Rhythm Biosciences Ltd (ASX:RHY) Achieves Key Milestones for ColoSTAT

Key Milestones Achieved

Rhythm Biosciences Ltd (ASX: RHY) has successfully completed its end-of-calendar-year 2024 milestones, as previously detailed in its October 2024 ASX announcement. The company has received its Research & Development Tax Incentive returns and delivered a second-generation Beta release candidate of the ColoSTAT® Multiplex Kits.

Core Product Development

The second-generation multiplex assay kits consist of five antibody-based assays combined into a single reaction for detecting colorectal cancer from patient blood samples. This advancement, produced by Quansys Biosciences, aligns with the milestone schedule and prepares the company for further testing and validation leading to a planned commercial launch in the second half of 2025. Nir Dvorski, Chief Operations Officer of Rhythm, stated, “This milestone is a major leap forward, bringing us closer to end-user clinical evaluation and commercialisation.”

Market Strategy and Engagement

Rhythm has engaged consultants across Australia, the UK, and the US to finalise its path to market. The company aims to secure marketing approval from relevant regulatory agencies while exploring the regulatory pathways for in vitro diagnostic medical devices. Efforts are underway to collaborate with laboratory partners, aiming for a commercial roll-out in the last half of 2025.

Financial and Corporate Updates

Rhythm received $3.23 million from its RDTI, enhancing its financial position. A recent placement of new shares drew strong interest, raising $3.5 million at a share price of $0.10. To optimise capital usage, Rhythm has appointed Acclime Corporate Services Australia Pty Ltd as Company Secretary effective January 6, 2025, following the departure of its previous Joint Company Secretaries.

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Motley Fool contributor Kiarra Jackson has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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