OPERATING HIGHLIGHTS (including post period)
- Point of Care (“POC”) COVID-19 test CE-marked 8 December 2021
- Genedrive® POC COVID-19 test submitted for approval to sell the product in the United Kingdom under the new Coronavirus Test Device Approvals (CTDA) regulation – approval pending
- Distribution agreements for POC COVID-19 signed covering Spain, Portugal, Oman and the United Arab Emirates. Initial commercial orders received subsequently in March 2022
- New Genedrive® System developed and CE-marked for Antibiotic Induced Hearing Loss (“AIHL”) launch
- Genedrive® MT-RNR1 test for AIHL now deployed into Manchester Hospital Trust for routine use
- Inspiration Healthcare (“IHC”) trained and commenced distributing the Genedrive® MT-RNR1 test in the UK and Ireland
- NICE Medtech Innovation Briefing to advise clinicians and commissioners on the Genedrive® MT-RNR1 test, due 29 March 2022
- JAMA Pediatrics paper (PALOH Study) published supports the implementation of the Genedrive® MT-RNR1 test in routine practice the Neonatal Intensive Care Units
- New product development programme for use of Genedrive® Point of Care device for stroke management in emergency care initiated
FINANCIAL HIGHLIGHTS
- No revenue in the period, (31 Dec 2020: £0.4m) owing to delayed product development
- Operating loss of £2.8m (31 Dec 2020: £2.9m)
- R&D spend reduced to £1.9m (31 Dec 2020: £2.3m)
- Debt free and cash of £6.3m at 31 December 2021 (30 June 2021: £2.6m)
- Cash of £6.0m as of 25 March 2022 following recent receipt of R&D tax credit of £1.2m
David Budd, CEO of genedrive plc, commented: “We have achieved some key milestones in this period, namely the CE marking of our Genedrive® POC COVID-19 test, which was closely followed by a number of distribution agreements with key territories. We have also made significant further progress with our AIHL system, establishing initial installations and generating significant evidence and support to make commercial progress. We believe the Company is well positioned to deliver on shareholder value; we have managed our cash position carefully and are poised to progress with our expanded portfolio. On behalf of the Board, I would like to thank our investors who continue to support us on this path as we move further into a commercial phase.”
