Genedrive Regulatory News (GDR)

13 July 2026

genedrive plc

("genedrive" or the "Company")

Trading Update

- Strong commercial progress and poised for continued growth in the next 12 months

- FY26 expected revenue of £1.4 million (FY25: c. £1.0 million), in line with Board expectations

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, today provides an unaudited trading update for the financial year ended 30 June 2026 ("FY26").

Dr Gino Miele, CEO of genedrive plc, said: "The last year has seen significant commercial and operational progress for genedrive. We have continued to expand adoption of both our MT-RNR1 and CYP2C19 tests across the NHS, advanced important national implementation initiatives and strengthened our international activities across Europe and the Middle East. The growing number of NHS business cases, increasing routine clinical use and continued international engagement provide further evidence of the demand for rapid pharmacogenetic testing.

"genedrive is in its strongest commercial and operational position to date. Supported by a strengthened financial position, expanding market opportunities and a growing body of real-world evidence, we are well positioned to build on this foundation, accelerate commercial adoption in the next 12 months and create sustainable long-term value for shareholders."

Genedrive® MT-RNR1

· Completion of the National Institute for Health and Care Research ("NIHR") and Office for Life Sciences ("OLS") funded National Institute for Health and Care Excellence ("NICE") MT-RNR1 Evidence-generation programme, with NICE expected to publish its final guidance around July 2027. NHS England ("NHSE") has commenced pre-market engagement to inform the NHS commercial strategy for national implementation across NHSE to coincide with final guidance issuance.

· Continued growth in locally funded NHS adoption of the Genedrive® MT-RNR1 ID Kit, including the transition to Business as Usual routine clinical use in a growing number of NHS sites, continued national rollout in Scotland, and approximately 25 business cases progressing through local UK NHS approval processes. The MT-RNR1 ID Kit is currently in use in over 20 Neonatal Intensive Care Units ("NICU") in the UK and internationally, with domestic use representing c. 10% of annual NICU admissions.

· More than 13,000 neonates have been tested in clinical settings using the Genedrive® MT-RNR1 ID Kit to date, with over 40 protected from irreversible, lifelong bilateral hearing loss (frequency of 1 in 317), and the test having been used by more than 900 NICU nurses. 

Genedrive® CYP2C19

· Publication of NHSE's CYP2C19 implementation plan and accompanying logistics pilot studies comparing point of care ("PoC") testing using genedrive with laboratory-based pathways. The studies demonstrated that c. 85% of patients had been discharged before laboratory-based test results were available, whereas genedrive's PoC test results were available for all patients whilst under the care of stroke team clinicians.

· Whilst subsequent commercial clarity from NHSE on the reimbursement pathway for CYP2C19 genetic testing is not yet available, the Company anticipates this to be delivered across both centralised genomic diagnostic laboratory and PoC pathways and continues to progress locally funded adoption of the Genedrive® CYP2C19 ID Kit.

· To address anticipated demand for laboratory-based CYP2C19 testing, the Company entered into a product development collaboration agreement with Thermo Fisher Scientific to develop the Genedrive® CYP2C19 HT Kit for deployment on Thermo Fisher Scientific's QuantStudioTM 5Dx, expanding the Company's addressable CYP2C19 opportunity across centralised diagnostic laboratories as well as near-patient testing pathways, with near-term focus on the UK market.

· Routine clinical use of the Genedrive® CYP2C19 ID Kit has continued at Salford's Hyperacute Stroke Unit ("HASU"), NHSE's largest HASU, with implementation also at North Bristol NHS Trust's Southmead Hospital Hyperacute and Acute Stroke Units, and use established at North West Anglia NHS Foundation Trust, all supporting adoption of rapid pharmacogenetic testing in acute stroke care. The Genedrive® CYP2C19 ID Kit is currently being used and assessed in approximately 15 sites in the UK and internationally.

· Continued use of the Genedrive® CYP2C19 ID Kit as a "test of change" in rural settings in Scotland.

International

· Further progress across key international markets including:

o  In Spain, the Genedrive® CYP2C19 ID Kit is now being evaluated across four pilot centres spanning stroke, peripheral artery disease and cardiovascular care pathways.

o  In the United Arab Emirates, a three-year commercial contract has been secured for the Genedrive® CYP2C19 ID Kit, with additional pilot programmes and hospital business cases progressing for both CYP2C19 and MT-RNR1 testing.

o  In Saudi Arabia, ongoing engagement with the Kingdom's Ministry of Health to support pilot implementation of MT-RNR1 testing, ongoing clinical use within National Guard Health Affairs hospitals and the establishment of a dedicated national procurement code to facilitate future procurement opportunities.

CYP2C19 FDA 510(k) programme 

· Since completion of the equity raise in March 2026, the Company has made continued progress, including completion of pre-submission engagement meetings with the FDA and subsequent feedback received. Externally conducted studies have commenced, which will generate, support and validate the data required for the pending FDA application. These studies are dependent on contracting and scheduling with independent third-party organisations and the Company does not currently have a definitive date for when such studies will be completed. The Company therefore wishes to update that the previously communicated submission timeframe, anticipated to be around June 2026, has been revised. The Company emphasises that the 510(k) application remains strategically of high priority and will further update the market on the 510(k) submission in due course.

Financials

· The Board expects to report total income of approximately £1.4 million for FY26 (FY25: c. £1.0 million), in line with the Board's expectations and reflecting commercial momentum and operational progress across the business. International revenue is expected to contribute approximately one quarter of total income, with the remainder generated domestically. The revenue product mix is anticipated to comprise approximately two-thirds MT-RNR1 income and one-third CYP2C19 income.

· The Company completed an equity raise in March 2026, which raised net proceeds of around £4.9 million. The unaudited cash position as of 30 June 2026 was c. £3.0 million including receipt of the R&D tax credit refund of c. £0.8 million, and the monthly cost base is approximately £0.5 million.

Board update

The recruitment process for a new independent Non-Executive Chairman as well as two other independent Non-Executive Directors is progressing and further announcements will be made in due course.

Outlook

The Board remains encouraged by increasing clinical adoption of both the Genedrive® CYP2C19 and MT-RNR1 ID Kits, the growing evidence base supporting point-of-care pharmacogenetic testing, and the continued progress towards wider NHS implementation. The commercial and operational progress achieved during FY26 reinforces the Board's confidence in the long-term opportunity for both products.

Looking ahead, the Company remains focused on converting commercial opportunities into routine clinical adoption, supporting the development of national commissioning and procurement pathways, expanding its presence in key international markets and advancing its U.S. regulatory strategy. The Board believes the increasing number of NHS adoption initiatives, together with growing international engagement, commercial activity and regulatory progress, provides a strong platform for further growth and value creation.

The Company continues to engage closely with NHS stakeholders, healthcare providers and international partners to support implementation of its technologies and generate additional real-world evidence demonstrating their clinical and economic value. The Board remains confident in the Company's strategy and committed to delivering innovative diagnostic solutions that improve patient outcomes while generating sustainable value for shareholders.

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About genedrive plc (http://www.genedrive.com).

genedrive plc is a UK-based, commercial-stage pharmacogenetic testing company focused on rapid, point-of-care diagnostic tests to guide safe and effective drug prescription in emergency and acute care settings.

genedrive's proprietary technology platform enables clinicians to prescribe safer and more effective therapies based on a patient's genetic profile, supporting improved outcomes while reducing pressure on healthcare systems, lowering downstream healthcare costs through the prevention of avoidable complications and earlier, more effective intervention

The Company has two CE-IVD approved and NICE-recommended tests in NHS clinical use. The Genedrive® CYP2C19 ID Kit identifies stroke patients who will not respond to the current standard of care, Clopidogrel, used to reduce risk of secondary stroke. The Genedrive® MT-RNR1 ID Kit helps prevent antibiotic-induced hearing loss (AIHL) in newborns, enabling treatment decisions within actionable timeframes at the point of care.

Headquartered in Manchester, genedrive is focused on scaling UK-developed precision diagnostics within routine care and leveraging real-world evidence to support broader international adoption and commercial growth.