Core Points - Anteris Technologies Global Corp. has postponed its Special Meeting of Stockholders to September 11, 2025, to allow more time for stockholder participation [1][2] - The Board of Directors recommends voting FOR the proposals in the definitive Proxy Statement filed with the SEC on August 18, 2025 [2] - The company’s lead product, the DurAVR Transcatheter Heart Valve, is designed to treat aortic stenosis and utilizes patented ADAPT tissue technology [8] Voting Details - Stockholders who have already voted do not need to take further action as their votes will remain counted [3] - Proxies must be submitted by 11:59 p.m. Eastern time on September 10, 2025, for Internet or telephone submissions, and by the close of business on the same date for mail submissions [4] - CDI holders must direct CDN to vote by 5:00 p.m. Central time on September 9, 2025 [5] Company Overview - Anteris Technologies is a global structural heart company focused on developing medical devices to restore heart function [7] - The company is based in Australia with a significant presence in Minneapolis, USA, and is committed to delivering solutions for structural heart disease [7]

Core Insights - Anteris Technologies reported significant progress in the second quarter of 2025, particularly in the clinical development of its DurAVR transcatheter heart valve (THV) [3][4] - The company is preparing for the PARADIGM trial, which aims to further validate the clinical benefits of DurAVR THV [5][8] Financial Performance - For the six months ended June 30, 2025, Anteris recorded net operating cash outflows of $41.0 million, primarily due to increased clinical, regulatory, and manufacturing activities [11] - Research and development (R&D) expenses for the second quarter were $16.3 million, focusing on the PARADIGM trial preparations and patient enrollment [11] - The company held $28.4 million in cash and cash equivalents as of June 30, 2025 [11] Clinical Development - A total of 130 patients have been treated with the DurAVR THV, with 49 patients treated in the first half of 2025 and 21 in the second quarter [4][15] - The company has qualified 79 sites for the PARADIGM trial, with significant preparatory work completed [5][15] - Anteris hosted both European and Global Investigator Meetings to align operational efforts for the PARADIGM trial [6][7] Corporate Governance - On June 10, 2025, Anteris appointed David Roberts and Gregory Moss to its Board of Directors to enhance leadership capabilities [9]

Core Insights - Anteris Technologies Global Corp. has appointed Mr. David Roberts and Mr. Gregory Moss to its Board of Directors, enhancing its leadership team as it prepares for the upcoming global pivotal clinical trial for its DurAVRTHV product [1][2][4] - The company is transitioning to a new growth phase following its NASDAQ listing in Q4 2024 and aims for U.S. and EMA licensure of the DurAVRTHV for patients with aortic stenosis [2][4] Leadership Appointments - Mr. David Roberts has extensive experience in the healthcare sector, currently serving as President of LeMaitre Vascular, Inc. since 2007, and has held various leadership roles since joining the company in 1997 [2][3] - Mr. Gregory Moss brings a strong legal and compliance background, having served as Chief Business and Legal Officer at Evommune, Inc., and previously held senior roles at Kadmon, culminating in a $1.9 billion acquisition in 2021 [3] Product Overview - Anteris' lead product, the DurAVR Transcatheter Heart Valve (THV), is designed to treat aortic stenosis and is the first biomimetic valve, aiming to replicate normal aortic blood flow [6] - The DurAVR THV is made from Anteris' patented ADAPT tissue technology, which has been clinically used for over 10 years and distributed to over 55,000 patients worldwide [6]

Core Viewpoint - Anteris Technologies reported its financial results for Q1 2025, highlighting significant clinical milestones and ongoing preparations for the PARADIGM Trial, which is crucial for the commercialization of its DurAVR Transcatheter Heart Valve (THV) [1][2]. Business & Operations - The company successfully submitted its Investigational Device Exemption (IDE) application to the FDA for the PARADIGM Trial, which is designed to assess the safety and effectiveness of the DurAVR THV [4][6]. - Over 100 patients have been treated with the DurAVR THV, marking a significant clinical milestone and demonstrating growing physician confidence in the technology [3][8]. - The PARADIGM Trial is set to commence in Q3 2025, pending FDA approval, and aims to provide robust clinical evidence for FDA Premarket Approval (PMA) [4][5]. - Anteris is expanding its global manufacturing capacity to support the PARADIGM Trial, with production facilities being scaled to at least three times the 2024 capacity levels [13]. Clinical Milestones - The company achieved a major clinical milestone with 100 patients treated with the DurAVR THV, including complex cases such as bicuspid aortic valve patients and valve-in-valve patients [8][9]. - One-year clinical data for DurAVR THV patients showed sustained favorable hemodynamic outcomes and a strong safety profile, with no valve or cardiovascular-related mortality reported [15][11]. Financial Results - For Q1 2025, net sales were $0.6 million, a decrease of 27% compared to $0.8 million in Q1 2024, primarily due to lower demand for tissue products [16]. - The loss after income tax for the quarter was $21.9 million, an increase of 36% from $16.2 million in the same period last year [17]. - Research and development expenses rose to $16.5 million, a 42% increase from $11.6 million in Q1 2024, driven by upscaling manufacturing capabilities and preparatory activities for the PARADIGM Trial [24]. Corporate and Financing Activities - Anteris was included in the FTSE Russell 2000 Index as of March 24, 2025, reflecting its position in the small-cap segment of the US equity market [20]. - The company raised an additional $0.47 million through the partial exercise of a green shoe option related to its December 2024 IPO [19].