New Risk • May 29
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 2025. 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 High level of non-cash earnings (34% accrual ratio). Market cap is less than US$10m (UK£4.52m market cap, or US$6.07m). Minor Risk Latest financial reports are more than 6 months old (reported September 2025 fiscal period end). New Risk • Jan 05
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 7.6% 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 High level of non-cash earnings (34% accrual ratio). Market cap is less than US$10m (UK£5.47m market cap, or US$7.40m). Minor Risk Share price has been volatile over the past 3 months (7.6% average weekly change). Reported Earnings • Nov 15
First half 2026 earnings released: UK£0.002 loss per share (vs UK£0.001 loss in 1H 2025) First half 2026 results: UK£0.002 loss per share (further deteriorated from UK£0.001 loss in 1H 2025). Revenue: UK£3.86m (down 6.6% from 1H 2025). Net loss: UK£397.0k (loss widened 103% from 1H 2025). Over the last 3 years on average, earnings per share has increased by 111% per year but the company’s share price has fallen by 14% per year, which means it is significantly lagging earnings. Announcement • Nov 10
Cambridge Nutritional Sciences plc Provides Earnings Guidance for the Fiscal Year 2026 Cambridge Nutritional Sciences plc provided earnings guidance for the fiscal year 2026. Company now expects full year sales to be lower than the previous year, as sales cycles for new customers prove to be longer than anticipated. Announcement • Nov 04
Cambridge Nutritional Sciences plc to Report First Half, 2026 Results on Nov 10, 2025 Cambridge Nutritional Sciences plc announced that they will report first half, 2026 results on Nov 10, 2025 New Risk • Aug 28
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.32m (US$9.89m) 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 High level of non-cash earnings (37% accrual ratio). Market cap is less than US$10m (UK£7.32m market cap, or US$9.89m). Announcement • Aug 28
Cambridge Nutritional Sciences plc, Annual General Meeting, Sep 25, 2025 Cambridge Nutritional Sciences plc, Annual General Meeting, Sep 25, 2025. Location: e space north, 181 wisbech, littleport, ely, cb6 1ra, United Kingdom Reported Earnings • Aug 19
First half 2025 earnings released: UK£0.001 loss per share (vs UK£0.003 loss in 1H 2024) First half 2025 results: UK£0.001 loss per share (improved from UK£0.003 loss in 1H 2024). Revenue: UK£4.13m (down 16% from 1H 2024). Net loss: UK£196.0k (loss narrowed 72% from 1H 2024). Revenue is expected to decline by 4.5% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in the United Kingdom are expected to grow by 5.7%. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has only increased by 5% per year, which means it is significantly lagging earnings growth. New Risk • Aug 19
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 102% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 102% per year for the foreseeable future. Minor Risks Latest financial reports are more than 6 months old (reported September 2024 fiscal period end). Large one-off items impacting financial results. Market cap is less than US$100m (UK£8.33m market cap, or US$11.3m). Announcement • Jul 31
Cambridge Nutritional Sciences plc to Report Fiscal Year 2025 Final Results on Aug 19, 2025 Cambridge Nutritional Sciences plc announced that they will report fiscal year 2025 final results at 8:00 AM, GMT Standard Time on Aug 19, 2025 New Risk • Jun 09
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 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: Minor Risks Latest financial reports are more than 6 months old (reported September 2024 fiscal period end). Large one-off items impacting financial results. Market cap is less than US$100m (UK£7.61m market cap, or US$10.3m). New Risk • Feb 18
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.85m (US$9.90m) 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 Risk Market cap is less than US$10m (UK£7.85m market cap, or US$9.90m). Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Large one-off items impacting financial results. New Risk • Jan 16
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 9.8% 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: Minor Risks Share price has been volatile over the past 3 months (9.8% average weekly change). Large one-off items impacting financial results. Market cap is less than US$100m (UK£8.92m market cap, or US$10.9m). Announcement • Nov 15
Cambridge Nutritional Sciences plc to Report First Half, 2025 Results on Nov 21, 2024 Cambridge Nutritional Sciences plc announced that they will report first half, 2025 results on Nov 21, 2024 New Risk • Nov 01
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.73m (US$9.99m) 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 Risk Market cap is less than US$10m (UK£7.73m market cap, or US$9.99m). Minor Risk Currently unprofitable and not forecast to become profitable next year (UK£300k net loss next year). Announcement • Aug 16
Cambridge Nutritional Sciences plc, Annual General Meeting, Sep 26, 2024 Cambridge Nutritional Sciences plc, Annual General Meeting, Sep 26, 2024. Location: poets house, st marys street, cb7 4ey, ely United Kingdom Reported Earnings • Jul 26
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full year 2024 results: UK£0.001 loss per share (improved from UK£0.014 loss in FY 2023). Revenue: UK£9.77m (up 30% from FY 2023). Net loss: UK£328.0k (loss narrowed 90% from FY 2023). Revenue exceeded analyst estimates by 8.6%. Earnings per share (EPS) also surpassed analyst estimates by 80%. Over the last 3 years on average, earnings per share has fallen by 48% per year but the company’s share price has fallen by 58% per year, which means it is performing significantly worse than earnings. Announcement • Jul 10
Cambridge Nutritional Sciences plc to Report Fiscal Year 2024 Results on Jul 25, 2024 Cambridge Nutritional Sciences plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Jul 25, 2024 New Risk • Jun 10
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 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 Risk Earnings have declined by 5.9% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported September 2023 fiscal period end). Market cap is less than US$100m (UK£10.4m market cap, or US$13.2m). Announcement • May 25
Cambridge Nutritional Sciences plc Appoints James Cooper to the Board as Chief Operating Officer and Executive Director Cambridge Nutritional Sciences plc announced that it has appointed James Cooper to the Board as Chief Operating Officer and Executive Director with immediate effect. James graduated from the University of Cambridge in 2014 and, prior to joining CNSL as Operations Director in January this year, has spent the previous 10 years at Chartwell Consulting Limited, a global operations consultancy firm, working most recently on assignments in the medical and pharmaceuticals sectors. Announcement • Jan 29
Cambridge Nutritional Sciences plc Announces Appointment of James Cooper as Operations Director Cambridge Nutritional Sciences plc announced the appointment of James Cooper as Operations Director. James joins from Chartwell Consulting where, since 2014, he was responsible for leading step change operational improvements across a wide range of manufacturing industries. During his nine-year tenure his responsibilities included working with industry leading executive teams to deliver financial benefits through sustained operational improvements, as well as designing and implementing multi-phase project plans to hit operational targets and successfully delivering large-scale complex projects. Most recently James helped to increase the productivity of a large QC lab within a pharmaceutical company and boost the output capacity of a medical biomaterial company. James has a demonstrable track record in leading large teams and bringing together multiple departments to drive towards shared goals. He also has an MSci in Materials Science, and a BA Hons in Natural Sciences from Cambridge University. Announcement • Nov 24
Cambridge Nutritional Sciences plc Provides Revenue Guidance for the Fiscal Year 2024 Cambridge Nutritional Sciences plc provided revenue guidance for the fiscal year 2024. The company is pleased with progress over the first half of the fiscal year as the Company builds a solid foundation from which it can continue to grow. Second half is expected to remain strong, although in the absence of any further backlog to fulfill, is expected to be slightly lower than first half of fiscal year 2024 with the full year's revenue expected to be in line with market expectations. Reported Earnings • Nov 24
First half 2024 earnings released: UK£0.003 loss per share (vs UK£0.004 loss in 1H 2023) First half 2024 results: UK£0.003 loss per share (improved from UK£0.004 loss in 1H 2023). Revenue: UK£4.93m (up 44% from 1H 2023). Net loss: UK£698.0k (loss narrowed 17% from 1H 2023). Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has fallen by 60% per year, which means it is significantly lagging earnings. New Risk • Nov 06
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 7.3% 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 Earnings have declined by 6.9% per year over the past 5 years. Market cap is less than US$10m (UK£5.59m market cap, or US$6.92m). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£1.2m net loss next year). Share price has been volatile over the past 3 months (7.3% average weekly change). Announcement • Nov 06
Cambridge Nutritional Sciences plc to Report First Half, 2024 Results on Nov 23, 2023 Cambridge Nutritional Sciences plc announced that they will report first half, 2024 results on Nov 23, 2023 Announcement • Aug 18
Omega Diagnostics Group plc Appoints Carolyn Rand as an Independent Non-Executive Director Omega Diagnostics Group PLC announced the appointment of Carolyn Rand to the Board as an independent Non-Executive Director, with immediate effect. Carolyn is a board professional with considerable experience in financial and business leadership, governance and strategy planning across public and private enterprises. Her current responsibilities include being Non-Executive Director and Audit Committee Chair for AIM-quoted global Technology business PCI-Pal plc, Non-Executive Director and Audit Committee Chair for AIM-quoted global technology business IQGeo Group plc, and Governor of the College of West Anglia. Throughout her career, Carolyn has held executive positions within high-growth technology and scientific businesses including as CFO of AIM-quoted payments technology business Bango plc, CFO of Zinwave, CEO of Isogenica. Carolyn is a Fellow of the Chartered Institute of Management Accountants having served as Regional Chair. Announcement • Aug 16
Omega Diagnostics Group PLC, Annual General Meeting, Sep 06, 2023 Omega Diagnostics Group PLC, Annual General Meeting, Sep 06, 2023, at 10:00 Coordinated Universal Time. Location: Poets House, St Mary's Street Ely Cambridgeshire United Kingdom New Risk • Aug 04
New major risk - Revenue and earnings growth Earnings have declined by 6.0% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 6.0% per year over the past 5 years. Market cap is less than US$10m (UK£5.82m market cap, or US$7.44m). Reported Earnings • Aug 03
Full year 2023 earnings released: UK£0.014 loss per share (vs UK£0.008 loss in FY 2022) Full year 2023 results: UK£0.014 loss per share (further deteriorated from UK£0.008 loss in FY 2022). Revenue: UK£7.55m (down 12% from FY 2022). Net loss: UK£3.17m (loss widened 125% from FY 2022). Announcement • Jul 28
Omega Diagnostics Group PLC to Report Fiscal Year 2023 Results on Aug 03, 2023 Omega Diagnostics Group PLC announced that they will report fiscal year 2023 results on Aug 03, 2023 Major Estimate Revision • Dec 01
Consensus forecasts updated The consensus outlook for 2023 has been updated. 2023 revenue forecast fell from UK£10.4m to UK£10.0m. 2023 losses expected to reduce from -UK£0.01 to UK£0 per share. Medical Equipment industry in the United Kingdom expected to see average net income decline 0.9% next year. Consensus price target of UK£0.12 unchanged from last update. Share price fell 6.9% to UK£0.034 over the past week. Price Target Changed • Nov 16
Price target decreased to UK£0.12 Down from UK£0.25, the current price target is provided by 1 analyst. New target price is 193% above last closing price of UK£0.041. Stock is down 90% over the past year. The company is forecast to post a net loss per share of UK£0.006 next year compared to a net loss per share of UK£0.0077 last year. Announcement • Oct 26
Omega Diagnostics Group PLC to Report First Half, 2023 Results on Nov 24, 2022 Omega Diagnostics Group PLC announced that they will report first half, 2023 results on Nov 24, 2022 Announcement • Oct 07
Omega Reports for the VISITECT® CD4 Advanced Disease Rapid Test, Issued by the World Health Organisation Omega reported for the VISITECT® CD4 Advanced Disease Rapid test, issued by the World Health Organisation ('WHO')on 3 October 2022. In August 2022, Omega confirmed the sale of its CD4 Business to Accubio Limited ('Accubio') and under the terms of the agreement the Company expects to receive up to an additional £4.0m, contingent on the successful outcome of the clinical study in Kenya, required in order to maintain the test's WHO pre-qualification status. The receipt of the draft Performance Evaluation is an important milestone in completing the pre-qualification process and in releasing the deferred consideration funds to the Company. The VISITECT® CD4 Advanced Disease Rapid Test was evaluated at the Kenya Medical Research Institute,Kisumu, Kenya on behalf of WHO, where a total of 300 specimens were analysed. The report concluded that the VISITECT® CD4 Advanced test showed high sensitivity of 96.0% (95% CI: 90.1-98.9) and a specificity of 96.0% (95% CI: 92.3-98.3) from whole blood specimens andhigh sensitivity of 95.0% (95% CI: 88.7-98.4) and a specificity of 97.0% (95% CI: 93.6-98.9)using capillary blood specimens. Repeatability and reproducibility on specimens with reference values <150 or >250 CD4+ T-cells/µL was 100%. These results are in line with management's expectations. Omega now has until 3 November 2022 to review and comment on the draft report and the results submitted. A summary of the Performance Evaluation report will then be included in the WHO prequalification Public Report if the product successfully meets all WHO prequalification requirements. Reported Earnings • Sep 13
Full year 2022 earnings: EPS misses analyst expectations Full year 2022 results: UK£0.008 loss per share (improved from UK£0.012 loss in FY 2021). Revenue: UK£8.54m (down 2.2% from FY 2021). Net loss: UK£1.41m (loss narrowed 33% from FY 2021). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 17%. Revenue is forecast to grow 23% p.a. on average during the next 2 years, compared to a 7.1% growth forecast for the Medical Equipment industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 38% per year, which means it is performing significantly worse than earnings. Announcement • Aug 31
Omega Diagnostics Group PLC LONDON Common Shares Deleted from OTC Equity Omega Diagnostics Group PLC LONDON Common Shares United Kingdom(GB) has been deleted from OTC Equity effective from August 30, 2022, due to Inactive Security. Announcement • Aug 03
Omega Diagnostics Group PLC, Annual General Meeting, Oct 05, 2022 Omega Diagnostics Group PLC, Annual General Meeting, Oct 05, 2022, at 10:00 Coordinated Universal Time. Location: 1 Exchange Crescent, Conference Square Edinburgh United Kingdom Announcement • Jul 06
An unknown buyer signed Heads of Terms to acquire CD4 Business of Omega Diagnostics Group PLC (AIM:ODX). An unknown buyer signed Heads of Terms to acquire CD4 Business of Omega Diagnostics Group PLC (AIM:ODX) on July 4, 2022. The net proceeds from the sale of the CD4 Business will enable our product and geographical expansion ambitions to be realised. The transaction is expected to complete shortly. Price Target Changed • Apr 27
Price target decreased to UK£0.18 Down from UK£0.25, the current price target is provided by 1 analyst. New target price is 309% above last closing price of UK£0.044. Stock is down 94% over the past year. The company is forecast to post a net loss per share of UK£0.041 next year compared to a net loss per share of UK£0.012 last year. Announcement • Apr 07
Omega Diagnostics Group plc Provides Revenue Guidance for the Full Year Ended 31 March 2022 Omega Diagnostics Group PLC provides revenue guidance for the full year ended 31 March 2022. The Company expects to report a 41% increase in revenues to £12.3 million (2021: £8.7 million), with the Health and Nutrition (H&N) division contributing £8.6 million of revenue (2021: £6.8 million). Prior year H&N sales are skewed by a large stocking order worth approximately £1.2 million placed by the Company's largest partner in China to seed the market in 2021. Announcement • Feb 12
Accubio Limited signed a conditional sale and purchase agreement to acquire Diagnostic Test kit Manufacturing Business and Facility in Alva, Scotland from Omega Diagnostics Group PLC (AIM:ODX) for £1 million. Accubio Limited signed a conditional sale and purchase agreement to acquire Diagnostic Test kit Manufacturing Business and Facility in Alva, Scotland from Omega Diagnostics Group PLC (AIM:ODX) for £1 million on February 11, 2022. The consideration will be paid in cash on completion. The manufacturing business is being sold as a going concern with approximately 109 full-time employees based in Alva transferring across with the business, with no resultant redundancies. The Agreement also covers the sale of certain fixed assets, including plant and equipment (although not any Government-funded equipment on site), as well as the assignment of the lease for the Alva site. The sale will significantly reduce the Groups fixed cost base and eliminate a number of potential future liabilities, whilst generating funds for further investment and growth. The sale is conditional on, amongst other things, the execution of a comprehensive transitional services agreement in line with the principles which have been agreed, the consent of the landlord to assign the Alva lease and the Secretary of State for the Department of Business, Energy and Industrial Strategy not issuing a Public Interest Intervention Notice requiring a review of the Sale, in each case prior to March 7, 2022. Geoff Nash, Edward Whiley, George Dollemore, Alice Lane and Charlotte Sutcliffe of finnCap Ltd acted as financial advisors to Omega Diagnostics in the transaction. Announcement • Feb 11
Omega Diagnostics Group PLC, Annual General Meeting, Mar 07, 2022 Omega Diagnostics Group PLC, Annual General Meeting, Mar 07, 2022, at 11:00 Coordinated Universal Time. Location: Shepherd & Wedderburn, 1 Exchange Crescent, Conference Square, Edinburgh, EH3 8UL Edinbburgh United Kingdom Agenda: Annual General Meeting. Reported Earnings • Nov 27
First half 2022 earnings: EPS and revenues miss analyst expectations First half 2022 results: UK£0.016 loss per share (down from UK£0.002 loss in 1H 2021). Revenue: UK£5.73m (up 81% from 1H 2021). Net loss: UK£2.88m (loss widened UK£2.59m from 1H 2021). Revenue missed analyst estimates by 6.1%. Earnings per share (EPS) also missed analyst estimates by 43%. Earnings per share (EPS) missed analyst estimates by 43%. Over the last 3 years on average, earnings per share has fallen by 37% per year but the company’s share price has increased by 16% per year, which means it is well ahead of earnings. Announcement • Sep 08
Omega Announces VISITECT COVID-19 Antigen Self-Test Submission Update Omega announced that all of the supporting data and documentation relating to its submission for CE marking for self-test use for the VISITECT COVID-19 antigen test have been filed with its European Notified Body. The submission process has been running in parallel with the Useability Study conducted by Ulster University since mid-July and the conclusion of the Ulster study was the final step in this process. The test is already CE marked for professional-use and once approved would allow the test to be sold in Europe for home-use as well. As the global market for antigen testing develops, the Company believes self-test approval will be a key requirement, as has already been seen in the UK. The submission is already under review by the Notified Body and the company will provide a further update on the process as it concludes. Executive Departure • Sep 02
Group Finance Director, Company Secretary & Executive Director Kieron Harbinson has left the company On the 30th of August, Kieron Harbinson's tenure as Group Finance Director, Company Secretary & Executive Director ended after 15.0 years in the role. As of June 2021, Kieron still personally held 542.53k shares (UK£292k worth at the time). Kieron is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 9.83 years. Reported Earnings • Jul 15
Full year 2021 earnings released: UK£0.012 loss per share (vs UK£0.049 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£8.73m (down 11% from FY 2020). Net loss: UK£2.10m (loss narrowed 69% from FY 2020). Over the last 3 years on average, earnings per share has fallen by 52% per year but the company’s share price has increased by 51% per year, which means it is well ahead of earnings. Announcement • Jul 03
Omega Diagnostics Group plc Announces FDA Submission for Emergency Use Authorization Omega Diagnostics Group PLC announced that following completion of the of US performance studies, its technology partner, Mologic Ltd. ("Mologic") has filed its submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its rapid point-of-care COVID-19 antigen test, for use under both the Omega's VISITECT brand and Global Access Diagnostics (GAD) brand. The Company will provide a further update on the process in due course. Announcement • Jun 08
Omega Diagnostics Gp Provides Regulatory Progress for Visitect® Covid-19 Test Omega provided the following update on VISITECT® COVID-19 Antigen test regulatory approvals. Omega announces that it has begun the process of engagement with its European Notified Body seeking CE marking of the VISITECT® COVID-19 Antigen test, a rapid point-of-care diagnostic test for the detection of active COVID-19 infections as a self-test. The Company is agreeing the protocols required for utilisation studies and will update shareholders as this process progresses. The test is already CE marked for professional-use and the Company is targeting approval by the end of July to allow the test to be sold in Europe for home-use as well. As the global market for Antigen testing develops the Company believes self-test approval will be a key product differentiator, as has already been seen in the UK. The Company also announces that its technology partner, Mologic Ltd. ("Mologic") has successfully completed the necessary performance studies required for regulatory approval in the US and is now in the final stages of preparing a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its rapid point-of-care COVID-19 antigen test, for use under both the Omega's VISITECT® brand and Global Access Diagnostics brand. Announcement • Jun 02
Omega Diagnostics Group plc Announces Positive Data for Covid-19 Antigen Test Omega Diagnostics Group PLC notes the publication of a manuscript entitled: "Accuracy of the Mologic COVID-19 rapid antigen test: a prospective multi-centre analytical and clinical evaluation" which provides positive study data relating to Mologic Ltd.'s ('Mologic') lateral flow antigen test for COVID-19. The study concludes that the Mologic test, which has been commercialized by Omega as the VISITECT® COVID-19 Antigen test, has fulfilled the WHO target diagnostic accuracy with a high sensitivity (93.2%-98.4%) detecting individuals with high viral load infections (Ct<20 and Ct<25). The VISITECT® COVID-19 Antigen test provides healthcare professionals with an accurate rapid test for the detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs in 10 minutes. The Mologic COVID-19 rapid test was evaluated in a prospective multicentre study across UK sites, where a total of 347 participants were enrolled. The Diagnostic accuracy and clinical performance of the test were investigated by comparing to gold standard RT-PCR results from individuals with and without COVID-19 symptoms attending secondary care facilities in Merseyside, ambulance services in Yorkshire, and drive-through testing facilities in Northumberland, UK. With data stratified by RT-PCR cycle threshold (Ct), sensitivity was shown to be high in individuals with highest viral loads (i.e. most likely to be highly contagious): 93.2% of samples with a Ct less than 25 and 98.4% of samples with a Ct less than 20. Overall sensitivity (including all cycle thresholds, so individuals with low viral loads as well) and specificity compared to the reference SARS-CoV-2 RT-PCR was 85.0% and 97.8% respectively. The study also concluded that the Mologic test replicated diagnostic accuracy in a variety of settings important for COVID-19 control (hospitals, ambulatory services, and drive-through centres) and on self-collected swab specimens. Announcement • May 06
Omega Diagnostics Group PLC Announces Positive Data for Mologic COVID-19 Antigen Test Omega Diagnostics Group PLC noted the Mologic COVID-19 lateral flow antigen test has been independently verified in a 665-person study in Germany by FIND a global not-for-profit foundation. The test was shown to demonstrate best-in-class performance with 100% specificity and 96.4% sensitivity (Cycle threshold <25) compared with laboratory PCR testing.
Omega has CE-Marked the Mologic lateral flow antigen test for COVID-19 and has launched the test for professional-use under Omega's VISITECT® brand. The VISITECT® COVID-19 Antigen test provides healthcare professionals with an accurate rapid test for the detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs in 10 minutes. Recent Insider Transactions Derivative • Apr 04
Independent Non-Executive Director exercised options and sold UK£192k worth of stock On the 31st of March, William Rhodes exercised 300k options at a strike price of around UK£0.15 and sold these shares for an average price of UK£0.79 per share. This trade did not impact their existing holding. As of today, William currently holds no shares directly. Company insiders have collectively sold UK£1.6m more than they bought, via options and on-market transactions in the last 12 months. Announcement • Mar 16
Omega Diagnostics Group plc Announces Contract with the Development of Health and Social Care to Provide Manufacturing Capacity for Covid-19 Lateral Flow Antigen Test Omega announced that a UK Public Sector contract disclosure has been published on March 14, 2021 in relation to Omega's contract with the Department of Health and Social Care ("DHSC") to provide manufacturing capacity for COVID-19 lateral flow antigen test, announced on 11 February 2021 (RNS: 6952O). Omega notes that in this public government disclosure the contract is stated to have an estimated total value of £374 million. The Company notes that under UK Government Public Sector contract disclosure rules this number necessarily represents a maximum of the potential value of the contract and care should be taken not to use this number as an estimate or forecast of the actual likely value of purchase orders to be received by the Company for the production of COVID-19 lateral flow antigen tests. The value of future purchase orders may be substantially less than stated in yesterday's public Government disclosure. In addition, the Company still awaits confirmation that a COVID-19 lateral flow antigen test has passed the necessary performance evaluation. Accordingly, there are no COVID-19 lateral flow antigen tests that can be manufactured by Omega, on behalf of the Government, at this time. As soon as the DHSC has access to a test that has successfully passed performance evaluation, it will be licensed to Omega for manufacture. When the test is ready for production Omega expects to receive purchase orders from the DHSC for these tests and, where appropriate, the Company will make further statements given that these production volumes are expected to result in substantial revenue growth for new financial year. Announcement • Mar 04
Omega Signs Contract with Screen4 Ltd Omega announced that it has signed a contract with Screen4 Ltd. to provide a testing service using the Mologic ELISA antibody test for COVID-19 from the Company's in-house testing laboratory in Littleport, Cambridgeshire. This follows the launch of the COVID-19 antibody testing service, as announced on 26 January 2021. The contract is for an initial term of three years. Screen4 is a leading provider of COVID-19 testing services and diagnostic testing services to the aviation, petrochemical, occupational health and consumer markets in the UK and across the Middle east and Far East regions. Screen4 is an Approved Provider under the UK Government General testing and 'Test to Release' Scheme in the UK. Announcement • Feb 25
Omega Diagnostics Group plc UK-RTC Statement on Abc-19Tm Rapid Antibody Test Omega announced by the UK Rapid Test Consortium ("UK-RTC"), of which Omega is a partner, which presents new data relating to the performance of the AbC-19TM rapid antibody test when used as a companion diagnostic to the Pfizer-BioNTech COVID-19 vaccine. The initial study performed at the University of Birmingham highlighted the effectiveness of the AbC-19TM rapid antibody test in demonstrating immune response following vaccination. During the study the AbC-19™ Rapid Test was used to test individuals who had been given a single dose of the Pfizer-BioNTech COVID-19 vaccine. In total 193 individuals who had received a COVID-19 vaccine were tested for the presence of IgG antibodies to the full trimeric spike using the AbC-19TM test. Of these individuals, a sub-set of 65 patients had been determined to have previously been infected with COVID-19, and 128 had no previous infection. The study also concluded that patients previously infected with COVID-19 showed a stronger immune response to the first dose of the Pfizer-BioNTech COVID-19 vaccine. Announcement • Feb 16
Omega Diagnostics Group plc Announces Abc-19 Rapid Antibody Test Performance Data Omega Diagnostics Group PLC notes the release issued by the UK Rapid Test Consortium ("UK-RTC"), of which Omega is a partner, welcoming a pre-print publication, funded by Public Health England (PHE), reviewing performance data on rapid antibody tests including the AbC-19TMRapid Test. The study, performed by scientists at PHE, and the Universities of Bristol, Warwick and Cambridge, examined the performance of four lateral flow rapid antibody tests using the same cohort of sample, and shows that the AbC-19TMis highly accurate when tested on samples from individuals previously positive for the virus by PCR and from samples collected pre-pandemic. All devices tested had accuracy of above 92% with the AbC-19 TM Rapid Test showing the high accuracy at 97.3%. The study remains subject to peer review. The AbC-19TM Rapid test confirms the presence of SARS-CoV-2 IgG neutralising antibodies to the spike protein of the COVID-19 virus in a small blood sample. These neutralizing antibodies may be produced as part of the body's immune response following COVID-19 infection or post-vaccination. They not only bind to a virus, but they bind in a manner that blocks infection. Recent Insider Transactions Derivative • Feb 16
Group Finance Director exercised options and sold UK£582k worth of stock On the 12th of February, Kieron Harbinson exercised 940k options at a strike price of around UK£0.14 and sold these shares for an average price of UK£0.76 per share. This trade did not impact their existing holding. Since March 2020, Kieron's direct individual holding has increased from 681.62k shares to 717.53k. Company insiders have collectively sold UK£1.1m more than they bought, via options and on-market transactions in the last 12 months. Announcement • Feb 12
Omega Announces Changes to Its Board Omega announced the appointment of Dr Simon Douglas as independent Non-Executive Chairman. Simon has been appointed to the Board with immediate effect, after a thorough search process that was conducted with the help of Snedden Campbell Ltd. Simon has also become a member of both the Audit Committee and the Remuneration Committee. Simon has 25 years of Board level experience at both early stage and public businesses within the Diagnostics, Life Science and BioPharma industries. As a result of the appointment, Bill Rhodes has stepped down from his position as Interim Non-Executive Chairman with immediate effect, but he remains as a Non-Executive Director of the company. Announcement • Feb 11
Omega Agrees Contract with the Department of Health and Social Care Omega announced that it has agreed a contract with the Department of Health and Social Care ("DHSC") to provide manufacturing capacity for COVID-19 lateral flow antigen tests, as part of the UK Government's well-publicised target of producing two million lateral flow tests per day. The intention is that as soon as the DHSC has access to a test that has successfully passed a performance evaluation, the test will be licensed for Omega to manufacture. As part of the contract, DHSC will loan a number of key pieces of manufacturing equipment. This will facilitate the necessary expansion in production capability in Omega's Alva-based facility, to ensure the tests are made available as soon as possible. The company anticipates that the above actions will provide the company with capacity to produce approximately 2 million tests per week by the end of April, when combining the Government-loaned equipment with its own manufacturing equipment. Omega expects that this capacity will be sufficient to meet the expected demand for lateral flow COVID-19 antigen tests, with enough remaining capacity to be used for VISITECT CD4 or COVID-19 antibody tests according to demand. Is New 90 Day High Low • Feb 08
New 90-day high: UK£0.92 The company is up 63% from its price of UK£0.56 on 10 November 2020. The British market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 2.0% over the same period. Announcement • Jan 28
Omega Diagnostics Group plc Announces the Launch of Covid-19 Antibody Laboratory-Based Testing Service Omega Diagnostics Group PLC provides update from Abingdon Health plc regarding the AbC-19TM Rapid Test, confirming their expectations for future supply arrangements with the Department of Health and Social Care, the ongoing efforts to obtain regulatory approvals in a total of 27 geographies, and the ongoing work to build data the set(s) around the use-case for the AbC-19 Rapid Test alongside vaccines. In addition, Omega will announce the launch of its COVID-19 antibody lab-based testing service in Littleport, Cambridgeshire, using the Mologic ELISA1 antibody test. This service will be offered to commercial occupational health partners, clinics and health care professionals in the UK. Reported Earnings • Dec 03
First half 2021 earnings released: UK£0.002 loss per share The company reported a soft first half result with weaker revenues and control over expenses, though losses reduced. First half 2021 results: Revenue: UK£3.16m (down 29% from 1H 2020). Net loss: UK£283.7k (loss narrowed 12% from 1H 2020). Over the last 3 years on average, earnings per share has fallen by 86% per year but the company’s share price has increased by 38% per year, which means it is well ahead of earnings. Is New 90 Day High Low • Nov 12
New 90-day low: UK£0.48 The company is down 15% from its price of UK£0.56 on 14 August 2020. The British market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is down 1.0% over the same period. Announcement • Nov 05
Omega Diagnostics Group PLC Announces Chinese Approval for Food Detective® Test Omega announced that the National Medical Products Administration ("NMPA"), formerly the China Food and Drug Administration, has approved the Company's Food Detective® test for self-test use in China. Further to the announcement on 2 April 2020 confirming NMPA approval for laboratory use of the Food Detective® test in China, Omega's development team has continued to work in conjunction with its distribution partner to support their efforts to achieve NMPA approval to allow the test to be used in people's homes. The Company will support its distribution partner to ensure that Food Detective® achieves commercial success in China as an approved home-use test. Announcement • Oct 28
Omega Diagnostics Group PLC to Report First Half, 2021 Results on Nov 30, 2020 Omega Diagnostics Group PLC announced that they will report first half, 2021 results on Nov 30, 2020 Announcement • Oct 08
Omega Diagnostics Group plc Announces First Order for One Million COVID-19 Lateral Flow Antibody Tests Omega Diagnostics Group PLC announced that the issued on October 7, 2020 by the UK Rapid Test Consortium ('UK-RTC'), of which Omega is a partner, on the UK Government's first order for one million COVID-19 lateral flow antibody tests (the "AbC-19 Rapid test"). This first order is part of the UK Government's plans to roll-out COVID-19 surveillance studies to help build a picture of how the virus has spread across the country. The AbC-19 Rapid test uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need for a patient sample to be sent to a laboratory. The test is currently CE-Marked for professional use and can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care. The UK-RTC are seeking approval from the MHRA for self-test use. The UK-RTC members are in the final stages of formalising an agreement for the supply of goods from members to Abingdon Health, following the Memorandum of Understanding that was signed in April 2020. Omega expects to manufacture approximately 175,000 of these first 1 million tests but over the term of this supply agreement, Omega will manufacture not less than 25% of the demand from total orders placed, either from the UK Government or, where allowed, third party customers. Is New 90 Day High Low • Oct 03
New 90-day high: UK£0.94 The company is up 123% from its price of UK£0.42 on 03 July 2020. The British market is down 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is down 3.0% over the same period. Announcement • Jul 10
Omega Diagnostics Group PLC to Report Fiscal Year 2020 Results on Jul 14, 2020 Omega Diagnostics Group PLC announced that they will report fiscal year 2020 results on Jul 14, 2020 Announcement • Jul 09
Omega Diagnostics Group PLC has completed a Follow-on Equity Offering in the amount of £3.01244 million. Omega Diagnostics Group PLC has completed a Follow-on Equity Offering in the amount of £3.01244 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 7,531,100
Price\Range: £0.4 Announcement • Jun 20
Omega Diagnostics Group PLC has completed a Follow-on Equity Offering in the amount of £8 million. Omega Diagnostics Group PLC has completed a Follow-on Equity Offering in the amount of £8 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 20,000,000
Price\Range: £0.4
Transaction Features: Subsequent Direct Listing