Financial Data and Key Metrics Changes - The company reported a delay in FDA approval by approximately one month due to a government shutdown, but European approval was achieved on time, and the paradigm study commenced largely as scheduled [46][47] - The cost structures are expected to reflect the scale-up into the study and the pathway to commercialization, with increased investments in R&D and manufacturing [47][48] - Access to capital has improved significantly with the company's data, transitioning from a penny dreadful to a legitimate multi-billion dollar product [48][52] Business Line Data and Key Metrics Changes - The company is focused on scaling up manufacturing and ensuring high-quality product delivery, with recent facility expansions tripling capacity [15][16] - The ADAPT process is highlighted for its unique anti-calcific response and improved patient outcomes, which is critical for clinical trials and production [12][13] Market Data and Key Metrics Changes - The company has seen a significant increase in liquidity, up 1,000%, following its listing on Nasdaq, which has improved access to capital [58] - The share price has been volatile, influenced by broader market trends, particularly in the MedTech sector, which has faced challenges [59][60] Company Strategy and Development Direction - The company aims to lead in the TAVR space by focusing on innovation and quality, with a commitment to patient outcomes and a strong corporate culture [4][5][6] - The management emphasizes the importance of quality and manufacturing processes to support the investment thesis and ensure successful commercialization [43][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting the importance of resilience and vision in navigating the complex healthcare landscape [7] - The company is positioned to lead the market, with competitors following its advancements in addressing aortic stenosis [44][45] Other Important Information - The company has expanded its distribution center significantly, preparing for increased volume in the upcoming months [33] - The leadership team includes experienced professionals from major global companies, enhancing the company's operational capabilities [43] Q&A Session Summary Question: What are the key milestones that support the investment thesis? - The integration of a team of leaders and experienced physicians has been crucial in achieving milestones, ensuring that the product meets market needs [76] Question: How does the company differentiate itself from competitors? - The company focuses on fundamentally different approaches to product development, aiming for significant improvements rather than incremental changes [70][71]

Financial Data and Key Metrics Changes - The company reported a slight delay in FDA approval, which was impacted by a government shutdown, but European approval was achieved on time and the paradigm study commenced largely as planned [74][75] - The cost structures are increasing as the company scales up for the study and commercialization, particularly in R&D and manufacturing, which is essential for future growth [75][76] - Access to capital has improved significantly with the company's data, transitioning from a penny dreadful to a legitimate multi-billion dollar product [76][79] Business Line Data and Key Metrics Changes - The company is focused on scaling up manufacturing and ensuring high-quality product delivery, with recent facility expansions tripling capacity [18][19] - The quality control lab is integral to ensuring that every component meets high standards before manufacturing, emphasizing patient safety and regulatory compliance [25][29] Market Data and Key Metrics Changes - The company has seen a significant increase in institutional support, with healthcare funds now investing heavily, indicating a shift in market perception [77][79] - The share price has been volatile, influenced by broader market trends rather than the company's clinical progress, with analysts generally maintaining a buy rating [86][90] Company Strategy and Development Direction - The company is committed to innovation in cardiac care, focusing on developing a valve that mimics a healthy aortic valve to reduce patient prosthesis mismatch [62][66] - The management emphasizes the importance of quality and manufacturing processes as critical to maintaining competitive advantage in the market [70][71] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's direction and the potential for significant impact in cardiac care, driven by a strong commitment to innovation and quality [6][72] - The competitive landscape is characterized by the company leading in scientific advancements, with competitors following its lead rather than the other way around [71][72] Other Important Information - The company has a diverse workforce, with a balanced gender ratio and a strong emphasis on cultural diversity, which is seen as beneficial for innovation and decision-making [83][84] - The transition to a U.S.-listed company has improved liquidity and access to capital, which is crucial for future growth and partnerships [85][86] Q&A Session Summary Question: What is the significance of the PPM rate in the clinical trial? - The company reported a 3% rate of patient prosthesis mismatch in their trial, significantly lower than traditional market-leading valves, which is expected to lead to better long-term patient outcomes [62][64] Question: How does the company plan to compete with other TAVR products? - Management stated that the company is leading the field in innovation and that competitors are following its advancements, indicating a strong competitive position [71][72] Question: What are the expectations for the upcoming paradigm trial? - The company is ahead of its goals for pivotal trial capacity and is well-prepared for the next phase of commercialization [19][20]

Annual Meeting December 2025 For personal use only NASDAQ: AVR | ASX: AVR Disclaimer Forward-Looking Statements This presentation (including oral commentary that accompanies this presentation) contains forward-looking statements, including statements related to our business, products and clinical trials and studies. Any statements about our expectations, beliefs, plans, predictions, forecasts, objectives, assumptions, or future events or performance are not historical facts and may be forward-looking. In so ...

MINNEAPOLIS and BRISBANE, Australia, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) today released 30-day clinical outcomes for the DurAVR® THV in one hundred severe aortic stenosis patients with small aortic annuli (aortic annulus area 404 ± 37mm2). The DurAVR® THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 97% freedom from ...

Core Insights - Anteris Technologies Global Corp. reported financial results for Q3 2025 and highlighted significant progress in regulatory approvals for the PARADIGM Trial in both Europe and the U.S. [1][3] Business & Operations - The company engaged positively with the FDA to advance the Investigational Device Exemption (IDE) for the PARADIGM Trial, with U.S. patient recruitment approval announced in November 2025 [4][8] - European regulatory activities progressed, with the first approval for the PARADIGM Trial secured in Denmark in October 2025, and the first patients treated in Denmark following this approval [5][8] - Operational infrastructure was strengthened, including advancements in quality management systems and manufacturing scale-up to support clinical activities and ISO 13485 certification for DurAVR THV production [6][8] Financial Performance - For the nine months ended September 30, 2025, the company's net operating cash outflows were $59.3 million, reflecting increased clinical, regulatory, and manufacturing requirements [9] - Research and Development (R&D) expenses for Q3 2025 were $16.8 million, primarily for preparatory activities related to the PARADIGM Trial and manufacturing capability upscaling [9] - The company held $9.1 million in cash and cash equivalents as of September 30, 2025 [9] PARADIGM Trial Overview - The PARADIGM Trial is a prospective randomized controlled trial designed to evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [11][12] - Approximately 1,000 patients will be enrolled across the U.S., Europe, and Canada, with a primary endpoint assessing non-inferiority on all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure [12][13] - The trial aims to provide robust clinical evidence to support an application for Premarket Approval (PMA) in the U.S. and CE Mark approval in Europe [13]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 12, 2025 Anteris Technologies Global Corp. Washington, D.C. 20549 FORM 8-K (Exact name of registrant as specified in its charter) Delaware 001-42437 99-1407174 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.) Toowong Tower, Level 3, Suite 302 9 Sherwood Road ...

Financial Performance - Net sales for the three months ended September 30, 2025, were $0.4 million, a decrease of 44% from $0.8 million in the same period of the prior year; for the nine months, net sales were $1.6 million, down 26% from $2.2 million[130]. - Cost of products sold for the three months ended September 30, 2025, was $0.1 million, a decrease of 72% from $0.4 million in the prior year; for the nine months, it was $0.5 million, down 61% from $1.2 million[131]. - R&D expenses for the three months ended September 30, 2025, were $16.8 million, an increase of 21% from $13.9 million in the prior year; for the nine months, R&D expenses were $49.6 million, up 30% from $38.1 million[132][133]. - Selling, general and administrative expenses for the three months ended September 30, 2025, were $5.8 million, a decrease of 17% from $7.0 million in the prior year; for the nine months, these expenses were $16.4 million, down 16% from $19.7 million[134][135]. - Net foreign exchange losses for the three months ended September 30, 2025, were $0.1 million, a decrease of 94% from $1.3 million in the prior year; for the nine months, losses were $0.6 million, an increase of 34% from $0.5 million[136][137]. - Net cash used in operating activities during the nine months ended September 30, 2025, was $59.3 million, an increase of 38% from $43.0 million in the prior year[144]. - Net cash used in investing activities during the nine months ended September 30, 2025, was $0.2 million, a decrease of 90% from $1.9 million in the prior year[145]. - Net cash used in financing activities during the nine months ended September 30, 2025, was $1.8 million, a decrease of 105% from net cash inflows of $34.4 million in the prior year[146]. - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash of $9.1 million, down from $70.5 million as of December 31, 2024[139]. - The company anticipates requiring additional funds to achieve long-term goals, including completing R&D and commercialization of current products[141]. Regulatory and Clinical Developments - The company has advanced regulatory activities in Europe, securing the first regulatory clearance in Denmark for the PARADIGM Trial, which commenced patient enrollment in October 2025[105]. - The PARADIGM Trial aims to provide primary clinical evidence for FDA Premarket Approval (PMA) of the DurAVR THV System, with a primary endpoint focused on all-cause mortality and cardiovascular hospitalization at one year post-procedure[106][107]. - As of September 2025, a total of 130 patients have been treated with the DurAVR THV worldwide, marking significant progress in clinical application[103]. Operational and Infrastructure Updates - The company is expanding its global manufacturing capacity to support the PARADIGM Trial, transitioning to new ISO Qualified Clean Room facilities to ensure reliable inventory supply[118]. - The company’s operational infrastructure is being strengthened to support upcoming clinical activities and future ISO 13485 certification, mitigating audit risks[108]. - The Transition Services Agreement with LeMaitre expired in January 2025, and the company does not expect ongoing revenues from this source[114]. Financial Commitments and Agreements - The company has commitments to purchase $0.3 million of plant and equipment as of September 30, 2025[150]. - A new 5-year lease agreement was entered into for a facility, resulting in a right-of-use asset and lease liability of $1.6 million[149]. - The company has the option to extend the lease of its Maple Grove facility for an additional two years[149]. Company Classification and Accounting - The company is classified as an "emerging growth company" under the JOBS Act, allowing for an extended transition period for new accounting standards[158]. - The company is also a "smaller reporting company," which allows for scaled disclosures and the presentation of only two years of audited financial statements[160]. - There were no significant changes to accounting policies during the nine months ended September 30, 2025[154]. - The company does not have any off-balance sheet arrangements[151]. - Management continually evaluates judgments and estimates related to financial statements, which could differ from actual results due to risks and uncertainties[153]. - The company has not adopted any new accounting standards yet, as indicated in the quarterly report[157]. Funding and Financial Health - The company has incurred losses since inception and anticipates continued losses, raising concerns about its ability to maintain operations without securing additional funding[109][120]. - The company generated approximately $25.2 million in gross proceeds from a private placement of Common Stock and CDIs in October and November 2025[111][122]. - Research and development (R&D) expenses are expected to increase as the company focuses on the commercialization of the DurAVR THV System, which includes various components like the ComASUR delivery system[110][117]. - The company consolidates v2vmedtech, inc. as a variable interest entity (VIE) and is the primary beneficiary due to control over significant activities and board positions[156].

Core Points - Anteris has received FDA approval to initiate the PARADIGM clinical trial for the DurAVR Transcatheter Heart Valve (THV) aimed at patients with severe calcific aortic stenosis [1][2] - The trial will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [4][5] - The PARADIGM Trial will enroll approximately 1000 patients across the United States, Europe, and Canada [5] Company Overview - Anteris Technologies Global Corp. is a global structural heart company focused on designing and commercializing advanced medical devices for heart function restoration [8] - The DurAVR THV is the first biomimetic valve designed to replicate the performance of a healthy human aortic valve, utilizing Anteris' patented ADAPT tissue technology [9] Trial Details - The PARADIGM Trial is a prospective randomized controlled trial (RCT) assessing non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure [5][6] - The trial is co-chaired by prominent cardiology experts, Dr. Michael J. Reardon and Professor Stephan Windecker [3] - The trial aims to provide robust clinical evidence to support a future Premarket Approval (PMA) application to the FDA [6][7]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cambium Networks Corporation (CMBM) has seen a remarkable increase of 306%, trading at $2.51 [3] - Teradyne, Inc. (TER) is up 21%, currently priced at $176.00 [3] - Bloom Energy Corporation (BE) has risen by 18%, trading at $134.50 [3] - Jamf Holding Corp. (JAMF) is up 15%, with a price of $12.85 [3] - CSG Systems International, Inc. (CSGS) has increased by 14%, trading at $79.00 [3] - Olympic Steel, Inc. (ZEUS) is also up 14%, currently priced at $34.20 [3] - Beta Bionics, Inc. (BBNX) has risen by 12%, trading at $27.20 [3] - Sonim Technologies, Inc. (SONM) is up 10%, currently priced at $12.49 [3] - Canadian Solar Inc. (CSIQ) has increased by 9%, trading at $16.67 [3] - Interlink Electronics, Inc. (LINK) is also up 9%, currently priced at $6.85 [3] Premarket Losers - Stride, Inc. (LRN) has experienced a significant decline of 41%, trading at $89.44 [4] - Varonis Systems, Inc. (VRNS) is down 29%, currently priced at $44.71 [4] - Akebia Therapeutics, Inc. (AKBA) has decreased by 26%, trading at $2.26 [4] - Avantor, Inc. (AVTR) is down 17%, currently priced at $12.40 [4] - GlucoTrack, Inc. (GCTK) has seen a decline of 13%, trading at $6.29 [4] - Tigo Energy, Inc. (TYGO) is down 13%, currently priced at $2.20 [4] - Generac Holdings Inc. (GNRC) has decreased by 9%, trading at $172.00 [4] - Polar Power, Inc. (POLA) is down 8%, currently priced at $3.71 [4] - Caesars Entertainment, Inc. (CZR) has seen a decline of 7%, trading at $20.50 [4] - Anteris Technologies Global Corp. (AVR) is also down 7%, currently priced at $4.46 [4]

Core Insights - Anteris Technologies Global Corp. announced positive one-year clinical outcomes for the DurAVR Transcatheter Heart Valve (THV) in patients with symptomatic severe aortic stenosis and small aortic annuli, demonstrating significant improvements in hemodynamics and safety [1][8]. Clinical Outcomes - The DurAVR THV achieved a mean pressure gradient (MPG) of 8.6 ± 2.6 mmHg and an effective orifice area (EOA) of 2.1 ± 0.2 cm at one year, with no valve-related mortality and no moderate or severe paravalvular leaks [8]. - At 30 days, the prosthesis-patient mismatch was only 1.5%, significantly lower than the 11.2% to 35.3% range seen with current commercial devices, indicating a reduction in a key predictor of valve failure [8]. Study Details - The pooled cohort included 65 patients from the ongoing EMBARK Study and the US Early Feasibility Study (EFS) who received the DurAVR THV [4]. - The encouraging results from over 100 patients will be further validated in the global pivotal trial known as the PARADIGM Trial, which is a prospective, randomized controlled trial comparing the DurAVR THV to existing transcatheter aortic valve replacements [5]. Product Information - The DurAVR THV is designed to mimic the performance of a healthy human aortic valve and is made from Anteris' patented ADAPT tissue, which has been clinically used for over 10 years in more than 55,000 patients worldwide [7]. - The system includes the DurAVR valve, ADAPT tissue, and the balloon-expandable ComASUR Delivery System, aimed at restoring normal aortic blood flow [7]. Company Overview - Anteris Technologies is a global structural heart company focused on developing innovative medical devices to restore heart function, with a significant presence in both Australia and the USA [6].