genedrive plc FY25 Results: Revenue Doubles Amid Going Concern Warning

genedrive FY25 results: commercial traction up, cash runway under pressure

genedrive plc has posted its audited results for the year to 30 June 2025. Revenue and other income doubled to £1.0m, the loss after tax narrowed to £5.2m, and the company stayed debt free at the year end. Operational momentum is clear across both flagship tests – CYP2C19 for stroke and MT‑RNR1 for neonates – with multiple NHS and international catalysts now live.

The sting in the tail: the company finished November with £0.32m cash against an average monthly cash burn of about £0.35m. Auditors flagged a “material uncertainty” around going concern. Heads of terms are agreed for a £1.0m shareholder loan, but it is not yet finalised.

Key FY25 numbers investors should note

CYP2C19 test: NICE endorsement, EU certification, and NHS adoption

CYP2C19 genotyping helps tailor antiplatelet therapy after stroke or transient ischaemic attack (TIA). genedrive’s rapid point‑of‑care test has strong tailwinds:

• NICE recommends the Genedrive CYP2C19 ID Kit as the preferred rapid platform in stroke and TIA. Other guideline bodies (CPIC, US FDA, American Heart Association) also support testing.
• CE‑certified under the EU IVDR in May 2025, enabling EU registrations and sales. UKCA marking already in place.
• Included on the NHS Dynamic Procurement System (DPS) – a framework that lets NHS trusts buy innovative tech directly.
• First commercial sales into Salford Royal, England’s largest Hyperacute Stroke Centre, and routine use at North West Anglia’s Peterborough City Hospital.
• Clinical validation in the DEVOTE study showed superior performance versus a lab platform for target coverage, speed, accuracy and failed tests.
• Scottish pathway: positive assessment by SHTG, with Scottish Government investment to support national pharmacogenetic testing in stroke, including rapid TIA testing.
• Part of an NHS England programme on delivering CYP2C19 testing at scale, informing a new NHS Implementation Guide presented at the UK Stroke Forum.
• US plan: 510(k) regulatory route identified and pre‑submission meetings held with the FDA. Submission planned for late‑Q4 FY26, subject to funding, with an estimated 3-4 month review thereafter.

Jargon watch: IVDR is the EU’s modern regulatory regime for diagnostics. The NHS DPS is a procurement route that speeds up adoption. FDA 510(k) is a clearance pathway showing equivalence to an existing device.

MT‑RNR1 test: real‑world use now, national roll‑out beginning

MT‑RNR1 screening identifies babies at risk of profound hearing loss if exposed to aminoglycosides. Progress is tangible:

• NICE Early Value Assessment gave the highest “conditional” recommendation; NIHR and OLS awarded around £500k to generate the real‑world evidence to move to a full recommendation (PALOH‑UK).
• In routine use at 14 hospitals – about 10% of the UK market – with national implementation underway in Scotland. The Scottish Government has committed £0.8m to a phased roll‑out across territorial boards.
• 20 babies with the MT‑RNR1 variant have already been identified since test introduction, avoiding lifelong hearing loss.
• Adoption beyond the UK includes Dublin’s Rotunda Hospital and a Memorandum of Understanding with Saudi Arabia’s Ministry of Health to pilot for potential national use.
• US pathway: FDA Breakthrough Device Designation is in place; de novo submission is expected towards the end of calendar 2026, subject to funding.

Breakthrough Device Designation gives priority interactions with the FDA. The de novo route is for innovative devices without a direct predicate.

Commercial ramp: where the growth is coming from

Total income rose to £1.0m, with £0.65m generated in H2. Management says it has current visibility for around £0.9m of total income already in FY26, driven by:

• Completion and submission of NICE EVA real‑world evidence for MT‑RNR1.
• Scotland’s phased national implementation of MT‑RNR1 and a CYP2C19 point‑of‑care pilot versus lab pathways, both started in October 2025.
• Manchester Foundation Trust’s 12‑month Acute Coronary Syndrome expansion using rapid CYP2C19 genotyping.

Internationally, early sales and distributor set‑ups are under way in Europe and the Middle East, including Italy, the Netherlands, UAE, Bahrain, Kuwait, Saudi Arabia and Qatar.

Cash, funding and going concern: the crux of the investment case

The board is frank: with £0.32m cash at 30 November 2025 and average burn of c.£0.35m per month, additional finance is needed “in the very near term”. The post year‑end conditional £3.6m equity raise did not complete after shareholders withheld approval; only £0.8m from the firm placing was received. Heads of terms are agreed for a £1.0m loan from the largest shareholder and discussions are progressing. Directors have taken a 20% pay cut until funding materially extends the runway through 2026.

The auditors included a going concern material uncertainty paragraph. That does not mean failure is inevitable; it means the funding outcome is not within management’s complete control. In my view, this is the key near‑term swing factor for the share price and for delivery of the US regulatory plan.

Why the operational progress matters for the NHS and beyond

• CYP2C19 at the point of care can move stroke patients to the right antiplatelet within about 70 minutes. The NHS Implementation Guide and NICE backing are strong catalysts for scale.
• MT‑RNR1 delivers a 26‑minute result in neonatal units, preventing severe, lifelong hearing loss. Real‑world UK data and Scotland’s national roll‑out are powerful reference points for export markets.
• Both products sit on the NHS DPS, lowering procurement friction, and both have CE‑IVD/NICE credentials – important badges for EU and Middle East markets.

Risks and watch‑outs

• Financing risk: completion of the £1.0m loan is not yet binding. Further capital will likely be required to bridge to profitability and to fund US submissions.
• Revenue timing: NHS adoption cycles and evidence generation can be slow; the £0.9m FY26 visibility is not the same as secured orders.
• R&D tax credit: the £0.4m receivable is “not assured” and depends on working capital to complete the claim process.
• Regulatory timelines: CYP2C19 510(k) now targeted for late‑Q4 FY26 and MT‑RNR1 de novo towards end‑2026 – both contingent on runway.

My take: solid clinical and policy positioning, but funding dictates the outcome

There is a lot to like operationally. genedrive has two CE‑IVD, NICE‑recommended, near‑patient genetic tests in routine NHS use, visible national roll‑out in Scotland, encouraging international pilots, and US routes defined with the FDA. Revenue doubled to £1.0m, and the loss narrowed to £5.2m despite the shift to commercial activities.

The counterweight is the balance sheet. With £0.32m at the end of November and burn of roughly £0.35m a month, execution now hinges on closing the £1.0m loan and mapping a longer‑term funding plan. If financing lands, the combination of NICE support, NHS procurement access and real‑world outcomes offers a credible runway to scale. If not, investors should be prepared for further dilution or strategic alternatives.

Bottom line: the clinical case is compelling; the commercial case is building; the funding case remains critical. This is high potential, high risk – and very news‑driven in the near term.