Highlights

  • Revenue and other income doubled to GBP 1m in FY25, compared to GBP 0.5m in FY24.
  • Loss after tax reduced to GBP 5.2m, reflecting a shift from pre-commercial to commercial focus.
  • Key regulatory approvals and NHS integrations support ongoing clinical and market adoption.

Genedrive plc (LSE:GDR) reported revenue and other income of GBP 1m for the year ended 30 June 2025, up from GBP 0.5m in the prior year. The Group recorded a loss after tax of GBP 5.2m, compared to GBP 7.1m in FY24. R&D and scientific expenditure remained at GBP 4.2m, maintaining investment in diagnostics, engineering, and product development.

The company completed a GBP 1.23m gross equity fundraising in March 2025 and closed the year with GBP 1.2m in cash and no debt (FY24: GBP 5.2m).

Genedrive® CYP2C19 Developments

The Genedrive® CYP2C19 test for antiplatelet therapy tailoring achieved CE-certification under IVDR in May 2025 and UKCA marking. It was accepted onto the NHS Dynamic Procurement System (DPS) and is in routine clinical use at Salford Royal Hospital and Peterborough City Hospital.

The DEVOTE study results, published in the Journal of Molecular Diagnostics, demonstrated performance advantages over laboratory platforms in target coverage, speed, accuracy, and failed tests. Market access and reimbursement strategies have been defined for Europe and the Middle East. For the US, the 510(k) regulatory submission pathway has been identified with initial positive feedback from the FDA. Translation of CYP2C19 IP to laboratory platforms is also underway.

Genedrive® MT-RNR1 Progress

The MT-RNR1 test, aimed at identifying newborns at risk of aminoglycoside-induced hearing loss, received a conditional recommendation from NICE’s Early Value Assessment pathway. Funding of approximately GBP 500k was awarded to support real-world evidence generation.

PALOH-UK has been launched across 14 hospitals, covering roughly 10% of the UK market. Scotland’s Accelerated Innovation Adoption pathway led to a GBP 0.8m government-supported phased national implementation, with 20 newborns identified as positive for the MT-RNR1 DNA variant. International deployment includes Dublin and discussions with the Saudi Ministry of Health under a pilot initiative. The US FDA Breakthrough Device Designation (BDD) is being pursued with planned de novo submission in late 2026.

Operational and Cash Position

Genedrive expanded operational capabilities, including onshoring assay production for CYP2C19 and MT-RNR1 to complement external vendor supply. Strategic partnerships and distributor networks were developed to support recurring revenue from routine clinical use sites. The company received an additional GBP 0.2m in non-dilutive grant funding under Innovate UK’s DEVOTE programme.

As of 30 November 2025, cash at bank stood at GBP 0.32m, with an average monthly cash burn of GBP 0.35m. Heads of terms have been agreed for a GBP 1m loan from the largest shareholder, with discussions ongoing to finalise the arrangement.

Share Price Snapshot
GDR was trading GBX 0.85 per share as of 05 December 2025.