0001140361-26-020896.txt : 20260513 0001140361-26-020896.hdr.sgml : 20260513 20260512203953 ACCESSION NUMBER: 0001140361-26-020896 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 19 CONFORMED PERIOD OF REPORT: 20260512 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20260513 DATE AS OF CHANGE: 20260512 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Anteris Technologies Global Corp. CENTRAL INDEX KEY: 0002011514 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] ORGANIZATION NAME: 08 Industrial Applications and Services EIN: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-42437 FILM NUMBER: 26970521 BUSINESS ADDRESS: STREET 1: 860 BLUE GENTIAN ROAD STREET 2: SUITE 340 CITY: EAGAN STATE: MN ZIP: 55121 BUSINESS PHONE: 651-493-0606 MAIL ADDRESS: STREET 1: 860 BLUE GENTIAN ROAD STREET 2: SUITE 340 CITY: EAGAN STATE: MN ZIP: 55121 8-K 1 ef20072992_8k.htm 8-K
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): May 12, 2026


Anteris Technologies Global Corp.
(Exact name of registrant as specified in its charter)


Delaware
001-42437
99-1407174
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)

Toowong Tower, Level 3, Suite 302
9 Sherwood Road
Toowong, QLD
Australia
4066
(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
Common Stock, par value $0.0001 per share
  
AVR
  
The Nasdaq Global Market

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 May 12, 2026 USA ET (May 13, 2026 AEST), Anteris Technologies Global Corp. (the “Company”) (i) filed the Form 10-Q for the quarter ended March 31, 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 March 31, 2026, both of which include unaudited and other historical financial information for the quarter ended March 31, 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 March 31, 2026
     
 
ASX Announcement regarding financial results for the quarter ended March 31, 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: May 12, 2026





By:
/s/ Wayne Paterson

Name:
Wayne Paterson

Title:
Vice Chairman and Chief Executive Officer


EX-99.1 2 ef20072992_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1


Anteris Announces Results for the First Quarter of 2026

MINNEAPOLIS, United States and BRISBANE, Australia 13 May 2026: Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended 31 March 2026, and provided a corporate update.
 
Q1 2026 Highlights
 
•
Completed aggregate capital raises totalling US$320 million in January 2026 to support execution of the PARADIGM Trial and advance the Company toward global commercialisation of the DurAVR® THV System
 
•
Advanced PARADIGM Trial recruitment, supported by ongoing regulatory and operational work to activate additional countries and sites – post quarter-end, U.S. enrolment commenced
 
•
Presented clinical data from the ongoing EMBARK Study and U.S. Early Feasibility Study (EFS) at Cardiovascular Research Technologies (CRT 2026) and Sydney Valves 2026, supporting ongoing scientific engagement and exchange with the clinical community

“Q1 2026 reflects strong execution across the PARADIGM Trial, with patient enrolment ongoing in Europe and continued progress on key recruitment activities globally. With the U.S. now on line and first patients enrolled, we are firmly executing our strategy and building momentum toward the commercial launch of DurAVR®,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.
 
Business & Operations
 
Following initiation of our global pivotal trial in Q4 2025, we are seeing continued progress across Europe, and the United States where patient enrolment has recently commenced.
 
Clinical centers are advancing through key start up milestones, including ethics and regulatory approvals, site initiation visits and investigator training, alongside active patient screening and enrolment at activated sites.
 
In the United States, recent coverage determination by the Centers for Medicare and Medicaid Services (CMS) is expected to facilitate patient recruitment by supporting reimbursement and facilitating 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.
 
Collectively, these activities are supporting growing enrolment momentum as additional sites come on line and contribute to trial execution.
 

860 Blue Gentian Road,
Suite 340
Eagan, MN, 55121
United States
T: +1 651 493 0606
info.us@anteristech.com
Anteris Technologies Global Corp.
Toowong Tower, Level 3, Suite 302
9 Sherwood Road, Toowong
QLD 4066, Australia
T: +61 1300 550 310 info.au@anteristech.com
ARBN: 677 960 235
BRISBANE | MINNEAPOLIS | GENEVA | MALAGA

anteristech.com

Financial Results
 
The financial results for Anteris for the quarter ended 31 March 2026, are presented below. All amounts in $ refer to U.S. dollars.
 
The Company’s net operating cash outflows for the three months ended 31 March 2026, were $28.7 million, attributable to clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. This clinical focus is reflected in the Company’s operating expenditures, with R&D expenses of $17.5 million driven by the upscaling of manufacturing and quality capabilities, including process design and validation activities and the expansion of headcount, and activities linked to the PARADIGM Trial, including clinical costs associated with the enrolment of additional patients and the scaling of our field-based clinical team. These were partly offset by reduced DurAVR® THV product research costs.
 
Anteris refers to the detailed financial information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks.
 
ENDS
 
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 enrol 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 structural heart 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® 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.
 
 2
Forward-Looking Statements
 
This announcement contains forward-looking statements, including statements regarding the expectation that achievement of CMS coverage will facilitate U.S. site activation, accelerating operational momentum across participating centers, and the PARADIGM Trial. 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. Readers are cautioned not to put undue reliance on forward-looking statements, and 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)
investors@anteristech.com
mchatterjee@bplifescience.com
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
LinkedIn https://www.linkedin.com/company/anteristech


 3
EX-99.2 3 ef20072992_ex99-2.htm EXHIBIR99.2
Exhibit 99.2

Results for announcement to the market

Name of entity:          Anteris Technologies Global Corp. (“ATGC”)
ARBN:                        677 960 235
Reporting period:      For the quarter ended 31 March 2026
 
The attached Form 10-Q Quarterly Report for the quarter ended 31 March 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 for the purposes of complying with the waiver conditions relating to ASX Listing Rule 4.7C in relation to quarterly activity reports. This information should be read in conjunction with the Form 10-Q and is provided to satisfy the Company’s ongoing disclosure obligations under the ASX Listing Rules.
 
Details of business activities during the quarter
 
Refer to the Form 10-Q and the “Anteris Announces Results for the First Quarter of 2026” announcement lodged with the ASX on 13 May 2026.
 
Aggregate amount of payments to related parties and their associates
 
During the first quarter of 2026, the aggregate amount of payments to related parties and their associates was US$2.3 million.  The quarterly amount includes fees paid to non-executive directors, as well as salary, annual incentive bonuses and discretionary bonuses linked to performance of 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
 
About Anteris
 
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart 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.
 

860 Blue Gentian Road,
Suite 340
Eagan, MN, 55121
United States
T: +1 651 493 0606
info.us@anteristech.com
Anteris Technologies Global Corp.
BRISBANE | MINNEAPOLIS | GENEVA | MALAGA

anteristech.com
Toowong Tower, Level 3, Suite 302
9 Sherwood Road, Toowong
QLD 4066, Australia
T: +61 1300 550 310 info.au@anteristech.com
ARBN: 677 960 235

Forward-Looking Statements
 
This announcement contains forward-looking statements, including statements regarding the expectation that achievement of CMS coverage will facilitate U.S. site activation, accelerating operational momentum across participating centers, and the PARADIGM Trial. 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. Readers are cautioned not to put undue reliance on forward-looking statements, and 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)
investors@anteristech.com
mchatterjee@bplifescience.com
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
LinkedIn
https://www.linkedin.com/company/anteristech


 2
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Document and Entity Information
May 12, 2026
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 12, 2026
Entity File Number 001-42437
Entity Registrant Name Anteris Technologies Global Corp.
Entity Central Index Key 0002011514
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 99-1407174
Entity Address, Address Line One Toowong Tower, Level 3, Suite 302
Entity Address, Address Line Two 9 Sherwood Road
Entity Address, Address Line Three Toowong
Entity Address, City or Town QLD
Entity Address, Country AU
Entity Address, Postal Zip Code 4066
City Area Code 61 7
Local Phone Number 3152 3200
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol AVR
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Written Communications false
Soliciting Material false
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