GENEDRIVE PLC

• ⚠

  Material uncertainty over going concern

  The Directors are reasonably confident, based on the progress of these discussions, that the necessary financing will be obtained and has agreed heads of terms for a £1m loan with its major shareholder. As at the date of approval of these financial statements, no binding agreements have been finalised. As a result, the successful completion of the financing is not wholly within the control of the Group and therefore, in conjunction with the inherent uncertainty with regards to revenue generation, represents a material uncertainty that may cast significant doubt on the Group's ability to continue as a going concern.

Values shown as filed in the company's annual accounts. — indicates the figure wasn't present under that line item in that period. About these numbers

• Turnover

  +130.1%

  £332,000 → £764,000

• Cash

  -77.2%

  £5,188,000 → £1,182,000

• Net assets

  -73.2%

  £5,359,000 → £1,438,000

• Employees

  0%

  43 → 43

• Operating profit

  -1.3%

  -£5,312,000 → -£5,380,000

• Profit before tax

  +30%

  -£7,750,000 → -£5,426,000

• Wages

  -1%

  £2,998,000 → £2,969,000

Each % is (latest − prior) ÷ |prior| for the line item as filed. The comparison is only shown when the latest and prior accounts cover broadly equal-length periods — short or long stubs (typical around incorporation or a year-end change) are suppressed rather than misrepresented. Lines a company doesn't report are omitted. About these numbers

Margins divide P&L lines by turnover. Gearing is liabilities over total assets. Current ratio is current assets over creditors falling due within one year. Interest cover is operating profit over absolute finance costs. Sector-distribution context coming next.

1. GENEDRIVE PLC 2016-07-22 → present
2. EPISTEM HOLDINGS PLC 2007-02-15 → 2016-07-22

Accounting basis

FRS 102

Reporting scope

Consolidated group

Auditor

RSM UK Audit LLP

Audit opinion

Unqualified (clean)

Going concern

Material uncertainty disclosed

“The Directors are reasonably confident, based on the progress of these discussions, that the necessary financing will be obtained and has agreed heads of terms for a £1m loan with its major shareholder. As at the date of approval of these financial statements, no binding agreements have been finalised. As a result, the successful completion of the financing is not wholly within the control of the Group and therefore, in conjunction with the inherent uncertainty with regards to revenue generation, represents a material uncertainty that may cast significant doubt on the Group's ability to continue as a going concern.”

Group structure

1. GENEDRIVE PLC · parent
   1. Genedrive Diagnostics Ltd 100% · England · provision of services to the medical, biotechnology and pharmaceutical industries
   2. Epistem SIP Trustees Ltd 100% · England · act as trustee to the Epistem Share Incentive Plan
   3. Genedrive Diagnostics (Northern Ireland) Ltd 100% · Northern Ireland · provision of services to the medical, biotechnology and pharmaceutical industries

Significant events

• “Genedrive® MT-RNR1 ID Kit received highest "conditional" recommendation by NICE's new Early Value Assessment (EVA) pathway, awarded NIHR and OLS Funding Package of c.£500k to address Real World Evidence generation requirements.”
• “Launch of PALOH UK across the four UK nations; in routine use at 14 hospitals, equating to c.10% of the UK market.”
• “Accepted onto the NHS Dynamic Procurement System (DPS).”
• “Scotland's Accelerated Innovation Adoption pathway (ANIA) referral to SHTG leading to Scottish Government committing £0.8m investment to support national phased implementation of pharmacogenetic testing of MT-RNR1 in newborn babies.”
• “20 babies identified as positive for the MT-RNR1 DNA variant since introduction of the test into Neonatal Intensive Care Units (NICU) in the UK, avoiding lifelong hearing loss.”
• “Implementation into Dublin's Rotunda Hospital.”
• “MOU with the Kingdom of Saudi Arabia (KSA) Ministry of Health to pilot the Genedrive® MT-RNR1 ID Kit for potential national implementation.”
• “Breakthrough Device Designation (BDD) from the U.S. FDA, planned submission under the de novo route expected towards the end of calendar year 2026.”
• “Genedrive® CYP2C19 ID Kit received several national and international guidelines supporting CYP2C19 pharmacogenetic testing (CPIC, NICE, US FDA, AHA).”
• “Completion of DEVOTE study; clinical performance published in Journal of Molecular Diagnostics.”
• “Achieved CE-certification (May 2025) under the European In Vitro Diagnostics Regulation (IVDR).”
• “First commercial sales to Salford Royal Hospital, England's largest Hyperacute Stroke Centre (HASU); currently in routine clinical use.”
• “North West Anglia Foundation NHS Trusts' Peterborough City Hospital implantation for routine clinical use.”
• “12-month expansion of use study to include Acute Coronary Syndrome (ACS) led by MFT.”
• “Scotland's Accelerated Innovation Adoption pathway (ANIA) referral to SHTG with positive value assessment leading to Scottish Government investment for national pharmacogenetic testing of CYP2C19 in Stroke patients.”
• “Included in Scotland pilot of CYP2C19 genotyping in rural areas for assessment against laboratory testing pathways.”
• “Inclusion in NHS England programme aimed at understanding how best to deliver CYP2C19 based genotyping at scale.”
• “Market access routes and reimbursement strategies defined in key initial international target countries, including Europe and the Middle East.”
• “510(k) route identified for regulatory submission for US market entry, planned for late-Q4 FY26.”
• “Revenue and other income increased 100% to £1m (2024: £0.5m).”
• “Loss after tax reduced to £5.2m (2024: £7.1m).”
• “Successful equity fundraise of £1.23m (gross) announced in March 2025.”
• “Cash at bank of £1.2m and debt free at 30 June 2025 (2024: £5.2m).”

Auditor, going-concern and subsidiary information is drawn from the narrative of the latest annual accounts. About these numbers

Filings

14

last 12 months

Capital events

8

last 24 months

Officers appointed

0

last 12 months

Officers resigned

0

last 12 months

Direct counts from the register. No score, no rating — see the Filing timeline for the underlying events.