Rhythm Biosciences Raises $3.75m, ColoSTAT® Hits 91% Sensitivity Milestone

Strong Start to FY26

Rhythm Biosciences Ltd (ASX, RHY) has delivered a robust operational update for the first quarter of FY26, underscoring its momentum in cancer diagnostics innovation. The company successfully raised $3.75 million in an oversubscribed placement, signaling strong investor confidence in its growth trajectory. This capital injection is earmarked primarily to support the commercial launch of ColoSTAT®, Rhythm’s blood-based colorectal cancer test, which has reached critical milestones in clinical validation and manufacturing readiness.

Advancing ColoSTAT® Towards Market

ColoSTAT® has completed its final clinical validation, demonstrating a 91% sensitivity in detecting colorectal cancer across all stages (I-IV) in individuals over 45 years old, a key demographic for screening. The test also boasts a high negative predictive value of 98%, positioning it as a viable alternative for symptomatic patients hesitant to undergo stool-based testing or colonoscopy. Manufacturing validation by US partner Quansys has been finalized, and Rhythm is progressing through the National Association of Testing Authorities (NATA) accreditation process, a prerequisite for commercial rollout in Australia. The company anticipates completing this accreditation by Q2 FY26, setting the stage for broader market entry.

Genetype Platform Growth and Strategic Partnerships

Complementing ColoSTAT®, Rhythm’s geneType platform continues to gain traction, with revenue more than doubling quarter-on-quarter. This growth is driven by strategic partnerships, including a personal agreement with the prestigious Memorial Sloan Kettering Cancer Center and a co-marketing arrangement with the Know Your Lemons Foundation to expand breast cancer risk assessment. The geneType platform leverages polygenic risk scores combined with clinical data to deliver personalized cancer risk insights, aligning well with the rising demand for precision medicine and preventative healthcare solutions.

Financial Position and Outlook

At quarter-end, Rhythm held $2.746 million in cash with an additional $85,000 in term deposits, supported by an expected $1.6 million Research and Development Tax Incentive refund in Q2 FY26. The company’s disciplined cash management and successful capital raise provide a solid runway to execute its FY26 objectives. CEO Dr David Atkins expressed confidence in delivering significant quarter-on-quarter growth and completing key commercialisation activities, particularly for ColoSTAT®.

Looking Ahead

Rhythm Biosciences is positioned for a transformative year as it moves from clinical validation to commercialisation. The upcoming months will be critical as the company seeks to secure NATA accreditation, expand geneType’s test menu, and establish further strategic partnerships. These developments could significantly enhance Rhythm’s footprint in the competitive cancer diagnostics market and improve early detection outcomes for patients globally.