AVR

MKT CAP $585.7MP/E —DIV YIELD —FCF YIELD -15.06%REV TTM $2.2M −9.6%NET INCOME −$103.6MNET CASH $249.9M52W 3.38 – 10.57NEXT EARNINGS Nov 12 EST.SEC XBRL · TTM TO Invalid Date

How AVR rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Item 1A Risk Factors Risks Related to Our Business Risks Related to Our Operating History and Financial Position We have a history of operating losses and may not achieve or maintain profitability in the future.
We have experienced recurring operating losses and negative cash flows from operating activities since inception.
For the years ended December 31, 2025 and 2024, we had total losses after income tax of $94.2 million and $76.0 million, respectively, and negative cash flows from operating activities of $77.8 million and $61.2 million, respectively.
As of December 31, 2025 and December 31, 2024, we had an accumulated deficit of $370.5 million and $276.4 million, respectively.
Unstable market and economic conditions, including as a result of geopolitical events, including current and potential 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.
Global economic and business activities 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.
The ongoing conflict and political and physical conditions in Ukraine and Russia, as well as in neighboring countries, may disrupt our EMBARK study in Tbilisi, Georgia, including the ability of third parties on which we rely to perform in accordance with our expectations.
In particular, our lead product, DurAVR ® THV System, is undertaking clinical trials designed to provide the primary clinical evidence on which the FDA could base a decision for premarket approval required for commercialization of the DurAVR ® THV System in the United States.
There can be no assurance that we will successfully complete the clinical trials and obtain premarket approval for the DurAVR ® THV System.
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.
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 System or other products.
The development and commercialization of our products is subject to many risks, including: • additional clinical trials may be required beyond what we currently expect; • the risk that our financial and other resources are not sufficient to complete the necessary clinical trials; • regulatory authorities may disagree with our interpretation of data from our clinical trials or may require that we conduct additional trials; • we may be unable to obtain and maintain regulatory clearance or approval of our products in any jurisdiction; • regulatory authorities may identify deficiencies in manufacturing processes; • regulatory authorities may lack sufficient resources to timely and completely address applications for regulatory clearance or approval of our products; • regulatory authorities may change their clearance or approval policies or adopt new regulations; • we, or our third-party manufacturers, may not be able to source or produce current Good Manufacturing Practice (“cGMP”) materials for the production of our products or product candidates; • our products, if approved, may not be able to be manufactured at a cost or in quantities necessary to make commercially successful products; • we may experience delays in the commencement of, enrollment of patients in and timing of our clinical trials or we may not be able to complete our clinical trials; • we may not be able to achieve and maintain compliance with all regulatory requirements applicable to our products or operations; • we may not be able to maintain a continued acceptable safety profile of our products following clearance or approval; • the market may not accept our products, if approved; • we may be unable to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations, and the effectiveness of our own or any future strategic collaborators’ marketing, sales and distribution strategy and operations will affect our profitability; • we may experience competition from existing products or new products that may emerge; • we may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect our products; and • we may not be able to obtain and maintain coverage and adequate reimbursement from third-party payors.
We currently have a number of products, including the DurAVR ® THV System, in development.
Further, given changes to the U.S. government’s policies 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 of the FDA and other regulatory 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 process our regulatory submissions, which would have a material adverse effect on our business.
Even if some of our products achieve market acceptance, the market may not prove to be large enough to allow us to generate significant revenues.
Fro m time to time, we may publicly disclose preliminary or top-line data from our preclinical studies and clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
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.
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, these partners include: • Bright Research, which is a clinical research organization that provides us with clinical data monitoring, project and site management, data management, and safety reporting services; • CRF, which provides us with core lab services and an independent clinical events committee; and • QMED, which provides clinical trial support for the EU, including the provision of life science services in the areas of regulatory affairs, training, quality assurance and control, clinical trial consultancy and submission support to the EU authorities.
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 premarket approval for a product.
Any failure to protect our information technology infrastructure and our products against cyber-based attacks, network security breaches, service interruptions, artificial intelligence or data corruption could materially disrupt our operations and adversely affect our business and operating results.
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.
Artificial intelligence technologies could present business, compliance and reputational risks.
Recent technological advances in AI and machine-learning technology both present opportunities and pose risks to us.
If we fail to keep pace with rapidly evolving technological developments in AI, our competitive position and business results may suffer.
We face risk of competitive disadvantage if our competitors more effectively use AI to better serve customers, drive internal efficiencies, and/or create new or enhanced products or services.
We have begun to incorporate AI capabilities into our operations and the introduction of these technologies, particularly generative AI, into internal processes, customer engagements, and/or new and existing product offerings may result in new or expanded risks and liabilities, including due to enhanced governmental or regulatory scrutiny, litigation, compliance issues, ethical concerns, confidentiality or security risks, as well as other factors that could adversely affect our business, reputation, and financial results.
In addition, our personnel could, unbeknownst to us, improperly utilize AI and machine learning-technology while carrying out their responsibilities.
The use of AI in the development of our products and services could also cause loss of intellectual property, as well as subject us to risks related to intellectual property infringement or misappropriation, data privacy and cybersecurity.
The use of AI can lead to unintended consequences, including generating content that appears correct but is factually inaccurate, misleading or otherwise flawed, or that results in unintended biases and discriminatory outcomes, which could harm our reputation and business and expose us to risks related to inaccuracies or errors in the output of such technologies.
Finally, multiple jurisdictions have either already put in place laws and regulations governing the use of AI, or are considering such laws and regulations.
Compliance with these laws, regulations, and industry frameworks may limit our ability to leverage AI or require us to substantially revise our approach to its use.
Certain investors are increasingly looking to companies that demonstrate strong ESG and sustainability practices as an indicator of long-term resilience.
Risks Related to Legal and Regulatory Matters We co uld become exposed to product liability claims that could harm our business and we may be unable to obtain insurance coverage at acceptable costs and adequate levels.

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Gone since FY2024

Risks Related to Our Business Risks Related to Our Operating History and Financial Position We have a history of operating losses and may not achieve or maintain profitability in the future.
We have experienced significant recurring operating losses and negative cash flows from operating activities since inception.
For the years ended December 31, 2024 and 2023, we had total losses after income tax of $76.0 million and $46.8 million, respectively, and negative cash flows from operating activities of $61.2 million and $34.6 million, respectively.
As of December 31, 2024 and December 31, 2023, we had an accumulated deficit of $276.4 million and $200.1 million, respectively.
There is substantial doubt about our ability to continue as a going concern.
As a result of our net loss and net cash outflows from operating activities, our independent external auditor included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended December 31, 2024 that indicated our results raise substantial doubt on our ability to continue as a going concern.
The conditions giving rise to this uncertainty and our plan with respect to this uncertainty are disclosed in Note 3 to our consolidated financial statements.
Our future viability as an ongoing business is dependent on our ability to attract additional capital and ultimately, upon our ability to develop future profitable operations.
There is no assurance that we will be successful in obtaining sufficient funding to fund continuing operations on terms acceptable to us, if at all.
The perception that we might be unable to continue as a going concern may also make it more difficult to obtain financing for the continuation of our operations on terms that are favorable to us, or at all, and could result in the loss of confidence from investors and employees.
Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.
If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that our investors will lose all or a part of their investment.
We will require substantial additional future financing and may be unable to raise sufficient capital, which could have a material impact on our R&D programs or commercialization of our products.
Unstable market and economic conditions, including as a result of geopolitical events, such as the war in Ukraine, 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.
Following the COVID-19 pandemic and in connection with geopolitical conflicts, global economic and business activities continue to face widespread uncertainties.
The ongoing conflict and political and physical conditions in Ukraine and Russia, as well as in neighboring countries, may disrupt our FIH study in Tbilisi, Georgia, including the ability of third parties on which we rely to perform in accordance with our expectations.
In particular, our lead product, DurAVR ® THV system, is undertaking clinical trials designed to provide the primary clinical evidence on which the FDA could base a decision for pre-market approval (as defined under “ Business - Government Regulation - United States FDA Regulation of Medical Devices ”) required for commercialization of the DurAVR ® THV system in the United States.
There can be no assurance that we will successfully complete the clinical trials and obtain pre-market approval for the DurAVR ® THV system.
All of our products, including 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.
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 DurAVR ® THV system or other products.
The development and commercialization of our products is subject to many risks, including: • additional clinical trials may be required beyond what we currently expect; • the risk that our financial and other resources are not sufficient to complete the necessary clinical trials; • regulatory authorities may disagree with our interpretation of data from our clinical trials or may require that we conduct additional trials; • we may be unable to obtain and maintain regulatory clearance or approval of our products in any jurisdiction; • regulatory authorities may identify deficiencies in manufacturing processes; • regulatory authorities may lack sufficient resources to timely and completely address applications for regulatory clearance or approval of our products; • regulatory authorities may change their clearance or approval policies or adopt new regulations; • we, or our third-party manufacturers, may not be able to source or produce current Good Manufacturing Practice (“cGMP”) materials for the production of our products or product candidates; • our products, if approved, may not be able to be manufactured at a cost or in quantities necessary to make commercially successful products; • we may experience delays in the commencement of, enrollment of patients in and timing of our clinical trials; • we may not be able to achieve and maintain compliance with all regulatory requirements applicable to our products or operations; • we may not be able to maintain a continued acceptable safety profile of our products following clearance or approval; • the market may not accept our products, if approved; • we may be unable to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations, and the effectiveness of our own or any future strategic collaborators’ marketing, sales and distribution strategy and operations will affect our profitability; • we may experience competition from existing products or new products that may emerge; • we may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect our products; and • we may not be able to obtain and maintain coverage and adequate reimbursement from third-party payors.
We currently have a number of products, including DurAVR ® THV system, in development.
Even if some of our products achieve market acceptance, the market may prove not to be large enough to allow us to generate significant revenues.
From time to time, we may publicly disclose preliminary or top-line data from our preclinical studies and clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
The success of many of our products may depend upon 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 DurAVR ® THV system.
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 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: • IQVIA, which is a clinical research organization that provides us with clinical data monitoring, project and site management, data management, and safety reporting services for the EFS; • CRF, which provides us with core lab services for the EFS and an independent clinical events committee; and • QMED, which provides clinical trial support for the EU, including the provision of life science services in the areas of regulatory affairs, training, quality assurance and control, clinical trial consultancy and submission support to the EU authorities.
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-market approval for a product.
Any failure to protect our information technology infrastructure and our products against cyber-based attacks, network security breaches, service interruptions or data corruption could materially disrupt our operations and adversely affect our business and operating results.
Investors are increasingly looking to companies that demonstrate strong ESG and sustainability practices as an indicator of long-term resilience, especially in light of events such as the COVID-19 pandemic.
Risks Related to Legal and Regulatory Matters We could become exposed to product liability claims that could harm our business.
Our products and operations are subject to extensive government regulation and any failure to comply with applicable requirements could harm our business.
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, could impact our ability to market a previously cleared, approved, or unregulated device.
Risks Relating to Our Common Stock The market price and trading volume of our Common Stock may be volatile and may be affected by economic conditions beyond our control.
Differences in the trading schedules, as well as volatility in the exchange rate of the two currencies, among other factors, may result different trading prices for our Common Stock and CDIs on the two exchanges.
ATL (which became a subsidiary of the Company following completion of the Reorganization) did not declare any dividends during fiscal years 2021, 2022, 2023 or 2024 and we do not anticipate that we will do so in the foreseeable future.
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies.
For example, we have elected to rely on an exemption from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”) relating to internal control over financial reporting, reduced disclosure obligations regarding executive compensation in this Form 10-K and our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation.
The Dodd-Frank Wall Street Reform and Consumer Protection Act, the Sarbanes-Oxley Act, the listing requirements of Nasdaq, and other applicable securities rules and regulations impose various requirements on public companies, including the filing of reports with respect to our business and operating results, establishment and maintenance of effective disclosure controls and procedures, maintenance and reporting of our system of internal control over financial reporting, and other corporate governance practices.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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