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Genedrive jumps on strong interim results, expected FDA approval for US sales

11:08, 28th March 2024
Victor Parker
Vox Newswire

Genedrive (GDRFollow | GDR, a molecular diagnostics company, announced unaudited interim results for the 6 months ended December 31, 2023 (1H23). Revenue and other income rose to £0.24m from £0.02m in 1H22. R&D spend remained roughly flat at £1.9m, and operating loss narrowed to £2.4m from £2.7m in 1H22. Cash was £1. 2m on March 20, 2024 following the receipt of a £0.8m R&D tax credit.

Operationally, the company achieved a number of milestones. The Genedrive MT-RNR1 pharmacogenetic test for antibiotic induced hearing loss is progressing through FDA approval, and GDR is in talks with a US-based medical company to support a cost-effective pathway for clinical trials. Additionally, GDR has signed an agreement with a US distributor to support the FDA study and future sales in the US.

In the UK, the Royal Sussex County Hospital in Brighton has adopted the MT-RNR1 kit for routine use, and GDR said it is in discussions with other hospitals in the UK and Ireland, with further near-term adoption expected. Last year, Genedrive made the decision to sell the MT-RNR1 kit direct in the UK and Ireland. Meanwhile, international sales of MT-RNR1 have commenced in France, Austria, Greece, Saudi Arabia, Turkey, and the Netherlands.

In March 2023, MT-RNR1 received a recommendation for use in the UK by the National Institute for Health and Care Excellence (NICE) under its Early Value Assessment Programme (EVA). Genedrive and its partner on the project Manchester University NHS Foundation trust have applied for £10m funding from the UK Office for Life Sciences, to address NICE EVA requirements.

At the same time, Genedrive's CYP2C19 pharmacogenetic test for stroke treatment selection achieved a UK Conformity Assessed (UKCA) marking, and received a £1.2m multi-partner grant for validation in NHS settings. Final NICE recommendations for the asset are expected in July 2024. In the UK, Genedrive will be selling the CYP2C19 kit through its direct sales team.

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Summing up Genedrive's interim results, the company delivered solid revenue growth, narrowed its operating loss significantly, and achieved material operational progress for its lead assets MT-RNR1 and CYP2C19. The former quickly generated strong sales momentum in the UK, and a distributor is in place to commence US sales, pending FDA approval. Therefore, MT-RNR1 holds strong short-term upside as sales outside the UK pick up. At the same time, Genedrive is prepping marketing and distribution for CYP2C19 in the UK, expecting strong initial revenues. Both assets address significant unmet medical needs.

Financially, substantial funding is expected from the Office for Life Sciences for evidence generation required by NICE for MT-RNR1. This should fast track the asset to a full recommendation by NICE, and then adoption by the NHS. To fund its ambitious growth strategy, including clinical trials and regulatory approval in US, Genedrive is expected to initiate equity funding in the coming weeks. Additionally, an announced cost control plan should keep expenses in check.

Investors welcomed today's results, sending GDR shares 9% higher.

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