Half-year Financial Report

GENinCode Plc

(“GENinCode” or the “Company”)

Interim results

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease (“CVD”) and risk of ovarian cancer announces its unaudited interim results for the six months ended 30 June 2026.

 Financial highlights

Post-period end.

• ESC Congress 2026, Munich – Milestone preliminary clinical results presented from Catalonia clinical implementation of CARDIO inCode-Score (CAD PRS) showing significant reduction in cardiovascular risk and major improvement in clinical risk factors including reductions in LDL-Cholesterol and improved smoking abstinence. Full publication is expected to be released H1 2027.   

Current trading and Outlook

• Over the first half of FY26, consolidated year-on-year revenues reduced mainly due to NHS cutbacks and the non-recurring Catalonia pilot study undertaken in H1 2025.
• While US sales volumes over the first half strengthened, supported by an increase in new clients onboarding following the US ACC/AHA guideline changes, sales under the Thermo Fisher collaboration have been delayed as parties focused on the manufacture and validation of CARDIO inCode-Score (CAD PRS), which has now been completed. 
• As a result of lower-than-expected NHS sales and slower uptake through Thermo Fisher in the US and EU, the Company now expects revenue for the full year to be approximately £3.2m, but with reduced impact on adjusted EBITDA following strong cost reductions over the year.
• The Company expects cash runway to Q1 2027.
•        Over the remainder of this year, the Company expects to focus on the following key deliverables:

-        Commercial implementation and scale-up of CARDIO inCode (CAD PRS) with Thermo Fisher

-        Commercial expansion of LIPID inCode in the EU and US.

-        US FDA De Novo submission and EU IVDR filing of CARDIO inCode-Score (CAD PRS).

-        Implementation of LIPID inCode and CARDIO inCode-Score (CAD PRS) with leading US healthcare institutions.

-        Negotiations regarding clinical adoption of CARDIO inCode-Score (CAD PRS) in Catalonia and Extremadura.

-        Clinical adoption of CARDIO inCode-Score (CAD PRS) in Mexico.

-        Growth of ROCA trust adoption in the NHS.

Matthew Walls, Chief Executive Officer of GENinCode Plc said: “The downturn in NHS revenues and the non-recurring Catalonia and Extremadura study revenues have impacted H1 2026 sales as we continue to develop our clinical and commercial discussions with these clients. We had hoped to achieve greater commercial traction with a launch of testing with Thermo Fisher but this is now expected later in the year. 

“We have multiple ongoing business development discussions with Thermo Fisher across the EU and US which, together with the recent US ACC/AHA guideline changes, have increased our US genetic test profile for prevention of heart disease. Our FDA De Novo submission is expected to be filed in November 2026 and EU IVDR in December 2026. While revenues have not been as strong as hoped, adjusted EBITDA losses have reduced over the period and are expected to improve further in the second half as revenues improve.”

For more information visit www.genincode.com

Enquiries:

About GENinCode:

GENinCode Plc is a UK based company specialising in genetic risk assessment of cardiovascular disease and surveillance of ovarian cancer. Cardiovascular disease is the leading cause of death and disability worldwide.

GENinCode operates business units in the UK, Europe through GENinCode S.L.U., and in the United States through GENinCode U.S. Inc.

GENinCode predictive technology provides patients and physicians with globally leading preventive care and treatment strategies. GENinCode invitro-diagnostic molecular tests combine clinical algorithms and bioinformatics to advance patient risk assessment to prevent the onset of cardiovascular disease and ovarian cancer.

Chief Executive’s Statement

For the six months ended 30 June 2026

On behalf of the Board, the following interim report covers the six-month period ended 30 June 2026 for GENinCode Plc. This statement provides a summary of progress over the first half of the 2026 financial year and the outlook over the next reporting period. 

Introduction

GENinCode is engaged in the prevention of cardiovascular disease (CVD) and ovarian cancer. GENinCode polygenic (multiple gene) tests and technology are novel and proprietary and focused on prevention of CVD which accounts for around 18 million deaths annually, representing approximately 31 per cent. of all deaths worldwide. CVD is the leading cause of death globally with the disease cost estimated to reach approximately $1.04 trillion by 2030.

The Company’s portfolio comprises advanced genomic precision tests using molecular genotyping, sequencing, and bioinformatics to risk assess patients’ DNA from a simple blood or saliva sample. DNA is analysed for the presence of genetic variants to determine a patient’s Polygenic Risk Score (PRS) and assess their cardiovascular ‘lifetime’ genetic risk.

2026 Interim Report

Revenue for the period was £1.1m (H1 2025: £1.6m), with an Adjusted EBITDA loss for the period of (£2.26m) (H1 2025: (£2.54m)). The Group is scaling its commercial programmes across the US, UK, and Europe.

US Business

GENinCode’s US strategy is targeting test engagement of the top US physicians in preventive cardiology and lipidology. The Company continues to build partnerships with US key opinion leaders (KOLs) and major institutions, supported by education programmes using our proprietary ‘SITAB’ system (System of Integrated Traceability Analysis and Biology) to deliver polygenic risk scores and data registry capability. Our testing continues to expand across institutions, community clinics, and executive health settings.

The Company has successfully onboarded over 80 top-tier institutional sites, mainly for the sale of LIPID inCode. Following the recent ACC/AHA primary prevention guideline updates and the Thermo Fisher Scientific (“Thermo Fisher”) collaboration, we are now in discussions with larger reference labs and imaging groups to sell CARDIO inCode-Score Coronary Artery Disease Polygenic Risk Score “(CAD PRS)”. Sales are expected to materially increase from the expanded insurance coverage if FDA approval is received. The Total Addressable Market for CARDIO inCode-Score (CAD PRS) is estimated at $10.5 billion, with a Serviceable Available Market of $4.5 billion. Initial market scoping indicates an addressable patient pool of approximately 21 million patients, of whom around 8.5 million are likely to be prescribed CARDIO inCode-Score (CAD PRS) once covered by insurance.

The Company is now finalising its updated CARDIO inCode-Score (CAD PRS) FDA De Novo Pre Market submission, which is expected to be filed in November 2026. The FDA filing includes new clinical data covering multi-ethnic population groups, and statistical and medical review analysis. US FDA approval of CARDIO inCode-Score (CAD PRS) would allow the test to be marketed nationally as a medical device, substantially expanding the market opportunity in the US. CARDIO inCode-Score (CAD PRS) is included in the US Centres for Medicare and Medicaid Services (CMS) Clinical Lab Fee Schedule at a median price of $500 per test.

The Company also expects to file its EU IVDR regulatory submission for CARDIO inCode-Score (CAD PRS) in December 2026 post the FDA filing.

Over the first half the Thermo Fisher Scientific collaboration has commissioned, manufactured and analytically validated CARDIO inCode-Score (CAD PRS) as a new Stock Keeping Unit (SKU) in preparation for US and EU sales. Commercial discussions have commenced and, whilst slower than expected, are now growing in number for the distribution and sale of CARDIO inCode-Score (CAD PRS) to laboratories across the US and Europe.

Prior to US FDA approval, laboratories would be introduced to CAD PRS as an ‘In House Assay’ for the prevention of heart disease. Once FDA medical device approval is received, the collaboration will extend to manufacturing and sale of the medical device to laboratories and test centres across the US. A similar approach will be adopted in the EMEA market.

Thermo Fisher was chosen as the preferred partner based on the design and development of the CARDIO inCode-Score (CAD PRS) test on Thermo Fisher’s proprietary QuantStudio™ 5 Dx Real Time PCR System. The QuantStudio™ 5 Dx Real Time PCR System is installed globally with significant installation coverage across the US and EMEA region. Increasing demand for CARDIO inCode-Score (CAD PRS) will be met by Thermo Fisher’s scale up of the test manufacturing. Thermo Fisher is a major global provider of genetic reagents to labs with an installed QuantStudio (QS Dx) platform user base.

GENinCode has built a significant body of clinical evidence around the clinical utility of the CARDIO inCode-Score (CAD PRS). In March 2026, the American College of Cardiology and American Heart Association announced an update to the Dyslipidemia and Lipid Management guidelines which now includes coronary artery disease polygenic risk scores “CAD PRS” as a new risk assessment tool for the primary prevention of heart disease. We are delighted to see CAD PRS included in the US guidelines to improve coronary heart disease risk Calculation, Personalisation and Reclassification (CPR) to prevent heart disease.   

LIPID inCode is a leading test for Familial Hypercholesterolemia (“FH”) with increasing recognition by the US Centres for Disease Control (CDC) of the public health importance of testing in order to identify individuals suffering with FH; these individuals are at high risk of ‘earlier in-life’ onset of cardiovascular disease, in the form of atherosclerosis and angina, leading to heart attack. LIPID inCode has received reimbursement coding and medical classification coding (ICD-10) coverage in the US with an average payer insurance reimbursement of $1,229, reflecting the Clinical Laboratory Fee Schedule for the test and the broad Familial Hypercholesterolemia panel of tests to identify FH genetic variants.

UK and Europe Business

Whilst we have made great progress to support the NHS for FH diagnosis and cardiovascular disease prevention, future progress has been curtailed by the major strategic, organisational, and funding changes across the NHS. The LIPID inCode implementation in the North-East and North-Cumbria (Newcastle) resulted in GENinCode processing approximately 3,000 FH tests over the past 36 months, enabling it to be the only region to meet the NHS 10 Year Plan for FH testing. FH genetic testing is critically important to diagnose patients in the population who are at high risk of heart disease and from these tests over 500 positive FH patients have been identified and diagnosed for treatment to prevent heart disease.

 https://thehealthinnovationnetwork.co.uk/case_studies/genomic-testing-for-cardiovascular-conditions/

There is continuing and growing demand for LIPID inCode in Spain and Italy and for the introduction of THROMBO inCode in public hospital labs.

Following successful pilot implementation of CARDIO inCode-Score (CAD PRS) in the Spanish regions of Catalonia and Extremadura we are now progressing negotiations for clinical implementation. The Catalonia region has a population of approx. 7.7 million, with an estimated 476,000 individuals at risk of a cardiovascular event e.g. heart attack. The Extremadura region has a population of approx. one million, with an estimated 50,000 individuals at risk of a cardiovascular event. CARDIO inCode-Score (CAD PRS) is expected to change clinical practice by identifying those individuals at high genetic risk and improving preventive treatment.

Clinical adoption of CARDIO inCode-Score (CAD PRS) is progressing in Mexico with Sohin Genetics and Grupo Angeles preparing to receive first samples in H2 2026. 

In August 2026, post the period end, milestone preliminary clinical results were presented at the European Society of Cardiology (ESC) Annual Congress in Munich.  The results from the Catalonia pilot clinical implementation of CARDIO inCode-Score (CAD PRS) delivered a significant reduction in cardiovascular risk and a major improvement in clinical risk factors including reductions in LDL-Cholesterol and improved smoking abstinence. The full publication is expected to be released H1 2027. Other pilots are underway in the Spanish regions including Andalucía, Basque region, and Baleares.

In Italy, direct business operations are expanding with partnerships such as Fondazione SISA supporting LIPID inCode. In Germany, LIPID inCode sales are developing through collaboration with Uniklinikum.

Following the agreement with University College London Hospitals (UCLH), the first trust to adopt the Risk of Ovarian Cancer Algorithm (ROCA), we are now discussing implementation with several trusts in the London and South-East region.   NICE guidelines recommend ROCA testing every four months for women at risk of ovarian cancer. The ROCA test is being discussed for implementation across several NHS regions, with support from Cancer Alliances and Specialised Services. The test has gained strong backing from gynaecological oncologists, geneticists, and genetic counsellors which despite its NICE recommendation requires budget allocation by individual NHS Trusts prior to clinical adoption.

International expansion of ROCA is progressing, with agreements signed in Switzerland and Austria in 2024, with plans to expand into Germany and Spain. The US market remains under evaluation, with ongoing considerations based on progress in the UK and Europe.

Intellectual Property

We maintain an ongoing intellectual property programme to strengthen our existing patent portfolio and advance our family of patents for both CARDIO inCode (CAD PRS) and THROMBO inCode. We will continue to build our intellectual property portfolio and actively evaluate in-licensing and acquisition opportunities as appropriate to enhance our competitive product positioning.

Financial review

Revenue for the period was £1.13m (H1 2025: £1.60m), with an Adjusted EBITDA loss for the period of (£2.26m) (H1 2025: (£2.54m)).

Although gross margin was lower at £534k (H1 2025: £849k), resulting from the lower revenues, admin expenses reduced to £2.79m (H1 2025: £3.39m). 

Revenue

Spain continues to be the largest region for revenue which was £902k for H1 2026; this represents a decrease of £147k  on the H1 2025 figure of £1,049k, mainly because last year’s revenue included £160k of revenues from the CARDIO inCode-Score (CAD PRS) pilot studies in the Spanish region of Catalonia.

Sales generated from the UK decreased to £64k (H1 2025: £383k), due almost entirely to the reduced NHS testing of LIPID inCode. Discussions continue with the NHS around future reinstatement.

Revenue recognised in the US was £53k (H1 2025: £88k). Whilst US sales volumes were ahead of last year, the time taken to receive payment from insurers continues to be a concern due to Insurance medical necessity reviews, denials and appeals, hence we have only recognised 15% of gross insurance invoices, versus 42% in H1 2025. We continue to take a cautious approach to revenue recognition whilst we establish payment arrangements with Insurers.

Gross profit

Gross profit was £534k (H1 2025: £849k). The gross profit margin decreased to 47.5% (H1 2025: 53.0%).

Geographically, the gross profit margins generated from Spain remained at 40% (H1 2025: 40%). As a result of closing down the Spanish lab facility in Girona in 2025, the Spanish operation continues to transfer its samples to the UK lab where margins are considerably higher than those made from the Spanish lab facility.

The Group benefitted from 55% margins from the UK sales and 60% margins from the US sales; these margins will improve substantially once volumes increase and US insurance payments start coming through.

Administrative expenses

In H1 2026, administrative expenses decreased to £2.79m (H1 2025: £3.39m). This decrease was mainly due to the £400k+ non-cash adverse impact of the strengthening of sterling against the US dollar over the H1 2025 period. However, there are around £200k of real cost savings within salaries, rent, and professional fees, which are expected to continue throughout the rest of the year. Considering that inflation was running at around 3% throughout H1 2026, the actuals savings are considerably greater.

Operating loss and adjusted earnings before interest tax and depreciation

The Group generated an operating loss of £2.54m (H1 2025: (£2.97m)).

Depreciation and amortisation decreased to £63k (H1 2025: £162k) and share based payments decreased to £216k (H1 2025: £266k).

Tax

The first half tax charge was £0k (H1 2025: credit of £4k).

Total comprehensive loss

Total comprehensive loss for the period increased to £2.56m (H1 2025: loss of £2.46m).

Exchange differences arising on translating foreign operations was (£45k), compared to £500k in H1 2025; this

represents the retranslation of the rest of the balance sheet (excluding the intercompany balances which are

included in the admin costs as highlighted above).

Non-current assets

The Company has a capitalised property plant and equipment total, net of depreciation of £105k at 30 June 2026 (31 December 2025: £113k), reflecting investment in equipment required to commission the UK laboratory in the latter part of 2022. Additionally, the Company has a capitalised intangible assets total, net of amortisation, of £88k (31 December 2025: £98k). This related to the application of new patents in various geographical regions.

The 'right-of-use’ asset representing the impact of leasing the new lab in Hammersmith, London was £83k at 30 June 2026 (31 December 2025: £124k). IFRS 16 introduces a single lessee accounting model and requires a lessee to recognise assets and liabilities for all leases with a term of more than 12 months unless the underlying asset is of low value. A lessee is required to recognise a right-of-use asset representing its right to use the underlying leased asset and a lease liability representing its obligation to make lease payments. 

Current Assets

The Group holds very little finished goods and work in progress, largely because approximately 60% of its revenues originate from service-based testing with test kits ‘made to order’ and then delivered directly from the kit manufacturer/supplier to the customer. 

Trade and Other Receivables increased from £1,074k at 31 December 2025 to £1,114k at 30 June 2026, reflecting greater than usual debtor balances in Spain and the US.

Non-Current Liabilities

Lease liability was £0k at 30 June 2026 (31 December 2025: £51k), relating to IFRS 16 requiring Right of Use lease liability being recognised.

Deferred taxation was £2k (31 December 2025: £2k).

Current Liabilities

Trade and Other Payables decreased from £2.11m at 31 December 2025 to £1.37m at 30 June 2026; the level of Trade and Other Payables was unusually high at 31 December 2025, partly due to relatively large amounts owed to our former lab provider in Spain, the contract of which terminated last year, as well as tighter than usual cash control at the year-end in advance of an imminent fundraise.

Lease liability was £98k at 30 June 2026 (31 December 2025: £95k), relating to IFRS 16 requiring Right of Use lease liability being recognised.

Cash flow and working capital

Operating cash outflow decreased from (£3.22m) in H1 2025 to (£3.05m) in H1 2026. The decrease is largely explained by the reduced operating losses in the period.

Net cash flows used in investing activities decreased from £25k in H1 2025 to £19k in H1 2026, reflecting a small amount of expenditure on laboratory equipment in the UK and US, offset by bank interest income.

Net cash flows from financing activities increased to £4.25m in the period (H1 2025: £3.68m). On 9th February 2026, the Company allotted a total of 466,159,095 new ordinary shares in connection with a fundraising at 1 pence per share; a net amount of £4.3m was raised (gross: £4.66m).

As a result of the above activities there was an overall increase in cash and cash equivalents of £1,157k from £827k at 31 December 2025 to £1,984k at 30 June 2026.

Capital structure

On 9th February 2026 the Company issued 466,159,095 shares at a price of 1 pence per share as a result of a fund raising of £4.66m in capital for the Group. A total of 23,000,000 shares were issued to the Directors of the Group under the same terms. Following the issue of the shares, the Group had 753,041,137 shares in issue at 30th June 2026.

On 7th May 2026, the Company announced that it had approved and granted new options over an aggregate of 83,847,292 new ordinary shares of 1 pence each in the Company to certain directors and employees of the Company, representing 11.13 per cent. of the Company’s existing share capital; the new options have an exercise price of 1 pence per share and are exercisable on the second anniversary of the date of grant. 

In addition, directors and employees of the Group surrendered options over an aggregate of 29,856,434 ordinary shares. Following the grant of the new options and the options surrender, there are options over a total of 85,923,543 ordinary shares in the Company, representing 11.41% of the Company’s existing issued share capital.

Current trading and Outlook

Over the first half of FY26, consolidated year-on-year revenues reduced mainly due to NHS cutbacks and the non-recurring Catalonia pilot study undertaken in H1 2025. While US sales volumes over the first half strengthened, supported by an increase in new clients onboarding following the US ACC/AHA guideline changes, sales under the Thermo Fisher collaboration have been delayed partly resulting from the focus on the manufacture and validation of CARDIO inCode-Score (CAD PRS), which has now been completed. 

As a result of lower-than-expected NHS sales and slower uptake through Thermo Fisher in the US and EU, the Company now expects revenue for the full year to be approximately £3.2m, but with a reduced impact on adjusted EBITDA following strong cost reductions over the year. The Company expects cash runway to Q1 2027.

Over the remainder of this year, the Company expects to focus on the following key deliverables:

-        Commercial implementation and scale-up of CARDIO inCode (CAD PRS) with Thermo Fisher

-        Commercial expansion of LIPID inCode in the EU and US.

-        US FDA De Novo submission and EU IVDR filing of CARDIO inCode-Score (CAD PRS).

-        Implementation of LIPID inCode and CARDIO inCode-Score (CAD PRS) with leading US healthcare institutions.

-        Negotiations regarding clinical adoption of CARDIO inCode-Score (CAD PRS) in Catalonia and Extremadura.

-        Clinical adoption of CARDIO inCode-Score (CAD PRS) in Mexico.

-        Growth of ROCA trust adoption in the NHS.

We continue to build our business and believe our tests are industry leading and will deliver significant investor returns. We would like to thank our investors, Board, management, and employees for their strength and determination in helping support and drive our business growth.

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

Matthew Walls

Chief Executive Officer

29 September 2026

GENinCode Plc

Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2026

GENinCode Plc

Consolidated Statement of Financial Position

As at 30 June 2026

GENinCode Plc

Consolidated Statement of Cash Flows

For the six months ended 30 June 2026

GENinCode Plc

Consolidated Statement of Changes in Equity

For the six months ended 30 June 2026

GENinCode Plc

Notes to the Consolidated Financial Statements

For the six months ended 30 June 2026

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 6 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 2025, prepared under UK adopted 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 UK adopted International Financial Reporting Standards (“IFRS”) 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 2025.

2.2                 Application of new and revised UK adopted 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, the geographical split of revenue generation is below.