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)

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]

[Anteris First Quarter 2025 Results](index=1&type=section&id=Anteris%20Announces%20Results%20for%20the%20First%20Quarter%20of%202025) [Q1 2025 Highlights](index=1&type=section&id=First%20Quarter%202025%20Highlights) Anteris reported significant progress in its clinical and operational programs, highlighted by the submission of its IDE application, treating over 100 patients with DurAVR®, positive one-year clinical data, and a strong cash position - Submitted the Investigational Device Exemption (IDE) for the DurAVR® THV's global pivotal clinical trial (PARADIGM Trial) to the FDA[6](index=6&type=chunk) - Achieved a clinical milestone of over **100 patients** successfully treated with the DurAVR® THV[6](index=6&type=chunk) - Reported positive one-year clinical data for DurAVR® THV, showing sustained favorable hemodynamic outcomes and a strong safety profile[6](index=6&type=chunk) - Ended the first quarter with a cash position of **$49.0 million (A$78.0 million)**[6](index=6&type=chunk) [Business & Operations Update](index=1&type=section&id=Business%20%26%20Operations) The company focused on advancing DurAVR® THV towards commercialization through PARADIGM pivotal trial preparations, including IDE submission, team scaling, manufacturing expansion, and significant clinical progress [Preparations for the PARADIGM Trial](index=1&type=section&id=Preparations%20for%20the%20PARADIGM%20Trial) Anteris submitted an IDE application for the PARADIGM Trial to the FDA, designing it as a head-to-head comparison against commercial TAVR devices, while expanding clinical teams and engaging trial centers for a Q3 2025 start - An IDE application for the PARADIGM Trial was submitted to the U.S. FDA, with trial commencement anticipated in **Q3 2025**, pending approval[7](index=7&type=chunk) - The PARADIGM Trial will be a randomized 1:1 study comparing the DurAVR® THV against commercially available devices like the SAPIEN or Evolut series THV[8](index=8&type=chunk) - A separate parallel registry is planned for valve-in-valve (ViV) TAVR patients to support market opportunity in this segment[9](index=9&type=chunk) - The company is expanding its global Clinical Specialist Team and working with its Contract Research Organisation to engage with planned trial centers in the U.S., Canada, and Europe[10](index=10&type=chunk) [Clinical Milestones and Data](index=2&type=section&id=Clinical%20Milestone%20%E2%80%93%20100%20patients%20successfully%20treated%20with%20the%20DurAVR%C2%AE%20THV) Anteris achieved a major milestone by successfully treating over 100 patients with the DurAVR® THV system, with one-year clinical data demonstrating sustained favorable hemodynamics and a strong safety profile - The **100th patient** was successfully treated with the DurAVR® THV System during the first quarter[11](index=11&type=chunk) - One-year data showed sustained favorable hemodynamics with an Effective Orifice Area (EOA) of **2.1 cm²**, Mean Pressure Gradient (MPG) of **8.6 mmHg**, and Doppler Velocity Index (DVI) of **0.58**[20](index=20&type=chunk) - The safety profile at one year was strong, with no valve or cardiovascular-related mortality and no reported prosthesis-patient mismatch (PPM) in small annuli patients[20](index=20&type=chunk) [Manufacturing Capacity Expansion](index=3&type=section&id=Expansion%20of%20global%20manufacturing%20capacity) Anteris is significantly expanding its global manufacturing capacity to support the PARADIGM Trial and commercial demand, including scaling production into new facilities and diversifying ADAPT® tissue sourcing - Manufacturing capacity is being scaled to at least **three times** the 2024 levels to support the PARADIGM Trial and anticipated commercial demand[16](index=16&type=chunk) - To mitigate supply chain risks, the ADAPT® tissue for the DurAVR® THV will be sourced from both the U.S. and Australia[16](index=16&type=chunk) [Q1 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) Anteris reported a 27% decrease in net sales to $0.6 million and a 36% increase in loss after income tax to $21.9 million, driven by higher R&D expenses, while SG&A expenses decreased Q1 2025 Financial Summary | Financial Metric | Q1 2025 ($ millions) | Q1 2024 ($ millions) | Change ($ millions) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Net Sales | 0.6 | 0.8 | -0.2 | -27% | | Loss after Income Tax | 21.9 | 16.2 | +5.8 | +36% | | R&D Expenses | 16.5 | 11.6 | +4.9 | +42% | | SG&A Expenses | 5.7 | 6.5 | -0.8 | -13% | - The increase in R&D expenses was primarily due to **$3.5 million** for upscaling manufacturing capabilities and **$1.5 million** for PARADIGM Trial preparatory activities[21](index=21&type=chunk) - The decrease in SG&A expenses was mainly due to a **$1.2 million** reduction in costs associated with the 2024 re-domicile and Nasdaq listing, partially offset by higher compliance costs[21](index=21&type=chunk) [Corporate and Financing Activities](index=4&type=section&id=Corporate%20and%20Financing%20Activities) Anteris raised an additional $0.47 million through a green shoe option exercise and gained increased visibility in the US equity market by being added to the FTSE Russell 2000® Index - In January 2025, underwriters partially exercised the green shoe option from the December 2024 IPO, raising an additional **$0.47 million** from the sale of **78,481 shares** at **$6.00 per share**[22](index=22&type=chunk) - Anteris was added to the FTSE Russell 2000® Index, which measures the performance of the small-cap segment of the US equity market, effective **March 24, 2025**[23](index=23&type=chunk) [About Anteris](index=4&type=section&id=About%20Anteris) Anteris Technologies is a global structural heart company developing medical devices like the DurAVR® THV, a biomimetic valve made with patented ADAPT® tissue, to treat conditions such as aortic stenosis - Anteris is a global structural heart company focused on designing, developing, and commercializing medical devices to restore healthy heart function[26](index=26&type=chunk) - The lead product, DurAVR® THV, is the first biomimetic valve, shaped to mimic the performance of a healthy human aortic valve and is designed to treat aortic stenosis[27](index=27&type=chunk) - DurAVR® THV is made using ADAPT® tissue, a patented anti-calcification technology that is FDA-cleared and has been used in over **55,000 patients**[27](index=27&type=chunk)

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].

Financial Performance - Net sales for the three months ended March 31, 2025, were $0.6 million, a decrease of $0.2 million (27%) compared to $0.8 million for the same period in the prior year, primarily due to lower demand for tissue products [106]. - Cost of products sold during the same period was $0.2 million, a decrease of $0.3 million (56%) compared to $0.5 million for the same period in the prior year, attributed to reduced net sales and changes in product mix [107]. - Loss before income taxes from continuing operations was $21.9 million for Q1 2025, an increase of $5.8 million (36%) compared to Q1 2024 [112]. - Net cash used in operating activities during Q1 2025 was $21.5 million, an increase of $6.0 million (38%) compared to $15.5 million in Q1 2024 [119]. - Cash and cash equivalents as of March 31, 2025, were $49.0 million, down from $70.5 million as of December 31, 2024 [115]. - The accumulated deficit as of March 31, 2025, was $298.3 million, up from $276.4 million as of December 31, 2024 [114]. Research and Development - R&D expenses increased to $16.5 million, an increase of $4.9 million (42%) compared to $11.6 million for the same period in the prior year, driven by upscaling manufacturing capabilities and preparatory activities for the Pivotal Trial [108]. - The company anticipates requiring substantial additional funds to achieve long-term goals and complete R&D of current products [116]. - The company expects to continue incurring substantial losses in the near future until regulatory approval is obtained for its products [116]. Operational Activities - The company has treated over 100 patients with the DurAVR® THV system across the United States, Canada, and Europe as of March 31, 2025 [85]. - The company is expanding global manufacturing capacity to support the PARADIGM Trial, aiming to increase capacity to at least three times the 2024 levels [96]. Capital and Financing - The initial public offering on December 12, 2024, raised net proceeds of $80.0 million after deducting underwriting discounts and expenses [86]. - Capital commitments relating to property leases were $1.3 million as of March 31, 2025 [115]. - The company had commitments to purchase $0.2 million of plant and equipment as of March 31, 2025 [124]. Other Income and Expenses - Selling, general and administrative expenses decreased to $5.7 million, a reduction of $0.8 million (13%) compared to $6.5 million for the same period in the prior year, mainly due to lower costs associated with the initial public offering [109]. - Other non-operating income decreased to $0.1 million, a decline of $0.3 million (78%) compared to $0.4 million for the same period in the prior year, primarily due to the recognition of additional government grants in the previous year [110]. - Net foreign exchange losses were $0.2 million, a change of $1.5 million (118%) compared to net foreign exchange gains of $1.2 million for the same period in the prior year, influenced by fluctuations in foreign exchange rates [111]. Cash Flow Activities - Net cash provided by investing activities during Q1 2025 was $1.1 million, a change of $1.8 million (255%) compared to cash outflows of $0.7 million in Q1 2024 [120]. - Net cash used in financing activities during Q1 2025 was $1.1 million, a change of $2.6 million (170%) compared to cash inflows of $1.6 million in Q1 2024 [121].

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]

Clinical Development and Trials - The DurAVR® THV system has been clinically developed with significant physician input, treating a total of 83 patients across the United States, Canada, and Europe as of January 2025[32]. - The FDA approved the early feasibility study for the DurAVR® THV system in November 2022, with 30-day post-procedure results showing a mean effective orifice area of 2.2 cm² and a mean pressure gradient of 7.5 mmHg[38]. - The anticipated design of the Pivotal Trial will be a prospective, randomized, controlled multicenter study to demonstrate non-inferiority of the DurAVR® THV compared to commercially available TAVR systems[36]. - The company has treated seven patients in ViV procedures using the DurAVR® THV system as of January 2025, indicating progress in clinical applications[39]. - Clinical trials have shown that the DurAVR® THV system resulted in an average effective orifice area (EOA) increase of 311% at 30 days and 294% at 12 months post-procedure in the first cohort[82]. - The mean pressure gradient (MPG) across the valve decreased by 87% at 30 days and 85% at 12 months from baseline in the first cohort[82]. - The six-minute walk test distance (6MWTD) improved by 21% at 30 days and 44% at 12 months post-procedure in the first cohort[82]. - The second cohort observed an average EOA increase of 164% at 30 days and 165% at 12 months post-procedure[83]. - The MPG across the valve in the second cohort decreased by 79% at 30 days and 80% at 12 months from baseline[83]. - The third cohort showed an average EOA increase of 170% at both 30 days and 12 months post-procedure[84]. - The MPG across the valve in the third cohort decreased by 87% at 30 days and 85% at 12 months from baseline[84]. - The fourth cohort demonstrated an average EOA increase of 165% at 30 days post-procedure[85]. - The fifth cohort reported an average EOA increase of 208% at 30 days post-procedure[86]. - The Early Feasibility Study (EFS) for the DurAVR® THV system commenced in August 2023, enrolling 15 patients across four heart valve centers in the U.S.[90]. - The EFS demonstrated a 100% precise placement and implant success for all 15 patients, with a 172% increase in average EOA from baseline at 30 days post-procedure[92]. - At 30 days post-procedure, there was an 82% reduction in mean pressure gradient (MPG) from baseline, and a 121% increase in DVI[92]. - No mortality, disabling stroke, life-threatening bleeding, or reinterventions were reported at 30 days post-procedure[92]. - The EU EFS is set to evaluate the safety and feasibility of the DurAVR® THV system, with plans to enroll up to 40 patients starting in January 2025[98]. - The DurAVR® THV was used for the first time in a Valve-in-Valve (ViV) procedure in Canada in July 2023, addressing patients with failing bioprosthetic aortic valves[96]. Market Opportunity and Financials - The total global market opportunity for TAVR related to severe aortic stenosis is expected to reach $9.9 billion by 2028, with North America and Europe accounting for 53% and 38% of the market share, respectively[46]. - The market opportunity for ViV procedures is projected to reach $2.5 billion by 2028, highlighting the growth potential in this segment[41]. - The annual volume of TAVR procedures in the United States has significantly increased, with an estimated 73,000 patients undergoing the procedure in 2019[41]. - The company reported total losses after income tax of $76.0 million for the year ended December 31, 2024, compared to $46.8 million for 2023, indicating a significant increase in losses year-over-year[209]. - Negative cash flows from operating activities were $61.2 million for 2024 and $34.6 million for 2023, reflecting ongoing financial challenges[209]. - As of December 31, 2024, the company had an accumulated deficit of $276.4 million, up from $200.1 million in 2023, highlighting the growing financial strain[209]. - The company completed its initial public offering on December 12, 2024, raising net proceeds of $80.1 million from the sale of 14,878,481 shares at a price of $6.00 per share[194]. Intellectual Property and Partnerships - The company has a strong intellectual property position with 51 issued patents and 53 pending patent applications, which supports its innovative technology[47]. - Anteris has a total of 51 active patents expiring between 2025 and 2042, and 53 pending patent applications as of December 31, 2024[102]. - The company entered into a development agreement with v2vmedtech in April 2023 to enhance its business operations and profitability through innovative heart valve repair technology[45]. - The company has a 30% interest in v2vmedtech, which focuses on implantable medical devices for mitigating heart valve regurgitation, with six pending patent applications[108]. - The company purchased 30% equity in v2vmedtech for $0.2 million and is providing development services for a heart valve repair device[121]. Regulatory Environment - The FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act, requiring extensive compliance for product design, testing, and marketing[149]. - New medical devices require either a 510(k) clearance, de novo classification, or pre-market approval (PMA), which can be resource-intensive and costly[150]. - Class III devices, such as the DurAVR® THV system, require PMA approval, which is generally more expensive and time-consuming than 510(k) processes[156]. - The FDA review of a PMA application typically takes between one and two years, but can be significantly longer depending on various factors[166]. - If the FDA's evaluation of a PMA is favorable, an approval letter is issued, allowing for commercial marketing of the device[168]. - Modifications to an approved device that affect safety or effectiveness require new PMAs or pre-market approval supplements[169]. - The IDE process is necessary for human clinical trials supporting medical device clearance, requiring FDA approval prior to commencing trials[162]. - The FDA may require post-approval studies or post-market surveillance for devices, ensuring long-term safety and effectiveness data[170]. - Manufacturers must comply with stringent cGMP regulations during the manufacturing process, including design, testing, and quality assurance procedures[172]. - The EUMDR, effective in 2021, imposes extensive regulatory requirements for medical devices in the EU, including clinical evidence and post-market surveillance[180]. - The IMDRF aims to harmonize medical device regulatory requirements across multiple countries, reducing the need for separate inspections[181]. - Non-compliance with FDA regulations can lead to sanctions, including fines, recalls, and operational restrictions[182]. Company Operations and Challenges - The company is committed to maintaining a strong corporate culture based on its AORTIC values (Accountability, Objectivity, Respect, Teamwork, Integrity, Courage) to enhance employee engagement and retention[201]. - The company has implemented training programs aimed at boosting company culture and increasing employee job satisfaction and productivity[203]. - The company is subject to evolving healthcare policies that may impact reimbursement rates and coverage for its products, potentially affecting market demand[190]. - The company faces regulatory compliance challenges due to numerous state, federal, and foreign laws governing health privacy and consumer protection, which could lead to significant penalties if not adhered to[191]. - The company is focused on developing and commercializing the DurAVR® THV system, with significant operating expenses expected to increase as the business grows[210]. - The company anticipates continued significant operating losses for the foreseeable future, raising doubts about its ability to achieve profitability[211]. - The company has historically devoted most of its financial resources to R&D, relying on equity financings and divestments to fund operations[217]. - The company faces substantial risks in completing clinical trials and obtaining regulatory approvals, which are critical for generating significant revenue[213]. - The company may encounter unforeseen expenses and complications typical of early-stage medical technology firms, impacting its financial condition[211]. - The ongoing geopolitical events, such as the war in Ukraine, may disrupt clinical studies and increase R&D expenses[228]. - The company must successfully manage growth and operational complexity to avoid negatively impacting its business and financial position[221]. - The company requires substantial additional financing to support R&D and commercialization efforts, with future capital requirements dependent on various factors[216]. - The lead product, DurAVR® THV system, is undergoing clinical trials necessary for FDA pre-market approval, with no assurance of successful completion[230]. - The company may face challenges in maintaining profitability and investor confidence if it cannot secure necessary funding or achieve commercial success[215].