Anteris Technologies (AVR) Q3 2025 TU earnings summary

Executive summary

• Achieved FDA approval to commence U.S. recruitment for the PARADIGM Trial in November 2025, following significant regulatory progress during Q3 2025.

• Secured first European regulatory approval for the PARADIGM Trial in Denmark, with initial patients treated in October 2025.

• Advanced operational readiness and manufacturing scale-up to support clinical activities, including ISO 13485 certification for DurAVRⓇ THV production.

Financial highlights

• Net operating cash outflows for the nine months ended September 30, 2025, totaled $59.3 million, reflecting increased clinical, regulatory, and manufacturing activities.

• R&D expenses for Q3 2025 were $16.8 million, primarily supporting PARADIGM Trial preparations and manufacturing upscaling.

• Selling, general, and administrative expenses for Q3 2025 were $5.8 million.

• Cash and cash equivalents as of September 30, 2025, stood at $9.1 million.

Outlook and guidance

• The PARADIGM Trial is expected to enroll approximately 1,000 patients across the U.S., Europe, and Canada, with the goal of supporting FDA Premarket Approval and CE Mark approval.

• Continued focus on regulatory milestones and clinical trial execution to drive long-term growth.