• Secured FDA and European regulatory approvals to commence PARADIGM pivotal study
• Progressed site and operational readiness for PARADIGM trial enrolment
• Strengthened quality management systems and advanced manufacturing scale-up

Anteris Technologies reported financial results for the quarter ended September 30, 2025, and provided a corporate update. Key highlights included securing FDA approval to commence patient recruitment for the PARADIGM pivotal study in the US, as well as advancing European regulatory activities to initiate the PARADIGM trial across multiple countries, with the first European patients treated in Denmark. The company also progressed site and operational readiness activities, such as investigator training and logistical setup, ahead of anticipated trial enrolment. Additionally, Anteris continued strengthening its operational infrastructure, advancing quality management system buildout and manufacturing scale-up to support upcoming clinical activities and future ISO 13485 certification. The company's net operating cash outflows for the nine months ended September 30, 2025, were $59.3 million, in line with the increase in clinical, regulatory and manufacturing requirements to support the PARADIGM trial. R&D expenses were $16.8 million, primarily for PARADIGM trial preparatory activities, manufacturing upscaling, and portfolio development. Selling, general and administrative expenses were $5.8 million. Anteris ended the quarter with $9.1 million in cash and cash equivalents.

The company did not provide any high-importance, price-sensitive forward-looking financial metrics in the announcement.

The announcement did not include any forward-looking outlook statements.