ProAxsis Ltd CEO Update Report – End Q4 2021

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ProAxsis Ltd CEO Update Report – End Q4 2021

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May 21, 2021

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Introduction

As 2022 commences, I am pleased to provide an update on the progress made with regard to a number of the company’s key objectives announced during 2021. The global coronavirus pandemic continues to create uncertainty in many markets, including in Respiratory Medicine research, but based on the strong underlying financial position established via Netscientific’s acquisition of outstanding shares in late 2020, the company has continued to target three key areas of growth, and thanks to the expertise of its core scientific team, has made significant progress in each of these:

An accelerated R&D programme
- The NE Premium assay has been created to offer improved sensitivity compared with the company’s existing ProteaseTag Active NE Immunoassay, thereby enabling usage in a wider range of biological samples. The development process for this assay has been partially supported by an R&D grant from Invest Northern Ireland and has proceeded extremely well with the assay now in the later stages of development prior to its anticipated registration with a CE Mark and commercial launch in 2022. The company’s target of a 100-fold improvement in sensitivity has been successfully achieved.

An enhancement to the existing product portfolio
- In February 2021, the company secured an agreement with the University of Geneva, providing ProAxsis with development and global commercialisation rights of a highly novel protease-related immunoassay for use in the monitoring of Bone Health in conditions such as osteoporosis. The K-POSTn assay format has since been modified by the ProAxsis team to offer maximum sensitivity and ease-of-use, and the company is planning to register the assay with a CE Mark in 2022.

Development of new revenue streams, including as part of the global response to the COVID-19 pandemic
- In mid-2021, ProAxsis executed an unprecedented deal for a company of its size when we agreed a Worldwide licensing deal with AstraZeneca for their internally-developed COVID-19 serology (antibody) assay. Whilst much of the focus of the scientific community and the public to date has been on antigen tests, to enable identification of current COVID-19 infection, we believe that there will be an increasing emphasis on antibody testing, to identify which individuals have detectable levels of antibodies following vaccination and/or COVID-19 infection. This is evidenced by data highlighting that booster shots are needed to raise antibody levels in order to better protect individuals against the recently-identified Omicron variant of the virus.

Since gaining access to the product, the ProAxsis team have continued to work closely with the team at AstraZeneca to modify the original prototype version of the assay, adapting various components and processes to create an easy-to-use, high-performance plasma-based assay for the identification of IgG antibodies raised against the COVID-19 virus for use in a clinical trial setting. Due to the nature of the coronavirus pandemic (increasing number of known variants, range of vaccines utilised globally, etc.), the assay development process is complex and time-consuming but the company has now run numerous samples, indicating that the assay is highly specific and sensitive for distinguishing between positive and negative samples.

In H1 2022, a World-renowned clinical partner who has supported multiple COVID-related assay development programmes, will conduct several of the required assay validation steps, which necessitates access to a cohort of very specific clinical samples, and which will provide key data for the dossier required to register the assay with a CE Mark. In parallel, the company continues to explore additional novel assay formats, and routes to market, for the product.

Supported by Innovate UK, the company has successfully developed the first 2-plex protease multiplex panel, which is now being validated for use in a range of biological samples. This assay enables simultaneous measurement of two key proteases (neutrophil elastase and proteinase 3) which have been associated with COVID-19 symptom severity, utilising a widely available multiplex platform. We are currently in discussion with potential commercialisation partners for this highly novel product and anticipate making a further announcement on the progress of this assay in due course.

These new products are forecast to contribute significant incremental sales in 2022. Additionally, the company has continued to expand both its commercial and scientific teams, and expects to announce further news on its laboratory expansion plans during 2022.

David Ribeiro CEO

May 21, 2021