AVR 8-K
Anteris Technologies Global Corp. (AVR)
8-K
2026-08-12
For: 2026-08-11
View Original
Added on
August 12, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 11, 2026
(Exact name of registrant as specified in its charter)
|
|
|
|
|
(State or Other Jurisdiction of Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
|
|
|
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Registrant’s telephone number, including area code: +61 7 3152 3200
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
|
||
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
| Item 2.02. |
Results of Operations and Financial Condition.
|
On August 11, 2026 USA ET (August 12, 2026 AEST), Anteris Technologies Global Corp. (the “Company”) (i) filed the Form 10-Q for the
quarter ended June 30, 2026 with a cover page (the “Results Announcement”) with the Australian Securities Exchange (“ASX”); and (ii) issued an ASX Announcement regarding the Company’s financial results for the quarter ended June 30, 2026, both of
which include unaudited and other historical financial information for the period ended June 30, 2026. The Results Announcement has been prepared for the purpose of complying with the reporting requirements of the ASX. Copies of the Results
Announcement and the ASX Announcement are attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
The information in this Item 2.02, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed to
be filed for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, unless such subsequent filing specifically
references this Current Report on Form 8-K.
| Item 9.01. |
Financial Statements and Exhibits.
|
(d) Exhibits.
The following exhibits are filed with this Current Report on Form 8-K:
|
Exhibit
No.
|
Description
|
|
|
Results Announcement, as filed with the ASX, for the quarter ended June 30, 2026
|
||
|
ASX Announcement regarding financial results for the period ended June 30, 2026
|
||
|
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL document)
|
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 hereunto duly authorized.
|
Anteris Technologies Global Corp.
|
||
|
Date: August 11, 2026
|
||
|
By:
|
/s/ Wayne Paterson
|
|
|
Name:
|
Wayne Paterson
|
|
|
Title:
|
Vice Chairman and Chief Executive Officer
|
|
Exhibit 99.1
Anteris Technologies Announces Results for the Second Quarter of 2026
MINNEAPOLIS, United States and BRISBANE, Australia August 12, 2026 (AEST) Anteris Technologies Global
Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function,
today reported financial results for the quarter ended June 30, 2026, and provided a corporate update.
Q2 2026 Highlights
| • |
Secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy, enabling reimbursement
for eligible procedures at U.S. sites.
|
| • |
Initiated U.S. recruitment in the PARADIGM Trial, with the first U.S. patients enrolled and treated in May 2026.
|
| • |
Expanded the PARADIGM Trial, with active recruitment underway in the U.S., Denmark and the Netherlands, and secured regulatory clearance in Canada and France.
|
| • |
Appointed Ms. Susan Knight and Mr. Stephen Denaro to the Board of Directors, broadening governance, financial and public company leadership as the Company advances the DurAVR® THV
toward commercialization.
|
| • |
Presented clinical and scientific progress at New York Valves 2026, including a symposium, innovation session feature, and pre-recorded live case presentation highlighting clinical experience
with the DurAVR® THV. The symposium recording is available on the Company’s website under the News section.
|
“Q2 marked an important period of execution for Anteris as we advanced the PARADIGM Trial across clinical, regulatory and reimbursement milestones. During the quarter,
we secured U.S. Medicare reimbursement for eligible procedures, initiated U.S. recruitment in the PARADIGM Trial, expanded active recruitment across key geographies and showcased growing clinical experience with DurAVR® at New York
Valves, a leading structural heart conference. These achievements, together with the continued strengthening of our Board, support our progress toward commercialization and our commitment to improving outcomes for patients with severe aortic
stenosis,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.
Business & Operations
During the quarter, we continued to advance execution of the global pivotal PARADIGM Trial across active European sites and commenced patient enrollment in the United
States.
Clinical centers are progressing through key start-up milestones, including ethics and regulatory approvals, site initiation visits and investigator training,
alongside patient screening and enrollment at activated sites. This includes selected Australian sites, which are progressing through initial start-up documentation, with activation and patient recruitment to follow subject to ethics committee
approval at each site.
In the United States, the CMS coverage determination represented a key execution milestone for the PARADIGM Trial, providing the reimbursement framework required to
support patient enrollment and broader site-level adoption. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32.
|
860 Blue Gentian Road, Suite 340
Eagan, MN, 55121 United States
T: +1 651 493 0606
|
Anteris Technologies Global Corp.
|
Toowong Tower, Level 3, Suite 302
9 Sherwood Road, Toowong
QLD 4066, Australia T: +61 1300 550 310 [email protected]
ARBN: 677 960 235 |
|
BRISBANE | MINNEAPOLIS | GENEVA | MALAGA
|
||
 |
||
|
anteristech.com
|
With this reimbursement framework now in place, we expect U.S. site activation and patient recruitment activities to continue advancing as additional centers begin
contributing to trial execution.
Financial Results
The financial results for Anteris for the quarter ended June 30, 2026, are presented below. All amounts in $ refer to U.S. dollars.
The Company’s net operating cash outflows for the three months ended June 30, 2026 were $20.8 million, primarily attributable to clinical, regulatory and manufacturing
requirements to support the PARADIGM Trial. Operating expenditures reflected the phased execution of the clinical program during the quarter, including the timing of U.S. site activation activities following receipt of the CMS coverage
determination in April 2026. R&D expenses of $23.4 million were driven by the scaling of manufacturing and quality capabilities, including process development and validation activities and expanded headcount, together with PARADIGM trial
related activities, including clinical costs associated with patient enrollment and the scaling of our field-based clinical team. These costs were partly offset by reduced DurAVR® THV product research costs.
Please see the detailed financial information contained in Anteris’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2026.
About the PARADIGM Trial
The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve
(“THV”) compared to commercially available transcatheter aortic valve replacements (TAVRs).
This head-to-head study will enroll approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the
DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post
procedure.
For further information, please refer to ClinicalTrials.gov NCT07194265.
About Anteris
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical
devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to
structural heart disease patients.
 |
2 |
Anteris’ lead product, the DurAVR® THV, 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 the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is
shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue
technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the
ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System.
Forward-Looking Statements
This announcement contains forward-looking statements, including, but not limited to, statements regarding the PARADIGM Trial, CMS reimbursement eligibility, clinical
development timelines and potential commercialization. Forward-looking statements include all statements that are not historical facts. 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. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal
period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Actual future events may vary from these forward-looking statements and readers are cautioned not to put undue reliance on forward-looking
statements. Other than as required by law, Anteris gives no representation or guarantee that the occurrence of any of the events or circumstances expressed or implied in these statements will occur. In addition, except as required by law, Anteris
does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.
Authorisation and Additional information
This announcement was authorised for release on the ASX by the Board of Directors.
For more information:
| Global Investor Relations |
Investor Relations (US)
|
| [email protected] |
| Debbie Ormsby |
Malini Chatterjee, Ph.D.
|
| Anteris Technologies Global Corp. |
Blueprint Life Science Group
|
| +61 1300 550 310 | +61 7 3152 3200 |
+1 917 330 4269
|
| Website |
www.anteristech.com
|
| X |
@AnterisTech
|
|
https://www.linkedin.com/company/anteristech
|
|
|
3 |
Exhibit 99.2
| Name of entity: |
Anteris Technologies Global Corp. (“ATGC”)
|
| ARBN: |
677 960 235
|
| Reporting period: |
For the quarter ended June 30, 2026
|
The attached Form 10-Q Quarterly Report for the quarter ended June 30, 2026 has been filed
with the U.S. Securities and Exchange Commission (“SEC”). It includes the condensed consolidated financial statements which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S.
GAAP”) and are denominated in U.S. dollars.
The following supplementary information is provided in connection with the Form 10-Q to satisfy the Company’s ongoing disclosure obligations under the ASX Listing
Rules. The information has been prepared in accordance with the waiver conditions granted by the ASX in relation to ASX Listing Rule 4.2A.3 for half year reports and 4.7C for quarterly activity reports, and should be read in conjunction with the
Form 10-Q.
The Company’s results for announcement to the market are as follows:
|
Six months to June 30,
|
|||||||||||||||||
|
|
2026
US$’000
|
|
2025
US$’000
|
Change
US$’000
|
Change
%
|
||||||||||||
|
Revenues from ordinary activities
|
1,503
|
1,174
|
329
|
28
|
%
|
||||||||||||
|
Loss from ordinary activities after tax
|
(51,675
|
)
|
(42,993
|
)
|
(8,682
|
)
|
20
|
%
|
|||||||||
|
Loss for the period attributable to members
|
(52,118
|
)
|
(42,698
|
)
|
(9,420
|
)
|
22
|
%
|
|||||||||
No dividend has been proposed or declared for the reporting period.
Details of business activities during the quarter
Refer to the Form 10-Q and the “Anteris Announces Results for the Second Quarter of 2026” announcement lodged with the ASX on August 12, 2026.
Aggregate amount of payments to related parties and their associates
During the second quarter of 2026, the aggregate amount of payments to related parties and their associates was US$583 thousand. The quarterly amount includes fees
paid to non-executive directors, as well as salary payments to the CEO, President and CFO. These payments were included in cash flows from operating activities.
There were no payments to related parties or their associates included in cash flows from investing activities.
ENDS
|
860 Blue Gentian Road, Suite 340
Eagan, MN, 55121 United States
T: +1 651 493 0606
|
Anteris Technologies Global Corp.
|
Toowong Tower, Level 3, Suite 302
9 Sherwood Road, Toowong
QLD 4066, Australia T: +61 1300 550 310 [email protected]
ARBN: 677 960 235 |
|
BRISBANE | MINNEAPOLIS | GENEVA | MALAGA
|
||
|
|
||
|
anteristech.com
|
About Anteris
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical
devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to
structural heart disease patients.
Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (“THV”), 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 the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the
first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’
patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of
the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System.
Forward-Looking Statements
This announcement contains forward-looking statements, including, but not limited to, statements regarding the PARADIGM Trial, CMS reimbursement eligibility, clinical
development timelines and potential commercialization. Forward-looking statements include all statements that are not historical facts. 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. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal
period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Actual future events may vary from these forward-looking statements and readers are cautioned not to put undue reliance on forward-looking
statements. Other than as required by law, Anteris gives no representation or guarantee that the occurrence of any of the events or circumstances expressed or implied in these statements will occur. In addition, except as required by law, Anteris
does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.
Authorisation and Additional information
This announcement was authorised for release on the ASX by the Board of Directors.
For more information:
| Investor Relations |
Investor Relations (US)
|
| [email protected] |
| Debbie Ormsby |
Malini Chatterjee, Ph.D.
|
| Anteris Technologies Global Corp. |
Blueprint Life Science Group
|
| +61 1300 550 310 | +61 7 3152 3200 |
+1 917 330 4269
|
| Website |
www.anteristech.com
|
| X |
@AnterisTech
|
|
https://www.linkedin.com/company/anteristech
|
|
|
2 |