AnteoTech : Response to ASX Query Letter

For personal use only

21 March 2022

Ms Alice Montefiore-King

Adviser, Listings Compliance (Sydney)

ASX Limited

By email

Response to ASX query letter dated 16 March 2022

We refer to your letter dated 16 March 2022, and respond as follows (using the terminology ASX has adopted in your letter):

1. Does ADO consider the following to be information that a reasonable person would expect to have a material effect on the price or value of its securities:

1. the Manufacturing Difficulties Information? No
2. the Sales Information?

No

1. the European Clinical Trial Information? No
2. the Regulatory Issues Information?

No

2. If the answer to any of questions 1 a), b), c) or d) above is 'no', please advise the basis for that view.

Manufacturing Difficulties Information

The basis for that view at paragraph 1(a) above by AnteoTech Limited (AnteoTech) is set out below:

• AnteoTech has made it clear in prior announcements that manufacturing is not a straight- forward process, as issues arise from time to time. The ordinary course of in vitro diagnostic (IVD) scale-up manufacture does not follow a linear path, involves some unpredictability, involves challenges including quality optimisation and quality control and, inevitably requires refinement. The comments provided in the webinar were merely intended to provide an update on the most recent issues that had been experienced and that AnteoTech was now close to resolving.

AnteoTech Ltd ACN 070 028 625

Unit 4, 26 Brandl St, Eight Mile Plains, Qld 4113, Australia

1. [phone]
   Wanteotech.com

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• AnteoTech refers to its Quarterly Business Update for the period ending 31 December
  2021 [released on ASX on 1 February 2022] which:

1. made it clear that IVD supply is heavily regulated and that in order to operate successfully organisations must ensure the consistent manufacture of product of the highest quality and performance. AnteoTech specifically noted that:
   "Any questionable aspect of quality or support will risk scrutiny by regulatory authorities whilst in market and this could lead to penalties and/or removal of product from the market. Many organisations close to AnteoTech have been the subject of such scrutiny and have been forced to remove product batches or entire products from the market and this has caused the organisation valuable reputational damage that will hinder further developments."

1. made reference to challenges in scaling up (which are common to IVD scale-up manufacture):

"Nano technology is a complex science with many variables. Scaling up the technology to produce a product with enough volume to supply a market can be a difficult process due the number of variables that can cause issues. Since April 2021 we have been gradually scaling production at Operon and have resolved issues relating to supplier material variations, batch quality of supplied particle, interface issues between Operon produced product and Axxin produced product. These types of issues are very common in IVD manufacturing, and we often use our close relationships with Operon, Ellume and other manufacturers to discuss issues and share resolution pathways.

It is inevitable that manufacturing will encounter difficulties in the future due to the many variables at play. However, having committed the effort of the last eight months we are now confident that our product can be produced at the scale required to support a large volume of sales."

1. states:
   "We have worked in partnership with Operon to identify several steps that can be optimised during the manufacturing process to secure maximum output. We are now working with Operon to implement these steps to ensure scale-up manufacturing processes are optimal for maximum capacity production runs. Separately, we continued quality testing across product batches with actual samples during the quarter."

Sales Information

The basis for that view at paragraph 1(b) above is set out below:

• Given the dynamic nature of the regulatory landscape and the need to ensure optimal manufacturing processes, AnteoTech has not provided any sales forecast for EuGeni nor shown any EuGeni related sales in any announcements (including its Appendix 4C and 4D and Interim Financial Reports), or otherwise provided any specific guidance as to time to market - nor is it prudent for AnteoTech to do so.
• AnteoTech is ensuring that quality controls are in place while at the same time pursuing regulatory and government (e.g. EU Common List) approvals in its chosen markets, which must be achieved prior to commencing sales.

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• The subject of regulatory and government approvals has been addressed in prior announcements on ASX:

1. The Chairman in his address at the 2021 AGM [released on ASX on 11 November
   2021] advised:

"Regulatory processes are now the focus, converting our CE approval to the different applicable requirements of each country in order to allow local sales to occur."

1. The Chairman's address, the CEO presentation and verbal presentation at the 2021
   AGM [released on ASX on 11 November 2021] are linked to AnteoTech's webpage. In the CEO presentation Mr Thomson outlined AnteoTech's strategy towards market entry with a new IVD product in the light of changing regulatory conditions and the need to protect AnteoTech's reputation to produce high quality products:

"IVD manufacture and distribution is one of the most highly regulated industries in the world. Regulatory requirements have increased dramatically at regional, country and jurisdictional levels during the pandemic and we have invested heavily to meet that challenge in the form of a now fully resourced Quality management team and regulatory resources. Our challenge is to leverage this capability to produce the required material for approvals including trials, at all jurisdictional levels but with particular focus on the larger regulatory requirements associated with the FDA in the US and the new IVDR regulations being implemented in Europe.

In the diagnostics industry reputation is everything. We must first ensure that our products can be trusted. Failure to do this will undo all other work we have completed. We must focus on providing the product to market utilising all quality processes to protect us from negative perceptions. Once achieved, trust in product will lead to advocation and we seek new leading expert opinion that supports our products claims and can be used as leverage to further market entry. Provision of marketing capability focusing on EuGeni's differentiators rounds out a set of market position elements that will drive sales into the segments that we target."

1. AnteoTech's Quarterly Business Update for the period ending 31 December 2021
   [released on ASX on 1 February 2022] contained several statements touching on the process to market:

"As a response to the ongoing evolution of variants and a need to ensure test performance standards are maintained, governments worldwide continue to set the quality bar higher by increasing the regulatory requirements for market entry and continued market participation. In Europe, this has manifested in broader adoption of the EU Common List for procurement of RATs in varied segments. In Australia, the TGA has adopted a guidance note from the European Commission's Medical Device Coordination Group (MDCG) on the clinical performance evaluation of RATs. The MDCG requirements underpin the new European In Vitro Diagnostic Regulations (IVDR) that focus on test efficacy using prospective sampling in the 0 - 7 days post-onset symptoms range. A prospective trial involves the recruitment of patients for direct harvesting of samples to be tested on the EuGeni platform for SARS-CoV-2 Ag RDT.

The TGA has advised us we must add prospective clinical data to support our test performance claims generated using stored samples to align our technical data with the MDCG guidelines. We are currently collecting this data via trials in Australia and Europe,

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which will also provide the required data set for entry to the EU Common List and IVDR registration.

To be able to confidently supply a volume of product into any market, a legal manufacturer must integrate three primary elements being Manufacturing, Distribution and Quality Management. Any scaled selling of product carries considerable commercial risk if the integration of these elements is not robust. Whilst we recognise that there has been a significant and immediate imperative to turn on sales to support the Life Science business, we have balanced our progression to ensure we also protect long term security of the business….".

1. AnteoTech's Appendix 4D and Interim Financial Report for the half year ended 31 December 2021 [released on ASX on 24 February 2022] also referred to the dynamic nature of the regulatory environment:

The regulatory landscape continues to shift, with Europe overlaying additional requirements, solely for COVID RAT's. Locally, regulatory authorities have expanded their requirements through the period. As a company we have responded to the changes with increased organisational capability and identified the need for additional clinical trial data to meet the revised regulatory requirements. The Life Sciences team is highly focussed on driving these trials to completion in a manner that addressed the current regulatory requirements to allow full market access across our target markets.

European Clinical Trial Information

The basis for that view at paragraph 1(c) is set out below:

• The design of a clinical trial and its subsequent implementation is a specialised area. To be able to conduct a clinical trial internal and external expertise is required including c the services of a Clinical Research Organisation (CRO), such as the Spanish CRO in AnteoTech's case. Establishing the requirements for such a trial is a complex and detailed exercise that must occur before any patients are tested.
• AnteoTech has provided detail in its prior announcements as to the processes and requirements involved with various clinical trials:

1. AnteoTech in its the Quarterly Business Update for the period ending 31 December
   2021 [released on ASX on 1 February 2022] stated:

"The TGA has advised us we must add prospective clinical data to support our test performance claims generated using stored samples to align our technical data with the MDCG guidelines."

"…. In December, the TGA contacted AnteoTech to indicate that additional clarification

information relating to planning for Variants of Concern.

The additional information was compiled and submitted to the TGA in January. Following a review of the additional information, the TGA has requested further clinical data be provided, together with other aspects of information. At the time of writing, AnteoTech was working through the details of the request with the TGA to determine

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the expected timeframe needed to gather the additional information and fulfil the conditions of the TGA's guidelines."

"Opportunities to procure the required member state sponsorship and run an efficient clinical trial in Europe were progresses during the Quarter, although strong competition exists for access to hospitals and clinics to run the trials."

"The Italian pharmacy RAT service targeted by AnteoTech's distributor Exxe requires EU Common List registration for participation. We will fulfil this requirement by running a clinical trial in Spain via the Spanish clinical research organisation AKRN."

1. AnteoTech's TGA Registration Update (3) [released on ASX on 10 February 2022] states:

"AnteoTech has had ongoing and constructive discussions with the TGA over the past week. These discussions focussed on the reconciliation of AnteoTech's dataset, which includes stored and direct patient samples, and the TGA's requirements for additional clinical evidence. Following these discussions, it has been concluded that AnteoTech's proposed approach of conducting new clinical trials represents the most expeditious pathway to meeting these data requirements.

The data generated from these trials will ensure that a new submission by AnteoTech will meet the TGA's regulatory requirements, as well as providing the Company with data for additional regulatory approval processes, including registration for the EU Common List. The trials will also provide further evidence of performance relating to new variants of concern listed by the World Health Organisation ("WHO"), lower limit of detection and other performance measures from a vaccinated population.

By undertaking a new submission, AnteoTech has the flexibility and opportunity to compile the new clinical data from studies in Australia and Europe and present this as a fresh and unencumbered submission to the TGA.

AnteoTech will provide updates as key milestones are achieved."

• It is noted that Therapeutic Goods Administration (TGA), World Health Organisation (WHO), European Commission Medical Device Co-ordination Group (MDCG), and EU Common List guidelines are publicly available documents. The processes and systems for conducting clinical IVD trials are publicly available, and not unique to AnteoTech's trials.
  Undertaking any clinical trial involves the establishment of trial protocols, selection of sites, ethics approvals and patient recruitment. The expected timeframes of such trials always have an element of uncertainty. This uncertainty has been evidenced previously by AnteoTech when delays due to change in COVID infection levels impacted a clinical trial being undertaken in India. AnteoTech included under the heading "Sample Use Case Validation Ongoing" as part of the AnteoTech announcement "AnteoTech appoints SE Asia Distributor" released on ASX platform on July 19, 2021:

"AnteoTech anticipated results from the evaluation in line with the initially indicated timeline of June 2021; however, the significant decrease of COVID-19 incidents in India has meant this is likely to take several more weeks to obtain sufficient data to evaluate efficacy. The timing of results and further updates to shareholders will be dependent on obtaining enough positive samples to clearly evaluate the test."

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