEO 
 Paul Foulger, CFO 
 
 Stifel Nicolaus Europe Limited (Nomad                         Tel: +44 (0)20 7710 7600 
  and Joint Broker) 
 Alex Price / Ben Maddison / Richard Short 
 
 Cenkos Securities Plc (Joint Broker)                          Tel: +44 (0)20 7397 8900 
 Giles Balleny 
 Dale Bellis / Michael Johnson (Sales) 
 
 Walbrook PR Limited                     Tel: 020 7933 8780 or genincode@walbrookpr.com 
 Anna Dunphy / Paul McManus / Louis Ashe-Jepson 
 

Chief Executive Officer's Statement

I am delighted to present the interim report for the six-month period ended 30 June 2021 for GENinCode Plc.

Following the successful admission of the Company to the LSE:AIM market on 22 July 2021 this report provides an introduction to GENinCode, a summary of progress over the first half and the outlook for the second half of the financial year.

Introduction

GENinCode is engaged in the risk assessment, prediction, and prevention of cardiovascular disease (CVD). Our products and technology have been developed with the aim of prognosing and predicting the onset of CVD to provide personalised treatment to improve patient outcomes. CVD accounts for around 18 million deaths annually, representing approximately 31 per cent. of all deaths worldwide with the global cost of CVD estimated to reach approximately $1.04 trillion by 2030.

CVD encompasses all conditions linked to the heart and blood vessels and is currently the leading cause of death globally. Four out of five deaths related to CVD are a result of heart attacks and strokes, and one third of these deaths occur prematurely in people under the age of 70. There are approximately 550 million people living with heart and circulatory diseases worldwide. This number has been rising due to changing lifestyles, ageing, and a growing population and improved survival rates from heart attacks and strokes.

In the US, CVD affects over 85 million people and accounts for more than one-third of all deaths. Common characteristics which put individuals at risk of CVD include raised blood pressure, high cholesterol levels, as well as obesity, lack of exercise and the co-occurrence of other diseases such as diabetes. Approximately 655,000 people in the US die from CVD each year, with coronary artery disease and heart attacks the most common.

The Company was incorporated in September 2018 to acquire the assets, intellectual property, and know-how of the Ferrer inCode and Gendiag.exe businesses, part of Grupo Ferrer Internacional S.A., a large Spanish multinational private pharmaceutical and healthcare company. The technology and products acquired included Cardio inCode(R) , Lipid inCode(R) , Thrombo inCode(R) and Sudd inCode(R) . Approximately EUR50 million has been invested in the research and development of these products since 2007. The Company has begun to commercialise these products in Europe and is now targeting the UK and US.

Multiple studies have shown that an individual's genetic load contributes between 40 to 50 per cent to the development of CVD, highlighting genetics as one of the most significant contributing factors to the onset of cardiovascular disease.

The Company's product portfolio draws on advanced genomic precision testing using polygenic (multiple-genes) technology, advanced molecular testing, genotyping, sequencing, and AI bioinformatics. Through a simple blood or saliva sample, the Company can analyse the genetic variants and medical information associated with CVD to determine a patient's Genetic Risk Score (GRS) which is used to assess a patient's cardiovascular risk.

The current standard of care for primary prevention and assessment of the risk of CVD has been in use and largely unchanged for many years. The advent of our polygenic risk assessment for CVD is able to identify and reclassify those individuals traditionally categorised at 'low' or 'intermediate' risk who are at higher genetic risk of a CVD event than their current standard of care risk assessment suggests. This enables earlier in life preventative measures to be adopted to lower the future risk of a CVD event.

GENinCode has a strong clinical evidence base, granted intellectual property portfolio with a vision to advance CVD risk assessment to more precisely align therapeutic treatment and lifestyle choices to improve patient outcomes.

Our products have commenced revenue generation in Europe. The GBP17m (before expenses) IPO raise completed in July 2021 will enable the Company to accelerate business growth and internationally expand our commercial program.

Business review

In the results for the six months ending 30 June 2021, the Company saw year-on-year revenue growth increase to GBP0.6m (H1 2020 GBP0.4m) primarily from its European business. The Company's key products are CE-Marked with Cardio inCode(R), Thrombo inCode(R), and Lipid inCode(R) generating the core product revenues. The Company has now commenced its expansion strategy in Europe, UK and the US which are the core markets for growth.

In Europe, the Company continues to build its business and evidence based polygenic product profile and recently announced sales and distribution arrangements with Longwood Diagnostics S.L. and Synlab Diagnostics S.A.U. to support its expansion in Spain. We are preparing Cardio inCode(R) for piloting for public health CVD risk assessment in the Spanish regions and expanding our sales team and collaborative partners in Italy and France.

As part of our US expansion strategy, and just prior to the IPO, we announced a strategic commercialisation agreement with EVERSANA Life Sciences Services, LLC. EVERSANA will act as the Company's US commercial services provider for the launch, market access and distribution of the Company's products. EVERSANA provides a broad range of commercial services to the life sciences industry. Its integrated solutions span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payors. EVERSANA has experience across many commercialisation areas, in particular reimbursement, pricing intelligence, market access and payor services. As such EVERSANA represent a strong US commercial partner capable of accelerating our growth in the US market.

The Company is in discussions to collaborate with two leading US hospital institutions, Indiana University Health and New York Presbyterian (which includes Weill Cornell and Columbia University hospitals) to work collaboratively to introduce the GENinCode technology and to access their Primary Care Patient networks. The proposed collaborations will initially introduce Cardio inCode(R) and Thrombo inCode(R) to the Indiana University Health and Weill Cornell networks and provide primary care clinical application of the GENinCode products once FDA regulatory approval has been obtained. These institutions will become the flagship hospital groups for product adoption in the mid-to-long term in the US.

We have applied to the FDA for Breakthrough Device designation in respect of our lead product Cardio inCode(R) with discussions continuing with the FDA. Despite the FDA delays in processing submissions, discussions remain constructive and progressive. There is no guarantee that Breakthrough Device designation (BDD) will be granted by the FDA and the BDD is independent of our de-novo market regulatory submission for Cardio inCode(R) which we intend to submit to the FDA over the coming months. Given the recent proposed repeal by the Centres for Medicare and Medicaid Services (CMS) of the Medicare Coverage for Innovative Technologies (MCIT) ruling we remain firmly focused on our de-novo market regulatory submission. We do not consider that the proposed repeal by CMS will have any material effect on our business as we already have a significant body of clinical evidence to support Medicare coverage at the local level from a Medicare Administrative Contractor (MAC).

In the UK, we announced our collaboration with Royal Brompton and Harefield hospitals (RB&H) to provide CVD clinical genetic testing. RB&H is part of Guy's and St Thomas' NHS Foundation Trust, the largest specialist heart and lung centre in England and one of the largest in Europe. In the NHS Long Term Plan 2019, the NHS identified CVD as a clinical priority and the single largest condition where lives can be saved by the NHS over the next 10 years. Under the collaboration, the Company will deliver its portfolio of polygenic CVD products and reporting systems, commencing with Lipid inCode(R) for the diagnosis of hypercholesterolemia. We will also jointly collaborate with RB&H to develop new genetic CVD tests based at the RB&H Genetics & Genomics Laboratory in London. The RB&H collaboration will enable the launch of the Company's commercial strategy to incorporate polygenic CVD testing in the UK.

Following the European outbreak of the COVID-19 pandemic in northern Spain and Italy we have undertaken a number of clinical studies to assess the severity of onset of COVID-19 to patients with a genetic predisposition to thrombosis using our Thrombo inCode(R) product. The first of these studies based at Hospital St Pau, Barcelona is expected to complete and present its publication over the coming months.

Financial review

Despite the challenges of the COVID-19 pandemic, our EU business held up well with solid year-on-year revenue growth over the first half of GBP600k (H1 2020 GBP414k). The first half was dominated by preparation for admission of the Company to the LSE:AIM, which was successfully completed on 22nd July 2021. The company raised GBP17.0 million (before expenses). The proceeds will be used to accelerate our commercial programme in the US, EU, and the UK.

In summary, sales grew by 44.9% to GBP600k with an adjusted EBITDA loss of (GBP978k) (H1 2020: (GBP369k)), the increased loss due to higher investment in Spain, UK and US as the Company prepares to commercially expand its core products.

Financial summary for the six months ended 30 June 2021

Revenue

Revenue for the period was GBP600k (H1 2020: GBP414k), an increase of 44.9%.

Gross profit

Gross profit was GBP320k (H1 2020: GBP202k). The gross profit margin was 53% (H1 2020: 49%). The gross margin percentage improved largely due to increased sales volumes and a better mix of product margins.

Administrative expenses

In H1 2021, administrative expenses increased to GBP1,330k (H1 2020: GBP581k). The increase was largely caused by an increase in infrastructure costs, predominantly staffing and professional costs, as the company prepared for its IPO . Administrative expenses included research and development (R & D) costs of GBP0.1m (H1 2020: GBP0.05m). Included within administrative expenses is a Share Based Payment of GBP17k (H1 2020: GBPnil).

   Operating loss and   adjusted   earnings   before   interest   tax   and   depreciation 

The Group generated an operating loss of GBP1.01m (H1 2020: GBP380k). We consider a more meaningful measure of underlying performance is obtained by examining adjusted EBITDA, which for H1 2021 was a loss of GBP978k (H1 2020: GBP369k)). This excludes the effects of share-based payments of GBP17k (H1 2020: GBPnil). The increase in operating loss and adjusted EBITDA is caused by the substantial increase in administrative expenses, being the increased investment in personnel and other infrastructure costs in advance of the intended commercialisation expansion in the US, the EU, and the UK.

Tax

There is a tax charge of GBPnil (H1 2020: GBP115k). The prior year tax charge related to the subsidiary in Spain and arose due to the Group reversing the deferred tax asset, recognised during the period ended 31 December 2019, as management consider the Group's ability to utilise the losses in the near future uncertain.

   Fixed   assets 

We have capitalised GBP711 (H1 2020: GBP143) of property plant and equipment and also GBP51k of intangible assets (H1 2020: GBPnil). This related to the application of new patents in various geographical regions which the management believe will enhance the value of the business.

   Cash   and   working   capital 

The gross cash position at 30 June 2021 was GBP978k (30 Jun 2020: GBP93k).

Net cash outflow from operations in H1 2021 was GBP976k (H1 2020: GBP357k). Inventory levels tend to be very low due to kits largely being made to order. Trade debtors decreased due to tighter credit control and payables de creased slightly as a result of increased administrative expenditure . We have seen

very   little   evidence   to   date   of  collection difficulties as a result of COVID-19. 

Capital structure

As at 30(th) June 2021, the Group had 114,361 shares in issue.

As a result of a bonus issue and subdivision of shares on 9(th) July 2021, the Group had 57,180,500 Ordinary shares in issue.

The Company successfully listed on AIM on 22 July 2021, issuing a further 38,636,366 at 44p per share and raising GBP17 million before expenses, resulting in a total of 95,816,866 Ordinary shares in issue at that date.

Outlook

The successful completion of the IPO and the GBP17m gross proceeds enables the Company to accelerate its commercial program to deliver a major advance in the current Standard of Care for CVD by identifying the early onset of atherosclerosis (ASCVD), more precise diagnosis and patient risk stratification and improved preventative care.

Our priority over the remainder of this year is to take advantage of our clinically advanced products and deliver the plans set out in our admission document with a focus on preparation for the US launch of Cardio inCode in 2022.

Over the coming months, we will target the following key deliverables:

-- Develop Cardio inCode (R) launch program with Eversana for introduction to US market in 2022

-- Continue to progress our Breakthrough Device Designation discussions with FDA for Cardio inCode (R)

   --      File Cardio inCode (R) de-novo submission for US regulatory approval with the FDA 

-- Establish CPT coding for Cardio inCode (R) and commence CMS payer and reimbursement discussions

   --      Complete RB&H set-up and commissioning for Lipid inCode (R) hypercholesterolemia testing 

-- Complete Indiana University and New York Presbyterian collaborations as flagship facilities for introduction of Cardio inCode (R) and Thrombo inCode (R)

   --      Appoint US CLIA (Clinical Laboratory Improvement Amendments) authorized testing facility 
   --      Complete and publish NHS Hypercholesterolemia study for Lipid inCode (R) 

-- Advance RB&H Lipid inCode hypercholesterolemia product with NHS, AHSN's and Private payer networks

-- Complete our first COVID-19 Thrombo inCode (R) evaluation study for genetic predisposition to thrombosis

Our products provide a significant advance in the clinical diagnosis and treatment of CVD and are increasingly being recognised as a major improvement the Standard of Care for management of CVD. Over the next reporting period we expect to see increasing product revenues driven from our EU business and the first UK revenues from our RB&H UK collaboration.

We will continue to increase investment in our manpower resource and expertise in order to take advantage of the growth opportunities open to us.

The Board of GENinCode believe our products and technology will deliver significant investor returns to our shareholders and we would like to thank our investors, Board, management and employees for their tireless effort and support over the past six months in driving business growth and delivering our successful IPO and admission to LSE:AIM.

I look forward to updating our investors on our forthcoming progress.

Matthew Walls

Chief Executive officer

16(th) September 2021

Consolidated Statement of Comprehensive Income

   For   the   6   months   ended   30 June 2021 
 
                                                   Unaudited   Unaudited       Audited 
                                                    6 months    6 months 
                                                          to          to    Year ended 
                                                     30 June     30 June   31 December 
                                         Notes          2021        2020          2020 
                                                         GBP         GBP           GBP 
 Continuing operations 
 Revenue                                             599,793     414,050       960,801 
 Cost of sales                                     (279,773)   (212,199)     (437,785) 
                                                ------------  ----------  ------------ 
 Gross profit                                        320,020     201,851       523,016 
 
 Administrative expenses                         (1,329,946)   (581,450)   (1,573,020) 
 Operating loss                                  (1,009,924)   (379,599)   (1,050,004) 
 Depreciation and amortisation                        14,795      10,924        22,687 
 Share-based payments                                 17,371           -             - 
                                                ------------  ----------  ------------ 
 EBITDA before exceptional items 
  and share-based payments                         (977,758)   (368,675)   (1,027,317) 
--------------------------------------  ------  ------------  ----------  ------------ 
 Finance Income                                            -           -            67 
 Finance costs                                             -           -             - 
                                                ------------  ----------  ------------ 
 Loss on ordinary activities 
  before taxation                                (1,009,924)   (379,599)   (1,049,937) 
 
 Corporation tax payable                   4               -   (114,844)     (116,067) 
                                                ------------  ----------  ------------ 
 Loss after taxation                             (1,009,924)   (494,443)   (1,166,004) 
                                                ------------  ----------  ------------ 
 
 Other comprehensive (expenses) 
  / income 
 Items that will not be reclassified 
  to profit or loss: 
 Exchange differences arising 
  on translating foreign operation                   (5,201)     (1,976)           440 
 Other comprehensive (expenses) 
  / income for the year, net 
  of income tax                                      (5,201)     (1,976)           440 
                                                ------------  ----------  ------------ 
 
 Total comprehensive loss for 
  the year                                       (1,015,125)   (496,419)   (1,165,564) 
                                                ============  ==========  ============ 
 
 Loss per ordinary share attributable 
  to 
 the owners of the parent during           6           Pence       Pence         Pence 
  the period 
 
 Basic                                              (883.10)    (696.57)    (1,342.90) 
 Diluted                                            (883.10)    (696.57)    (1,342.90) 
 

Consolidated Statement of Financial Position

As at 30 June 2021

 
                                          Unaudited   Unaudited       Audited 
                                           6 months    6 months    Year ended 
                                                 to          to 
                                            30 June     30 June   31 December 
                                Notes          2021        2020          2020 
 Non-current assets                             GBP         GBP           GBP 
 Intangible Assets                          176,096      91,409       139,486 
 Property, Plant & Equipment                  9,252       7,783        11,129 
 Financial Assets                                 -           -         1,809 
 Total non-current assets                   185,348      99,192       152,424 
                                       ------------  ----------  ------------ 
 
 Current assets 
 Inventory                                    9,953           -        18,156 
 Trade and other receivables                234,140     186,593       248,589 
 Financial Assets                                 -       4,475             - 
 Cash and bank balances                     978,000      92,859     2,003,072 
 Total current assets                     1,222,093     283,927     2,269,817 
                                       ------------  ----------  ------------ 
 
 Total Assets                             1,407,441     383,119     2,422,241 
                                       ============  ==========  ============ 
 
 Current liabilities 
 Trade and other payables                   584,656     495,061       563,495 
 Total current liabilities                  584,656     495,061       563,495 
                                       ------------  ----------  ------------ 
 
 Total liabilities                          584,656     495,061       563,495 
                                       ============  ==========  ============ 
 
 Net current assets / 
  (liabilities)                             637,437   (211,134)     1,706,322 
                                       ============  ==========  ============ 
 
 Net assets                                 822,785   (111,942)     1,858,746 
                                       ============  ==========  ============ 
 
 Equity 
 Share capital                    5         114,361      76,459       114,361 
 Share Premium                            3,279,346     715,623     3,317,553 
 Share based payment                         17,371           -             - 
  reserve 
 Retained deficit                       (2,588,293)   (904,024)   (1,573,168) 
                                            822,785   (111,942)     1,858,746 
                                       ============  ==========  ============ 
 

Consolidated Statement of Cash Flows

   For   the   6   months   ended   30 June 2021 
 
                                                       Unaudited   Unaudited       Audited 
                                                        6 months    6 months    Year ended 
                                                              to          to 
                                                         30 June     30 June   31 December 
                                                            2021        2020          2020 
                                            Notes            GBP         GBP           GBP 
 Cash flows from operating activities 
      Loss before taxation                           (1,009,924)   (379,599)   (1,049,937) 
 Adjustments for: 
    Share based charged adjustment                        17,371           -             - 
    Depreciation and amortization                         14,795      10,924        22,773 
 Operating loss before working 
  capital changes                                      (977,758)   (368,675)   (1,027,164) 
 Cash used in operations 
    Decrease / (Increase) in trade 
     and other receivables                                14,448     114,837        42,529 
    (Decrease) / Increase in trade 
     and other payables                                 (21,161)   (103,424)      (34,990) 
    Increase in inventory                                  8,203           -      (18,156) 
 Net cash outflow from operating 
  activities                                           (976,268)   (357,262)   (1,037,781) 
--------------------------------------------------  ------------  ----------  ------------ 
 Investing activities 
    Purchase of property, plant 
     and equipment                                         (711)       (143)       (5,198) 
    Purchase of intangible assets                       (51,242)           -      (63,075) 
 Net cash flows used in investing 
  activities                                            (51,953)       (143)      (68,273) 
--------------------------------------------------  ------------  ----------  ------------ 
 Financing activities 
    Issue of ordinary shares (net 
     of issue expenses)                                        -     367,985     3,026,142 
    Proceeds from loan issue                                   -           -             - 
 Net cash flows from financing 
  activities                                                   -     367,985     3,026,142 
--------------------------------------------------  ------------  ----------  ------------ 
 Net change in cash and cash equivalents             (1,028,221)      10,580     1,920,088 
 Cash and cash equivalents at 
  the beginning of the period                          2,003,072      85,149        85,149 
 Exchange (losses) on cash and 
  cash equivalents                                         3,149     (2,870)       (2,165) 
--------------------------------------------------  ------------  ----------  ------------ 
 Cash and cash equivalents at 
  the end of the period                                  978,000      92,859     2,003,072 
--------------------------------------------------  ------------  ----------  ------------ 
 

Consolidated Statement of Changes in Equity

   For   the   6   months   ended   30 June 2021 
 
                                  Share       Share      Retained      Other         Total 
                                capital     premium       profits   reserves        equity 
                                    GBP         GBP           GBP        GBP           GBP 
 Balance at 1 Jan 2020           66,960           -     (407,605)          -     (340,645) 
 Other comprehensive income           -           -       (1,976)          -       (1,976) 
 Shares Issued                    9,499     715,623             -          -       725,122 
 Loss for the period ended 
  30 June 2020                        -           -     (494,443)          -     (494,443) 
                               --------  ----------  ------------  ---------  ------------ 
 Balance at 30 June 2020         76,459     715,623     (904,024)          -     (111,942) 
 Other comprehensive income           -           -         2,417          -         2,417 
 Shares issued                   37,902   2,601,930             -          -     2,639,832 
 Loss for the period ended 
  31 December 2020                    -           -     (671,561)          -     (671,561) 
                               --------  ----------  ------------  ---------  ------------ 
 Balance at 31 December 2020    114,361   3,317,553   (1,573,168)          -     1,858,746 
 Other comprehensive income           -           -       (5,201)          -       (5,201) 
 Loss for the six months 
  ended 30 June 2021                  -           -   (1,009,924)          -   (1,009,924) 
 Capitalisation of IPO costs          -    (38,207)             -          -      (38,207) 
 Share based payments                 -           -             -     17,371        17,371 
                               --------  ----------  ------------  ---------  ------------ 
 Balance at 30 June 2021        114,361   3,279,346   (2,588,293)     17,371       822,785 
                               --------  ----------  ------------  ---------  ------------ 
 
 
 Share capital is the amount subscribed for shares at nominal value. 
 Share premium is the amount subscribed for share capital in excess 
  of nominal value less share issue costs. 
 Other reserves arise from the share options issued by the company during 
  the period ended 30 June 2021. 
 Retained earnings represents accumulated profit or losses to date. 
 

Notes to the Consolidated Financial Statements

   For   the   6   months   ended   30 June 2021 
   1.            General information 

GENinCode plc (the "Company") is a public limited company admitted to trading on the AIM market of the London Stock Exchange on 22 July 2021. The Company is incorporated and domiciled in England and Wales. The registered office of the Company is One, St. Peters Square, England, M2 3DE. The registered company number is 11556598.

The Company was incorporated on 06 September 2018.

The Company's principal activity is the development and commercialisation of clinical genetic tests, to provide predictive analysis of risk to a patient's health based on their genes.

The financial information set out in this half yearly report does not constitute statutory accounts as defined in

Section 434 of the Companies Act 2006. The statutory financial statements for the year ended 31 December 2020, prepared under International Financial Reporting Standards ("IFRS"), have been filed with the Registrar of Companies. The auditor's report on those financial statements was unqualified and did not contain statements under Sections 498(2) and 498 (3) of the Companies Act 2006.

Copies of the annual statutory accounts and the Interim Report can be found on the Company's website at

www.genincode.com.

   2.            Significant accounting policies and basis of preparation 
   2.1           Statement of compliance 

This half yearly report has been prepared using the historical cost convention, on a going concern basis and in accordance with International Financial Reporting Standards ("IFRS") as adopted by the European Union, IFRS Interpretations Committee (IFRIC) and the Companies Act 2006 applicable to companies reporting under IFRS, using accounting policies which are consistent with those set out in the financial statements for the year ended 31 December 2020.

   2.2           Application of new and revised International Financial Reporting Standards (IFRSs) 

There are no IFRSs or IFRIC interpretations that are effective for the first time in this financial period that would be expected to have a

material impact on the Company.

   3.            Segmental reporting 

The Company has one reportable segment, namely that is the development and commercialisation of clinical genetic tests, to provide predictive analysis of risk to a patient's health based on their genes, all within Spain.

Notes to the Consolidated Financial Statements (cont.)

   For   the   6   months   ended   30 June 2021 
 
 4.         Taxation 
                                                       6 months to                     6 months           12 months 
   Income taxes recognised in profit                    30 June 2021                    to                 to 
   or loss                                                                              30 June 2020       31 Dec 2020 
                                                                               GBP               GBP               GBP 
  Current tax 
  GEN inCode SLU                                                                 -         (114,844)         (116,067) 
  Tax credit for the period                                                      -         (114,844)         (116,067) 
------------------------------------  --------------------------------------------  ----------------  ---------------- 
 
   5.         Share capital 
  Issued share capital comprises                                      30 June 2021      30 June 2020       31 Dec 2020 
                                                                               GBP               GBP               GBP 
  76,549 Ordinary shares of GBP1 
   each (30 June 2020: 76,549 
   shares) 
   (31 December 2020: 76,459 shares)                                        76,459            76,459            76,459 
  37,902 B Ordinary shares of GBP1 
   each (30 June 2020: Nil shares) 
   (31 December 2020: 37,902 shares)                                        37,902                 -            37,902 
 
   6.         Loss per share 
                                                       6 months to                     6 months           12 months 
                                                        30 June 2021                    to                 to 
                                                                                        30 June 2020       31 Dec 2020 
                                                                               GBP               GBP               GBP 
  Basic and diluted loss per share 
  Loss after tax (GBP)                                                 (1,009,924)         (494,443)       (1,166,004) 
  Weighted average number of shares                                        114,361            70,983            86,827 
  Basic and diluted loss per share 
   (pence)                                                                (883.10)          (696.57)        (1,342.90) 
------------------------------------  --------------------------------------------  ----------------  ---------------- 
 
   As the Company is reporting a loss from continuing operations for 
   the period then, in accordance with IAS 33, the share options are 
   not considered dilutive because the exercise of the share options 
   would have an anti-dilutive effect. The basic and diluted earnings 
   per share as presented on the face of the income statement are therefore 
   identical. 
 7.         Events after the 
             reporting 
             date 
      The Company has evaluated all events and transactions that occurred 
       after 30 June 2021 up to the date of signing of the financial statements. 
 
       By special resolution passed on 5 July 2021, the Company reduced 
       its share premium account by GBP2,808,032. 
 
       By resolution dated 9 July 2021, the Company approved the issue 
       of 305,836 Ordinary Shares of GBP1 each and 151,608 B Ordinary Shares 
       of GBP1 each by way of bonus issue, conditional on the re-registration. 
 
       By resolution dated 9 July 2021, the Company approved the subdivision 
       of each of the issued and to be issued Ordinary Shares of GBP1 each 
       into 100 Ordinary Shares of GBP0.01 each, conditional on the re-registration, 
       and approved the subdivision of each of the issued and to be issued 
       B Ordinary Shares of GBP1 each into 100 B Ordinary Shares of GBP0.01, 
       conditional on the re-registration. 
 
       By resolution dated 9 July 2021, the Company approved the conversion 
       of 18,951,000 B Ordinary Shares into 18,951,000 Ordinary Shares, 
       conditional on the EIS / VCT Placing. 
 
 
 
 
 
 
       Notes to the Consolidated Financial Statements (cont.) 
       For the 6 months ended 30 June 2021 
 
 
 7.       Events after the reporting date (cont.) 
 As a result of the above transactions, at 9 July 2021, the Company 
  had 57,180,500 Ordinary shares in issue. 
 
  The Company successfully listed on AIM on 22 July 2021, issuing a 
  further 38,636,366 at 44p per share and raising GBP17 million before 
  expenses, resulting in a total of 95,816,866 Ordinary shares in issue 
  at that date. 
 
 
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September 16, 2021 01:59 ET (05:59 GMT)

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