AVR 10-K & 10-Q changes, risk factors and insider trading

We have experienced significant recurring operating losses and negative cash flows from operating activities since inception. For the years ended December 31, 20242025 and 2023,2024, we had total losses after income tax of $76.0$94.2 million and $46.8$76.0 million, respectively, and negative cash flows from operating activities of $61.2$77.8 million and $34.6$61.2 million, respectively. As of December 31, 20242025 and December 31, 2023,2024, we had an accumulated deficit of $276.4 $370.5 million and $200.1$276.4 million, respectively. We expect to continue to incur additional losses for the foreseeable future. The losses and negative cash flows have primarily been due to the substantial investments we have made to develop our products, costs related to our sales and marketing efforts, costs related to clinical and regulatory initiatives to obtain marketing approval, and infrastructure improvements.

To become and remain profitable, we must succeed in identifying, developing, conducting successful clinical trials for,for obtaining regulatory clearance and approval for, and eventually commercializing, manufacturing and supplying products, including DurAVR® THV system,System, that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing clinical trials and preclinical studies of our products, continuing to discover and develop additional products, obtaining regulatory clearance and approval for any products that successfully complete clinical trials, developing manufacturing processes and methods, devising and implementing processes for transferring technology and manufacturing processes to a network of third-party manufacturing sites, establishing necessary quality control, establishing marketing capabilities, and commercializing and ultimately selling any approved products. We may never succeed in any or all of these activities and, even if we do, we may never generate revenue that is sufficient to achieve profitability. Even if we do achieve profitability, we may not be able to sustain profitability or meet outside expectations for our profitability. If we are unable to achieve or sustain profitability or to meet outside expectations for our profitability, the price of our Common Stock could be materially adversely affected.

Unstable market and economic conditions, including as a result of geopolitical events, suchincluding ascurrent theand warpotential in Ukraine,conflicts, may have serious adverse consequences on our business, financial condition, results of operations or liquidity, either directly or through adverse impacts on certain of the third parties on which we rely to conduct certain aspects of our preclinical studies or clinical trials.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. From time to time, the global credit and financial markets have experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, rising inflation and monetary supply shifts, rising interest rates, labor shortages, declines in consumer confidence, declines in economic growth, increases in unemployment rates, recession risks, and uncertainty about economic and geopolitical stability. Following the COVID-19 pandemic and in connection with geopolitical conflicts, globalGlobal economic and business activities continue to face widespread uncertainties. Further, following the transition to a new U.S. presidential administration in January 2025, there have been changes implemented to U.S. tax, fiscal, trade, healthcare, and other government regulatory policy. These and any future policy changes are difficult to predict, could affect the geopolitical landscape, and give rise to circumstances that are outside of our control. There can be no assurance that future deterioration in credit and financial markets and confidence in economic conditions will not occur. Our general business strategy may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions. A severe or prolonged economic downturn, or additional global financial or political crises, could result in a variety of risks to our business, including delayed clinical trials or preclinical studies, delayed approval of our products, delayed ability to obtain patents and other intellectual property protection, weakened demand for our products, if approved, or our ability to raise additional capital when needed on acceptable terms. If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay or abandon clinical development plans. In addition, there is a risk that one or more of our current service providers, manufacturers, suppliers and other partners may not survive an economic downturn, which could directly affect our ability to attain our operating goals on schedule and on budget.

Additionally, in February 2022, Russia commenced a military invasion of Ukraine. The ongoing conflict and political and physical conditions in Ukraine and Russia, as well as in neighboring countries, may disrupt our FIHEMBARK study in Tbilisi, Georgia, including the ability of third parties on which we rely to perform in accordance with our expectations. Moreover, our ability to conduct 12-month follow-ups with our study participants may be adversely affected as a result of the ongoing conflict, which could significantly delay our clinical development plans and potential clearance or approval of products or cause us to increase our R&D expenses to conduct one or more additional studies, any of which could increase our costs and jeopardize our ability to successfully commercialize our products, if approved.

In particular, our lead product, DurAVR® THV system,System, is undertaking clinical trials designed to provide the primary clinical evidence on which the FDA could base a decision for pre-market premarket approval (as defined under “Business - Government Regulation - United States FDA Regulation of Medical Devices”) required for commercialization of the DurAVR® THV systemSystem in the United States. There can be no assurance that we will successfully complete the clinical trials and obtain pre-marketpremarket approval for the DurAVR® THV system.System.

The clinical development, manufacturing, sales and marketing of our products are subject to extensive regulation as medical devices by regulatory authorities in the United States, the United Kingdom, the European Union, Australia and elsewhere. Our ability to generate revenue from sales of any of our products depends heavily on the successful identification, development, regulatory clearance or approval for and eventual commercialization of any products. All of our products, including the DurAVR® THV, will require significant preclinical and clinical development, regulatory clearance or approval, establishment of sufficient manufacturing supply, including commercial manufacturing supply, and may require us to build a commercial organization and make substantial investment and significant marketing efforts before we generate any revenue from product sales. We are not permitted to market or promote any of our products before we receive regulatory clearance or approval from the FDA or comparable foreign regulatory authorities. Obtaining regulatory clearances and approvals for new products and manufacturing processes can take a number of years and involve expenditure of substantial resources, and, despite the substantial time and expense invested, we may never receive such regulatory clearance or approval for the DurAVR® THV systemSystem or other products. The development and commercialization of our products is subject to many risks, including:

We currently have a number of products, including the DurAVR® THV system,System, in development. We conduct extensive preclinical studies and clinical trials to demonstrate the safety and efficacy in humans of our products in order to obtain regulatory clearance or approval for the sale of our products. Preclinical studies and clinical trials are expensive, complex, can take many years and have uncertain outcomes. None of, or only a small number of, our R&D programs may actually result in the commercialization of a product. We will not be able to commercialize our products if preclinical studies do not produce successful results or if clinical trials do not demonstrate safety and efficacy in humans.

Obtaining regulatory clearances and approvals for new products and manufacturing processes can take a number of years and involve the expenditure of substantial resources. Despite the substantial time and expense invested, regulatory clearance or approval is never guaranteed. The number, size and design of clinical trials that will be required will vary depending on the product or condition for which the product is intended to be used and the regulations and guidance documents applicable to any particular product. Additionally, during the review process and prior to approval, the FDA or other regulatory bodies could require additional data, which could delay approval. The FDA or other regulators can delay, limit or deny clearance or approval of a product for many reasons, including governmental resources availability and allocation, or adopt new policies or regulations requiring new or different evidence of safety and efficacy for the intended use of a product. InFurther, addition, even if such clearance or approval is secured, the approved labeling may have significant labeling limitations, including limitations on the indications for which we can market a product, or require onerous risk management programs. Furthermore, from time to time,given changes to the applicableU.S. legislation,government’s regulationspolicies and priorities since the current presidential administration entered office in January 2025, there is substantial uncertainty as to how, if at all, the administration will seek to modify or revise the requirements and policies mayof bethe introducedFDA thatand changeother theseregulatory agencies. There is also uncertainty as to how other measures being implemented by the current administration across the government will impact our activities and those of the FDA and its operations. Over the last several years, the U.S. government has experienced prolonged shutdowns and certain regulatory agencies, such as the FDA, have had to furlough employees and halt critical activities. If a government shutdown were to occur, it could significantly impact the ability of agencies to timely review and approval processes forprocess our products,regulatory submissions, which maywould makehave ita morematerial difficult andadverse costlyeffect toon obtainour or maintain regulatory clearances and approvals.business.

If our products do not gain market acceptance or if our customers prefer our competitors’ products, our potential revenue growth would be limited, which would adversely affect our business, financial condition and results of operations. Even if some of our products achieve market acceptance, the market may not prove not to be large enough to allow us to generate significant revenues.

We expect to face increasingly intense competition as new technologies become available. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Any products that we successfully develop and commercialize will compete with existing products and new products that may become available in the future. The highly competitive nature ofof, and rapid technological changes in the medical technology industry could render our products or our technology obsolete, less competitive or uneconomical. Our competitors may, among other things:

The success of many of our products may depend upon the knowledge and experience of certain key physicians and heart valve centers.

We work with leading global physicians who form our Global Medical Advisory Board, which provides guidance to us on building clinical validation of the DurAVR® THV system.System. These physicians provide considerable knowledge and experience. These physicians may assist us as researchers, marketing consultants, product trainers and consultants and as public speakers. If new laws or other developments limit our ability to appropriately engage these professionals or with the heart valve centers of which they are a part or to continue to receive their advice and input or we are otherwise unsuccessful in maintaining strong working relationships with these physicians or their heart valve centers, then the development, marketing and use of our products could suffer, which could have a material adverse effect on our business, financial condition and results of operations.

We rely on third parties to conduct our clinical trials and preclinical studies. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to seek or obtain regulatory clearance and approval for or commercialize our products may be delayed.

While the third parties upon which we rely change from time to time and for each study, historically these partners include:

In addition, we and the third parties we work with are required to comply with Good Laboratory Practice (“GLP”) and Good Clinical Practice (“GCP”) requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities. Furthermore, our clinical trials must be conducted with materials manufactured in accordance with cGMP regulations. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of the third parties we work with or our trial sites fail to comply with applicable GLP, GCP or other requirements, the data generated in our preclinical studies or clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional studies or trials before approving our marketing applications, if ever. Furthermore, our clinical trials must be conducted with materials manufactured in accordance with cGMP regulations. Failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process and our goal of receiving pre-marketpremarket approval for a product.

Any failure to protect our information technology infrastructure and our products against cyber-based attacks, network security breaches, service interruptionsinterruptions, artificial intelligence or data corruption could materially disrupt our operations and adversely affect our business and operating results.

In addition, our information technology infrastructure and products are vulnerable to cyber-based attacks. Cyber-based attacks can include computer viruses, denial-of-service attacks, phishing attacks, ransomware attacks and other introduction of malware to computers and networks; unauthorized access through the use of compromised credentials; exploitation of design flaws, bugs or security vulnerabilities; intentional or unintentional acts by employees or other insiders with access privileges; and intentional acts of vandalism by third parties and sabotage. Further, cybersecurity threats and the techniques used in cyber-based attacks change, develop, and evolve rapidly, including from emerging technologies, such as advanced forms of artificial intelligence (“AI”) and quantum computing. In addition, laws of applicable jurisdictions can expose us to investigations and enforcement actions by regulatory authorities and claims from individuals potentially resulting in penalties and significant legal liability if our information technology security efforts are inadequate.

Investors, regulators, legislators, customers, consumers, employees, and other key stakeholders are increasingly focusing on areas of corporate responsibility, and particularly matters related to ESG factors. Such matters could include, among other things, environmental stewardship, diversity, equity, and inclusion initiatives, supply chain practices, good corporate governance, workplace conduct, and support for local communities. Institutional investors have expressed expectations with respect to ESG matters that they use to guide their investment strategies and may, in some cases, choose not to invest in us if they believe our ESG policies are lagging or inadequate. Other stakeholders also have expectations regarding ESG factors, such as employees or potential employees who desire to work for a company that reflects their personal values. These areas of focus are continuing to evolve, as are the criteria on which investors assess companies’ performance in these areas. InvestorsCertain investors are increasingly looking to companies that demonstrate strong ESG and sustainability practices as an indicator of long-term resilience,resilience. especially in light of events such as the COVID-19 pandemic. Keeping up with and meeting these expectations may disrupt our business and divert the attention of our management, and we may be unable to make the investments in ESG programs that our competitors with greater financial resources are able to make. Failure to meet the expectations of investors and other stakeholders in these areas may damage our reputation, impact employee retention, impact the willingness of our customers to do business with us, or otherwise impact our financial results and stock price.

We could become exposed to product liability claims that could harm our business.business and we may be unable to obtain insurance coverage at acceptable costs and adequate levels.

Our products and operations are subject to extensive government regulationregulation, including environmental, health and safety regulations, which could result in substantial costs and any failure to comply with applicable requirements could harm our business.

Regulatory agencies may refuse to grant approval or clearance or disagree with our interpretation of the data, or disagree with our interpretation of the regulatory requirements, such as products that are subject to enforcement discretion or consumer products that do not meet the definition of an FDA-regulated medical device. Furthermore, the FDA and other regulatory agencies could change their policies, adopt additional regulations, or revise existing regulations, or change regulatory and policy priorities, each of which could impact how our products are regulated, prevent or delay approval or clearance of devices, couldor impact our ability to market a previously cleared, approved, or unregulated device. Our failure to comply with regulatory requirements of the FDA or other applicable regulatory requirements in the United States or elsewhere could subject us to administratively or judicially imposed sanctions. These sanctions could include warning letters, fines, civil penalties, criminal penalties, injunctions, debarment, product seizure or detention, product recalls and total or partial suspension of production, sale and/or promotion. Any of the foregoing actions could have a material adverse effect on our financial condition and results of operations. In addition to any such sanctions for noncompliance described above, commencement of an enforcement proceeding, inspection or investigation could divert substantial management attention from the operation of our business and, as a result, have an adverse effect on our business.

Risks RelatingRelated to Our Common Stock

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) summarizes the significant factors affecting the operating results, financial condition and liquidity, and cash flows of our company for the year ended December 31, 2024.2025. The Company was incorporated under the laws of the state of Delaware to become the holding company of our business pursuant to the Reorganization. Prior to completion of the Reorganization, the Company had no business or operations and, following completion of the Reorganization, the business and operations of the Company consists solely of the business and operations of ATGC and its subsidiaries. Our financial statements as of December 31, 2023 and as of and for the years ended December 31, 20232024 and 20242025 consolidate, and our future financial statements will consolidate,consolidate ATGC as an operating subsidiary. This MD&A should be read in conjunction with our consolidated financial statements, the accompanying notes to consolidated financial statements and other financial information included in this Form 10-K. 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- lookingforward-looking statements. You should carefully read the section titled “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section of this Form 10-K titled “CautionarySpecial Note Regarding Forward-Forward-Looking Looking Statements.Statements”.

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,System, representswas designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis — a uniquepotentially productlife-threatening opportunitycondition inresulting from a newnarrowing of the aortic valve. The balloon-expandable DurAVR® THV classis the first biomimetic valve, which is shaped to mimic the performance of single-piecea hearthealthy valves, for the treatment ofhuman aortic stenosis.valve and aims to replicate normal aortic blood flow. Our DurAVR® THV systemSystem consists of a single-piece, biomimetic valve made with our proprietary ADAPT® tissue-enhancing technology and deployed with our balloon expandable ComASUR® balloon-expandableDelivery delivery system.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 proprietarypatented 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® balloon-expandableDelivery delivery system,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 December 2025, more than 130 patients have been implanted with the DurAVR® THV system.worldwide.

As a development-stage company, we have incurred significant losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future and there can be no assurance that we will ever achieve or maintain profitability.

The 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 Reorganization, the accounts of ATL,ATPL, its wholly-owned subsidiaries, and entities for which ATLATPL has a controlling financial interest. Intercompany transactions, balances and unrealized gains and losses on transactions between such entities are eliminated.

Our management has determined that the activities of the business as reviewed by the Vice Chairman and Chief Executive Officer, the chief operating decision maker,maker (“CODM”), are one segment, being the development and commercialization of the ADAPT® anti-calcification tissue. This is focused on the DurAVR® THV system.System.

We currently derive revenue from the sale of regenerative tissue products. Such sales arehave historically been made principally to 4C and to LeMaitre,LeMaitre Vascular, Inc. (“LeMaitre”), a distributor of medical products, to whom we sold ourthe distribution rights for CardioCel™ and VascuCel™ patch business in 2019 in order to focus on development of our proprietary ADAPT® tissue for the DurAVR® THV system.System. UnderConcurrent with such sales, we entered into a distributiontransition agreement,services agreement (the “Transition Services Agreement”) with LeMaitre, pursuant to which we manufacturemanufactured and sell thesold CardioCel™ and VascuCel™ products to LeMaitre. The Transition Services Agreement with LeMaitre expired in January 2025. We recognized revenue from LeMaitre during January 2025 in accordance with the terms of the Transition Services Agreement; however, we do not expect to receive any significant futureongoing revenues from LeMaitre.LeMaitre Theassociated initialtherewith. termWe ofwere ouralso Supplyparty to the 4C Agreement, a supply and Licenselicense Agreementagreement with 4C, expireswhich had an initial seven-year term that expired on June 1, 2026,2025, at whichand timeunder itits terms would automatically renewsrenew for successive one-year terms.periods unless either party provided written notice of non-renewal at least 180 days prior to the applicable renewal date. On November 26, 2025, we notified 4C that we were not renewing the 4C Agreement, which will terminate on June 1, 2026. We will not incur any early termination penalties in connection with its non-renewal of the 4C Agreement.

R&D has been a significant focus for us with investments in the DurAVR® THV system,System, including the DurAVR® THV, the ComASUR® deliveryDelivery system,System, a disposable crimper, and an expandable access sheath, as we advanceaim towardsfor commercial use.commercialization. These components are collectively managed as part of the overall DurAVR® THV systemSystem rather than as separate projects. Since late 2021, when our DurAVR® THV delivery system was first used in human trials in Tbilisi, Georgia, R&D efforts have focused on incorporating feedback from the early clinical trial and progressing towards commercialization. These costs have included, among others, preclinical and clinical studies, design iterations, lablaboratory services, clinical data monitoring, project and site management, travel, data management and safety of the study.

Net sales in 20242025 was $2.7$1.9 million, a decrease of $0.03$0.8 million (1%29%), compared to $2.7 million in 2023,2024, primarily due to lowera decrease in sales volumesof CardioCel™ and VascuCel™ products pursuant to the expiration of the LeMaitre Transition Services Agreement in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2024.2025.

Cost of products sold in 20242025 was $1.4$0.6 million, a decrease of $0.4$0.9 million (23%60%), compared to $1.9$1.4 million in 2023,2024, primarily due to a changedecrease in sales of CardioCel™ and VascuCel™ products following the mixexpiration of the LeMaitre Transition Services Agreement in January 2025, partly offset by increased demand for other higher-yielding tissue products sold.in 2025.

R&D expenses in 20242025 were $51.5$69.1 million, an increase of $20.6$17.7 million (67%34%) compared to $30.9$51.5 million in 2023.2024. This is primarily due to $16.0an increase of $19.8 million relating to preparatory activities associated with the Pivotal Trial, including on-going product development, $3.9 million relatingrelated to the upscaling of manufacturing capabilitiesand quality capabilities, including theprocess expansiondesign and validation activities, and an increase in R&D headcount, an increase of headcount, $1.3$5.5 million relatingrelated to v2vmedtechPARADIGM developmentTrial andpreparatory $0.6 millionactivities, relating to increasedincluding clinical costs including those associated with the enrollment of additional patients.patients Thisand wasthe partiallyscaling of our field-based clinical team, and an increase of $1.0 million related to an expansion of our medical affairs activities. These variances were partly offset by alower reductionDurAVR® THV product research costs of $9.5 million in medical2025 affairsas we shift our focus to clinical, regulatory and manufacturing activities ahead of $1.4the million.PARADIGM Trial.

Other non-operating income, net in 20242025 was $2.4$0.5 million, ana increasedecrease of $0.5$2.0 million (26%81%) compared to $1.9$2.4 million in 2023,2024, primarily due to the recognition of holdback income in 2024 of $0.9 million fromrelated to a transaction with LeMaitre in 2019.2019 EFSfor reimbursementwhich income of $0.3 millionthere was recognized in 2023, and we did not haveno corresponding income in 2024.2025. In 2024, $0.8 million of government grants relating to the Australian R&D Tax Incentive were recognized with no corresponding income in 2025.

Net foreign exchange gainslosses in 20242025 were $1.4$0.7 million compared to $0.6$1.4 million of net foreign exchange lossesgains in 2023,2024, awhich change of $2.1 million (327%),was primarily due to the change in foreign exchange rates on intercompany and cash balances. In 2025, the United States dollar depreciated by 8% relative to the Australian dollar. In 2024, the United States dollar appreciated by 9% relative to the Australian dollar (“AUD $”).dollar.

Debt issuance costs in 2024 waswere $0.5 millionmillion, primarily due to the entry into a secured convertible note facility enteredin into during the year.2024. The convertible notes were recognized at fair value through profit or loss which resulted in the costs being expensed when incurred. We did not have a corresponding charge in 2023. See “Liquidity and Capital Resources — Convertible Note Facility” for additional details regarding the secured convertible note facility.2025.

Net incomeloss attributable to non-controlling interests (“NCI”) was $0.3$0.1 million,million anin increase2025, a decrease of $1.1$0.4 million (144%125%) compared to a $0.7$0.3 million lossincome in 20232024. primarilyThe duemovement toreflects the useapplication of the hypothetical liquidation at book approach to measure the NCI interest which is impacted by movements in creditors and prepayments.interest.

We have experienced significant recurring operating losses and negative cash flows from operating activities since inception. As of December 31, 20242025 and December 31, 2023,2024, we had an accumulated deficit of $276.4$370.5 million and $200.1$276.4 million, respectively.

In recent years, our operations have mainlyprimarily been financed through the issuance of capital stock, including in our initial public offering, the 2025 Private Placement, as well as through convertible notes, sales of regenerative tissue products and R&D tax incentives from the Australian government. AdditionalWe have also generated additional funding has come through interest earned fromon cash deposits. As of December 31, 20242025 and December 31, 2023,2024, we had cash and cash equivalents of $70.5$12.6 million and $21.1$70.5 million, respectively. As of December 31, 20242025 and December 31, 2023,2024, we had capital commitments of $1.4$2.2 million and $1.6$1.4 million, respectively, relating to the lease of properties.properties, Weand we did not have any other material capital expenditure commitments or contingent liabilities as of December 31, 2024. We do not believe that our current cash on hand would fund our cash needs for the 12 months following December 31, 2024, and that we will need to access the capital markets and debt markets to fund our cash needs. 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.2025.

We anticipate that we will require substantial additional funds in order to achieve our long-term goals and complete the R&D of our current products. 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 substantial 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.

Net cash used in investing activities in 20242025 was $2.3$0.6 million, a decrease of $0.3$1.7 million (12%74%), compared to $2.6$2.3 million in 2023,2024. This decrease primarily duereflects tothe $0.2receipt of $1.4 million ofdeferred costsproceeds from LeMaitre in 2025 relating to the acquisition2019 sale of v2vmedtechdistribution inrights, 2023.for Wewhich didthere notwas have ano corresponding cash outflowinflow in 2024. Additionally, investing cash outflows for plant and equipment decreased by $0.3 million compared with 2024.

We have used various accounting policies to prepare the consolidated financial statements in accordance with generally accepted accounting principles in the United States (“United StatesU.S. GAAP”). Our significant accounting policies and estimates are more fully described in Notenote 2 to our audited consolidated financial statements.

The preparation of the consolidated financial statements in conformity with United StatesU.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the 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.

We face a number of risks that could materially and adversely affect our business, results of operations, cash flow, liquidity, or financial condition. Please refer to the factors discussed in Part I, Item 1A. “Risk Factors” in the Annual Report. Other than the supplemental risk factorfactors provided below, there have been no material changes or additions to our risk factors discussed in such report that could materially impact our business, results of operations, cash flow, liquidity, or financial condition.

Anteris is a structural hearthealthcare 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® Transcatheter Heart Valve (“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 a narrowing of the aortic valve. The balloon-expandable DurAVR® THV is thea firstnew class of 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 ComASUR® balloon-expandable delivery system (the “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 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.

Recruitment to the PARADIGM Trial commenced in Europe in October 2025. In November 2025, followedwe by receipt ofreceived FDA Investigational Device Exemption (“IDE”) approvalapproval, forenabling expansion of the trial ininto Novemberthe 2025.United States. In April 2026, we secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under athe Centers for Medicare & Medicaid Services (“CMS”) national coverage policy. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. ThisRecruitment milestone supportedin the activationUnited ofStates our initialsubsequently U.S.commenced, sites as part ofwith the PARADIGM Trial with first patients enrolled and treated duringin May 2026.

Recruitment remains ongoing, with planned expansion into additional clinical sites and countries to further acceleratesupport patient enrollment. The PARADIGM Trial is supported by early clinical experience from over 130 patients treated with the DurAVR® THV.

Our management has determined that the activities of the business as reviewed by our Vice Chairman and Chief Executive Officer, who also serves as our chief operating decision maker, are one segment, being the development and commercialization of the DurAVR® THV System which includes the ADAPT® anti-calcification tissue. This is focused on the DurAVR® THV System.

The Supply and License Agreement with 4C (the “4C Agreement”), had an initial seven-year term that ended on June 1, 2025, and under its terms would automatically renew for successive one-year periods unless either party provided written notice of non-renewal at least 180 days prior to the applicable renewal date. On November 26, 2025, we notified 4C that we would not renew the 4C Agreement for the next renewal term. The agreement4C willAgreement expireexpired on June 1, 2026,2026. The Company expects to continue supplying products under purchase orders issued prior to the expiration of the 4C Agreement, generally on the same commercial terms and noconditions earlythat terminationapplied penaltiesunder arethe anticipated4C in connection with its non-renewal.Agreement. The expiration of the 4C Agreement is not expected to have a material impact on our financial results.

R&D has been a significant focus with investments in the DurAVR® THV System, including the DurAVR® THV, the ComASUR® Delivery System, a disposable crimper, and an expandable access sheath. 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 clinical insights to refine and advance the technology, supporting the pathway toward 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 monitoring of the study.

During the threesix months ended MarchJune 31,30, 2026, the Anteris teamwe continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All productionProduction (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) is being progressively scaled into new ISOor Qualifiedexpanded Clean Room facilities, increasing manufacturing capacity relative to 2025 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the PARADIGM Trial. In addition, the gold-standard ADAPT® tissue for the DurAVR® THV is planned to 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 areas that support operational readiness and long-term growth capacity for clinical and commercial success.

Net sales duringfor the threesix months ended MarchJune 31,30, 2026 waswere $0.5$1.5 million, compared to $0.6$1.2 million for the same period in the prior year.year, Therepresenting decreasean increase of $0.1 million was primarily due to net sales in the three months ended March 31, 2025 included $0.3 million from(28%). The increase primarily reflects increased sales of tissue products to 4C and was partially offset by the salecessation of sales of CardioCel™ and VascuCel™ products to LeMaitre in connection withunder the Transition Services Agreement,Agreement with LeMaitre, which expired in January 2025, offset by an increase of net sales of tissue products to 4C increasing by $0.2 million in the three months ended March 31, 2026 compared to the prior year.2025.

Cost of products sold duringfor the threesix months ended MarchJune 31,30, 2026 was $0.1$347 million, a decrease of $0.1 million (45%),thousand, compared to $0.2$355 millionthousand for the same period in the prior year.year, Thea decrease inof cost2%. Cost of products sold wasremained generally consistent with the prior-year period, despite a 28% increase in net sales primarily due to thea inclusionshift in sales mix toward higher-margin tissue product sales to 4C, partially offset by the three months ended March 31, 2025 of amounts associated with salesabsence of CardioCel™ and VascuCel™ productsproduct sales under the Transition Services Agreement with LeMaitre.LeMaitre, Thiswhich decrease was partially offset by increased production volumes due to increasesexpired in demandJanuary for tissue products from 4C in 2026.2025.

R&D expenses during the three months ended MarchJune 31,30, 2026 were $17.5$23.4 million, an increase of $1.0 million (6%), compared to $16.5$16.3 million for the same period in the prior year.year, representing an increase of $7.0 million (43%). This increase was primarily due to an increase of $2.0$3.6 million in the three months ended MarchJune 31,30, 2026 related to the upscaling of manufacturing and quality capabilities, including process designdevelopment and validation activities and the expansion of headcount, and an increase of $1.0$3.1 million related to activities linked to the PARADIGM Trial, including the scaling of our field based clinical team.team, and higher stock-based payment expenses of $1.4 million resulting from increases in the share price and headcount. These were partly offset by reduced DurAVR® product research costs of $2.0$0.7 millionmillion, asand welower shiftedv2vmedtech development expenses of $0.6 million, reflecting reduced development activities following our focusdecision to clinical,cease regulatoryfurther andv2vmedtech manufacturing activities ahead of the PARADIGM Trial.funding.

Selling, general and administrative expenses during the three months ended MarchJune 31,30, 2026 were $6.9$8.4 million, an increase of $1.3 million (22%) compared to $5.0 million for the same period in the prior year, whichrepresenting an increase of $3.4 million (68%). This increase was primarily due to higher employee relatedcosts costs,associated with headcount growth, increased share basedstock-based payment expenses, and additional consulting costs.and IT expenditures to support the expansion of our operations.

Other non-operating income, net during the three months ended MarchJune 31,30, 2026 was $1.7$2.4 million, an increase of $1.6 million compared to $0.1 million for the same period in the prior year, whichrepresenting an increase of $2.3 million (1,535%). Other non-operating income, net during the six months ended June 30, 2026 was $4.1 million, compared to $0.2 million for the same period in the prior year, representing an increase of $3.9 million (1,633%). The increases during both periods were primarily due to interesthigher investment income earned on money-market fund deposits and U.S. Treasury securities following the January 2026 capital raises.

Net foreign exchange losses during the three months ended MarchJune 31,30, 2026 were $0.1 millionmillion, compared to $0.2$0.3 million of net foreign exchange losses for the same period in the prior year, which amounted torepresenting a decrease of $0.1$0.2 million (57%66%),. The decrease primarily duereflects to the change inlower foreign exchange ratesmovements recognized on foreign currency denominated intercompany and cash balances. InDuring the firstthree quartermonths ofended June 30, 2026, the United StatesU.S. dollar depreciated by 2%approximately 1% relative to the Australian dollar (“AUD $”)., Incompared to a depreciation of approximately 4% during the firstthree quartermonths ofended 2025,June the United States dollar depreciated by 1% relative to the AUD $.30,2025.

Income tax expense duringfor the threesix months ended MarchJune 31,30, 2026 was $0.5 million, compared to nil for the same period in the prior year,year. representing anThe increase of $0.5 million, primarilywas due to the recognition of withholding tax expense incurredrecognized during the period in connection with amounts payable by the Company’sour Swiss subsidiary. No income tax expense was recognized during the three months ended June 30, 2026 or 2025.

We have experienced recurring operating losses and cash outflows from operating activities since inception. As of MarchJune 31,30, 2026 and December 31, 2025, we had an accumulated deficit of $393.6$422.7 million and $370.5 million, respectively.

In recent years, our operations have primarily been financed through the issuance of capital stock as well as through convertible notes, sales of regenerative tissue products and R&D tax incentives from the Australian government. We have also generated additional funding through interest earned on cash deposits. AsIn May 2026, we established an ATM equity offering program pursuant to a sales agreement with TD Cowen, under which we may offer and sell shares of Marchour 31,Common 2026Stock andhaving Decemberan 31,aggregate 2025,offering we had cash and cash equivalentsprice of $283.2up to $250.0 million andfrom $12.6 million, respectively. As of March 31, 2026 and December 31, 2025, we had capital commitments of $3.0 million and $2.2 million, respectively relatingtime to the lease of properties, and we did not have any other material capital expenditure commitments or contingent liabilities.time.

Net cash used in operating activities during the threesix months ended MarchJune 31,30, 2026 was $28.7$49.5 million, an increase of $7.2 million (33%), compared to $21.5$41.0 million in the same period in the prior year, reflecting an increase of $8.5 million (21%), primarily due to higher cash expendituresoutflows for R&D, including costs relating to the upscaling of manufacturing capabilities including process design and validation activities, preparatory and ongoing activities linked to the PARADIGM Trial, and an increase in salaries and wages fromrelating a growth into headcount and the timing of payments to suppliers, including the settlement of liabilities outstanding at December 31, 2025.growth.

Net cash used in investing activities during the threesix months ended MarchJune 31,30, 2026 was $0.2$0.8 million, compared to net cash provided by investing activities of $1.1$0.6 million in the same period in the prior year, reflecting a decrease of $1.3$1.4 million (116%).million. This decrease was primarily due to the receipt of $1.4 million of deferred proceeds from LeMaitre in the prior year, relating to the 2019 sale of distribution rights, for which there was no corresponding inflow in the current year. Additionally, cashCash outflows for purchases of plant and equipment were $0.8 million during the threesix months ended MarchJune 31,30, 20262026, werewhich $0.1is millionbroadly lowerconsistent than inwith the same period in 2025.

Net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2026 was $299.5$298.6 million, compared to net cash used in financing activities of $1.1$1.5 million in the same period of the prior year, reflecting an increase of $300.6$300.2 million. During the threesix months ended MarchJune 31,30, 2026, we received proceeds of $308.3 million from the issuance of shares of Common Stock net of underwriting fees, which werewas partially offset by $8.2$8.6 million of share issuance transactioncosts costs.paid Induring the threeperiod, including costs associated with the establishment of the ATM program. During the six months ended MarchJune 31,30, 2025, we received proceeds of $0.6 million werefrom receivedshare issuances and incurred $1.2 million of transaction costs related to share issues and cash outflows of $1.2 million were incurred related to transaction costs from theour 2024 initial public offering. Additionally,In addition, we repaid $0.6$0.9 million of outstanding insurance-related supplier financing debt during the period, representing an increase of $0.1 million compared toboth the samecurrent period in theand prior year.periods.

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 March 31, 2026, we had contractual commitments (on an undiscounted basis) for property leases of $3.5 million, which were recognized on a discounted basis at $3.0 million.

(12) Predominantly used for R&D, manufacturing of the DurAVR® THV System and regulatory compliance teams.

At MarchJune 31,30, 2026, we had commitments to purchase $0.1$0.3 million of plant and equipment.

Our significant accounting policies are discussed in Note 2, “Basis of PreparationPresentation and Summary of Significant Accounting Policies” in our Annual Report. There were no significant changes to these policies during the threesix months ended MarchJune 31,30, 2026.

Consolidation of VIEsv2vmedtech

See Note 2 to our condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q for more information.

We are an “emerging growth company” (an “EGC”), as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). The JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an EGC to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period for any new or revised accounting standards during the period in which we remain an EGC. As a result, the information that we provide to our investors may be different than what you might receive from other public reporting companies. However, we may adopt certain new or revised accounting standards early.