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ATOMO DIAGNOSTICS LIMITED AGM Information 2021

Oct 27, 2021

64440_rns_2021-10-27_14cd7a4f-5e87-42ea-b4eb-97e2465e5e2e.pdf

AGM Information

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ASX Announcement

28 October 2021

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Atomo Diagnostics Limited 2021 Annual General Meeting Chair’s Address

On behalf of my fellow directors, I warmly welcome you to this year’s Annual General Meeting for Atomo Diagnostics, the second since our ASX listing last year. I am mindful of our shared circumstances and, for some, the continuing challenges arising from the COVID 19 pandemic. So before I start this address, let me please offer the Atomo Board’s well wishes for you and your loved ones.

The pandemic saw Atomo respond promptly to the public health need for accurate, rapid diagnostics. Working with partners, we sought to ensure the timely and regular supply for Australians of rapid tests to diagnose the presence of COVID 19 antigens and corresponding antibodies[1] . We redrew arrangements with Access Bio to secure access to more than 20 million rapid antigen tests, for clinical and personal use.

I am mindful that our register comprises more than 8,500 shareholders. It’s fair to assume that some of you are more recent investors. So let me share a little of Atomo’s background. As you know, Atomo develops, commercialises, and supplies devices for rapid diagnostic tests. We also sell finished rapid tests for professional users and consumers. Our tests detect infectious diseases, chronic health conditions and consumer wellness.

We have developed a range of unique, integrated devices for blood-based rapid diagnostic testing. Our devices minimise complexity; prioritise ease of use and accuracy of results, delivered within 15 minutes. So when it comes to testing for the presence of the COVID 19 virus, we offer our blood based antibody test and partner with Access Bio in offering the Atomo branded antigen test.

The public health response to COVID 19 is accelerating profound changes already directing the future state of rapid diagnostics. These changes are led by decentralising diagnostics without loss of accuracy in results. So faster to test, to diagnose and so faster to act and respond. These changes are core to Atomo’s longstanding beliefs in improving the speed and accuracy of Point of Care and Consumer diagnostics, across an ever-broadening range of tests.

You are familiar with our describing Atomo in terms of its two pillars. The first is Atomo Product such as our HIV Rapid Tests and our supplying the OEM needs of our partners such as NG Biotech in France and Access Bio in the US. As we continue growing, participating within changing demands, needs and behaviours, led by our strategy. Reflecting our strategy, as you have seen in the extensive ramp-up in production capacity over the last 18 months, you will hear us describing our activities increasingly in terms of demand.

Our meeting demand draws on our core competencies – meeting the need for the rapid diagnosis of infectious diseases; working with global partners meeting their OEM demands for our devices and components, and excitingly, responding to the growing demand for self-testing sometimes, described as telehealth or remote medicine.

You have recently received our Annual Report for the financial year ending 30 June 2021. In its opening pages, we include our Vision, Mission Statement and Values. Our focus is steadfast on improved rapid diagnostics at the user’s point of care, simply believing that more equitable and affordable access to accurate diagnoses and treatment allows people to enjoy healthier lives. We see

1 COVID-19 rapid testing detects SARS-COV-2, the virus that causes COVID-19. Atomo Diagnostics Limited ACN 142 925 684 Level 2, 701 – 703 Parramatta Road, Leichhardt NSW 2040 Australia

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the last 18 months or so as helping confirm the fundamental belief underpinning Atomo’s collective purpose and corresponding strategy.

We are proud of the work that we do in Global Health. We announced collaborating with Viatris Inc (the merger of our longstanding partner Mylan Pharmaceuticals, and Pfizer’s Upjohn Business). Working together, we secured a multi-year agreement with the global health agency, Unitaid. This agreement expands access to our HIV self-test platform for those in low and middle-income countries. We have now received orders for several countries and in the first quarter of this financial year delivered 250,000 tests.

I want now to discuss our capabilities and regulatory approvals. I explained at the last AGM that we had doubled our production capacity to 750,000 devices monthly and delighted to confirm that we have nearly doubled that capacity again and can now manufacture 1.3 million devices monthly. The continued development of our established platform includes the deployment of digital eHealth solutions. We are also excited by the work that we are doing in applying our platform technologies beyond our proven capabilities in lateral flow blood tests.

Turning to our working with regulators. The TGA’s inclusion in the ARTG of the Atomo COVID 19 Antibody and Antigen tests allowed swift delivery of tests across Australia. We are now progressing in seeking approval for the Atomo Antigen Self-Test. We are also pleased by the leadership shown by the TGA and acknowledge the advocacy of AFAO (the Australian Federation of AIDS Organisation) that will allow our HIV Rapid Test to be sold directly through pharmacies. This is in addition to already being available through our website. It should materially alter awareness of Atomo’s Rapid HIV SelfTest, the only TGA approved HIV self-test.

On behalf of Atomo’s Board and Management, we thank the tireless efforts of those who have provided valuable services and advice to Atomo – Gillian Nairn of Dolmatoff Nairn, Grant Hummel of HWLE, Gareth Few and Dries Martens of, BDO, Canaccord, Bell Potter, Morgans, Alex Munro and Nick Navarro.

Atomo's Board of Directors share substantial commercial, governance, and industry experience across the critical aspects of our business. One of the Board’s priorities is to ensure that we have capabilities and domain expertise to govern our global business effectively. We were delighted this year to welcome Deborah Neff to the Board. Deborah brings a wealth of experience and skills extending the Board’s diversity and depth. I look forward to shortly introducing Deborah to you. The balance of our Board comprises Connie Carnabuci, Paul Kasian, Curt LaBelle, John Kelly and me. Connie chairs our People, Culture and Remuneration Committee, Paul chairs our Audit and Risk Committee - leading critical pillars in our corporate governance processes. I sit on both Committees.

I note we referenced in Curt’s biography, his membership of the Board’s Audit and Risk Committee. If re-elected today, Curt will be stepping down from this Committee from 1 November 2021 to allow for greater involvement in Atomo’s US initiatives. With Deborah Neff joining the Committee recently, the Committee will continue to meet the ASX recommended minimum membership of three NonExecutive Directors.

Lastly and most importantly, the Board recognises the outstanding efforts of the Atomo team. These efforts are under the tireless leadership of CEO John Kelly, alongside his executive team of CFO Will Souter and COO Mark Smith. Atomo’s continued growth has seen us call out additional appointments that are underway in particular in the US as well as strengthening our Head Office team.

We believe that changes within healthcare, especially diagnostics, are being accelerated by the COVID 19 pandemic. The decentralisation of health care aligns with Atomo’s core competencies. Our planning reflects the rapidly changing landscape. We are excited about the years ahead and I welcome John to talk about what we are up to now and as excitingly what’s next. We thank you for your enthusiastic support, questions, and interest in Atomo.

Atomo Diagnostics Limited ACN 142 925 684 Level 2, 701 – 703 Parramatta Road, Leichhardt NSW 2040 Australia

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For more information, please contact:

Jane Lowe John Kelly IR Department Atomo Diagnostics Limited [email protected] [email protected] Phone: +61 411 117 774 Phone: +61 401 922 279

This announcement was authorised by John Keith, Chair of the Board.

About Atomo

Atomo is an Australian medical device company supplying unique, integrated rapid diagnostic test (RDT) devices to the global diagnostic market. Atomo’s patented devices simplify testing procedures and enhance usability for professional users and untrained self-testers. The Company has supply agreements in place for tests targeting infectious diseases including COVID-19, HIV and viral vs bacterial differentiation.

See more at www.atomodiagnostics.com.

Atomo Diagnostics Limited ACN 142 925 684 Level 2, 701 – 703 Parramatta Road, Leichhardt NSW 2040 Australia