Anteris Technologies Global Corp.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001140361-26-043027
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 98 previous paragraphs and 96 current paragraphs.
59 unchanged; 33 reworded; 4 added; 6 removed; 0 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 (4)
Current report
During the third quarter of 2026, we continued execution of the PARADIGM Trial across active sites in the United States, Canada, Denmark, the Netherlands and France, with further site activation and enrollment following completion of key start-up activities, including site qualification, investigator training and operational readiness.
Current report
Subsequent to September 30, 2026, the trial received regulatory clearance from the German Federal Institute for Drugs and Medical Devices, supporting expansion into Germany. In Australia, the trial received Human Research Ethics Committee approval and authorization from the Therapeutic Goods Administration under the Clinical Trial Notification pathway, further extending the trial’s geographic reach.
Current report
On September 1, 2026, we assumed occupancy as the primary tenant of our Northcross facility in Brooklyn Park, Minnesota, providing us with the ability to expand our manufacturing capacity in preparation for commercialization.
Current report
Income tax benefit for the three months ended September 30, 2026 was $272 thousand, compared to nil for the same period in the prior year. The benefit was due to recognition of the recoverable portion of the Swiss withholding tax incurred. No income tax expense was recognized during the three months ended September 30, 2025.
Removed paragraphs (6)
Previous 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.
Previous 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.
Previous 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.
Previous report
(2) Predominantly used for R&D, manufacturing of the DurAVR® THV System and regulatory compliance teams.
Previous 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.
Previous 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.
Reworded paragraphs (33)
Previous wording
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our annual report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2026 (the “Annual Report”). Except for historical information, the matters discussed in this MD&A contain various forward-looking statements that involve risks and uncertainties and are based upon judgments concerning various factors beyond our control. Our actual results could differ materially from those anticipated in these forward-looking statements. Please also see the section of this Form 10-Q titled “Cautionary Note Regarding Forward-Looking Statements.”
Current wording
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q (this “Form 10-Q”) and our annual report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2026 (the “Annual Report”). Except for historical information, the matters discussed in this MD&A contain various forward-looking statements that involve risks and uncertainties and are based upon judgments concerning various factors beyond our control. Our actual results could differ materially from those anticipated in these forward-looking statements. Please also see the section of this Form 10-Q titled “Cautionary Note Regarding Forward-Looking Statements.”
Previous wording
The PARADIGM Trial is a prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either a transcatheter aortic valve replacement (“TAVR”) using the DurAVR® THV or TAVR using a commercially available and approved THV in an “All Comers Randomized Cohort.” The primary end point of the PARADIGM Trial is a composite of all-cause mortality, all stroke and cardiovascular hospitalization at one year post-procedure. The endpoint will be evaluated as a non-inferiority analysis. Subjects with a failed surgical bioprosthesis in need of a valve-in-valve TAVR will be enrolled in a separate parallel registry.
Current wording
The PARADIGM Trial is a prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either a transcatheter aortic valve replacement (“TAVR”) using the DurAVR® THV or TAVR using a commercially available and approved THV in an “All Comers Randomized Cohort.” The primary endpoint of the PARADIGM Trial is a composite of all-cause mortality, all stroke and cardiovascular hospitalization at one year post-procedure. The endpoint will be evaluated as a non-inferiority analysis. Subjects with a failed surgical bioprosthesis in need of a valve-in-valve TAVR will be enrolled in a separate parallel registry.
Previous 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.
Current wording
Recruitment to the PARADIGM Trial commenced in Europe in October 2025. In November 2025, we received U.S. Food and Drug Administration (“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. Following receipt of CMS reimbursement eligibility, recruitment in the United States commenced, with the first patients enrolled and treated in May 2026.
Previous 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.
Current wording
Recruitment remains ongoing, with planned expansion into additional clinical sites 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
It is anticipated that the design of the PARADIGM Trial will provide the primary clinical evidence on which the FDA could base a decision for Premarket Approval (“PMA”), which is required for commercialization of the DurAVR® THV System in the United States. We anticipate CE Mark approval will progress in parallel to the PMA.
Current wording
We anticipate that the design of the PARADIGM Trial will provide primary clinical evidence on which the FDA could base a decision for Premarket Approval (the “PMA”), which is required for commercialization of the DurAVR® THV System in the United States. We anticipate CE Mark approval will progress in parallel to the PMA.
Previous wording
In January 2026, we completed an underwritten public offering, pursuant to which we issued and sold 40,000,000 shares of our Common Stock, including the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $5.75 per share (the “2026 Public Offering”) and a stock purchase agreement with Covidien Group S.à r.l. (“Medtronic”), a wholly owned subsidiary of Medtronic plc, pursuant to which we issued and sold to Medtronic 15,652,173 shares of Common Stock at a purchase price of $5.75 per share (the “Medtronic Private Placement”), which collectively generated gross proceeds of approximately $320.0 million, before deducting underwriting discounts and commissions, placement agent fees, and offering expenses.
Current wording
In January 2026, we completed an underwritten public offering, pursuant to which we issued and sold 40,000,000 shares of our Common Stock, including the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $5.75 per share (the “2026 Public Offering”) and entered into a stock purchase agreement with Covidien Group S.à r.l. (“Medtronic”), a wholly owned subsidiary of Medtronic plc, pursuant to which we issued and sold to Medtronic 15,652,173 shares of Common Stock at a purchase price of $5.75 per share (the “Medtronic Private Placement”), which collectively generated gross proceeds of approximately $320.0 million, before deducting underwriting discounts and commissions, placement agent fees, and offering expenses.
Previous wording
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 wording
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. As of September 30, 2026, no shares of Common Stock had been sold under the ATM program.
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 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.
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. We expect 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
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.
Current wording
During the nine months ended September 30, 2026, we continued to expand global manufacturing capacity to scale production for the PARADIGM Trial and prepare for commercialization. On September 1, 2026, we assumed occupancy as the primary tenant of our Northcross facility in Brooklyn Park, Minnesota, providing additional capacity to scale production of the DurAVR® THV, the ComASUR® Delivery System and related components. This additional capacity is intended to support a reliable, scaled inventory supply for future commercialization. In addition, we plan to source the ADAPT® tissue for the DurAVR® THV from both the United States and Australia to mitigate supply chain risks. These investments support operational readiness and long-term growth capacity for clinical and future commercial success.
Previous wording
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 wording
Net sales for the three months ended September 30, 2026 were $519 thousand, compared to $429 thousand for the same period in the prior year, representing an increase of $90 thousand (21%). The increase primarily reflects increased sales of tissue products to 4C.
Previous wording
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 wording
Net sales for the nine months ended September 30, 2026 were $2.0 million, compared to $1.6 million for the same period in the prior year, representing an increase of $0.4 million (26%). 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.
Previous wording
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 wording
Cost of products sold for the three months ended September 30, 2026 was $126 thousand, compared to $123 thousand for the same period in the prior year, representing an increase of $3 thousand (2%). 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.
Previous wording
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 wording
Cost of products sold for the nine months ended September 30, 2026 was$473 thousand, compared to $478 thousand for the same period in the prior year, representing a decrease of $5 thousand (1%). Cost of products sold remained generally consistent with the prior-year period, despite a 26% 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.
Previous wording
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 wording
R&D expenses during the three months ended September 30, 2026 were $21.3 million, compared to $16.8 million for the same period in the prior year, representing an increase of $4.5 million (27%). This increase was primarily due to an increase of $4.3 million in the three months ended September 30, 2026 related to activities linked to the PARADIGM Trial, including the enrollment of additional patients and scaling of our field based clinical team, and an increase of $2.2 million related to the upscaling of manufacturing and quality capabilities, including process development, validation activities and an increase in employee levels. These were partly offset by reduced stock-based payment expenses of $0.9 million resulting from the period-to-period reduction in share price, and, lower v2vmedtech development expenses of $0.8 million reflecting reduced development activities following our decision to cease further v2vmedtech funding.
Previous 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.
Current wording
R&D expenses during the nine months ended September 30, 2026 were $62.2 million, compared to $49.6 million for the same period in the prior year, representing an increase of $12.6 million (25%). This increase was primarily due to an increase of $8.2 million in the nine months ended September 30, 2026 related to activities linked to the PARADIGM Trial, including the enrollment of additional patients and scaling of our field based clinical team, an increase of $7.8 million related to the upscaling of manufacturing and quality capabilities, including process development, validation activities and an increase in employee levels, and higher stock-based payment expenses of $0.6 million resulting from increases in the share price and headcount. These were partly offset by reduced DurAVR® product research costs of $2.7 million and lower v2vmedtech development expenses of $1.6 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 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.
Current wording
Selling, general and administrative expenses during the three months ended September 30, 2026 were $8.9 million, compared to $5.8 million for the same period in the prior year, representing an increase of $3.1 million (55%). 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
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 wording
Selling, general and administrative expenses during the nine months ended September 30, 2026 were $24.2 million, compared to $16.4 million for the same period in the prior year, representing an increase of $7.8 million (47%). This increase was primarily due to higher employee costs associated with headcount growth, increased stock-based payment expenses, and additional consulting, marketing and IT expenditures to support the expansion of our operations.
Previous 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.
Current wording
Other non-operating income, net during the three months ended September 30, 2026 was $2.6 million, compared to $147 thousand for the same period in the prior year, representing an increase of $2.5 million (1,669%). Other non-operating income, net during the nine months ended September 30, 2026 was $6.7 million, compared to $386 thousand for the same period in the prior year, representing an increase of $6.4 million (1,647%). 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, as well as CMS reimbursements associated with the PARADIGM Trial.
Previous wording
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 wording
Net foreign exchange gains during the three months ended September 30, 2026 were $160 thousand, compared to $83 thousand net foreign exchange losses for the same period in the prior year, representing a change of $243 thousand. The change primarily reflects lower foreign exchange movements recognized on foreign currency denominated intercompany and cash balances. During the three months ended September 30, 2026 and 2025, the U.S. dollar depreciated by approximately 1% relative to the Australian dollar (“AUD $”).
Previous 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.
Current wording
Net foreign exchange losses during the nine months ended September 30, 2026 were $38 thousand, compared to $611 thousand for the same period in the prior year, representing a decrease of $573 thousand (94%). The decrease primarily reflects lower foreign exchange movements recognized on foreign currency denominated intercompany and cash balances. During the nine months ended September 30, 2026, the U.S. dollar depreciated by approximately 4% relative to the AUD $, compared to depreciation of approximately 6% during the nine months ended September 30, 2025.
Previous 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.
Current wording
Income tax expense for the nine months ended September 30, 2026 was $220 thousand, compared to nil for the same period in the prior year. The expense was due to withholding tax payable by our Swiss subsidiary, partially offset by the recognition of a recoverable portion of that withholding tax during the third quarter. No income tax expense was recognized during the nine months ended September 30, 2025.
Previous 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.
Current wording
We have experienced recurring operating losses and cash outflows from operating activities since inception. As of September 30, 2026 and December 31, 2025, we had an accumulated deficit of $449.5 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. 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.
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 at-the-market (“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. As of September 30, 2026, no shares of Common Stock had been sold under the ATM program.
Previous wording
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 wording
As of September 30, 2026, we had cash, cash equivalents and restricted cash of $236.3 million, including $3.6 million classified as a non-current asset. Of this amount, $3.5 million relates to cash collateral supporting a standby letter of credit associated with a property lease. As of September 30, 2026 and December 31, 2025, we had lease liabilities of $15.9 million and $2.2 million, respectively relating to existing leased properties.
Previous 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.
Current wording
Net cash used in operating activities during the nine months ended September 30, 2026 was $72.4 million, compared to $59.3 million in the same period in the prior year, reflecting an increase of $13.1 million (22%), 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
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 wording
Operating cash outflows were also impacted by the settlement of elevated working capital liabilities outstanding at December 31, 2025, including supplier payments made following the completion of our January 2026 capital raising activities. Interest received increased to $5.9 million during the nine months ended September 30, 2026, compared to $0.6 million during the same period in 2025, primarily reflecting higher average cash balances following our January 2026 capital raising activities.
Previous 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.
Current wording
Net cash used in investing activities during the nine months ended September 30, 2026 was $2.2 million, compared to $199 thousand in the same period in the prior year, reflecting an increase in cash used of $2.0 million. The increase primarily reflected higher purchases of plant and equipment, which increased by $0.6 million. The prior year investing cash outflow was partially offset by the receipt of $1.4 million of deferred proceeds from LeMaitre relating to the 2019 sale of distribution rights, for which there was no corresponding inflow in the current year.
Previous 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.
Current wording
Net cash provided by financing activities during the nine months ended September 30, 2026 was $298.4 million, compared to net cash used in financing activities of $1.8 million in the same period of the prior year, reflecting an increase in cash provided of $300.2 million. During the nine months ended September 30, 2026, we received proceeds of $308.6 million from the issuance of shares of Common Stock net of underwriting fees, which was partially offset by $8.8 million of share issuance costs paid during the period, including costs associated with the establishment of the ATM program. During the nine months ended September 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 $1.2 million of insurance-related supplier financing debt, compared to $1.1 million during the same period in 2025.
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.
Current wording
We lease laboratory and manufacturing facilities and offices. The leases typically include options to renew at which time the lease payments are subject to market adjustments and/or set price increases. Extension and termination options are included in a number of the leases to allow for flexibility in terms of corporate growth and managing the assets used in our operations. The leases expire between June 2028 and August 2037, and certain leases include options to extend. As of September 30, 2026, future undiscounted contractual lease payments totaled $16.9 million.
Previous wording
The locations and uses of our material properties are as follows:
Current wording
The locations of our material properties are as follows:
Previous wording
At June 30, 2026, we had commitments to purchase $0.3 million of plant and equipment.
Current wording
At September 30, 2026, we had commitments to purchase $0.4 million of plant and equipment.
Previous 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.
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 nine months ended September 30, 2026.
Previous wording
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 wording
During the nine months ended September 30, 2026, we reassessed our consolidation conclusions relating to v2vmedtech under ASC 810 and concluded that v2vmedtech no longer meets the definition of a variable interest entity. As of September 30, 2026, we owned approximately 30% of the outstanding voting interests of v2vmedtech and retained the right to appoint two of the three members of the v2vmedtech board of directors. As a result of these governance rights, we continued to have a controlling financial interest in v2vmedtech and therefore continued to consolidate v2vmedtech in our condensed consolidated financial statements.