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ODX Omega Diagnostics Group Plc

Discussion in 'General Share Chat (ODX)' started by Mongoose82, Jun 28, 2016.

  1. Groucho

    Groucho Member

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    13 July 2021


    OMEGA DIAGNOSTICS GROUP PLC

    ("Omega" "Company" or the "Group")


    FINAL RESULTS

    FOR THE YEAR ENDED 31 MARCH 2021


    Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food sensitivity testing, announces its audited results for the year ended 31 March 2021.


    Omega provide high quality in-vitro diagnostics products for use in hospitals, clinics, laboratories and healthcare practitioners in over 75 countries and specialise in the areas of health and nutrition and global health.



    Financial Highlights:

    · Revenue decreased by 11% to £8.73m (2020: £9.82m)

    · EBITDA loss of £2.20m (2020: £0.89m profit)

    · Statutory loss for the year of £2.10m (2020: loss of £6.83m)

    · Adjusted loss before tax* of £3.15m (2020: loss of £0.40m)

    · Adjusted EPS (1.0p) (2020: (0.2p))

    · Statutory EPS (1.2p) (2020: (4.9p))

    · Cash balances of £5.8m (2020: overdraft of £0.6m)


    * Adjusted for amortisation of intangible assets, share based payment charges and exceptional items.


    Operational & Post-Period End Highlights:


    · Chinese regulatory approval of Food Detective® test for both laboratory settings and self-test use

    · Supply agreement signed with Clinton Health Access Initiative (CHAI) to accelerate access of VISITECT® CD4 Advanced Disease in low and middle-income countries

    · VISITECT® CD4 Advanced Disease test received WHO prequalification

    · Placing and open offer which raised £10.5m net of expenses to enable capacity increase of lateral flow tests

    · Contract signed with the Department of Health and Social Care ("DHSC") to provide manufacturing capacity for COVID-19 lateral flow antigen tests

    · Appointment of Dr Simon Douglas as Non-Executive Chairman of the Group

    · CE mark and launch of Mologic's lateral flow antigen test for COVID-19, to be sold for professional-use under Omega's VISITECT® brand and FDA Emergency Use Authorization submitted

    · Over £2m invested in facility refurbishment and new equipment to accommodate increased capacity expected from both COVID-19 and CD4 manufacturing throughput

    · As announced separately today, Kieron Harbinson has notified the board he will step down from his position as Group Finance Director in August 2021. The Company has agreed to appoint Christopher Lea as Chief Financial Officer


    Commenting, Simon Douglas, Non-executive Chairman, said: "While conditions in the UK and in many parts of the world have improved significantly over the past few months, there remains considerable uncertainty around the world as countries ease or increase restrictions to manage the global COVID-19 pandemic. Challenges remain for much of our international customer base but the Board believes the Company has the expertise to meet these challenges and capitalise on opportunities as we have done over the past year. CD4 is a unique product and gaining traction in countries where HIV remains a serious challenge. We intend to build on this in the short term through further country registrations and international distribution. In addition our strategy and focus to deliver high value instrument-free diagnostic products will be enhanced over the next 36 months through the introduction of a further range of lateral flow tests for diseases often associated with Advanced HIV and a damaged immune system. The recovery of the Health and Nutrition business should continue with growth in China and the USA anticipated over the next two years as their economies open up. COVID-19 antigen testing still remains a significant opportunity for us, although very much dependent on the UK Government's decisions as to test selection and timing."
     
    Last edited: Jul 13, 2021
  2. Groucho

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  3. Groucho

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    27 July 2021


    AbC-19TM IgG LFD successfully used semi-quantitively to monitor vaccine responses to variant proteins


    - AbC-19TM able to detect different levels of antibody response to the AstraZeneca and Pfizer vaccines as well as those post-infection

    - Antibody testing has the potential to be a key tool in maintaining public safety, confidence in the vaccines and supporting effective vaccine booster campaigns


    York, U.K. 27 July 2021: Abingdon Health plc (AIM: ABDX) ("Abingdon" or "the Company"), a leading international developer and manufacturer of high quality and effective rapid tests, is pleased to note the publication of an article illustrating the use of the AbC-19TM IgG spike antibody lateral flow device (AbC-19TM LFD) in semi-quantitative format and antibody responses against covid variants of concern.

    The article demonstrates that AbC-19TM is able to monitor antibody response following vaccination or natural infection. The paper shows differences in strength of antibody response with the Pfizer and AstraZeneca ("AZ") vaccines and the induced antibody responses to the original Wuhan variant, on which the vaccines are based. It also shows that these antibodies cross-react to the 'spike protein' of different variants of concern. This study was conducted using the AbC-19TM LFD and prototypes based on different covid variants. The results demonstrated a stronger antibody response in those vaccinated by Pfizer, compared to AZ, whilst noting the cohort vaccinated with AZ were older, which the authors noted may have an effect on antibody response.

    The authors used a semi-quantitative score card to record the strength of the test-line response on the LFD. They illustrated pictorially and in graphical format a proportional response of line intensity to the concentrations of neutralising antibodies in a serial dilution of the WHO standard 20/136 from 1000 IU/mL down to 7.8 IU/mL which covers the range that previous research has shown to be indicative of immunity. (The WHO standard 20/136 is for the calibration and harmonization of serological assays detecting anti-SARS-CoV-2 neutralising antibodies).

    The article by researchers at the University of Birmingham is published as: Ebanks, D et al, "Cross reactivity of serological response to SARS-CoV-2 vaccination with viral variants of concern detected by lateral flow immunoassays" Journal of Infection on 26th July 2021. To view the full paper, please click here.


    Chris Yates, Chief Executive Officer of Abingdon Health commented: "With the successful roll-out of vaccinations in the UK and many other countries, it is now imperative that we monitor the neutralising antibody levels in the worldwide population to maintain the safety of the public and instill confidence in people as they return to normal life. This study demonstrates how AbC-19TM can be used to monitor antibody response alongside vaccines as well as the neutralising antibody response following natural infection. The AbC-19TM test will allow individuals to know their own status, which is becoming a growing concern, and allow healthcare agencies and healthcare professionals worldwide to manage the continued vaccination roll-out and to develop effective and targeted booster vaccination programmes. The study also shows the ability of our scientists to pivot the format of the test if other variants of concern present which generate a different antibody response.

    Importantly, due to the utility of the score card used alongside the AbC-19TM test for these applications, Abingdon intends to make a supplementary product available, initially for research use only, in August which provides a semi-quantitative result which will may indicate the strength of antibody response and possibly immunity."
     
  4. Groucho

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    06 September 2021

    OMEGA DIAGNOSTICS GROUP PLC

    ("Omega" or the "Company" or the "Group")


    VISITECT® COVID-19 antigen test self-test submission update

    All supporting data and documentation now submitted to Omega's European Notified Body


    Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food sensitivity, announces 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.


    Colin King, CEO of Omega, said: "As a result of a lot of hard work by our team and Ulster University, we are very pleased to have submitted all of the information required for self-test use approval for our VISITECT® COVID-19 antigen test. Once approval is granted, we anticipate strong demand for a UK developed and manufactured product.

    "Furthermore, we believe we have a high-quality, high-performance product with significant global appeal, including the US market, due to that market's size and high barriers to entry."
     
  5. Groucho

    Groucho Member

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    13 September 2021

    RNS Reach


    Poolbeg Pharma plc

    Poolbeg Pharma to present at investor conferences


    13 September 2021 - Poolbeg Pharma (AIM: POLB), 'Poolbeg' or the 'Company', a clinical stage infectious disease pharmaceutical company with a capital light clinical model, today announces that members of its management team will be attending four upcoming investor events across September and October.

    · Proactive Investors One2One Forum (virtual) on 16 Sep 2021. Registration Link: click here

    · Small Company Champion Investor Presentation on 17 Sep 2021 at The Menphys Hub, Bassett Street South, Wigston, Leicester LE18 4PE. Registration Link: click here

    · Shares Magazine Investor Webinar (virtual) on 5 Oct 2021. Registration link will be available on the Poolbeg Pharma website: click here

    · London South East Webinar (virtual) on 19 Oct 2021. Registration link will be available on the Poolbeg Pharma website: click here

    The above event details may be subject to change. Further information and any updates will be on the events section of the Poolbeg Pharma website.


    Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:

    "Following continuing demand after an oversubscribed AIM listing in July and a share price above the IPO price, I am looking forward to sharing how our capital light model and a scalable platform for growth will deliver value creation for our shareholders. Poolbeg Pharma is targeting a rapidly expanding market of infectious diseases, which is expected to exceed $250B by 2025. These events will be an opportunity to discuss our attractive, Phase II ready lead asset (POLB 001) tackling the inflammatory response to severe influenza, and our special access to a unique data bank of 20 years of infectious disease data in humans which we will mine to identify new, compelling therapeutics."
     
  6. Groucho

    Groucho Member

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    15 September 2021

    OMEGA DIAGNOSTICS GROUP PLC

    ("Omega" or the "Company" or the "Group")


    AGM Statement


    Omega (AIM: ODX), the medical diagnostics company focused on Global Health (CD4 and COVID-19) and Health and Nutrition, will hold its Annual General Meeting ('AGM') today at 11am at Omega House, Hillfoots Business Village, Alva, Clackmannanshire, FK12 5DQ. Simon Douglas, Non-executive Chairman, provides the following update to shareholders ahead of the meeting:

    As outlined in our Final Results statement in July, we are confident that the Company is well positioned for exciting growth, and this remains the case as we move into the second half of the year.

    Our Health and Nutrition Division continues to show early signs of recovery towards pre-pandemic revenue levels, and we have a strategic plan in place to deliver substantial growth from this division, particularly given the opportunities we see in both China and the US.

    In terms of our Global Health Division, we remain optimistic about the long-term prospects for the roll-out of our VISITECT® CD4 Advanced Disease test, the first and the world's only instrument-free point of care test for monitoring CD4 levels, essential for the effective management of advanced HIV. We have received excellent feedback from external clinical studies and evaluations in key countries and can see positive indications that long term funders are supporting the roll out of the Advanced Disease initiative. We therefore remain confident that the market potential for our product reaching 4m to 6m tests a year within the next three to five years, representing an opportunity to generate £12m to £18m in annualised revenues.

    We also remain confident in delivering significant value from opportunities within the COVID-19 testing space. Our positive dialogues with the third parties introduced to us by the Department of Health and Social Care (DHSC) are advancing and we are optimistic that these will conclude successfully and positively impact on our H2 performance.

    Regulatory approvals in the US and CE marking for self-test use for our VISITECT® COVID-19 Antigen test will provide the catalyst for sales opportunities. We recently announced submission for CE marking for self-test use and we are now waiting for our European Notified Body to complete the review of our submission. MHRA approval for sale in the UK is expected to follow soon after CE marking for self-test use is confirmed. The US Food and Drug Administration (FDA) is reviewing the Mologic submission for professional use for the same test, and we expect a positive outcome for both submissions.

    Advancement towards further regulatory approvals and commercial progress for the AbC-19TM rapid test continues. We had hoped for further news to update shareholders with on this progress, however the prospects for this test have not changed and we still believe there is a significant opportunity for this COVID-19 antibody test.

    The cash position of the Company remains healthy and we will provide a short update on trading for the six months ending 30 September 2021 in November. We look forward to updating shareholders on any further progress in the meantime.
     

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