Tillkännagivande • May 06
Genedrive Plc Transitions MT-RNR1 Test To Business As Usual Clinical Service Genedrive plc announced that, from 1 May 2026, University Hospitals Sussex NHS Foundation Trust hospitals transitioned to Business as Usual routine clinical service of the Genedrive MT-RNR1 ID kit for the prevention of Antibiotic Induced Hearing Loss in neonates admitted to Neonatal Intensive Care Units. UHS Royal County Sussex Hospital's Trevor Mann Baby Unit provides specialist care for approximately 400 NICU admissions annually and has been a participating site in the PALOH-UK programme, which aims to address National Institute for Clinical Care and Excellence Real World Evidence generation requirements. To date, nearly 40 babies in NICUs have been identified with the MT-RNR1 variant since introduction of the test in the UK, enabling alternative antibiotic prescription and reducing the risk of aminoglycoside-induced lifelong hearing loss. Funding for PALOH-UK sites is provided by the Office for Life Sciences and National Institute for Health and Care Research and will cease by June 2026, with some sites completing earlier. Subsequent review and issuance of final guidance by NICE is expected around July 2027. Genedrive has two CE-IVD approved and NICE-recommended tests in NHS clinical use. The Genedrive CYP2C19 ID Kit identifies stroke patients who will not respond to the current standard of care, Clopidogrel, used to reduce risk of secondary stroke. The Genedrive MT-RNR1 ID Kit helps prevent antibiotic-induced hearing loss in newborns, enabling treatment decisions within actionable timeframes at the point of care. Tillkännagivande • Apr 23
Genedrive plc Announces Nhs England Commercial Strategy for Rapid Mt-Rnr1 Testing Genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, welcomed publication from NHS England of a Preliminary market engagement notice under the Procurement Act 2023, to inform the NHS commercial strategy for rapid genetic MT-RNR1 testing in neonates to prevent antibiotic induced hearing loss. To date, since introduction, the rapid MT-RNR1 test has been used as part of routine clinical practice by approximately 900 neonatal nurses for over 10,000 babies admitted to NICUs, enabling more than 30 to avoid lifelong hearing loss as a result of aminoglycoside antibiotic exposure. In the UK, Genedrive® MT-RNR1 ID kit is being implemented and used in the Neonatal Intensive Care Units ("NICU") of 14 hospitals across the four UK nations as part of a real world evidence generation programme (PALOH-UK) funded by the National Institute for Health and Care Research (NIHR) and the UK Government Office for Life Sciences (OLS). The test also has conditional recommendation for use in the NHS by the National Institute for Health and Care Excellence ("NICE") whilst further real world evidence is generated. Genedrive estimates that annual NICU admissions in these NICUs represent approximately 10% of admissions in the UK. Additionally, since October 2025, implementation of the Genedrive® MT-RNR1 ID kit into all NHS Scotland Health boards has been actively progressing under a phased implantation programme with the Accelerated National Innovation Adoption (ANIA) pathway led by the Scottish Centre for Sustainable Delivery. The PALOH-UK programme is scheduled to complete by July 2026, with subsequent NICE review and issuance of final guidance communicated to be approximately July 2027. Post PALOH-UK and ahead of final guidance, business case progression will continue as planned to enable PALOH-UK sites to rapidly transition to Business as Usual use. In addition to anticipated timelines, the premarket engagement notes anticipate a publication date of tender notice of 1 January 2027 and go-live target date of 1 July 2027, subject to NICE guidance outcome. Reported Earnings • Apr 02
First half 2026 earnings released: UK£0.003 loss per share (vs UK£0.004 loss in 1H 2025) First half 2026 results: UK£0.003 loss per share. Revenue: UK£570.0k (up 63% from 1H 2025). Net loss: UK£2.44m (loss widened 4.8% from 1H 2025). New Risk • Mar 31
New major risk - Negative shareholders equity The company has negative equity. Total equity: -UK£415k This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Negative equity (-UK£415k). Shareholders have been substantially diluted in the past year (163% increase in shares outstanding). Minor Risks Revenue is less than US$5m (UK£1.2m revenue, or US$1.5m). Market cap is less than US$100m (UK£15.3m market cap, or US$20.1m). Tillkännagivande • Mar 09
genedrive plc has completed a Follow-on Equity Offering in the amount of £0.909643 million. genedrive plc has completed a Follow-on Equity Offering in the amount of £0.909643 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 90,964,264
Price\Range: £0.01
Transaction Features: Rights Offering Tillkännagivande • Dec 09
genedrive plc, Annual General Meeting, Dec 31, 2025 genedrive plc, Annual General Meeting, Dec 31, 2025. Location: 46 grafton street, m13 9xx, manchester United Kingdom Reported Earnings • Dec 07
Full year 2025 earnings released Full year 2025 results: Revenue: UK£954.0k (up 90% from FY 2024). Net loss: UK£5.23m (loss narrowed 26% from FY 2024). Tillkännagivande • Dec 03
genedrive plc to Report Fiscal Year 2025 Results on Dec 05, 2025 genedrive plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Dec 05, 2025 Tillkännagivande • Dec 02
genedrive plc Announces Pilot Programme Study Results Underpinning Nhs Implementation Guide for Cyp2c19 Genotype Testing Presented At the Uk Stroke Forum genedrive plc notes the presentation of two posters by authors from NHS England ("NHSE") Network of Excellence in Pharmacogenomics, the NHSE Genomics Unit, NHSE National Stroke Programme, and Manchester Centre for Genomic Medicine at the UK Stroke Forum, Aberdeen, 25-27 November 2025. Data presented in these posters underpinned the recently published "NHS implementation guide for CYP2C19 genotype testing to guide Clopidogrel use after ischaemic stroke or transient ischaemic attack ("TIA") to support prescribing decisions in stroke. As outlined in the online presentation (Personalising Medicines with Genomics), the National Pilot Programme was conducted at four geographically diverse NHS stroke units across England. The results included laboratory CYP2C19 testing assessed at Doncaster, St. George's and Exeter (December 2024 - April 2025), and Point-of Care ("PoC") rapid CYP2C19 genetic testing assessed using the Genedrive®? CYP2C19 ID kit at Salford Royal Hospital's Hyper Acute Stroke Centre (March 2025 - April 2025). Key findings and conclusions from these were; A higher prevalence of patients unlikely to respond to clopidogrel identified in the near-patient arm (33%) versus the laboratory arm (29%)." The Company estimates that an additional c. 4,200 stroke patients benefitting from alternative prescribing decisions could be identified annually using the Genedrive CYP2C19 ID Kit due to its increased target coverage and ethnic inclusivity. Test results impacted prescription practices, guiding prescription changes and aligning treatment with patients' genetic profiles for better outcomes. Notably, 100% of patients in the genedrive PoC arm requiring clopidogrel prescription had their results available whilst on-ward, whereas 88% of patients in the laboratory arm had been discharged (requiring follow-up activities for prescription change activities). Genedrive®? CY P2C19 ID kit "test failure rate of 0.49%, in the acute clinical setting. Implementation of Genedrive®? CYp2C19 testing was feasible, scalable and effective in providing immediate availability of results during acute clinical settings. Moreover, the findings substantiate the clinical utility of CYP2C19 Genotype-guided antiplatelet therapy in the management of patients with ischemic stroke or TIA, particularly with diverse British and European populations. Rapid availability of test results enables actionable prescription choices and reduces the risk of less effective medications being prescribed for secondary prevention of stroke. CYP2C19 interventional testing is estimated to offer PS160M of value annually to the UK NHS, with rapid CYP2C19 testing estimated to release 62,500 bed days and 235,000 healthcare professional hours annually and aligns perfectly with NHS 10-year plan ambitions for realising the patient and financial benefits of shifting spending to prevention from treatment. Tillkännagivande • Nov 27
Genedrive plc Announces Nhs Implementation Guide Published for Cyp2c19 Genotype Testing genedrive plc notes the publication of the "NHS implementation guide for CYP2C19 genotype testing to guide Clopidogrel use after ischaemic stroke ("IS") or transient ischaemic attack ("TIA") to support prescribing decisions in stroke. Following the National Institute for Health and Care Excellence ("NICE") recommendation for CYP2C19 Genotypeing in TIA and IS including the Genedrive®? CYP2C19 ID Kit as the preferred rapid testing platform, and a national pilot implementing both laboratory and "rapid testing" approaches, the implementation guide encourages stroke services to use the guide to plan how CYP2C19 genotyping could be integrated locally. Interim presentation of the pilot results highlighted that the vast majority of stroke patients had moved further down the care pathway by the time results were available from laboratory testing (which takes several days to weeks), whereas actionable results were available from rapid testing within just over one hour. The guide notes that; Patients at hyperacute stroke units typically have a short length of stay, which may be more suitable for rapid testing. In the context of TIA and non-disabling stroke, clopidogrel is typically started immediately. Turnaround time of laboratory testing means patients may require an additional appointment to change their prescription. This group of patients may be receiving less effective secondary prevention for the days between the test and until an alternative medicine is started. Rapid testing may reduce the need for follow-up appointments or additional communication to other services to action a prescribing decision. Tillkännagivande • Nov 26
genedrive plc Announces Scotland National Roll-Out of Genedrive MT-RNR1 ID Kit genedrive plc note the recent media coverage of its Genedrive MT-RNR1 ID Kit, which reduces the risk of deafness in newborn babies and introduced initially by NHS Greater Glasgow and Clyde. The Genedrive MT-R NR1 ID Kit will start being used for babies requiring antibiotic treatment for infections within the Neonatal Intensive Care Unit at the Royal Hospital for Children ("RHC") in Glasgow, with the Royal Alexandra Hospital and Princess Royal Maternity Hospital to follow soon after, as part of a phased rollout to all NHS Scotland Health Boards with neonatal units over the coming months. New Risk • Oct 15
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 89% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (30% average weekly change). Shareholders have been substantially diluted in the past year (89% increase in shares outstanding). Revenue is less than US$1m (UK£613k revenue, or US$819k). Market cap is less than US$10m (UK£3.59m market cap, or US$4.79m). Minor Risk Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). New Risk • Oct 13
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (29% average weekly change). Revenue is less than US$1m (UK£613k revenue, or US$818k). Market cap is less than US$10m (UK£2.49m market cap, or US$3.32m). Minor Risks Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Shareholders have been diluted in the past year (15% increase in shares outstanding). Tillkännagivande • Sep 24
genedrive plc has filed a Follow-on Equity Offering in the amount of £0.3 million. genedrive plc has filed a Follow-on Equity Offering in the amount of £0.3 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 150,000,000
Price\Range: £0.002
Security Features: Attached Warrants Tillkännagivande • Aug 21
genedrive plc Announces the Genedrive MT-RNR1 ID Kit Is Being Introduces by NHS Greater Glasgow and Clyde genedrive plc announced that the Genedrive MT-RNR1 ID Kit, which reduces the risk of deafness in newborn babies is being introduced by NHS Greater Glasgow and Clyde in September 2025 as part of the national rollout funded by the Scottish Government ("Genetic test to prevent hearing loss in newborns to begin national rollout in NHS Greater Glasgow and Clyde - NHSGGC). The Genedrive MT-R NR1 ID Kit will start being used for babies requiring antibiotic treatment for infections within the Neonatal Intensive Care Unit at the Royal Hospital for Children ("RHC") in Glasgow next month, with the Royal Alexandra Hospital and Princess Royal Maternity Hospital to follow soon after. It will be rolled out to all territorial health boards with neonatal units over the next 18 months. The initiative follows an assessment by the Chief Scientist Office funded Accelerated National Innovation Adoption ("ANIA") pathway, led by the Centre for Sustainable Delivery ("CfSD"), and a Programme for Government commitment from the Scottish Government to provide PS0.8 million to support national adoption. It follows the ongoing UK-wide PALOH (Pharmacogenetics to Avoid Loss of Hearing) programme and assessment by the Scottish Health Technologies Group. Scotland's Public Health Minister Jenni Minto visited the RHC neonatal unit to meet clinicians and representatives from the West of Scotland Innovation Hub ("WoSIH"), who have played a leading role in bringing the innovation to Scotland. Ms Minto also discussed the planned national rollout with members of the CfSD and once fully implemented, it is anticipated that more than 3,000 newborn babies would be tested during the first year. Dr Helen McDevitt, Consultant Neonatologist with NHSGGC and clinical lead for the PALOH-UK study at the RHC, said: "The introduction of this point-of-care genetic testing for newborn babies requiring antibiotic treatment for bacterial infection is a landmark moment for neonatal care in Scotland. By introducing this test, the Company is at the forefront of Point of Care pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on how individual genetics impact a medicines ability to work for you. Therefore, by using pharmacogenetics, medicine choices can be personalised, made safer and more effective. The Company has launched its two products, the Genedrive MT- RHC MT-RNR1 ID kit and the Genedrive CYP2C19 ID Kit, both developed and validated in collaboration with NHS partners and deployed on its point of care thermocycler platform. Both tests are single-use disposable cartridges which are ambient temperature stable, circumventing the requirement for cold chain logistics. The Directors believe the Genedrive MT-MNR1 ID Kit is a worlds-first and allows clinicians to make a decision on antibiotic use in neonatal intensive care units within 26 minutes, ensuring vital care is delivered, avoiding adverse effects potentially otherwise encountered and with no negative impact on the patient care pathway. Its CYP2C19ID Kit is a world-first and allows clinicians to making a decision on antibiotic use in Neonatal intensive care units within 26 days, ensuring vital care is delivered. Its CYP2C 19 ID Kit is delivered, avoiding adverse effects potential otherwise encountered and with no negative impacts on the patient care pathway. its CYP2C19 ID kit is expected to provide PS0.8m to support national adoption. New Risk • Aug 13
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of British stocks, typically moving 9.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m (UK£613k revenue, or US$832k). Market cap is less than US$10m (UK£4.59m market cap, or US$6.23m). Minor Risks Share price has been volatile over the past 3 months (9.5% average weekly change). Shareholders have been diluted in the past year (15% increase in shares outstanding). Tillkännagivande • Aug 13
Genedrive plc Provides Earnings Guidance for the Year Ending June 30, 2025 genedrive plc provided earnings guidance for the year ending June 30, 2025. For the period, the company expects a doubling of total income of circa. £1 million (FY24: £0.5 million), driven by increased sales momentum in half year 2025 which saw income of £0.65 million (Fist half of 2025 £0.35 million). The Company's overheads in 2025 remained in line with the prior year however with a strategic shift towards focussed commercial activities. New Risk • Jul 30
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.50m (US$9.93m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m (UK£613k revenue, or US$812k). Market cap is less than US$10m (UK£7.50m market cap, or US$9.93m). Minor Risk Shareholders have been diluted in the past year (15% increase in shares outstanding). Tillkännagivande • May 30
genedrive CYP2C19 ID Kit Receives CE-Certification Under the European in Vitro Diagnostics Regulation genedrive plc announced the successful certification of its rapid CYP2C19 ID Kit genotyping platform under the European In Vitro Diagnostic Regulation ("IVDR") 2017/746. The IVDR replaces the In Vitro Diagnostic Directive ("IVDD") and is the current required regulatory basis for placing on the market, making available and putting into service any new In Vitro diagnostic medical devices within the European Union, with CE-IVD certification recognised for facilitating registration in several non-European countries. Approximately 30% of individuals, and up to 56% in certain ethnic groups, carry DNA variants in the CYP2C19 gene which result in sub-optimal activity of the antiplatelet drug Clopidogrel, commonly prescribed in patients with serious cardiovascular events such as Ischaemic Stroke ("IS"), Transient Ischaemic Attack ("TIA") and Acute Coronary Syndrome, where patients with these variants who are prescribed Clopidogrel typically experiencing worse outcomes. The Genedrive® CYP2C19 ID Kit identifies five of these DNA variants, some of which are particularly important in certain ethnicities. It enables rapid identification of patients who are unlikely to respond to Clopidogrel, in time-critical emergency healthcare settings where rapid appropriate antiplatelet prescription is crucial. The Genedrive® CYP2C19 ID Kit rapid test is best in class, recommended by the National Institute for Health and Care Excellence ("NICE") as the rapid genotyping platform of choice for use in the NHS, with dominant health economics, wider patient group coverage, and performance shown to be superior to laboratory testing methods. Tillkännagivande • May 05
genedrive plc Announces CYP2C19 ID Kit CE-IVD Certification Update genedrive plc announces that the Notified Body responsible for its certification under the European In Vitro Diagnostic Regulation (IVDR 2017/746) has informed the Company that whilst expedited significantly, the review and subsequent independent certification process of the Genedrive® CYP2C19 ID Kit has been delayed by approximately one month. Reported Earnings • Apr 02
First half 2025 earnings released: UK£0.004 loss per share (vs UK£0.02 loss in 1H 2024) First half 2025 results: UK£0.004 loss per share. Revenue: UK£350.0k (up 47% from 1H 2024). Net loss: UK£2.33m (loss widened 14% from 1H 2024). Tillkännagivande • Apr 01
genedrive plc has completed a Follow-on Equity Offering in the amount of £0.226309 million. genedrive plc has completed a Follow-on Equity Offering in the amount of £0.226309 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 15,087,261
Price\Range: £0.015 Tillkännagivande • Mar 28
genedrive plc has filed a Follow-on Equity Offering. genedrive plc has filed a Follow-on Equity Offering.
Security Name: Ordinary Shares
Security Type: Common Stock
Price\Range: £0.015 Tillkännagivande • Dec 07
genedrive plc, Annual General Meeting, Dec 30, 2024 genedrive plc, Annual General Meeting, Dec 30, 2024. Location: the incubator building, grafton street, m13 9xx, manchester United Kingdom Reported Earnings • Dec 01
Full year 2024 earnings released: UK£0.047 loss per share (vs UK£0.055 loss in FY 2023) Full year 2024 results: UK£0.047 loss per share. Net loss: UK£7.08m (loss widened 37% from FY 2023). Tillkännagivande • Nov 22
genedrive plc to Report Fiscal Year 2024 Results on Nov 29, 2024 genedrive plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Nov 29, 2024 Tillkännagivande • Nov 21
genedrive plc Announces Successful Funding Award to Its Clinical Partners from the National Institute for Health and Care Research in Collaboration with the UK Government Office for Life Sciences genedrive plc announced a successful funding award to its clinical partners from the National Institute for Health and Care Research (NIHR) in collaboration with the UK Government Office for Life Sciences (OLS) to address evidence generation requirements of the National Institute for Health and Care Excellence ("NICE") Early Value Assessment ("EVA") for the Genedrive® MT-RNR1 ID kit. The NIHR/OLS Real World Evidence Programme is aimed specifically at technologies like the Genedrive® MT-RNR1 ID kit which have been recommended for use in the NHS via the NICE EVA, to enable the addressing of real-world evidence gaps and the potential subsequent provision of a full (non-conditional) recommendation by NICE to accelerate the widespread adoption and implementation into the NHS. The programme is clinician consortia-based and will be led by principal investigators Professor Bill Newman and Dr. John McDermott (University of Manchester /Manchester University NHS Foundation Trust), with 14 separate hospital Neonatal Intensive Care Units across England (inclusive of some sites which have already implemented the Genedrive® MT-RNR1 ID test as part of routine clinical use), Scotland, Wales and Northern Ireland (inclusive of nine sites already utilising the Genedrive® MT-RNR1 ID test in routine clinical practice). The start date was 1 November 2024 with a maximum duration of 18 months, with sites phased into group 1 (sites already currently using the test) and group 2 (remaining sites). Group 1 site testing is funded under the programme for six months from project initiation, following which funding for continuity of routine clinical practice will be required to be sought from alternative sources by those sites. Revenue to Genedrive for the MT-RNR1 ID kit under the programme is expected to be approximately £500,000. Whilst scheduled for a maximum of 18 months, performance data can be submitted to the NICE EVA Evidence Generation team at an earlier point if the team believes the evidence generation requirements have been successfully fulfilled. Performance data generated during the programme is also expected to contribute towards clinical performance data requirements for FDA as part of planned De novo submission process required for commercial entry into the U.S. New Risk • Oct 14
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Shareholders have been substantially diluted in the past year (416% increase in shares outstanding). Revenue is less than US$1m (UK£272k revenue, or US$355k). Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Market cap is less than US$100m (UK£13.6m market cap, or US$17.7m). Tillkännagivande • Aug 06
Genedrive plc Announces CEO Changes genedrive plc announced that its Chief Executive Officer ("CEO"), James Cheek, has left the Company with immediate effect by mutual agreement. James has been succeeded as CEO by Dr. Gino Miele PhD, currently Chief Scientific Officer ("CSO") who has been with the Company since 2011, serving as R&D Director and since September 2023 as CSO and an Executive Board Director. Prior to joining the Company Gino served as an Associate Director for clinical translational genomics at Wyeth and Pfizer. Gino has been a key driver in the development of the genedrive instrumentation and products, positioning the Company at the forefront of pharmacogenomic testing in emergency healthcare settings and with the wider team has facilitated regulatory approval processes for the products throughout the UK, Europe and the Middle East. Gino was instrumental in the NICE approval processes for both the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit, securing the Group's clinical trial agreement in the U.S., the recent FDA breakthrough device designation, and together with the genedrive commercial team is actively involved in generating a growing list of revenue opportunities in the UK and more widely. Tillkännagivande • Jul 15
Genedrive plc Receives Breakthrough Device Designation from the U.S. Food and Drug Administration genedrive plc announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration for the Genedrive® MT-RNR1 ID Kit. The Genedrive® MT-RNR1 kit is the world's first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that can cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those infants identified by the Genedrive® MT-RNR1 ID kit as carrying the variant can then be given alternative antibiotics. It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems. The Breakthrough Devices Program1 is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorisation. Breakthrough Devices must meet the FDA's standards for device safety and effectiveness in order to be authorised for marketing. Devices subject to premarket approval applications ("PMA"), premarket notification 510(k), or requests for De Novo classification request are eligible for Breakthrough Device Designation if the device meets FDA criteria that it "provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions", in addition to "there being No Approved or Cleared Alternatives" and "Device Availability being in the Best Interest of Patients". The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different programme options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritised review of their submission In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over US$1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage. Extrapolating from UK figures, the Company estimates that approximately 1,000 babies per annum in U.S. Neonatal Intensive Care Units ("NICU") are at risk of aminoglycoside induced hearing loss. Genedrive intends to pursue the FDADe Novoregulatory pathway for entry into the U.S. market. The FDA De Novo pathway provides a vehicle for establishing new predicate devices that can reflect modern standards for performance and safety and can serve as a basis for future clearances. De Novo classification is a risk-based classification process used when there is a lack of a predicate device already cleared by the FDA. Tillkännagivande • May 31
genedrive plc has completed a Follow-on Equity Offering in the amount of £6 million. genedrive plc has completed a Follow-on Equity Offering in the amount of £6 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 138,799,994
Price\Range: £0.015
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 135,177,430
Price\Range: £0.015
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 126,022,576
Price\Range: £0.015
Transaction Features: Regulation S; Rights Offering; Subsequent Direct Listing New Risk • May 23
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 185% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (27% average weekly change). Shareholders have been substantially diluted in the past year (185% increase in shares outstanding). Revenue is less than US$1m (UK£272k revenue, or US$346k). Market cap is less than US$10m (UK£4.72m market cap, or US$6.01m). Tillkännagivande • May 11
genedrive plc has filed a Follow-on Equity Offering in the amount of £3.5 million. genedrive plc has filed a Follow-on Equity Offering in the amount of £3.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 233,333,333
Price\Range: £0.015
Transaction Features: Regulation S New Risk • Apr 05
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 55% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£3.9m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m (UK£272k revenue, or US$344k). Minor Risk Market cap is less than US$100m (UK£9.13m market cap, or US$11.5m). Tillkännagivande • Mar 16
genedrive plc to Report First Half, 2024 Results on Mar 28, 2024 genedrive plc announced that they will report first half, 2024 results on Mar 28, 2024 New Risk • Feb 06
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.89m (US$9.94m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£3.9m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Revenue is less than US$1m (UK£55k revenue, or US$69k). Market cap is less than US$10m (UK£7.89m market cap, or US$9.94m). Minor Risk Shareholders have been diluted in the past year (45% increase in shares outstanding). Tillkännagivande • Dec 07
genedrive plc, Annual General Meeting, Dec 29, 2023 genedrive plc, Annual General Meeting, Dec 29, 2023, at 10:00 Coordinated Universal Time. Location: 46-48 Grafton Street Manchester United Kingdom New Risk • Dec 05
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of British stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£3.9m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Revenue is less than US$1m (UK£55k revenue, or US$69k). Minor Risks Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (UK£10.6m market cap, or US$13.4m). Reported Earnings • Dec 01
Full year 2023 earnings released: UK£0.055 loss per share (vs UK£0.055 loss in FY 2022) Full year 2023 results: UK£0.055 loss per share (in line with FY 2022). Net loss: UK£5.15m (loss widened 10% from FY 2022). Over the last 3 years on average, earnings per share has increased by 94% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. New Risk • Nov 20
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.97m (US$9.97m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m (UK£68k revenue, or US$85k). Market cap is less than US$10m (UK£7.97m market cap, or US$9.97m). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Share price has been volatile over the past 3 months (9.4% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Tillkännagivande • Nov 17
genedrive plc to Report Fiscal Year 2023 Results on Nov 30, 2023 genedrive plc announced that they will report fiscal year 2023 results on Nov 30, 2023 New Risk • Oct 18
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (UK£68k revenue, or US$83k). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (14% increase in shares outstanding). Market cap is less than US$100m (UK£10.1m market cap, or US$12.3m). Tillkännagivande • Sep 12
genedrive plc Announces Chief Executive Officer Changes genedrive plc announced the appointment of James Cheek as Chief Executive Officer of the Company. James will take up the positions and will succeed David Budd, who has notifiecd the Company of his intention to step down from the role with immediate effect. James brings extensive commercial and operational experience at a senior level through a successful career with established diagnostic companies such as Cepheid, Beckman Coulter, and Roche Diagnostics, as well as serving as an executive board member of the British In Vitro Diagnostics Association (BIVDA). The Board believes James' experience, especially his extensive involvement in selling into the NHS, will be valuable as the Company expands its commercial footprint and opportunities within the UK and more widely. Tillkännagivande • Sep 06
Genedrive plc Achieves UKCA Marking Registration for its New Genedrive CYP2C19 System genedrive plc announced it has achieved UKCA marking registration for its new Genedrive CYP2C19 System. It is a point of care pharmacogenomic test that can differentiate between patients that could respond to clopidogrel treatment and those that will not, allowing more effective drug treatment to be prescribed on a personalised basis. The test can be performed at the bedside or in a ward, and can deliver a clinically actionable result in about one hour. Poor response to treatment following stroke is common, effecting up to 30% of patients in the general population and in a recent report up to 50% in certain ethnic groups. In the UK, the National Institute for Health and Care Excellence ("NICE") recommended in May 2023 draft guidance that people who have had an ischaemic stroke or transient ischaemic attack ("TIA") should have a CYP2C19 genetic test prior to treatment. It's estimated that there are over 60 million ischaemic strokes per year globally and over 100,000 in the UK each year. The Genedrive®? CYP2C19 test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, which are instrumental in the loss of metabolism function and poor activation of clopidogrel in a patient. The Genedrive System automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan. Like all genedrive products, the tests are presented in a temperature stable, freeze-dried format, allowing testing to be performed by healthcare workers, away from laboratory locations. In its performance evaluations, the test achieved 99% accuracy in detecting the variants that underpin loss of metabolism function. UKCA marking now allows the Company to begin commercialisation in the UK, and actively engage in the DEVOTE programme (previously announced in May 2023), which will generate additional performance data in an acute care setting. This expanded dataset is required for CE marking submission, which will allow for commercialisation in the EU. Submission is expected in the first half of 2024 once genedrive's engagement with DEVOTE has completed. In the United Kingdom, the Company will be selling the product through its direct sales team, and momentum for adoption is expected to be influenced by positive final NICE recommendations for CYP2C19 testing, which are expected in December 2023. Reported Earnings • Nov 22
Full year 2022 earnings released: UK£0.055 loss per share (vs UK£0.012 loss in FY 2021) Full year 2022 results: UK£0.055 loss per share (further deteriorated from UK£0.012 loss in FY 2021). Net loss: UK£4.68m (loss widened UK£3.98m from FY 2021). Over the last 3 years on average, earnings per share has increased by 42% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings. Board Change • May 31
High number of new directors Chief Financial Officer & Director Russ Shaw was the last director to join the board, commencing their role in 2022. Board Change • Apr 27
High number of new directors Chief Financial Officer & Director Russ Shaw was the last director to join the board, commencing their role in 2022. Buying Opportunity • Apr 08
Now 25% undervalued after recent price drop Over the last 90 days, the stock is down 11%. The fair value is estimated to be UK£0.43, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 55% over the last 3 years. Earnings per share has grown by 26%. Reported Earnings • Mar 30
First half 2022 earnings released First half 2022 results: Net income: (down UK£991.0k from profit in 1H 2021). Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has only increased by 3% per year, which means it is significantly lagging earnings growth. Reported Earnings • Nov 10
Full year 2021 earnings released: UK£0.012 loss per share (vs UK£0.55 loss in FY 2020) The company reported a decent full year result with reduced losses and improved control over expenses, although revenues were weaker. Full year 2021 results: Revenue: UK£687.0k (down 35% from FY 2020). Net loss: UK£691.0k (loss narrowed 96% from FY 2020). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Board Change • Sep 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Non-Executive Director Chris Henry Yates was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Mar 27
First half 2021 earnings released: EPS UK£0.019 (vs UK£0.089 loss in 1H 2020) First half 2021 results: Revenue: UK£355.0k (down 43% from 1H 2020). Net income: UK£991.0k (up UK£4.03m from 1H 2020). Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has increased by 21% per year, which means it is well ahead of earnings. Is New 90 Day High Low • Mar 13
New 90-day high: UK£1.49 The company is up 217% from its price of UK£0.47 on 11 December 2020. The British market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Life Sciences industry, which is up 22% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is UK£0.26 per share. Is New 90 Day High Low • Feb 07
New 90-day high: UK£0.98 The company is up 45% from its price of UK£0.68 on 09 November 2020. The British market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Life Sciences industry, which is up 33% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is UK£0.26 per share. Is New 90 Day High Low • Jan 14
New 90-day low: UK£0.42 The company is down 68% from its price of UK£1.33 on 15 October 2020. The British market is up 15% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 32% over the same period. Is New 90 Day High Low • Dec 07
New 90-day low: UK£0.49 The company is down 45% from its price of UK£0.90 on 08 September 2020. The British market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 15% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is UK£0.21 per share. Reported Earnings • Nov 30
Full year 2020 earnings released: UK£0.55 loss per share The company reported a poor full year result with increased losses and weaker revenues and control over expenses. Full year 2020 results: Revenue: UK£1.06m (down 55% from FY 2019). Net loss: UK£19.4m (loss widened 434% from FY 2019). Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has increased by 14% per year, which means it is tracking significantly ahead of earnings growth. Analyst Estimate Surprise Post Earnings • Nov 30
Earnings beat expectations, revenue disappoints Revenue missed analyst estimates by 37%. Earnings per share (EPS) exceeded analyst estimates by 245%. Over the next year, revenue is forecast to grow 193%, compared to a 20% growth forecast for the Life Sciences industry in the United Kingdom. Reported Earnings • Nov 19
Full year 2020 earnings released: UK£0.55 loss per share The company reported a poor full year result with increased losses and weaker revenues and control over expenses. Full year 2020 results: Revenue: UK£1.06m (down 55% from FY 2019). Net loss: UK£19.4m (loss widened 434% from FY 2019). Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has increased by 11% per year, which means it is tracking significantly ahead of earnings growth. Analyst Estimate Surprise Post Earnings • Nov 19
Earnings beat expectations, revenue disappoints Revenue missed analyst estimates by 37%. Earnings per share (EPS) exceeded analyst estimates by 245%. Over the next year, revenue is forecast to grow 315%, compared to a 20% growth forecast for the Life Sciences industry in the United Kingdom. Is New 90 Day High Low • Nov 10
New 90-day low: UK£0.68 The company is down 21% from its price of UK£0.86 on 11 August 2020. The British market is down 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is UK£0.20 per share. Is New 90 Day High Low • Sep 18
New 90-day high: UK£1.34 The company is up 10.0% from its price of UK£1.21 on 19 June 2020. The British market is down 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Life Sciences industry, which is flat over the same period.