Anteris Technologies Global Corp(AVR) - 2024 Q4 - Annual Results

Financial Performance - Net Sales for 2024 were $2.7 million, primarily from tissue product sales[11] - Net Loss after Income Tax for 2024 was$76.0 million, driven by increased operating expenses related to research and development[12] - Closing cash balance at December 31, 2024, was $70.5 million[11] - The company concluded 2024 with a strong cash position, having drawn down AUD$7.5 million from a secured convertible note facility[14] Fundraising and IPO - Anteris successfully raised $88.8 million through its U.S. IPO on Nasdaq, completing its re-domiciliation to the United States[5] Regulatory and Clinical Trials - The company plans to submit an Investigational Device Exemption (IDE) application to the FDA in Q1 2025 for the DurAVR® THV system's Pivotal Trial[4] - The Pivotal Trial is expected to include up to 80 sites and enroll 1,000 to 1,200 patients with severe aortic stenosis[10] - Anteris performed the first two cases of the DurAVR® THV's European Early Feasibility Study (EU-EFS) in January 2025[6] - The company has treated 86 patients with the DurAVR® THV to date, generating positive patient data to support the IDE submission[5] Manufacturing Expansion - Anteris expanded its manufacturing capabilities in Malaga, AU, and Minneapolis, US, to support the upcoming Pivotal Trial[9]