Netscientific Regulatory News (NSCI)

NetScientific plc

("NetScientific", the "Group" or the "Company")

ProAxsis Update

ProAxsis announces "impressive" results in performance evaluation of the in-licensed AstraZeneca COVID-19 antibody test

· Successful completion of evaluation of the AstraZeneca COVID-19 antibody test

· The assay showed exceptional levels of sensitivity and specificity of 100% and 99.3% respectively

· Successful development strengthens ProAxsis's expanding product range and international customer offering

· Additive to NetScientific's Trans-Atlantic plans

NetScientific plc (AIM: NSCI), the international life sciences and sustainability technology investment and commercialisation Group announces that its wholly owned subsidiary ProAxsis has completed the development and validation of the AstraZeneca COVID-19 antibody test with "impressive performance evaluation results."

In June 2021 ProAxsis entered into an exclusive licensing agreement with the global biopharmaceutical company AstraZeneca, under which ProAxsis took responsibility for completing the development, validation and global commercialisation of a SARS-CoV-2 (the virus associated with COVID-19) serology ELISA (enzyme-linked immunosorbent assay).

The detailed independent performance evaluation study by Prof. Tara Moore of Ulster University, analysed over 1,100 clinical serology samples. The assay was able to detect IgG antibodies in blood samples from previously infected individuals, vaccinated individuals, and also detected IgG from individuals known to be infected by the different SARS-CoV-2 variants - Alpha, Delta and Omicron. Furthermore, strong evidence of assay specificity for SARS-CoV-2 antibodies was found when the assay was assessed against over 100 serology from virus infections including common corona virus, influenza virus and many other common respiratory viruses.

The assay showed exceptional levels of sensitivity and specificity of 100% and 99.3% respectively, and enabled the SARS-CoV-2 antibodies to be measured and tracked over time in individuals. The test uses a simple blood sample, and will be launched into the research and clinical trials markets, which are a core part of ProAxsis's business. This successful development reinforces the standing of ProAxsis, and this test further strengthens its expanding product range and international customer offering.

Registration of the assay for a CE Mark has been formally submitted.

John Clarkson, Chairman of NetScientific and ProAxsis commented: 

"The global AstraZeneca licence for this antibody test provides a valuable addition to ProAxsis's respiratory diagnostics offerings and expanded product range in a post-COVID-19 world. The clinical trials market is a core part of ProAxsis's business, and this test provides further commercial opportunities for ProAxsis. Over 3,500 COVID-19 related clinical trials are currently either recruiting or in preparation around the World, involving approximately 1 million subjects.

"The successful completion of this high-profile exercise marks another significant milestone in the implementation of ProAxsis' growth strategy. After signing the global licence agreement with AstraZeneca, it has been a period of hard work, with rigorous testing, development and validation by the highly skilled ProAxsis team, complemented by the excellent work of Professor Tara Moore. By any standards, this is an excellent result. This highly sensitive and specific test provides a significant enhancement to the company's commercial offering; further extending product range and reinforcing the continued international expansion. This fits well with NetScientific's Trans-Atlantic bridges and global strategic plans."

Prof. Smith, NetScientific PLC Non-Executive Director, said: "COVID-19 restrictions are generally lifting around the world, but the virus has not gone away. Whilst Omicron was a milder variant, future strains may be more virulent. We are learning to live with the reality that COVID will be with us for some time, with potentially serious consequences for elderly and vulnerable people. This test's accuracy and ability to detect multiple assay variants makes it an especially valuable tool for vital research, supporting ongoing and future pandemic response strategies and the individual.

"The serology ELISA developed by ProAxsis is impressively able to detect the various strands and mutations of the SARS-CoV-2 virus. It is excellent news that we can play our part and help deliver real benefits to the community, through the application of ProAxsis' expertise in respiratory assays."

NetScientific holds 100% of the issued shares and 95% of ProAxsis on a fully diluted basis.

The full text of the announcement from ProAxsis Limited is reproduced below and is available online here: (https://proaxsis.com).

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ProAxsis announces "impressive" results in Performance Evaluation of COVID-19 antibody test

Date: May 16, 2022

ProAxsis Limited (www.proaxsis.com), the Belfast-based respiratory diagnostics company, has successfully completed the Performance Evaluation study of the COVID-19 antibody test, initially created by AstraZeneca, with impressive results.

The assay has exceptional levels of sensitivity and specificity of 100% and 99.3% respectively, and enables the SARS-CoV-2 antibodies to be measured and tracked over time in individuals. This assay requires a simple blood sample and will be launched into the research and clinical trials markets, further strengthening ProAxsis's expanding product range and international customer offering.  

ProAxsis previously announced that it had entered into an exclusive licensing agreement with the global biopharmaceutical company AstraZeneca for the Worldwide commercialisation rights of a SARS-CoV-2 (the virus associated with COVID-19) serology Enzyme-Linked ImmunoSorbent Assay (ELISA) that detects antibodies to SARS-CoV-2. The highly skilled ProAxsis team have further developed and validated this valuable assay, which in addition has been rigorously tested by Professor Tara Moore, a leading expert in this field.

Hence, ProAxsis is now delighted to confirm that the necessary work for CE Marking has been completed and as such, a notification has been sent to the MHRA. The company expects acknowledgment of receipt from the MHRA shortly, which is a prerequisite of market launch.

In return for providing access to the required intellectual property and technical know-how, AstraZeneca will receive an undisclosed royalty fee on future Global net sales of the assay.

Speaking about the news, Professor Tara Moore, Professor of Precision Medicine at Ulster University, commented:

"This assay performed exceptionally well in the Performance Evaluation study which analysed >1100 clinical serology samples demonstrating levels of sensitivity and specificity of 100% and 99.3% respectively, which was extremely impressive.  The assay was able to detect IgG antibodies in blood samples from previously infected individuals, vaccinated individuals and also detected IgG from individuals known to be infected by the different SARS-CoV-2 variants - Alpha, Delta and Omicron. Furthermore, strong evidence of assay specificity for SARS-CoV-2 antibodies was found when the assay was assessed against over 100 serology from virus infections including common corona virus, influenza virus and many other common respiratory viruses. The full data set will be published in a peer reviewed journal at the earliest opportunity."

Ruth March, SVP, Precision Medicine, AstraZeneca, added:

"The development of this serology ELISA by our team is another example of AstraZeneca's comprehensive response to the COVID-19 pandemic. We are delighted to see the formal validation of the assay and the results of the independent Performance Evaluation study that has formed a critical part of the submission for registration of the assay with a CE Mark."

Dr David Ribeiro, CEO of ProAxsis, said:

"This is clearly great news for both ProAxsis and AstraZeneca. The initial work conducted by AstraZeneca provided a strong framework for our team to further develop, optimise and validate the antibody assay. A critical component of the validation process was the completion of an external independent Performance Evaluation study, and we greatly appreciate the efforts of Professor Tara Moore to complete this work in a timely and highly professional manner."

Any enquiries concerning the new SARS-CoV-2 serology assay can be directed to info@proaxsis.com.

About ProAxsis

ProAxsis Limited is a commercial diagnostics company, based in Northern Ireland, and with a rapidly growing global client list of pharmaceutical companies and academic laboratories. The company has already CE Marked their activity-based immunoassays targeting Neutrophil Elastase (NE) and Proteinase 3, as biomarkers of lung infection and inflammation in chronic respiratory diseases such as COPD, cystic fibrosis and bronchiectasis. 

This technology has been translated into a point-of-care test (NEATstik®), to enable ongoing monitoring of active NE levels. Recently published data has shown that measuring active NE levels using NEATstik® enables identification of patients with airway bacterial infection and those patients at highest risk of suffering pulmonary exacerbations over the subsequent 12 months. 

In addition to proteases, the company also has significant expertise in the measurement of other inflammatory biomarkers, including IL-6, IL-8 and TNF-alpha. Grant-funded R&D funded projects for a variety of targets remain a key area of focus.

Aside from the provision of assays, ProAxsis can offer sample analysis at its purpose-built laboratory facility in Belfast and is currently supporting a number of pharmaceutical company-sponsored Phase I, II and III clinical trials.

ProAxsis is a wholly owned subsidiary of NetScientific Plc.

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The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014. Following the publication of this announcement, this inside information is now considered to be in the public domain.

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About NetScientific

NetScientific plc (AIM: NSCI) is an active holding company, that invests in, develops, commercialises and realises shareholder value in life sciences/healthcare, sustainability and technology companies, which offer significant growth potential in the UK, Europe and USA, as well as globally.

The Group has nearly trebled its portfolio from 8 to 22 companies, either through direct subsidiary, balance sheet investment or capital under advisory, varying from start-up private companies to publicly listed equities.

NetScientific delivers shareholder returns through a proactive and hands-on management approach to their portfolio companies; identifying, investing in, and helping to build game-changing companies. The Group targets value inflection points and the release of value through partial or full exits from trade sales, public listings, or equity sales. The Company has a strong transatlantic and growing international presence, providing attractive expansion prospects.

NSCI can deploy a capital-light investment structure; utilising the power of the PLC Brand, and the NetScientific balance sheet to anchor future investments and achieve a multiplier effect by attracting 3rd party investment for the portfolio companies.

NetScientific is headquartered in London, United Kingdom, and was admitted to trading on AIM, a market operated by the London Stock Exchange, in 2013 (website: www.netscientific.net).