Rhythm Biosciences Ltd. announced that after receipt and analysis of a thorough application review and its most recent engagement with the Australian Therapeutic Goods Administration (TGA), the Company has decided to withdraw its current ColoSTAT® application for an Australian Register of Therapeutic Goods (ARTG) listing (announced 12 May 2022). The Company intends to submit a new ColoSTAT® application with the TGA, in line to better meet their feedback and questions posed. The new ColoSTAT® application will be submitted at a date to be determined, however is expected to be in the current calendar year.

A subsequent announcement will be released to the ASX at the time the new application is submitted. It should be noted, that RHY's submission was detailed, technical and in excess of 1,300 pages. The Company believes it is in a position to be able to answer the majority of questions within the required timeframe sought by the TGA, being 20 business days, however a minority of the questions require new internal analytical testing by RHY, which require three different production batches of commercially made ColoSTAT® test-kits from company's overseas based manufacturer Biotem.

Coupled with the logistical and supply chain timing, this would prevent RHY being able to receive these commercially made test-kits and answer the minority of questions raised by the TGA. In recent discussions with the TGA, in line with their normal policies, they have advised that they would be reluctant to provide an extension beyond the 20 business days, required by RHY, to sufficiently answer all questions within the 26-page response. This intended withdrawal does not impede the Company's proposed market entry activities into other CE Mark conforming territories and additional international markets, including the U.S.A.