ATOMO DIAGNOSTICS LIMITED — Capital/Financing Update 2026

Jan 19, 2026

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ASX Announcement

20 January 2026

Atomo Secures Exclusive Licence for a Novel Liver Function Test on Pascal

SYDNEY, 20 January, Australia, 2026 - Atomo Diagnostics Limited (ASX:AT1) (Atomo) is pleased to announce signing an exclusive global licensing agreement with the Burnet Diagnostics Initiative, part of The Macfarlane Burnet Institute for Medical Research and Public Health. The agreement remains in effect until the date of expiry of the last of all of the patents forming part of the Patent Rights, projected to be December 2044.

The license for Burnet’s novel liver function test assay supports commercialisation of a rapid test for the immediate detection of liver injury through measurement of alanine aminotransferase (ALT), a key indicator of liver inflammation and damage. Delivered on Atomo’s proven Pascal cassette at the point-of-care and in the home, the test enables early identification of liver inflammation of any cause, giving the test commercial utility across a broad range of clinical applications.

The initial focus is monitoring for drug-induced liver injury (DILI) where rapid elevations in ALT require an urgent clinical response. Atomo previously disclosed fulfilling an order from Burnet for 20,000 Pascal cassettes to support supply of finished tests to a multinational pharmaceutical company to enable real-time monitoring of DILI in a US drug trial. (AT1 Quarterly Activity Report Q3 FY24, 29[th] April 2024).

The global market potential for an easy-to-use rapid test that can be utilised by patients commencing drug treatments with known liver injury risk is significant. With product development substantively complete, diagnostic performance established and a large multinational pharmaceutical company evaluating the test, Atomo believes the securing of an exclusive worldwide license for the test is material.

Level 1, 3-5 George St Leichhardt NSW 2040

Atomo Diagnostics Limited ACN 142 925 684

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Other priority clinical applications identified by Atomo and Burnet include routine screening and monitoring of common chronic liver conditions such as viral hepatitis (B and C), fatty liver disease and alcoholic liver disease.

The agreement between Atomo and Burnet builds on the successful partnership between the parties for a development program to commercialise a novel test to detect Active Syphilis, under a federal government CRC-P grant. (AT1: ASX Announcement 24th March 2025: Atomo Secures Exclusive Licence for a Novel Syphilis Test on Pascal).

Under this agreement for a Pascal Liver Function test, Atomo commits to pay Burnet royalty payments as a percentage of net revenues generated by the Product, with a lower royalty rate applied to sales in low-middle income countries (LMIC’s) where pricing is typically lower. Whilst the agreed royalty arrangements are commercial in confidence, Atomo confirms they are consistent with royalties that are standard for an agreement of this nature in the diagnostics industry.

There are no material conditions that need to be fulfilled before the agreement comes into full effect, however under the agreement Atomo commits to an immediate licencing milestone payment to Burnet of $150,000.

Royalty payments to Burnet under the agreement will not be applicable until after the Product has secured regulatory approval. Licencing milestone payments are also due upon the Product securing regulatory approvals in the US (FDA), Europe (IVDR) and Australia (TGA), with the regulatory milestone payments totalling $650,000 in the event the Product is approved in all key markets. The extensive development and clinical work undertaken to date on Pascal reduces product development risk and anticipated timelines to regulatory submissions.

Level 1, 3-5 George St Leichhardt NSW 2040

Atomo Diagnostics Limited ACN 142 925 684

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Atomo Managing Director John Kelly said, “We have developed an excellent working relationship with Burnet through our existing partnership on Active Syphilis and are delighted to expand this strategic engagement to now include an exciting novel Liver test with broad clinical utility across a ran ge of common acute and chronic liver conditions”.

Burnet Institute Director of Commercialisation Jen Barnes said, “The Burnet Diagnostics Initiative is focused on developing market-ready products that address real-world clinical needs and improve outcomes for patients. An easy-to-use point-of-care ALT test has the potential to benefit multiple patient populations across a range of conditions by enabling earlier detection, faster clinical decision-making, and more timely access to appropriate care. We are delighted to partner with Atomo to bring this important innovation to market as quickly as possible and expand its impact globally.”

For more information, please contact:

John Kelly Atomo Diagnostics john.kelly@atomodiagnostics.com Phone: +61 401 922 279

This announcement was authorised by the Managing Director & Board.

About Atomo

Atomo is an Australian headquartered medical device company supplying unique, integrated rapid diagnostic test (RDT) devices to the global diagnostic market.

Atomo’s unique patented devices simplify testing procedures, enhance usability and improve reliability across rapid point-of-care (POC) and at-home testing applications. The Company has successfully commercialised a number of products across international markets and has supply agreements in place for testing applications targeting infectious diseases including HIV, COVID-19, viral vs bacterial differentiation, as well as the early detection of pregnancy.

See more at www.atomodiagnostics.com

Level 1, 3-5 George St Leichhardt NSW 2040

Atomo Diagnostics Limited ACN 142 925 684