Anteris Technologies Q3 net loss widens to $26.8M
AVR reported $236.3 million in cash, cash equivalents and restricted cash; management believes existing cash will cover operating requirements for at least 12 months.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
10-Q
Anteris Technologies Global Corp. (AVR) reported third-quarter 2026 net sales of $519,000, up from $429,000 a year earlier, while net loss increased to $26.8 million from $22.2 million. For the nine months ended September 30, 2026, sales were $2.0 million versus $1.6 million and net loss was $78.5 million versus $65.2 million. Quarterly research and development expense rose 27% to $21.3 million, primarily reflecting PARADIGM Trial activity and manufacturing scale-up.
Cash, cash equivalents and restricted cash totaled $236.3 million at September 30, 2026; management believes existing cash and cash equivalents will meet operating requirements for at least 12 months under its current plan. January public and private stock sales generated approximately $320.0 million gross; a separate ATM program permits sales from time to time for an aggregate offering price of up to $250.0 million, with no shares sold through September 30. The PARADIGM Trial received German regulatory clearance; in Australia, it received ethics committee approval and TGA authorization under the Clinical Trial Notification pathway. Material weaknesses in internal control remained unremediated as of September 30, 2026, and disclosure controls were ineffective solely because of those weaknesses.
1 point · 0 major1 major · 3 points
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Minor pointNet sales increased 21% in Q3 and 26% for nine months.
Negative
- Major pointMaterial weaknesses remained unremediated as of September 30, 2026.
- Moderate pointThird-quarter net loss rose 21% to $26.8 million.
- Moderate pointNine-month operating cash use increased 22% to $72.4 million.
Filing Explained
Of $236.3 million reported at September 30, $3.5 million was restricted as lease collateral, not unrestricted cash.
The company reports that its completed January 2026 public offering and Medtronic private placement issued 55,652,173 shares; 97,493,429 shares were outstanding on
The
Key Figures
Third-quarter net sales: $519,000
Nine-month net sales: $2.0 million
Third-quarter net loss: $26.8 million
+5 more
8 metrics
Third-quarter net sales
$519,000
Three months ended September 30, 2026; $429,000 in 2025
Nine-month net sales
$2.0 million
Nine months ended September 30, 2026; $1.6 million in 2025
Third-quarter net loss
$26.8 million
Three months ended September 30, 2026; $22.2 million in 2025
Nine-month net loss
$78.5 million
Nine months ended September 30, 2026; $65.2 million in 2025
Net cash used in operating activities
$72.4 million
Nine months ended September 30, 2026; $59.3 million in 2025
Cash, cash equivalents and restricted cash
$236.3 million
As of September 30, 2026
ATM aggregate offering price
Up to $250.0 million
ATM equity offering program established in May 2026
Third-quarter research and development expense
$21.3 million
Three months ended September 30, 2026; $16.8 million in 2025
Key Terms
Premarket Approval, Investigational Device Exemption, at-the-market, material weakness
4 terms
Premarket Approval regulatory
"Data from the PARADIGM Trial is intended to support a Premarket Approval"
Premarket approval is the formal regulatory clearance required before certain medical devices can be sold, based on detailed evidence that the product is safe and effective. For investors, it’s a major milestone because receiving approval typically clears the way for commercial sales and reduces regulatory uncertainty, while failure or delays can block revenue and raise the risk profile; think of it like a safety certificate needed before a new car model can be sold.
Investigational Device Exemption regulatory
"received U.S. Food and Drug Administration Investigational Device Exemption approval"
An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.
at-the-market financial
"established an at-the-market equity offering program"
"At-the-market" is a method for companies to sell new shares of stock directly into the open market over time, rather than all at once. It allows companies to raise money gradually, similar to selling slices of a pie instead of the entire pie at once, which can help manage the sale's impact on the stock price. This approach gives investors a steady supply of shares while providing companies with flexible funding options.
material weakness financial
"material weaknesses in our internal control over financial reporting"
A material weakness is a significant flaw in the systems and checks a company uses to ensure its financial reports are accurate, meaning errors or fraud could happen and not be caught. For investors it matters because it raises the risk that reported results are unreliable—similar to finding a hole in a ship’s hull—potentially leading to corrected financials, regulatory action, reduced trust, and negative effects on stock value and borrowing costs.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How did AVR’s third-quarter 2026 revenue and loss compare with 2025?
AVR reported net sales of $519,000 for the three months ended September 30, 2026, compared with $429,000 a year earlier, and net loss of $26.8 million, compared with $22.2 million. For the nine months, net sales were $2.0 million versus $1.6 million, and net loss was $78.5 million versus $65.2 million.
How much cash does AVR have, and what are its ATM program terms?
Cash, cash equivalents and restricted cash totaled $236.3 million as of September 30, 2026. The ATM program permits sales from time to time for an aggregate offering price of up to $250.0 million; no shares had been sold under the program by September 30. Management believes existing cash and cash equivalents will meet operating requirements for at least 12 months under its current plan.
What is the status of AVR’s PARADIGM Trial?
Recruitment is ongoing for the randomized, controlled, multicenter international trial of the DurAVR transcatheter heart valve. The trial received German regulatory clearance, and in Australia it received Human Research Ethics Committee approval and Therapeutic Goods Administration authorization under the Clinical Trial Notification pathway. The company intends the trial data to support a U.S. Premarket Approval application.
Why were AVR’s disclosure controls ineffective?
Management concluded that disclosure controls and procedures were ineffective as of September 30, 2026, solely as a result of material weaknesses in internal control over financial reporting. The weaknesses related to deficiencies in control procedures and segregation of duties, and remained unremediated at that date.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended September 30, 2026
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number 001-42437
(Exact name of Registrant as specified in its Charter)
| | | |
| (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| | | |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: +61 7 3152 3200
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
| | | | | The |
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YES ☒ NO ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). YES ☒ NO☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| | ☒ | Smaller reporting company | |
| Emerging growth company | | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YES ☐ NO ☒
The number of shares outstanding of the registrant’s Common Stock as of November 9, 2026 was 97,493,429 .
1
ANTERIS TECHNOLOGIES GLOBAL CORP.
FORM 10-Q
For the quarterly period ended September 30, 2026
TABLE OF CONTENTS
| Page | |||
| PART I FINANCIAL INFORMATION | 1 | ||
|
Item 1. Financial Statements (Unaudited)
|
1 | ||
|
Condensed Consolidated Statements of Operations
|
1 | ||
|
Condensed Consolidated Statements of Comprehensive Loss
|
2 | ||
|
Condensed Consolidated Balance Sheets
|
3 | ||
|
Condensed Consolidated Statements of Stockholders’ Equity
|
4 | ||
|
Condensed Consolidated Statements of Cash Flows
|
6 | ||
|
Notes to the Condensed Consolidated Financial Statements
|
7 | ||
|
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
|
14 | ||
|
Item 3. Quantitative and Qualitative Disclosures About Market Risk
|
20 | ||
|
Item 4. Controls and Procedures
|
20 | ||
|
PART II OTHER INFORMATION
|
21 | ||
|
Item 1. Legal Proceedings
|
21 | ||
|
Item 1A. Risk Factors.
|
21 | ||
|
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
|
21 | ||
|
Item 3. Defaults Upon Senior Securities
|
21 | ||
|
Item 4. Mine Safety Disclosures
|
21 | ||
|
Item 5. Other Information
|
22 | ||
|
Item 6. Exhibits
|
22 | ||
2
Table of Contents
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain matters discussed in this Quarterly Report on Form 10-Q (this “Form 10-Q”), including statements regarding our future results of operations and financial position, business strategy, product development, and plans and objectives of management for future operations, contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, both as amended. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements, which are subject to risks, include, but are not limited to, statements about:
●
our current and future research and development (“R&D”) activities, including site activations, trial enrollment, clinical testing and manufacturing and related costs and timing;
●
our product development and business strategy, including the potential size of the markets for our products and future development and/or expansion of our products in our markets;
●
our ability to commercialize products and generate product revenues;
●
any statements concerning anticipated regulatory activities, including our ability to obtain regulatory clearances;
●
our R&D expenses;
●
the sufficiency of our capital resources;
●
our ability to raise additional funding when needed; and
●
risks facing our operations and intellectual property.
We have based the forward-looking statements contained in this Form 10-Q largely on our current expectations, estimates, forecasts and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-Q, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section titled “Risk Factors” in 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”), as such risks and uncertainties may be amended, supplemented or superseded from time to time by our subsequent reports on Forms 10-Q and 8-K we file with the SEC, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.
The forward-looking statements made in this Form 10-Q relate only to events as of the date on which the statements are made. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
You should read this Form 10-Q and the documents that we reference in this Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this Form 10-Q by these cautionary statements.
This Form 10-Q contains certain data and information that we obtained from various publications. Statistical data in these publications also include projections based on a number of assumptions. In addition, the nature of the medical technology industry results in significant uncertainties for any projections or estimates relating to the growth prospects or future condition of our industry. Furthermore, if any one or more of the assumptions underlying the market data are later found to be incorrect, actual results may differ from the projections based on these assumptions. You should not place undue reliance on these forward-looking statements.
All references in this Form 10-Q to our common stock, par value $0.0001 per share (“Common Stock”) shall include the shares represented by CHESS Depository Interests (“CDIs”), each of which represents one underlying share of Common Stock, unless the context suggests otherwise.
3
Table of Contents
Part I. Financial Information
Item 1.
Financial Statements
ANTERIS TECHNOLOGIES GLOBAL CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands of U.S. dollars, except per share information; unaudited)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||
| Note |
2026
$ |
2025
$ |
2026
$ |
2025
$ | ||||||||||||||||
| Net sales | ||||||||||||||||||||
| Costs and expenses: | ||||||||||||||||||||
|
Cost of products sold
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
|
Research and development expense
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
|
Selling, general and administrative expense
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
|
Other non-operating income, net
|
||||||||||||||||||||
|
Interest and amortization of debt discount and expense
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
|
Net foreign exchange (losses)/gains
|
( | ) | ( | ) | ( | ) | ||||||||||||||
|
Fair value movement of derivatives
|
||||||||||||||||||||
|
Loss before income taxes from continuing operations
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Income tax benefit/(expense) | ( | ) | ||||||||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Total (loss)/gain is attributable to: | ||||||||||||||||||||
|
Non-controlling interests
|
10 | ( | ) | |||||||||||||||||
|
Stockholders of the Company
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||
|
Share information
|
||||||||||||||||||||
| Basic and diluted loss per share ($ per share) | 8 | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands of U.S. dollars; unaudited)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
|
2026
$ |
2025
$ |
2026
$ |
2025
$ | |||||||||||||
|
Net loss
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
|
Other comprehensive (loss)/income, net of tax:
|
||||||||||||||||
|
Foreign currency translation adjustments
|
( | ) | ( | ) | ||||||||||||
|
Other comprehensive (loss)/income for the period, net of tax
|
( | ) | ( | ) | ||||||||||||
|
Total comprehensive loss
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
|
Total comprehensive loss is attributable to:
|
||||||||||||||||
|
Non-controlling interests
|
( | ) | ||||||||||||||
|
Stockholders of the Company
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| ( | ) | ( | ) | ( | ) | ( | ) | |||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands of U.S. dollars, except share quantities; unaudited)
| Note |
September 30,
2026
$ |
December 31, 2025
$ | ||||||||||
|
ASSETS
|
||||||||||||
| Current Assets | ||||||||||||
|
Cash, cash equivalents and restricted cash
|
4 | |||||||||||
|
Accounts receivable from customers, net of allowances
|
||||||||||||
|
Inventories
|
||||||||||||
|
Prepaid expenses
|
||||||||||||
|
Other current assets
|
||||||||||||
| Total Current Assets | ||||||||||||
|
Non-Current Assets
|
||||||||||||
|
Plant and equipment, net
|
||||||||||||
|
Operating lease right-of-use assets, net
|
6 | |||||||||||
|
Intangible assets, net
|
||||||||||||
|
Other assets
|
4 | |||||||||||
| Total Non-Current Assets | ||||||||||||
| TOTAL ASSETS | ||||||||||||
| LIABILITIES | ||||||||||||
| Current Liabilities | ||||||||||||
|
Accounts payable
|
||||||||||||
|
Accrued and other liabilities
|
5 | |||||||||||
|
Current portion of operating lease liabilities
|
||||||||||||
|
Current portion of debt obligations
|
||||||||||||
| Total Current Liabilities | ||||||||||||
| Non-Current Liabilities | ||||||||||||
|
Long-term operating lease liabilities
|
6 | |||||||||||
|
Long-term debt obligations
|
||||||||||||
|
Other liabilities
|
||||||||||||
| Total Non-Current Liabilities | ||||||||||||
| TOTAL LIABILITIES | ||||||||||||
| COMMITMENTS AND CONTINGENCIES | 11 | |||||||||||
| STOCKHOLDERS’ EQUITY | ||||||||||||
| Common stock, $ |
7 | |||||||||||
| Preferred stock, $ |
||||||||||||
|
Additional paid in capital
|
||||||||||||
|
Accumulated other comprehensive loss
|
( | ) | ( | ) | ||||||||
|
Accumulated deficit
|
( | ) | ( | ) | ||||||||
|
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)
|
( | ) | ||||||||||
|
Non-controlling interests
|
10 | ( | ) | |||||||||
|
TOTAL EQUITY (DEFICIT)
|
( | ) | ||||||||||
|
TOTAL LIABILITIES AND EQUITY
|
||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands of U.S. dollars, except share quantities; unaudited)
|
| Common stock |
Additional
Paid
in Capital
$
|
Accumulated
Other Comprehensive
Loss
$
|
Accumulated
Deficit
$
|
Total
Stockholders’
Equity
$
|
Non-controlling
interests
$
|
Total Equity
$
| |||||||||||||||||||||||||
|
Shares
Quantity
|
Par Value
$
| |||||||||||||||||||||||||||||||
|
Balance at December 31, 2025
|
( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||
|
Net (loss)/gain
|
- | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
|
Other comprehensive gain
|
- | |||||||||||||||||||||||||||||||
|
Common stock issued
|
||||||||||||||||||||||||||||||||
|
Stock-based compensation
|
- | |||||||||||||||||||||||||||||||
|
Balance at March 31, 2026
|
( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
|
Net (loss)/gain
|
- | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
|
Other comprehensive gain
|
- | |||||||||||||||||||||||||||||||
|
Common stock issued
|
( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
|
Stock-based compensation
|
- | |||||||||||||||||||||||||||||||
|
Balance at June 30, 2026
|
( | ) | ( | ) | ||||||||||||||||||||||||||||
|
Net loss
|
- | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
|
Other comprehensive loss
|
- | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
|
Common stock issued
|
||||||||||||||||||||||||||||||||
|
Stock-based compensation
|
- | |||||||||||||||||||||||||||||||
|
Balance at September 30, 2026
|
( | ) | ( | ) | ||||||||||||||||||||||||||||
4
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands of U.S. dollars, except share quantities; unaudited)
|
| Common stock |
Additional
Paid
in Capital
$
|
Accumulated
Other Comprehensive
Loss
$
|
Accumulated
Deficit
$
|
Total
Stockholders’
Equity
$
|
Non-controlling
interests
$
|
Total Equity
$
| |||||||||||||||||||||||||
|
Shares
Quantity
|
Par Value
$
| |||||||||||||||||||||||||||||||
|
Balance at December 31, 2024
|
( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
|
Net loss
|
- | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||
|
Other comprehensive gain
|
- | |||||||||||||||||||||||||||||||
|
Common stock issued
|
||||||||||||||||||||||||||||||||
|
Stock-based compensation
|
- | |||||||||||||||||||||||||||||||
|
Balance at March 31, 2025
|
( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
|
Net loss
|
- | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||
|
Other comprehensive gain
|
- | |||||||||||||||||||||||||||||||
|
Common stock issued
|
||||||||||||||||||||||||||||||||
|
Stock-based compensation
|
- | |||||||||||||||||||||||||||||||
|
Balance at June 30, 2025
|
( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
|
Net (loss)/gain
|
- | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
|
Other comprehensive gain
|
- | |||||||||||||||||||||||||||||||
|
Stock-based compensation
|
- | |||||||||||||||||||||||||||||||
|
Balance at September 30, 2025
|
( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands of U.S. dollars; unaudited)
| Nine months ended September 30, | ||||||||||||
| Note |
2026
$ |
2025
$ | ||||||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||||||
|
Net loss
|
( | ) | ( | ) | ||||||||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
|
Depreciation and amortization expense
|
||||||||||||
|
Equity-settled stock-based compensation
|
||||||||||||
|
Net foreign exchange losses
|
||||||||||||
|
Other items
|
( | ) | ||||||||||
|
Change in operating assets and liabilities:
|
||||||||||||
|
Accounts receivable, prepayments and other assets
|
( | ) | ||||||||||
|
Inventories
|
||||||||||||
|
Accounts payable, accrued and other liabilities
|
( | ) | ||||||||||
|
NET CASH USED IN OPERATING ACTIVITIES
|
( | ) | ( | ) | ||||||||
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||||||
|
Acquisition of plant and equipment
|
( | ) | ( | ) | ||||||||
|
Acquisition of intangible assets
|
( | ) | ||||||||||
|
Deferred proceeds from sale of distribution rights
|
||||||||||||
|
NET CASH USED IN INVESTING ACTIVITIES
|
( | ) | ( | ) | ||||||||
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
||||||||||||
|
Proceeds from issuance of shares, net of underwriting fees
|
7 | |||||||||||
|
Share issue transaction costs
|
7 | ( | ) | ( | ) | |||||||
|
Tax withholding paid on net-settled equity awards
|
7 | ( | ) | ( | ) | |||||||
|
Repayment of debt
|
( | ) | ( | ) | ||||||||
|
Principal payments on finance lease obligations
|
( | ) | ( | ) | ||||||||
|
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES
|
( | ) | ||||||||||
|
Effect of exchange rate movements on cash, cash equivalents and restricted cash
|
( | ) | ( | ) | ||||||||
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH
|
||||||||||||
|
Net change during the period
|
( | ) | ||||||||||
|
Balance at beginning of period
|
||||||||||||
|
Balance at end of period
|
4 | |||||||||||
|
SUPPLEMENTAL CASH FLOW INFORMATION
|
||||||||||||
|
Operating cash outflows relating to operating leases
|
||||||||||||
|
Non-cash additions to right-of-use assets and lease liabilities
|
||||||||||||
|
Cash received for research and development tax incentive
|
||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026
1.
DESCRIPTION OF BUSINESS
The principal activities of Anteris Technologies Global Corp. (“ATGC,” “Anteris,” “Company,” “we,” “us,” or “our”) include:
●
Continued research and development (“R&D”) of the DurAVR® Transcatheter Heart Valve (“THV”), consisting 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”), designed to address unmet medical needs in the treatment of aortic stenosis. The DurAVR® THV, with its single piece, native-shaped biomimetic design is built to mimic the performance of a healthy aortic valve and to restore normal laminar blood flow. This new class of technology can be used to treat new aortic stenosis patients and to treat aortic stenosis patients where their current bioprosthetic aortic valve is failing (“valve-in-valve”).
●
Advancing the DurAVR® THV clinical program, including ongoing patient recruitment and data collection for the randomized global pivotal study (the “PARADIGM Trial”), expansion into additional geographies, and continued site activation and training. Data from the PARADIGM Trial is intended to support a Premarket Approval (“PMA”) application in the United States and a parallel CE Mark approval in Europe. These are key milestones on the path to commercialization.
2.
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). These policies have been consistently applied to all the periods presented, unless otherwise stated. The accompanying condensed consolidated financial statements of the Company are unaudited. In the opinion of management, all adjustments necessary for a fair statement of results of operations, cash flows, and financial position have been made. The results of operations for the three and nine months ended September 30, 2026 and 2025 are not necessarily indicative of results that may be expected for the full year or any other subsequent interim period.
Unless noted otherwise, all dollar amounts are in thousands of United States dollars (“U.S. dollars” or “$”). Some amounts may not reconcile due to rounding.
The Company is an emerging growth company (“EGC”), as defined in Section 2(a) of the Securities Act of 1933, as amended (the “Securities Act”), and may elect to use the extended transition period provided under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) for complying with new or revised accounting standards applicable to public companies. The Company expects to cease qualifying as an EGC beginning with its Annual Report on Form 10-K for the year ending December 31, 2026. As a result, certain EGC accommodations will no longer be available.
The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations of future events that management believes to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties.
The accounting policies adopted in the preparation of the condensed consolidated financial statements are consistent with those adopted and disclosed in the Group’s (defined below) financial statements for the year ended December 31, 2025, except for the adoption of certain accounting standards impacting disclosures only, as discussed below. These condensed consolidated financial statements do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes for the year ended December 31, 2025 as included in the Company’s 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”).
(a)
Principles of consolidation
The condensed consolidated financial statements include the accounts of ATGC, its wholly-owned subsidiaries, and entities for which the Company has a controlling financial interest. ATGC and its subsidiaries together are referred to in these financial statements as the “Group”.
Subsidiaries are all those entities over which the Group has control. Control is the power to govern the financial and operating policies of an entity. All subsidiaries of ATGC have a reporting year end of December 31. Intercompany transactions, balances and unrealized gains or losses on transactions between entities in the Group are eliminated.
7
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026
2.
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
(b)
Recently Adopted Accounting Standards
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740) Improvements to Income Tax Disclosures. ASU 2023-09 intends to enhance income tax disclosures to address investor requests for more information about the tax risks and opportunities present in an entity’s worldwide operations and primarily requires further disaggregation of existing disclosures related to the effective tax rate reconciliation and income taxes paid. As an EGC, the Company elected to apply the extended transition period and will adopt ASU 2023‑09 for the year ending December 31, 2026. The ASU impacts annual disclosure requirements only and did not have an impact on the Company’s condensed consolidated financial statements. The Company will apply the disclosure requirements prospectively beginning with the year ending December 31, 2026.
(c)
New Accounting Standards Not Yet Adopted
The FASB has issued several new accounting pronouncements during the first nine months of 2026. The Company has determined that there are no new accounting pronouncements issued but not yet adopted that would have a material impact on the Company's financial position, results of operations, or cash flows.
For further details on new accounting pronouncements issued in prior years but not yet adopted, refer to Note 2(y) in the consolidated financial statements for the year ended December 31, 2025 as included in the Annual Report.
3.
INCOME TAX
The Company’s provision for interim periods is determined using an estimate of the annual effective tax rate, adjusted for discrete items arising in that period. The Company’s effective tax rate differs from the U.S. statutory tax rate primarily due to valuation allowances on its deferred tax assets as it is more likely than not that some, or all, of the Company’s deferred tax assets will not be realized. Income tax expense for the nine months ended September 30, 2026 includes a discrete tax expense related to a Swiss withholding tax settlement arising from a prior‑period tax audit, partially offset by a reimbursement of withholding tax recoverable during the third quarter of 2026.
Deferred tax assets and liabilities are determined based upon the differences between the unaudited condensed consolidated financial statements carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. The Company has provided a full valuation allowance against the net deferred tax assets as the Company has determined that it was more likely than not that the Company would not realize the benefits of net deferred tax assets.
4.
CASH, CASH EQUIVALENTS AND RESTRICTED CASH
| (in thousands) |
September 30, 2026
$ | December 31, 2025
$ | ||||||
|
Cash at bank
|
||||||||
|
Cash equivalents (1)
|
||||||||
|
Current restricted cash
|
||||||||
|
Total current cash, cash equivalents and current restricted cash
|
||||||||
|
Non-current restricted cash (2)
|
||||||||
|
Total cash, cash equivalents and restricted cash in the Condensed Consolidated Statements of Cash Flows
|
||||||||
(1)
(2)
5.
ACCRUED AND OTHER LIABILITIES
|
(in thousands)
|
September 30, 2026
$ |
December 31, 2025
$ | ||||||
|
Current
|
||||||||
|
Accrued liabilities
|
||||||||
|
Employee compensation and withholdings
|
||||||||
|
Lease asset retirement obligation
|
||||||||
|
Cash-settled stock-based payment provision
|
||||||||
8
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026
6.
LEASES
In April 2026, the Company, through a wholly owned subsidiary, entered into a lease agreement for office and warehouse space located in Brooklyn Park, Minnesota. The lease commenced on September 1, 2026 and was classified as an operating lease. Upon commencement, the Company recognized a right-of-use asset and corresponding lease liability of approximately $13.4 10.0 %.
Refer to Note 11 Commitments and Contingencies, for information regarding the standby letter of credit associated with the lease.
7.
EQUITY
Share Capital
For information on the pertinent rights and privileges of the Company’s outstanding shares, refer to Note 13 Equity in the audited consolidated financial statements for the year ended December 31, 2025 as included in the Annual Report.
The following issuances of Common Stock occurred during the nine months ended September 30, 2026:
●
On January 22, 2026, the Company completed an underwritten public offering (the “2026 Public Offering”) of 40,000,000 shares of its Common Stock, which included 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 generated gross proceeds of approximately $230.0 million, prior to deducting underwriting discounts and commissions and offering expenses. The 2026 Public Offering was made pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-292565), which was previously filed with the SEC and declared effective on January 8, 2026, and a prospectus supplement dated January 20, 2026.
●
On January 20, 2026, the Company entered into a stock purchase agreement with Covidien Group S.à r.l. (“Medtronic”), a wholly owned subsidiary of Medtronic plc, pursuant to which the Company 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”). The Medtronic Private Placement closed on January 22, 2026, immediately after the completion of the 2026 Public Offering, and generated gross proceeds of approximately $90.0 million, before deducting placement agent fees and estimated offering expenses. The issuance and sale of the shares of Common Stock to Medtronic in the Medtronic Private Placement was not registered under the Securities Act and the shares were issued and sold in reliance on the exemption provided by Section 4(a)(2) of the Securities Act.
●
During the three months ended June 30, 2026, a total of 182,011 RSUs vested, including 35,160 RSUs held by directors. Upon settlement, 25,565 shares of Common Stock were withheld to satisfy employee payroll tax‑withholding obligations and were accounted for as share repurchases. As a result, the Company issued 156,446 shares of Common Stock upon settlement.
●
In June 2026, Mr. McDonnell exercised 62,001 stock options with a weighted-average exercise price of $6.28 per share of Common Stock. Upon exercise, 39,595 shares of Common Stock were withheld under a net settlement arrangement to satisfy the exercise price and were accounted for as share repurchases. As a result, the Company issued 22,406 shares of Common Stock to Mr. McDonnell upon exercise.
●
During the three months ended September 30, 2026, a total of 3,998 RSUs vested. Upon settlement, 715 shares of Common Stock were withheld to satisfy employee payroll tax‑withholding obligations and were accounted for as share repurchases. As a result, the Company issued 3,283 shares of Common Stock upon settlement.
●
During the three months ended September 30, 2026, 113,000 stock options were exercised, including 60,000 stock options exercised by Mr. St Denis (director and named executive officer). The options exercised had a weighted average exercise price of $5.61 per share of Common Stock. Upon exercise, 80,828 shares of Common Stock were withheld under a net settlement arrangement to satisfy the exercise price and employee payroll tax‑withholding obligations and were accounted for as share repurchases. As a result, the Company issued 32,172 shares of Common Stock upon settlement.
●
During the three months ended September 30, 2026, investors exercised 47,068 CDI warrants for $7.93 per share (AUD $11.50 ) raising $0.4 million.
For the comparable nine-month period ended September 30, 2025, the Company issued:
●
In January 2025, following the Company’s IPO, the underwriters partially exercised the over-allotment option, resulting in the issuance of 78,481 shares of Common Stock at $6.00 per share, for gross proceeds of $0.5 million.
●
In March 2025, certain directors exercised 289,500 stock options, resulting in the issuance of 32,959 shares of Common Stock, including both net-settled and cash-settled exercises, with cash proceeds of $0.1 million.
●
In March 2025, investors exercised 10,000 stock options for $6.22 per share, for gross proceeds of $0.1 million.
●
During the three months ended March 31, 2025, 831 unlisted stock options were exercised by employees (excluding directors and named executive officers). These options had a weighted average exercise price of $3.99 per share.
●
During the three months ended June 30, 2025, 283 unlisted stock options were exercised by employees (excluding directors and named executive officers). These options had a weighted average exercise price of $2.39 per share.
9
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026
8.
LOSS PER SHARE
The table below presents the computation of basic and diluted loss per share:
|
| Three months ended September 30, |
|
Nine months ended September 30,
| ||||||||||||||
|
2026
|
2025
|
2026
|
2025
| ||||||||||||||
|
Loss for the period, attributable to stockholders of the Company
|
$’000
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
|
Weighted average number of shares outstanding: used in the denominator in calculating basic and diluted loss per share
|
Number
|
||||||||||||||||
|
Basic and diluted loss per share
|
$
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
|
Securities excluded as their inclusion would be anti-dilutive
|
Number
|
||||||||||||||||
9.
STOCK-BASED COMPENSATION
(a)
Stock-based compensation expense
The following table presents the components and classification of stock-based compensation expense recognized for stock options, share price performance (“SPP”) rights, cash incentive units (“CIUs”), restricted stock units (“RSUs”) and shares of Common Stock issued to employees and directors:
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
| |||||||||||||
|
(in thousands)
|
2026
$
|
2025
$
|
2026
$
|
2025
$
| ||||||||||||
|
Equity-settled stock-based payments (including stock options and RSUs)
|
||||||||||||||||
|
Cash-settled stock-based payments (including SPP rights and CIUs)
|
( | ) | ||||||||||||||
|
Total stock-based compensation expense
|
||||||||||||||||
|
Classification of stock-based compensation expense
|
||||||||||||||||
|
Cost of products sold
|
||||||||||||||||
|
Research and development expense
|
||||||||||||||||
|
Selling, general and administrative expense
|
||||||||||||||||
|
Total stock-based compensation expense
|
||||||||||||||||
As of September 30, 2026, there was $10.4 million of total unrecognized compensation cost related to non-vested stock-based compensation arrangements granted. That cost is expected to be recognized over a weighted-average period of 1.5 years.
(b)
Stock-based awards activity
Stock options
The following table summarizes stock option activity for employees and directors during the three and nine months ended September 30, 2026 and 2025:
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
| |||||||||||||
|
Number of stock options
|
2026 | 2025 | 2026 | 2025 | ||||||||||||
|
Outstanding at beginning of period
|
||||||||||||||||
|
Granted
|
||||||||||||||||
|
Forfeited / Expired
|
( | ( | ( | ( | ||||||||||||
|
Exercised
|
( | (1) | ( | (1) | ( | (2) | ||||||||||
|
Outstanding at end of period
|
||||||||||||||||
(1)
(2)
10
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026
9.
STOCK-BASED COMPENSATION (continued)
RSUs
The following table summarizes RSU activity for employees and directors during the three and nine months ended September 30, 2026 and 2025:
|
|
Three months ended September 30, |
|
Nine months ended September 30, | |||||||||||||
|
Number of RSUs
|
2026 | 2025 | 2026 | 2025 | ||||||||||||
|
Outstanding at beginning of period
|
||||||||||||||||
|
Granted
|
||||||||||||||||
|
Forfeited
|
( | ( | ( | ( | ||||||||||||
|
Settled
|
( | ( | (1) | |||||||||||||
|
Outstanding at end of period
|
||||||||||||||||
(1)
SPP rights
On September 13, 2026, 283,336 service-based SPP rights were forfeited and cancelled as the share price on the vesting date was less than the base price.
CIUs
During the nine months ended September 30, 2026, the Company granted 55,804 CIUs, all of which were granted during the second quarter of 2026. The carrying amount of the CIU liabilities was $0.2 million as of September 30, 2026. No
(c) Fair Value Disclosures
Stock options
The following table provides the weighted average fair value of options granted to employees during the periods indicated and the related weighted average inputs (based on number of options granted) used in the Black-Scholes model.
| Three months ended September 30, 2026 | Nine months ended
September 30, 2026 | Three and nine months ended September 30, 2025 | ||||||||||
| Quantity granted during the period | ||||||||||||
| Weighted average fair value per option at grant date | $ | $ | $ | |||||||||
| Assumptions used: | ||||||||||||
| Share price at grant date range | $ | $ | $ | |||||||||
| Exercise price range | $ | $ | $ | |||||||||
| Expected volatility range | % | % | | |||||||||
| Expected life range | | | | |||||||||
| Expected dividends | Nil | Nil | | |||||||||
| Risk-free interest rate range | | | | |||||||||
RSUs
The weighted-average grant date fair value of RSUs granted during the three and nine months ended September 30, 2026 was $8.35 and $7.69 per RSU, respectively. The weighted-average grant date fair value of RSUs granted during the three and nine months ended September 30, 2025 was $3.80 and $3.46 per RSU, respectively. The fair value of the RSUs was determined based on the market value of the Company’s Common Stock on the grant date, which represents the fair value of the underlying shares.
11
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026
9.
STOCK-BASED COMPENSATION (continued)
SPP rights
The inputs used in the measurement of the fair values at reporting date of the SPP rights were as follows:
| Service- and performance-based SPP | September 30, 2026 | December 31, 2025 | ||||||
| Weighted average fair value per SPP | $ | $ | ||||||
| Share price at measurement date | $ | $ | ||||||
| Base price | $ | $ | ||||||
| Expected volatility (weighted average) | % | % | ||||||
| Expected life (weighted average) | | | ||||||
| Risk-free interest rate (based on government bonds) | % | % | ||||||
10.
INVESTMENT IN V2VMEDTECH
In April 2026, the Company elected to discontinue further development contributions to v2vmedtech, inc. (“v2vmedtech”) under its Contribution and Stock Purchase Agreement. As a result of this election, the related development agreement was terminated and the Company ceased providing funding and development activities to v2vmedtech.
Following termination of the development agreement, the Company reassessed its consolidation conclusions relating to v2vmedtech under ASC 810, considering the termination of its funding obligations, the cessation of executive management involvement and changes in v2vmedtech’s operational activities. Based on this reassessment, the Company concluded that v2vmedtech no longer meets the definition of a variable interest entity and subsequently assessed its controlling financial interest under the voting interest entity model of ASC 810.
As of September 30, 2026, the Company 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, the Company continued to have a controlling financial interest in v2vmedtech and therefore continued to consolidate v2vmedtech in its condensed consolidated financial statements. The Company will reassess its consolidation conclusion whenever facts and circumstances indicate that a change in control may have occurred.
11.
COMMITMENTS AND CONTINGENCIES
As of September 30, 2026, the Group had commitments to purchase $0.4 million of plant and equipment, compared to $0.1 million at December 31, 2025.
The Company is involved in various ongoing proceedings arising in the normal course of business, including proceedings related to product, labor, intellectual property and other matters. Management does not believe that the ultimate resolution of these matters will have a material adverse effect on the Company's financial position, results of operations or cash flows.
The Company is required to maintain a $3.5 million irrevocable standby letter of credit securing its obligations under the lease of its Brooklyn Park, Minnesota facility. The amount of the letter of credit may be reduced upon satisfaction of certain contractual milestones. The letter of credit is collateralized by $3.5 million of restricted cash, which is classified as a non-current asset in the condensed consolidated balance sheet and is set to expire on April 21, 2027, subject to automatic annual renewal unless notice of non-extension is provided by the issuing bank.
12.
SEGMENT REPORTING
(a)
Description of segments
Segment information is presented using a management approach, meaning that segment information is provided on the same basis as information is used for internal reporting purposes by the chief operating decision maker (the “CODM”) which is the Company’s Vice Chairman and Chief Executive Officer, who makes key strategic decisions. The CODM is responsible for the allocation of resources and assessing the performance of the Group. Management has determined that the activities of the business as reviewed by the CODM are one segment, being the development and commercialization of the DurAVR® THV System which includes the ADAPT® anti-calcification tissue.
12
Table of Contents
ANTERIS TECHNOLOGIES GLOBAL CORP.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026
12.
SEGMENT REPORTING (continued)
(b)
Segment information
The revenue and cost information relating to all of the ADAPT® products including both the DurAVR® THV System and regenerative tissue products are regularly reviewed by the CODM on an aggregate basis.
The CODM assesses performance and allocates resources based on the Company’s Condensed Consolidated Statements of Operations and key components and processes of the Company’s operations are managed centrally. Segment asset information is not used by the CODM to allocate resources. As a single reportable segment entity, the Company’s segment performance measure is net income or loss.
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
|
(in thousands)
|
2026
$ |
2025
$ |
2026
$ |
2025
$ | ||||||||||||
|
Net sales from external customers
|
||||||||||||||||
|
Depreciation & amortization
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
|
Interest income
|
||||||||||||||||
|
Interest expense
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
|
Other segment items
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
|
Segment net loss
|
( | ) | ( | ) | ( | ) | ( | ) | ||||||||
No detailed asset information by reportable segment has been reported given that the single segment’s information is already presented in the Condensed Consolidated Balance Sheets. Refer to the Condensed Consolidated Statements of Cash Flows for significant non-cash items and total expenditure for additions of long-lived assets.
(c)
Geographic information
Segment revenues (net sales) have been based on the geographic location of the customers taking possession of the products.
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
|
(in thousands)
|
2026
$ |
2025
$ |
2026
$ |
2025
$ | ||||||||||||
|
United States
|
||||||||||||||||
|
Australia
|
||||||||||||||||
|
Germany
|
||||||||||||||||
(d)
Major customers
The following table summarizes revenues from major customers that individually accounted for 10% or more of the Company's total revenues.
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
|
(in thousands)
|
2026
$ |
2025
$ |
2026
$ |
2025
$ | ||||||||||||
|
Customer A
|
||||||||||||||||
|
Customer B
|
||||||||||||||||
The total amounts outstanding from these customers were $0.2 million and $28 thousand as of September 30, 2026 and December 31, 2025, respectively.
13
Table of Contents
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
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.”
Overview
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.
We intend to establish the safety and effectiveness of the DurAVR® THV in patients with severe aortic stenosis in our global pivotal study (the “PARADIGM Trial”).
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.
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.
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.
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.
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.
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.
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.
Financial Overview
As a development-stage company, we have incurred losses since our inception. We anticipate that we will continue to incur losses for the foreseeable future and there can be no assurance that we will ever achieve or maintain profitability.
We expect expenses for our research, clinical validation, development, design, manufacturing and marketing will increase and, as a result, we will need additional capital to fund our operations. Any future funding could involve a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all.
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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.
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.
Any failure to raise capital or enter into such other arrangements as and when needed could have a negative impact on our financial condition and our ability to market our products.
Principles of Consolidation and Operating Segments
The condensed consolidated financial statements include the accounts for our company, our wholly owned subsidiaries, and entities for which we have a controlling financial interest. Intercompany transactions, balances and unrealized gains and losses on transactions between such entities are eliminated.
Our management has determined that the activities of the business as reviewed by 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.
Components of Results of Operations
Revenue and Other Income
We currently derive revenue from the sale of regenerative tissue products. Such sales have historically been made principally to 4C Medical Technologies, Inc. (“4C”) and, in prior periods, to LeMaitre Vascular, Inc. (“LeMaitre”), a distributor of medical products. In 2019, we sold the distribution rights for CardioCel™ and VascuCel™ to LeMaitre in order to focus on development of our proprietary ADAPT® tissue for the DurAVR® THV System and, in connection therewith, we entered into a Transition Services Agreement pursuant to which we manufactured and sold CardioCel™ and VascuCel™ products to LeMaitre. The Transition Services Agreement with LeMaitre expired in January 2025, and we do not expect to receive any future revenue from LeMaitre.
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.
Expenses
Our most significant expenses are research and development (“R&D”) and selling, general and administrative expenses.
Cost of products sold in 2026 reflects the manufacturing cost from the sale of regenerative tissue products to 4C. In 2025, cost of products sold also included manufacturing costs related to sales to LeMaitre. These expenditures include raw materials and consumables, plus other costs attributable to the manufacturing of these products.
R&D Expense
R&D has been a significant focus with investments in the DurAVR® THV System, including the DurAVR® THV, the ComASUR® Delivery System, a disposable crimper, and an expandable access sheath. These components are collectively managed as part of the overall DurAVR® THV System rather than as separate projects. Since late 2021, when our DurAVR® THV was first used in human trials in Tbilisi, Georgia, R&D efforts have focused on incorporating clinical insights to refine and advance the technology, supporting the pathway toward commercialization. These costs have included, among others, preclinical and clinical studies, design iterations, lab services, clinical data monitoring, project and site management, travel, data management and safety monitoring of the study.
During the 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.
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Results of Operations
The following tables set forth our results of operations (in thousands, except percentages).
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||
| 2026 | 2025 | % Change | 2026 | 2025 | % Change | |||||||||||||||||||
|
Net sales
|
$ | 519 | $ | 429 | 21 | % | $ | 2,022 | $ | 1,603 | 26 | % | ||||||||||||
|
Costs and expenses:
|
||||||||||||||||||||||||
|
Cost of products sold
|
(126 | ) | (123 | ) | 2 | % | (473 | ) | (478 | ) | (1 | )% | ||||||||||||
|
Research and development expense
|
(21,333 | ) | (16,810 | ) | 27 | % | (62,159 | ) | (49,606 | ) | 25 | % | ||||||||||||
|
Selling, general and administrative expense
|
(8,901 | ) | (5,761 | ) | 55 | % | (24,235 | ) | (16,448 | ) | 47 | % | ||||||||||||
|
Operating loss
|
(29,841 | ) | (22,265 | ) | 34 | % | (84,845 | ) | (64,929 | ) | 31 | % | ||||||||||||
|
Other non-operating income, net
|
2,600 | 147 | 1,669 | % | 6,742 | 386 | 1,647 | % | ||||||||||||||||
|
Interest and amortization of debt discount and expense
|
(17 | ) | (15 | ) | 13 | % | (175 | ) | (63 | ) | 178 | % | ||||||||||||
|
Net foreign exchange (losses)/gains
|
160 | (83 | ) | N/A | (38 | ) | (611 | ) | (94 | )% | ||||||||||||||
|
Fair value movement of derivatives
|
- | 7 | (100 | )% | 35 | 15 | 133 | % | ||||||||||||||||
|
Loss before income taxes from continuing operations
|
(27,098 | ) | (22,209 | ) | 22 | % | (78,281 | ) | (65,202 | ) | 20 | % | ||||||||||||
|
Income tax benefit/(expense)
|
272 | - | 100 | % | (220 | ) | - | (100 | )% | |||||||||||||||
|
Net loss
|
(26,826 | ) | (22,209 | ) | 21 | % | (78,501 | ) | (65,202 | ) | 20 | % | ||||||||||||
|
Total (loss)/gain is attributable to:
|
||||||||||||||||||||||||
|
Non-controlling interests
|
- | 35 | (100 | )% | 443 | (260 | ) | N/A | ||||||||||||||||
|
Stockholders of the Company
|
$ | (26,826 | ) | $ | (22,244 | ) | 21 | % | $ | (78,944 | ) | $ | (64,942 | ) | 22 | % | ||||||||
Net Sales
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.
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.
Cost of Products Sold
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.
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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.
R&D Expense
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.
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.
Selling, General and Administrative Expense
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.
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.
Other Non-Operating Income, Net
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.
Net Foreign Exchange (Losses)/Gains
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 $”).
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.
Income Tax (Expense)/Benefit
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.
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.
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Liquidity and Capital Resources
Capital Requirements and Sources of Liquidity
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.
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.
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.
We anticipate that we will require additional funds in order to achieve our long-term goals including completing the R&D of our current products. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our products and sales of our products have commenced. We therefore expect to continue to incur substantial losses in the near future. However, based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to meet our operating requirements for at least the next 12 months.
Our future capital requirements are difficult to forecast and will depend on many factors, including:
•
the scope, results and timing of clinical trials;
•
the costs of preparing and completing the PARADIGM Trial of our DurAVR® THV System;
•
the costs and time required to obtain PMA from the FDA for our DurAVR® THV System; and
•
the costs of establishing marketing, sales and distribution capabilities.
We may seek to raise any necessary capital through a combination of public or private equity offerings or debt financings. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we decide to raise capital by issuing equity securities, the issuance of such equity securities may result in dilution to our existing stockholders. We cannot give any assurance that we will be successful in completing any financings or that any such equity or debt financing will be available to us if and when required or on satisfactory terms.
Cash Flows
The following table summarizes our primary sources and uses of cash for the periods presented (in thousands, except percentages):
| Nine Months Ended September 30, | ||||||||||||
| 2026 | 2025 | % Change | ||||||||||
|
Net cash provided by (used in):
|
||||||||||||
|
Operating activities
|
$ | (72,373 | ) | $ | (59,276 | ) | (22 | )% | ||||
|
Investing activities
|
(2,225 | ) | (199 | ) | (1,018 | )% | ||||||
|
Financing activities
|
298,370 | (1,827 | ) | 16,431 | % | |||||||
|
Effect of exchange rate movements on cash, cash equivalents and restricted cash
|
(14 | ) | (37 | ) | 62 | % | ||||||
|
Net change in cash, cash equivalents and restricted cash
|
$ | 223,758 | $ | (61,339 | ) | 465 | % | |||||
Operating Activities
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.
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.
Investing Activities
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.
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Financing Activities
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.
Contractual Obligations and Commitments
Leases
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.
The locations of our material properties are as follows:
|
Location of Facility
|
Lease expiry date | Extension options |
|
9435 Winnetka Avenue North, Brooklyn Park, MN 55444
|
August 31, 2037 | Two seven-year options |
|
11600-11628 96th Avenue North, Maple Grove, MN 55369
|
April 30, 2030 | One two-year option |
|
26 Harris Road, Malaga WA 6090, Australia
|
July 31, 2029 | Two two-year options |
All properties are leased. Our properties are well maintained, are in good operating condition, and are suitable for current requirements. We do not anticipate difficulty in renewing existing leases as they expire or in finding alternative facilities.
Commitments
At September 30, 2026, we had commitments to purchase $0.4 million of plant and equipment.
Off-Balance Sheet Arrangements
We currently do not have, and did not have during the periods presented, any off-balance sheet arrangements.
Critical Accounting Policies and Estimates
We have used various accounting policies to prepare the condensed consolidated financial statements in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”).
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes thereto. Management continually evaluates its judgments and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations regarding future events that management believes to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties and may be material.
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.
Consolidation of v2vmedtech
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.
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.
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New Accounting Standards Not Yet Adopted
See Note 2 to our condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q for more information.
Emerging Growth Company and Smaller Reporting Company Status
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.
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.
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.
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
We are an SRC, as defined by Rule 12b-2 under the Exchange Act, and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.
Item 4.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of September 30, 2026, management, with the participation and supervision of our Chief Executive Officer and our Chief Financial Officer, has evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, solely as a result of the material weaknesses in our internal control over financial reporting described below, as of September 30, 2026, our disclosure controls and procedures were not effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended September 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Previously Reported Material Weaknesses
In connection with the preparation of our financial statements for the years ended December 31, 2024 and 2023, our management and our independent auditors identified material weaknesses in the design and operating effectiveness of our internal control over financial reporting, which remained unremediated as of December 31, 2025. The material weaknesses identified by our management and our independent auditors relate to (i) a lack of appropriately designed, implemented and documented procedures and controls, and (ii) deficiencies in the segregation of duties.
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.
Management has initiated and continues to implement a remediation plan to address the material weaknesses described above. During the year ended December 31, 2025 and through the quarter ended September 30, 2026, we implemented changes to our internal control over financial reporting, including enhancements to our control environment, improvements to process-level controls, and formal documentation of policies, processes, risks, and controls. Segregation of duties has been enhanced across the control environment and financial reporting systems through system automation, strengthened month-end controls, and enhanced review procedures.
During 2026, management continued to implement its remediation plan, including further enhancements identified through assessments of the design and implementation of key controls. Remediation activities remain ongoing.
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While we believe that these efforts will improve our internal control over financial reporting, the design and implementation of our remediation is ongoing and will require sufficient validation and testing to demonstrate the operating effectiveness of the relevant controls. The actions that we are taking are subject to ongoing senior management review, as well as oversight by the Audit and Risk Committee. We will not be able to conclude whether the steps we are taking will fully remediate the material weaknesses in our internal control over financial reporting until we have completed our remediation efforts and subsequent evaluation of their effectiveness. The material weaknesses remained unremediated as of September 30, 2026.
PART II. Other Information
Item 1.
Legal Proceedings
In the ordinary course of our operations, and from time-to-time, we are party to various claims and lawsuits.
We are not party to any material legal proceedings, and no such proceedings are, to management’s knowledge, threatened against us.
Item 1A.
Risk Factors
We face a number of risks that could materially and adversely affect our business, results of operations, cash flow, liquidity, or financial condition. Please refer to the factors discussed in Part I, Item 1A. “Risk Factors” in the Annual Report. Other than the supplemental risk factors provided below, there have been no material changes or additions to our risk factors discussed in such report that could materially impact our business, results of operations, cash flow, liquidity, or financial condition.
Although we have received regulatory approvals to begin the PARADIGM Trial, there can be no guarantee that the study will be successful or that we will receive PMA from the FDA as a result.
Although we have received approval from the FDA to proceed with the PARADIGM Trial under the IDE, the current approval from the FDA to proceed could be revoked, the study could be unsuccessful, and PMA from the FDA may not be obtained or could be revoked. Even if we obtain PMA for our DurAVR® THV System, the FDA or other regulatory authorities may require expensive or burdensome post-market testing or controls. Any delay in, or failure to receive or maintain, clearance or approval for our DurAVR® THV System could prevent us from generating revenue or achieving profitability. Additionally, the FDA and other regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some physicians from using our products and adversely affect our reputation and the perceived safety and efficacy of our products.
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
(a)
Recent Sales of Unregistered Securities
None.
(b)
Use of Proceeds
Not applicable.
(c)
Issuer Purchases of Equity Securities
The following table presents information regarding purchases of shares of Common Stock during the three months ended September 30, 2026.
|
Period
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Total number of shares purchased (1) |
Average price paid per share |
Total number of shares purchased as part of publicly announced plans or programs |
Maximum number (or approximate dollar value) of shares that may yet be purchased under the plans or programs | ||||||||||||
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July 1-31 2026
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- | - | - | - | ||||||||||||
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August 1-31 2026
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45,787 | $ | 9.58 | - | - | |||||||||||
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September 1-30 2026
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35,756 | $ | 8.16 | - | - | |||||||||||
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Total
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81,543 | $ | 8.96 | - | - | |||||||||||
(1) Of the shares of Common Stock purchased, 715 shares were withheld to satisfy employee payroll tax‑withholding obligations arising from the vesting of restricted stock units. The remaining shares were withheld to cover both the exercise price and the employee payroll tax‑withholding obligations arising from net-settled stock option exercises. None of these shares were purchased pursuant to a publicly announced repurchase plan or program.
Item 3.
Defaults Upon Senior Securities.
Not applicable.
Item 4.
Mine Safety Disclosures.
Not applicable.
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Item 5.
Other Information
Trading Plans - Directors and Officers
During the three months ended September 30, 2026, none
Item 6.
Exhibits
The exhibits listed in the Exhibit Index below are filed, furnished, or incorporated by reference as part of this Quarterly Report on Form 10-Q.
Exhibit Index
| Exhibit Number | Description | Incorporated by Reference | Filed | ||
| Form | Date | Number | Herewith | ||
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2.1 †
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Scheme Implementation Deed, dated August 13, 2024, by and between Anteris Technologies Global Corp. and Anteris Technologies Ltd
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S-1 | 11/22/2024 | 2.1 | |
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3.1
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Second Amended and Restated Certificate of Incorporation of Anteris Technologies Global Corp.
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8-K | 12/16/2024 | 3.1 | |
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3.2
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Amended and Restated Bylaws of Anteris Technologies Global Corp.
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8-K | 12/16/2024 | 3.2 | |
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4.1
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Reference is made to Exhibits 3.1 and 3.2
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||||
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4.2
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Form of Common Stock Warrant
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10-Q | 11/12/2025 | 4.2 | |
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4.3
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Form of Confirmation Letter (containing the terms of the CDI Warrants)
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10-Q | 11/12/2025 | 4.3 | |
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10.1
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Employment Agreement, between Anteris Technologies Global Corp. and Brent Moen, dated September 4, 2026.
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8-K | 9/08/2026 | 10.1 | |
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10.2
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First Amendment to Supply & Quality Agreement, between Anteris Aus Operations Pty Ltd and Harvey Industries Group Pty Ltd, dated September 22, 2026.
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8-K | 9/23/2026 | 10.1 | |
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10.3#
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Deed of Extension and Variation of Lease, dated August 11, 2026, by and between Giacomel Pty Ltd, Anteris Aus Operations Pty Ltd and Anteris Technologies Pty Ltd
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X | |||
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10.4
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Form of Option Award Adjustment Notice (Director) (IPO – 2024)
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X | |||
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10.5
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Form of Option Award Adjustment Notice (Employee) (IPO – 2024)
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X | |||
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10.6
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Form of Share Price Performance Plan (SPP) Unit Adjustment Notice (IPO – 2024)
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X | |||
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10.7
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Form of Notice of Contingent Grant and Restricted Stock Unit Agreement (Non-Employee Director – Australia) (December 2024)
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X | |||
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10.8
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Notice of Contingent Grant and Restricted Stock Unit Agreement, dated December 16, 2024, by and between Anteris Technologies Global Corp. and John Seaberg
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X | |||
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10.9
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Notice of Contingent Grant and Restricted Stock Unit Agreement, dated December 16, 2024, by and between Anteris Technologies Global Corp. and Wayne Paterson
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X | |||
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10.10
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Notice of Contingent Grant and Restricted Stock Unit Agreement, dated December 16, 2024, by and between Anteris Technologies Global Corp. and David St Denis
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X | |||
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10.11
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Notice of Grant and Restricted Stock Unit Agreement, dated December 16, 2024, by and between Anteris Technologies Global Corp. and Matthew McDonnell
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X | |||
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10.12
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Form of Notice of Contingent Grant and Restricted Stock Unit Agreement (New Non-Employee Director – US)
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X | |||
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10.13
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Notice of Grant and Restricted Stock Unit Agreement, dated December 3, 2025, by and between Anteris Technologies Global Corp. and Stephen Denaro
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X | |||
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10.14
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Form of Notice of Grant and Restricted Stock Unit Agreement (Non-Employee Director – US)
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X | |||
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10.15
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Notice of Contingent Grant and Restricted Stock Unit Agreement, dated March 4, 2026, by and between Anteris Technologies Global Corp. and Wayne Paterson
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X | |||
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10.16
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Notice of Contingent Grant and Restricted Stock Unit Agreement, dated March 4, 2026, by and between Anteris Technologies Global Corp. and David St Denis
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X | |||
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10.17
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Notice of Grant and Restricted Stock Unit Agreement, dated March 4, 2026, by and between Anteris Technologies Global Corp. and Matthew McDonnell
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X | |||
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10.18
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Anteris Technologies Global Corp. Non-Employee Director Compensation Policy (As Amended and Restated Effective September 12, 2026)
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X | |||
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| Exhibit Number | Description | Incorporated by Reference | Filed | ||
| Form | Date | Number | Herewith | ||
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10.19
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Notice of Contingent Grant and Nonqualified Stock Option Agreement, dated September 13, 2026, by and between Anteris Technologies Global Corp. and Wayne Paterson
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X | |||
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10.20
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Notice of Contingent Grant and Nonqualified Stock Option Agreement, dated September 13, 2026, by and between Anteris Technologies Global Corp. and David St Denis
|
X | |||
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10.21
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Form of Notice of Contingent Grant and Performance-Based Restricted Stock Unit Agreement for Wayne Paterson and David St Denis
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X | |||
| 10.22 | Form of Notice of Grant of Nonqualified Stock Option Agreement for Brent Moen | X | |||
| 10.23 | Notice of Grant of Nonqualified Stock Option Agreement for Matthew McDonnell | X | |||
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31.1
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Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X | |||
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31.2
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Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X | |||
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32.1*
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Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X | |||
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101.INS
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Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
|
X | |||
|
101.SCH
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Inline XBRL Taxonomy Extension Schema Document.
|
X | |||
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101.CAL
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Inline XBRL Taxonomy Extension Calculation Linkbase Document.
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X | |||
|
101.DEF
|
Inline XBRL Taxonomy Extension Definition Linkbase Document.
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X | |||
|
101.LAB
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Inline XBRL Taxonomy Extension Label Linkbase Document.
|
X | |||
|
101.PRE
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
X | |||
|
104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document and contained in Exhibit 101)
|
X | |||
*
This certification attached as Exhibit 32.1 that accompanies this Form 10-Q, is deemed furnished and not filed with the U.S. Securities and Exchange Commission (the “SEC”) and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
†
Certain information in this exhibit has been redacted pursuant to Item 601(a)(6) of Regulation S-K.
# Certain identified information has been excluded from this exhibit pursuant to Rule 601(b)(10) of Regulation S-K because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized, in the City of Eagan, State of Minnesota, on the 10th day of November, 2026.
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Anteris Technologies Global Corp.
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||
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By:
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/s/ Wayne Paterson
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|
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Name:
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Wayne Paterson
|
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Title:
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Vice Chairman and Chief Executive Officer (Principal Executive Officer)
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|
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By:
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/s/ Brent Moen
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Name:
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Brent Moen
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|
|
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Title:
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Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
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