Anteris Technologies Global Corp.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
AVR$5.69+2.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0001140361-25-030146
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001140361-25-041643
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 90 previous paragraphs and 92 current paragraphs.
58 unchanged; 29 reworded; 4 added; 3 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
During the third quarter of 2025, we advanced regulatory activities in parts of Europe, with the goal of securing clearance to commence the PARADIGM Trial in those countries. In October 2025, we secured the first European regulatory clearance in Denmark and subsequently enrolled and treated the first patients marking the formal initiation of the PARADIGM Trial. We continued to engage with the U.S. Food and Drug Administration (the “FDA”) during the quarter, to advance the Investigational Device Exemption (“IDE”) for the PARADIGM Trial, which FDA approval was received for in the fourth quarter of 2025. In parallel, cross-functional teams completed site and operational readiness activities, namely investigator training, study material preparation, and logistical set up, ahead of anticipated enrolment and pending receipt of regulatory clearance and Institutional Review Board (“IRB”) approval.
Current report
We continued strengthening our operational infrastructure during the third quarter of 2025, advancing quality management system (“QMS”) buildout to support upcoming clinical activities and future ISO 13485 certification. Key quality procedures and standard operating documents were released to establish the framework for a mature, compliant system and mitigate audit risk. In parallel, manufacturing scale-up activities progressed, including cross-training of inspection personnel, expansion of clean room capacity, and ongoing process development initiatives for projected DurAVR® THV demand.
Current report
During October and November 2025, we completed a private placement of Common Stock and CDIs, each with accompanying warrants, generating gross proceeds of approximately $25.2 million. The transaction closed after the balance sheet date and will be reflected in the next reporting period.
Current report
In October and November 2025, we completed a private placement of our Common Stock, CDIs and accompanying warrants that generated approximately $25.2 million in gross proceeds, which have been received.
Removed paragraphs (3)
Previous report
We clinically developed our DurAVR® THV system over several years with significant physician input with the goal of addressing hemodynamic limitations of the current standard-of-care products. As of June 2025, a total of 130 patients have been treated with the DurAVR®THV worldwide. In November 2021, we commenced our first-in-human (“FIH”) study at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia.
Previous report
In the second quarter of 2025, the Anteris team made considerable progress strengthening its clinical infrastructure and manufacturing capabilities in preparation for the PARADIGM Trial. A key focus was the qualification of trial sites, including feasibility assessments to confirm each site’s access to a suitable aortic stenosis patient population and their capacity to conduct the PARADIGM Trial to the highest standards. Preparatory activities, including site contracting with planned centers across the U.S., Europe and Canada, are well advanced, with 79 sites now qualified to participate. Ongoing collaborative work with the FDA to progress the IDE application has been a major focus this quarter, in addition to proactively scaling the manufacturing of all key products to meet the anticipated inventory demands of the upcoming PARADIGM Trial.
Previous report
In the second quarter of 2025, the qualification of trial sites was a key focus, including feasibility assessments to confirm each site’s access to a suitable aortic stenosis patient population and their capacity to conduct the PARADIGM Trial to the highest standards. Preparatory activities, including site contracting with planned centers across the U.S., Europe and Canada, are well advanced, with 79 sites now qualified to participate. Ongoing collaborative work with the FDA to progress the IDE application has been a major focus this quarter, in addition to proactively scaling the manufacturing of all key products to meet the anticipated inventory demands of the upcoming PARADIGM Trial.
Reworded paragraphs (29)
Previous wording
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report. Except for historical information, the matters discussed in this MD&A contain various forward-looking statements that involve risks and uncertainties and are based upon judgments concerning various factors beyond our control. Our actual results could differ materially from those anticipated in these forward-looking statements. Please also see the section of this Form 10-Q titled “Cautionary Note Regarding Forward-Looking Statements.
Current wording
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our annual report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 12, 2025, and amended on April 29, 2025 (as amended, the “Annual Report”). Except for historical information, the matters discussed in this MD&A contain various forward-looking statements that involve risks and uncertainties and are based upon judgments concerning various factors beyond our control. Our actual results could differ materially from those anticipated in these forward-looking statements. Please also see the section of this Form 10-Q titled “Cautionary Note Regarding Forward-Looking Statements.”
Previous wording
Anteris is a structural heart company dedicated to revolutionizing cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Our lead product, the DurAVR® THV system, represents a unique product opportunity in a new THV class of single-piece heart valves, for the treatment of aortic stenosis. Our DurAVR® THV system consists of a single-piece, biomimetic valve made with our proprietary ADAPT® tissue-enhancing technology and deployed with our ComASUR® balloon-expandable delivery system. ADAPT® is our proprietary anti-calcification tissue shaping technology that is designed to reengineer xenograft tissue into a pure, single-piece collagen bioscaffold. Our proprietary ADAPT® tissue has been clinically demonstrated to be calcium free for up to 10 years post-procedure, according to Performance of the ADAPT-Treated CardioCel™ Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes, published by William Neethling et. al., and has been distributed for use in over 55,000 patients globally in other indications. Our ComASUR® balloon-expandable delivery system, which was developed in consultation with physicians, is designed to provide precise alignment with the heart’s native commissures to achieve accurate placement of the DurAVR® THV system.
Current wording
Anteris is a structural heart company dedicated to revolutionizing cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Our lead product, the DurAVR® THV System, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis— a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. Our DurAVR® THV System consists of a single-piece, biomimetic valve made with our proprietary ADAPT® tissue-enhancing technology and deployed with our balloon expandable ComASUR® Delivery System. ADAPT® is our proprietary anti-calcification tissue shaping technology that is designed to reengineer xenograft tissue into a pure, single-piece collagen bioscaffold. Our patented ADAPT® tissue has been clinically demonstrated to be calcium free for up to 10 years post-procedure, according to Performance of the ADAPT-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes, published by William Neethling et. al., and has been distributed for use in over 55,000 patients globally in other indications. Our balloon expandable ComASUR® Delivery System, which was developed in consultation with physicians, is designed to provide precise alignment with the heart’s native commissures to achieve accurate placement of the DurAVR® THV. As of September 2025, a total of 130 patients have been treated with the DurAVR®THV worldwide.
Previous wording
On December 12, 2024, our Registration Statement relating to our initial public offering (the “IPO”) became effective pursuant to which we issued and sold 14,800,000 shares of Common Stock at a public offering price of $6.00 per share. On January 14,2025, TD Cowen, Barclays and Cantor (the underwriters’ representatives) partially exercised the over-allotment option granted by the Company, pursuant to which we issued and sold an additional 78,481 shares of Common Stock at the purchase price of $6.00 per share. We received net proceeds of $80.0 million for the IPO and subsequent over-allotment option, after deducting the underwriting discounts, commissions and offering expenses.
Current wording
On December 12, 2024, our Registration Statement relating to our initial public offering (the “IPO”) became effective pursuant to which we issued and sold 14,800,000 shares of our Common Stock at a public offering price of $6.00 per share. On January 14, 2025, TD Cowen, Barclays and Cantor (the underwriters’ representatives) partially exercised the over-allotment option granted by the Company, pursuant to which we issued and sold an additional 78,481 shares of Common Stock at the purchase price of $6.00 per share. We received net proceeds of $80.0 million for the IPO and subsequent over-allotment option, after deducting the underwriting discounts, commissions and offering expenses.
Previous wording
In the first quarter of 2025, an investigational device exemption (“IDE”) for the PARADIGM Trial was submitted to the FDA. It is anticipated that the primary end point of the PARADIGM Trial will be to demonstrate non-inferiority of the DurAVR®THV system compared with commercially available TAVR systems (SAPIEN or Evolut series THV) for treatment of subjects with severe calcific aortic stenosis. We anticipate that the design of the PARADIGM Trial will be a prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either TAVR using the DurAVR®THV or TAVR using a commercially available and approved THV from competitors. We anticipate that the subjects will include a broad array of risk profiles. We anticipate that subjects with a failed surgical bioprosthesis in need of a valve-in-valve TAVR will be enrolled in a separate parallel registry. If we obtain IDE approval from the FDA, we intend to perform site activation and seek Institutional Review Board (“IRB”) approval for commencement of the study at each site. Subject to the foregoing, we anticipate enrollment to begin in the third quarter of 2025. Such a trial would be designed to provide the primary clinical evidence on which the FDA could base a decision for the Premarket Approval (“PMA”) that is required for commercialization of the DurAVR®THV system in the United States. We anticipate CE Mark approval will progress in parallel to the PMA.
Current wording
The PARADIGM Trial is a prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either a transcatheter aortic valve replacement (“TAVR”) using the DurAVR® THV or TAVR using a commercially available and approved THV in an “All Comers Randomized Cohort.” The primary end point of the PARADIGM Trial is a composite of all-cause mortality, all stroke and cardiovascular hospitalization at 1-year post-procedure. The endpoint will be evaluated as a non-inferiority analysis. We anticipate that the subjects will include a broad array of risk profiles. Subjects with a failed surgical bioprosthesis in need of a valve-in-valve TAVR will be enrolled in a separate parallel registry.
Previous wording
The condensed consolidated financial statements include the accounts for our company, our wholly-owned subsidiaries, and entities for which we have a controlling financial interest, and for periods prior to the series of reorganization transactions we completed prior to our U.S. initial public offering (the “Reorganization”), the accounts of Anteris Technologies Pty Ltd (“ATPL”, formerly Anteris Technologies Ltd), its wholly-owned subsidiaries, and entities for which ATPL had a controlling financial interest. Intercompany transactions, balances and unrealized gains and losses on transactions between such entities are eliminated.
Current wording
The condensed consolidated financial statements include the accounts for our company, our wholly-owned subsidiaries, and entities for which we have a controlling financial interest, and, for periods prior to the series of reorganization transactions we completed prior to our IPO (the “Reorganization”), the accounts of Anteris Technologies Pty Ltd (“ATPL”, formerly Anteris Technologies Ltd), its wholly-owned subsidiaries, and entities for which ATPL had a controlling financial interest. Intercompany transactions, balances and unrealized gains and losses on transactions between such entities are eliminated.
Previous wording
Our management has determined that the activities of the business as reviewed by the Vice Chairman and CEO, the chief operating decision maker, are one segment, being the development and commercialization of the ADAPT® anti-calcification tissue. This is focused on the DurAVR® THV system.
Current wording
Our management has determined that the activities of the business as reviewed by our Company’s Vice Chairman and CEO, who also serves as the Company’s chief operating decision maker, are one segment, being the development and commercialization of the ADAPT® anti-calcification tissue. This is focused on the DurAVR® THV System.
Previous wording
We currently derive revenue from the sale of regenerative tissue products. Such sales have historically been made principally to 4C Medical Technologies, Inc. (“4C”) and to LeMaitre Vascular, Inc. (“LeMaitre”), a distributor of medical products, to whom we sold the distribution rights for CardioCel™ and VascuCel™ in 2019 in order to focus on development of our proprietary ADAPT® tissue for the DurAVR® THV system. Concurrent with such sale, we entered into a Transition Services Agreement pursuant to which we manufactured and sold CardioCel™ and VascuCel™ products to LeMaitre. The Transition Services Agreement with LeMaitre expired in January 2025. We do not expect to receive any significant future revenues from LeMaitre. The Supply and License Agreement with 4C, which had an initial seven-year term that ended on June 1, 2025, and was automatically renewed for a one-year term in accordance with its renewal provisions. Successive one-year terms automatically renew under the Transition Services Agreement absent prior indication to the contrary. Either we or 4C may terminate the 4C Agreement upon 180 days written notice to the other party at the end of the initial term or any renewal term or in the event of an uncured breach or if the other party becomes insolvent, files a petition for bankruptcy or upon the occurrence of similar events.
Current wording
We currently derive revenue from the sale of regenerative tissue products. Such sales have historically been made principally to 4C Medical Technologies, Inc. (“4C”) and to LeMaitre Vascular, Inc. (“LeMaitre”), a distributor of medical products, to whom we sold the distribution rights for CardioCel™ and VascuCel™ in 2019 in order to focus on development of our proprietary ADAPT® tissue for the DurAVR® THV System. Concurrent with such sale, we entered into a Transition Services Agreement pursuant to which we manufactured and sold CardioCel™ and VascuCel™ products to LeMaitre. The Transition Services Agreement with LeMaitre expired in January 2025 and we do not expect to receive any ongoing revenues from LeMaitre associated therewith. The Supply and License Agreement with 4C, which had an initial seven-year term that ended on June 1, 2025, and was automatically renewed for a one-year term in accordance with its renewal provisions. Successive one-year terms automatically renew under the Transition Services Agreement absent prior indication to the contrary. Either we or 4C may terminate the 4C Agreement upon 180 days written notice to the other party at the end of the initial term or any renewal term or in the event of an uncured breach or if the other party becomes insolvent, files a petition for bankruptcy or upon the occurrence of similar events.
Previous wording
We earn other income primarily from tax incentive payments under the Australian Government’s R&D Tax Incentive Plan for R&D activities conducted in Australia that meet specified regulatory criteria. A refundable tax offset is available to eligible companies with an annual aggregate turnover of less than AUD $20.0 million. Eligible companies can receive a refundable tax offset for a percentage of their R&D spending.
Current wording
We earn other income primarily from tax incentive payments under the Australian Government’s R&D Tax Incentive Plan for research and development (“R&D”) activities conducted in Australia that meet specified regulatory criteria. A refundable tax offset is available to eligible companies with an annual aggregate turnover of less than AUD $20.0 million. Eligible companies can receive a refundable tax offset for a percentage of their R&D spending.
Previous wording
R&D has been a significant focus for us with investments in the DurAVR® THV system, including the DurAVR® THV, the ComASUR® delivery system, a disposable crimper, and an expandable access sheath, as we advance towards commercial use. These components are collectively managed as part of the overall DurAVR® THV system rather than as separate projects. Since late 2021, when our DurAVR® THV was first used in human trials in Tbilisi, Georgia, R&D efforts have focused on incorporating feedback from the clinical trials and progressing towards commercialization. These costs have included, among others, preclinical and clinical studies, design iterations, lab services, clinical data monitoring, project and site management, travel, data management and safety of the study.
Current wording
R&D has been a significant focus for us with investments in the DurAVR® THV System, including the DurAVR® THV, the ComASUR® delivery system, a disposable crimper, and an expandable access sheath, as we aim for commercialization. These components are collectively managed as part of the overall DurAVR® THV System rather than as separate projects. Since late 2021, when our DurAVR® THV was first used in human trials in Tbilisi, Georgia, R&D efforts have focused on incorporating feedback from the clinical trials and progressing towards commercialization. These costs have included, among others, preclinical and clinical studies, design iterations, lab services, clinical data monitoring, project and site management, travel, data management and safety of the study.
Previous wording
During the first and secound quarters of 2025, the Anteris team continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All production (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) is being scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity to at least three times the 2024 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the anticipated commencement of the PARADIGM Trial. In addition, the gold-standard ADAPT® tissue for the DurAVR® THV will be sourced from both the U.S. and Australia moving forward to help mitigate supply chain risks. This progress reflects the strategic deployment of capital into infrastructure that supports operational readiness and long-term growth capacity for clinical and commercial success.
Current wording
During the nine months ended September 30, 2025, the Anteris team continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All production (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) is being scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity relative to 2024 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the commencement of the PARADIGM Trial. In addition, the gold-standard ADAPT® tissue for the DurAVR® THV will be sourced from both the United States and Australia moving forward to help mitigate supply chain risks. This progress reflects the strategic deployment of capital into infrastructure that supports operational readiness and long-term growth capacity for clinical and commercial success.
Previous wording
Net sales during the three months ended June 30, 2025 was $0.6 million, compared to $0.6 million for the same period in the prior year. Net sales during the six months ended June 30, 2025 was $1.2 million, a decrease of $0.2 million (16%), compared to $1.4 million for the same period in the prior year. The movements in each period are primarily due to the Transition Services Agreement with LeMaitre, which included sales of CardioCel™ and VascuCel™ products, expiring in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2025.
Current wording
Net sales during the three months ended September 30, 2025 was $0.4 million, compared to $0.8 million for the same period in the prior year. Net sales during the nine months ended September 30, 2025 was $1.6 million, compared to $2.2 million for the same period in the prior year. The movements in each period are primarily due to the Transition Services Agreement with LeMaitre, which included sales of CardioCel™ and VascuCel™ products, expiring in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2025.
Previous wording
Cost of products sold during the three months ended June 30, 2025 was$0.1 million, a decrease of $0.2 million (53%), compared to $0.3 million for the same period in the prior year. Cost of products sold during the six months ended June 30, 2025 was$0.4 million, a decrease of $0.4 million (55%), compared to $0.8 million for the same period in the prior year. The movements in each period are primarily due to a reduction in net sales following the LeMaitre Transition Services Agreement expiring in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2025.
Current wording
Cost of products sold during the three months ended September 30, 2025 was $0.1 million, a decrease of $0.3 million (72%), compared to $0.4 million for the same period in the prior year. Cost of products sold during the nine months ended September 30, 2025 was $0.5 million, a decrease of $0.8 million (61%), compared to $1.2 million for the same period in the prior year. The movements in each period are primarily due to the change in net sales following the LeMaitre Transition Services Agreement expiring in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2025.
Previous wording
R&D expenses during the three months ended June 30, 2025 were $16.3 million, an increase of $3.7 million (29%), compared to $12.6 million for the same period in the prior year. This is primarily due to an increase of $5.0 million relating to the upscaling of manufacturing and quality capabilities, including process design and validation activities and the expansion of headcount, and a further $0.6 million related to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and the scaling of our field based clinical team. These variances were partly offset by reduced DurAVR® product research costs of $2.2 million in the second quarter of 2025 as we shift our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.
Current wording
R&D expenses during the three months ended September 30, 2025 were $16.8 million, an increase of $2.9 million (21%), compared to $13.9 million for the same period in the prior year. This is primarily due to an increase of $5.8 million relating to the upscaling of manufacturing and quality capabilities, including process design and validation activities and the expansion of headcount, a further $1.0 million related to preparatory activities linked to the PARADIGM Trial, including the scaling of our field based clinical team and $0.3 million related to an increase in v2vmedtech development activities. These variances were partly offset by reduced DurAVR® product research costs of $4.6 million in the second quarter of 2025 as we shift our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.
Previous wording
R&D expenses during the six months ended June 30, 2025 were $32.8 million, an increase of $8.6 million (36%), compared to $24.2 million for the same period in the prior year. This is primarily due to an increase of $9.1 million relating to the upscaling of manufacturing and quality capabilities including process design and validation activities and the expansion of headcount, and a further $2.5 million relating to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and the scaling of our field based clinical team. These variances were partly offset by lower DurAVR® product research costs of $3.1 million in the first six months of 2025 as we shift our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.
Current wording
R&D expenses during the nine months ended September 30, 2025 were $49.6 million, an increase of $11.5 million (30%), compared to $38.1 million for the same period in the prior year. This is primarily due to an increase of $14.9 million relating to the upscaling of manufacturing and quality capabilities including process design and validation activities and the expansion of headcount, a further $3.4 million relating to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and the scaling of our field based clinical team and $0.5 million related to an expansion of our medical affairs activities. These variances were partly offset by lower DurAVR® product research costs of $7.7 million in the nine months ended September 30, 2025 as we shift our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.
Previous wording
Selling, general and administrative expenses during the six months ended June 30, 2025 were $10.7 million, a decrease of $2.0 million (16%) compared to $12.7 million for the same period in the prior year, primarily due to a $1.0 million decline in share-based payment expenses associated with directors and executive management, $0.6 million lower marketing spend and a $0.1 million decrease in legal, tax and compliance costs, which included additional fees related to compliance with dual listing requirements and other operational matters in 2025, and in 2024 included costs related to re-domiciliation, listing of our common stock on Nasdaq and conducting our initial public offering.
Current wording
Selling, general and administrative expenses during the three months ended September 30, 2025 were $5.8 million, a decrease of $1.2 million (17%) compared to $7.0 million for the same period in the prior year, primarily due to a reduction of $0.9 million in share-based payment expenses associated with directors and executive management, $0.2 million lower travel and entertainment spend and a $0.1 million decrease in legal, tax and compliance costs, which included additional fees related to compliance with dual listing requirements, capital raising activities and other operational matters in 2025, and in 2024 included costs related to our re-domiciliation, listing of our Common Stock on Nasdaq and conducting our IPO.
Previous wording
Selling, general and administrative expenses during the three months ended June 30, 2025 were $5.0 million, a decrease of $1.1 million (19%) compared to $6.2 million for the same period in the prior year, primarily due to a reduction of $0.5 million in share-based payment expenses associated with directors and executive management and $0.4 million lower marketing spend. Expenses relating to legal, tax and compliance were relatively flat and included additional fees related to compliance with dual listing requirements and other operational matters in 2025 compared to 2024, which included costs related to our re-domiciliation, listing of our common stock on Nasdaq and conducting our initial public offering.
Current wording
Selling, general and administrative expenses during the nine months ended September 30, 2025 were $16.4 million, a decrease of $3.2 million (16%) compared to $19.7 million for the same period in the prior year, primarily due to a $1.9 million decline in share-based payment expenses associated with directors and executive management, $0.5 million lower marketing spend, a $0.5 million reduction in travel and entertainment costs and a $0.4 million decrease in legal, tax and compliance costs, which included additional fees related to compliance with dual listing requirements, capital raising activities and other operational matters in 2025, and in 2024 included costs related to re-domiciliation, listing of our Common Stock on Nasdaq and conducting our IPO.
Previous wording
Net foreign exchange losses during the three months ended June 30, 2025 were $0.3 million compared to $0.4 million of net foreign exchange losses for the same period in the prior year, a decrease of $0.1 million (23%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the second quarter of 2025, the United States dollar depreciated by 4% relative to the Australian dollar. In the second quarter of 2024, the United States dollar depreciated by 1% relative to the Australian dollar.
Current wording
Net foreign exchange losses during the three months ended September 30, 2025 were $0.1 million compared to $1.3 million of net foreign exchange losses for the same period in the prior year, a decrease of $1.2 million (94%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the third quarter of 2025, the United States dollar depreciated by 1% relative to the Australian dollar. In the third quarter of 2024, the United States dollar depreciated by 5% relative to the Australian dollar.
Previous wording
Net foreign exchange losses during the six months ended June 30, 2025 were $0.5 million compared to $0.8 million of net foreign exchange gains for the same period in the prior year, a change of $1.4 million (163%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the first half of 2025, the United States dollar depreciated by 5% relative to the Australian dollar. In the first half of 2024, the United States dollar appreciated by 3% relative to the Australian dollar.
Current wording
Net foreign exchange losses during the nine months ended September 30, 2025 were $0.6 million compared to $0.5 million of net foreign exchange losses for the same period in the prior year, a change of $0.2 million (34%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the nine months ended September 30, 2025, the United States dollar depreciated by 6% relative to the Australian dollar. In the nine months ended September 30, 2024, the United States dollar depreciated by 1% relative to the Australian dollar.
Previous wording
We have experienced recurring operating losses and cash outflows from operating activities since inception. As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of $319.1 million and $276.4 million, respectively.
Current wording
We have experienced recurring operating losses and cash outflows from operating activities since inception. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $341.3 million and $276.4 million, respectively.
Previous wording
In recent years, our operations have mainly been financed through the issuance of capital stock, including in the IPO on the Nasdaq Global Market, debt financing, convertible notes, sales of regenerative tissue products and R&D tax incentives from the Australian government. Additional funding has been derived from interest earned from cash deposits. As of June 30, 2025 and December 31, 2024, we had cash, cash equivalents and restricted cash of $28.4 million and $70.5 million, respectively. As of June 30, 2025 and December 31, 2024, we had capital commitments relating to the lease of properties of $2.4 million and $1.4 million, respectively. We did not have any other material capital expenditure commitments or contingent liabilities as of June 30, 2025 or December 31, 2024. We do not believe that our current cash on hand would fund our cash needs for the 12 months following June 30, 2025. We will need additional capital to fund our operations. However, our forecast of the period of time through which our financial resources will be adequate to support our operations involves risks and uncertainties, and actual results could vary materially.
Current wording
In recent years, our operations have mainly been financed through the issuance of capital stock, including through our IPO on the Nasdaq Global Market, the Private Placement, debt financing, convertible notes, sales of regenerative tissue products and R&D tax incentives from the Australian government. Additional funding has been derived from interest earned from cash deposits. As of September 30, 2025 and December 31, 2024, we had cash, cash equivalents and restricted cash of $9.1 million and $70.5 million, respectively. As of September 30, 2025 and December 31, 2024, we had capital commitments relating to the lease of properties of $2.2 million and $1.4 million, respectively. We did not have any other material capital expenditure commitments or contingent liabilities as of September 30, 2025 or December 31, 2024. We do not believe that our current cash on hand would fund our cash needs for the 12 months following September 30, 2025. Even with the proceeds from the Private Placement, we will need additional capital to fund our operations. However, our forecast of the period of time through which our financial resources will be adequate to support our operations involves risks and uncertainties, and actual results could vary materially.
Previous wording
We anticipate that we will require additional funds in order to achieve our long-term goals including completing the research and development of our current products and commercialization thereof. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our products and sales of our products have commenced. We therefore expect to continue to incur losses in the near future. In order to address our short-term capital needs, we intend to raise funds through the issuance of our capital stock or other securities.
Current wording
We anticipate that we will require additional funds in order to achieve our long-term goals including completing the R&D of our current products and commercialization thereof. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our products and sales of our products have commenced. We therefore expect to continue to incur losses in the near future. In order to address our short-term capital needs, we intend to raise funds through the issuance of our capital stock or other securities.
Previous wording
Net cash used in operating activities during the six months ended June 30, 2025 was $41.0 million, an increase of $12.1 million (42%), compared to $28.9 million in the same period in the prior year, primarily due to an increase in R&D expenses relating to the upscaling of manufacturing capabilities including process design and validation activities, preparatory activities linked to the PARADIGM Trial, clinical costs associated with the enrollment of additional patients and an increase in salaries and wages linked to growth in headcount. This increase was partly offset by a reduction in selling, general and administrative expenses relating to lower marketing spending and a decrease in legal, tax and compliance costs linked to a reduction in costs from 2024, which included our re-domiciliation, listing of our common stock on Nasdaq and conducting our initial public offering, relative to 2025, which included additional costs related to compliance with dual listing requirements and other operational matters.
Current wording
Net cash used in operating activities during the nine months ended September 30, 2025 was $59.3 million, an increase of $16.3 million (38%), compared to $43.0 million in the same period in the prior year, primarily due to an increase in R&D expenses relating to the upscaling of manufacturing capabilities including process design and validation activities, preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and an increase in salaries and wages linked to growth in headcount. This increase was partly offset by a reduction in selling, general and administrative expenses relating to lower marketing spending, a decline in travel and entertainment costs and a decrease in legal, tax and compliance costs linked to a reduction in costs from 2024, which included our re-domiciliation, listing of our Common Stock on Nasdaq and conducting our IPO, relative to 2025, which included additional costs related to compliance with dual listing requirements and other operational matters. Additionally, $0.6 million of proceeds relating to the Australian R&D Tax Incentive were received in the nine months ended September 30, 2025. In 2024, this corresponding inflow was received in the fourth quarter.
Previous wording
Net cash provided by investing activities during the six months ended June 30, 2025 was $0.6 million, a change of $1.9 million (142%), compared to cash outflows of $1.4 million in the same period in the prior year. This is primarily due to the receipt of $1.4 million deferred proceeds from LeMaitre relating to the sale of distribution rights in 2019. We did not have a corresponding cash inflow in 2024. Investing cash outflows for plant and equipment were $0.6 million lower than in the same period in 2024.
Current wording
Net cash used in investing activities during the nine months ended September 30, 2025 was $0.2 million, compared to cash outflows of $1.9 million in the same period in the prior year, a decrease of $1.7 million (90%). This decrease primarily reflects the receipt of $1.4 million deferred proceeds from LeMaitre relating to the 2019 sale of distribution rights, for which there was no corresponding inflow in 2024. Additionally, investing cash outflows for plant and equipment were $0.3 million lower than in the same period in 2024.
Previous wording
Net cash used in financing activities during the six months ended June 30, 2025 was $1.5 million, a change of $17.5 million (110%), compared to cash inflows of $15.9 million in the same period in the prior year. In the first half of 2025, we received net cash proceeds of $0.6 million from the issuance of shares of Common Stock, offset by net cash outflows of $1.2 million in transaction costs relating to our U.S. initial public offering, completed in December 2024, which were paid during the period. $0.9 million cash outflows were associated with supplier financing arrangements to fund our annual insurance premiums, which was an increase of $0.5 million on the same period in the prior year. In the first half of 2024, net cash provided by financing activities was $15.9 million relating to proceeds from share issuances including the exercise of options for new shares in ATPL of $17.4 million, partly offset by $1.1 million in related transaction costs.
Current wording
Net cash used in financing activities during the nine months ended September 30, 2025 was $1.8 million, compared to net cash inflows of $34.4 million in the same period of the prior year, a decrease of $36.3 million (105%). For the nine months ended September 30, 2025, we received net cash proceeds of $0.6 million from the issuance of shares of Common Stock, partially offset by $1.2 million in transaction costs related to our IPO, completed in December 2024, which were paid during the period. Additionally, $1.1 million of cash outflows were associated with supplier financing arrangements to fund our annual insurance premiums, an increase of $0.6 million on the same period in the prior year. For the nine months ended September 30, 2024, net cash provided by financing activities was $34.4 million, primarily reflecting proceeds from share issuances including the exercise of options for new shares in ATPL of $37.1 million, partly offset by $2.1 million in related transaction costs.
Previous wording
We lease laboratory and manufacturing facilities and offices. The leases typically include options to renew at which time the lease payments are subject to market adjustments and/or set price increases. Extension and termination options are included in a number of the leases to allow for flexibility in terms of corporate growth and managing the assets used in our operations. The leases expire between April 2026 and April 2030 and some include options to extend. At June 30, 2025, we had contractual commitments (on an undiscounted basis) for property leases of $3.0 million, which were recognized on a discounted basis at $2.4 million.
Current wording
We lease laboratory and manufacturing facilities and offices. The leases typically include options to renew at which time the lease payments are subject to market adjustments and/or set price increases. Extension and termination options are included in a number of the leases to allow for flexibility in terms of corporate growth and managing the assets used in our operations. The leases expire between April 2026 and April 2030 and some include options to extend. At September 30, 2025, we had contractual commitments (on an undiscounted basis) for property leases of $2.8 million, which were recognized on a discounted basis at $2.2 million.
Previous wording
At June 30, 2025, we had commitments to purchase $0.2 million of plant and equipment.
Current wording
At September 30, 2025, we had commitments to purchase $0.3 million of plant and equipment.
Previous wording
We have used various accounting policies to prepare the condensed consolidated financial statements in accordance with generally accepted accounting principles in the United States (“United States GAAP”).
Current wording
We have used various accounting policies to prepare the condensed consolidated financial statements in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”).
Previous wording
The preparation of condensed consolidated financial statements in conformity with United States GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes thereto. Management continually evaluates its judgments and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations regarding future events that management believes to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties and may be material.
Current wording
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes thereto. Management continually evaluates its judgments and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations regarding future events that management believes to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties and may be material.
Previous wording
Our significant accounting policies are discussed in Note 2, “Basis of Preparation and Summary of Significant Accounting Policies” in our Annual Report. There were no significant changes to these policies during the six months ended June 30, 2025.
Current wording
Our significant accounting policies are discussed in Note 2Basis of Preparation and Summary of Significant Accounting Policies in our Annual Report. There were no significant changes to these policies during the nine months ended September 30, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
It is anticipated that the design of the PARADIGM Trial will provide the primary clinical evidence on which the FDA could base a decision for the Premarket Approval (“PMA”) that is required for commercialization of the DurAVR®THV System in the United States. We anticipate CE Mark approval will progress in parallel to the PMA.