Interim Report: Six Months to Sep 30, 2024

This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation No 596/2014 which is part of English law by virtue of the European (Withdrawal) Act 2018, as amended.  On publication of this announcement via a regulatory information service, this information is considered to be in the public domain.

16 December 2024

EDX Medical Group plc

AQSE: EDX

("EDX Medical" or the "Company")

Interim Report and Financial Statements for

the six-month period ended 30 September 2024

CAMBRIDGE, UK: EDX Medical Group, plc, which develops innovative digital diagnostic products and services for the personalised treatment for cancer, heart disease and infectious diseases, today announces publication of its Interim Report and Financial Statements for the six-month period ended 30 September 2024.

Highlights:

• Launch of a range of tests for determining hereditary risk of cancer and cardiovascular disease.
• Company appointed as exclusive distributors of class-leading cancer diagnostic tests in UK and Nordic markets by Caris Life Sciences inc, Curesponse Ltd and MirDetect GmbH.
• ​In-licensing of IP to support development of an advanced 5-FU / DPYD chemotherapy safety test.
• ​Admission to the Apex Segment of AQSE Growth Market.
• ​Cash balance at 30 September 2024 - £2, 308,069

Jason Holt, Chairman of EDX Medical Group plc, commented:

"During the reporting period, EDX Medical made further significant steps in expanding and accelerating its capabilities to provide innovative digital diagnostic products that can help healthcare professionals deliver improved outcomes for patients with cancer, cardiovascular disease and infectious diseases.

"In addition to our expanding development programme, we successfully established new commercial partnerships with several companies in the oncology sector, providing our clients with exclusive access to a number of unique, market-ready world-class tests, with exceptional clinical support. Our commercial team in the UK and Nordic markets is expanding, in order to launch and support these products and services.

"These new relationships complement our own development efforts and in particular the collaboration with Thermo Fisher EMEA Ltd, which embraces multiple underlying projects, with an exciting European dimension. This programme is focused on licensing exclusive rights to innovative assays with 'proof of concept' data and progressing the prototypes through a robust development process to secure regulatory approval, ready for international commercialisation. We are investing in personnel, equipment and logistics to support this programme and our emerging commercial operations.

"As we pass our second anniversary as a listed company, we are entering into a new phase that combines a portfolio contributing near and mid-term revenues commencing in 2025, with an expanded pipeline of global product development opportunities. However, the market for digital diagnostic products is in its infancy and the pace of change is rapid, therefore accurately forecasting revenue growth in detail is challenging at this time. The directors expect to provide further updates in this regard in the first quarter of 2025, but we are confident that 2025 is a year of considerable potential for EDX Medical."

ENDS

Contacts:

Notes for Editors:

About EDX Medical Group plc

The EDX Medical Group plc is listed on the Apex Segment of the AQSE Growth Market (TIDM: EDX).

EDX Medical was founded by Professor Sir Christopher Evans, OBE, a medical and life sciences entrepreneur with more than 30 years of experience, together with CEO, Dr Mike Hudson.

By translating clinical insights into pragmatic solutions combining advanced biological and digital technologies, EDX Medical seeks to cost effectively improve the detection and characterisation of disease in order to personalise treatment in a timely fashion. Early disease detection and biologically-based personal treatment optimisation is considered to be the most impactful way of reducing deaths and lowering the cost of healthcare globally.

EDX Medical Group provides doctors, hospitals and insurers/payers with access to a portfolio of the best clinical diagnostics products and services. The Company operates its own facilities in Cambridge and Oxford, UK, and has a number of significant strategic partnerships including; a product technology collaboration with Thermo Fisher EMEA Ltd, a logistics partnership with Fedex and a distribution agreement with Caris Life Sciences inc, each world leaders in their respective fields.

www.edxmedical.com

EDX Medical Group Plc

Interim Report and Financial Statements

For the six-month period ended 30 September 2024

Company registration number: 13277385 (England and Wales)

INTERIM MANAGEMENT REPORT

During the reporting period, EDX Medical made further significant steps in expanding and accelerating its capabilities to provide innovative digital diagnostic products that can help healthcare professionals deliver improved outcomes for patients with cancer, cardiovascular disease and infectious diseases.

The Company has focused on securing access to a portfolio of 'market-ready' world-class oncology diagnostics as top priority, whilst simultaneously enhancing its own development pipeline. We successfully established new commercial partnerships with several companies in the oncology sector, providing our clients with exclusive access to a number of unique, market-ready world-class tests, with exceptional clinical support, underscoring our commitment to providing our clients with early access to existing innovative products and services, in partnership with the following companies:

Caris Life Sciences, a leading US-based precision medicine company with unequalled clinical experience has appointed EDX Medical as the exclusive UK distributor of their US-market-leading tumour molecular profiling products and services.

Curesponse Ltd ("Curesponse"). EDX Medical is now marketing the cResponse™ cancer assay in the UK, Sweden, Finland, Norway and Denmark. cResponse™ assesses how an individual patient's living tumour tissue responds to selected medicines, providing valuable data to assist in the identification of the most effective treatments

Shortly after the reporting period the Company entered into an exclusive agreement for the UK and Nordic markets with mir|detect GmbH ("mir|detect") for the sale and distribution   of the M371 testicular cancer diagnostic - a simple blood test that enables highly accurate detection of critical biomarkers of testicular cancer in its early stages.

Our commercial team in the UK and Nordic markets is expanding, in order to launch and support these products and services. The Company recently welcomed Eric Vick, joining as Chief Commercial Officer to lead commercial operations.

These new relationships complement our own development efforts and in particular the collaboration with Thermo Fisher EMEA Ltd, which embraces multiple underlying projects, with an exciting European dimension. This programme is focused on licensing exclusive rights to innovative assays with 'proof of concept' data and progressing the prototypes through a robust development process to secure regulatory approval, ready for international commercialisation.

The EDX Medical development pipeline was also enhanced by in-licensing new intellectual property funded by Cancer Research UK (CRUK), from Oxford University Innovation Ltd (OUI). This will enable EDX Medical to develop a much-improved test to determine safety and dose management for individual patients receiving 5-fluorouracil (5-FU), capecitabine and related chemotherapy medications

The Company also recently announced the launch of a range of laboratory assays to identify inherited genes associated with an increased risk of cancer and cardiovascular disease.

We are investing in personnel, equipment and logistics to support this programme and our emerging commercial operations.

As we pass our second anniversary as a listed company, we are entering into a new phase that combines a portfolio contributing near and mid-term revenues commencing in 2025, with an expanded pipeline of global product development opportunities. However, the market for digital diagnostic products is in its infancy and the pace of change is rapid, therefore accurately forecasting revenue growth in detail is challenging at this time. The directors expect to provide further updates in this regard in the first quarter of 2025, but we are confident that 2025 is a year of considerable potential for EDX Medical.

Financial Summary

During the period, the majority of the Company's administrative expenditure has related to expenses incurred in connection with preparing the Company to be able to deliver in line with the strategy outlined above. The loss for the six-month period was £1,699,298 (loss in period to 30 September 2023: £1,336,723)

Trade and other receivables as at 30 September 2024 were £546,307 (September 2023: £531,543).

The cash balance as at 30 September 2024 was £2,308,069 (September 2023: £1,104,801).

Trade and other payables at 30 September 2024 were £395,054 (September 2023: £547,846 ).

Overall, at the period-end, net assets/(liabilities) were £1,784,459 (September 2023: (£388,000).

The Company is now listed on the Apex segment of the AQSE Growth Market.

Finally, as Chairman of EDX Medical Group plc, I would like to thank my fellow Board directors, shareholders and the teams within the Group who are working to grow our business in 2024 and beyond.

Jason Holt

Chairman | EDX Medical Group plc

The notes on pages 8 to 12 form part of these interim financial statements.

CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 SEPTEMBER 2024

The Interim Report and Financial Statements were approved by the Board of Directors and authorised for issue on 16 December 2024.

The notes on pages 8 to 12 form part of these interim financial statements.

For the six-month period ended 30 September 2023

The notes on pages 8 to 12 form part of these interim financial statements.

NOTES TO THE INTERIM FINANCIAL STATEMENTS

FOR THE SIX-MONTH PERIOD ENDED 30 SEPTEMBER 2024

1.  Company information

EDX Medical Group Plc (the "Company") is a public limited company, limited by shares (not guarantee) and is incorporated and domiciled in the UK. The address of the registered office is 211 Cambridge Science Park Milton Road, Cambridge, England, CB4 0WA The registered number of the Company is 13277385. The consolidated interim financial statements consolidate those of the Company and its subsidiaries (the "Group").  The principal activity of the Group is that of creating innovative health testing solutions and developing biological and digital technologies to improve the detection of diseases and disorders. 

2.  Summary of significant accounting policies

Basis of preparation

These condensed consolidated interim financial statements include the results of the Company and its subsidiaries for the six months ended 30 September 2024 and have not been audited. These condensed consolidated interim financial statements do not comprise statutory accounts within the meaning of section 434 of the Companies Act 2006.

These condensed consolidated interim financial statements have been prepared in accordance with the AQSE Growth Market rules and the recognition and measurement requirements of UK-adopted International Accounting Standards ("UK-IAS") and adopting the accounting policies that were applied in the 31 March 2024 annual financial statements.

The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group's most recent annual financial statements for the period ended 31 March 2024 and should be read in conjunction with these financial statements which is available on the Group's website www.edxmedical.co.uk  

In the opinion of the Directors, the interim consolidated financial information presents fairly the financial position, and results from operations and cash flows for the period.

The auditor's report on the statutory financial statements for the period ended 31 March 2024 was unqualified but did contain a material uncertainty with respect of going concern.

Basis of consolidation

The consolidated interim financial statements consolidate the interim financial statements of the Company and the results of its subsidiary undertakings EDX Medical Ltd, Torax Biosciences Limited and Hutano Diagnostics Ltd and EDX Medical Ireland Ltd made up to 30 September 2024.

Subsidiaries are entities over which the Group has control. The Group controls an entity when the Group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the Group. They are deconsolidated from the date that control ceases.

Intangible Asset

Amortisation is charged on a straight-line basis and is included in administrative expenses in the statement of comprehensive income. A License was acquired by the Group during the period which has an indefinite life that will be tested for impairment at the year end date. Other intangibles are amortised from the date they are available for use. The rates applicable, which represent the Directors' best estimate of the useful economic life, are:

-       Technology - 10 years straight line

-       Trademarks - 10 years straight line

-       Patent - 20 years straight line

Useful lives are reconsidered if circumstances relating to the asset change or if there is an indication that the initial estimate requires revision. Gains and losses of disposals are determined by comparing the proceeds with the carrying amount and are recognised in the consolidated statement of comprehensive income.

NOTES TO THE INTERIM FINANCIAL STATEMENTS (CONTINUED)

FOR THE SIX-MONTH PERIOD ENDED 30 SEPTEMBER 2024

2.  Summary of significant accounting policies (continued)

Going concern

The condensed consolidated interim financial information for the six months ended 30 September 2024 have been prepared on the going concern basis. The forecasts for the Group include due consideration for contracted minimum revenues, potential future capital in-flows, continued operating losses, projected increase in cash-burn of the Group for a minimum period of at least twelve months from the date of approval of these interim financial statements.

However, the Group forecasts assume that further equity fundraising will be required in the next twelve months in order to implement its growth strategy and operate as a going concern. Although the entity has had past success in fundraising and continues to attract interest from investors, making the Board confident that such fundraising will be available to provide the required capital, there can be no guarantee that such fundraising will be available and, accordingly, this constitutes a material uncertainty over going concern, which the auditors made reference to in their audit report for the year ended 31 March 2024.

Notwithstanding the above, the Board has considered various alternative operating strategies should these be necessary in the light of fundraising not being available and actual trading performance not matching the Group's forecasts given current macro-economic conditions and is satisfied that such revised operating strategies could be adopted, if and when necessary. This includes the ability to call upon Sir Christopher Evans, a director of the Company, to extend sufficient loans. Therefore, the Directors consider the going concern basis of preparation is appropriate.

The interim financial statements have been prepared on a going concern basis and do not include the adjustments that would be required should the going concern basis of preparation no longer be appropriate.

3.  Cost of sales

During the period, a credit note of £141,139 was received from a supplier for prior year invoices, following the termination of the agreement. The amount was offset against the cost of sales.

4.   Other gains - net

5.  Net finance expense

6.  Loss per share

Basic and diluted loss per share

The calculation of basic and diluted loss per share is based on the loss attributable to equity holders divided by the weighted average number of shares in issue during the period.

The loss incurred by the Group means that the effect of any outstanding warrants and options would be considered anti-dilutive and is ignored for the purposes of the loss per share calculation.

7.  Intangible assets

8.  Trade and other receivables

9.   Convertible loan

Convertible loan note

On 23 August 2024, the CLN Agreement was extended from initial expiry date of 31 October 2024 to 31 March 2025.

At 30 September 2024, the Company remeasured the derivative element at fair value using the Black Scholes option pricing model based on the exercise price of £0.06. The fair value at 30 September 2024 was £511,234, resulting in a loss on revaluation of the derivative being recognised of £13,495. Significant assumptions used in the fair value analysis include the volatility rate and the estimated date of conversion. The volatility of 94.01% was used in the determination of the fair value at 30 September 2024.

Period ended 30 September 2024

9.   Convertible loan (continued)

Period ended 30 September 2023

10.  Share capital  

Period ended 30 September 2024

Period ended 30 September 2023

The holders of ordinary shares are entitled to one voting right per share and, subject to the provisions of the Companies Act 2006, are entitled to dividends out of the profits of the Company available for distribution.

Rights, preferences, and restrictions

All ordinary shares are equally eligible to receive dividends and the repayment of capital and represent equal votes at meetings of Shareholders. There are no rights of redemption attaching to the ordinary shares.

11. Events after the reporting period

On 23 October 2024, EDX Medical Group Plc announced that the Company has received a strategic investment of £300,000 from a private investor via the placing of 2,727,272 new ordinary shares of 1p each in the Company at a price of 11p per share.

On 1 November 2024, EDX Medical Group Plc announced the warrant holders who were issued with a total of 5,370,000 warrants in 2021 have each agreed to waive and cancel their rights to subscribe for Ordinary Shares in EDX Medical in accordance with the terms of the Warrant Instruments.