Core Insights - Anteris Technologies has initiated the global pivotal trial for its DurAVR Transcatheter Heart Valve (THV) aimed at patients with severe calcific aortic stenosis, marking a significant step towards commercialization [1][2] - The PARADIGM Trial will provide comparative evidence on the safety and effectiveness of the DurAVR THV against existing transcatheter aortic valve replacements (TAVRs) [3][4] Company Overview - Anteris Technologies is a global structural heart company focused on developing innovative medical devices to restore heart function, with a strong presence in both Australia and the United States [7] - The DurAVR THV is designed to treat aortic stenosis and is the first biomimetic valve, utilizing Anteris' patented ADAPT tissue technology, which has been clinically used for over 10 years [8][9] Trial Details - The PARADIGM Trial is a prospective randomized controlled trial that will enroll approximately 1,000 patients, comparing the DurAVR THV to commercially available TAVRs [4][6] - The primary endpoint of the trial is to assess non-inferiority in terms of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure [4]

MINNEAPOLIS and BRISBANE, Australia, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced that one-year clinical outcomes with the DurAVR® Transcatheter Heart Valve (THV) will be presented by Rishi Puri MD PhD, at TCT® 2025 – The 37th Annual Transcatheter Cardiovascular Therap ...

MINNEAPOLIS and BRISBANE, Australia, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced today it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic s ...

MINNEAPOLIS and BRISBANE, Australia, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced that after convening its Special Meeting of Stockholders (the “Special Meeting”) virtually on Thursday, September 18, 2025, at 5:00 p.m. Central time (being 8:00 a.m. AEST on Friday, Sep ...

Group 1 - Two stocks in the health care sector are signaling potential warnings for momentum-focused investors as of September 18, 2025 [1] - The Relative Strength Index (RSI) is a key momentum indicator, with values above 70 indicating that a stock may be overbought [2] - Major overbought stocks in the health care sector include 89bio Inc and Anteris Technologies Global Corp [3] Group 2 - 89bio has agreed to be acquired by Roche for $14.50 per share, representing a 79% premium over its closing stock price on September 17, with an RSI value of 82.2 [6] - 89bio's stock has a 52-week high of $11.84 and gained 1.4% to close at $8.08 on Wednesday [6] - Anteris Technologies reported mixed quarterly results, with a stock gain of approximately 48% over the past month and a 52-week high of $8.79, but its shares fell 1.8% to close at $5.61 [6]

Group 1 - Two stocks in the health care sector are showing signs of being overbought, which may concern momentum-focused investors [1][2] - The Relative Strength Index (RSI) is a key momentum indicator, with values above 70 indicating overbought conditions [2] - 89bio Inc has agreed to be acquired by Roche for $14.50 per share, representing a 79% premium over its closing stock price on September 17 [6] - Anteris Technologies reported mixed quarterly results, with a stock price increase of approximately 48% over the past month [6] Group 2 - 89bio's stock has a 52-week high of $11.84 and an RSI value of 82.2, indicating strong momentum [6] - Anteris Technologies has a 52-week high of $8.79 and an RSI value of 75.9, suggesting it is also in an overbought condition [6] - The stock price of 89bio closed at $8.08, while Anteris Technologies closed at $5.61, reflecting recent price movements [6]

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]

[Financial Performance Summary](index=1&type=section&id=Financial%20Performance%20Summary) For the six months ending June 30, 2025, Anteris Technologies reported a 16% decrease in revenue to $1.17 million compared to the same period in 2024, with the loss from ordinary activities after tax increasing by 23% to $43.0 million and the net loss attributable to members growing by 22% to $42.7 million Financial Performance Overview | | Six months to June 30, | | | | |---|---|---|---|---| | | 2025 (US$'000) | 2024 (US$'000) | Change (US$'000) | Change (%) | | Revenues from ordinary activities | 1,174 | 1,398 | (224) | (16%) | | Loss from ordinary activities after tax | (42,993) | (34,972) | (8,021) | 23% | | Loss for the period attributable to members | (42,698) | (35,057) | (7,641) | 22% | - No dividend has been proposed or declared for the reporting period[3](index=3&type=chunk) [Capital Management and Use of Funds](index=1&type=section&id=Capital%20Management%20and%20Use%20of%20Funds) The company raised net proceeds of $80.0 million from its initial public offering in December 2024, primarily allocating these funds to the development of the DurAVR® THV and its pivotal trial ($37.6 million), with the remainder used for working capital and general corporate purposes, including debt repayment, while payments to related parties totaled $640,000 in Q2 2025 - The company completed an initial public offering on December 12, 2024, issuing 14,878,481 shares at $6.00 per share, raising net proceeds of **$80.0 million** after expenses[5](index=5&type=chunk)[6](index=6&type=chunk) - As of June 30, 2025, the use of IPO proceeds included: - **$37.6 million** for the ongoing development and pivotal trial of DurAVR® THV - **$14.1 million** for net working capital, v2vmedtech expenditure, and other corporate purposes, which included a **$6.4 million** debt repayment[9](index=9&type=chunk) - During Q2 2025, aggregate payments to related parties and their associates, including executive remuneration and director fees, amounted to **$640,000**[6](index=6&type=chunk) [Company and Product Overview](index=2&type=section&id=Company%20and%20Product%20Overview) Anteris is a global structural heart company focused on developing medical devices, with its lead product, the DurAVR® Transcatheter Heart Valve (THV), a biomimetic valve designed to treat aortic stenosis using patented ADAPT® tissue, which has been clinically used in over 55,000 patients worldwide - Anteris is a global structural heart company focused on designing, developing, and commercializing medical devices to restore healthy heart function[10](index=10&type=chunk) - The company's lead product is the DurAVR® Transcatheter Heart Valve (THV), a balloon-expandable, biomimetic valve designed to treat aortic stenosis by mimicking a healthy human aortic valve[11](index=11&type=chunk) - DurAVR® THV utilizes ADAPT® tissue, Anteris's patented, FDA-cleared anti-calcification technology, which has been clinically used for over 10 years in more than **55,000 patients**[11](index=11&type=chunk)

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]

[PART I FINANCIAL STATEMENTS](index=6&type=section&id=PART%20I%20FINANCIAL%20STATEMENTS) This section presents the unaudited condensed consolidated financial statements of Anteris Technologies Global Corp. for the first half of 2025 [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Anteris Technologies' unaudited consolidated financial statements, highlighting increased losses, cash burn, and going concern doubt [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's operating results, showing widening losses primarily due to increased R&D expenses Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $618 | $632 | $1,174 | $1,398 | | Research and development expense | $(16,340) | $(12,634) | $(32,796) | $(24,189) | | Operating loss | $(20,884) | $(18,471) | $(42,664) | $(36,256) | | Loss after income tax | $(21,062) | $(18,819) | $(42,993) | $(34,972) | | Basic and diluted loss per share | $(0.58) | $(0.98) | $(1.18) | $(1.90) | - The company's operating loss and net loss widened for both the three and six-month periods ended June 30, 2025, compared to the prior year, primarily due to a significant increase in Research and Development expenses[17](index=17&type=chunk) [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, showing a significant decrease in cash and total assets Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $28,438 | $70,458 | | Total Current Assets | $32,212 | $74,651 | | TOTAL ASSETS | $39,878 | $80,699 | | TOTAL LIABILITIES | $15,846 | $18,017 | | TOTAL STOCKHOLDERS' EQUITY | $24,406 | $62,761 | - The company's cash position decreased significantly by approximately **$42 million**, from **$70.5 million** at the end of 2024 to **$28.4 million** as of June 30, 2025, reflecting high cash burn from operations[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines the company's cash movements, indicating increased cash usage from operating activities Consolidated Cash Flow Highlights (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | NET CASH USED IN OPERATING ACTIVITIES | $(41,024) | $(28,903) | | NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES | $573 | $(1,363) | | NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES | $(1,533) | $15,946 | | Net change during the period | $(42,020) | $(13,906) | - Net cash used in operating activities increased to **$41.0 million** for the first six months of 2025, up from **$28.9 million** in the same period of 2024, driven by the net loss adjusted for non-cash items[27](index=27&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's operations, going concern status, segment reporting, and key customer relationships - The company's principal activities consist of the continued research and development of its DurAVR® THV system, compiling data for FDA approval to commence the PARADIGM Trial, and co-developing a heart valve repair device with v2vmedtech, inc[35](index=35&type=chunk) - The financial statements have been prepared on a going concern basis, but the company's recurring losses (**$43.0 million** for H1 2025) and net cash outflows from operations (**$41.0 million** for H1 2025) raise substantial doubt about its ability to continue as a going concern for one year from the issuance date of the financials[49](index=49&type=chunk)[54](index=54&type=chunk) - The company operates as a single reportable segment focused on the development and commercialization of the ADAPT® anti-calcification tissue, primarily for the DurAVR® THV system[89](index=89&type=chunk) - Two major customers, Customer A and Customer B, accounted for a significant portion of the company's revenue in the first six months of 2025 and 2024[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and results, highlighting R&D increases, recurring losses, and the need for additional capital - The company is a structural heart company focused on its lead product, the DurAVR® THV system, for treating aortic stenosis. As of June 2025, **130 patients** have been treated with the device worldwide[100](index=100&type=chunk)[101](index=101&type=chunk) - An Investigational Device Exemption (IDE) for the PARADIGM Trial was submitted to the FDA in Q1 2025. The company anticipates enrollment to begin in Q3 2025, subject to FDA approval[103](index=103&type=chunk) - In Q2 2025, the company focused on strengthening clinical infrastructure and manufacturing capabilities for the PARADIGM Trial, qualifying **79 trial sites** across the U.S., Europe, and Canada[104](index=104&type=chunk) - The company's current cash on hand is not sufficient to fund its needs for the **12 months** following June 30, 2025, and it will need to raise additional capital to fund operations[135](index=135&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, highlighting increased R&D expenses and widening operating losses Comparison of Operations (Six Months Ended June 30) | Line Item | 2025 (in thousands) | 2024 (in thousands) | % Change | | :--- | :--- | :--- | :--- | | Net sales | $1,174 | $1,398 | (16)% | | Research and development expense | $(32,796) | $(24,189) | 36% | | Selling, general and administrative expense | $(10,687) | $(12,679) | (16)% | | Operating loss | $(42,664) | $(36,256) | 18% | - R&D expenses for the six months ended June 30, 2025, increased by **$8.6 million (36%)** year-over-year, driven by the upscaling of manufacturing and quality capabilities (**$9.1 million**) and preparatory activities for the PARADIGM Trial (**$2.5 million**)[128](index=128&type=chunk) - Selling, general and administrative expenses decreased by **$2.0 million (16%)** for the first six months of 2025 compared to the prior year, primarily due to lower share-based payment expenses and reduced marketing spend[130](index=130&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's cash position and capital needs, emphasizing the necessity for additional funding - As of June 30, 2025, the company had cash, cash equivalents, and restricted cash of **$28.4 million** and an accumulated deficit of **$319.1 million**[134](index=134&type=chunk)[135](index=135&type=chunk) - Management states that current cash is insufficient to fund operations for the next **12 months** and that additional funds will be required to achieve long-term goals, including the completion of R&D and commercialization of products[135](index=135&type=chunk)[136](index=136&type=chunk) Summary of Cash Flows (Six Months Ended June 30, in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Operating activities | $(41,024) | $(28,903) | | Investing activities | $573 | $(1,363) | | Financing activities | $(1,533) | $15,946 | [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Anteris is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[157](index=157&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to material weaknesses in internal control over financial reporting - Management, including the CEO and CFO, concluded that as of June 30, 2025, the company's disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting[158](index=158&type=chunk) - The identified material weaknesses relate to (i) a lack of appropriately designed, implemented, and documented procedures and controls, and (ii) deficiencies in the segregation of duties[161](index=161&type=chunk) - Remediation efforts are in process, including documenting processes and controls and reviewing segregation of duties. However, these controls have not operated for a sufficient period to confirm their effectiveness, and the material weaknesses are not yet considered remediated[162](index=162&type=chunk)[163](index=163&type=chunk) [PART II OTHER INFORMATION](index=35&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information on legal proceedings, risk factors, equity sales, and other corporate disclosures [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings are currently active or threatened against it - The company is not party to any material legal proceedings[166](index=166&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors.) There have been no material changes to the risk factors previously disclosed in the company's Annual Report - There have been no material changes to the risk factors discussed in the company's Annual Report[167](index=167&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the allocation of **$80.0 million** net IPO proceeds for DurAVR® THV development and working capital - The company received net proceeds of **$80.0 million** from its initial public offering, which became effective on December 12, 2024[169](index=169&type=chunk) - As of June 30, 2025, the use of IPO proceeds included: - **$37.6 million** for DurAVR® THV development and the PARADIGM Trial - **$14.1 million** for net working capital, v2v expenditures, and other general corporate purposes, including debt repayment[174](index=174&type=chunk) [Defaults Upon Senior Securities](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[171](index=171&type=chunk) [Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[172](index=172&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans during Q2 2025 - No directors or officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended June 30, 2025[173](index=173&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the Form 10-Q, including CEO and CFO certifications - An index of exhibits filed with the Form 10-Q is provided, including certifications pursuant to the Sarbanes-Oxley Act of 2002[175](index=175&type=chunk)[177](index=177&type=chunk)