GENinCode expects 2026 revenues to increase year-on-year and for EBITDA losses to reduce, moving the company towards breakeven.
The group reported audited results for the year ended 31 December 2025 with revenue rising 14% to £3.1m (2024: £2.7m), adjusted EBITDA loss widening to £4.9m (2024: loss £4.4m) and gross margin improving to 59% (2024: 53%).
Cash at 31 December 2025 was £0.8m (2024: £1.1m) and post-period the company completed a £4.7m placing to support commercial scale-up.
GENinCode completed the FDA De Novo supervisory review for CARDIO inCode-Score, is finalising an updated De Novo PMA submission expected in Q3 2026 targeting approval by end-Q4 2026, and has a Thermo Fisher collaboration to manufacture and distribute the CAD PRS test across US and EMEA.
Commercial traction strengthened with LIPID inCode and CARDIO inCode growing in the US and Europe, roughly 45 institutional sites onboarded at the end of 2025 and over 70 by April, New York State clinical approval for CARDIO inCode and inclusion in the 2025 US clinical lab fee schedule, and post-period ACC/AHA guideline updates recognising CAD PRS.
The company said it will prioritise commercial expansion with Thermo Fisher, increased revenues, margin improvement and FDA submission during 2026 and will host an investor presentation on 10 June at 11am BST.