Quarterly Business Update

Period Ending 31 March 2022

ASX Code: ADO

Shares on Issue 1,988 million

CEO

Mr Derek Thomson

Company Secretary Mr Tim Pritchard

Principal and Registered Office

Unit 4, 26 Brandl St

Eight Mile Plains Qld, 4113, Australia

Telephone +61 7 3219 0085

Internetwww.anteotech.com

Emailcontact@anteotech.com

ABN 75 070 028 625

Key Activities

Activities for the quarter focused on:

Life Sciences - realigning the COVID-19 Rapid Antigen Test1 (RAT) program to fulfil Therapeutic Goods Administration (TGA) and European Union (EU) Common List requirements through European clinical trials and increasing distributor engagement to position for increased sales subject to securing EU Common List and TGA approvals.

Energy - promotion of AnteoX with key industry partners to Illustrate further proof points of improved electrochemical performance outcomes.

Highlights for the Q3 FY22 Quarter Include:

  • Technology transfer for manufacturing Combo SARS-CoV-2 Influenza A/B Ag Rapid Diagnostic Test (RDT) with Operon has commenced.

  • Australian clinical trial progresses as planned.

  • Contracted Clinical Research Organisation (CRO) in Spain to conduct prospective clinical trials for COVID-19 RAT - to support TGA and EU Common List registrations

  • Distributor stocking and customer orders for EuGeni Readers and Covid-19 RATs in Europe.

  • Continued technical progress with collaborators with results demonstrating that AnteoX binder formulation improved the test battery's cycle life by up to 100% at 70% capacity retention.

  • AnteoX increased anode tensile strength by up to 56%, helping to manage the volume expansion of silicon-containing anodes, thereby improving battery electrochemical performance and longevity

Life Sciences

The focus for this quarter was on achieving approvals for the Company's Covid-19 RAT with preparation for the clinical trial to fulfil both the EU Common List data requirements and to support the TGA application. Following an internal review and guidance from external consultants on the Covid-19 RAT regulatory requirements, AnteoTech has mapped out an approach to conducting prospective clinical trials in Europe that, if successful, will fulfil requirements for both inclusion on the EU Common List and TGA approval.

Clinical Trials

European Clinical Trial

A Spanish CRO has been contracted to conduct the Prospective Clinical Trial for the EuGeni Covid-19 RAT. During the quarter, a significant amount of work was undertaken to prepare the clinical protocols and screen trial sites across Europe. The final site selection and site visits, a key step in the clinical trial process, have now been completed. At the time of writing, ethics protocols for each site were under review by the individual study sites and the CRO. It is anticipated that patient recruitment will have commenced at the first trial site by end April.

Once the trial has commenced, to ensure the integrity of the clinical trial and adhere to the ethics protocol of the trial, AnteoTech will refrain from reporting or commenting on the trial or its progress until it is complete and all reports are finalised.

Australian Clinical Trial

The clinical trial underway in Victoria is ongoing and continues to progress as planned.

AnteoTech will provide information on the outcome at the conclusion of the trial and on receipt of a final report.

Progress on Market Entry and Regulatory Approvals

European Market Entry - Distributor Stocking and Customer Orders Received

Following several distributor meetings focused on identifying market segments outside the EU Common List requirement in Europe, AnteoTech's distributors have secured a number of initial orders for delivery in April, positioning EuGeni in the European market. The review of current market trends in, Spain, Greece, Italy and Romania is continuing, and constantly evolving as COVID-19 regulations change with the course of the pandemic.

UK Market Entry

In March, AnteoTech received correspondence from the UK Medicines & Healthcare products Regulatory Agency (MHRA) in relation to the submission for the EuGeni Covid-19 RAT approval. While AnteoTech's EuGeni Covid-19 RAT and Reader are registered with the MHRA, AnteoTech is now required to complete a submission to the UK Competent Authority to enable market entry and subsequent customer use. This submission requires information in relation to cross reactivity of the test and additional sensitivity/specificity calculations based on a broad range of Ct values. AnteoTech therefore intends to provide the UK Competent Authority with a submission incorporating the requested data once the European clinical trial has been completed.

Southeast Asian Market Entry

Engagement with Biomed Global, our southeast Asian distributor, during the quarter was focused on the identification and evaluation of market segments within Malaysia and Indonesia that align to a profitable business relationship for Biomed Global and AnteoTech. There has been significant downward pressure on test pricing over the past 6 months as earlier supply shortages have been overcome, and the market is flooded with supply. Current market dynamics in Thailand, Vietnam andMyanmar have made it difficult for Biomed to gain traction and interest in these territories, resulting in market entry for the Covid-19 RAT in these territories being postponed for the time being.

Biomed and AnteoTech are working in partnership to secure an additional evaluation of the EuGeni platform and Covid-19 RAT to establish a pathway for registration in Malaysia. AnteoTech has committed to undertake face to face training with the evaluating laboratory once approval has been granted for the evaluation by the Medical Device Agency Malaysia. This approach will ensure a clear understanding of the assessment protocol and processing of swab specimens on the EuGeni platform

EuGeni Multiplex (Combo SARS-CoV-2 Influenza A/B Ag RDT)

The multiplex test development continued to progress during the quarter, with R&D batches prepared in February showing excellent performance attributes when internally tested, head-to-head, with similar products that are currently on the market.

The design of the assay was also officially locked in during the quarter, which was followed by bi-lateral visits with Operon to commence the manufacturing technology transfer process. At the end of March, the initial manufacturing transfer process to Operon was completed, with the first small batch runs to occur in April. While the manufacture of a multiplex test is not uncommon practice, the manufacturing transfer for the Combo SARS-CoV-2 Influenza A/B Ag RDT is, in its nature more complex as it requires three separate processes, one for each of the viruses. As a result, the multiplex transfer process can take longer as it is more involved than the existing Covid-19 RAT.

Once consistent manufacturing runs are achieved which pass all internal Quality Control (QC) processes, AnteoTech will then produce commercially manufactured lots for the purposes of clinical trials. Discussions with CROs to facilitate the trials have begun, with commencement of the clinical trials once manufacturing processes have been finalised and technology transfer successfully completed.

Sepsis Biomarker Family of Tests

Development work on the Sepsis Biomarker Family of tests is ongoing. Internal testing continues to focus on refining the algorithm of the EuGeni Reader platform to consistently calculate the quantitative value of a sample.

In-house evaluation has demonstrated that both the IL-6 and Procalcitonin (PCT) tests are performing well across the clinically relevant sample range.

In evaluating the global Sepsis market, it has become evident that a comprehensive regulatory plan and market analysis for entry pathways are needed before committing to a manufacturing program for these biomarkers. This body of work will determine the best market entry strategy, helping align clinical trials with regulatory requirements in each market.

While there is a great need for Sepsis testing, it is also a niche and emerging field in the Point of Care setting. In addition, Point of Care testing is vastly different worldwide, requiring a targeted and strategic approach to the market entry. AnteoTech remains committed to developing biomarkers to aid in the diagnosis of Sepsis. At the same time, we continue to work through the regulatory and market requirements as we strategically allocate our resources to the rollout of tests for the EuGeni platform.

AnteoBind Headlines at Merck Conference

Following two years of virtual conferences, the Merck Annual 2022 Two-Day IVD Conference was once again held in person in Spain. Addressing a full audience of immunoassay and molecular diagnostic manufacturers, In vitro research scientists and IVD assay R&D scientists, AnteoTech's Head of Life Science, Dr Charlie Huang, presented an overview of AnteoBind technology as it applies to Activated Merck Estapor® Europium Microspheres for Lateral Flow Assay Development.

The presentation was very well received with AnteoTech fielding a range of several enquiries relating to the use of AnteoBind with nanoparticles and Luminex beads, as well as contract services for bio-conjugation/assay development services.

Upcoming Conferences

ECCMID Portugal

Aligning with business development activities in Europe, AnteoTech will be showcasing EuGeni at the upcoming 32nd European Congress of Clinical Microbiology & Infectious Diseases, which will take place in Lisbon, Portugal, on 23 - 26 April 2022.

Merck - Rapid Point of Care Test Development Workshop

AnteoTech will participate in a hands-on multi-day workshop in partnership with Kinematic Automation and Axxin, providing participants with an in-depth, three-day journey through the development and manufacture of a lateral flow test, incorporating raw materials research, and development considerations plus machinery. May 3-5, 2022, in Seattle, Washington, U.S.A..

Conference Follow Up Actions in the Coming Quarter:

Post ECCMID meetings will be arranged with distributors across several European countries:

1. A comprehensive review will be conducted of in-market requirements for ongoing COVID testing incorporating direct customer feedback.

2. From this review, an updated identification and assessment of the Point of Care market segments (both in and outside of the traditional Pathology testing markets) will be formulated

3. Future market specific candidate assays will be identified and prioritised for review in the commercial assessment process

Post Merck conference in Spain and the workshop in Seattle key actions include:

1. Qualification of customer opportunities for their potential to provide additional business for AnteoTech Contract Services.

2. Development of a customer engagement plan with a view to maximising engagement and potential business opportunities while attending the AACC event in Chicago in July 2022

Appointment of Head of Products and Services

Mr Pierre Nathie has been appointed as Head of Products and Services to co-ordinate the Company's R&D, Manufacturing, Quality Control, Regulatory assessments and to interface with the Sales and Marketing team.

Energy

Introduction

The global lithium ion battery market is expected to grow by 30% p.a2 over the next 10 years driven by EVs, other road transport and grid applications. The battery storage market is demanding constant improvement to battery chemistries and next generation batteries will need to be low cost ($/kWh), have a long life span (cycle life) and operate safely. While current technology is based on battery anode material dominated by graphite, silicon has the capacity to store 10 times the capacity of graphite for a given weight. So, increasing the percentage of silicon in the anode results in an increase in the energy density and a reduction in the cost/kWh.

Anteotech's focus on the development of advanced battery materials which enable high silicon content in battery anode materials was supported by recent presentations at the International Battery Seminar in Florida. McKinsey outlined their view on the evolution of battery chemistries over the coming decade as described below.

2 McKinsey & Company presentation to International Battery Seminar Florida March 2022

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Anteotech Limited published this content on 21 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 April 2022 01:14:02 UTC.