Anteris Technologies Global Corp. (ASX:AVR) has reported financial results for the quarter ended September 30, 2026, disclosing net operating cash outflows of $22.9 million and providing a corporate update covering PARADIGM Trial progress, a new facility occupancy, and a chief financial officer appointment.

Key Points

  • Net operating cash outflows for the three months ended September 30, 2026, were $22.9 million, primarily attributable to clinical, regulatory and manufacturing requirements supporting the PARADIGM Trial.
  • R&D expenses for the quarter were $21.3 million, driven by scaling of manufacturing and quality capabilities and PARADIGM Trial-related activities including patient enrollment costs.
  • The Company assumed occupancy as primary tenant of the Northcross facility in Brooklyn Park, Minnesota on September 1, providing additional production capacity for DurAVR THVs and the ComASUR Delivery System.
  • Brent Moen was appointed Chief Financial Officer, effective September 11, 2026.
  • Subsequent to quarter-end, the PARADIGM Trial received regulatory clearance from Germany's BfArM and received HREC approval and TGA authorisation under the Clinical Trial Notification pathway in Australia.

PARADIGM Trial Enrollment and Geographic Expansion

During the quarter ended September 30, 2026, Anteris continued execution of the global pivotal PARADIGM Trial across active sites in the United States, Canada and Europe, including Denmark, the Netherlands and France. The Company increased site activation in the United States and expanded the trial into Canada and France following completion of site qualification, investigator training and operational readiness activities. Subsequent to quarter-end, the trial received regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices (BfArM), and in Australia received Human Research Ethics Committee approval and authorisation from the Therapeutic Goods Administration under the Clinical Trial Notification pathway.

Northcross Facility Occupancy and Production Capacity

On September 1, 2026, Anteris assumed occupancy as the primary tenant of the Northcross facility in Brooklyn Park, Minnesota. According to the filing, the facility provides additional capacity to scale production of the DurAVR THVs, the ComASUR Delivery System and related components in preparation for commercialisation. The ComASUR Delivery System is designed to support controlled deployment and accurate placement of the balloon-expandable DurAVR THV, which the company describes as a new class of biomimetic transcatheter aortic valve.

Q3 2026 Financial Results and R&D Expenditure

The Company's net operating cash outflows for the three months ended September 30, 2026, were $22.9 million, with the filing attributing this primarily to clinical, regulatory and manufacturing requirements supporting the ongoing PARADIGM Trial. R&D expenses of $21.3 million were driven by scaling of manufacturing and quality capabilities, including process development and validation activities and expanded headcount, together with PARADIGM Trial-related activities. The filing states these costs were partly offset by reduced DurAVR THV product research costs. Full financial details are contained in Anteris' Quarterly Report on Form 10-Q for the quarter ended September 30, 2026.