Genedrive (GDR) Trading Update summary

Financial performance and outlook

• Total income for FY25 reached approximately £1m, doubling from FY24 and showing strong H2 momentum with £0.65m generated in the second half.

• Overheads remained stable year-on-year, with a strategic shift towards focused commercial activities.

• Early FY26 income visibility stands at around £0.6m, supported by ongoing and upcoming UK healthcare initiatives.

• International sales are gaining traction, particularly in Europe and the Middle East, with further growth expected.

• Cash balances are approximately £700k, with active assessment of financing options for additional working capital.

Strategic and regulatory developments

• NICE Early Value Assessment completion and submission is expected to drive wider UK implementation.

• Scotland's phased national implementation and Manchester NHS Foundation Trust's genotyping programme are set to begin in FY26.

• Anticipated FDA 510(k) submission for the CYP2C19 ID Kit in early 2026, with a 3-4 month review process.

• UK healthcare reforms will introduce mandated NHS funding for MedTech, diagnostics, and digital products by April 2026.

• The new 'innovator passport' will facilitate rapid adoption of robustly assessed technologies across NHS organisations.

Product and market positioning

• Two CE-IVD certified, NICE-recommended rapid genetic testing products address critical needs in neonatology, neurology, and cardiology.

• The MT-RNR1 ID Kit enables antibiotic decisions in neonatal care within 26 minutes, while the CYP2C19 ID Kit guides antiplatelet therapy in stroke patients in 70 minutes.

• Both products are single-use, ambient-stable cartridges, eliminating cold chain requirements.

• Initial commercial traction is evident in Italy, Netherlands, UAE, Bahrain, Kuwait, Saudi Arabia, and Qatar.

• Commercial strategy focuses on in-market sales, geographic expansion, and strategic M&A.