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Anteris Technologies Global Corp.

For the period ended Jun 30, 2026. Filed Aug 11, 2026.

View on SEC.gov

About this filing

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.

Jun 30, 2026 · Filed Aug 11, 2026

AVR$5.69+2.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-12.

0001140361-26-020806

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-11.

0001140361-26-032232

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The 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 86 previous paragraphs and 98 current paragraphs.

55 unchanged; 23 reworded; 20 added; 7 removed; 1 previous and 0 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 (20)

Current report

We received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (“ANSM”) during June 2026, enabling patient recruitment to commence at leading centers in France and further supporting expansion of the trial across Europe.

Current report

In May 2026, we established an at-the-market (“ATM”) equity offering program pursuant to a sales agreement with TD Securities (USA) LLC (“TD Cowen”), under which we may offer and sell shares of our Common Stock having an aggregate offering price of up to $250.0 million from time to time. We intend to use any net proceeds from the ATM program, together with our existing cash and cash equivalents, primarily to support the ongoing development of the DurAVR® THV System, with the remainder for working capital and other general corporate purposes.

Current report

Net sales for the three months ended June 30, 2026 were $1.0 million, compared to $0.6 million for the same period in the prior year, representing an increase of $0.4 million (63%). The increase primarily reflects increased sales of tissue products to 4C.

Current report

Net sales for the six months ended June 30, 2026 were $1.5 million, compared to $1.2 million for the same period in the prior year, representing an increase of $0.3 million (28%). The increase primarily reflects increased sales of tissue products to 4C and was partially offset by the cessation of sales of CardioCel™ and VascuCel™ products under the Transition Services Agreement with LeMaitre, which expired in January 2025.

Current report

Cost of products sold for the three months ended June 30, 2026 was$233 thousand, compared to $148 thousand for the same period in the prior year, representing an increase of $85 thousand (57%). Cost of products sold increased in line with the increase in sales volumes of tissue products to 4C. Gross margin remained generally consistent with the prior-year period.

Current report

Cost of products sold for the six months ended June 30, 2026 was$347 thousand, compared to $355 thousand for the same period in the prior year, a decrease of 2%. Cost of products sold remained generally consistent with the prior-year period, despite a 28% increase in net sales primarily due to a shift in sales mix toward higher-margin tissue product sales to 4C, partially offset by the absence of CardioCel™ and VascuCel™ product sales under the Transition Services Agreement with LeMaitre, which expired in January 2025.

Current report

R&D expenses during the six months ended June 30, 2026 were $40.8 million, compared to $32.8 million for the same period in the prior year, representing an increase of $8.0 million (24%). This increase was primarily due to an increase of $5.6 million in the six months ended June 30, 2026 related to the upscaling of manufacturing and quality capabilities, including process development and validation activities and the expansion of headcount, and an increase of $3.9 million related to activities linked to the PARADIGM Trial, including the scaling of our field based clinical 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 $2.4 million, and lower v2vmedtech development expenses of $0.8 million, reflecting reduced development activities following our decision to cease further v2vmedtech funding.

Current report

Selling, general and administrative expenses during the six months ended June 30, 2026 were $15.3 million, compared to $10.7 million for the same period in the prior year, representing an increase of $4.6 million (43%). This increase was primarily due to higher employee costs associated with headcount growth, increased stock-based payment expenses, and additional consulting and IT expenditures to support the expansion of our operations.

Current report

Net foreign exchange losses during the six months ended June 30, 2026 were $0.2 million, compared to $0.5 million for the same period in the prior year, representing a decrease of $0.3 million (63%). The decrease primarily reflects lower foreign exchange movements recognized on foreign currency denominated intercompany and cash balances. During the first half of 2026, the U.S. dollar depreciated by approximately 3% relative to the AUD $, compared to a depreciation of approximately 5% during the first half of 2025.

Current report

As of June 30, 2026, we had cash, cash equivalents and restricted cash of $260.9 million, including $3.5 million classified as a non-current asset. This relates to cash collateral supporting a standby letter of credit associated with a property lease. As of June 30, 2026 and December 31, 2025, we had lease liabilities of $2.9 million and $2.2 million, respectively relating to existing leased properties. In addition, as of June 30, 2026, we had entered into a long-term property lease that had not yet commenced and therefore was not recognized as a lease liability in the condensed consolidated balance sheet. The future undiscounted contractual lease payments associated with this arrangement are $23.2 million over the lease term.

Current report

Operating cash outflows were also impacted by timing of the settlement of working capital liabilities that were outstanding at December 31, 2025, which were elevated due to the timing of supplier payments prior to the completion of our January 2026 capital raising activities. Interest received increased to $3.8 million during the six months ended June 30, 2026, compared to $0.4 million during the same period in 2025, primarily reflecting higher average cash balances following our January 2026 capital raising activities.

Current report

The lease liabilities recognized as of June 30, 2026 relate to leases expiring between July 2026 and April 2030, and certain leases include options to extend. As of June 30, 2026, future contractual lease payments associated with these recognized leases totaled $3.4 million. In addition, as of June 30, 2026, we had entered into a long-term property lease that had not yet reached its commencement date and therefore was not recognized as a lease liability in the condensed consolidated balance sheet. Future undiscounted contractual lease payments associated with this lease are $23.2 million over the lease term.

Current report

(1) In April 2026, we entered into a long-term lease arrangement for additional office and warehouse space, with the lease term commencing on September 1, 2026. Accordingly, no lease liability was recognized as of June 30, 2026. We will evaluate and recognize the lease in accordance with ASC 842 upon commencement of the lease term.

Current report

(3) Subsequent to June 30, 2026, we amended the lease agreement to replace the single five-year extension option with one three-year extension option and two two-year extension options. As a result, we will remeasure the lease liability and ROU asset in the period the amendment was executed.

Current report

We consolidate entities in which we have a controlling financial interest. Determining whether a controlling financial interest exists requires significant judgment and consideration of the relevant facts and circumstances, including ownership interests, governance rights, board representation and contractual arrangements. Changes in these facts and circumstances may require reassessment of our consolidation conclusions.

Current report

During the six months ended June 30, 2026, we reassessed our consolidation conclusions relating to v2vmedtech under ASC 810 following the termination of its funding obligations under the Contribution and Stock Purchase Agreement with v2vmedtech, the cessation of our executive management involvement in v2vmedtech and changes in the operational activities of v2vmedtech. Based on this reassessment, we concluded that v2vmedtech no longer meets the definition of a variable interest entity.

Current report

We subsequently assessed whether we maintained a controlling financial interest in v2vmedtech under the voting interest entity model of ASC 810. Although we own approximately 30% of the outstanding voting interests of v2vmedtech, as of June 30, 2026, we retained the right to appoint two of the three members of the v2vmedtech board of directors. The v2vmedtech board of directors is responsible for directing the business and affairs of v2vmedtech and making decisions regarding its significant activities. As a result, we concluded that we continued to have a controlling financial interest in v2vmedtech and therefore continue to consolidate v2vmedtech in our condensed consolidated financial statements.

Current report

Based on our public float as of June 30, 2026, we expect to become a large accelerated filer and cease qualifying as an EGC beginning with our Annual Report on Form 10-K for the year ending December 31, 2026. As a result, the extended transition period for complying with new or revised accounting standards and certain other accommodations available to EGCs will no longer be available beginning with that report. We will also be required to comply with the filing deadlines applicable to large accelerated filers and include an attestation report of our independent registered public accounting firm on our internal control over financial reporting beginning with our Annual Report on Form 10-K for the year ending December 31, 2026.

Current report

We are currently a “smaller reporting company” (an “SRC”), as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on our public float as of June 30, 2026, we expect to no longer qualify as an SRC. However, we expect to be permitted to continue using SRC scaled disclosure accommodations through our Annual Report on Form 10-K for the year ending December 31, 2026, with full non-SRC disclosure requirements beginning with our Quarterly Report on Form 10-Q for the quarter ending March 31, 2027.
Removed paragraphs (7)

Previous report

Net sales during the three months ended March 31, 2026 was $0.5 million, compared to $0.6 million for the same period in the prior year. The decrease of $0.1 million was primarily due to net sales in the three months ended March 31, 2025 included $0.3 million from the sale of CardioCel™ and VascuCel™ products to LeMaitre in connection with the Transition Services Agreement, 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.

Previous report

Cost of products sold during the three months ended March 31, 2026 was $0.1 million, a decrease of $0.1 million (45%), compared to $0.2 million for the same period in the prior year. The decrease in cost of products sold was primarily due to the inclusion in the three months ended March 31, 2025 of amounts associated with sales of CardioCel™ and VascuCel™ products under the Transition Services Agreement with LeMaitre. This decrease was partially offset by increased production volumes due to increases in demand for tissue products from 4C in 2026.

Previous report

Subsequent to March 31, 2026, we entered into a long‑term lease arrangement for additional office and warehouse space in Brooklyn Park, Minnesota to address the upcoming expiration of certain significant facility arrangements and to support ongoing and planned operational and manufacturing activities. This lease will result in increased future lease payment obligations.

Previous report

We consolidate a VIE when the reporting entity (a) has an economic interest in another legal entity (known as a “variable interest”) that conveys more than insignificant exposure to potential losses of or benefits from the other legal entity; and (b) has power over the most significant economic activities of the legal entity. There is significant judgment over the analysis to determine whether an entity is a VIE, to determine whether we have a variable interest and to determine whether we are the primary beneficiary of a VIE.

Previous report

We determined that v2vmedtech, inc. (“v2vmedtech”) is a VIE and that we are the primary beneficiary of v2vmedtech. This determination is based on our having both power over the most significant activities of v2v, primarily through holding a majority of the positions on v2vmedtech’s board of directors (although v2vmedtech’s non-Anteris shareholder representative on the v2vmedtech board of directors presently maintains certain veto rights), controlling the appointment of the chief executive officer and chief financial officer roles, being the exclusive partner to develop v2vmedtech’s products, and benefits through equity ownership.

Previous report

We are also a “smaller reporting company” (a “SRC”), as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We may continue to be a SRC even after we are no longer an EGC. We may take advantage of certain of the scaled disclosures available to SRCs. As a SRC, we will present only two years of audited annual financial statements, plus any required unaudited interim condensed financial statements, and related management’s discussion and analysis of financial condition and results of operations.
Reworded paragraphs (23)

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® 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 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 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.

Current wording

Anteris is a healthcare 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 a new 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.

Previous wording

Recruitment to the PARADIGM Trial commenced in Europe in October 2025, followed by receipt of FDA Investigational Device Exemption (“IDE”) approval for the trial in November 2025. In April 2026, we secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a 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. This milestone supported the activation of our initial U.S. sites as part of the PARADIGM Trial with first patients enrolled and treated during May 2026.

Current wording

Recruitment to the PARADIGM Trial commenced in Europe in October 2025. In November 2025, we received FDA Investigational Device Exemption (“IDE”) approval, enabling expansion of the trial into the United States. In April 2026, we secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under the Centers for Medicare & Medicaid Services (“CMS”) Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. Recruitment in the United States subsequently commenced, with the first patients enrolled and treated in May 2026.

Previous wording

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

Current wording

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

Previous wording

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 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 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.

Previous wording

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 agreement will expire on June 1, 2026, and no early termination penalties are anticipated in connection with its non-renewal. The expiration of the 4C Agreement is not expected to have a material impact on our financial results.

Current wording

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 4C Agreement expired on June 1, 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 conditions that applied under the 4C Agreement. The expiration of the 4C Agreement is not expected to have a material impact on our financial results.

Previous wording

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 of the study.

Current wording

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.

Previous wording

During the three months ended March 31, 2026, 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 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.

Current wording

During the six months ended June 30, 2026, we continued to expand global manufacturing capacity to scale for the PARADIGM Trial. Production (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) is being progressively scaled into new or expanded 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 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.

Previous wording

R&D expenses during the three months ended March 31, 2026 were $17.5 million, an increase of $1.0 million (6%), compared to $16.5 million for the same period in the prior year. This increase was primarily due to an increase of $2.0 million in the three months ended March 31, 2026 related to the upscaling of manufacturing and quality capabilities, including process design and validation activities and the expansion of headcount, and an increase of $1.0 million related to activities linked to the PARADIGM Trial, including the scaling of our field based clinical team. These were partly offset by reduced DurAVR® product research costs of $2.0 million as we shifted our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.

Current wording

R&D expenses during the three months ended June 30, 2026 were $23.4 million, compared to $16.3 million for the same period in the prior year, representing an increase of $7.0 million (43%). This increase was primarily due to an increase of $3.6 million in the three months ended June 30, 2026 related to the upscaling of manufacturing and quality capabilities, including process development and validation activities and the expansion of headcount, an increase of $3.1 million related to activities linked to the PARADIGM Trial, including the scaling of our field based clinical 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 $0.7 million, and lower v2vmedtech development expenses of $0.6 million, reflecting reduced development activities following our decision to cease further v2vmedtech funding.

Previous wording

Selling, general and administrative expenses during the three months ended March 31, 2026 were $6.9 million, an increase of $1.3 million (22%) compared to the same period in the prior year, which increase was primarily due to higher employee related costs, increased share based payment expenses, and additional consulting costs.

Current wording

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

Previous wording

Other non-operating income, net during the three months ended March 31, 2026 was $1.7 million, an increase of $1.6 million compared to $0.1 million for the same period in the prior year, which increase was primarily due to interest earned on money-market fund deposits following the January 2026 capital raises.

Current wording

Other non-operating income, net during the three months ended June 30, 2026 was $2.4 million, compared to $0.1 million for the same period in the prior year, representing 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 higher investment income earned on money-market fund deposits and U.S. Treasury securities following the January 2026 capital raises.

Previous wording

Net foreign exchange losses during the three months ended March 31, 2026 were $0.1 million compared to $0.2 million of net foreign exchange losses for the same period in the prior year, which amounted to a decrease of $0.1 million (57%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the first quarter of 2026, the United States dollar depreciated by 2% relative to the Australian dollar (“AUD $”). In the first quarter of 2025, the United States dollar depreciated by 1% relative to the AUD $.

Current wording

Net foreign exchange losses during the three months ended June 30, 2026 were $0.1 million, compared to $0.3 million for the same period in the prior year, representing a decrease of $0.2 million (66%). The decrease primarily reflects lower foreign exchange movements recognized on foreign currency denominated intercompany and cash balances. During the three months ended June 30, 2026, the U.S. dollar depreciated by approximately 1% relative to the Australian dollar (“AUD $”), compared to a depreciation of approximately 4% during the three months ended June 30,2025.

Previous wording

Income tax expense during the three months ended March 31, 2026 was $0.5 million, compared to nil for the same period in the prior year, representing an increase of $0.5 million, primarily due to the recognition of withholding tax expense incurred during the period in connection with amounts payable by the Company’s Swiss subsidiary.

Current wording

Income tax expense for the six months ended June 30, 2026 was $0.5 million, compared to nil for the same period in the prior year. The increase was due to withholding tax recognized during the period in connection with amounts payable by our Swiss subsidiary. No income tax expense was recognized during the three months ended June 30, 2026 or 2025.

Previous wording

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

Current wording

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

Previous wording

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. As of March 31, 2026 and December 31, 2025, we had cash and cash equivalents of $283.2 million and $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 relating to the lease of properties, and we did not have any other material capital expenditure commitments or contingent liabilities.

Current wording

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. In 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 our Common Stock having an aggregate offering price of up to $250.0 million from time to time.

Previous wording

Net cash used in operating activities during the three months ended March 31, 2026 was $28.7 million, an increase of $7.2 million (33%), compared to $21.5 million in the same period in the prior year, primarily due to higher cash expenditures 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, an increase in salaries and wages from a growth in headcount and the timing of payments to suppliers, including the settlement of liabilities outstanding at December 31, 2025.

Current wording

Net cash used in operating activities during the six months ended June 30, 2026 was $49.5 million, compared to $41.0 million in the same period in the prior year, reflecting an increase of $8.5 million (21%), primarily due to higher cash outflows 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 relating to headcount growth.

Previous wording

Net cash used in investing activities during the three months ended March 31, 2026 was $0.2 million, compared to net cash provided of $1.1 million in the same period in the prior year, a decrease of $1.3 million (116%). 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, cash outflows for purchases of plant and equipment during the three months ended March 31, 2026 were $0.1 million lower than in the same period in 2025.

Current wording

Net cash used in investing activities during the six months ended June 30, 2026 was $0.8 million, compared to net cash provided by investing activities of $0.6 million in the same period in the prior year, reflecting a decrease of $1.4 million. This decrease was 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. Cash outflows for purchases of plant and equipment were $0.8 million during the six months ended June 30, 2026, which is broadly consistent with the same period in 2025.

Previous wording

Net cash provided by financing activities during the three months ended March 31, 2026 was $299.5 million, compared to net cash used in financing activities of $1.1 million in the same period of the prior year, reflecting an increase of $300.6 million. During the three months ended March 31, 2026, we received proceeds of $308.3 million from the issuance of shares of Common Stock net of underwriting fees, which were partially offset by $8.2 million of share issuance transaction costs. In the three months ended March 31, 2025, proceeds of $0.6 million were received related to share issues and cash outflows of $1.2 million were incurred related to transaction costs from the 2024 public offering. Additionally, we repaid $0.6 million of outstanding insurance-related supplier financing debt during the period, representing an increase of $0.1 million compared to the same period in the prior year.

Current wording

Net cash provided by financing activities during the six months ended June 30, 2026 was $298.6 million, compared to net cash used in financing activities of $1.5 million in the same period of the prior year, reflecting an increase of $300.2 million. During the six months ended June 30, 2026, we received proceeds of $308.3 million from the issuance of shares of Common Stock net of underwriting fees, which was partially offset by $8.6 million of share issuance costs paid during the period, including costs associated with the establishment of the ATM program. During the six months ended June 30, 2025, we received proceeds of $0.6 million from share issuances and incurred $1.2 million of transaction costs related to our 2024 initial public offering. In addition, we repaid $0.9 million of outstanding insurance-related supplier financing debt during both the current and prior periods.

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 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.

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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

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 three months ended March 31, 2026.

Current wording

Our significant accounting policies are discussed in Note 2, “Basis of Presentation 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, 2026.

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

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.
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Previous report — wording carried elsewhere

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.